ABC60mg+3TC30mg disp. tabs/PAC-60

NOTE: The description below is for a standard product. It is not specific to patent status and pricing policies that may apply at country level. This information is available on request from Supply Division: Contact: supply@unicef.org

General Description
Abacavir Sulfate equivalent to 60mg Abacavir + Lamivudine 30mg dispersible tablet, bottle pack of 60

Technical Specifications
Each dispersible tablet contains Abacavir Sulfate equivalent to 60mg Abacavir plus Lamivudine 30mg.
Tablets should be scored with at least one break line to allow for division of tablets into two parts, each containing the same amount of active ingredients.
Tablets are used to prepare an oral suspension.
Pack comes with a warning card

Therapeutic class
Abacavir and Lamivudine are nucleoside reverse transcriptase inhibitors (NRTI).

Standard shelf life
3 Years (36 Months)

Other available formulations
The product may also be available in other formulations, pack sizes, or in combinations with other ARVs.

Guidelines for use
For more details, please see WHO treatment guidelines
http://www .who.int/hiv/pub/guidelines/en/index.html
and WHO Essential Medicines Library http://www.who.int/emlib/ or your regional/national guidelines.

Details about paediatric dosage schemes can be found at www.who.int/hiv/topics/paediatri c/en/

WHO generic tool for assessing paediatric ARV dosing
http://www. who.int/hiv/paediatric/generictool/en/

Indications
Management of HIV infection in children in combination with at least one other antiretroviral drug. By mouth (oral) PO.

Storage
Do not store above 30° (86ºF).
Store in tightly closed original container
Keep out of reach and sight of children

Dispensing instructions
Dispense in original container. Do not repack Pack comes with
Warning Card
Can be taken without regard to food

Tablets are to be dispersed in 5ml water immediately before administration and the suspension should be consumed completely to ensure adequate dose.

Regulatory Status
For latest updates check the list of ‘Prequalified Medicines’ on the WHO website ‘Prequalification Programme’. http://apps.who.int/prequal/

For latest updates check the list of ‘USFDA approved and tentatively approved’ items on the USFDA website.

http://www.fda.gov/default.htm

http:/ /www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/