Gemcitabine Injection 38mg/ml (1.4gm/36.8ml) (Gemilife)

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Gemcitabine Injection 38mg/ml (200mg/5.26ml, 1gm/26.3ml, 1.4gm/36.8ml, 2gm/52.6ml)
b) Gemcitabine Injection 100mg/ml (200mg/2ml, 1gm/10ml, 1.5gm/15ml, 2gm/20ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Gemcitabine Injection 38mg/ml (200mg/5.26ml, 1gm/26.3ml, 1.4gm/36.8ml, 2gm/52.6ml)
Each vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine…………38mg
Propylene Glycol………………………..30%v/v
Polyethylene Glycol 400USNF…….20%v/v
Sodium Hydroxide USNF……………..q.s. to adjust pH
Hydrochloric Acid USNF……………...q.s. to adjust Ph
Water for Injection USP……………...q.s.

c) Gemcitabine Injection 100mg/ml (200mg/2ml, 1gm/10ml, 1.5gm/15ml, 2gm/20ml)
Each vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine…………100mg
Propylene Glycol………………………..78%v/v
Polyethylene Glycol 400USNF…….52%v/v
Sodium Hydroxide USNF……………..q.s. to adjust pH
Hydrochloric Acid USNF……………...q.s. to adjust Ph
Water for Injection USP……………...q.s.

THERAPEUTIC INDICATION:

Gemcitabine is used in combination with other medicines to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery and also use to treat advanced ovarian cancer.

PACKING:

38mg/ml
1) 200mg/5.26ml
2) 1gm/26.3ml
3) 1.4gm/36.8ml
4) 2gm/52.6ml

100mg/ml
1) 200mg/2ml
2) 1gm/10ml
3) 1.5gm/15ml
4) 2gm/20ml

DIRECTION OF USE:

For I.V. use only - Must be diluted before use.
See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
CAUTION: Gemcitabine is potentially cytotoxic. Great care should be taken to prevent inhaling and exposing the skin to it.
Cytotoxic Agent: Wear gloves at all times when handling containers.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
MULTIPLE USE VIAL – Should be use within 28 hours after initial puncture.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C (36° F to 46° F). Do not Refrigerate.
Dosage: As directed by the Oncologist.

Gemcitabine Injection 38mg/ml (1.4gm/36.8ml) (Gemilife) Technical Specification:

Product Name:Gemcitabine Injection 38mg/ml (1.4gm/36.8ml)
Brand Name:Gemilife
Strength:38mg/ml (200mg/5.26ml,1gm/26.3ml,1.4gm/36.8ml, 2gm/52.6ml),
100mg/ml (200mg/2ml, 1gm/10ml, 1.5gm/15ml, 2gm/20ml)
Dosage Form:Liquid Injection
Packing:38mg/ml (200mg/5.26ml,1gm/26.3ml,1.4gm/36.8ml, 2gm/52.6ml) – SINGLE USE VIAL
100mg/ml (200mg/2ml, 1gm/10ml, 1.5gm/15ml, 2gm/20ml) – MULTIPLE USE VIAL
Route of Administration:For I.V. use only – Must be diluted before use
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: Gemcitabine is used in combination with other medicines to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery and also use to treat advanced ovarian cancer.
Storage:Store at 2°C to 8°C (36° F to 46° F). Do not Refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gemcitabine Injection 38mg/ml (1.4gm/36.8ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gemcitabine Injection 38mg/ml (1.4gm/36.8ml)
    Each vial contains
    Gemcitabine Hydrochloride USP
    Equivalent to Gemcitabine…………38mg
    Propylene Glycol………………………..30%v/v
    Polyethylene Glycol 400USNF…….20%v/v
    Sodium Hydroxide USNF……………..q.s. to adjust pH
    Hydrochloric Acid USNF………………q.s. to adjust Ph
    Water for Injection USP………………q.s.

THERAPEUTIC INDICATION:

Gemcitabine is used in combination with other medicines to treat a type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body and cannot be treated with surgery and also use to treat advanced ovarian cancer.

PACKING:

38mg/ml

  • 200mg/5.26ml
  • 1gm/26.3ml
  • 4gm/36.8ml
  • 2gm/52.6ml

100mg/ml

  • 200mg/2ml
  • 1gm/10ml
  • 5gm/15ml
  • 2gm/20ml

DIRECTION OF USE:

For I.V. use only – Must be diluted before use.

See package insert for complete prescribing information.

CAUTION & WARNING:

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

CAUTION: Gemcitabine is potentially cytotoxic. Great care should be taken to prevent inhaling and exposing the skin to it.

Cytotoxic Agent: Wear gloves at all times when handling containers.

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

MULTIPLE USE VIAL – Should be use within 28 hours after initial puncture.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 2°C to 8°C (36° F to 46° F). Do not Refrigerate.

Dosage: As directed by the Oncologist.