KETOCONAZOLE HRA Tablet (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Ketoconazole HRA 200 mg tablets.
Qualitative and quantitative composition
Each tablet contains 200 mg ketoconazole. Excipient with known effect: each tablet contains 19 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Off-white to light cream, round, 10 mm diameter, biconvex.
Therapeutic indications
Ketoconazole HRA is indicated for the treatment of endogenous Cushings syndrome in adults and adolescents above the age of 12 years.
Posology and method of administration
Treatment should be initiated and supervised by physicians experienced in endocrinology or internal medicine and having the appropriate facilities for monitoring of biochemical responses since the dose ...
Contraindications
Hypersensitivity to ketoconazole and/or to any imidazole antifungal medication, or to any of the excipients listed in section 6.1. Acute or chronic liver disease and/or if pre-treatment liver enzymes levels ...
Special warnings and precautions for use
Monitoring of liver function Liver enzymes should be monitored in all patients receiving Ketoconazole HRA. Due to the risk of serious hepatic toxicity, close follow-up of patients is required (see section ...
Interaction with other medicinal products and other forms of interaction
See section 4.3 Contraindications for the list of the medicinal products that are contraindicated during treatment with Ketoconazole HRA. Medicinal products affecting the absorption of Ketoconazole HRA ...
Fertility, pregnancy and lactation
Pregnancy There are insufficient clinical data regarding the use of Ketoconazole HRA in pregnant women. Preclinical data show that Ketoconazole HRA crosses the placenta and is teratogenic. Ketoconazole ...
Effects on ability to drive and use machines
No specific studies have been conducted to assess the effect of ketoconazole on the ability to drive or use machines. Patients should be warned about the potential for dizziness and somnolence (see section ...
Undesirable effects
Summary of the safety profile The most frequent adverse reactions are adrenal insufficiency, nausea, vomiting, abdominal pain, diarrhoea, pruritus, rash and the hepatic enzymes increased. The most serious ...
Overdose
There is no known antidote to Ketoconazole HRA. The maximal dose that was used for treatment of Cushings syndrome is 1600 mg/day. In the event of accidental overdose, treatment consists of supportive measures. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Imidazole derivatives ATC code: J02AB02 Mechanism of action Ketoconazole is a steroidogenesis inhibitor. Ketoconazole is an imidazole derivative that is a potent inhibitor of ...
Pharmacokinetic properties
Absorption Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption. Mean peak plasma concentrations of approximately 3.5 μg/ml are reached within 1 to 2 hours, following ...
Preclinical safety data
The toxicological profile of ketoconazole has been established from long term studies in rats and dogs. Bone fragility and broken legs were reported in rats but were not observed in other species. Consistent ...
List of excipients
Maize starch Lactose monohydrate Povidone Microcrystalline cellulose Silica colloidal Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/Alu blister of 10 tablets. Pack sizes containing 6 blisters of 10 tablets.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Laboratoire HRA Pharma, 15 rue Béranger, 75003 Paris, France
Marketing authorization number(s)
EU/1/14/965/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 November 2014
Date of revision of the text
22 August 2017
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