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Mycinor

  • 25mg Tablet » Priced per Tablet £0.49
  • 75mg Tablet » Priced per Tablet £0.70
  • 150mg Tablet » Priced per Tablet £1.30
  • 300mg Tablet » Priced per Tablet £1.90

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£0.49 to £1.90

Description

Mycinor contains the antibiotic clindamycin made by Norbook. It is particularly effective against certain types of bacteria and can penetrate into particular tissues within the body much better than many other antibiotics. Vets will often choose this antibiotic based on these characteristics (and ideally culture and sensitivity testing). It is licensed in particular for the treatment of infected wounds and abscesses, and infections involving the mouth, bone and skin. Treatment can be given once or twice daily for a period of 4 days up to a month or more, depending on the particular case.

Mycinor Tablets are white to off-white circular tablets that can be divided into equal halves for oral administration to dogs
Each Mycinor Tablet contains:
25, 75, 150 or 300mg Clindamycin (as Clindamycin Hydrochloride)

Uses


Mycinor Tablets are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections, caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis), Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.


Dosage & Administration


For oral administration only.

1. For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs, administer either:

• 5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or
• 11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis. To help provide antimicrobial cover during dental procedures, a 10 day course is recommended. This should be initiated five days before dental therapy and continued for five days thereafter. In dogs, treatment may be extended to a maximum of 28 days based on clinical judgement.

2. For the treatment of superficial pyoderma in dogs, administer either:

• 5.5 mg/kg of bodyweight every 12 hours, or
• 11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.

3. For the treatment of osteomyelitis in dogs, administer:

• 11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

Dosage table
Bodyweight Superficial pyoderma, dental infections, wounds and abscesses, Osteomyelitis

For Dosing Guide Visit:
http://norbrook.com/uploads/Dosage_-_Mycinor.bmp

Contraindictions, Warnings etc


Do not use in animals that are hypersensitive to preparations containing clindamycin or lincomycin.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastrointestinal disturbance.

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Vomiting and diarrhoea have occasionally been observed.
Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical situation.

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Mycinor Tablets should be used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonise each other at their site of action at the 50S ribosomal sub-unit.

Pharmaceutical Precautions


Do not store above 25°C.
Store in a dry place.
Wash hands after handling tablets.
Care should be taken to avoid accidental ingestion.
In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or label to the doctor
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Need help or advice? Contact us:

  • Landline: 01582 842096
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All prices include VAT where applicable.

Medication Datasheets

150mg Tablet » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. Name of the veterinary medicinal product

    Mycinor 150 mg Tablets for Dogs

  2. Qualitative and quantitative composition

    Active Substance: Each tablet contains 150 mg Clindamycin (as 162.6 mg Clindamycin hydrochloride)

    For the full list of excipients, see section 6.1.
    
  3. Pharmaceutical form

    Tablet A white to off-white circular tablet with a score line on one side. The tablet can be divided into two equal parts.

  4. Clinical Particulars

4.1 Target species

    Dogs

4.2 Indications for use, specifying the target species

Mycinor 150 mg Tablets are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections, caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis), Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.

4.3 Contraindications

Do not use in known cases of hypersensitivity to clindamycin, lincomycin or to any of the excipients.
Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastrointestinal disturbance.

4.4 Special Warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Special Precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after handling tablets. Care should be taken to avoid accidental ingestion.
In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or label to the doctor.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical situation.

4.7 Use during pregnancy, lactation or lay

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.  Therefore, the administration of the veterinary medicinal product during pregnancy and lactation should be the subject of a benefit-risk assessment by the veterinarian.  

4.8 Interaction with other medicinal products and other forms of interaction

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.  Clindamycin should be used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they both target the ribosome 50S subunit and antagonist effects may develop.

4.9 Amounts to be administered and administration route

For oral administration only.

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or 11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis.  To help provide antimicrobial cover during dental procedures, a 10 day course is recommended.  This should be initiated five days before dental therapy and continued for five days thereafter.  In dogs, treatment may be extended to a maximum of 28 days based on clinical judgement. 

For the treatment of superficial pyoderma in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours, or 11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.

For the treatment of osteomyelitis in dogs, administer:

11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In a tolerance study a dose rate of 3 times the recommended dose of 11 mg/kg bodyweight of Clindamycin administered twice daily over a period of 30 consecutive days did not demonstrate adverse effects.

