Bimadine Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sulfadimidine

Available from:

Bimeda Animal Health Limited

ATC code:

QJ01EQ03

INN (International Name):

Sulfadimidine

Dosage:

25 g/sachet

Pharmaceutical form:

Powder for oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

sulfadimidine

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
07 June 2019
CRN008RM4
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimadine Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each individual sachet contains:
Active substance:
Sulfadimidine 25 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of diseases in monogastric calves caused
by or associated with organisms sensitive to
sulfadimadine.
4.3 CONTRAINDICATIONS
Do not use local anaesthetics of the procaine group during treatment
as they are antagonistic.
Do not exceed the recommended dosage or the period of treatment.
Do not use in animals known to be hypersensitive to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the recommended dosage or the period of treatment.
The dose should be calculated to the nearest gram.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Prolonged treatment may lead to risk of vitamin K deficiency,
agranulocytosis and haemolytic anaemia.
Health Products Regulatory Authority
07 June 2019
CRN008RM4
Page 2 of 3
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
The procaine of procaine benzylpenicillin and of the procaine group of
local anaesthetics is an analogue of PABA and will
antagonise sulfonamides. There is interaction and antagonism between
sulfonamides and vitamin B complex.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration.
Initial dose: 2 g per 10 kg (equivalent to 1 sachet per 125 kg
bodyweight), followed by daily doses of 1 g per 10 kg bodyweight
(equivalent t