OXYTETRACYCLINE 20% W/V L.A. SOLUTION FOR INJECTION, 20% W/V

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

OXYTETRACYCLINE

Boleh didapati daripada:

Kela n.v.

Kod ATC:

QJ01AA06

INN (Nama Antarabangsa):

OXYTETRACYCLINE

Dos:

20 %w/v

Borang farmaseutikal:

Solution for Injection

Jenis preskripsi:

POM

Kumpulan terapeutik:

Bovine

Kawasan terapeutik:

Oxytetracycline

Tanda-tanda terapeutik:

Antibacterial

Status kebenaran:

Authorised

Tarikh kebenaran:

1988-10-01

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytetracycline 20% w/v L.A. Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, pale yellow to brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prophylaxis of susceptible bacterial infections.
Some specific indications are: respiratory infections such as pasteurellosis, bronchopneumonia, bovine respiratory
disease complex.
4.3 CONTRAINDICATIONS
Do not use in animals with severe renal insufficiency.
Do not use in animals with known hypersensitivity to tetracyclines.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
Active substance
Oxytetracycline
200 mg
as Oxytetracycline hydrochloride
Excipients
Sodium formaldehyde sulfoxylate
5 mg
For a full list of excipients see section 6.1.
IRISH MEDICINES BOARD
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_Date Printed 10/02/2014_
_CRN 7013325_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Warm the solution to body temperature before use.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible,
therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target
bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS
In order to prevent any possible reaction, direct contact with the drug must be avoided.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient swelling at the injection site.
During the period of tooth development, including late pregnancy, th