Crinone gel vaginal

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

progesterone

Disponible des:

Central Pharma (Contract Packing) Limited

Codi ATC:

G03DA04

Designació comuna internacional (DCI):

progesterone

Dosis:

80mg/g

formulario farmacéutico:

gel vaginal

Unidades en paquete:

(6) pre-filled plastic applicators 1,125g, (15) pre-filled plastic applicators 1,125g

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2018-12-27

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.3.1 PAGE 2 OF 16
3

1. NAME OF THE MEDICINAL PRODUCT

Crinone 8% w/w Progesterone Vaginal
Gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient



Progesterone

mg/dose
90
%
w/w
8.0

Excipient with known effect: Contains Sorbic acid 0.08% w/w
(0.9mg/1.125 g dose)
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Vaginal gel

4. CLINICAL PARTICULARS

4.1
THERAPEUTIC INDICATIONS

Treatment of infertility due to inadequate luteal phase.
For
use
during
in-vitro
fertilisation,
where
infertility
is
mainly
due
to
tubal,
idiopathic
or
endometriosis linked sterility associated with normal ovulatory
cycles.

4.2
POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Intravaginal application

Treatment of infertility due to inadequate luteal phase

One application (1.125g 8% gel) every day, starting after documented
ovulation or arbitrarily
on the 18
th
– 21
st
day of the cycle.

Use during in-vitro fertilisation

Daily
application
of
Crinone
8%
gel
should
be
continued
for
30
days
if
there
is
laboratory
evidence of pregnancy.

_Paediatric population_
Not applicable

Older people
Not applicable

Method of Administration

Crinone is applied directly from the specially designed sealed
applicator into the vagina. The
a p p l i c a t o r
s h o u l d
b e
r e m o v e d
f r o m
t h e
s e a l e d
w r a p p e r .
T h e
tw i s t - o f f
c a p
s h o u ld
n o t
b e
removed at this time.

1. The applicator should be gripped firmly by the thick end. It should
be shaken down like a
thermometer to ensure that the contents are at the thin end.
2. The tab should be twisted off and discarded.
1.3.1 PAGE 3 OF 16
4

3. The applicator may be inserted while patient is in a sitting
position or when lying on her
back with the knees bent. The thin end of applicator should be gently
inserted well into the
vagina.
4. The thick end of the applicator should be pressed firmly to deposit
gel. The applicato