Tulieve 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Tulathromycin

Dostopno od:

Norbrook Laboratories Limited

Koda artikla:

QJ01FA94

INN (mednarodno ime):

Tulathromycin

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cattle, Pigs, Sheep

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

2020-04-16

Lastnosti izdelka

Revised: March 2022
AN: 01916/2021 & 01918/2021
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Tulathromycin
EXCIPIENTS:
100 mg
Citric Acid (E330)
Monothioglycerol
19.2 mg
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs and sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Treatment and metaphylaxis of bovine respiratory disease (BRD)
associated with
_Mannheimia haemolytica_, _Pasteurella multocida,_ _Histophilus somni
_and_ Mycoplasma _
_bovis_ susceptible to tulathromycin. The presence of the disease in
the group must be
established before the product is used.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated
with _Moraxella bovis_
susceptible to tulathromycin.
Revised: March 2022
AN: 01916/2021 & 01918/2021
Page 2 of 9
Pigs
Treatment and metaphylaxis of swine respiratory disease (SRD)
associated with
_Actinobacillus pleuropneumoniae_, _Pasteurella multocida,_
_Mycoplasma hyopneumoniae, _
_Haemophilus parasuis_ and _Bordetella bronchiseptica_ susceptible to
Tulathromycin. The
presence of the disease in the group must be established before the
product is used.
The veterinary medicinal product should only be used if pigs are
expected to develop the
disease within 2–3 days.
Sheep
Treatment of the early stages of infectious pododermatitis (foot rot)
associated with
virulent _Dichelobacter nodosus_ requiring systemic treatment.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of
the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross resistance occurs with other macrolides. Do not administer
simultaneously with
antimicrobials with a similar mode of action such as other macrolides
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