Intradine 30.89% w/v Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Sulphadimidine

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01EQ03

INN (International Name):

Sulphadimidine

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

1988-06-02

Summary of Product characteristics

Revised 13/11/2008 –
AN 00770/2008
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Intradine 30.89% w/v Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains;
Sulfadimidine
308.9mg
(as Sulfadimidine sodium)
333.3mg
EXCIPIENTS:
Chlorocresol
1.0mg
Sodium formaldehyde sulphoxylate
1.0mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection
A clear, pale yellow solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Sheep
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of infections caused by or associated with
organisms sensitive to sulfadimidine. Sulfadimidine has been shown to
be
effective in vitro against the following bacterial species:
_Actinobacillus lignieresi_
_Bordetella bronchiseptica_
Revised 13/11/2008 –
AN 00770/2008
2
_Escherichia coli_
_Mannheimia haemolytica_
_Salmonella dublin_
_Salmonella typhimurium_
The product has been shown to be effective in the treatment of
coccidiosis
and foul in the foot.
4.3
CONTRAINDICATIONS
Contraindicated in known cases of hypersensitivity to sulphonamides
and
in animals with severe liver damage or blood dyscrasias.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
To
minimise
the
risk
of
injection
site
tissue
reaction
following
subcutaneous administration it is recommended that the dose be
divided,
administered at separate sites and well massaged.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to likely variability (time, geographical) in the occurrence of
resistant
bacteria
for
sulfadimidine,
bacteriological
sampling
and
susceptibility
testing are recommended.
Adequate water must be available during period of treatment.
Particular
care must be taken in the case of animals suffering from renal damage.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental injection. In case of
accid