Tulinovet 100 mg/mL Solution for Injection for Cattle, Pigs and Sheep

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Tulathromycin

Tersedia dari:

VMD NV

Kode ATC:

QJ01FA94

INN (Nama Internasional):

Tulathromycin

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cattle, Pigs, Sheep

Area terapi:

Antimicrobial

Status otorisasi:

Authorized

Tanggal Otorisasi:

2020-09-16

Karakteristik produk

Revised: January 2022
AN: 01598/2021
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulinovet 100 mg/mL solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains
ACTIVE SUBSTANCE:
Tulathromycin
100 mg
EXCIPIENT:
Monothioglycerol
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow or slightly brown 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.
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
Revised: January 2022
AN: 01598/2021
Page 2 of 8
presence of the disease in the group must be established before the
product is used. The
veterinary medical 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
or lincosamides.
Sheep:
The effica