Q7391_octacillin_697_m.1_9.tp

Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200
OCTACILLIN® 697 MG/G POWDER FOR USE IN
2. Handle this product with great care to avoid DRINKING WATER FOR CHICKENS
exposure, taking all recommended precautions. Wearprotective clothing, impervious gloves and either a Qualitative and quantitative composition Contains:
disposable half mask respirator conforming to Euro- pean Standard EN149 or a non-disposable respirator Amoxicillin (as amoxicillin trihydrate) 697 mg/g conforming to European Standard EN140 with a filter For a full list of excipients, see Excipients.
to EN143 when mixing and handling the product.
Pharmaceutical form
water. White to pale yellow-white powder.
3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice Clinical particulars
and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more producing eggs for human consumption).
serious symptoms and require urgent medical atten-tion.
ens caused by bacteria susceptible to amoxicillin.
Not effective against beta-lactamase producing Use during pregnancy and lactation: birds in lay producing eggs for human consumption.
hypersensitivity to penicillin or other substances of Use in breeders only according to the benefit/risk assessment by the responsible veterinarian.
Do not use in rabbits, guinea pigs, hamsters, gerbils tion by inhibition of bacterial cell wall synthesis Special precautions for use in animals: during multiplication. It is therefore in principle not product should be based on susceptibility testing and compatible with bacteriostatic antibiotics (e.g. tetra- should take into account official and local antimicro- cyclines) which inhibit multiplication. Synergism oc- Inappropriate use of the product may increase the prevalence of bacteria resistance to amoxicillin and Amounts to be administered and administration The recommended dosage is 10-20 mg of the product per kg live weight (8-16 mg/kg amoxicillin Special precautions to be taken by the person admin- trihydrate) per day administered in the drinking water.
istering the veterinary medicinal product to ani- The higher dose is advised when treating severe infections. Treatment should be given for a period of hypersensitivity (allergy) following injection, inhala- 3-5 consecutive days. The following formula may be tion, ingestion or skin contact. Hypersensitivity to used to calculate the amount of product required per penicillins may cause cross-reactions to cephalospo- rins and vice versa. Allergic reactions to these sub-stances may occasionally be serious.
1. People with known hypersensitivity to penicillin or cephalosporin should avoid contact with theproduct.
If the required amount of product is calculated by with other penicillins which is of practical significance the total daily water intake, the following is a guide: - Birds 0-4 weeks of age: 6-12 g product/100 litres Both long term treatment and sub-therapeutic dosages can select for antimicrobial resistance.
- Birds older than 4 weeks: 10-20 g product/100 Amoxicillin is generally active against some gram- negative and most gram-positive bacteria, e.g. peni- It is recommended that the product be adminis- tered once daily in the drinking water. It is advisable Pasteurella spp., Clostridium spp., Salmonella spp., to restrict drinking water for approximately 2 hours Haemophilus paragallinarum, and E. coli. Resistance (less in hot weather) prior to medication. The use of amongst E. coli strains is not uncommon.
suitably calibrated weighing equipment for the ad-ministration of the calculated amount of product is recommended. The calculated total daily amount of tion amoxicillin is rapidly absorbed. Maximum amox- powder is scattered onto the surface of 5-10 litres of icillin concentrations (between 1-2 μg/ml) are reached clean water and stirred until evenly dispersed. This within 1-2 hours. Serum protein binding is low.
solution is then added, whilst stirring, into an amount Amoxicillin is widely distributed throughout the body.
of drinking water that will be consumed within Amoxicillin is mainly eliminated via the kidneys in the approximately 2 hours. Maximum solubility of the active form. A smaller part of the administered dose product in water is approximately 6 g/litre.
of amoxicillin is excreted in the bile. Plasma half-life If, however, continuous medication is preferred time of amoxicillin in chickens is approximately 1 then the drinking water should be refreshed with medicated water at least twice daily. In all cases Pharmaceutical particulars
ensure that there is no access to unmedicated water whilst medicated water is being offered. When all dium citrate, silica colloidal anhydrous.
medicated water has been consumed, turn on thenormal water supply again. Any unused medicated water should be discarded after 12 hours.
studies, this veterinary medicinal product must not To ensure a correct dosage body weight should be be mixed with other veterinary medicinal products.
