Equilis Injection for Horses

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

Inactivated vaccine containing per dose of 1 ml:
Purified haemagglutinin subunits from equine influenza viruses: 100 AU1 A/equi-1/ Prague/1/ 56; 50 AU A/equi-2/ Newmarket/1/93; 50 AU A/equi-2/ Newmarket/2/93 with an ISCOM-Matrix (375 microgram purified Saponin; 125 microgram Cholesterol; 62.5 microgram Phosphatidylcholine).
1 Antigenic Units

Uses

Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.

Onset of immunity:	2 weeks after completion of the primary vaccination course.
Duration of immunity:	5 months after completion of the primary vaccination course.
	12 months after the first revaccination.

Dosage and administration

Dose: 1 ml by intramuscular administration in horses.
Vaccination schedule (see table)
Primary vaccination course
Administer one dose (1ml) by intramuscular injection according to the following schedule:
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.
Revaccination (see Vaccination schedule table)
The first revaccination (third dose) is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against tetanus and equine influenza, containing the strains A/equi 1/Prague 56, A/equi 2/Newmarket 1/93 and A/equi 2/Newmarket 2/93, is recommended to maintain immunity levels for the influenza component (see Vaccination schedule table).

Vaccination schedule table - Equilis Prequenza
V1	V2	5	V3	12	V4	12	V5
0	1		6		18		30 months
Scheme 1
Prequenza Te	Prequenza Te		Prequenza		Prequenza Te		Prequenza
Scheme 2
Prequenza	Prequenza		Prequenza		Prequenza		Prequenza

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Allow the vaccine to reach a temperature of 15°C - 25°C before use.
Can be used during pregnancy and lactation.

Contra-indications, warnings, etc

A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases, which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Following the administration of a double dose of vaccine, no side-effects other than those described above have been observed except for some depression on the day of vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies. However, if vaccination is given at 4 months of age owing to increased infection risk then the primary course should be given from 6 months of age.
Only healthy animals should be vaccinated.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
Operator warning
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store between + 2°C and +8°C. Protect from light. Do not freeze.
Do not use after the expiry date stated on the label.
Disposal advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cartons with 10 glass vials of 1 ml.
Cartons with 1, 5 or 10 pre-filled syringes with needles.
Not all pack sizes may be marketed.

Further information

Nil.

Marketing authorisation number

EU/2/05/056/001-002.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

Inactivated vaccine containing per dose of 1 ml:
Purified haemagglutinin subunits from equine influenza viruses: 100 AU1 A/equi-1/ Prague/1/ 56; 50 AU A/equi-2/ Newmarket/1/93; 50 AU A/equi-2/ Newmarket/2/93 with an ISCOM-Matrix (375 microgram purified Saponin; 125 microgram Cholesterol; 62.5 microgram Phosphatidylcholine).
1 Antigenic Units

Uses

Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.

Onset of immunity:	2 weeks after completion of the primary vaccination course.
Duration of immunity:	5 months after completion of the primary vaccination course.
	12 months after the first revaccination.

Dosage and administration

Dose: 1 ml by intramuscular administration in horses.
Vaccination schedule (see table)
Primary vaccination course
Administer one dose (1ml) by intramuscular injection according to the following schedule:
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.
Revaccination (see Vaccination schedule table)
The first revaccination (third dose) is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against tetanus and equine influenza, containing the strains A/equi 1/Prague 56, A/equi 2/Newmarket 1/93 and A/equi 2/Newmarket 2/93, is recommended to maintain immunity levels for the influenza component (see Vaccination schedule table).

Vaccination schedule table - Equilis Prequenza
V1	V2	5	V3	12	V4	12	V5
0	1		6		18		30 months
Scheme 1
Prequenza Te	Prequenza Te		Prequenza		Prequenza Te		Prequenza
Scheme 2
Prequenza	Prequenza		Prequenza		Prequenza		Prequenza

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Allow the vaccine to reach a temperature of 15°C - 25°C before use.
Can be used during pregnancy and lactation.

Contra-indications, warnings, etc

A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases, which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Following the administration of a double dose of vaccine, no side-effects other than those described above have been observed except for some depression on the day of vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies. However, if vaccination is given at 4 months of age owing to increased infection risk then the primary course should be given from 6 months of age.
Only healthy animals should be vaccinated.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
Operator warning
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store between + 2°C and +8°C. Protect from light. Do not freeze.
Do not use after the expiry date stated on the label.
Disposal advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cartons with 10 glass vials of 1 ml.
Cartons with 1, 5 or 10 pre-filled syringes with needles.
Not all pack sizes may be marketed.

