ZAVESCA Capsule, hard (2020)
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Περιεχόμενα
Name of the medicinal product
Zavesca 100 mg capsules.
Qualitative and quantitative composition
Each capsule contains 100 mg miglustat. For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule, hard. White capsules with OGT 918 printed in black on the cap and 100 printed in black on the body.
Therapeutic indications
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is ...
Posology and method of administration
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate. Posology Dosage in type 1 Gaucher disease Adult The recommended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Tremor Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment. In type 1 Gaucher ...
Interaction with other medicinal products and other forms of interaction
Limited data suggest that co-administration of Zavesca and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of miglustat in pregnant women. Studies in animals have shown reproductive toxicity, including dystocia (see section 5.3). The potential risk for humans ...
Effects on ability to drive and use machines
Zavesca has negligible influence on the ability to drive and use machines. Dizziness has been reported as a common adverse reaction, and patients suffering from dizziness should not drive or use machines. ...
Undesirable effects
Summary of the safety profile The most common adverse reactions reported in clinical studies with Zavesca were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4). The most ...
Overdose
Symptoms No acute symptoms of overdose have been identified. Zavesca has been administered at doses of up to 3000 mg/day for up to six months in HIV positive patients during clinical trials. Adverse events ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products ATC Code: A16AX06 Type 1 Gaucher disease Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide ...
Pharmacokinetic properties
Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and ...
Preclinical safety data
The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration). Further effects seen in animals at doses that ...
List of excipients
Capsule contents: Sodium starch glycollate Povidone (K30) Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Printing ink: Black iron oxide (E172) Shellac
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
ACLAR/ALU blister strips supplied as a box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Marketing authorization number(s)
EU/1/02/238/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 November 2002 Date of latest renewal: 08 December 2012
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