CRESEMBA Hard capsule (2020)
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Περιεχόμενα
Name of the medicinal product
CRESEMBA 100 mg hard capsules.
Qualitative and quantitative composition
For the full list of excipients, see section 6.1. Each capsule contains 100 mg isavuconazole (as 186.3 mg isavuconazonium sulfate).
Pharmaceutical form
Hard capsule. Swedish Orange (reddish-brown) capsule body marked with 100 in black ink and a white cap marked with C in black ink. Capsules length: 24.2 mm.
Therapeutic indications
CRESEMBA is indicated in adults for the treatment of: invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1). Consideration should be given ...
Posology and method of administration
Posology Loading dose The recommended loading dose is two capsules (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total). Maintenance dose The recommended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration with ketoconazole (see section 4.5). Co-administration with high-dose ritonavir (>200 mg every ...
Special warnings and precautions for use
Hypersensitivity Caution should be used in prescribing isavuconazole to patients with hypersensitivity to other azole antifungal agents. Hypersensitivity to isavuconazole may result in adverse reactions ...
Interaction with other medicinal products and other forms of interaction
Potential of medicinal products to affect the pharmacokinetics of isavuconazole Isavuconazole is a substrate of CYP3A4 and CYP3A5 (see section 5.2). Co-administration of medicinal products which are inhibitors ...
Pregnancy and lactation
Pregnancy There are no data from the use of CRESEMBA in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. CRESEMBA must not ...
Effects on ability to drive and use machines
Isavuconazole has a moderate potential to influence the ability to drive and use machines. Patients should avoid driving or operating machinery if symptoms of confusional state, somnolence, syncope, and/or ...
Undesirable effects
Summary of the safety profile The frequency of adverse reactions shown in Table 2 is based on data from 403 patients with invasive fungal infections treated with CRESEMBA in phase 3 studies. The most common ...
Overdose
Symptoms Symptoms reported more frequently at supratherapeutic doses of CRESEMBA (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives ATC code: J02AC05 Mechanism of action Isavuconazole is the active moiety formed after oral or intravenous administration of ...
Pharmacokinetic properties
Isavuconazonium sulfate is a water-soluble prodrug that can be administered as an intravenous infusion or orally as hard capsules. Following administration, isavuconazonium sulfate is rapidly hydrolysed ...
Preclinical safety data
In rats and rabbits, isavuconazole at systemic exposures below the therapeutic level were associated with dose-related increases in the incidence of skeletal anomalies (rudimentary supernumerary ribs) ...
List of excipients
Capsule contents: Magnesium citrate (anhydrous) Microcrystalline cellulose Talc Silica, colloidal anhydrous Stearic acid Capsule shell: Hypromellose Water Red iron oxide (E172) (capsule body only) Titanium ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months.
Special precautions for storage
Do not store above 30°C. Store in the original packaging in order to protect from moisture.
Nature and contents of container
14 hard capsules (in two aluminum blisters), with each capsule pocket connected to a pocket with desiccant.
Special precautions for disposal and other handling
This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lörrach, Germany
Marketing authorization number(s)
EU/1/15/1036/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 October 2015
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