Further information

Nil.

Marketing authorisation number

EU/2/05/056/001-002.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

Inactivated vaccine containing per dose of 1 ml purified haemagglutinin subunits from equine influenza viruses: 100 AU1 A/equi-1/ Prague/1/ 56; 50 AU A/equi-2/ Newmarket/1/93; 50 AU A/equi-2/ Newmarket/2/93 and 40 Lf2 Tetanus toxoid, with an ISCOM-Matrix (375 microgram purified Saponin; 125 microgram Cholesterol; 62.5 microgram Phosphatidylcholine).
1Antigenic units
2Flocculation equivalents; corresponds with = 30 IU/ml guinea pig serum in the PhEur potency test.

Uses

Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Influenza

Onset of immunity:	2 weeks after the primary vaccination course.
Duration of immunity:	5 months after the primary vaccination course.
	12 months after the first revaccination.

Tetanus

Onset of immunity:	2 weeks after the primary vaccination course.
Duration of immunity:	17 months after the primary vaccination course.
	24 months after the first revaccination.

Dosage and administration

Dose: 1 ml by intramuscular administration in horses.
Vaccination schedule (see table)
Primary vaccination course
Administer one dose (1ml) by intramuscular injection according to the following schedule:
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.
Revaccination (see Vaccination schedule table)
Influenza
The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equi 1/Prague 56, A/equi 2/Newmarket 1/93 and A/equi 2/Newmarket 2/93, is recommended to maintain immunity levels for the influenza component (see Vaccination schedule table).
Tetanus
The first revaccination is given not later than 17 months after the primary vaccination course. Thereafter a maximum interval of two years is recommended (see Vaccination schedule table).

Vaccination schedule table - Equilis prequenza TE
V1	V2	5	V3	12	V4	12	V5	12	V6
0	1		6		18		30		42 months
Prequenza Te	Prequenza Te		Prequenza		Prequenza Te		Prequenza		Prequenza Te

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later).
Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared with horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Allow the vaccine to reach room temperature (15-25°C) before use.
Can be used during pregnancy and lactation.

Contra-indications, warnings, etc

A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Following the administration of a double dose of vaccine, no side-effects other than those described above have been observed except for some depression at the day of vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Only healthy animals should be vaccinated.
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
Operator warning
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store between +2°C and +8°C. Protect from light. Do not freeze.
Do not use after the expiry date stated on the label.
Disposal advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cartons with 10 glass vials of 1 ml.
Cartons with 1, 5 or 10 pre-filled syringes with needles.
Not all pack sizes may be marketed.

Further information

Nil.

Marketing authorisation number

EU/2/05/057/001-004.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

Inactivated vaccine containing per dose of 1 ml purified haemagglutinin subunits from equine influenza viruses: 100 AU1 A/equi-1/ Prague/1/ 56; 50 AU A/equi-2/ Newmarket/1/93; 50 AU A/equi-2/ Newmarket/2/93 and 40 Lf2 Tetanus toxoid, with an ISCOM-Matrix (375 microgram purified Saponin; 125 microgram Cholesterol; 62.5 microgram Phosphatidylcholine).
1Antigenic units
2Flocculation equivalents; corresponds with = 30 IU/ml guinea pig serum in the PhEur potency test.

Uses

Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Influenza

Onset of immunity:	2 weeks after the primary vaccination course.
Duration of immunity:	5 months after the primary vaccination course.
	12 months after the first revaccination.

Tetanus

Onset of immunity:	2 weeks after the primary vaccination course.
Duration of immunity:	17 months after the primary vaccination course.
	24 months after the first revaccination.

Dosage and administration

Dose: 1 ml by intramuscular administration in horses.
Vaccination schedule (see table)
Primary vaccination course
Administer one dose (1ml) by intramuscular injection according to the following schedule:
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.
Revaccination (see Vaccination schedule table)
Influenza
The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equi 1/Prague 56, A/equi 2/Newmarket 1/93 and A/equi 2/Newmarket 2/93, is recommended to maintain immunity levels for the influenza component (see Vaccination schedule table).
Tetanus
The first revaccination is given not later than 17 months after the primary vaccination course. Thereafter a maximum interval of two years is recommended (see Vaccination schedule table).

