TOLFEDINE 4 % W/V SOLUTION FOR INJECTION FOR DOGS AND CATS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
29-08-2015
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Ingredient activ:
TOLFENAMIC ACID
Disponibil de la:
Vetoquinol Ireland Limited
Codul ATC:
QM01AG02
INN (nume internaţional):
TOLFENAMIC ACID
Dozare:
4 %w/v
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Canine, Feline
Zonă Terapeutică:
Tolfenamic acid
Indicații terapeutice:
N.S.A.I.D
Statutul autorizaţiei:
Authorised
Data de autorizare:
1993-08-12
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfedine 4% w/v Solution for Injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Sterile solution for injection
A clear colourless to slightly yellow sterile aqueous solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, Cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN DOGS : inflammatory and painful post operative syndromes
IN CATS : adjuvant treatment of upper respiratory disease in association with antimicrobial therapy
4.3 CONTRAINDICATIONS
Tolfenamic acid is contra-indicated in case of cardiac disease
Do not use in animals with impaired hepatic function or acute renal insufficiency
Tolfenamic acid is contra-indicated in case of ulceration or digestive bleeding, in case of blood dyscrasia or
hypersensitivity to tolfenamic acid.
Do not inject intramuscularly in cats.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
NSAIDS can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with
bacterial infections appropriate concurrent antimicrobial therapy should be instigated
The use of insulin-type needle/syringe is advisable particularly in low-weight animals to ensure an accurate dose.
Each ml contains
ACTIVE SUBSTANCE
Tolfenamic acid
40 mg
EXCIPIENTS
Benzyl alcohol
10.4 mg
Sodium formaldehyde sulfoxylate
5 mg
For a full list of excipients see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/08/2015_
_CRN 7021600_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in animals less than 6 weeks of age, or in aged animals, may involve additional risk. If such a us
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