3TC30mg+NVP50mg+AZT60mg disp. tab/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:
Lamivudine 30mg + Nevirapine 50mg + Zidovudine 60mg dispersible tablets, bottle pack of 60

Technical Specifications:
Each dispersible tablet contains Lamivudine 30mg, Nevirapine 50mg and Zidovudine 60mg. Tablets are used to prepare an oral suspension.

Therapeutic class:
Nucleoside Reverse Transcriptase Inhibitors (NRTI)

Standard shelf life:
2 years

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 click the links listed below:

WHO treatment guidelines

and

WHO Essential Medicines Library

or your regional national guidelines

For details about paediatric dosage schemes, please click the links listed below:

WHO HIV/AIDS

WHO Generic tool for assessing paediatric ARV dosing

Indications:
Management of HIV-1 infection in children and adults. Administration by mouth (oral), PO, as dispersible tablet for oral suspension

Storage:
Do not store above 30°C (86°F).
Store in tightly closed original container
Protect from light.
Keep out of reach and sight of children.

Dispensing instructions:
Dispense in original container. Do not repack.
Tablets are to be dispersed in 5ml water immediately before administration
Lamivudine/Nevirapine/Zidovudine dispersible tablets 30mg/50mg/60mg is a fixed-dose combination, and cannot be used during the 2 week period of nevirapine lead-in therapy.

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/