ELVANSE Capsule, hard (2019)
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Περιεχόμενα
Name of the medicinal product
Elvanse 20 mg capsules, hard. Elvanse 30 mg capsules, hard. Elvanse 40 mg capsules, hard. Elvanse 50 mg capsules, hard. Elvanse 60 mg capsules, hard. Elvanse 70 mg capsules, hard.
Qualitative and quantitative composition
<u>20 mg Capsules:</u> Each capsule contains 20 mg lisdexamfetamine dimesylate, equivalent to 5.9 mg of dexamfetamine. <u>30 mg Capsules:</u> Each capsule contains 30 mg lisdexamfetamine dimesylate, equivalent ...
Pharmaceutical form
Capsule, hard. <u>Elvanse 20 mg capsule:</u> ivory opaque body and ivory opaque cap, printed S489 and 20 mg in black ink. <u>Elvanse 30 mg capsule:</u> white opaque body and pink opaque cap, printed S489 ...
Therapeutic indications
Elvanse is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years and over when response to previous methylphenidate treatment ...
Posology and method of administration
Treatment must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders. Pre-treatment evaluation Prior to prescribing, it is necessary to conduct ...
Contraindications
Hypersensitivity to sympathomimetic amines or any of the excipients listed in section 6.1. Concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment (hypertensive crisis ...
Special warnings and precautions for use
Abuse and dependence Stimulants including Elvanse have a potential for abuse, misuse, dependence, or diversion for non-therapeutic uses that physicians should consider when prescribing this product. Stimulants ...
Interaction with other medicinal products and other forms of interaction
In vitro enzyme inhibition In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amfetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. Although ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well controlled studies of Elvanse in pregnant women. Dexamfetamine, the active metabolite of lisdexamfetamine, crosses the placenta. Lisdexamfetamine dimesylate had ...
Effects on ability to drive and use machines
Elvanse can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation and blurred vision. These could have a moderate influence on the ability to drive and use machines. ...
Undesirable effects
Summary of the safety profile Adverse reactions observed with Elvanse treatment mainly reflect side effects commonly associated with stimulant use. Very common adverse reactions include decreased appetite, ...
Overdose
The prolonged release of dexamfetamine after administration of Elvanse should be considered when treating patients with overdose. Manifestations of acute overdosage with amfetamines include restlessness, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Centrally Acting Sympathomimetics ATC code: N06BA12 Mechanism of action Elvanse is a pharmacologically inactive prodrug. After oral administration, lisdexamfetamine is rapidly ...
Pharmacokinetic properties
Absorption After oral administration, lisdexamfetamine dimesylate is rapidly absorbed from the gastrointestinal tract of healthy adults and children (6 to 12 years) with ADHD, thought to be mediated by ...
Preclinical safety data
In repeat dose toxicity studies the major findings were changes in behaviour, such as increased activity typical of stimulant administration, with associated reductions in body weight gain, growth measurements ...
List of excipients
Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Capsule shells Gelatin Black ink (shellac and black iron oxide E172) Capsule shell colourants: 20 mg: titanium dioxide (E171) and yellow ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
High density polyethylene bottle and a polypropylene child resistant cap with a foil inner seal. Pack sizes: 28 or 30. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Shire Pharmaceutical Contracts Limited, 1 Kingdom Street, London, W2 6BD, UNITED KINGDOM
Marketing authorization number(s)
30mg: PL 08081/0050 50mg: PL 08081/0051 70mg: PL 08081/0052 20mg: PL 08081/0062 40mg: PL 08081/0063 60mg: PL 08081/0064
Date of first authorization / renewal of the authorization
01/02/2013
Date of revision of the text
07 November 2019
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