Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Duphamox
Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Presentation
Duphamox is a stable, off-white suspension for injection containing 150 mg of amoxicillin (as Amoxicillin Trihydrate) per ml. Each ml also contains Butylhydroxyanisole 0.08 mg and Butylhydroxytoluene 0.08 mg as antioxidants.
Uses
Duphamox is indicated in the treatment and control of infections caused by organisms sensitive to amoxicillin.
Amoxicillin is a broad-spectrum semi-synthetic penicillin bactericidal in action. In vitro it is effective against a wide range of Gram-positive and Gram-negative bacteria which include:
Actinomyces bovis, Actinobacillus equuli, Actinobacillus lignieresi, Bacillus anthracis, Bordetella bronchiseptica, Clostridium spp, Corynebacterium spp, Erysipelothrix rhusiopathiae, Escherichia coli, Fusiformis spp, Haemophilus spp, Moraxella spp, Pasteurella spp, Proteus mirabilis, Salmonella spp, Staphylococci and Streptococci (non-penicillinase producing) in cattle, sheep, pigs, dogs and cats.
Dosage and administration
Shake well before use.
Cattle, sheep and pigs: By intramuscular injection only.
Dogs and cats: By subcutaneous or intramuscular injection.
Massage the site after injection.
The recommended dosage rate is 7 mg per kg bodyweight once daily for up to 5 days (equivalent to 0.25 ml per 5 kg daily).
The suggested dosage rates are
Cattle | 450 kg | 20.0 ml |
Sheep | 65 kg | 3.0 ml |
Pigs | 150 kg | 7.0 ml |
Dogs | 20 kg | 1.0 ml |
Cats | 5 kg | 0.25 ml |
Normal aseptic precautions should be observed. Use a dry syringe for extraction of suspension to avoid hydrolysis of amoxicillin.
If dose volume exceeds 20 ml in cattle or 10 ml in sheep and pigs, it should be divided and injected into two sites.
A separate site should be used for each administration.
An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.
Contra-indications, warnings, etc
FOR ANIMAL TREATMENT ONLY
Do not use in known cases of hypersensitivity to penicillin or cephalosporins.
Not suitable for intravenous or intrathecal administration.
Not to be used in small herbivores such as rabbits, guinea pigs, gerbils and hamsters.
Not effective against penicillinase-producing organisms.
Occasional local tissue reaction may result from the use of this product.
Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows only after 24 hours from the last treatment.
Not for use in sheep producing milk intended for human consumption.
Animals must not be slaughtered for human consumption during treatment.
Cattle may be slaughtered for human consumption only after 18 days from the last treatment.
Sheep may be slaughtered for human consumption only after 10 days from the last treatment.
Pigs may be slaughtered for human consumption only after 16 days from the last treatment.
Operator warning
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 if you know you are sensitised, or if you have been advised not to work with such preparations.
2.Handle this 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 with breathing, are more serious symptoms and require urgent medical attention.
Wash hands after use.
Pharmaceutical precautions
Do not store above 25°C. Protect from light. Shake well before use.
This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry, sterile needle and syringe.
Keep out of the reach and sight of children.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Legal category
POM-V
Packaging Quantities
Multidose vials of 100 ml.
Further information
After the administration of Duphamox, amoxicillin is absorbed and widely distributed in the body and high levels are found in kidney, urine, liver and bile. Amoxicillin has a rapid bactericidal action which normally prevents the recrudescence of respiratory infections. As with other penicillins, absence of toxicity is normally encountered. Animals with functional rumens should only be treated parenterally.
Disposal
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Marketing authorisation number
Vm 01596/4092.