NUBEQA Film-coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
NUBEQA 300 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 300 mg of darolutamide. Excipient with known effect: Each film-coated tablet contains 186 mg of lactose monohydrate (see section 4.4). For the full list of excipients, ...
3. Pharmaceutical form
Film-coated tablet (tablet). White to off-white, oval tablets with a length of 16 mm and a width of 8 mm, marked with 300 on one side, and BAYER on the other side.
4.1. Therapeutic indications
NUBEQA is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
4.2. Posology and method of administration
Treatment should be initiated and supervised by a specialist physician experienced in treatment of prostate cancer. Posology The recommended dose is 600 mg darolutamide (two tablets of 300 mg) taken twice ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Women who are or may become pregnant (see section 4.6).
4.4. Special warnings and precautions for use
Renal impairment The available data in patients with severe renal impairment are limited. As exposure might be increased those patients should be closely monitored for adverse reactions (see sections 4.2 ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on darolutamide CYP3A4 and P-gp inducers Darolutamide is a substrate of CYP3A4 and P-glycoprotein (P-gp). Use of strong and moderate CYP3A4 inducers and P-gp inducers ...
4.6. Fertility, pregnancy and lactation
This medicinal product is not indicated in women of childbearing potential. It is not to be used in women who are, or may be, pregnant or breast-feeding (see sections 4.1 and 4.3). Women of childbearing ...
4.7. Effects on ability to drive and use machines
NUBEQA has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most frequently observed adverse reaction is fatigue/asthenic conditions (15.8%). Tabulated list of adverse reactions The adverse reactions observed are listed in Table ...
4.9. Overdose
The highest dose of darolutamide studied clinically was 900 mg twice daily, equivalent to a total daily dose of 1800 mg. No dose limiting toxicities were observed with this dose. Considering the saturable ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Endocrine therapy, anti-androgens ATC code: L02BB06 Mechanism of action Darolutamide is an androgen receptor (AR) inhibitor with a flexible polar-substituted pyrazole structure ...
5.2. Pharmacokinetic properties
General introduction Darolutamide consists of two diastereomers [(S,R)-darolutamide and (S,S)-darolutamide] which interconvert via the main circulating metabolite called keto-darolutamide. In vitro, all ...
5.3. Preclinical safety data
Systemic toxicity In repeated dose toxicity studies in rats and dogs, the main findings were changes in the male reproductive organs (decreases in organ weight with atrophy of the prostate and epididymides). ...
6.1. List of excipients
Tablet core: Calcium hydrogen phosphate (E341) Croscarmellose sodium Lactose monohydrate Magnesium stearate (E470b) Povidone (E1201) Film-coating: Hypromellose Lactose monohydrate Macrogol (E1521) Titanium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf life: 3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/Aluminium foil blisters containing 16 film-coated tablets. Each pack contains 96 or 112 film-coated tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
8. Marketing authorization number(s)
EU/1/20/1432/001 112 film-coated tablets EU/1/20/1432/002 96 film-coated tablets
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 27 March 2020
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