CRESEMBA Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
CRESEMBA 200 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium sulfate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for concentrate for solution for infusion. White to yellow powder.
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 one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total). ...
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 ...
Fertility, 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
Mannitol Sulfuric acid (for pH-adjustment)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 48 months. Chemical and physical in-use stability after reconstitution and dilution has been demonstrated for 24 hours at 2°C to 8°C, or 6 hours at room temperature. From a microbiological ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Nature and contents of container
One 10 mL Type I glass vial with rubber stopper and an aluminum cap with plastic seal.
Special precautions for disposal and other handling
Reconstitution One vial of the powder for concentrate for solution for infusion should be reconstituted by addition of 5 mL water for injections to the vial. The vial should be shaken to dissolve the powder ...
Marketing authorization holder
Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lörrach, Germany
Marketing authorization number(s)
EU/1/15/1036/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 October 2015
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