Sporanox

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Itraconazole 10 mg/mL

Available from:

Janssen-Cilag (New Zealand) Ltd

INN (International Name):

Itraconazole 10 mg/mL

Dosage:

10 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Itraconazole 10 mg/mL Excipient: Caramel Cherry flavour 654536 Cherry flavour 654595 Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Propylene glycol Purified water Saccharin sodium Sodium hydroxide Sorbitol

Units in package:

Bottle, glass, 150 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

Therapeutic indications:

SPORANOX oral solution is indicated for the: · treatment of oral and/or oesophageal candidiasis in HIV-positive or other immunocompromised patients. · prophylaxis of fungal infections in neutropenic patients.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 150 mL - 24 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C

Authorization date:

1995-12-21

Patient Information leaflet

SPORANOX
®
ORAL SOLUTION (230619) ACMI
1
SPORANOX
® ORAL
SOLUTION
_Itraconazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SPORANOX Oral
Solution. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SPORANOX
Oral Solution against the benefits this
medicine is expected to have for you.
If you have any concerns about
taking SPORANOX Oral Solution,
ask your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT SPORANOX ORAL
SOLUTION IS USED FOR
SPORANOX Oral Solution is a
medicine used for:
•
the treatment of candida (yeast)
infections of the mouth, throat
and/or foodpine (gullet) in
patients who have a lowered
resistance to disease.
•
the prevention of fungal
infections in certain patients who
may have a lowered resistance.
SPORANOX works by killing or
stopping the growth of the fungus
that causes the infection.
Your doctor may have prescribed
SPORANOX Oral Solution for
another reason. Ask your doctor if
you have any questions about why
this medicine has been prescribed for
you.
BEFORE YOU TAKE
SPORANOX ORAL
SOLUTION
_WHEN YOU MUST NOT TAKE IT _
Do not take SPORANOX Oral
Solution if:
•
you are pregnant or may become
pregnant.
If there is any chance of you
becoming pregnant, talk to your
doctor about the need for highly
effective contraception. Once
you have finished taking
SPORANOX, you should
continue using highly effective
contraception until you have had
your next period. Tell your
doctor immediately if you do
become pregnant while taking
SPORANOX.
•
you have a condition called heart
failure (also called congestive
heart failure or CHF),
SPORANOX could make it
worse. If your doctor decides that
you need to take SPORANOX
even if you have this condition,
be sure to get immediate medical
help if you have shortness of
breath, unexpected weight gain,
swe

Summary of Product characteristics

18.230609
1
SPORANOXorlsol (230918) ADS
SPORANOX
®
ITRACONAZOLE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SPORANOX
®
itraconazole 10 mg/mL oral solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml SPORANOX Oral Solution contains 10 mg itraconazole.
Excipient(s) with known effect:
Sorbitol (7.92 g in 40 mL of solution). Products containing sorbitol
may have a laxative effect or
cause diarrhoea.
For a full list of excipients, see SECTION 6.1
3. PHARMACEUTICAL FORM
Oral solution.
SPORANOX Oral Solution is clear, yellow to slightly amber solution
with an odour of cherry.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPORANOX oral solution is indicated for the:
•
treatment
of
oral
and/or
oesophageal
candidiasis
in
HIV-positive
or
other
immunocompromised patients.
•
prophylaxis of fungal infections in neutropenic patients.
4.2 DOSE AND METHOD OF ADMINISTRATION
For optimal absorption, SPORANOX oral solution should be taken without
food. The solution
should be swished in the oral cavity and swallowed. There should be no
rinsing after swallowing.
TREATMENT OF ORAL CANDIDIASIS
200 mg (2 measuring cups or 20 mL) once a day or 100 mg (1 measuring
cup or 10 mL) twice a
day for 1 week. If there is no response after 1 week, treatment should
be continued for another
week.
TREATMENT OF OESOPHAGEAL CANDIDIASIS
100 mg (1 measuring cup, i.e. 10 mL) daily for a minimum treatment of
three weeks. Treatment
should continue for 2 weeks following resolution of symptoms. Doses up
to 200 mg (2 measuring
cups, i.e. 20 mL) per day may be used based on the clinical response
of the patient.
18.230609
2
SPORANOXorlsol (230918) ADS
TREATMENT OF FLUCONAZOLE-RESISTANT ORAL AND/OR OESOPHAGEAL CANDIDIASIS
200 to 400 mg (2-4 measuring cups or 20-40 mL) daily in one or two
intakes for 2 weeks. If there
is no response after 2 weeks, treatment should be continued for
another 2 weeks. The 400 mg
daily dose should not be used for longer than 14 days if there are no
signs of improvement.
PROPHYLAXIS OF FUNGAL INFECTIONS
5 mg/kg per day adminis