Dinalgen 300 mg/ml Oral Solution for Use in Drinking Water for Cattle and Pigs

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Ketoprofen

थमां उपलब्ध:

Ecuphar Veterinaria S.L.U.

ए.टी.सी कोड:

QM01AE03

INN (इंटरनेशनल नाम):

Ketoprofen

फार्मास्यूटिकल फॉर्म:

Oral solution

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Cattle, Pigs

चिकित्सीय क्षेत्र:

Anti Inflammatory

प्राधिकरण का दर्जा:

Expired

प्राधिकरण की तारीख:

2009-03-31

उत्पाद विशेषताएं

Revised: May 2018
AN: 01585/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DINALGEN 300 mg/ml oral solution for cattle and pigs (All countries
except UK, IE, ES,
DK, SE and FI)
DINALGEN 300 mg/ml oral solution for use in drinking water for cattle
and pigs. (UK and
IE)
DINALGEN CONCENTRADO 300 mg/ml oral solution for cattle and pigs (ES)
DINALGEN (DK)
DINALGEN VET 300 mg/ml oral solution for cattle and pigs (SE and FI)
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 Cattle 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.
Revised: May 2018
AN: 01585/2017
Page 2 of 7
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 S