determined as accurately as possible to avoid under- dosing. The uptake of medicated water depends on product as packaged for sale: 2 years.
the clinical condition of the animals. In order to obtain Shelf life after first opening the immediate packag- the correct dosage the concentration of amoxicillin Shelf life after dilution or reconstitution according authorised for use in laying birds producing eggs for dicinal product does not require any special storage conditions prior to opening. After opening, anyremaining content can be stored for 3 months if Pharmacological
properties Pharmacotherapeutic
stored dry and re-closed with clip (after folding the group: Beta-lactam antibacterial, Penicillin.
edge of the opened sachet). As metal tanks may negatively influence stability of the product, metaltanks should not be used for storage of solutions.
Keep out of the reach and sight of children.
ent, 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 ing of the following materials: on the outside a white beta-lactamases, which can hydrolyse the molecules layer, inside different transparent layers, a sub-layer causing the beta-lactam ring structure to open, ren- of aluminium and an inner layer of polyethylene. Pack The information for staphylococcal beta-lactamase Aluminium sachets consisting of the following is encoded in a plasmid and may be transferred by materials: on the outside a plastic layer, inside layers bacteriophage to other bacteria. In G-bacteria beta- of aluminium and polyamide and an inner layer of lactamases are encoded in either chromosomes or in polyethylene. Pack sizes are 100, 250, 500 and 1000 g.
plasmids and they may be constitutive or inducible.
Plasmids may be transferred between bacteria or waste materials derived from such veterinary Some bacteria are intrinsically resistant to amoxi- medicinal products should be disposed of in accor- cillin, because they have decreased affinity for the antibiotic. Decreased affinity may also be acquired byhomologous recombination between genes of differ- Marketing authorisation holder Eurovet Animal
ent species. Other instances of bacterial resistance Health BV, Handelsweg 25, 5531 AE Bladel, The are caused by the inability of the agent to penetrate to its site of action (some G-bacteria) or by energydependent efflux systems for pumping the antibiotic Marketing authorisation number Vm 16849/4004
authorisation
In general, practical development of resistance in renewal 06.09.2004
vitro against amoxicillin like all penicillins occursslowly and stepwise, with an existing cross-resistance Date of revision of the text September 2012
Any other information
Octacillin 697 mg/g Powder for Use in Drinking Water To be supplied only on veterinary prescription.
for Chickens 100 g: 08714225152179Octacillin 697 mg/g Powder for Use in Drinking Water Legal category POM-V
for Chickens 250 g: 08714225152056Octacillin 697 mg/g Powder for Use in Drinking Water GTIN (Global Trade Item No)
Requested by: [email protected]
Approved datasheets found: 1
Creation date: 9/10/2013 14:26:56 (UK)
Approved for book but not on website: 0
Datasheets marked as draft (ignored): 0
Octacillin 697 mg/g Powder for Use in Drinking Not authorised for use in laying birds producing Directory of participants
Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200Fax: 01939 211201email: [email protected] LIST OF PRODUCTS BY THERAPEUTIC INDICATION List of Products by Therapeutic Indication
PHARMACEUTICALS
Antimicrobials
Oral preparations
List of Products by Species
Please note that a species in brackets after a product name may not necessarily be a part of that product namebut is intended to make the index easier to use.
Chickens
Octacillin 697 mg/g Powder for Use in Drinking Water Octacillin 697 mg/g Powder for Use in Drinking Water List of Products by Active Ingredients
This index of non-proprietary names (active ingredients) is provided to enable users of the Compendium toidentify the brand names of relevant products when only the non-proprietary names are known.
It should be noted that although different products may contain the same active ingredient this does not implythat they are equivalent in regard to bioavailability or therapeutic activity.
Some products contain a number of ingredients and it has not been possible in every instance to identify suchproducts by a reference in this index to each ingredient.
Non-proprietary name in bold type. Proprietary name in ordinary type.
Amoxicillin Trihydrate
Octacillin 697 mg/g Powder for Use in Drinking GRED
IN
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Alphabetical Index of Products

Source: http://eurovet-ah.nl/files/dechra/Downloads/Pharma/Datasheets/Octacillin_697_mg_g_Powder_for.pdf%2008-10-2013.pdf