Dinalgen 60 mg/ml Solution for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoprofen

Available from:

Laboratorios Dr Esteve SA

ATC code:

QM01AE

INN (International Name):

Ketoprofen

Authorization status:

Expired

Summary of Product characteristics

Revised: 06 August 2010
AN: 00601/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DINALGEN 60 mg/ml solution for injection for pigs (all countries
except FI and
SE)
DINALGEN VET 60 mg/ml solution for injection for pigs (FI)
DINALGEN VET (SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of the product contains:
Ketoprofen
60 mg
Benzyl alcohol (E1519)
10 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
Reduction of pyrexia in cases of respiratory disease and Postpartum
Dysglactia
Syndrome/Mastitis, Metritis, Agalactiae (MMA syndrome) in sows, in
combination
with appropriate anti-infective therapy.
4.3
CONTRAINDICATIONS
Do not use in animals where there is the possibility of
gastro-intestinal ulceration
or bleeding, in order not to aggravate their situation.
Do not use in animals suffering from cardiac, hepatic, or renal
disease.
Do not use in dehydrated or hypovolemic or hypotensive animals due to
the
potential risk of increased renal toxicity.
Do not use in animals that have previously shown signs of
hypersensitivity to
ketoprofen or aspirin or any of the excipients.
Do not use where there is evidence of blood dyscrasia or blood
coagulation
disturbances
See also section 4.7
Page 1 of 5
Revised: 06 August 2010
AN: 00601/2010
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Since gastric ulceration is a common finding in PMWS (Post-weaning
Multisystemic Wasting Syndrome), the use of ketoprofen in pigs
affected by this
pathology is not recommended, in order not to aggravate their
situation.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not exceed the recommended dose or duration of treatment
When administering to pigs of less than 6 weeks of age it is necessary
to
adjust the dose accurately as well as to perform a close clinical
follow-up.
ii.
Special precautions to