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Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg)
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Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Technical Specification:

Product Name:Darunavir Ethanolate & Ritonavir Tablets
Brand Name:Generic
Strength:(400mg+50mg), (600mg+100mg), (800mg+100mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:30 Tablets in a bottle
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Protease Inhibitors, Antiviral
Indication: Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone. Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.
Storage:Store at a temperature not exceeding 30℃. Store in a cool & dry place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
  • Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
  • Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………400mg
    Ritonavir USP…………………50mg
    Excipients………………………q. s
    Color: Titanium Dioxide USP
  • Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………600mg
    Ritonavir USP…………………100mg
    Excipients………………………q. s
    Color: Yellow Oxide of Iron USP-NF
  • Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………800mg
    Ritonavir USP…………………100mg
    Excipients………………………q. s
    Color: Indigo Carmine Lake


THERAPEUTIC INDICATIONS:

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.

Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the container tightly closed.
Tablet to be swallowed as a whole, not to be chewed or crushed.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
NOT TO EXCEED THE PRESCRIBED DOSAGE.

WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
 Store at a temperature not exceeding 30℃.
Store in a cool & dry place.
Protect from Light & moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
B. Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
C. Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………400mg
Ritonavir USP………………...50mg
Excipients……………………...q. s
Color: Titanium Dioxide USP

 B) Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………600mg
Ritonavir USP………………...100mg
Excipients……………………...q. s
Color: Yellow Oxide of Iron USP-NF

C) Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………800mg
Ritonavir USP………………...100mg
Excipients……………………...q. s
Color: Indigo Carmine Lake

THERAPEUTIC INDICATIONS:

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.
Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep container tightly closed.
Tablet to be swallowed as a whole, not to be chewed or crushed.

KEEP MEDICINE OUT OF REACH OF CHILDREN.
NOT TO EXCEED PRESCRIBED DOSAGE.
WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
Store at temperature not exceeding 30℃.
Store in cool & dry place.
Protect from Light & moisture.
Dosage:
As directed by the Physician.