FAMPYRA Prolonged-release tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Fampyra 10 mg prolonged-release tablets.
Qualitative and quantitative composition
Each prolonged-release tablet contains 10 mg of fampridine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Prolonged-release tablet. An off-white, film coated, oval biconvex 13 8 mm tablet with flat edge debossed with A10 on one side.
Therapeutic indications
Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Posology and method of administration
Treatment with Fampyra is restricted to prescription and supervision by physicians experienced in the management of MS. Posology The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart ...
Contraindications
Hypersensitivity to fampridine or to any of the excipients listed in section 6.1. Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine). Patients with prior history ...
Special warnings and precautions for use
Seizure risk Treatment with fampridine increases seizure risk (see section 4.8). Fampyra should be administered with caution in the presence of any factors which may lower seizure threshold. Fampyra should ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is contraindicated (see section 4.3). Fampridine is eliminated ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of fampridine in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure it is preferable to ...
Effects on ability to drive and use machines
Fampyra has a moderate influence on the ability to drive and use machines because Fampyra can cause dizziness.
Undesirable effects
The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting. Adverse reactions identified are mostly neurological ...
Overdose
Symptoms Acute symptoms of overdose with Fampyra were consistent with central nervous system excitation and included confusion, tremulousness, diaphoresis, seizure, and amnesia. Central nervous system ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other nervous system drugs ATC code: N07XX07 Pharmacodynamic effects Fampyra is a potassium channel blocker. By blocking potassium channels, Fampyra reduces the leakage of ionic ...
Pharmacokinetic properties
Absorption Orally administered fampridine is rapidly and completely absorbed from the gastrointestinal tract. Fampridine has a narrow therapeutic index. Absolute bioavailability of Fampyra prolonged-release ...
Preclinical safety data
Fampridine was studied in oral repeat dose toxicity studies in several animal species. Adverse responses to orally administered fampridine were rapid in onset, most often occurring within the first 2 hours ...
List of excipients
<u>Tablet core:</u> Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate <u>Film-coat:</u> Hypromellose Titanium dioxide (E-171) Polyethylene glycol 400
Incompatibilities
Not applicable.
Shelf life
3 years. After first opening a bottle, use within 7 days.
Special precautions for storage
Store below 25°C. Store the tablets in the original packaging in order to protect from light and moisture.
Nature and contents of container
Fampyra is supplied in either bottles or blister packs. <u>Bottles:</u> HDPE (high-density polyethylene) bottle with polypropylene caps, each bottle contains 14 tablets and a silica gel desiccant. Pack ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP, Badhoevedorp, The Netherlands
Marketing authorization number(s)
EU/1/11/699/001 EU/1/11/699/002 EU/1/11/699/003 EU/1/11/699/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 July 2011 Date of latest renewal: 18 May 2017
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