TOLFINE

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

TOLFENAMIC ACID

Mevcut itibaren:

Vetoquinol Ireland Limited

ATC kodu:

QM01AG02

INN (International Adı):

TOLFENAMIC ACID

Doz:

4 %w/v

Farmasötik formu:

Solution for Injection

Reçete türü:

POM

Terapötik grubu:

Bovine, Porcine

Terapötik alanı:

Tolfenamic acid

Terapötik endikasyonlar:

N.S.A.I.D

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2000-02-04

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
PER 100 ML
Tolfenamic acid
4%
w/v
EXCIPIENT
Benzyl alcohol
1.04% w/v
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Tolfine is indicated:
-
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.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed 20 ml per injection site.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/08/2015_
_CRN 7021600_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the stated dosage and duration of treatment.
Use aseptic precautions when administering the product.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
None known.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
There are occasional reports of collapse following rapid intravenous injection in cattle.
When administering intravenously, the product should be injected slowly. At the first signs of intolerance, the injection
should be interrupted.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product may be used during pregnancy and lactation.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Do n