Sporanox I.V. 250mg/25ml solution for infusion ampoules and diluent

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Itraconazole

Disponible des:

Janssen-Cilag Ltd

Codi ATC:

J02AC02

Designació comuna internacional (DCI):

Itraconazole

Dosis:

10mg/1ml

formulario farmacéutico:

Solution for infusion

Vía de administración:

Intravenous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05020100; GTIN: 5012674059500

Informació per a l'usuari

- 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 affec

Fitxa tècnica

OBJECT 1
SPORANOX I.V. 10 MG/ML CONCENTRATE AND SOLVENT
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 02-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Sporanox IV 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
d