Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gonadorelin hydrochloride
Esteve Pharmaceuticals Ltd
H01CA01
Gonadorelin hydrochloride
100microgram
Powder and solvent for solution for injection
Intravenous; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050100; GTIN: 5039021001401
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 Lugege kogu dokumenti
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 Lugege kogu dokumenti