Powder for suspension for Injection Triptorelin 3.75mg (Prostazar SR)
Categories: , , , , ,
Date:

Powder for suspension for Injection Triptorelin 3.75mg (Prostazar SR) Technical Specification:

Product Name:Powder for suspension for Injection Triptorelin  3.75mg
Brand Name:Prostazar SR
Strength:3.75mg, 11.25mg, 22.5mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.M. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Triptorelin is a hormone drug that you might have as a treatment for prostate cancer that is advanced (spread to other parts of your body) locally advanced with or without radiotherapy or surgery
Storage:Store the vials in the original carton between 2°C to 8°C (36° to 46° F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Powder for suspension for Injection Triptorelin 3.75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Powder for suspension for Injection Triptorelin 3.75mg
    Each sterile lyophilized vial contains:
    Triptorelin Pamoate
    Equivalent to Triptorelin.….…3.75mg
    (Lyophilized powder for suspension for injection)
    Excipients:
    Anhydrous Citric Acid USP….q.s.
    Mannitol USP……………………..q.s.
    Water for Injection USP……..q.s.

THERAPEUTIC INDICATION:

Triptorelin is a hormone drug that you might have as a treatment for prostate cancer that is advanced (spread to other parts of your body) locally advanced with or without radiotherapy or surgery

PACKING:

  • Powder for suspension for Injection Triptorelin 3.75mg – 1 Month
  • Powder for suspension for Injection Triptorelin 11.25mg – 3 Month
  • Powder for suspension for Injection Triptorelin 22.5mg – 6 Month

DIRECTION OF USE:

For Intramuscular use only.

Reconstitution: Must reconstitute with 2 ml sterile water for injection USP prior to administration and use the preparation immediately.

For further information refer package insert.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

Opening instructions: Open the top and bottom flaps initially and then open the side flap.

TRANSPORT ONLY IN REFRIGERATION CHAIN.

INJECT INSTANTLY AFTER MIXING.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F). Protect from light.

Dosage: As directed by an Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Powder for suspension for Injection Triptorelin 3.75mg
b) Powder for suspension for Injection Triptorelin 11.25mg
c) Powder for suspension for Injection Triptorelin 22.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Powder for suspension for Injection Triptorelin 3.75mg
Each sterile lyophilized vial contains:
Triptorelin Pamoate
Equivalent to Triptorelin.….…3.75mg
(Lyophilized powder for suspension for injection)
Excipients:
Anhydrous Citric Acid USP….q.s.
Mannitol USP……………………..q.s.
Water for Injection USP……..q.s.

b) Powder for suspension for Injection Triptorelin 11.25mg
Each sterile lyophilized vial contains:
Triptorelin Pamoate
Equivalent to Triptorelin.….…11.25mg
(Lyophilized powder for suspension for injection)
Excipients:
Anhydrous Citric Acid USP….q.s.
Mannitol USP……………………..q.s.
Water for Injection USP……..q.s.

c) Powder for suspension for Injection Triptorelin 22.5mg
Each sterile lyophilized vial contains:
Triptorelin Pamoate
Equivalent to Triptorelin.….…22.5mg
(Lyophilized powder for suspension for injection)
Excipients:
Anhydrous Citric Acid USP….q.s.
Mannitol USP……………………..q.s.
Water for Injection USP……..q.s.

THERAPEUTIC INDICATIONS:

Triptorelin is a hormone drug that you might have as a treatment for prostate cancer that is advanced (spread to other parts of your body) locally advanced with or without radiotherapy or surgery

PACKING:

1) Powder for suspension for Injection Triptorelin 3.75mg – 1 Month
2) Powder for suspension for Injection Triptorelin 11.25mg – 3 Month
3) Powder for suspension for Injection Triptorelin 22.5mg – 6 Month

DIRECTION OF USE:

For Intramuscular use only.
Reconstitution: Must reconstitute with 2 ml sterile water for injection USP prior to administration and use the preparation immediately.
For further information refer package insert.

CAUTION AND WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Opening instructions: Open the top and bottom flaps initially and then open the side flap.
TRANSPORT ONLY IN REFRIGERATION CHAIN.
INJECT INSTANTLY AFTER MIXING.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE AND DOSAGE:

Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F).
Protect from light.
Dosage: As directed by an Oncologist.