Engemycin

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Engemycin 10% (DD) Solution for injection

Presentation

A clear, yellow aqueous solution for injection containing 100 mg per ml of oxytetracycline (as the hydrochloride). Antioxidant sodium formaldehyde sulphoxylate 5mg per ml.

Uses

The treatment of infections caused by organisms sensitive to oxytetracycline in horses, cattle, sheep, pigs, dogs and cats.

In vitro, oxytetracycline is active against a range of both Gram-positive and Gram-negative microorganisms including: Streptococcus spp., Staphylococcus spp., Listeria monocytogenes, Mannheimia haemolytica, Haemophilus parahaemolyticus, Bordetella bronchiseptica, and against Chlamydophila abortus (formerly Chlamydia psittaci), the causative organism of enzootic abortion in sheep.

Dosage and administration

DD=Dual Dosage. Engemycin 10% (DD) can be administered either at a low dose rate for a 24 hour duration of activity or at a high dose rate for prolonged duration of activity.

24 hour dosage regime

The recommended dosage rate is 3–10 mg/kg bodyweight (depending on age and species – see table), by intramuscular or intravenous injection in large animals, subcutaneous or intramuscular injection in small animals.

The treatment may be repeated at 24 hour intervals up to 4 times (5 treatments in all). Intravenous injections must be given slowly over a period of at least one minute.

Prolonged action dosage regime

10 or 20 mg/kg bodyweight depending on age and species (see table) by intramuscular injection only, repeated once after 48–60 hours if required. This dosage regime is not advised for use in horses, dogs or cats.

Engemycin 10% (DD) Dosage table

Animal

Weight

24 hour dosage

Prolonged action dosage

Dose

Volume

Dose

Volume

kg

mg/kg

ml

mg/kg

ml

Horse

500

5

25

Not recommended

Foal

100

10

10

Not recommended

Cow

500

3

15

10

50

Calf

100

8

8

20

20

Sow/boar

150

5

7.5

10

15

Pig

25

8

2

20

5

Sheep

50

8

4

20

10

Lamb

25

8

2

20

5

Dog

10

10

1

Not recommended

Cat

5

10

0.5

Not recommended

Prophylactic treatment of enzootic abortion in sheep

20 mg/kg administered about day 95–100 of gestation. A further treatment may be given 2–3 weeks later.

Before administration, clean the area of the injection site and swab with spirit.

Maximum recommended dose at any one site: 20 ml for cattle, 10 ml for sheep and pigs.

Repeat doses should be administered at different sites, and the sites massaged well after injection.

Contra-indications, warnings, etc

Do not administer to horses during concomitant therapy with corticosteroids.

A transient swelling may be observed following intramuscular administration in horses and subcutaneous administration in dogs.

The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to discolouration.

Photodermatitis may occur after treatment if exposure to intense sunlight occurs.

Not for intravenous administration in dogs or cats.

It is not recommended to administer bacteriostatic and bactericidal antimicrobials concurrently.

Overdose: Oxytetracyline has low toxicity, but is irritant. Overdosage should be avoided, particularly in horses. No recommended treatment.

Operator warnings

Take care to avoid accidental injection.

In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.

Wash hands after use.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption after the number of days stated below. Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows after the number of days stated below.

24 hour dose

Cattle milk

144 hours (6 days)

Cattle meat

35 days

Sheep

14 days

Pigs

14 days

Prolonged action dose

Cattle milk

144 hours (6 days)

Cattle meat

21 days

Sheep

14 days

Pigs

10 days

Not for use in sheep producing milk for human consumption.

Not for use in horses for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Do not freeze. Keep container in outer carton.

Dilution with calcium salts is not recommended as this may lead to precipitation of crystals.

When the container is broached for the first time, calculate the discard date and write this in the space provided on the label. (A statement of the in-use shelf life of the product is given on the packaging insert, from which the discard date may be calculated.)

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Glass bottles or polyethylene terephthalate (PET) bottles containing 100 ml.

Further information

This product has been specifically formulated to reduce pain on injection without the need for addition of a local anaesthetic.

As with other tetracyclines, caution should be exercised in treating horses under stress.

Exercise caution in animals with renal or hepatic impairment.

Marketing Authorisation Holder (if different from distributor)

Intervet International BV, NL.

Represented by Intervet UK Ltd.

Marketing authorisation number

Vm 06376/4007.

Engemycin LA 200 mg/ml Solution for injection

Presentation

A sterile aqueous solution containing Oxytetracycline Dihydrate equivalent to 200 mg/ml Oxytetracycline base.

Sodium Formaldehyde Sulphoxylate 4 mg/ml as an antimicrobial preservative.

Uses

Engemycin LA is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity. Blood levels persist for at least 4 days. After administration by the intramuscular route maximum blood levels are achieved after 4 to 8 hours making Engemycin LA suitable for the treatment of acute infections. Oxytetracycline has shown to be effective in vitro against the following bacterial species.

Bordetella bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Haemophilus somnus, Mannheimia haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.

Engemycin LA is indicated for use in cattle, sheep and pigs in the treatment of:

Atrophic rhinitis caused by B. bronchiseptica, M. haemolytica and P. multocida.

Navel/joint ill caused by A. pyogenes, E. coli and S. aureus.

Mastitis caused by A. pyogenes, E. coli, S. aureus, S. agalactiae, or S. uberis.

Metritis caused by E. coli or S. pyogenes.

Pasteurellosis and infections of the respiratory tract caused by M. haemolytica and P. multocida.

