VOLTFAST Powder for oral solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Voltfast Sachets 50mg Powder for Oral Solution.
2. Qualitative and quantitative composition
The active ingredient is potassium [o-[(2,6-dichlorophenyl)-amino]-phenyl-acetate (diclofenac potassium). One sachet contains 50 mg of diclofenac potassium. One sachet also contains 50mg aspartame (E951). ...
3. Pharmaceutical form
Powder for oral solution. White to light yellow powder for oral solution.
4.1. Therapeutic indications
Short-term treatment of all grades of pain and inflammation in the following acute conditions: Post traumatic pain, inflammation and swelling, e.g. due to sprains. Acute musculo-skeletal disorders such ...
4.2. Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The contents of the sachet should be dissolved with stirring ...
4.3. Contraindications
Known hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 Active gastric or intestinal ulcer, bleeding or perforation History of gastrointestinal bleeding or perforation, ...
4.4. Special warnings and precautions for use
General Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see section 4.2 Posology and GI and cardiovascular risks ...
4.5. Interaction with other medicinal products and other forms of interaction
(Including interactions observed with other dosage forms of diclofenac potassium and diclofenac sodium) Observed Interactions to be considered CYP2C9 inhibitors: Caution is recommended when co-prescribing ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
4.7. Effects on ability to drive and use machines
Patients who experience dizziness, vertigo, somnolence or other central nervous system disturbances while taking Voltfast, including visual disturbances, should not drive or operate machines.
4.8. Undesirable effects
Adverse drug reactions from clinical trials and/or spontaneous or literature cases (Table 1) are listed by MedRA system order class. Within each system organ class, the adverse drug reactions are ranked ...
4.9. Overdose
Symptoms There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances <b>ATC code:</b> M01AB05 Mechanism of action Voltfast contains ...
5.2. Pharmacokinetic properties
Absorption Diclofenac is rapidly and completely absorbed from diclofenac potassium. Mean peak plasma concentrations of 5.5 micromol/L are attained after 5-20 minutes after ingestion of one sachet of 50mg. ...
5.3. Preclinical safety data
Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended ...
6.1. List of excipients
Potassium hydrogen carbonate Mannitol Aspartame Saccharin sodium Glyceryl dibehenate Mint flavour Anise flavour
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with anything other than water.
6.3. Shelf life
3 years.
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
Sachet consisting of coupled paper/aluminium/polyethylene, hermetically sealed in four directions. Three sachets are packaged in one carton.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Wisdom Pharmaceutical Technology Co Limited, Wilton Park House, Wilton Place, Dublin 2, Ireland
8. Marketing authorization number(s)
PA2308/001/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 14 July 2006 Date of last renweal: 25 July 2008
10. Date of revision of the text
June 2020
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