Withdrawal period

Not applicable.

  1. pharmacological properties

Pharmacotherapeutic group: Anti-infectives for systemic use; Antibacterials for systemic use; Macrolides, Lincosamides and Streptogramins; Clindamycin.

ATC vet code: QJ01FF01

5.1 Pharmacodynamic properties

Mycinor Tablets contain Clindamycin hydrochloride, which is a chlorinated analogue of the natural antibiotic produced by Streptomyces lincolnensis var lincolnensis. They are indicated for the treatment of infected wounds, abscesses, infected mouth cavities, dental infections and superficial pyoderma. Clindamycin is primarily a bacteriostatic agent whose action is through the inhibition of bacterial protein synthesis at the ribosomal (50s sub-unit) level. Its efficacy is time dependent and concentration independent, although it may show some bactericidal action when high concentrations are used to treat sensitive strains.

Clindamycin has in vitro activity against the following micro-organisms:

Aerobic Gram-positive cocci, including: Staphylococcus intermedius and Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Staphylococcus epidermidis, Streptococcus spp (except Streptococcus faecalis). Anaerobic Gram-negative bacilli, including: Bacteroides spp, Fusobacterium spp. Clostridia: Most Cl.perfringens are susceptible; other species such as Cl. sporogenes and Cl. tertium frequently are resistant to clindamycin.

Most Gram-negative aerobic bacteria are resistant, including the enterobacteriacae . Cross-resistance will occur between clindamycin and lincomycin. Clindamycin should not be used simultaneously with chloramphenicol or macrolides as this may lead to antagonism and potential cross-resistance. In cases where inducible resistance is detected, clinical failure during treatment with clindamycin may occur by selection of resistant mutants and the use of clindamycin would be best avoided in severe infection.

5.2 Pharmacokinetic properties

Absorption: Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following administration of the therapeutic dose.

Serum values: Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.

Metabolism and Excretion: Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites are excreted via the urine and faeces. Nearly all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

  1. Pharmaceutical particulars

6.1 List of excipients

Cellulose, microcrystalline (Avicel PH102) Lactose, Monohydrate Povidone Silicon dioxide Croscarmellose sodium (AcDiSol) Magnesium stearate

6.2 Incompatibilities

None known.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

Special precautions for storage

Do not store above 25°C.
Store in a dry place.

Nature and composition of immediate packaging

Packs of 150 tablets in polypropylene tubs with low density polyethylene lids and cotton wool wadding.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
  1. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited Station Works Camlough Road Newry Co Down BT35 6JP

  1. MARKETING AUTHORISATION NUMBER

    Vm 02000/4309

  2. DATE OF FIRST AUTHORISATION

    07 March 2012

  3. DATE OF REVISION OF THE TEXT

    May 2017

Approved 24 May 2017

25mg Tablet » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. Name of the veterinary medicinal product

    Mycinor 25 mg Tablets for Dogs

  2. Qualitative and quantitative composition

    Active Substance: Each tablet contains 25 mg Clindamycin (as 27.1 mg Clindamycin hydrochloride)

    For the full list of excipients, see section 6.1.
    
  3. Pharmaceutical form

    Tablet. A white to off-white circular tablet with a score line on one side. The tablet can be divided two into equal parts.

  4. Clinical Particulars

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Mycinor 25 mg Tablets are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections, caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis), Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.

4.3 Contraindications

Do not use in known cases of hypersensitivity to clindamycin, lincomycin or to any of the excipients.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastrointestinal disturbance.

4.4 Special Warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Special Precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after handling tablets.
Care should be taken to avoid accidental ingestion.
In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or label to the doctor.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts.  In cases of superinfection, appropriate measures must be taken according to the clinical situation.

4.7 Use during pregnancy, lactation or lay

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.  Therefore, the administration of the veterinary medicinal product during pregnancy and lactation should be the subject of a benefit-risk assessment by the veterinarian.  

4.8 Interaction with other medicinal products and other forms of interaction

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.  Clindamycin should be used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they both target the ribosome 50S subunit and antagonist effects may develop. 

4.9 Amounts to be administered and administration route

For oral administration only.

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or 11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis.  To help provide antimicrobial cover during dental procedures, a 10 day course is recommended.  This should be initiated five days before dental therapy and continued for five days thereafter.  In dogs, treatment may be extended to a maximum of 28 days based on clinical judgement. 

