Lamivudine 150mg tabs/PAC-60 gb

General Description
Lamivudine 150mg film coated tablets, pack of 60
(gb = generic / bottle pack)

Technical Specifications
Each film coated scored tablet contains 150mg of Lamivudine
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.

Therapeutic class
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI)

Standard shelf life
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 www.who.int/hiv/pub/guidelines/en/index.html and WHO Essential Medicines Library www.who.int/emlib/ or your regional/national guidelines.

Details about paediatric dosage schemes can be found at http://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/
Details about paediatric dosage schemes can be found at www.who.int/hiv/topics/paediatric/en/index.html and www.who.int/hiv/paediatric/Sum_WHO_ARV_Ped_ARV_dosing.pdf

Indications
Management of HIV infection in combination with at least two other antiretroviral drugs. By mouth (oral) PO.
Prevention of mother to child transmission (PMTCT): In combination with other drugs in the therapy for prevention of maternal-fetal transmission of HIV.

Packaging and storage
Do not store above 30ºC (86ºF). Store in a tightly closed container. Do not freeze.
Keep out of reach and sight of children.
Keep in original pack.

Dispensing instructions
Dispense in original container. Do not repack

Regulatory Status
WHO prequalified
USFDA tentatively approved

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

For latest updates check the list of USFDA approved and tentatively approved items on the USFDA website. www.fda.gov/default.htm, www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/

FURTHER INFORMATION
Component of a kit
(S1400097) is a component of S9901003- IEHK 2011 PEP Kit