CHORAPUR 1500IU Powder and solvent for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHORIONIC GONADOTROPHIN, HUMAN

Available from:

Ferring Pharmaceuticals Limited Drayton Hall, Church Road, West Drayton UB7 7PS, United Kingdom

ATC code:

G03GA01

INN (International Name):

CHORIONIC GONADOTROPHIN, HUMAN 1500 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

CHORIONIC GONADOTROPHIN, HUMAN 1500 IU

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2017-08-25

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CHORAPUR 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
CHORAPUR 5000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
CHORIONIC GONADOTROPHIN
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 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 nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CHORAPUR is and what it is used for
2.
What you need to know before you use CHORAPUR
3.
How to use CHORAPUR
4.
Possible side effects
5.
How to store CHORAPUR
6.
Contents of the pack and other information
1.
WHAT CHORAPUR IS AND WHAT IT IS USED FOR
CHORAPUR belongs to a group of medicines called gonadotrophins (sex
hormones). It controls the
release of eggs from the ovaries in women, and controls production of
the male hormone
testosterone, in men.
CHORAPUR contains the active ingredient human chorionic gonadotrophin
(hCG) (a protein
hormone) which is extracted and purified from the urine of pregnant
women. The gonadotrophins
play a vital role in fertility and reproduction.
_In Women _
In female infertility it can be used to cause women to ovulate
(ovulation induction). CHORAPUR is
also used along with other fertility drugs, to help produce eggs in
medically assisted reproduction
programmes (IVF treatment).
_In Men _
CHORAPUR is used in men to help treat low sperm count. CHORAPUR is
used either alone or in
combination with other gonadotrophins (hMG, FSH). CHORAPUR is also
used in men before a
stimulation treatment to assess the function of the testes where the
reproductive organs are not
working correctly due to a lack of sex hormones.
_In Children _
CHORAPUR

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CHORAPUR 1500 IU and 5000 IU powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of CHORAPUR 1500 contains 1500 IU highly purified human
chorionic gonadotrophin
(hCG).
Each vial of CHORAPUR 5000 contains 5000 IU highly purified human
chorionic gonadotrophin
(hCG).
The active ingredient in CHORAPUR is extracted and purified from the
urine of pregnant women.
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 lyophilised cake.
Appearance of the solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1500 IU
_Andrology _
Establishment of fertility in cases of hypogonadotrophic hypogonadism
(also in combination with
hMG or FSH).
_Paediatric population _
Treatment of undescended testes.
5000 IU
Therapy
_Gynaecology _
In anovulatory or oligo-ovulatory women to trigger ovulation and
luteinisation induction after
stimulation of follicle growth.
For Assisted Reproductive Technology (ART) program such as in vitro
fertilisation: triggering of
final follicular maturation and luteinisation after stimulation of
follicle growth.
_Paediatric population _
Delayed puberty in boys with concomitant hypogonadotrophic
hypogonadism.
Diagnostic use
_Andrology _
Assessment of the function of the testes with hypogonadotrophic
hypogonadism before a
stimulation treatment.
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_Paediatric population _
Differential diagnosis of cryptorchidism and anorchism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1500 IU
_Andrology _
Treatment with CHORAPUR should be performed under the supervision of a
physician
experienced in the treatment of fertility problems.
In case of hypogonadotrophic hypogonadism, 1 vial of CHORAPUR 1500 IU
twice a week
(corresponding to 3000 IU chorionic gonadotrophin per week) in
combination with hMG or FSH
over a period of several months.
The treatment sh