Q1630_clavudale_500_mg.1_8.tp

Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200
CLAVUDALE® 500 MG TABLETS FOR DOGS
Body weight (kg)
Number of tablets twice
Presentation
Amoxicillin (as amoxicillin trihydrate) 400 mg, Clavulanic acid (as potassium clavulanate) 100 mg.
Excipients: Erythrosine (E127) 7.5 mg. Also contains silica (colloidal anhydrous), magnesium stearate,sodium starch glycolate (type A), cellulose (micro-crystalline).
In refractory cases the dose may be doubled to 20 Pink, oblong scored tablets. The tablet can be mg amoxicillin/5 mg clavulanic acid/kg body weight For the treatment of bacterial infections sus- Routine cases involving all indications: The major- ceptible to amoxicillin in combination with clavulanic ity of routine cases respond to between 5 and 7 days acid where clinical experience and/or sensitivity test- therapy. Lack of effect after 5 to 7 days of treatment ing indicates the product as the drug of choice.
Chronic or refractory cases: In chronic cases, longer Skin infections (including deep and superficial courses of antibacterial therapy may be required. In pyodermas) associated with Staphylococci and Strep- such circumstances, overall treatment length is at the clinician’s discretion, but must be long enough to Infections of the oral cavity (mucous membrane) ensure complete resolution of the bacterial disease.
associated with Clostridia, Corynebacteria, Staphylo-cocci, Streptococci, Bacteroides spp. and Pasteurel- Contraindications, warnings, etc
bits, guinea pigs, hamsters and gerbils.
Urinary tract infections associated with Staphylo- Do not use in animals with known hypersensitivity cocci, Streptococci, Escherichia coli and Proteus spp.; to penicillin or substances of the beta-lactam group.
Respiratory tract infections associated with Staph- Do not use in animals with either oliguria or anuria Gastrointestinal infections associated with Escheri- Do not use in cases of known resistance to the chia coli and Proteus spp.
combination of amoxicillin and clavulanic acid.
Special precautions for use in animals: Caution is Dosage and administration
advised on the use of the product in small herbivores only. The dosage rate is 10 mg amoxicillin/2.5 mg other than those listed in the ‘Contraindications’ clavulanic acid/kg body weight twice daily. The tablets In animals with hepatic and renal dysfunction, the To ensure a correct dosage, body weight should be dosing regimen should be carefully evaluated.
determined as accurately as possible to avoid under- Use of the product should be based on susceptibil- ity testing and should take into account official The following table is intended as a guide to national and regional policies with respect to the use dispensing the product at the standard dose rate of of broad-spectrum antibiotics. Do not use in cases of 10 mg amoxicillin/2.5 mg clavulanic acid/kg twice bacteria sensitive to narrow-spectrum penicillins or to amoxicillin as a single substance. Use of the product deviating from the instructions given in the Penicillins may increase the effect of aminoglyco- SPC may increase the prevalence of bacteria resistant to amoxicillin and clavulanic acid, and may decrease Overdose: Mild gastrointestinal symptoms (diar- the effectiveness of treatment with other beta-lactam rhoea and vomiting) may occur more frequently after antibiotics, due to the potential for cross-resistance.
Special precautions to be taken by the person Pharmaceutical precautions
administering the veterinary medicinal product to 25˚C. Divided tablets should be stored in the blister animals: Penicillins and cephalosporins may cause pack. Any divided tablet portions remaining after 12 hypersensitivity (allergy) following injection, inhala- hours should be discarded. Do not use after the tion, ingestion or skin contact. Hypersensitivity to expiry date stated on the blister and the carton.
penicillins may lead to cross-reactions to cephalospo- Shelf life of the veterinary medicinal product as rins and vice versa. Allergic reactions to these sub- stances may occasionally be serious.
Shelf life after first opening the immediate packag- - Do not handle this product if you know you are sensitised, or if you have been advised not to work Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary - Handle this product with great care to avoid medicinal products should be disposed of in accor- exposure, taking all recommended precautions.
- If you develop symptoms following exposure such as a skin rash, you should seek medical advice and Legal category POM-V
show the doctor this warning. Swelling of the face,lips or eyes or difficulty with breathing are more Packaging quantities
serious symptoms and require urgent medical atten- film, heat sealed with aluminium foil (20 μm) in strips of 6 tablets. Cartons containing 12 or 24 tablets. Not Adverse reactions: Mild gastrointestinal signs (di- arrhoea and vomiting) may occur after administration Further information
be supplied only on veterinary prescription. Keep out Allergic reactions (skin reactions, anaphylaxis), blood dyscrasia and colitis may occasionally occur. In Manufacturer: Laboratorio Reig Jofre´ SA, Jarama these cases, discontinue administration and give s/n Polı´go Industrial, 45007 Toledo, Spain.
Use during pregnancy and lactation: Laboratory studies in rats and mice have not produced any Marketing authorisation holder (if different from
evidence of teratogenic or foetotoxic effects. No distributor)
studies have been conducted in pregnant or lactating Industrial Estate, Talke Pits, Stoke-on-Trent, Stafford- dogs. Use only according to the benefit/risk assess- ment by the responsible veterinarian.
Marketing authorisation number Vm 10434/4053
Interactions: Bacteriostatic antibiotics (e.g. chlo- ramphenicol, macrolides, sulfonamides and tetracy- GTIN (Global Trade Item No)
clines) may inhibit the antibacterial effects of Clavudale 500 mg Tablets for Dogs 12 tablets: The potential for allergic cross-reactivity with other Clavudale 500 mg Tablets for Dogs 24 tablets: Requested by: [email protected]
Approved datasheets found: 1
Creation date: 10/10/2012 14:25:26 (UK)
Approved for book but not on website: 0
Datasheets marked as draft (ignored): 0
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.
Dogs
Clavudale 500 mg Tablets for Dogs
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
Clavulanic Acid
GRED
IN
E
IV
Alphabetical Index of Products

Source: http://www.specific-diets.ru/files/dechra/Downloads/Pharma/Datasheets/Clavudale_500_mg_Tablets-10-10-12.pdf