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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Itraconazole

Pieejams no:

Janssen-Cilag Ltd

ATĶ kods:

J02AC; J02AC02

SNN (starptautisko nepatentēto nosaukumu):

Itraconazole

Deva:

10 milligram(s)/millilitre

Zāļu forma:

Concentrate and solvent for solution for infusion

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Triazole derivatives; itraconazole

Autorizācija statuss:

Marketed

Autorizācija datums:

2003-08-22

Lietošanas instrukcija

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPORANOX I.V. 10 MG/ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR
INFUSION
(itraconazole)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT SPORANOX I.V. IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPORANOX I.V.
3.
HOW YOU WILL BE GIVEN SPORANOX I.V.
4.
POSSIBLE SIDE EFFECTS
5.
HOW SPORANOX I.V. IS STORED
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SPORANOX I.V. IS AND WHAT IT IS USED FOR
Sporanox I.V. is one of a group of medicines called "antifungals".
These medicines are used to treat
infections caused by fungi including yeasts.
SPORANOX I.V. IS USED TO:

Treat fungal infections of the internal organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPORANOX I.V.
YOU SHOULD NOT BE GIVEN SPORANOX I.V. IF:

You are ALLERGIC (hypersensitive) to any of the ingredients in
Sporanox I.V. (listed in section 6
Contents of the pack and other information)

You are PREGNANT, think you might be pregnant or are trying to become
pregnant, (see the section on
Pregnancy)

Your kidney function is seriously reduced

You cannot have sodium chloride by injection.

You are taking any of the following medicines:
o
terfenadine or mizolastine (antihistamines for allergies)
o
bepridil, ivabradine or ranolazine - used to treat angina (crushing
chest pain)
o
nisoldipine, lercanidipine or eplerenone (used for high blood
pressure)
o
cisapride (used for stomach upsets)
o
domperidone (for nausea and vomiting)
o
midazolam by mouth or triazolam (used to help you sleep or for
anxiety)
o
lovastatin or simvastatin (used to lower cholesterol)
o
lurasidone, pimozide or sertindole (for conditions affect

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sporanox I.V. 10 mg/ml concentrate and solvent for solution for
infusion.
2 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.
3 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:
(a) 25 ml of Sporanox IV 10 mg/ml concentrate for infusion, a
colourless solution presented in a glass ampoule.
(b) 50 ml of 0.9 % Sodium Chloride Injection solvent for solution for
infusion, a colourless solution presented in
a polypropylene bag.
(c) Extension line with 2
-
way stopcock and in
-
line filter.
4 CLINICAL PARTICULARS
4.1 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 ineffective. (This may be due to
underlying pathology, insensitivity of the pathogen or
drug toxicity).
Treatment of aspergillosis, candidosis and cryptococcosis (including
cryptococcal meningitis): in immunocompromised
patients with cryptococcosis and in all patients with cryptococcosis
of the central nervous system.
Consideration should be given to national and/or local guidance
regarding the appropriate use of antifungal agents.
4.2 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 of the