SPORANOX ORAL SOLUTION

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

ITRACONAZOLE

Dostępny od:

J-C HEALTH CARE LTD

Kod ATC:

J02AC02

Forma farmaceutyczna:

SOLUTION

Skład:

ITRACONAZOLE 10 MG/ML

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Grupa terapeutyczna:

ITRACONAZOLE

Dziedzina terapeutyczna:

ITRACONAZOLE

Wskazania:

Sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. Prevention of fungal infection during neutropenia of immunodeficient patients.

Data autoryzacji:

2014-05-31

Ulotka dla pacjenta

∘ MEDICINES TO TREAT PAIN
• alfentanil, buprenorphine, oxycodone or sufentanil
)for pain(
• meloxicam )for joint inflammation and pain(
∘ OTHER MEDICINES
• alitretinoin )given by mouth( )for eczema(
• cabergoline )for Parkinson’s disease(
• cannabis-based products including medicines )for
nausea and vomiting or muscle spasms in patients
with multiple sclerosis(
• cinacalcet )for an overactive thyroid(
• dienogest or ulipristal )contraceptives(
• eliglustat )for Gaucher’s disease(, used in patients
whose body cannot break down certain medicines
• ivacaftor )for cystic fibrosis(
• methadone )to treat drug addiction(
• repaglinide or saxagliptin )for diabetes(
This is not a complete list, so tell the doctor if you are
taking or planning to take any of these medicines, or
any other medicine.
USE OF THE MEDICINE WITH FOOD
Do not take Sporanox Oral Solution together with food
or a drink, as it reduces the ability of the body to absorb
the medicine. Always take Sporanox Oral Solution one
hour before eating or drinking to help the body absorb
the medicine.
ELDERLY
Sporanox Oral Solution is not usually intended for the
elderly. The doctor may prescribe it in special cases.
PREGNANCY
Do not take Sporanox Oral Solution if you are pregnant,
unless instructed to do so by the doctor.
If you are of child-bearing age and could become
pregnant, consult a doctor. Use effective contraceptives
to make sure that you do not become pregnant while
you are taking this medicine. As Sporanox Oral Solution
remains in the body for some time after you stop taking
it, continue to use some form of contraception until your
next period after treatment is discontinued.
If you discover that you are pregnant after starting
treatment with Sporanox Oral Solution, stop the treatment
and tell the doctor immediately.
Before you take any medicine, always tell the doctor if you
are pregnant, think you might be pregnant or are trying
to become pregnant.
BREASTFEEDING
If you are breastfeeding, do not take Sporanox Oral
Solution,

Charakterystyka produktu

Sporanox oral sol 08_2021_sub
(ןכרצלו אפורל םינולע ןוכדעו השגהל
תויחנה להונ ךותמ 5.8.6 ףיעס ) ןכרצל ןולעו
אפורל ןולע – עדימב המילה תרהצה
1.
NAME OF THE MEDICINAL PRODUCT
SPORANOX
ORAL SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL SPORANOX Oral Solution contains 10 mg itraconazole.
Excipients with known effect
Each mL of SPORANOX Oral Solution contains:
400 mg hydroxypropyl-β (cyclodextrin);
190 µl sorbitol liquid non-crystallising
100 µl propylene glycol;
0.005 mg ethanol.( Ethanol is present as an ingredient in cherry
flavor 1 in an amount of 0,005 mg per mL in
each mL oral solution)
For the 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 treatmemt of :
1. Oropharyngeal and esophageal candidiasis,
2. Prevention of fungal infection during neutropenia in
immunodeficient patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For optimal absorption, SPORANOX Oral Solution
should be taken without food (patients are advised to
refrain from eating or drinking for at least 1 hour after intake).
For the treatment of oral and/or oesophageal candidosis, the oral
solution
should be swished around the oral
cavity (approx. 20 seconds) and swallowed. There should be no rinsing
after swallowing.
Treatment of oral and/or oesophageal candidosis200 mg (2 measuring
cups) per day in two
intakes, or alternatively in one intake, for 1 week. If there is no
response after 1 week, treatment
should be continued for another week.
Sporanox oral sol 08_2021_sub
Treatment of fluconazole resistant oral and/or oesophageal candidosis:
100 to 200 mg (1-
2 measuring cups) twice daily 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 tha