Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Mecasermin, Quantity: 10 mg/mL
Ipsen Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; benzyl alcohol; polysorbate 20; glacial acetic acid; sodium acetate trihydrate; water for injections
Subcutaneous
1 vial
(S4) Prescription Only Medicine
For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor 1 deficiency (Primary IGFD).,Severe Primary IGFD is defined by:,? height standard deviation score less than or equal to ?3.0 and,? Baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months and,? basal IGF-1 levels below the 2.5th percentile for age and gender and,? GH sufficiency.,? Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.,IGF-1 and GH levels must be performed using validated assays with paediatric normal ranges.
Visual Identification: Clear and colourless solution in a 5 mL clear glass vial with a grey stopper and aluminium flip-off seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-11-22
INCRELEX ® 1 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems. INCRELEX ® _mecasermin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about INCRELEX. It does not contain all the available information. It does not take the place of talking to your child's doctor or pharmacist. All medicines have risks and benefits. Your child's doctor has weighed the risks of them being given INCRELEX against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD BEING GIVEN THIS MEDICINE, ASK YOUR CHILD'S DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT INCRELEX IS USED FOR INCRELEX is a solution for injection that contains mecasermin which is a synthetic insulin-like growth factor-1 (IGF 1), which is similar to the IGF 1 made by your body. It is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their bodies do not make enough IGF 1. This condition is called primary IGF 1 deficiency. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOUR CHILD. Your child's doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for children under the age of 2 years. BEFORE GIVING INCRELEX _WHEN YOUR CHILD MUST NOT BE _ _GIVEN IT _ DO NOT GIVE INCRELEX IF YOUR CHILD: CURRENTLY HAS ANY TUMOUR OR GROWTH, EITHER CANCEROUS OR NON-CANCEROUS HAVE HAD CANCER IN THE PAST HAS ANY CONDITIONS WHICH MAY INCREASE THE RISK OF CANCER. There is an increased risk of tumours and growths (both cancerous and non-cancerous) in children and adolescents treated with INCRELEX. If any new growth, skin lesio Prečítajte si celý dokument
Increlex Product Information v1, 22 November 2019 1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION INCRELEX ® MECASERMIN 10 MG/ML SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE mecasermin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 10 mg of mecasermin*. Each vial of 4 mL contains 40 mg of mecasermin*. *Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF 1) produced in _Escherichia coli_ . _Excipient with known effect: _ One mL contains 9 mg of benzyl alcohol. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor 1 deficiency (Primary IGFD). Severe Primary IGFD is defined by: • height standard deviation score ≤ –3.0 and • Baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months and • basal IGF-1 levels below the 2.5th percentile for age and gender and • GH sufficiency. ▼ Increlex Product Information v1, 22 November 2019 2 • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. IGF-1 and GH levels must be performed using validated assays with paediatric normal ranges. 4.2 DOSE AND METHOD OF ADMINISTRATION INCRELEX is supplied as a multi-dose solution. Each vial is for use in one patient only. Treatment with mecasermin should be under the supervision of a paediatric endocrinologist. There should be documented confirmation of the diagnosis of severe IG Prečítajte si celý dokument