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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Bristol-Myers Squibb Pharmaceutical Limited
Διεύθυνση Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Name of the medicinal product

Videx 125 mg gastro-resistant hard capsule Videx 200 mg gastro-resistant hard capsule. Videx 250 mg gastro-resistant hard capsule. Videx 400 mg gastro-resistant hard capsule.

Qualitative and quantitative composition

Each gastro-resistant capsule, hard contains 125 mg, 200 mg, 250 mg or 400 mg of didanosine. For a full list of excipients, see section 6.1.

Pharmaceutical form

Gastro-resistant capsule, hard. 125 mg: Gastro-resistant capsules are opaque white and embossed in tan with 6671 on one half, and BMS 125 mg on the other half. 200 mg: Gastro-resistant capsules are opaque ...

Therapeutic indications

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

Posology and method of administration

Oral use. Because didanosine absorption is reduced in the presence of food, Videx gastro-resistant capsules should be administered on an empty stomach (at least 2 hours before or 2 hours after a meal) ...

Contraindications

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

Special warnings and precautions for use

Pancreatitis is a known serious complication among HIV infected patients. It has also been associated with didanosine therapy and has been fatal in some cases. Didanosine should be used only with extreme ...

Interaction with other medicinal products and other forms of interaction

Specific interaction studies have been conducted with zidovudine, stavudine, ranitidine, loperamide, metoclopramide, foscarnet, trimethoprim, sulfamethoxazole, dapsone and rifabutin, without evidence of ...

Pregnancy and lactation

Pregnancy: There are no adequate data from the use of didanosine in pregnant women and it is not known whether didanosine can cause foetal harm or affect reproductive capacity when administered during ...

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 of HIV infection. In data collected earlier involving monotherapy regimens, no different safety ...

Overdose

There is no known antidote for didanosine overdosage. Experience in early studies, in which didanosine was initially administered at doses ten times the recommended doses, indicates that the anticipated ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nucleoside reverse transcriptase inhibitor ATC Code: J05AF02 Didanosine (2', 3'-dideoxyinosine) is an inhibitor of the in vitro replication of HIV in cultured human cells and ...

Pharmacokinetic properties

Adults Absorption: Didanosine is rapidly degraded at an acidic pH. Therefore, the granules in the Videx gastro-resistant capsules release didanosine into the higher pH of the small intestine. Compared ...

Preclinical safety data

The lowest dose to cause death in acute toxicity studies in the mouse, rat and dog was greater than 2000 mg/kg which is equivalent to approximately 300 times the maximum recommended human dose (tablet). ...

List of excipients

Sodium carmellose Diethyl phthalate 30% methacrylic acid copolymer dispersion (EUDRAGIT L30D-55) Sodium starch glycolate (Type A) Talc Capsule shell: Gelatin Sodium laurilsulfate Titanium dioxide (E171) ...

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 and 3 cards (30 capsules) per carton or with 10 hard capsules per blister card and 6 cards (60 capsules) ...

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 UB8 1DH

Marketing authorization number(s)

Videx EC 125 mg gastro-resistant hard capsule: PL 11184/0083 Videx EC 200 mg gastro-resistant hard capsule: PL 11184/0084 Videx EC 250 mg gastro-resistant hard capsule: PL 11184/0085 Videx EC 400 mg gastro-resistant ...

Date of first authorization / renewal of the authorization

10/06/2009

Date of revision of the text

10/06/2009
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