TOLFINE SOLUTION FOR INJECTION VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TOLFENAMIC ACID

متاح من:

ELIEZER LINEVITZ LTD.

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

TOLFENAMIC ACID 4 G / 100 ML

طريقة التعاطي:

I.M, I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

VETOQUINOL, FRANCE

الخصائص العلاجية:

In cattle and pigs, non steroid anti inflamatory. Antipyretic and analgesic.

تاريخ الترخيص:

2020-02-23

نشرة المعلومات

1
CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
TOLFINE SOLUTION FOR INJECTION VETERINARY, 4%
2.
ACTIVE INGREDIENT and its quantity in a dose unit
Tolfenamic Acid 40 mg/ 1 mL
INACTIVE INGREDIENTS : Each mL contains:
Benzyl alcohol 10.4 mg
For the full list of inactive ingredients , see Section 13:
"Additional information."
3.
WHAT IS THE MEDICINE INTENDED FOR
An anti-inflammatory, anti-pyretic, pain-alleviating solution
indicated for use in
cattle for the treatment of acute mastitis concomitantly with
antibacterial
therapy, and in pigs for the treatment of the Metritis Mastitis
Agalactia
syndrome concomitantly with antibacterial therapy.
THERAPEUTIC GROUP: non-steroidal anti-inflammatory drugs (NSAIDs)
4.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient,
to any of the inactive ingredients listed in section 13.
5.
SIDE EFFECTS
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.
Side effects can be reported to the Ministry of Health by clicking on
the link
"Adverse Drug Reactions Report" that appears on the home page of the
Ministry of Health web site (www.health.gov.il), which leads to an
online form
for
reporting
side
effects.
Alternatively
you
can
use
the
following
link:
https://sideeffects.health.gov.il_ _
6.
TARGET SPECIES
2
Cattle, Pigs
7.
DOSAGE AND ADMINISTRATION ROUTE
Cattle: mastitis – 4 mg / kg of bodyweight (1 ml / 10 kg of
bodyweight) by
intravenous injection. Use for conditions other than mastitis: 2 mg /
kg of
bodyweight (1 ml / 20 kg of bodyweight) via intramuscular route in the
neck
area.
Pigs: MMA Syndrome – 2 mg / kg of bodyweight (1 ml / 20 kg of
bodyweight) –
via intramuscular injection in the neck.
8.
HOW TO USE THE PROD

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TOLFINE SOLUTION FOR INJECTION VETERINARY
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Tolfenamic acid 40 mg
EXCIPIENTS
Benzyl alcohol 10.4 mg
For the 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
Anti -inflammatory, antipyretic and analgesic, indicated for:
- in cattle, as an adjunct in the treatment of acute mastitis, in
combination with antibacterial
treatment.
- in pigs, as an adjunct in the treatment of Metritis Mastitis
Agalactia syndrome, in
combination with antibacterial treatment.
.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients listed
in section 6.1.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed 20 ml per injection site.
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.
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Any suspected adverse events should be reported to the
Ministry of Health
according to the National Regulation by using an online form:
https://sideeffects.health.gov.il/
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product may be used during pregnancy and lactation.
4.8 INTERACTION WITH OTH