Terramycin/LA 200 mg/ml Solution for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Oxytetracycline

Saatavilla:

Zoetis UK Limited

ATC-koodi:

QJ01AA06

INN (Kansainvälinen yleisnimi):

Oxytetracycline

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle, Pigs, Sheep

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

1990-07-27

Valmisteyhteenveto

Revised: November 2022
AN: 00972/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TERRAMYCIN/LA 200 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Oxytetracycline (as dihydrate) …………………200 mg
EXCIPIENT:
Sodium Formaldehyde Sulfoxylate…………….2.20 mg
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Light to dark yellowish brown solution. It may have a green tint.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle: for the treatment and control of pasteurellosis and pneumonia
caused by
oxytetracycline-sensitive organisms, and as an aid in the treatment of
infectious
bovine keratoconjunctivitis due to sensitive strains of _Moraxella
bovis_. May also
be of value for foul-in-the-foot.
Pigs: for the treatment of pneumonia caused by _Pasteurella_.
Sheep:
for
the
control
of
enzootic
abortion
and
pneumonia
caused
by
oxytetracycline-sensitive organisms. The product may be an aid in the
treatment
of foot rot, acute severe mastitis, infectious ovine
keratonconjunctivitis (pink-
eye).
4.3
CONTRAINDICATIONS
Not recommended for dogs, cats and horses.
Revised: November 2022
AN: 00972/2022
Page 2 of 6
Use with caution in animals with hepatic or renal impairment.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not to be injected subcutaneously.
Bacterial resistance may exist or develop after prolonged use of
tetracyclines.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
It is recommended in cattle that not more than 10ml, and in sheep and
pigs not more than 5 ml, be injected at any one intramuscular site
(see
also 4.9).
Do not dilute.
The period of time between first and last dose withdrawal from a
multi-
dose vial should not be longer than 28 days. Discard unused material.
Contamination of broached vials during use should be avoided.
If concurrent treatmen