Bactidiaryl Oral Powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Neomycin sulfate; Tetracycline hydrochloride

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01RA90

INN (International Name):

Neomycin sulfate; Tetracycline hydrochloride

Dosage:

.

Pharmaceutical form:

Oral powder

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

tetracyclines, combinations with other antibacterials

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bactidiaryl Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g contains :
Active substances:
Tetracycline hydrochloride 0.25 g
Neomycin sulphate 500 000 IU
Excipients:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by strains sensitive to tetracycline
and/or neomycin.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not relevant.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 3
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration.
Bactidiaryl may be administered alone or combined with milk. Dilute
with tepid water and administer orally. It is recommended
that milk is withdrawn at the start of the treatment.
Calves: 1 pack per 50 kg bw, diluted in 1 or 2 litres of tepid water
every 12 hours or ½ pack diluted in one litre of water twice in
the morning and twice in the afternoon.
The treatment should be repeated for 2 to 3 days.
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF
NECESSARY
None known.
4.11 WITHDRAWAL PERIOD(S)
Meat: 8 days.Milk: Not applicable.
5 PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiinfectant for systemic use;
tetracyclines, combinations with other antibacterials.
ATCvet code: QJ01RA90
Bactidiaryl is