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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Videx EC 125mg, 200mg, 250mg and 400mg Gastro-resistant Capsules (2012)

Εκδότης

Εκδότης Bristol-Myers Squibb Pharmaceutical Limited
Διεύθυνση Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Videx 125 mg gastro-resistant hard capsule Videx 200 mg gastro-resistant hard capsule. Videx 250 mg gastro-resistant ...

Qualitative and quantitative composition

Each gastro-resistant capsule, hard contains 125 mg, 200 mg, 250 mg or 400 mg of didanosine. For a full ...

Pharmaceutical form

Gastro-resistant capsule, hard. 125 mg: Gastro-resistant capsules are opaque white and embossed in tan ...

Therapeutic indications

Videx is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected ...

Posology and method of administration

Oral use. Because didanosine absorption is reduced in the presence of food, Videx gastro-resistant capsules ...

Contraindications

Hypersensitivity to didanosine or to any of the excipients. Children younger than 6 years (risk of inadvertent ...

Special warnings and precautions for use

Pancreatitis is a known serious complication among HIV infected patients. It has also been associated ...

Interaction with other medicinal products and other forms of interaction

Specific interaction studies have been conducted with zidovudine, stavudine, ranitidine, loperamide, ...

Pregnancy and lactation

Pregnancy: There are no adequate data from the use of didanosine in pregnant women and it is not known ...

Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.

Undesirable effects

Adults Most of the serious adverse events observed have generally reflected the recognised clinical course ...

Overdose

There is no known antidote for didanosine overdosage. Experience in early studies, in which didanosine ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleoside reverse transcriptase inhibitor ATC Code: J05AF02 Didanosine (2', ...

Pharmacokinetic properties

Adults Absorption: Didanosine is rapidly degraded at an acidic pH. Therefore, the granules in the Videx ...

Preclinical safety data

The lowest dose to cause death in acute toxicity studies in the mouse, rat and dog was greater than 2000 ...

List of excipients

Sodium carmellose Diethyl phthalate 30% methacrylic acid copolymer dispersion (EUDRAGIT L30D-55) Sodium ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Polyvinyl Chloride/Polyethylene/ACLAR/Aluminium foil blisters with 10 hard capsules per blister card ...

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Bristol-Myers Squibb Pharmaceuticals Limited Uxbridge Business Park Sanderson Road Uxbridge Middlesex ...

Marketing authorization number(s)

Videx EC 125 mg gastro-resistant hard capsule: PL 11184/0083 Videx EC 200 mg gastro-resistant hard capsule: ...

Date of first authorization / renewal of the authorization

10/06/2009

Date of revision of the text

10/06/2009
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.