Increxxa 25 mg/ml Solution for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tulathromycin

Available from:

Elanco GmbH

ATC code:

QJ01FA94

INN (International Name):

Tulathromycin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2020-09-16

Summary of Product characteristics

Unlimited Renewal: May 2024
AN: 03951/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Increxxa 25 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tulathromycin
25 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 solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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
product is used. The
veterinary medicinal product should only be used if pigs are expected
to develop the
disease within 2–3 days.
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 similar mode of action such as other macrolides or
lincosamides.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the 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)
Unlimited Renewal: May 2024
AN: 03951/2023
Page 2 of 5
epidemiological information about susceptibility of the target
bacteria. Official, national and
regional antimicrobial policies should be taken into account when the
product is used.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to the tulathromycin and may decrease
the effectiveness
of treatment with other macrolide