Leuprolide Acetate Injection 1mg/0.5ml

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Leuprolide Acetate Injection 1mg/ml (4mg/4ml)
b) Leuprolide Acetate Injection 1mg/0.5ml
c) Leuprolide Acetate Injection 14mg/2.8ml (1mg/0.2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Leuprolide Acetate Injection 1mg/ml (4mg/4ml)
Each ml contains
Leuprolide Acetate USP………….1mg
Benzyl Alcohol NF…………………….9mg
(as preservative)
Sodium Chloride USP…………..6.3mg
Water for Injection USP….…..q.s.

b) Leuprolide Acetate Injection 1mg/0.5ml
Each 0.5 ml contains
Leuprolide Acetate USP………….1mg
Benzyl Alcohol NF…………………….4.5mg
(as preservative)
Sodium Chloride USP…………..3.15mg
Water for Injection USP….…..q.s.

c) Leuprolide Acetate Injection 14mg/2.8ml (1mg/0.2ml)
Each 0.2 ml contains
Leuprolide Acetate USP………….1mg
Benzyl Alcohol NF…………………….1.8mg
(as preservative)
Sodium Chloride USP…………..0.95mg
Water for Injection USP….…..q.s.

THERAPEUTIC INDICATION:

Leuprorelin also known as leuprolide is a manufactured version of a hormone used to treat prostate cancer. It is also being studied in the treatment of other conditions and types of cancer.

PACKING:

1) 1mg/ml (4mg/4ml)
2) 1mg/0.5ml
3) 14mg/2.8ml (1mg/0.2ml) – 14 Day Patient Administration Kit
Contents: one 2.8ml Vial Leuprolide Acetate, 14 Disposable syringes, 28 Alcohol Swabs, Prescribing Information

DIRECTION OF USE:

For subcutaneous use only
See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Important (14mg/2.8ml (1mg/0.2ml)): Dispense with prescription label positioned to remain with kit during use.
Fragile. Handle with care.
Not for use in newborns.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C. Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.

Leuprolide Acetate Injection 1mg/0.5ml Technical Specification:     

Product Name:Leuprolide Acetate Injection 1mg/0.5ml
Brand Name:Leuprolide Acetate
Strength:1mg/ml (4mg/4ml), 1mg/0.5ml, 14mg/2.8ml (1mg/0.2ml)
Dosage Form:Liquid Injection
Packing:1mg/0.5ml – SINGLE USE AMPOULE
1mg/ml (4mg/4ml), 14mg/2.8ml (1mg/0.2ml) – MULTIPLE USE VIAL
Route of Administration:For subcutaneous 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: Leuprorelin also known as leuprolide is a manufactured version of a hormone used to treat prostate cancer. It is also being studied in the treatment of other conditions and types of cancer.
Storage:Store between 2°C to 8°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Leuprolide Acetate Injection 1mg/0.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Leuprolide Acetate Injection 1mg/0.5ml
    Each 0.5 ml contains
    Leuprolide Acetate USP………….1mg
    Benzyl Alcohol NF…………………….4.5mg
    (as preservative)
    Sodium Chloride USP…………..3.15mg
    Water for Injection USP….…..q.s.

THERAPEUTIC INDICATION:

Leuprorelin also known as leuprolide is a manufactured version of a hormone used to treat prostate cancer. It is also being studied in the treatment of other conditions and types of cancer.

PACKING:

  • 1mg/ml (4mg/4ml)
  • 1mg/0.5ml
  • 14mg/2.8ml (1mg/0.2ml) – 14 Day Patient Administration Kit
    Contents: one 2.8ml Vial Leuprolide Acetate, 14 Disposable syringes, 28 Alcohol Swabs, Prescribing Information

DIRECTION OF USE:

For subcutaneous use only

See package insert for complete prescribing information.

CAUTION & WARNING:

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

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

Important (14mg/2.8ml (1mg/0.2ml)): Dispense with prescription label positioned to remain with kit during use.

Fragile. Handle with care.

Not for use in newborns.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C. Protect from light. Do not freeze.

Dosage: As directed by the Oncologist.