ABC120mg+3TC60mg disp. tabs/PAC-30 gb

General Description
Abacavir Sulfate equivalent to 120mg Abacavir + Lamivudine 60mg dispersible tablet, bottle pack of 30

Technical Specifications
Each dispersible tablet contains Abacavir Sulfate equivalent to 120mg Abacavir plus Lamivudine 60mg.
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.
Product comes with a warning card

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

Standard shelf life
2 years (24 months)

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

Indications
Management of HIV infection in children in combination with at least one other antiretroviral drug.

Route of Administration
By mouth (oral) PO.

Storage
Do not store above 30°C
Store in tightly closed original container, protect from moisture. 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

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/

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/paediatric/en/index.html

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