CRINONE 8% PROGESTERONE VAGINAL GEL

Country: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

PROGESTERONE

Fáanlegur frá:

MERCK SDN. BHD.

INN (Alþjóðlegt nafn):

PROGESTERONE

Einingar í pakka:

2.6gm1Pieces Pieces; 2.6 gm 15 Pieces Pieces

Framleitt af:

Dendron Brands Limited

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CRINONE
® PROGESTERONE VAGINAL GEL
Progesterone (8% w/w)
WHAT IS IN THIS LEAFLET
1.
What Crinone is used for
2.
How Crinone works
3.
Before you use Crinone
4.
How to use Crinone
5.
While you are using Crinone
6.
Side Effects
7.
Storage and Disposal of Crinone
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CRINONE IS USED FOR
Crinone is used to supplement
progesterone in women who have
luteal phase defect. Crinone is also
used to supplement or replace your
own natural progesterone in Assisted
Reproductive Technology procedures
(eg IVF). Your doctor may have
prescribed Crinone for another
purpose. Ask your doctor if you have
any questions why Crinone has been
prescribed for you.
HOW CRINONE WORKS
Crinone is a vaginal gel that contains
natural progesterone.
Progesterone is a hormone that is
produced by the ovaries during the
second half of the menstrual cycle.
It is an essential hormone for
preparing the uterus (womb) for
pregnancy and on-going support of
pregnancy.
The lack of normal progesterone
production by the ovaries in the
second half of the menstrual cycle is
called luteal phase defect. Women
who have this defect may have
difficulties in becoming pregnant and
may have a higher risk of miscarriage.
BEFORE YOU USE CRINONE
_- When you must not use it _
Do not use Crinone if:
You have ever had an allergic reaction
to progesterone or to any of the
ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic
reaction may include:
•
rash (itching or hives) on the skin
•
swelling of the face, lips, tongue or
other parts of the body
•
shortness of breath, wheezing or
•
troubled breathing or a tight
feeling in your chest
Do not use Crinone if you have, or
have had any of the following
conditions:
•
porphyria (rare genetic disease
which affects mainly the skin or
nervous system)
•
abnormal vaginal bleeding that has
not been diagnosed, or is due to a
recent or current missed abortion o

Vara einkenni

1.
NAME OF THE MEDICINAL PRODUCT
Crinone 8% Progesterone Vaginal Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g vaginal gel contains 80 mg of progesterone.
Each applicator delivers 1.125 g of vaginal gel containing 90 mg of
progesterone.
Excipient with known effect:
Sorbic acid 0.9 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FROM
Vaginal gel
A smooth white to off-white gel
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Progesterone supplementation of the luteal phase in adults as part of
an ART (assisted
reproductive technology) procedure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
From the day of embryo transfer, 1.125 g Crinone vaginal gel (90 mg
progesterone) should be
inserted into the vagina once daily. Once the laboratory findings
confirm pregnancy, this therapy
should be continued for a total treatment duration of 30 days.
Small white globules may appear as vaginal discharge possibly due to
gel accumulation, up to
several days after usage.
_Paediatric population _
There is no relevant use of Crinone in the paediatric population.
Method of Administration
Patients should be instructed on how to administer Crinone, see
section 6.6.
4.3 CONTRAINDICATIONS
1.
Known hypersensitivity to progesterone or any of the excipients listed
in section 6.1.
2.
Undiagnosed vaginal bleeding
3.
Known or suspected malignancy of the breast or genital organs.
4.
Porphyria
5.
Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or
patients with a history of
these conditions.
6.
Missed abortion.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Crinone includes sorbic acid as an excipient. Sorbic acid may cause
local skin reactions (e.g.
contact dermatitis). Local skin reactions might also occur on the
penis of the partner when
having intercourse following vaginal application of Crinone. This may
be prevented by the use
of condoms.
Gynaecological check-ups are required before and regularly under
therapy with the drug;
endometrial hyperplasia in particular should be ruled out