Crinone 8% w/w progesterone vaginal gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

PCO Manufacturing Ltd.

ATC code:

G03DA04

INN (International Name):

Progesterone

Dosage:

8 percent weight/weight

Pharmaceutical form:

Vaginal gel

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

progesterone

Authorization status:

Authorised

Authorization date:

2013-02-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CRINONE
® 8% W/W
PROGESTERONE VAGINAL GEL
PROGESTERONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist or nurse.
•
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Crinone is and what it is used for
2.
What you need to know before you use Crinone
3.
How to use Crinone
4.
Possible side effects
5.
How to store Crinone
6.
Contents of the pack and other information
1.
WHAT CRINONE IS AND WHAT IT IS USED FOR
Crinone 8% w/w Progesterone Vaginal Gel contains
progesterone and is used for the treatment of
infertility due to a deficiency of the female hormone
progesterone during the menstrual cycle.
During the menstrual cycle, an egg develops in the ovary
during the first 14 days. This is called the follicular phase
of the menstrual cycle. Ovulation then occurs and leaves
a corpus luteum in the ovary. This is called the luteal
phase of the menstrual cycle. This corpus luteum
produces progesterone for 12-16 days which helps to
thicken and maintain the lining of the uterus (womb) ready
for a fertilised egg. If fertilisation of the egg does not
occur, the progesterone level falls and the lining of the
uterus is shed (menstruation). If the egg is fertilised and
the embryo implants in the lining of the uterus, the corpus
luteum continues to produce progesterone to support the
pregnancy until the embryos placenta takes over at 10
weeks into the pregnancy. In some women the
progesterone produced in the luteal phase is absent or
insufficient to maintain the lining of the uterus and support
early d

Summary of Product characteristics

Health Products Regulatory Authority
06 January 2023
CRN00DC16
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crinone 8% w/w progesterone vaginal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Mg/dose
%w/w
Progesterone
90
8.0
Excipients: Contains sorbic acid
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
_Product imported from Czech Republic, Greece, Italy, Bulgaria and
Romania_
White to off white gel contained in a white plastic applicator.
4 CLINICAL PARTICULARS
As per PA2286/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2286/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerin
Liquid Paraffin
Hydrogenated Palm Oil Glycerides
Carbomer 974P
Sorbic acid (E200)
Polycarbophil
Sodium hydroxide
Purified water
6.2 INCOMPATIBILITIES
No incompatibilities were found with the usual contraceptive devices.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Health Products Regulatory Authority
06 January 2023
CRN00DC16
Page 2 of 2
Do not Freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
A single use, one piece, white polyethylene applicator with a
twist-off top, designed for intravaginal application.
Each applicator contains 1.45g of gel and delivers 1.125g of gel.
Each applicator is individually sealed.
The applicators are packed in cardboard boxes containing 15 units of
Crinone 8% progesterone vaginal gel.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/301/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: