Cetrotide powder lyophilized for solution for s/c injection

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

cetrorelix (cetrorelix acetate)

Dostopno od:

Baxter Oncology GmbH

Koda artikla:

H01CC02

INN (mednarodno ime):

cetrorelix (cetrorelix acetate)

Odmerek:

0,25mg

Farmacevtska oblika:

powder lyophilized for solution for s/c injection

Enote v paketu:

N7 glass vials with powder, N7 prefilled syringes with solvent 1ml, N14 needles, N14 alcohol swabs; N1 glass vials with powder,

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2018-04-05

Lastnosti izdelka

2
1.
NAME OF THE MEDICINAL PRODUCT
Cetrotide 0.25 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.25 mg cetrorelix (as acetate).
After reconstitution with the solvent provided, each mL of the
solution contains 0.25 mg cetrorelix.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilisate
Appearance of the solvent: clear and colourless solution
The pH of the reconstituted solution is 4.0-6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of premature ovulation in patients undergoing a controlled
ovarian stimulation, followed
by oocyte pick-up and assisted reproductive techniques.
In clinical trials Cetrotide was used with human menopausal
gonadotropin (HMG), however, limited
experience with recombinant follicule-stimulating hormone (FSH)
suggested similar efficacy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cetrotide should only be prescribed by a specialist experienced in
this field.
Posology
The first administration of Cetrotide should be performed under the
supervision of a physician and
under conditions where treatment of possible allergic/pseudo-allergic
reactions (including life-
threatening anaphylaxis) is immediately available. The following
injections may be self-administered
as long as the patient is made aware of the signs and symptoms that
may indicate hypersensitivity, the
consequences of such a reaction and the need for immediate medical
intervention.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered
once daily, at 24 h intervals, either in
the morning or in the evening. Following the first administration, it
is advised that the patient be kept
under medical supervision for 30 minutes to ensure there is no
allergic/pseudo-allergic reaction to the
injection.
_Elderly_
There is no relevant use of Cetrotide in the geriatric population.
_Paediatric population_
There is no relevant use of Cetrotide in th