OXTRA DD 100 mg/ml solution for injection for cattle, sheep, pigs, horses, dogs and cats

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Oxytetracycline hydrochloride

Tersedia dari:

FATRO S.p.A.

Kode ATC:

QJ01AA06

INN (Nama Internasional):

Oxytetracycline hydrochloride

Dosis:

100 milligram(s)/millilitre

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapi:

oxytetracycline

Status otorisasi:

Authorised

Tanggal Otorisasi:

2020-09-18

Karakteristik produk

Health Products Regulatory Authority
09 October 2020
CRN009Z3P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
OXTRA DD 100 mg/ml solution for injection for cattle, sheep, pigs,
horses, dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Oxytetracycline (as oxytetracycline hydrochloride)
​100
mg​
​
EXCIPIENTS:
​
​
​
Sodium formaldehyde sulfoxylate
​5
​
mg
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow to brown-yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs, horses, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by organisms susceptible to
oxytetracycline in horses, cattle, sheep, pigs, dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in horses during concomitant corticosteroid therapy.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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.
Official and local antimicrobial policies should be taken into account
when the product is used.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to
oxytetracycline
and
may
decrease
the
effectiveness
of
treatment
with
other
tetracyclines
due
to
the
potential
for
cross-resistance.
The product should be used cautiously in animals with hepatic or renal
impairment.
Use with caution in horses with gastro-intestinal disturbances or
under stress.
See 4.7 before use in male animals.
Do not dilute the product.
If concurre