Darunavir 400mg tabs/PAC-60 gb

General Description
Darunavir 400mg tablets, bottle pack of 60

Technical Specifications
Each film coated tablet contains Darunavir Ethanolate, equivalent to 400mg Darunavir.
Note: tablets must be administered in combination with Ritonavir 100mg as a booster.

Therapeutic class
Protease Inhibitor (PI)

Standard shelf life
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
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
www.who.int/hiv/topics/paediatric/en/index.html

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

Indications
Management of HIV-1 infection in infected adults and children above 6 years of age in combination with 100mg Ritonavir as a booster to Darunavir and in combination with at least two other antiretroviral drugs.
Administration: per mouth (PO)

Storage
Do not store above 30ºC
Store in tightly closed original container.
Keep out of reach and sight of children.

Dispensing instructions
Dispense in original container. Do not repack.

Regulatory Status
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/