MIRCERA Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe. MIRCERA 50 micrograms/0.3 ml solution for injection ...
Qualitative and quantitative composition
<strong>MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe:</strong> One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration ...
Pharmaceutical form
Solution for injection in pre-filled syringe (injection). The solution is clear and colourless to slightly yellowish.
Therapeutic indications
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).
Posology and method of administration
Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment. Posology Treatment of symptomatic anaemia in adult chronic ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Uncontrolled hypertension.
Special warnings and precautions for use
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established. Caution should be exercised with escalation of MIRCERA doses in patients ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. There is no evidence that MIRCERA alters the metabolism of other medicinal products.
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of MIRCERA in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal ...
Effects on ability to drive and use machines
MIRCERA has no or negligible influence on the ability to drive and use machines.
Undesirable effects
(a) Summary of the safety profile The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients treated with MIRCERA and 1,103 with another ESA. Approximately 6% of patients ...
Overdose
The therapeutic range of MIRCERA is wide. Individual responsiveness must be considered when treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antianemic preparations ATC code: B03XA03 Mechanism of action MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the ...
Pharmacokinetic properties
The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis. Following subcutaneous ...
Preclinical safety data
Non-clinical data show no special hazard for humans based on conventional studies of cardiovascular safety pharmacology, repeat dose toxicity and reproductive toxicity. The carcinogenic potential of methoxy ...
List of excipients
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine Poloxamer 188 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. The end-user may remove the medicinal product from refrigeration for storage ...
Nature and contents of container
Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap (bromobutyl rubber) and a needle 27G1/2. Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 ...
Special precautions for disposal and other handling
The pre-filled syringe is ready for use. The sterile pre-filled syringe does not contain any preservative and is to be used for a single injection only. Only one dose should be administered per syringe. ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/07/400/008 EU/1/07/400/009 EU/1/07/400/010 EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018 EU/1/07/400/019 EU/1/07/400/020 EU/1/07/400/021 EU/1/07/400/022 EU/1/07/400/023 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 July 2007 Date of latest renewal: 15 May 2012
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