Huvexxin 25 mg/ml solution for injection for pigs

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Tulathromycin

Saatavilla:

Huvepharma NV

ATC-koodi:

QJ01FA94

INN (Kansainvälinen yleisnimi):

Tulathromycin

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

tulathromycin

Valtuutus päivämäärä:

2023-02-03

Valmisteyhteenveto

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Huvexxin 25 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE:
Tulathromycin
25 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
Pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
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.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of the excipients.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the 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.
2
Use of the veterinary medicinal 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, national and regional antimicrobial policies should be taken
into account when the veterinary
medicinal product is used.
Use of the veterinary medicinal product deviating from the
instructions