Vaccination schedule table - Equilis prequenza TE
V1	V2	5	V3	12	V4	12	V5	12	V6
0	1		6		18		30		42 months
Prequenza Te	Prequenza Te		Prequenza		Prequenza Te		Prequenza		Prequenza Te

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later).
Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared with horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Allow the vaccine to reach room temperature (15-25°C) before use.
Can be used during pregnancy and lactation.

Contra-indications, warnings, etc

A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Following the administration of a double dose of vaccine, no side-effects other than those described above have been observed except for some depression at the day of vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Only healthy animals should be vaccinated.
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
Operator warning
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store between +2°C and +8°C. Protect from light. Do not freeze.
Do not use after the expiry date stated on the label.
Disposal advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cartons with 10 glass vials of 1 ml.
Cartons with 1, 5 or 10 pre-filled syringes with needles.
Not all pack sizes may be marketed.

Further information

Nil.

Marketing authorisation number

EU/2/05/057/001-004.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

Composition
Inactivated equine herpes virus type 1 (EHV1) and type 4 (EHV4) and inactivated influenza virus. The vaccine contains aluminium hydroxide and Immunostim™ to enhance the immunising effect. Sodium timerfonate is added as preservative. The vaccine may contain traces of antibiotics (neomycin, aureomycin), ovalbumin, and formaldehyde as remnants of the antigen production.

1 Dose (2 ml) contains:
inact. EHV1, strain RAC-H	at least 107.8 TCID50
inact. EHV4, strain 2252	at least 106.5 TCID50
inact. influenza virus, A/equi 1/Prague/1/56	50 μg HA
inact. influenza virus, A/equi 2/Newmarket/1/93 (American-type)	20 μg HA
inact. influenza virus, A/equi 2/Newmarket/2/93 (European-type)	20 μg HA

Uses

For active immunisation of horses and ponies for reduction of respiratory disease caused by equine herpesvirus type 1 (EHV 1), equine herpesvirus type 4 (EHV 4) or equine influenza virus (EIV) of A/equi 1 and the current "American" and "European" strains of A/equi 2.
Specific claims
EHV 1:
In the presence of field infections the vaccine induces complement fixing (CF) and virus neutralising (VN) antibody titres leading to a significant reduction of the duration of virus excretion and a notable reduction of the virus re-isolation rate compared to unvaccinated controls as demonstrated in a challenge trial.
EHV 4:
In the presence of field infections the vaccine induces complement fixing (CF) and virus neutralising (VN) antibody titres leading to a notable reduction of clinical signs (i.e. pyrexia and nasal discharge) and of challenge virus excretion in the vaccinates compared to the unvaccinated controls.
In the presence of field infections immunity against EHV-1 and EHV-4 is established within two weeks after the basic vaccination. Data from challenge experiments one month after primary vaccination show protective immunity. Revaccination at 6 months interval maintains the active immunity.
EIV:
The vaccine induces haemagglutination-inhibiting (HI) and single radial haemolysis (SRH) antibody levels against equine influenza strains of A/equi-1/Prague 1/56 ((H7N7) and of the current ‘European’ and ‘American’ variants of the A/equi-2/Newmarket 2/93 and Newmarket 1/93 (H3N8) subtypes.
This results in a significant reduction of the level and duration of virus excretion and a significant reduction of clinical signs (pyrexia, coughing, nasal discharge) upon infection with equine influenza virus.
Within two weeks after the basic vaccination protective immunity against EIV is obtained.
Revaccination at 6 months interval maintains the active immunity.

Dosage and administration

For horses : deep intramuscular injection of 2 ml into the neck or into the pectoral muscles.
Basic immunisation:
All horses not previously vaccinated should be vaccinated twice at an interval of about 6 weeks (V1-V2), followed by a third vaccination two to six months later (V 3).
Foals should ideally be vaccinated at about six months of age. If vaccinating foals between 4 and 6 months of age, one should first test for the presence of maternally derived antibodies. Foals should not be vaccinated before 4 months of age.
Revaccination:
Every 6 months.
The vaccine syringe should be shaken well before use. Avoid the introduction of contamination during use. Use only sterile needles for administration.
Additional information
All the horses in a herd should be vaccinated (herd immunity), to reduce pressure of infection within the population. At least the first two vaccinations of the basic vaccination scheme should have been given to any new horse before placing in a stable, before any change of stable, and before attending at tournaments or races.
To optimise protection that is induced by the vaccine against EHV and EIV the following requirements must be met:
- Regular vaccinations of the entire herd.
- Avoid transfer of unimmunised or sick horses into correctly immunised herds.
Operator warning:
In the case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.

