Oki 80mg/ml Oral drops, solution

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

KETOPROFEN LYSINE

Предлага се от:

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

АТС код:

M01AE03

INN (Международно Name):

KETOPROFEN LYSINE 8 g

Лекарствена форма:

ORAL DROPS, SOLUTION

Композиция:

KETOPROFEN LYSINE 8 g

Вид предписание :

POM

Терапевтична област:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2009-01-21

Листовка

1
INSERT LEAFLET
OKI 80 MG/ML ORAL DROPS, SOLUTION
M01AE03
ketoprofen lysine salt
COMPOSITION
100 ml of solution contain:
_active ingredient:_ ketoprofen lysine salt 8 g per 100 ml (1 drop
contains 4 mg) equal to ketoprofen 5 g di per 100 ml
_excipients:_ sodium alginate, sorbitol 70%, dihydroxypropane, sodium
saccharine, methyl-p-hydroxybenzoate, mint
flavour, purified water q.b.
PHARMACEUTICAL FORM AND CONTENT
Oki 80 mg/ml oral drops, solution – 30 ml bottle
PHARMACOTHERAPEUTIC CLASS
Anti-inflammatory, antirheumatic, non-steroidal drugs. Propionic acid
derivatives
MARKETING AUTHORIZATION HOLDER
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milano
Italy
MANUFACTURER
Dompé spa – L’Aquila
THERAPEUTIC INDICATIONS
Symptomatic and short-term treatment of painful inflammatory
conditions in some cases accompanied by pyrexia.
CONTRAINDICATIONS
OKi drops should not be administered in the following cases:
-
Hypersensitivity to ketoprofen and to other components, to other
NSAIDs or to the excipients
-
patients in whom acetylsalycilic acid or other non-steroidal
anti-inflammatory drugs have caused asthma
attacks, bronchospasm, acute rhinitis, nasal polyps, urticaria or
angioneurotic oedema_ _
-
Active peptic ulcer, or previous gastrointestinal bleeding, ulceration
or perforation related to the previous
treatment or history of recurrent peptic ulcer (two or more episodes
of demonstrated ulceration or bleeding) or
chronic dyspepsia.
- ulcerative colitis, Crohn’s disease
- previous bronchial asthma
- severe heart failure
- serious renal and liver dysfunction
- haemorragic diatesis and other coagulation diseases, or patients
under anticoagulant therapy.
- Pregnancy and lactation (see section “special warnings”)
- children under six years
PRECAUTIONS FOR USE
The use of Oki 80 mg/ml oral drops solution 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.

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
OKi 80 mg/ml oral drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of solution contain:
active ingredient: ketoprofen lysine salt 8 g (1 drop contains 4 mg)
corresponding to 5 g of
ketoprofen
For the excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral drops solution
4. CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
Symptomatic and short-term treatment of painful inflammatory
conditions in some cases
accompanied by pyrexia.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Adults: 20 (twenty) drops, equivalent to 80 mg of ketoprofen lysine
salt, three times a day.
Children: aged between 6 and 14 years: 1 drop every 3 kg of body
weight, three times a day or as
indicated on medical prescription. A quantity of 20 drops per
administration should never however
be exceeded.
Elderly: the dosage should be established carefully by the doctor, who
may reduce the doses
indicated above, if necessary (see section 4.4).
Patients with liver failure: treatment should be started at the
minimum daily dose (see section 4.4).
Patients with mild or moderate kidney failure: the diuretic volume and
renal function should be
monitored (see section 4.4).
OKi 80 mg/ml oral drops solution should not be administered to
patients with severe liver and
kidney dysfunction (see section 4.3).
Dilute the drops in half a glass of still water, mix and take
preferably with meals.
Undesiderables effects may be minimised by using the shortest duration
necessary to control
symptoms (see section 4.4)
4.3 CONTRAINDICATIONS
OKi drops should not be administered in the following cases:
- hypersensitivity to the active substance, to other NSAIDs or to the
excipients
- patients in whom substances with the same mechanism of action ( for
example
acetylsalycilic acid or other NSAIDs) cause asthma attacks,
bronchospasm, acute rhinitis,
nasal polyps, urticaria or angioneurotic oedema
-active peptic ulcer, or previous gastrointestinal bleeding,
ulceration or perforation related to