AMFEXA Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Amfexa 5 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 5 mg dexamfetamine sulfate. <u>Excipient with known effect:</u> Isomalt (E953) 147.5 mg per tablet For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets. White, round, cloverleaf-shaped tablets of 8.4 mm diameter with a notched, cross-scored line on the top side and a cross-scored line embossed with S on each quarter on the rear side. The score ...
4.1. Therapeutic indications
Dexamfetamine is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate ...
4.2. Posology and method of administration
Posology Treatment must be under the supervision of a specialist in childhood and/or adolescents behaviour disorders. Careful dose titration is necessary at the start of treatment with dexamfetamine. Dose ...
4.3. Contraindications
Known hypersensitivity to the active substance or any of the excipients listed in section 6.1. Known hypersensitivity to sympathomimetic amines. Glaucoma. Phaeochromocytoma. Symptomatic cardiovascular ...
4.4. Special warnings and precautions for use
Precautions to be taken before handling or administering the medicinal product Pre-treatment screening Prior to prescribing, it is necessary to conduct a baseline evaluation of a patients cardiovascular ...
4.5. Interaction with other medicinal products and other forms of interaction
Because of possible hypertensive crisis, dexamfetamine is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section ...
4.6. Pregnancy and lactation
Pregnancy Data from a cohort study of in total approximately 5570 pregnancies exposed to amfetamine in the first trimester do not suggest an increased risk of congenital malformation. Data from another ...
4.7. Effects on ability to drive and use machines
Dexamfetamine can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision. It may have a moderate influence on the ability to drive and ...
4.8. Undesirable effects
Information on the frequency of these effects was obtained from published clinical studies and meta-analyses as well as the MHRA safety information. Side-effect assessment is based on the following categories: ...
4.9. Overdose
Signs and symptoms Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, aggression, tremors, hyperreflexia, muscle twitching, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psychoanaleptics; psychostimulants, agents used for ADHD and nootropics; centrally acting sympathomimetics <b>ATC Code:</b> N06BA02 Mechanism of action Dexamfetamine is ...
5.2. Pharmacokinetic properties
Absorption Dexamfetamine is highly lipophilic and rapidly absorbed from the gastrointestinal tract. The pharmacokinetics of the tablets was measured in 18 healthy subjects. Following the administration ...
5.3. Preclinical safety data
Animal studies on general toxicity, safety pharmacology, genotoxicity and carcinogenicity of dexamfetamine did not reveal any adverse effects not already known in humans. In studies on the reproductive ...
6.1. List of excipients
Isomalt (E953) Crospovidone Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
6.5. Nature and contents of container
Boxes containing 20, 30, 50, or 100 tablets in PVC/PE/PVdC clear blisters heat sealed to aluminium foil. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany
8. Marketing authorization number(s)
PL 11243/0021
9. Date of first authorization / renewal of the authorization
15/09/2014
10. Date of revision of the text
14/01/2021
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