BACTIDIARYL ORAL POWDER

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

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SPC SPC (SPC)
07-12-2016

active_ingredient:

TETRACYCLINE HYDROCHLORIDE, NEOMYCIN SULFATE

MAH:

Vetoquinol Ireland Limited

ATC_code:

QJ01RA90

INN:

TETRACYCLINE HYDROCHLORIDE, NEOMYCIN SULFATE

dosage:

Unknown

pharmaceutical_form:

Oral Powder

prescription_type:

POM

therapeutic_group:

Bovine

therapeutic_area:

Tetracyclines, combinations with other antibacterials

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

1988-10-01

SPC

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bactidiaryl Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/11/2016_
_CRN 7024756_
_page number: 1_
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not relevant.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
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recommended that milk is withdrawn at the start of the treatment.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 NECESS
                                
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