Septicaemia caused by S. dublin and S. pyogenes.

Erysipelas caused by E. rhusiopathiae.

Engemycin LA can also be used in the control of enzootic abortion in sheep.

Dosage and administration

The recommended dosage rate is 20 mg/kg bodyweight (1 ml per 10 kg bodyweight) by deep intramuscular injection. This product is recommended for a single administration only. Maximum recommended dose at any one site:

Cattle

  20 ml

Pigs

  10 ml

Sheep

   5 ml

Piglets

1 day

 0.2 ml

7 days

 0.3 ml

14 days

 0.4 ml

21 days

 0.5 ml

over

21 days

 1.0 ml/10 kg

An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important for small doses.

Contra-indications, warnings, etc

1. Engemycin LA is not recommended for use in horses, dogs and cats.

2. Not for use in animals suffering from renal or hepatic damage.

3. The use of tetracyclines during the period of tooth and bone development, including late pregnancy, may lead to tooth discolouration.

4. If concurrent treatment is administered use a separate injection site.

5. Although Engemycin LA is well tolerated, occasionally a slight reaction of a transient nature has been observed.

Operator warning

Wash hands after use. In case of contact with eyes or skin, wash immediately with water as irritation may occur.

Withdrawal periods

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows after 240 hours (10 days) from the last treatment and milk from ewes may be taken after 168 hours (7 days) from the last treatment.

Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human consumption only after 31 days from the last treatment.

Pigs may be slaughtered for human consumption only after 18 days from the last treatment.

Sheep may be slaughtered for human consumption only after 9 days from the last treatment.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Do not dilute Engemycin LA.

Following withdrawal of the first dose use the product within 28 days. Keep container in outer carton.

When the vial is broached and the contents exposed to air the solution may darken but the potency will be unchanged.

When the product is broached for the first time, calculate the discard date and write this in the space provided on the label. (A statement of the in-use shelf life of the product is given on the packaging insert, from which the discard date may be calculated.)

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Multidose vials of 100 ml.

Further information

If stored as directed, Engemycin LA can be expected to retain its potency for 2 years from the manufacture date. When the vial has been broached and the contents exposed to air, the solution may darken but the potency will be unchanged.

Marketing authorisation number

Vm 01708/4338.

Engemycin Spray 3.84% w/w cutaneous spray, suspension for cattle, sheep and pigs

Presentation

A spray container with 200 ml product contains:

Active substance:

Oxytetracycline hydrochloride 5.00 g (3.84% w/w)

(equivalent to oxytetracycline 4.63 g (3.56% w/w))

Excipients:

Patent blue V (E131) as colouring agent

Uses

For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs:

-Treatment of foot infections caused in particular by: Dichelobacter nodosus, Fusobacterium necrophorum and other Fusobacterium spp., and Bacteroides spp.

-Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions.

Dosage and administration

Shake well before use. The spray container is suitable to be used in upright and inverted positions. Before application properly clean the surface to be treated, spray the product for 1-2 seconds, at a distance of 15-20 cm, until the area has a homogeneous colour. Repeat the treatment every 12 hours for 1 to 3 days, depending on the healing process.

To achieve the best results in case of pedal lesions the following instructions are recommended:

-Fully clean the foot area, completely removing foreign material, exudates and necrotic tissue.

-Keep the animal on dry ground for 12 hours after each application.

Contra-indications, warnings, etc

Do not use for treatment of teats in order to prevent the product from getting into milk.

The animals should be treated in a well ventilated area.

Do not spray in or near the eyes.

Whenever possible, product use should be based on bacterial susceptibility testing.

No negative effects due to the use of the product during pregnancy and lactation are known.

Interactions (if applicable)

None known.

Operator warnings

Because of the risk of sensitisation and contact dermatitis, the user should avoid skin contact. Wear appropriate impermeable gloves whilst handling the product.

Because of risk of eye irritation, contact with the eyes should be avoided.

Protect the eyes and face.

Do not spray on a naked flame or any incandescent material.

Do not pierce or burn the container, even after use.

Avoid inhaling vapours.

Apply the product in the open air or in a well ventilated area.

Wash hands after use.

Do not eat or smoke whilst administering the product.

In case of accidental ingestion or in case of contact with eyes, seek medical advice immediately and show the label to the physician.

Withdrawal period

Cattle, sheep:

Meat and offal: Zero days.

Milk: Zero hours.

Pigs:

Meat and offal: Zero days.

Stained part of the pig skin must be removed prior to the rest of the animal being used for human consumption.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50°C. Keep away from sources of ignition - No smoking.

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

Pressurised lacquered aluminium spray container containing in each 200 ml pack 5 g oxytetracycline hydrochloride and a blue colourant. The spraying valve consists of lacquered tinplate and different plastic materials and enables the container to be operated in upright and inverted positions.

Further information

Nil

Marketing authorisation number

Vm 01708/4545.

Need help or advice? Contact us:

  • Freephone: 0800 084 2608
  • Mon - Fri: 8:30am - 7:00pm
  • Sat: 10:00am - 3:00pm
  • Email: support@viovet.co.uk

All prices include VAT where applicable.

Information regarding the safe use of all licensed medication supplied in the UK can be found on the Veterinary Medicine Directorate website. Follow this link and then search for the brand name of the product to find the official Summary of Product Characteristics for that product. Unlicensed medication, such as herbal supplements, will not be found here and there is no such formal recognition of any scientifically proven therapeutic effects from any unlicensed medication.

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