Gonadorelin 100microgram powder and solvent for solution for injection vials

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Gonadorelin hydrochloride

Disponibil de la:

Esteve Pharmaceuticals Ltd

Codul ATC:

H01CA01

INN (nume internaţional):

Gonadorelin hydrochloride

Dozare:

100microgram

Forma farmaceutică:

Powder and solvent for solution for injection

Calea de administrare:

Intravenous; Subcutaneous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 06050100; GTIN: 5039021001401

Prospect

PATIENT INFORMATION LEAFLET
GONADORELIN 100 MICROGRAMS POWDER
FOR SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET:
1. What Gonadorelin injection is and what it is used for
2. Before you take Gonadorelin injection
3. How to take Gonadorelin injection
4. Possible side effects
5. How to store Gonadorelin 100 micrograms powder for solution for
injection
6. Further information 1. WHAT GONADORELIN INJECTION IS AND WHAT IT IS USED FOR
This product’s full name is Gonadorelin 100 micrograms powder for
solution for
injection. In this leaflet it is referred to as Gonadorelin or
Gonadorelin injection.
The powder in the vial contains 100 micrograms of the active
ingredient gonadorelin as
gonadorelin hydrochloride and lactose monohydrate. The powder is
dissolved in 1 ml of
sterile water for injections before use.
Gonadorelin is a synthetically produced hormone which is the same as a
naturally occurring hormone (LH/FSH-RH).
Gonadorelin injection is used to help check whether the hormones
called luteinising
hormone (LH) and follicle-stimulating hormone (FSH), which occur
naturally within the
human body, are being produced and released at the correct levels.
LH stimulates egg production (ovulation) from the ovary in the female,
and the
hormone testosterone from the testicle in the male. FSH stimulates the
ovaries
to release eggs, and the testicles to produce sperm. 2. BEFORE YOU TAKE GONADORELIN INJECTION
DO NOT TAKE GONADORELIN INJECTION IF YOU:
• are ALLERGIC (hypersensitive) to Gonadorelin, similar medicines,
or to lactose.
• are, or suspect you may

Caracteristicilor produsului

OBJECT 1
GONADORELIN 100 MICROGRAMS POWDER FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 08-Jun-2016 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Gonadorelin 100 micrograms powder for solution for injection
HRF 100 microgram
2. Qualitative and quantitative composition
Each vial contains 100 micrograms of gonadorelin as gonadorelin
hydrochloride.
After reconstitution with 1 ml of water for injections, the resulting
solution contains 100 micrograms/ml
of gonadorelin as gonadorelin hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Gonadorelin as a single injection is indicated for evaluating the
functional capacity and response of the
gonadotropes of the anterior pituitary. The LH response is used in
testing patients with suspected
gonadotropin deficiency, whether due to the hypothalamus alone or in
combination with anterior pituitary
failure. Gonadorelin injection is also indicated for evaluating
residual gonadotropic function of the
pituitary following removal of a pituitary tumour or surgery and/or
irradiation.
The gonadorelin test complements the clinical assessment of patients
with a variety of endocrine
disorders involving the hypothalamic-pituitary axis. In cases where
there is a normal response, it indicates
the presence of functional pituitary gonadotropes. The single
injection test does not determine the patho-
physiological cause for the subnormal response and does not measure
pituitary gonadotropic reserve.
4.2 Posology and method of administration
Posology
_Adults and Elderly_
100 micrograms, subcutaneously or intravenously. In females for whom
the phase of the menstrual cycle
can be established, the test should be performed in the early
follicular phase (days 1-7).
_Paediatric population_
The safety and efficacy of gonadorelin in children under one year have
not been established. No data are
available.
Route of administration
For subc