Oki 60mg suppositories

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

KETOPROFEN LYSINE

Tilgængelig fra:

Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy

ATC-kode:

M01AE03

INN (International Name):

KETOPROFEN LYSINE 60 mg

Lægemiddelform:

SUPPOSITORY

Sammensætning:

KETOPROFEN LYSINE 60 mg

Recept type:

POM

Terapeutisk område:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Autorisation status:

Withdrawn

Autorisation dato:

2009-01-21

Indlægsseddel

Insert leaflet
OKI 60 MG SUPPOSITORIES
M01AE03
Ketoprofen lysine salt
COMPOSITION
One suppository contains: ketoprofen lysine salt, 60 mg.
Excipients: semi-synthetic glycerides.
PHARMACEUTICAL FORM AND PRESENTATION
Suppositories.
Box of 10 suppositories.
THERAPEUTIC CLASS
Non-steroidal anti-inflammatory.
MARKETING AUTHORISATION HOLDER IN ITALY
Dompé farmaceutici S.p.A.,
Via San Martino 12
20122 Milano
Italy.
MANUFACTURER
Istituto De angeli s.r.l. – Pharmaceutical plant Reggello (FI)
INDICATIONS
Symptomatic and short-term treatment of inflammatory conditions
associated with pain, such as those affecting the
osteoarticular apparatus, post-operational pain and otitis.
CONTRAINDICATIONS
Active peptic ulcer or an history of gastrointestinal bleeding,
ulceration or perforation related to previous active
treatment
or
history
of
recurrent
haemorrhage/peptic
ulcer
(two
or
more
different
episodes
of
ulceration
or
haemmorrage demonstrated) or chronic dyspepsia.
Gastritis, serious renal failure, leukopenia and thrombocytopenia,
serious blood clotting disorders, colitis ulcerative and
serious heart failure
_HYPERSENSITIVITY TO KETOPROFEN. _
There is the risk of cross-hypersensitivity reactions with
acetylsalycilic acid or other non-steroidal anti-inflammatory
drugs. For this reason ketoprofen should not be given to patients in
whom acetylsalycilic acid or other non-steroidal
anti-inflammatory drugs have caused the appearance of symptoms of
asthma, rhinitis, urticaria.
Children under 6 years old.
WARNINGS AND PRECAUTIONS FOR USE
The use of OKi 60 mg suppositories with concomitant NSAIDS, including
cyclooxygenase-2 selective should be avoid.
Undesiderables effects may be minimised by using the minimum effective
dose for the shortest duration necessary to
control symptoms.
Gastrointestinal bleeding, ulceration and perforation:
gastrointestinal bleeding, ulceration or perforation, which can be
fatal, has been reported with all NSAIDS at any time during treatment,
with or without warning symptoms or a previous
history of seriou

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
OKi 60 mg suppositories
OKi 30 mg suppositories
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Suppositories 60 30
Each suppository contains:
Active ingredient: Ketoprofen lysine salt 60 mg 30 mg
3. PHARMACEUTICAL FORM
Suppositories
4. CLINICAL INFORMATION
_4.1 THERAPEUTIC INDICATIONS _
Symptomatic and short-term treatment of painful inflammatory
conditions such as those
affecting the osteoarticular system, post-operative pain and otitis.
_4.2 DOSAGE AND METHOD OF ADMINISTRATION _
As the recommended dose should be between 1 and 2 mg/Kg per
administration, the following
dosage regimen is recommended:
children aged over 6 years:
- body weight of less than 30 Kg: 1 OKi 30 mg suppository 2-3 times a
day
- body weight of more than 30 Kg: 1 OKi 60 mg suppository 2-3 times a
day.
_4.3 CONTRAINDICATIONS _
Active peptic ulcer or an history of gastrointestinal bleeding,
ulceration or perforation related to
previous active treatment or history of recurrent haemorrhage/peptic
ulcer (two or more
different episodes of ulceration or haemmorrage demonstrated) or
chronic dyspepsia.
Gastritis, serious renal failure, leukopenia and thrombocytopenia,
serious blood clotting
disorders and serious heart failure.
_HYPERSENSITIVITY TO KETOPROFEN. _
There is the risk of cross-hypersensitivity reactions with
acetylsalycilic acid or other nonsteroidal
anti-inflammatory drugs. For this reason ketoprofen should not be
given to patients in
whom acetylsalycilic acid or other non-steroidal anti-inflammatory
drugs have caused the
appearance of symptoms of asthma, rhinitis, urticaria.
Children aged under 6 years.
_4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
The use of OKi 60 mg suppositories and Oki 30 mg suppositories with
concomitant NSAIDS,
including cyclooxygenase-2 selective should be avoid.
Undesiderables effects may be minimised by using the minimum effective
dose for the shortest
duration necessary to control symptoms (see section 4.2 and the below
paragraphs on
gastrointe