VOTUBIA Dispersible tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Votubia 1 mg dispersible tablets. Votubia 2 mg dispersible tablets. Votubia 3 mg dispersible tablets. Votubia 5 mg dispersible tablets.
Qualitative and quantitative composition
Votubia 1 mg dispersible tablets Each dispersible tablet contains 1 mg everolimus. Excipient with known effect: Each dispersible tablet contains 0.98 mg lactose. Votubia 2 mg dispersible tablets Each dispersible ...
Pharmaceutical form
Dispersible tablet. <u>Votubia 1 mg dispersible tablets:</u> White to slightly yellowish, round, flat tablets of approximately 7.1 mm in diameter, with a bevelled edge and no score, engraved with D1 on ...
Therapeutic indications
Refractory seizures associated with tuberous sclerosis complex (TSC) Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without ...
Posology and method of administration
Treatment with Votubia should be initiated by a physician experienced in the treatment of patients with TSC and therapeutic drug monitoring. Posology Careful titration may be required to obtain the optimal ...
Contraindications
Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Non-infectious pneumonitis Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus. Non-infectious pneumonitis (including interstitial lung disease) was described very ...
Interaction with other medicinal products and other forms of interaction
Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of PgP. Therefore, absorption and subsequent elimination of everolimus may be influenced by products that affect CYP3A4 ...
Pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing ...
Effects on ability to drive and use machines
Votubia may have a minor or moderate influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment ...
Undesirable effects
Summary of the safety profile Three randomised, double-blind, placebo-controlled pivotal phase III studies, including double-blind and open label treatment periods, and a non-randomised, open-label, single-arm ...
Overdose
Reported experience with overdose in humans is very limited. Single doses of up to 70 mg have been given with acceptable acute tolerability in the adult population. It is essential to assess everolimus ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors ATC code: L01XE10 Mechanism of action Everolimus is a selective mTOR (mammalian target of rapamycin) ...
Pharmacokinetic properties
Absorption In patients with advanced solid tumours, peak everolimus concentrations (C<sub>max</sub>) are reached at a median time of 1 hour after daily administration of 5 and 10 mg everolimus under fasting ...
Preclinical safety data
The non-clinical safety profile of everolimus was assessed in mice, rats, minipigs, monkeys and rabbits. The major target organs were male and female reproductive systems (testicular tubular degeneration, ...
List of excipients
Butylated hydroxytoluene (E321) Magnesium stearate Lactose monohydrate Hypromellose Crospovidone type A Mannitol Cellulose microcrystalline Silica colloidal anhydrous
Incompatibilities
Not applicable.
Shelf life
<u>Votubia 1 mg dispersible tablets:</u> 2 years. <u>Votubia 2 mg dispersible tablets:</u> 3 years. <u>Votubia 3 mg dispersible tablets:</u> 3 years. <u>Votubia 5 mg dispersible tablets:</u> 3 years. ...
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.
Nature and contents of container
Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 1 dispersible tablets. <u>Votubia 1 mg dispersible tablets:</u> Packs containing 30 1 dispersible tablets. <u>Votubia 2 mg ...
Special precautions for disposal and other handling
Instructions for use and handling Using an oral syringe The prescribed dose of Votubia dispersible tablets should be placed in a 10 ml oral dosing syringe graduated in 1 ml increments. A total of 10 mg ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
Votubia 1 mg dispersible tablets: EU/1/11/710/016 Votubia 2 mg dispersible tablets: EU/1/11/710/009-011 Votubia 3 mg dispersible tablets: EU/1/11/710/012-013 Votubia 5 mg dispersible tablets: EU/1/11/710/014-015 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 02 September 2011 Date of latest renewal: 28 July 2015
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