SPC

1. Name of the Veterinary Medicinal Product Mamyzin
2. Qualitative and Quantitative Composition Penethamate hydriodide contained in one vial of either 5g (5 million IU) or 10g (10 million IU). A second vial contains either 15ml or 30ml sterile diluent containing 1.5mg/ml methyl parahydroxybenzoate Ph Eur, as preservative.
3. Pharmaceutical FormPowder for suspension for injection.
4. Pharmacological properties Penethamate hydriodide is a prodrug which releases benzylpenicillin quantitatively at hydrolysis. The pKa-value of penethamate hydriodide is 8. 4. This means that in aqueous solution at physiological pH of 7.2, 8.2% of the drug will be present as the uncharged molecule while
91.8% will be present as the ion. In aqueous solution penethamate is hydrolysed to form benzylpenicillin and diethylaminoethanol. After intramuscular injection the prodrug itself as well as the released alcohol, diethylaminoethanol has not shown any unexpected pharmacological effects. Its mode of action is by prevention of cell wall synthesis during bacterial cell growth and is primarily bactericidal. The in vitro spectrum of activity is mainly within the gram+ve class of bacteria eg Staphylococcus spp, Streptococcus spp, Clostridium spp, acillus spp etc.
5. Clinical Particulars
5.0 Target Species Cattle, dairy
5.1 Indications for use Mastitis caused by penicillin sensitive organisms.
5.2 Contraindications Do not use in animals known to be hypersensitive to penicillin.
5.3 Undesirable Effects Allergic reactions can be seen, in which diarrhoea may occur.
5.4 Special Precaution(s) for Use Do not administer by intravenous injection.
5.5 Pregnancy and Lactation Can be used during pregnancy.
5.6 Interaction with other veterinary medicinal products and other forms of interaction Should not be administered concurrently with bacteriostatic antibiotics.
5.7 Posology and Method of Administration Reconstitution: Reconstitute the suspension using the entire contents of the 5g vial with the 15ml vial of diluent OR the 10g vial with the 30ml vial of diluent provided. Use only 5g vial with 15ml diluent and 10g vial with 30ml diluent to provide the correct dose. Shake well after reconstitution. Dosage: The dose is 10-15mg penethamate hydriodide per kg bodyweight. This is equivalent to 3.5-5.5ml of the reconstituted suspension per 100kg bodyweight. Shake well before administration. The injection can be repeated with a time interval of 24 hours for up to 4 days in total. For intramuscular use. Do not administer intravenously.
5.8 Overdose Not applicable.
5.9 Special Warnings for each target species None. 5.10 Withdrawal Periods Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 7 days from the last treatment. Milk for human consumption must not be taken from a cow during treatment. Milk for human consumption may only be taken from 72 hours from the last treatment. 19 1027 Monograph 7/12/04 9:32 AM Page 20
5.11 Special Precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

1.Do not handle this product is you know you are sensitised, or if you have been advised not to work with such preparations.
2.Handle the product with great care to avoid exposure, taking all recommended precautions.
3.If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the Doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
4.Wash hands after use.
5.In the event of self-administration, seek medical advice.
6. Pharmaceutical Particulars
6.1 Incompatibilities (major) None known.
6.2 Shelf Life, if necessary after reconstitution of the product, or when the container is opened for the first time
3 years.
6.3 Special Precautions for Storage Do not store above 25°C. After reconstitution, use immediately. Discard unused suspension.
6.4 Nature and Contents of Container Colourless, Type I Ph Eur glass vials, closed with butyl rubber stoppers and metal caps, containing 5 or 10g of powder and 15 or 30ml diluent to produce a reconstituted suspension.
6.5 Name or style and permanent address or registered place of business of the holder of the authorisation to place the product on the market Boehringer Ingelheim Limited Ellesfield Avenue Bracknell Berkshire RG128YS UK


6.6 Special Precautions for the disposal of unused veterinary medicinal product or waste material, derived from such veterinary medicinal products Unused product and containers should be disposed of in accordance with national requirements.
7. Additional Information
Marketing authorisation numbers:
UK Vm 00015/4062
Ireland VPA 10007/36/1
Legal Category POM
Date of revision of SPC: May 2002

References

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3) Biggs,A (2004) CLINICAL FORUM. STREP. UBERIS. UK Vet – October 2004
4) Friton, G et al. (2007) PHARMACOKINETICS IN PLASMA AND MILK OF BENZYLPENICILLIN FOLLOWING REPEATED INTRAMUSCULAR ADMINISTRATION OF MAMYZIN (PENETHAMATE HYDRIODIDE) IN LACTATING COWS – Blackwell Publishing, J.Vet. Pharmacol Therap 26 (Suppl 1)100 - 101
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18) Guerie-Faublée et al. (2002) ANTIMICROBIAL SUSCEPTILITY OF STREPTOCOCCUS SPECIES ISOLATED FROM CLINICAL MASTITIS IN DAIRY COWS. Int. J. of Acute Mic.Ag. 19, 219-226
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PENETHAMATE. XXI World Buiatrics Congress, Dec 4 - 8 2000, 143
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MAMMITES CLINIQUES. Société Nationale des Groupements Techniques Veterinaire Congress. Nantes, May 2007
25) McDougall et al. (1998) EFFICACY OF TWO ANTIMICROBIAL TREATMENT IN CURING CLINICAL AND SUB-CLINICAL MASTITIS IN LACTATING DAIRY COWS. New Zealand Veterinary Journal 46, 226 - 232
26) St Rose et al. (2007) EFFECT OF PENTHAMATE HYDRIODIDE TREATMENT ON BACTERIOLOGICAL CURE, SOMATIC CELL COUNT AND MILK PRODUCTION OF COWS WITH CHRONIC SUB-CLINICAL STREP UBERIS OR STREP AGALCTIAE INFECTION, Journal of Dairy Research (2007) 70, 387 - 394
27) Timothy Bray Humphris, New Zealand – clinical field trial. Data on file
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29) Bryan & Friton (2004) INVESTIGATION ON PENETHAMATE HYDRIODIDE (MAMYZIN) USE IN HEIFERS WITHIN 7 DAYS PREPARTUM. XXIII World Buiatrics Congress, Quebec 2004
30) P Moroni et al. (2002) NEW STRATEGY IN THE MANAGEMENT AND CONTROL OF STAPHYLOCOCCUS AUREUS INTRAMAMMARY INFECTIONS IN HEIFER IN ITALIAN DAIRY HERD. 41st National Mastitis Council Meeting, Feb 3 - 6, 2002. Orlando, Florida Photographs on pages 4, 6, 12 and 13 were kindly provided by Dr. Maureen Milne BVMS MVM DCHP MRCVS, Premier Vets, 23 Brynford Street, Holywell, Clywd, CH8 7RD.