EFV600mg+3TC300mg+TDF300mg tabs/PAC-30

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:
Efavirenz 600mg + Lamivudine 300mg + Tenofovir Disoproxil Fumarate 300mg, equivalent to 245mg Tenofovir Disoproxil 300mg, film coated tablets, bottle pack of 30

Technical Specifications:
Each film coated tablet contains Efavirenz 600mg, Lamivudine 300mg and Tenofovir Disoproxil Fumarate 300mg, equivalent to 245mg Tenofovir Disoproxil as fixed dose combination.

Therapeutic class:
Efavirenz is a Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
Lamivudine is Nucleoside Reverse Transcriptase Inhibitors (NRTI)
Tenofovir is a Nucleotide Reverse Transcriptase Inhibitor (NtRTI)

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.

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 adults and adolescents over 12 years of age, and weighing more than 40kg. By mouth (oral), PO

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

Dispensing instructions:
Dispense in original container. Do not repack
Advise patient to take the medicine on empty stomach and at bedtime, especially in the first 2-4 weeks to reduce CNS effects.

Regulatory Status:
For latest updates, please click the links listed below:

List of WHO Prequalified Medicines


List of USFDA approved and tentatively approved items