For the treatment of superficial pyoderma in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours, or 11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.

For the treatment of osteomyelitis in dogs, administer:

11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

 Overdose (symptoms, emergency procedures, antidotes), if necessary

In a tolerance study, a dose rate of 3 times the recommended dose of 11 mg/kg bodyweight of Clindamycin  administered twice daily over a period of 30 consecutive days did not demonstrate adverse effects.

 Withdrawal period

Not applicable.

5. pharmacological properties

Pharmacotherapeutic group: Anti-infectives for systemic use; Antibacterials for systemic use; Macrolides, Lincosamides and Streptogramins; Clindamycin.

ATC vet code: QJ01FF01

5.1 Pharmacodynamic properties

Mycinor Tablets contain Clindamycin hydrochloride, which is a chlorinated analogue of the natural antibiotic produced by Streptomyces lincolnensis var lincolnensis. They are indicated for the treatment of infected wounds, abscesses, infected mouth cavities, dental infections and superficial pyoderma. Clindamycin is primarily a bacteriostatic agent whose action is through the inhibition of bacterial protein synthesis at the ribosomal (50s sub-unit) level. Its efficacy is time dependent and concentration independent, although it may show some bactericidal action when high concentrations are used to treat sensitive strains.

Clindamycin has in vitro activity against the following micro-organisms:

Aerobic Gram-positive cocci, including: Staphylococcus intermedius and Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Staphylococcus epidermidis, Streptococcus spp (except Streptococcus faecalis). Anaerobic Gram-negative bacilli, including: Bacteroides spp, Fusobacterium spp. Clostridia: Most Cl.perfringens are susceptible; other species such as Cl. sporogenes and Cl. tertium frequently are resistant to clindamycin.

Most Gram-negative aerobic bacteria are resistant, including the enterobacteriacae . Cross-resistance will occur between clindamycin and lincomycin. Clindamycin should not be used simultaneously with chloramphenicol or macrolides as this may lead to antagonism and potential cross-resistance. In cases where inducible resistance is detected, clinical failure during treatment with clindamycin may occur by selection of resistant mutants and the use of clindamycin would be best avoided in severe infection.

5.2 Pharmacokinetic properties

Absorption: Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following administration of the therapeutic dose.

Serum values: Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.

Metabolism and Excretion: Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites are excreted via the urine and faeces. Nearly all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

  1. Pharmaceutical particulars

6.1 List of excipients

Cellulose, microcrystalline (Avicel PH102) Lactose Monohydrate Povidone Silicon dioxide Croscarmellose sodium (AcDiSol) Magnesium Stearate

6.2 Incompatibilities

None known.

 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

 Special precautions for storage

Do not store above 25°C.
Store in a dry place.

 Nature and composition of immediate packaging

Packs of 150 tablets in polypropylene tubs with low density polyethylene lids and cotton wool wadding.

 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited Station Works Camlough Road Newry Co Down BT35 6JP

  1. MARKETING AUTHORISATION NUMBER

    Vm 02000/4307

  2. DATE OF FIRST AUTHORISATION

    07 March 2012

  3. DATE OF REVISION OF THE TEXT

    May 2017

Approved: 24 May 2017

300mg Tablet » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. Name of the veterinary medicinal product

    Mycinor 300 mg Tablets for Dogs

  2. Qualitative and quantitative composition

    Active Substance: Each tablet contains 300 mg Clindamycin (as 325.2 mg Clindamycin hydrochloride)

    For the full list of excipients, see section 6.1.
    
  3. Pharmaceutical form

    Tablet. A white to off-white caplet-shaped tablet with a score line on both sides. The tablet can be divided into two equal parts.

  4. Clinical Particulars

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Mycinor 300 mg Tablets are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections, caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis), Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.

4.3 Contraindications

Do not use in known cases of hypersensitivity to clindamycin, lincomycin or to any of the excipients.  

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastrointestinal disturbance.

4.4 Special Warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Special Precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after handling tablets. Care should be taken to avoid accidental ingestion.
In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or label to the doctor.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts.  In cases of superinfection, appropriate measures must be taken according to the clinical situation.

4.7 Use during pregnancy, lactation or lay

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.  Therefore, the administration of the veterinary medicinal product during pregnancy and lactation should be the subject of a benefit-risk assessment by the veterinarian.  

