国家: 以色列
语言: 英文
来源: Ministry of Health
ITRACONAZOLE
J-C HEALTH CARE LTD
J02AC02
SOLUTION
ITRACONAZOLE 10 MG/ML
PER OS
Required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
ITRACONAZOLE
ITRACONAZOLE
Sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. Prevention of fungal infection during neutropenia of immunodeficient patients.
2014-05-31
∘ 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, 阅读完整的文件
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 阅读完整的文件