SPEDRA Tablet (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Spedra 50 mg tablets.
Qualitative and quantitative composition
Each tablet contains 50 mg of avanafil. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Pale yellow oval tablets, debossed with 50 on one side.
Therapeutic indications
Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.
Posology and method of administration
Posology Use in adult men The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see section 5.1). Based on individual efficacy and tolerability, the dose ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see section ...
Special warnings and precautions for use
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Cardiovascular ...
Interaction with other medicinal products and other forms of interaction
Potential for pharmacodynamic interactions with avanafil Nitrates Avanafil was shown to augment the hypotensive effects of nitrates compared to placebo in healthy subjects. This is thought to result from ...
Fertility, pregnancy and lactation
Pregnancy Spedra is not indicated for use in women. There are no data from the use of avanafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, ...
Effects on ability to drive and use machines
Spedra has minor influence on the ability to drive and use machines. As dizziness and altered vision were reported in clinical trials with avanafil, patients should be aware of how they react to Spedra ...
Undesirable effects
Summary of the safety profile The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program. The most common adverse reactions reported in clinical ...
Overdose
Single dose of up to 800 mg of avanafil have been given to healthy subjects and multiple daily doses up to 300 mg have been given to patients. Adverse reactions were similar to those seen at lower doses ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction ATC code: G04BE10 Mechanism of action Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate ...
Pharmacokinetic properties
Avanafil is rapidly absorbed after oral administration, with a median T<sub>max</sub> of 30 to 45 minutes. Its pharmacokinetics are dose-proportional over the recommended dose range. It is eliminated predominantly ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. ...
List of excipients
Mannitol Fumaric acid Hydroxypropylcellulose Hydroxypropylcellulose, low substituted Calcium carbonate Magnesium stearate Yellow iron oxide (E172)
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Marketing authorization number(s)
EU/1/13/841/001-003 EU/1/13/841/012-014
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 June 2013 Date of latest renewal: 23 April 2018
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