4.8 Interaction with other medicinal products and other forms of interaction

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.  Clindamycin should be used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they both target the ribosome 50S subunit and antagonist effects may develop. 

4.9 Amounts to be administered and administration route

For oral administration only.

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or 11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis.  To help provide antimicrobial cover during dental procedures, a 10 day course is recommended.  This should be initiated five days before dental therapy and continued for five days thereafter.  In dogs, treatment may be extended to a maximum of 28 days based on clinical judgement. 

For the treatment of superficial pyoderma in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours, or 11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.

For the treatment of osteomyelitis in dogs, administer:

11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In a tolerance study a dose rate of 3 times the recommended dose of 11 mg/kg bodyweight of Clindamycin administered twice daily over a period of 30 consecutive days did not demonstrate adverse effects.

Withdrawal period

Not applicable.
  1. pharmacological properties

Pharmacotherapeutic group: Anti-infectives for systemic use; Antibacterials for systemic use; Macrolides, Lincosamides and Streptogramins; Clindamycin.

ATC vet code: QJ01FF01

5.1 Pharmacodynamic properties

Mycinor Tablets contain Clindamycin hydrochloride, which is a chlorinated analogue of the natural antibiotic produced by Streptomyces lincolnensis var lincolnensis. They are indicated for the treatment of infected wounds, abscesses, infected mouth cavities, dental infections and superficial pyoderma. Clindamycin is primarily a bacteriostatic agent whose action is through the inhibition of bacterial protein synthesis at the ribosomal (50s sub-unit) level. Its efficacy is time dependent and concentration independent, although it may show some bactericidal action when high concentrations are used to treat sensitive strains.

Clindamycin has in vitro activity against the following micro-organisms:

Aerobic Gram-positive cocci, including: Staphylococcus intermedius and Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Staphylococcus epidermidis, Streptococcus spp (except Streptococcus faecalis). Anaerobic Gram-negative bacilli, including: Bacteroides spp, Fusobacterium spp. Clostridia: Most Cl.perfringens are susceptible; other species such as Cl. sporogenes and Cl. tertium frequently are resistant to clindamycin.

Most Gram-negative aerobic bacteria are resistant, including the enterobacteriacae . Cross-resistance will occur between clindamycin and lincomycin. Clindamycin should not be used simultaneously with chloramphenicol or macrolides as this may lead to antagonism and potential cross-resistance. In cases where inducible resistance is detected, clinical failure during treatment with clindamycin may occur by selection of resistant mutants and the use of clindamycin would be best avoided in severe infection.

5.2 Pharmacokinetic properties

Absorption: Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following administration of the therapeutic dose.

Serum values: Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.

Metabolism and Excretion: Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites are excreted via the urine and faeces. Nearly all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

  1. Pharmaceutical particulars

6.1 List of excipients

Cellulose, microcrystalline (Avicel PH102) Lactose, Monohydrate Povidone Silicon dioxide Croscarmellose sodium (AcDiSol) Magnesium stearate

6.2 Incompatibilities

None known.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

Special precautions for storage

Do not store above 25°C.
Store in a dry place.        

Nature and composition of immediate packaging

Packs of 100 tablets in polypropylene tubs with low density polyethylene lids and cotton wool wadding.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
  1. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited Station Works Camlough Road Newry Co Down BT35 6JP

  1. MARKETING AUTHORISATION NUMBER

    Vm 02000/4310

  2. DATE OF FIRST AUTHORISATION

    07 March 2012

  3. DATE OF REVISION OF THE TEXT

    May 2017

Approved 24 May 2017

75mg Tablet » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. Name of the veterinary medicinal product

    Mycinor 75 mg Tablets for Dogs

  2. Qualitative and quantitative composition

    Active Substance: Each tablet contains 75 mg Clindamycin (as 81.3 mg Clindamycin hydrochloride)

    For the full list of excipients, see section 6.1.
    
  3. Pharmaceutical form

    Tablet. A white to off-white circular tablet with a score line on one side. The tablet can be divided into two equal parts.

  4. Clinical Particulars

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Mycinor 75 mg Tablets are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections, caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis), Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.

4.3 Contraindications

Do not use in known cases of hypersensitivity to clindamycin, lincomycin or to any of the excipients.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastrointestinal disturbance.

4.4 Special Warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Special Precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after handling tablets. Care should be taken to avoid accidental ingestion.
In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or label to the doctor.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia and yeasts.  In cases of superinfection, appropriate measures must be taken according to the clinical situation.

