SPORANOX I.V. Concentrate and solvent for solution for infusion Ref.[6947] Active ingredients: Itraconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Janssen-Cilag Ltd., 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form

Sporanox IV 10 mg/ml concentrate and solvent for solution for infusion.

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:

  • 25 ml of Sporanox IV 10 mg/ml concentrate for infusion, a colourless solution presented in a glass ampoule.
  • 50 ml of 0.9% Sodium Chloride Injection solvent for solution for infusion, a colourless solution presented in a polypropylene bag.
  • Extension line with 2-way stopcock and in-line filter.

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 contains 3.33 mg itraconazole. One single dose of 200 mg itraconazole corresponds to 60 ml of the admixed solution.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Itraconazole

Itraconazole is a triazole derivative that inhibits fungal 14α-demethylase, resulting in a depletion of ergosterol and disruption of membrane synthesis by fungi.
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

Pack sizes and marketing

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 port, and containing 52 to 56 ml of 0.9% Sodium Chloride Injection.

Extension line: Polyvinylchloride tubing with 2-way stopcock and in-line filter.

Marketing authorization holder

Janssen-Cilag Ltd., 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 00242/0344

22 July 1999/21st July 2009

Drugs

Drug Countries
SPORANOX Austria, Australia, Brazil, Canada, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Malta, Mexico, New Zealand, Singapore, Turkey, United Kingdom, United States, South Africa
 
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