MIMPARA Film-coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Mimpara 30 mg film-coated tablets. Mimpara 60 mg film-coated tablets. Mimpara 90 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride). Excipient with known effect: Mimpara 30 mg film-coated tablets: Each 30 mg tablet contains 2.74 mg of lactose. Mimpara 60 mg film-coated ...
Pharmaceutical form
Film-coated tablet (tablet). Mimpara 30 mg film-coated tablets: Light green, oval (approximately 9.7 mm long and 6.0 mm wide), film-coated tablet marked AMG on one side and 30 on the other. Mimpara 60 ...
Therapeutic indications
Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment ...
Posology and method of administration
Secondary hyperparathyroidism Adults and elderly (>65 years) The recommended starting dose for adults is 30 mg once per day. Mimpara should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypocalcaemia (see sections 4.2 and 4.4).
Special warnings and precautions for use
Serum calcium Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult and paediatric patients treated with Mimpara. Manifestations of hypocalcaemia may include ...
Interaction with other medicinal products and other forms of interaction
Medicinal products known to reduce serum calcium Concurrent administration of other medicinal products known to reduce serum calcium and Mimpara may result in an increased risk of hypocalcaemia (see section ...
Fertility, pregnancy and lactation
Pregnancy There are no clinical data from the use of cinacalcet in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, parturition or postnatal development. ...
Effects on ability to drive and use machines
Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking Mimpara (see section 4.4).
Undesirable effects
a) Summary of the safety profile Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo-controlled studies ...
Overdose
Doses titrated up to 300 mg once daily have been administered to adult patients receiving dialysis without adverse outcome. A daily dose of 3.9 mg/kg was prescribed to a paediatric patient receiving dialysis ...
Pharmacodynamic properties
Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents ATC code: H05BX01 Mechanism of action The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the ...
Pharmacokinetic properties
Absorption After oral administration of Mimpara, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours. Based on between-study comparisons, the absolute bioavailability of cinacalcet ...
Preclinical safety data
Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the maximum human dose for secondary HPT (180 mg daily). The non-teratogenic dose in rats was 4.4 times, on ...
List of excipients
Tablet core: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone Crospovidone Magnesium stearate Colloidal anhydrous silica Tablet coat: Carnauba wax Opadry II green: (Lactose monohydrate, ...
Incompatibilities
Not applicable.
Shelf life
Blister: 5 years. Bottle: 5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aclar/PVC/PVAc/Aluminium blister containing 14 tablets. Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton. High Density Polyethylene (HDPE) bottle with a ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Marketing authorization number(s)
EU/1/04/292/001 – 30 mg carton with 14 tablets EU/1/04/292/002 – 30 mg carton with 28 tablets EU/1/04/292/003 – 30 mg carton with 84 tablets EU/1/04/292/004 – 30 mg bottle with 30 tablets EU/1/04/292/005 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 October 2004 Date of latest renewal: 23 September 2009
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