NEFOTEK 100 mg/ml solution for injection for cattle, horses and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketoprofen

Available from:

Vetpharma Animal Health, S.L.

ATC code:

QM01AE03

INN (International Name):

Ketoprofen

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

ketoprofen

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2012-02-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NEFOTEK 100 mg/ml solution for injection for cattle, horses and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
A clear, colourless to yellow solution. Free from visible particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs and horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Cattle:_ Anti-inflammatory and analgesic treatment of diseases in the
musculoskeletal system and the udder.
_Pigs:_
Anti-inflammatory and antipyretic treatment
of
Postpartum Dysgalactia Syndrome –PDS -
(Metritis Mastitis
Agalactia Syndrome) and respiratory diseases.
_Horses:_ Anti-inflammatory and analgesic treatment of diseases in the
musculoskeletal system and joints.
Symptomatic analgesic treatment for colic. Postoperative pain and
swelling.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, or to
any of the excipients.
Do not
use in animals suffering from gastro-intestinal
lesions,
haemorrhagic diathesis,
blood dyscrasia,
impaired
hepatic, cardiac or renal function.
Do not use in foals in their first month of life.
Do not use other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within 24 hours of each other.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCE:
Ketoprofen
100 mg
EXCIPIENTS:
Benzyl alcohol (E1519) 10
mg
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