IMPAVIDO Hard capsules (2015)
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Περιεχόμενα
Name of the medicinal product
Impavido 10 mg hard capsules. Impavido 50 mg hard capsules.
Qualitative and quantitative composition
1 hard capsule contains: Impavido 10 mg: 10 mg Miltefosine. Impavido 50 mg: 50 mg Miltefosine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsules. Impavido 10 mg hard capsules: White powder in a red, opaque hard capsule of size 3 with a white imprint PLB on the body and MILT 10 on the cap. Impavido 50 mg hard capsules: White powder ...
Therapeutic indications
Treatment of visceral Leishmaniasis caused by Leishmania donovani, indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs). Treatment of cutaneous Leishmaniasis caused by Leishmania ...
Posology and method of administration
Impavido hard capsules are for oral use. The dosage of Impavido hard capsules depends on body weight. Visceral leishmaniasis Body weight Daily Dosage Number of Hard capsules 30-31 kg 60 mg 6 hard capsules ...
Contraindications
Hypersensitivity to the active substance or any of the excipients. Pre-existing severe damage of liver or kidney function (see section 4.4). Sjögren-Larsson Syndrome. Pregnancy and women of childbearing ...
Special warnings and precautions for use
In immunocompromised patientsImpavido may only be used afterfailure ofstandard therapy as only limited experience is available on therapeutic use of Impavido in such patients. In 39 HIV co-infected patients ...
Interaction with other medicinal products and other forms of interaction
In vitro investigations have shown that interactions are unlikely with medications that are metabolised by cytochrome P450 or glucuronised or conjugated otherwise. However, the possibility of interactions ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of miltefosine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Impavido is contraindicated in pregnancy (see ...
Effects on ability to drive and use machines
Impavido may cause undesirable effects such as nausea which may impair the patients ability to concentrate and react properly. In such cases patients should refrain from driving cars and using machines. ...
Undesirable effects
The most commonly reported adverse drug reactions are transient gastrointestinal discomfort, vomiting, diarrhea, and elevation of liver enzymes and serum creatinine. These effects are usuallymild to moderate ...
Overdose
A specific antidote against miltefosine is not known. Gastrointestinalsymptoms(nausea, vomiting, loss of appetite) are to be expected in case of acute overdose. Adverse effects on liver, kidney, and retinal ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiprotozoal ATC code: P01CX Miltefosine has a marked direct antileishmanial activity in vitro and in animal models. Leishmania donovani was the most sensitive species in promastigote ...
Pharmacokinetic properties
Due to the hemolytic nature of miltefosine, no study in humans with intravenous administration can be performed to assessthe bioavailability after oral use. In rats and dogs, however, an absolute bioavailability ...
Preclinical safety data
Toxicological studies with miltefosine have been performed in mice,rats, dogs and rabbits. Adverse reactions not observed in clinicalstudies, butseen in animals at exposure levels similar to clinical exposure ...
List of excipients
Hard capsule content: Collodial anhydroussilica Microcrystalline cellulose Lactose monohydrate Talc Magnesium stearate Hard capsule shell: Gelatin Titanium dioxide Ferric oxide, Purified water Printing ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Impavido 10 mg: Pack with 56 hard capsulessealed in 8 aluminium/aluminium blisterstrips, each containing 7 hard capsules. Impavido 50 mg: Packs with 28 and 56 hard capsulessealed in 4 and 8 aluminium/aluminium ...
Special precautions for disposal and other handling
Any unused product or waste materialshould be disposed in accordance with localrequirements. The hard capsule should not be break, crush, dissolve, or chew Impavido before swallowing.
Marketing authorization holder
Megapharm Ltd, P.O. Box 514, Hod Hasharon, 4510501, Israel Manufacturer: Paesel + Lorei GmbH & Co. KG, Rheinberg, Germany
Marketing authorization number(s)
Impavido 10 mg: 154-05-34311 Impavido 50 mg: 154-06-34313
Date of first authorization / renewal of the authorization
June 2015
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