SPORANOX I.V. Concentrate and solvent for solution for infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Sporanox IV 10 mg/ml concentrate and solvent for solution for infusion.
Qualitative and quantitative composition
Each ml of the Sporanox IV concentrate contains 10 mg itraconazole. One ampoule with 25 ml contains 250 mg itraconazole (itraconazole trihydrochloride salt formed in situ). Each ml of the admixed solution ...
Pharmaceutical form
Concentrate and solvent for solution for infusion. Sporanox IV 10 mg/ml concentrate and solvent (0.9% Sodium Chloride Injection) for solution for infusion is presented in a procedure pack consisting of: ...
Therapeutic indications
Sporanox IV is indicated for the treatment of histoplasmosis. Sporanox IV is indicated in the following systemic fungal conditions when first-line systemic anti-fungal therapy is inappropriate or has proved ...
Posology and method of administration
This product is supplied with an extension line with a 2-way stopcock and 0.2 μm in-line filter. The dedicated extension line including the in-line filter must be used to ensure the correct administration ...
Contraindications
Sporanox IV is contraindicated in patients with a known hypersensitivity to itraconazole or to any of the excipients. Sporanox IV cannot be used when administration of Sodium Chloride Injection is contraindicated. ...
Special warnings and precautions for use
Cross hypersensitivity There is no information regarding cross hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used in prescribing Sporanox IV to patients with ...
Interaction with other medicinal products and other forms of interaction
Itraconazole is mainly metabolized through CYP3A4. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole. Similarly, itraconazole ...
Fertility, pregnancy and lactation
Pregnancy Sporanox IV must not be used during pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus (see section 4.3). In animal ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances ...
Undesirable effects
Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) with Sporanox Intravenous treatment identified from clinical trials and/or from spontaneous reporting were cough, ...
Overdose
Symptoms In general, adverse events reported with overdose have been consistent with adverse drug reactions already listed in this SmPC for itraconazole (see section 4.8). Treatment In the event of overdose, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotic for systemic use, triazole derivatives ATC code: J02AC02 Mechanism of action Itraconazole inhibits fungal 14α-demethylase, resulting in a depletion of ergosterol ...
Pharmacokinetic properties
Itraconazole General pharmacokinetic characteristics Peak plasma concentrations of itraconazole are reached at the end of the intravenous infusion, declining thereafter. Peak plasma concentrations of hydroxy-itraconazole ...
Preclinical safety data
Itraconazole Nonclinical data on itraconazole revealed no indications for gene toxicity, primary carcinogenicity or impairment of fertility. At high doses, effects were observed in the adrenal cortex, ...
List of excipients
Hydroxypropyl-β-cyclodextrin Propylene glycol Hydrochloric acid concentrated Sodium hydroxide (for pH adjustment) Water for injections 0.9% Sodium Chloride Injection: Sodium chloride Water for injections ...
Incompatibilities
Itraconazole has the potential to precipitate when Sporanox IV is diluted in solutions other than the 50 ml 0.9% sodium chloride injection supplied.
Shelf life
Shelf life Sporanox IV (as packaged): 2 years. 0.9% Sodium Chloride Injection: 3 years. Admixed Solution: 24 hours.
Special precautions for storage
Sporanox IV: Do not store above 25°C. Store in the original container. 0.9% Sodium Chloride Injection: Do not store above 25°C. Do not freeze. Admixed solution: Protect from direct sunlight. From a microbiological ...
Nature and contents of container
Sporanox IV: 25 ml siliconised type I colourless glass ampoule with 25 ml containing 250 mg itraconazole. 0.9% Sodium Chloride: Flexible polypropylene infusion bag, equipped with a flexible inlet and outlet ...
Special precautions for disposal and other handling
Itraconazole has the potential to precipitate when 25 ml of Sporanox IV concentrate are diluted in solutions other than 50 ml 0.9% Sodium Chloride Injection. The full amount of 25 ml of Sporanox IV concentrate ...
Marketing authorization holder
Janssen-Cilag Ltd., 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0344
Date of first authorization / renewal of the authorization
22 July 1999/21<sup>st</sup> July 2009
Date of revision of the text
10 December 2017
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