Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Somatropin 12mg (41.4IU [13.8mg] with overage.)
Pfizer New Zealand Limited
Somatropin 12 mg (41.4IU [13.8mg] with overage.)
12 mg
Powder for injection
Active: Somatropin 12mg (41.4IU [13.8mg] with overage.) Excipient: Dibasic sodium phosphate Glycine Mannitol Monobasic sodium phosphate Mannitol Metacresol Water for injection
Cartridge, 1 x GoQuick multidose pen (not marketed),
Prescription
Prescription
Pfizer Health AB
Adults Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. Patients must also fulfill the following criteria. Childhood onset: Patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with GENOTROPIN MINIQUICK is started. Adult onset: Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. Prader-Willi syndrome, for improvement of body composition.
Package - Contents - Shelf Life: Cartridge, 1 x GoQuick multidose pen - - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 months unopened stored at or below 25°C - Cartridge, 1 x Prefilled dual - 12 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 4 weeks reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 months unopened stored at or below 25°C - Cartridge, 5 x Prefilled dual compartment - 60 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 4 weeks reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 months unopened stored at or below 25°C
1989-02-03
Page 1 of 4 GENOTROPIN 5.3 MG AND 12 MG CARTRIDGES RECOMBINANT HUMAN SOMATROPIN (RHGH) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GENOTROPIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using GENOTROPIN against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GENOTROPIN IS USED FOR GENOTROPIN is a growth hormone. GENOTROPIN promotes the growth of long bones (for example: upper legs) in children with reduced height due to lower than normal levels of growth hormone. It is also used to treat reduced growth in girls with Turner’s syndrome and in children prior to the onset of puberty who have long-term kidney problems causing growth disturbance. GENOTROPIN is also used in adults who have low levels of growth hormone due to a disease in the pituitary gland or hypothalamus in the brain. GENOTROPIN is used for children and adults who have a genetic disorder called Prader- Willi syndrome (symptoms include intellectual impairment, uncontrollable urge to eat). However, your doctor may prescribe GENOTROPIN for another purpose. Ask your doctor if you have any questions about why GENOTROPIN has been prescribed for you. BEFORE YOU USE GENOTROPIN WHEN YOU MUST NOT USE GENOTROPIN (DISCUSS WITH YOUR DOCTOR) YOUR DOCTOR WILL NOT PRESCRIBE GENOTROPIN IF YOU: • are a child and have closed epiphyses (this means that your bones have finished growing) • have an active tumour or evidence of cancer growth • are currently being treated for cancer • have a serious injury or illness, or surgical procedures requiring intensive therapy • have Prader-Willi syndrome and are severely overweight or have breathing difficulties • are allergic to any of the ingredients of GENOTROPIN. DO NOT USE GENOTR Lugege kogu dokumenti
Version: pfdgentv10821 Supersedes: pfdgentv11119 Page 1 of 12 NEW ZEALAND DATA SHEET 1. PRODUCT NAME GENOTROPIN ® 5 mg powder for injection with solvent. GENOTROPIN _®_ 5.3 mg powder for injection with solvent. GENOTROPIN _®_ 12 mg powder for injection with solvent. GENOTROPIN _GoQuick_ _®_ 5 mg powder for injection with solvent. GENOTROPIN _GoQuick_ _®_ 5.3 mg powder for injection with solvent. GENOTROPIN _GoQuick_ _®_ 12 mg powder for injection with solvent. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GENOTROPIN / GENOTROPIN _ GoQuick_ 5 mg powder for injection with solvent. One cartridge contains 5 mg somatropin*. After reconstitution the concentration of somatropin is 5 mg/mL. GENOTROPIN / GENOTROPIN _ GoQuick_ 5.3 mg powder for injection with solvent. One cartridge contains 5.3 mg somatropin*. After reconstitution the concentration of somatropin is 5.3 mg/mL. GENOTROPIN / GENOTROPIN _ GoQuick_ 12 mg powder for injection with solvent. One cartridge contains 12 mg somatropin*. After reconstitution the concentration of somatropin is 12 mg/mL. *produced in _Escherichia coli_ cells by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. In the two-chamber cartridge there is a white powder in the front compartment and a clear solution in the rear compartment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHILDREN Growth disturbance due to insufficient secretion of growth hormone (GH) and growth disturbance associated with Turner syndrome or chronic renal insufficiency. Prader-Willi syndrome, for improvement of growth and body composition. Version: pfdgentv10821 Supersedes: pfdgentv11119 Page 2 of 12 ADULTS Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for GH deficiency. Patients must also fulfil the following criteria. _Childhood onset:_ Patients who were diagnosed as growth hormone deficient during childhood must be retested and their growth Lugege kogu dokumenti