Nafpenzal Dry Cow
AN: 00665/2015
Revised: October 2015
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nafpenzal Dry Cow
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g syringe contains:
Active substances:
Procaine benzylpenicillin 300 mg
Dihydrostreptomycin(as the sulphate) 100 mg
Nafcillin (as the sodium salt) 100 mg
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Intramammary suspension.
White, to off-white suspension.
4. CLINICAL PARTICULARS
4.1. Target Species
Cattle (dry cows)
4.2. Indications for use, specifying the target species
For dry cow therapy (treatment of existing subclinical infections and the prevention of new infections which might occur during the dry period, caused by bacteria sensitive to penicillin, streptomycin or nafcillin).
4.3 Contraindications
Do not use in case of hypersensitivity to penicillin, nafcillin or dihydro-streptomycin, or to any of the excipients.
Do not use in lactating animals.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa.
Allergic reactions to these substances are occasionally serious.
Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure, taking all recommended precautions.
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 with breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Occasional allergies to penicillin have been observed, but these are uncommon.
4.7 Use during pregnancy, lactation or lay
Pregnancy
The product is indicated for use during pregnancy. No toxic effects have been observed on the foetus.
Lactation
Do not use in lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
Antagonism between Nafpenzal DC and preparations containing bacteriostatic compounds may occur. Resistant bacteria might emerge that show a cross resistance to other beta-lactam antibiotics or aminoglycosides.
4.9 Amounts to be administered and administration route
The contents of one syringe are infused into each quarter via the teat canal when the cow is dried off at the end of each lactation.
Before use, milk the udder completely dry and clean the end of the teat thoroughly.
After breaking off the tip of the cap (for partial insertion) or removing the cap from the end of the syringe (for full insertion) insert the nozzle carefully into the teat opening.
Squeeze the complete contents of the syringe slowly into the teat and massage gently to disperse the suspension upwards into the quarter. Massage the quarter with care.
The syringe may be used only once. Part used syringes must be discarded safely.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal Period(s)
Meat and offal: 28 days.
Milk: Treatment to calving interval ≥ 46 days: 36 hours.
Treatment to calving interval < 46 days: 46 days plus 36 hours after last treatment.
5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Combination of antibacterials for intramammary use; procaine benzylpenicillin, combinations with other antibacterials.
ATCvet Code: QJ51RC23.
5.1 Pharmacodynamic properties
Penicillin is a beta-lactam antibiotic which has bactericidal activity against mainly Gram-positive bacteria and some Gram-negative aerobes. It is sensitive to beta-lactamase (penicillinase) inactivation.
Nafcillin is a penicillinase resistant, semisynthetic penicillin.
Dihydrostreptomycin is an aminoglycoside antibiotic which has bactericidal activity against primarily aerobic, Gram-negative bacteria.
Synergism between penicillin and dihydrostreptomycin combined produces a greater activity than the use of either drug by itself, and these in further combination with nafcillin ensure a spectrum of activity against a wide range of bacteria including penicillin-resistant staphylococci.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Aluminium stearate
Liquid paraffin
6.2 Incompatibilities
None known.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and composition of immediate packaging
Each 3 g syringe is made of low density polyethylene.
The syringes are packed in a sachet. The sachet is packed in a carton. Packs of 20 and 120 syringes.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
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
Intervet International B.V.
Represented in UK by:
Intervet UK Ltd.
Walton Manor
Walton
Milton Keynes
Buckingham
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 06376/4011
9. DATE OF THE FIRST AUTHORISATION
26 August 1976
10. DATE OF REVISION OF THE TEXT
October 2015
Approved: 27 October 2015
