Reneira 150mg capsules capsules hard

Страна: Вірменія

мова: англійська

Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активний інгредієнт:

pregabalin

Доступна з:

Lek Pharmaceuticals d.d.

Код атс:

N03AX16

ІПН (Міжнародна Ім'я):

pregabalin

Дозування:

150mg

Фармацевтична форма:

capsules hard

Одиниць в упаковці:

(14/2x7) in blister

Тип рецепту:

Prescription

Статус Авторизація:

Registered

Дата Авторизація:

2017-12-08

Характеристики продукта

m12 - en-spc - 740
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Reneira
®
75 mg, capsules
Reneira
®
150 mg, capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
International nonproprietary name: pregabalin.
Reneira
®
75 mg: Each capsule contains 75 mg pregabalin.
Reneira
®
150 mg: Each capsule contains 150 mg pregabalin.
For the list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules, hard.
Reneira
®
75 mg: Red opaque cap and white opaque body, filled with white to
nearly white powder.
Reneira
®
150 mg: White opaque capsules, filled with white to nearly white
powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Neuropathic pain_
Reneira is indicated for the treatment of peripheral and central
neuropathic pain in adults.
_Epilepsy_
Reneira is indicated as adjunctive therapy in adults with partial
seizures with or without
secondary generalisation.
_Generalised Anxiety Disorder_
Reneira is indicated for the treatment of Generalised Anxiety Disorder
(GAD) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose range is 150 to 600 mg per day given in either two or three
divided doses.
_Neuropathic pain_
Pregabalin treatment can be started at a dose of 150 mg per day given
as two or three divided doses.
Based on individual patient response and tolerability, the dose may be
increased to 300 mg per day
after an interval of 3 to 7 days, and if needed, to a maximum dose of
600 mg per day after an
additional 7-day interval.
_Epilepsy_
Pregabalin treatment can be started with a dose of 150 mg per day
given as two or three divided doses.
en-spc
Pg. 1
m12 - en-spc - 740
Based on individual patient response and tolerability, the dose may be
increased to 300 mg per day
after 1 week. The maximum dose of 600 mg per day may be achieved after
an additional week.
_Generalised Anxiety Disorder_
The dose range is 150 to 600 mg per day given as two or three divided
doses. The need for treatment
should be reassessed regularly.
Pregabalin treatment can be started with a dos