DINALGEN 300 mg/ml oral solution for use in drinking water for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketoprofen

Available from:

Ecuphar Veterinaria S.L.U.

ATC code:

QM01AE03

INN (International Name):

Ketoprofen

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

ketoprofen

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2009-04-08

Summary of Product characteristics

Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DINALGEN 300 mg/ml oral solution for use in drinking water for cattle
and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance:
Ketoprofen
300
mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fattening attle and Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Fattening Cattle and Pigs: Treatment for the reduction of pyrexia and
dyspnoea associated with respiratory disease in
combination with anti-infective therapy, as appropriate.
4.3 CONTRAINDICATIONS
Do not administer to suckling calves.
Do not administer to fasting animals or animals with limited access to
feed.
Do not use in animals where there is the possibility of
gastrointestinal alterations, ulceration or bleeding in order not to
aggravate their situation.
Do not use in dehydrated or hypovolemic or hypotensive animal due to
the potential risk of increased renal toxicity.
Do not administer to swine fattened at extensive or semi-extensive
production farms with access to soil or foreign objects that
may damage the gastric mucosa, or with a high parasite burden, or
under a severe stress situation.
Do not use in animals suffering from cardiac, hepatic, or renal
disease.
Do not use where there is evidence of blood dyscrasia.
Do not use in case of hypersensitivity to ketoprofen or aspirin or to
any of the excipients.
Do not use other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within 24 hours of each other.See also
section 4.7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
As ketoprofen may provoke gastrointestinal ulcerations, the use is not
recommendedin cases of PMWS (post-weaning
multisystemic wasting syndrome) because ulcers are already frequently
associated with this pat