VOLTAROL Suppositories (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Voltarol Suppositories 12.5mg, 25mg, 50mg and 100mg.
Qualitative and quantitative composition
The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium). Each suppository contains 12.5mg, 25mg, 50mg and 100mg diclofenac sodium Ph.Eur. For a full list of excipients, ...
Pharmaceutical form
Suppositories.
Therapeutic indications
Voltarol 25mg, 50mg and 100mg suppositories. Adults and Elderly Relief of all grades of pain and inflammation in a wide range of conditions, including: arthritic conditions: rheumatoid arthritis, osteoarthritis, ...
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 Special warnings and precautions for use). Not to be taken ...
Contraindications
Hypersensitivity to the active substance or any of the excipients. Active, gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, relating to previous ...
Special warnings and precautions for use
General Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration and GI and ...
Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. Lithium: If used concomitantly, Voltarol may increase plasma ...
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 or ...
Effects on ability to drive and use machines
Patients who experience visual disturbances, dizziness, vertigo, somnolence, central nervous system disturbances, drowsiness or fatigue while taking NSAIDs should refrain from driving or operating machinery. ...
Undesirable effects
Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, ...
Overdose
Symptoms There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Nonsteroidal anti-inflammatory drugs (NSAIDs) In 15 clinical studies involving the use of rectal diclofenac in the treatment of postoperative pain in children with an overall ...
Pharmacokinetic properties
There is limited kinetic data from 6 children aged 6-16 years with juvenile chronic arthritis who received a once daily dose of diclofenac for 2 weeks. When corrected for a body weight of 75kg, kinetic ...
Preclinical safety data
None stated.
List of excipients
Voltarol suppositories also contain suppository mass 5 (a waxy base composed of hard fat).
Incompatibilities
None known.
Shelf life
Shelf life: Three years.
Special precautions for storage
Protect from heat (store below 30°C). Medicines should be kept out of the reach of children.
Nature and contents of container
The suppositories are white to yellowish, torpedo-shaped, with smooth or slightly rough surfaces and a slightly fatty odour, and are sealed in a composite foil made of polyvinylchloride (PVC) laminated ...
Special precautions for disposal and other handling
For rectal use only.
Marketing authorization holder
Novartis Pharmaceuticals UK Ltd., Trading as Geigy Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Marketing authorization number(s)
12.5mg: PL 00101/0472 25mg: PL 00101/0473 50mg: PL 00101/0474 100mg: PL 00101/0475
Date of first authorization / renewal of the authorization
11 July 1997 / 29 July 2007
Date of revision of the text
30 March 2017
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