ITRACONAZOLE Oral solution (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Itraconazole 10 mg/ml Oral Solution.
Qualitative and quantitative composition
1 ml Itraconazole oral solution contains 10mg itraconazole. Excipients with known effect: Each ml of Itraconazole oral solution contains 283.1mg of sorbitol E420, 103.6mg of propylene glycol (E1520), less ...
Pharmaceutical form
Oral solution. Itraconazole oral solution is a clear, yellow solution.
Therapeutic indications
Itraconazole oral solution is indicated: For the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients. As prophylaxis of deep fungal infections anticipated ...
Posology and method of administration
For optimal absorption, Itraconazole oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake). A graduated measuring cup is provided to ...
Contraindications
Itraconazole oral solution is contraindicated in patients with a known hypersensitivity to itraconazole or to any of the excipients (See section 6.1). Co-administration of a number of CYP3A4 substrates ...
Special warnings and precautions for use
Use in patients with gastro-intestinal motility impairment When treating patients with severe fungal infections or when administering it as fungal prophylaxis to those with abnormal gastro-intestinal motility, ...
Interaction with other medicinal products and other forms of interaction
Itraconazole is mainly metabolized through CYP3A4. Other substances that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole. Similarly, itraconazole ...
Fertility, pregnancy and lactation
Pregnancy Itraconazole oral solution must not be used during pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus (see 4.3 Contraindications). ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances ...
Undesirable effects
Approximately 9% of patients can be expected to experience adverse reactions while taking itraconazole. In patients receiving prolonged (approximately 1 month) continuous treatment especially, the incidence ...
Overdose
Symptoms In general, adverse events reported with overdose have been consistent with adverse drug reactions already listed in this SmPC for itraconazole (see section 4.8). Treatment In the event of an ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotic for systemic use, triazole derivative ATC code: J02AC02 Mode of action Itraconazole inhibits fungal 14α-demethylase, resulting in a depletion of ergosterol and disruption ...
Pharmacokinetic properties
Itraconazole General pharmacokinetic characteristics Peak plasma concentrations are reached within 2.5 hours following administration of the oral solution. As a consequence of non-linear pharmacokinetics, ...
Preclinical safety data
Itraconazole Nonclinical data on itraconazole revealed no indications for genotoxicity, primary carcinogenicity or impairment of fertility. At high doses, effects were observed in the adrenal cortex, liver ...
List of excipients
Hydroxypropyl-β-cyclodextrin Sorbitol 70% (E420) Propylene glycol Cherry flavour Caramel (contains ethanol and propylene glycol) Sodium saccharin dihydrate Hydrochloric acid and sodium hydroxide (for pH ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 18 months as packaged for sale. 1 month after first opening the container.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Type III 150 ml amber glass bottle, with child resistant polyethylene screw cap and LDPE internal coating, in a cardboard carton. A graduated measuring cup is provided. Graduation is from 2.5-30ml, initially ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
UK: Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England IE: Athlone Laboratories Limited, Ballymurray, Co Roscommon, Ireland
Marketing authorization number(s)
PL 18157/0258 PA 0298/023/001
Date of first authorization / renewal of the authorization
27/03/2013
Date of revision of the text
15 February 2019
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