Nevirapine oral susp. 10mg/ml/BOT-100ml

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
Nevirapine oral suspension 10mg/ml, bottle pack of 100ml with oral dispensing syringe

Technical specifications
Each 5ml contains Nevirapine Hemihydrate 51.75mg equivalent to Nevirapine 50mg.
Pack comes with oral dispensing syringe.

Therapeutic class
Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)

Standard shelf life
2 Years
The product should be used within 4 weeks of opening.

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/paediatri c/en/

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

Indications
Management of HIV infection in combination with at least two other antiretroviral drugs. By mouth (oral), PO
Prevention of mother-to-child transmission in HIV-infected patients.

Storage
Do not store above 30ºC (86ºF). Do not freeze
Store in a tightly closed container.
Keep protected from light
Keep out of reach and sight of children

Note: Use suspension within 1 (one) month after opening

Dispensing instructions
Shake the suspension gently before administration
The entire dose, especially for volumes less than 5ml, should be measured and administered accurately using a dose measuring oral syringe or cup. If a measuring cup is used, rinse it with a small amount of drinking water and administer the rinse to the patient.
May be taken with or without regard to food.

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/