Ketoxyme 100 mg/ml Solution for Use in Drinking Water

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Ketoprofen

Saatavilla:

Andersen, S.A.

ATC-koodi:

QM01AE03

INN (Kansainvälinen yleisnimi):

Ketoprofen

Lääkemuoto:

Solution for use in drinking water

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Pigs

Terapeuttinen alue:

Anti Inflammatory NSAID

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

2014-08-05

Valmisteyhteenveto

Revised: July 2019
AN: 01241/2018
Page 1 of 5
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 (E 1519)
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,
as
appropriate.
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 cases of hypersensitivity to ketoprofen, or aspirin or
to any of the
excipients.
Do not use where there is evidence of blood dyscrasia.
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
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.
Revised: July 2019
AN: 01241/2018
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoid use in dehydrated, h