TERIZIDON Capsules, hard (2016)
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Περιεχόμενα
Name of the medicinal product
TERIZIDON, 250 mg, capsules, hard.
Qualitative and quantitative composition
Active substance: Terizidone. 1 TERIZIDON capsule, hard contains 250 mg terizidone. Excipient with known effect: Contains lactose (see section 4.4). For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsules, hard. TERIZIDON is a green, opaque capsule, hard.
Therapeutic indications
TERIZIDON is indicated for adults within the scope of an anti-tuberculosis combination therapy for the treatment of tuberculosis, caused by Mycobacterium tuberculosis (see sections 4.4 and 5.1). TERIZIDON ...
Posology and method of administration
Posology 750-1000 mg terizidone per day are generally administered to adults in 3 or 4 single doses, meaning 3 or 4 TERIZIDON capsules, hard. The maximum daily dose is 1000 mg terizidone. Dosage for patients ...
Contraindications
Hypersensitivity to the active substance, cycloserine or to any of the excipients listed in section 6.1 Severe renal insufficiency (serum creatinine >2 mg/dl) Severe cerebral sclerosis Alcoholism Psychological ...
Special warnings and precautions for use
Patients should be monitored during the inpatient and outpatient therapy phases due to the possibility of psychological side effects and nervous system side effects (see section 4.8). Outpatient treatment ...
Interaction with other medicinal products and other forms of interaction
Interactive influences between TERIZIDON and other medicinal substances Index 1: Contraindicated Index 2: Simultaneous intake not recommended Index 3: Simultaneous intake only under monitoring of efficacy ...
Fertility, pregnancy and lactation
Pregnancy It is not known whether terizidone passes through the placenta. However, due to the fact that terizidone (prodrug) hydrolyzes to D-cycloserine, it can be expected that the intake of TERIZIDON ...
Effects on ability to drive and use machines
Due to central nervous side effects, TERIZIDON can alter reaction capabilities also when used according to the intended purpose. The ability for active participation in road traffic or the operation of ...
Undesirable effects
The incidence rates of side effects are based on the following categories: Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000) Not ...
Overdose
As a result of overdose, the side effects listed in section 4.8 may worsen. The central nervous system is particularly affected. Headaches, dizziness, confusion, drowsiness, excitability, paraesthesia, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drug for the treatment of tuberculosis ATC code: J04AK03 Mechanism of action Terizidone is a Schiff base consisting of 2 D-cycloserine molecules and 1 molecule of terephthalaldehyde. ...
Pharmacokinetic properties
The Schiff base terizidone is a prodrug, which hydrolyzes after oral intake into cycloserine. Absorption Terizidone is reabsorbed quickly and almost completely from the gastrointestinal tract after oral ...
Preclinical safety data
From the studies carried out on chronic toxicity, there are no indications which might lead to a suspicion of possible unknown side effects occurring in patients. With reference to the genotoxicity, terizidone ...
List of excipients
Lactose monohydrate Gelatine Talcum Purified water Magnesium stearate (Ph. Eur.) Copovidone Titanium dioxide (E171) Iron(III) hydroxide-oxide x H<sub>2</sub>O (E172) Indigo carmine (E132)
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Capsules, hard in PVC/aluminium blister packs. Original package containing 50 capsules, hard. Package for hospital use containing 1050 capsules, hard.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald – Insel Riems, Germany, phone: +49 30 338427-0, fax: +49 3 83 51 308, e-mail: info@RIEMSER.com
Marketing authorization number(s)
82515.00.00
Date of first authorization / renewal of the authorization
15 May 2012
Date of revision of the text
07/2016
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