4.7 Use during pregnancy, lactation or lay

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.  Therefore, the administration of the veterinary medicinal product during pregnancy and lactation should be the subject of a benefit-risk assessment by the veterinarian.  

4.8 Interaction with other medicinal products and other forms of interaction

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.  Clindamycin should be used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they both target the ribosome 50S subunit and antagonist effects may develop. 

4.9 Amounts to be administered and administration route

For oral administration only.

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or 11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis.  To help provide antimicrobial cover during dental procedures, a 10 day course is recommended.  This should be initiated five days before dental therapy and continued for five days thereafter.  In dogs, treatment may be extended to a maximum of 28 days based on clinical judgement. 

For the treatment of superficial pyoderma in dogs, administer either:

5.5 mg/kg of bodyweight every 12 hours, or 11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.

For the treatment of osteomyelitis in dogs, administer:

11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In a tolerance study a dose rate of 3 times the recommended dose of 11 mg/kg bodyweight of Clindamycin administered twice daily over a period of 30 consecutive days did not demonstrate adverse effects.

Withdrawal period

Not applicable.
  1. pharmacological properties

Pharmacotherapeutic group: Anti-infectives for systemic use; Antibacterials for systemic use; Macrolides, Lincosamides and Streptogramins; Clindamycin.

ATC vet code: QJ01FF01

5.1 Pharmacodynamic properties

Mycinor Tablets contain Clindamycin hydrochloride, which is a chlorinated analogue of the natural antibiotic produced by Streptomyces lincolnensis var lincolnensis. They are indicated for the treatment of infected wounds, abscesses, infected mouth cavities, dental infections and superficial pyoderma. Clindamycin is primarily a bacteriostatic agent whose action is through the inhibition of bacterial protein synthesis at the ribosomal (50s sub-unit) level. Its efficacy is time dependent and concentration independent, although it may show some bactericidal action when high concentrations are used to treat sensitive strains.

Clindamycin has in vitro activity against the following micro-organisms:

Aerobic Gram-positive cocci, including: Staphylococcus intermedius and Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Staphylococcus epidermidis, Streptococcus spp (except Streptococcus faecalis). Anaerobic Gram-negative bacilli, including: Bacteroides spp, Fusobacterium spp. Clostridia: Most Cl.perfringens are susceptible; other species such as Cl. sporogenes and Cl. tertium frequently are resistant to clindamycin.

Most Gram-negative aerobic bacteria are resistant, including the enterobacteriacae . Cross-resistance will occur between clindamycin and lincomycin. Clindamycin should not be used simultaneously with chloramphenicol or macrolides as this may lead to antagonism and potential cross-resistance. In cases where inducible resistance is detected, clinical failure during treatment with clindamycin may occur by selection of resistant mutants and the use of clindamycin would be best avoided in severe infection.

5.2 Pharmacokinetic properties

Absorption: Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following administration of the therapeutic dose.

Serum values: Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.

Metabolism and Excretion: Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites are excreted via the urine and faeces. Nearly all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

  1. Pharmaceutical particulars

6.1 List of excipients

Cellulose, microcrystalline (Avicel PH102) Lactose, Monohydrate Povidone Silicon dioxide Croscarmellose sodium (AcDiSol) Magnesium stearate

6.2 Incompatibilities

None known.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

Special precautions for storage

Do not store above 25°C.
Store in a dry place.

Nature and composition of immediate packaging

Packs of 150 tablets in polypropylene tubs with low density polyethylene lids and cotton wool wadding.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
  1. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited Station Works Camlough Road Newry Co Down BT35 6JP

  1. MARKETING AUTHORISATION NUMBER

    Vm 02000/4308

  2. DATE OF FIRST AUTHORISATION

    07 March 2012

  3. DATE OF REVISION OF THE TEXT

    May 2017

Approved: 24 May 2017

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

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Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews

Q & A

Below are some recent questions we've received regarding Mycinor, including answers from our team.

11 December 2018 at 5:57pm

When to dose

Susan

My dog has been given 150mg of Mycinor tablets to take .Should I give them before,after or with his food.

  • Website Content Developer

Hi Susan,

You can find this out on the information sheet that comes with the medication. Otherwise, we would advise contacting your vet for this info.

Best wishes,

VioVet.