Oki 160mg suppositories

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

KETOPROFEN LYSINE

Beszerezhető a:

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

ATC-kód:

M01AE03

INN (nemzetközi neve):

KETOPROFEN LYSINE 160 mg

Gyógyszerészeti forma:

SUPPOSITORY

Összetétel:

KETOPROFEN LYSINE 160 mg

Recept típusa:

POM

Terápiás terület:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2009-01-21

Betegtájékoztató

Insert leaflet
OKI 160 MG SUPPOSITORIES
M01AE03
Ketoprofen lysine salt
COMPOSITION
One suppository contains:
Active ingredient: ketoprofen lysine salt 160 mg.
Excipients: semi-synthetic glycerides.
PHARMACEUTICAL FORM AND CONTENT
Suppositories - Box of 10 suppositories.
THERAPEUTIC CLASS
Non-steroidal anti-inflammatory drug.
MARKETING AUTHORISATION HOLDER
Dompé farmaceutici S.p.A.,
Via San Martino 12
20122 Milano
Italy.
MANUFACTURER
Istituto de Angeli s.r.l. – Pharmaceutical Plant Reggello
TERAPEUTIC INDICATIONS
Symptomatic treatment of inflammatory conditions associated with pain,
such as: rheumatoid arthritis, ankylosing
spondylitis, painful arthrosis, extra-articular rheumatism,
post-traumatic inflammation.
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. The suppositories should not be administered to
patients with haemorrhoid disturbances or who
have recently suffered from proctitis.
_HYPERSENSITIVITY TO KETOPROFEN _
There is a possibility of crossover hypersensitivity with
acetylsalicylic acid or other non-steroidal anti-inflammatory
drugs. This means that ketoprofen should not be taken by patients in
whom acetylsalicylic acid or other non-steroidal
anti-inflammatory drugs have provoked such symptoms as asthma,
rhinitis or urticaria. Pregnancy and breast-feeding.
PRECAUTIONS FOR USE
The use of OKi 160 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 pe

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
OKi 160 mg suppositories
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One suppository contains : active ingredient : ketoprofen lysine salt
160 mg
3. PHARMACEUTICAL FORM
Suppositories
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Symptomatic treatment of inflammatory states associated with pain,
such as : rheumatoid arthritis,
ankylosing spondilitis, painful arthritis, extra-articular rheumatism,
post-traumatic inflammation
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
Adults: 1 suppostory 2 times a day or according to medical
prescription.
The posology for the treatment of elderly patients must be carefully
established by the physician,
who will take into consideration the possibility of reducing the
dosage mentioned above.
The maximum daily dose is 200 mg of ketoprofen, corresponding to 320
mg of ketoprofen lysine
salt. The balance of risks and benefits should be carefully considered
before commencing treatment
with 200 mg daily, and higher doses are not recommended (see also
section 4.4)
Undesiderables effects may be minimised by using the shortest duration
necessary to control
symptoms (see section 4.4)
_4.3 CONTRA-INDICATIONS _
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 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. Pregnancy. Lactation
_4.4 SPECIAL WARNINGS AND PRE