Crinone 8% w/w progesterone vaginal gel

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Progesterone

Prieinama:

LTT Pharma Limited

ATC kodas:

G03DA; G03DA04

INN (Tarptautinis Pavadinimas):

Progesterone

Dozė:

8 percent weight/weight

Vaisto forma:

Vaginal gel

Vartojimo būdas:

Intravaginal application

Vienetai pakuotėje:

15 units

Recepto tipas:

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

Pagaminta:

Central Pharma (Contract Packaging) Ltd

Farmakoterapinė grupė:

Sex hormones

Gydymo sritis:

Pregnen (4) derivatives; progesterone

Terapinės indikacijos:

Infertility due to inadequate luteal phase

Autorizacija statusas:

Authorised

Leidimo data:

2015-03-06

Pakuotės lapelis

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.
Your medicine is called Crinone 8% w/w
progesterone vaginal gel but will be referred to as
Crinone throughout the leaflet.
WHAT IS IN THIS LEAFLET:
What Crinone is and what it is used for
What you need to know before you use
Crinone
How to use Crinone
Possible side effects
How to store Crinone
Contents of the pack and other information
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
development

Prekės savybės

Health Products Regulatory Authority
22 October 2018
CRN008N50
Page 1 of 3
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 with known effect: contains sorbic acid 0.08% w/w
(0.9mg/1.125g dose)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
_Product imported from the Czech Republic:_
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
Glycerol
Light Liquid Paraffin
Hydrogenated Palm Oil
Carbomer 974P
Sorbic acid
Polycarbophil
Sodium hydroxide
Purified water
Health Products Regulatory Authority
22 October 2018
CRN008N50
Page 2 of 3
6.2 INCOMPATIBILITIES
No incompatibilities were found with the usual contraceptive devices.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister 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.
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
one is wrapped
up and sealed in a paper/aluminium/polyethylene foil overwrap.
The applicators are packed in cardboard boxes containing 15 units of
Crinone 8%
progesterone vaginal gel.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch, Worcestershire B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/146/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Health Products Regulatory Authority
22 October 2018
CRN008