Octacillin® WSP
Introduction
Company name: Alpharma Belgium bvba
Address: Garden Square,
Laarstraat 16
2610 Antwerp - Belgium
Telephone: +44 1728621556 (Mobile: +44 7740 483818)
Fax: +44 1728621556
Email: patrick.garland@alpharma.com
Telephone: +44 140 025 0911 (Mobile: +44 771 734 5108)
Email: philip.keogh@alpharma.com
Website: www.alpharmaah.com
Qualitative and quantitative composition
Amoxicillin (as Amoxicillin trihydrate Ph. Eur.) 697 mg/g
Pharmaceutical form
Powder for oral solution.
Clinical particulars
Target species
Chickens (excluding laying birds).
Indications for use
Octacillin® is indicated for the treatment of primary infections in chickens and secondary infections, which arise following viral or mycoplasmal infection or following the use of some live viral vaccines. Amoxicillin is active against some Gram-negative and most Gram-positive bacteria e.g. penicillin sensitive Staphylococci, Streptococci, Pasteurella spp., Clostridium spp., Salmonella spp., Haemophilis paragallinarum and E. Coli.
Not effective against beta-lactamase producing organisms.
Contra-indications
Do not administer to animals sensitive to penicillin.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other small herbivores.
Undesirable effects
Allergic reactions may be observed occasionally in sensitive individuals.
Special precautions for use
None.
Use during pregnancy, lactation and egg production
Not for use in laying birds.
Interactions
Amoxicillin exerts its bactericidal action by inhibition of bacterial cell wall synthesis during multiplication. It is therefore in principle not compatible with bacteriostatic antibiotics (e.g. tetracyclines) which inhibit multiplication. Synergism occurs with ß-lactam antibiotics and aminoglycosides.
Posology and method of administration
The recommended dosage is 10-20 mg/kg live weight Octacillin® powder (8-16 mg/kg amoxicillin trihydrate) per day administered in the drinking water. The higher dose is advised when treating severe infections. Treatment should be given for a period of 3-5 consecutive days. The following formula may be used to calculate the amount of Octacillin® required per day:
g OCTACILLIN® | = | no. birds x average livewt (kg) |
per day | 50 (for 20mg/kg) or 100 for 10mg/kg) |
If the required amount of Octacillin® is calculated by the total daily water intake, the following is a guide:
•Birds 0-4 weeks of age: 6-12 g Octacillin® / 100 litres water uptake/day
•Birds older than 4 weeks:10-20 g Octacillin® / 100 litres water uptake/day
It is recommended that Octacillin® be administered once daily in the drinking water. It is advisable to restrict drinking water for approximately 2 hours (less in hot weather) prior to medication. The use of suitably calibrated weighing equipment for the administration of the calculated amount of Octacillin® is recommended. The calculated total daily amount of powder is scattered onto the surface of 5-10 litres of clean water and stirred until evenly dispersed. This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 2 hours. Maximum solubility of Octacillin® in water is approximately 6 g/litre.
If, however, continuous medication is preferred then the drinking water should be refreshed with medicated water at least twice daily. In all cases ensure that there is no access to unmedicated water whilst medicated water is being offered. When all medicated water has been consumed, turn on the normal water supply again. Any unused medicated water should be discarded after 12 hours.
Overdose
Amoxicillin is a compound with a very high therapeutic ratio. It is very unlikely that an overdose of Octacillin® will have adverse effects on the treated animal. No specific treatment or antidote is recommended.
Special warning for each target species
None.
Withdrawal periods
Meat: 24 hours from last treatment
Eggs: not intended for use in laying birds
Special precautions to be taken by the person administering the medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may cause 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. Wear protective clothing, impervious gloves and either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter to EN 143 when mixing and handling the product. Wash hands immediately after handling the product.
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.
Pharmacological particulars
Pharmacodynamic properties:
The active ingredient, amoxicillin, is a bactericidal antibiotic of the beta-lactam class. It acts by inhibition of bacterial cell wall synthesis. Amoxicillin is not resistant to the action of beta-lactamases, which can hydrolyse the molecules causing the beta-lactam ring structure to open, rendering it antibiotically inactive.
Pharmaceutical particulars
Major incompatibilities
None known.
Shelf life and in-use shelf life
Shelf-life: 2 years
After reconstitution with water, any product remaining after 12 hours should be discarded. As metal tanks may negatively influence stability of the product, metal tanks should not be used for storage of solutions.
After opening of the sachet, any remaining content can be stored for 3 months if stored dry and re-closed with clip (after folding the edge of the opened sachet).
Storage precautions
None required.
Nature and contents of container
The primary packaging material of the product Octacillin® comprises aluminium sachets of 100, 250, 500 and 1000 gram. The sachets consist of the following materials: on the outside a white layer, inside different transparent layers, a sub-layer of aluminium and an inner layer of polyethylene.
Precautions for disposal of unused product
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing authorisation holder
Eurovet Animal Health B.V.
Handelsweg 25
5531 AE Bladel, The Netherlands.
PO Box 179, 5530 AD Bladel, The Netherlands.
Marketing authorisation number
Vm 16849/4004.
Date of the first authorisation or date of renewal
06 September 2004.
Date of revision of the text
22 December 2004
Any other information
Nil.
Legal category
POM-V