KETOXYME 100 MG/ML SOLUTION FOR USE IN DRINKING WATER.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

KETOPROFEN

Available from:

Andersen, S.A.

ATC code:

QM01AE03

INN (International Name):

KETOPROFEN

Dosage:

100 Mg/Ml

Pharmaceutical form:

Infus/Pdr/Oral Soln

Prescription type:

POM

Therapeutic group:

Porcine

Therapeutic area:

Ketoprofen

Therapeutic indications:

N.S.A.I.D

Authorization status:

Authorised

Authorization date:

2014-08-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketoxyme 100 mg/ml solution for use in drinking water.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ketoprofen
100 mg
EXCIPIENTS:
Benzyl alcohol
20 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Symptomatic treatment for reduction of pyrexia associated with infectious respiratory diseases in pigs in combination
with an appropriate anti-infective therapy.
4.3 CONTRAINDICATIONS
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 animals 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 in animals with a history of hypersensitivity to ketoprofen, aspirin or any of the excipients.
Do not use where there is evidence of blood dyscrasia.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Water intake of treated animals should be monitored to ensure adequate intake. Individual animal medication,
preferably by injection, will be required if daily water intake is insufficient.
HEALTH PRODUCTS REGULATORY AUTHORITY
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