EFV600mg+3TC300mg+TDF300mg tab/PAC-30 gb

General Description
Efavirenz 600mg + Lamivudine 300mg + Tenofovir Disoproxil Fumarate 300mg, equivalent to 245mg Tenofovir Disoproxil 300mg, film coated tablets, bottle pack of 30
(gb = generic / bottle pack)

Technical Specifications
Each film coated tablet contains Efavirenz 600mg, Lamivudine 300mg and Tenofovir Disoproxil Fumarate 300 mg, equivalent to 245 mg 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 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/

Indications
Management of HIV-1 infection in adults and adolescents over 12 years of age, and weighing more than 40 kg. 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 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/