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
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
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
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
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
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