Nemotan tablets film-coated

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

nimodipine

Tillgänglig från:

Medochemie Ltd (Factory AZ)

ATC-kod:

C08CA06 վերարտադրված դեղ

INN (International namn):

nimodipine

Dos:

30mg (30/3x10/) in blister

Läkemedelsform:

tablets film-coated

Enheter i paketet:

30mg (30/3x10/) in blister

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2017-10-05

Produktens egenskaper

SPCNIMOTABS3.0-CY
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nemotan 30mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg of nimodipine
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, white, film coated tablets for oral administration.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
“Nemotan” is indicated for the prevention of ischaemic
neurological deficits following
aneurysmal subarachnoid haemorrhage.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ANEURYSMAL SUBARACHNOID HAEMORRHAGE:_
PROPHYLACTIC ADMINISTRATION
ADULTS:
The recommended dose is two tablets (60mg) at 4-hourly intervals
(total daily dose 360mg)
to be taken with water. Prophylactic administration should commence
within four days of
onset of subarachnoid haemorrhage and should be continued for 21 days.
In the event of surgical intervention, administration of the Nemotan
tablets should be
continued (dosage as mentioned above) to complete the 21 days
treatment period.
SPCNIMOTABS3.0-CY
2
In patients who develop adverse reactions the dose should be reduced
as necessary or the
treatment discontinued.
_TRAUMATIC SUBARACHNOID HAEMORRHAGE:_
Not recommended as a positive benefit to risk ratio has not been
established (see Section
4.4).
SPECIAL POPULATIONS:
_Patient with hepatic impairment_
Severely disturbed liver function, particularly liver cirrhosis, may
result in an increased
bioavailability of nimodipine due to a decreased first-pass capacity
and a reduced metabolic
clearance. The effects and side-effects, e.g. reduction in blood
pressure, may be more
pronounced in these patients.
In such cases, the dose should be reduced (depending on the blood
pressure) or, if necessary,
discontinuation of the treatment should be considered..
Upon co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers a
dose adaptation
may be necessary (see Section 4.5).
_ _
_Elderly_
There are no special dosage requirements for use in the elderly.
_ _
_Pediatric population_
Safety and effica