Dexalgin inject solution for injection/infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

dexketoprofen (dexketoprofen trometamol)

Доступна с:

A. Menarini Manufacturing Logistics and Services S.r.l.

код АТС:

M01AE17

ИНН (Международная Имя):

dexketoprofen (dexketoprofen trometamol)

дозировка:

25mg/ml

Фармацевтическая форма:

solution for injection/infusion

Штук в упаковке:

(1) ampoules 2ml, (5) ampoules 2ml, (10) ampoules 2ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2019-06-13

Характеристики продукта

SUMMARY
OF
PRODUCT
CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
Dexalgin® inject
50 mg/2ml solution for injection/ infusion
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each ampoule of 2 ml contains: dexketoprofen 50 mg (as dexketoprofen
trometamol). Each ml of
solution for injection/ infusion contains dexketoprofen 25 mg (as
dexketoprofen trometamol)
Excipients with known effects:
Each ampoule of 2 ml contains 200 mg ethanol (96 percent).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Solution for injection/ infusion.
Clear and colourless solution.
pH (7.0-8.0)
Osmolarity (270-328 mOsmol/l)
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of acute pain of moderate to severe intensity,
when oral administration is not
appropriate such as post-operative pain, renal colic and low back
pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose is 50 mg every 8 – 12 hours. If necessary, the
administration can be repeated 6
hours apart. The total daily dose should not exceed 150 mg.
Dexalgin® inject solution for injection/ infusion is intended for
short term use and the treatment must
be limited to the acute symptomatic period (no more than two days).
Patients should be switched to an
oral analgesic treatment when possible.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
In case of moderate to severe postoperative pain, Dexalgin® inject
solution for injection/ infusion can
be used in combination with opioid analgesics, if indicated, at the
same recommended doses in adults
(see section 5.1).
_Elderly _
No dosage adjustment is generally necessary in older patients. However
because of the physiological
decline in renal function in elderly patients a lower dose is
recommended in case of mild renal
function impairment: 50 mg total daily dose (see section 4.4).
_ _
_ _
_Hepatic impairment _
The dosage should be reduced to 50 mg total daily d