Pregnyl 5,000unit powder and solvent for solution for injection ampoules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Chorionic gonadotrophin human

제공처:

Organon Pharma (UK) Ltd

ATC 코드:

G03GA01

INN (International Name):

Chorionic gonadotrophin human

복용량:

5000unit

약제 형태:

Powder and solvent for solution for injection

관리 경로:

Subcutaneous; Intramuscular

수업:

Schedule 4 (CD Anab)

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 06050100; GTIN: 5013257000780 5013257000797

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR USER
Pregnyl® 5000 I.U.powder for solution for injection
(Human Chorionic Gonadotrophin)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or
nurse.
•
This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What is Pregnyl and what is it used for?
2. When should you not use this medicine or when should you be extra
careful with this
medicine?
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT IS PREGNYL AND WHAT IS IT USED FOR?
Pregnyl belongs to a group of medicines called gonadotrophins (sex
hormones). It controls the
release of eggs from the ovary in women, and controls production of
the male hormone,
testosterone in men.
WOMEN
In female infertility it can be used to cause women to ovulate
(OVULATION INDUCTION)
. Pregnyl is
also used along with other fertility drugs, to help produce eggs in
medically assisted reproduction
programmes
(IVF TREATMENT)
.
MEN
In men it is used to help treat
DELAYED PUBERTY
,
UNDESCENDED TESTES
or oligospermia
(LOW SPERM
COUNT)
.
ASK YOUR DOCTOR
if you are unsure why you have been given Pregnyl.
2. WHEN SHOULD YOU NOT USE THIS MEDICINE OR WHEN SHOULD YOU BE EXTRA
CAREFUL WITH THIS
MEDICINE?
WHEN SHOULD YOU NOT USE THIS MEDICINE?
•
If you are
ALLERGIC
(hypersensitive) to human chorionic gonadotrophin (hCG) or any of the
other ingredients of this medicine (listed in section 6).
•
If you have a
THYROID
,
ADRENAL
or
PITUITARY
illness which is not being treated.
•
If you have
CANCER
, (especially a horm

제품 특성 요약

OBJECT 1
PREGNYL 5000IU
Summary of Product Characteristics Updated 18-May-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Pregnyl ® 5000 I.U. powder for solution for injection.
2. Qualitative and quantitative composition
Pregnyl consists of a freeze-dried powder for injection. The active
ingredient [human chorionic
gonadotrophin (hCG)] which is obtained from the urine of pregnant
women, has luteinizing hormone
(LH) activity.
An ampoule contains 5000 I.U. hCG.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection. The powder is a white, dry powder
or cake.
4. Clinical particulars
4.1 Therapeutic indications
In the female
Sterility due to the absence of follicle-ripening or ovulation.
In combination with FSH or HMG, promotion of controlled superovulation
in medically assisted
reproduction programmes.
In the male
Hypogonadotrophic hypogonadism.
Delayed puberty associated with insufficient gonadotrophic pituitary
function. Sterility in selected cases
of deficient spermatogenesis.
4.2 Posology and method of administration
Posology
_In the female_
_Sterility due to the absence of follicle-ripening or ovulation._
5,000–10,000 IU hCG to induce ovulation, following treatment with an
FSH (Follicle Stimulating
Hormone) or HMG (Human Menopausal Gonadotrophins) preparation.
_In combination with FSH or HMG, promotion of controlled
superovulation in medically assisted _
_reproduction programmes._
5,000–10,000 IU hCG 30 - 40 hours after the last FSH or HMG
injection. Pregnyl should not be
administered if the following criteria have not been met: at least 3
follicles greater than 17mm in diameter
are present with 17ß estradiol levels of at least 3500 pmol/L (920
picogram/ml). Oocyte collection is
carried out 32 - 36 hours after the hCG injection.
_As luteal phase support_, two to three injections of 1,000 to 3,000
IU hCG each may be given within nine
days of ovulation or embryo transfer, for example on day 3, 6 and 9
after ovulation induction or embryo
t