TOLFEDOL, 40 MG/ML, SOLUTION FOR INJECTION FOR CATTLE, PIGS, CATS AND DOGS
Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Ciri produk
(SPC)
05-09-2015
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Bahan aktif:
TOLFENAMIC ACID
Boleh didapati daripada:
SP Veterinaria, S.A.
Kod ATC:
QM01AG02
INN (Nama Antarabangsa):
TOLFENAMIC ACID
Dos:
40 Mg/Ml
Borang farmaseutikal:
Solution for Injection
Jenis preskripsi:
POM
Kumpulan terapeutik:
Bovine, Canine, Feline, Porcine
Kawasan terapeutik:
Tolfenamic acid
Tanda-tanda terapeutik:
N.S.A.I.D
Status kebenaran:
Authorised
Tarikh kebenaran:
2015-08-21
Ciri produk
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tolfenamic acid ……………………………………………… 40 mg
EXCIPIENTS:
Benzyl alcohol (E1519)………………………………………..10.4 mg
Sodium formaldehyde sulphoxylate………………………….. 5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellowish sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs, cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN CATTLE: as an adjunct in the treatment of pneumonia by improving general conditions and nasal discharge and as an
adjunct in the treatment of acute mastitis.
IN PIGS: as an adjunct in the treatment of Metritis Mastitis Agalactia syndrome.
IN DOGS: for the treatment of inflammation associated with musculo-skeletal disorders and for the reduction of post-
operative pain.
IN CATS: as an adjunct in the treatment of upper respiratory disease in association with antimicrobial therapy, if
appropriate.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/08/2015_
_CRN 7018098_
_page number: 1_
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.
Do not use in case of hypersensitivity to the
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