Contra-indications, warnings, etc

Avoid vaccination of sick horses, or horses that have intercurrent disease, heavy parasitic infestation or are in poor general condition, since in these cases no satisfactory immune response can be guaranteed.
Equilis Resequin is an adjuvanted vaccine and immunisation may occasionally result in temporary swellings at the injection site. Flat swellings up to 7 cm may occur. Larger swellings can be seen only on very rare occasions. Typically, these swellings do not cause any trouble and disappear within weeks. An increase in body temperature of up to 1.5°C may occasionally occur on the day after vaccination.
Occasional hypersensitivity reactions caused by egg-derived constituents in the vaccine may occur.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
The vaccine can be used during pregnancy and lactation.
Withdrawal period: Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store at between +2°C and +8°C, store out of light and do not freeze.
Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Box with pre-filled syringes: 5 × 2 ml

Further information

Nil

Marketing authorisation number

Vm 06376/4031.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

One dose (0.2 ml) contains a live, modified strain of Streptococcus equi TW928 109.0 to 109.4 cfu*.
*Colony forming units.

Uses

For the immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses. The onset of immunity is established at two weeks after basic vaccination. The duration of immunity is up to 3 months.
A priming response is maintained for up to six months after basic vaccination. Therefore only a single dose of vaccine is needed to restore immunity.
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas.
The vaccine strain is deletion mutant with a limited growth potential in mammalian tissue. It is able to multiply locally at the submucosal injection site for a short period and is shed into the oro-nasal cavity over a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose.

Dosage and administration

Dosage:0.2 ml of reconstituted vaccine by submucosal vaccination.
Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Revaccination: Revaccinate every three months to maintain immunity.
A priming response is maintained for up to six months after basic vaccination. Therefore only a single dose of vaccine is needed to restore immunity.
It is recommended that all horses stabled together are vaccinated. Allow the solvent to reach room temperature (15 - 25°C). Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided. Do NOT shake and wait 1 minute after addition of the solvent. Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided with the vaccine (see Figure 1) and connect the applicator to the needle (see Figure 2). Restrain the animal’s head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole content of the syringe into the inside of the upper lip (see Figure 3).
Figure 1:

Figure 2:

Figure 3:

Contra-indications, warnings, etc

Do not use in pregnant or lactating mares.
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection. Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE. As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely. Only healthy horses should be vaccinated. Ensure that the lyophilisate is completely reconstituted before use. Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed.
Adverse reactions
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours. The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm. This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort. The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge of fluid and inflammatory cells. A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Slight enlargements, which may be transiently painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination. In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination. In rare cases, inappetence, fever and shivering may be observed. In very rare cases depression may develop.
In addition to the clinical signs given above, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes. The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter. Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination. Slight apathy may occasionally be observed one day after vaccination.
Special precautions to be taken by the person administering the vaccine
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries. In case of accidental self injection, seek medical advice immediately and show the package insert or the label to the physician.
To the user: This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue. Accidental self injection may result in an inflammatory reaction with severe pain and swelling. If you are accidentally injected with this product seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
To the physician: This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine with attenuated virulence. However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection. Anti-inflammatory therapy is indicated even if only a very small amount of the product is injected. An additional antibiotic treatment should be considered for safety reasons. The sensitivity of the vaccine is listed in Section Interactions below.
Interactions
Limited information is available on the safety and efficacy from the use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered concurrently or simultaneously. The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin. The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimethoprim-sulfa combinations. Do not use antibiotics within one week after vaccination. Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Lyophilisate: Store refrigerated (+2°C to +8°C). Protect from light.
Solvent: This medicinal product does not require any special storage conditions.
Reconstituted vials should be used within 4 hours.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Legal category

POM-V

Packaging Quantities

1 pack contains 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, 10 applicators, 10 syringes with needles.

Further information

In the challenge studies performed by Intervet 75% of horses showed a significant reduction in clinical signs and abscess formation at the recommended dose.
For any information about this veterinary medicinal product, please contact the Marketing Authorisation Holder.

Marketing authorisation number

EU/2/04/043/001.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

One dose (0.2 ml) contains a live, modified strain of Streptococcus equi TW928 109.0 to 109.4 cfu*.
*Colony forming units.

Uses

For the immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses. The onset of immunity is established at two weeks after basic vaccination. The duration of immunity is up to 3 months.
A priming response is maintained for up to six months after basic vaccination. Therefore only a single dose of vaccine is needed to restore immunity.
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas.
The vaccine strain is deletion mutant with a limited growth potential in mammalian tissue. It is able to multiply locally at the submucosal injection site for a short period and is shed into the oro-nasal cavity over a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose.

