Huvexxin 100 mg/ml solution for injection for cattle, pigs and sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tulathromycin

Available from:

Huvepharma NV

ATC code:

QJ01FA94

INN (International Name):

Tulathromycin

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tulathromycin

Authorization date:

2023-02-03

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Huvexxin 100 mg/ml solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE:
Tulathromycin
100 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Monothioglycerol
5 mg
Propylene glycol
Citric acid
Hydrochloric acid, concentrated
Sodium hydroxide (for pH adjustment)
Water for injections
Clear colourless solution, free from visible particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, pigs and sheep.
3.2
INDICATIONS FOR USE FOR EACH 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 veterinary
medicinal 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 presence of the disease in the group
must
be established before the veterinary medicinal 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.
3.3
CONTRAINDICATIONS
2
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of the excipients.
3.4
SPECIAL WARNINGS
Cross resistance occurs with other macrolides. Do not administer
simultaneously with antimicrobials