KetoProPig 100 mg/ml Oral Solution for Use in Drinking Water for Pigs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Ketoprofen

Commercializzato da:

Labiana Life Sciences S.A.U

Codice ATC:

QM01AE03

INN (Nome Internazionale):

Ketoprofen

Forma farmaceutica:

Oral solution

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Pigs

Area terapeutica:

Anti Inflammatory NSAID

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2008-07-16

Scheda tecnica

Revised: October 2013
AN: 01121/2012
Page 1 of 7
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KetoProPig 100 mg/ml Oral Solution for use in drinking water for Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
-
ACTIVE SUBSTANCE
Ketoprofen: 100 mg
-
EXCIPIENTS
Benzyl Alcohol (E1519): 20 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Transparent and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (fattening pigs)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Symptomatic treatment for reduction of pyrexia in cases of acute
infectious
respiratory disease in fattening 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 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.
Revised: October 2013
AN: 01121/2012
Page 2 of 7
Do not use in animals with a history of hypersensitivity to
ketoprofen, aspirin
or any of the excipients.
See also section 4.7
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As
ketoprofen
may
provoke
gastrointestinal
ulcerations,
the
use
is
not
recommended