Dosage and administration

Dosage:0.2 ml of reconstituted vaccine by submucosal vaccination.
Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Revaccination: Revaccinate every three months to maintain immunity.
A priming response is maintained for up to six months after basic vaccination. Therefore only a single dose of vaccine is needed to restore immunity.
It is recommended that all horses stabled together are vaccinated. Allow the solvent to reach room temperature (15 - 25°C). Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided. Do NOT shake and wait 1 minute after addition of the solvent. Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided with the vaccine (see Figure 1) and connect the applicator to the needle (see Figure 2). Restrain the animal’s head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole content of the syringe into the inside of the upper lip (see Figure 3).
Figure 1:

Figure 2:

Figure 3:

Contra-indications, warnings, etc

Do not use in pregnant or lactating mares.
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection. Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE. As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely. Only healthy horses should be vaccinated. Ensure that the lyophilisate is completely reconstituted before use. Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed.
Adverse reactions
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours. The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm. This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort. The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge of fluid and inflammatory cells. A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Slight enlargements, which may be transiently painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination. In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination. In rare cases, inappetence, fever and shivering may be observed. In very rare cases depression may develop.
In addition to the clinical signs given above, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes. The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter. Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination. Slight apathy may occasionally be observed one day after vaccination.
Special precautions to be taken by the person administering the vaccine
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries. In case of accidental self injection, seek medical advice immediately and show the package insert or the label to the physician.
To the user: This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue. Accidental self injection may result in an inflammatory reaction with severe pain and swelling. If you are accidentally injected with this product seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
To the physician: This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine with attenuated virulence. However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection. Anti-inflammatory therapy is indicated even if only a very small amount of the product is injected. An additional antibiotic treatment should be considered for safety reasons. The sensitivity of the vaccine is listed in Section Interactions below.
Interactions
Limited information is available on the safety and efficacy from the use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered concurrently or simultaneously. The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin. The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimethoprim-sulfa combinations. Do not use antibiotics within one week after vaccination. Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Lyophilisate: Store refrigerated (+2°C to +8°C). Protect from light.
Solvent: This medicinal product does not require any special storage conditions.
Reconstituted vials should be used within 4 hours.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Legal category

POM-V

Packaging Quantities

1 pack contains 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, 10 applicators, 10 syringes with needles.

Further information

In the challenge studies performed by Intervet 75% of horses showed a significant reduction in clinical signs and abscess formation at the recommended dose.
For any information about this veterinary medicinal product, please contact the Marketing Authorisation Holder.

Marketing authorisation number

EU/2/04/043/001.

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk

Presentation

Suspension for injection containing purified Tetanus Toxoid (40Lf* per dose). 375 ug Purified Saponin, 125 µg Cholesterol and 62.5 µg Phosphatidycholine are added as adjuvants. Traces of Thiomersal are present.
* Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test

Uses

Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
Onset of immunity: 2 weeks after the primary vaccination course.
Duration of immunity: 17 months after the primary vaccination course, 24 months after the first revaccination.

Dosage and administration

Vaccination schedule: Primary vaccination course Administer one dose (1ml), by intramuscular injection, according to the following schedule:
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.
Revaccination:The first revaccination is given not later than 17 months after the basic vaccination course. Thereafter a maximum interval of two years is recommended (see scheme).

In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Concurrent active and passive immunisation (emergency vaccination) The vaccine can be used together with Tetanus antitoxin Behring for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus Antitoxin Behring at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Te should be repeated at least four weeks later. Concurrent use of Equilis Te and Tetanus Antitoxin Behring may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum. Can be used during pregnancy and lactation.

Contra-indications, warnings, etc

A diffuse hard or soft swelling (max. diameter 5 cm) may occur, regressing within 2 days. Pain at the injection site can occur occasionally. In some cases fever may occur for 1 day, and up to 3 days in exceptional circumstances. Following the administration of a double dose of vaccine, no side-effects other than those described above have been observed except for some depression at the day of vaccination. Only healthy animals should be vaccinated. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Antitoxin Behring. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. Do not mix with any other veterinary medicinal product.
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Operator warning: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal periods: Zero days
For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Store at 2° to 8°C. Protect from light. Do not freeze.
Disposal advice: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cardboard box with 10 pre-filled syringes with needles.

Further information

Nil

Marketing authorisation number

EU/2/05/055/001-002.