FORSTEO Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
FORSTEO 20 micrograms/80 microliters solution for injection in pre-filled pen.
Qualitative and quantitative composition
Each dose of 80 microliters contains 20 micrograms of teriparatide*. One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL). * Teriparatide, rhPTH(1-34), ...
Pharmaceutical form
Solution for injection. Colourless, clear solution.
Therapeutic indications
FORSTEO is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence ...
Posology and method of administration
Posology The recommended dose of FORSTEO is 20 micrograms administered once daily. The maximum total duration of treatment with FORSTEO should be 24 months (see section 4.4). The 24-month course of FORSTEO ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and breast-feeding (see sections 4.4 and 4.6). Pre-existing hypercalcaemia. Severe renal impairment. ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Serum and urine calcium In normocalcaemic ...
Interaction with other medicinal products and other forms of interaction
In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose did not alter the cardiac effect of digoxin. However, sporadic case reports have suggested that hypercalcaemia ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in females Women of childbearing potential should use effective methods of contraception during use of FORSTEO. If pregnancy occurs, FORSTEO should be discontinued. ...
Effects on ability to drive and use machines
FORSTEO has no or negligible influence on the ability to drive and use machines. Transient, orthostatic hypotension or dizziness was observed in some patients. These patients should refrain from driving ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness. Tabulated list of adverse reactions Of patients ...
Overdose
Signs and symptoms FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks. The effects of overdose that might be expected include ...
Pharmacodynamic properties
Pharmaco-therapeutic group: Calcium homeostasis, parathyroid hormones and analogues ATC code: H05AA02 Mechanism of action Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of ...
Pharmacokinetic properties
Distribution The volume of distribution is approximately 1.7 L/kg. The half-life of FORSTEO is approximately 1 hour when administered subcutaneously, which reflects the time required for absorption from ...
Preclinical safety data
Teriparatide was not genotoxic in a standard battery of tests. It produced no teratogenic effects in rats, mice or rabbits. There were no important effects observed in pregnant rats or mice administered ...
List of excipients
Glacial acetic acid Sodium acetate (anhydrous) Mannitol Metacresol Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years. Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C. Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C. Other in-use ...
Special precautions for storage
Store in a refrigerator (2°C–8°C) at all times. The pen should be returned to the refrigerator immediately after use. Do not freeze. Do not store the injection device with the needle attached.
Nature and contents of container
2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen. FORSTEO is available ...
Special precautions for disposal and other handling
FORSTEO is supplied in a pre-filled pen. Each pen should be used by only one patient. A new, sterile needle must be used for every injection. Each FORSTEO pack is provided with a user manual that fully ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/03/247/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 June 2003 Date of the latest renewal: 13 February 2013
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