Gemcitabine for Injection USP 1000mg (Gemilife) Technical Specification:
| Product Name: | Gemcitabine for Injection USP 1000mg |
| Brand Name: | Gemilife |
| Strength: | 200mg, 1000mg, 1.4gm, 2gm |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE DOSE VIAL |
| Route of Administration: | For I.V. infusion 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: | 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 vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Do not refrigerate after reconstitution. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Gemcitabine for Injection USP 1000mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Gemcitabine for Injection USP 1000mg
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1000mg
Excipients……………………………….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.
DIRECTION OF USE:
For Intravenous infusion only.
Reconstitution for 1000mg: Reconstitute with 25ml Sodium Chloride injection IP (0.9% w/v) and shake gently to make a clear solution
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
Patients receiving therapy with Gemcitabine for Injection should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Solutions of reconstituted Gemcitabine for Injection should not be refrigerated, as crystallization may occur.
Gemcitabine Hydrochloride is potentially cytotoxic. Great care should be taken to prevent inhaling particles and exposing the skin to it.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Infusion time and dose frequency: Increased toxicity with infusion time >60 minutes or dosing more frequently than once weekly.
WARNINGS AND PRECAUTIONS
Gemcitabine is used with cisplatin is indicated at first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
CONTRAINDICATIONS
Gemcitabine for Injection is contraindicated in those patients with a known hypersensitivity to the drug.
Administer solution within 24 hours.
Do not refrigerate after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Do not refrigerate after reconstitution.
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Gemcitabine for Injection USP 200mg
b) Gemcitabine for Injection USP 1000mg
c) Gemcitabine for Injection USP 1.4gm
d) Gemcitabine for Injection USP 2gm
b) Gemcitabine for Injection USP 1000mg
c) Gemcitabine for Injection USP 1.4gm
d) Gemcitabine for Injection USP 2gm
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Gemcitabine for Injection USP 200mg
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..200mg
Excipients……………………………….q.s.
b) Gemcitabine for Injection USP 1000mg
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1000mg
Excipients……………………………….q.s.
c) Gemcitabine for Injection USP 1.4gm
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1.4gm
Excipients……………………………….q.s.
d) Gemcitabine for Injection USP 2gm
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..2gm
Excipients……………………………….q.s.
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..200mg
Excipients……………………………….q.s.
b) Gemcitabine for Injection USP 1000mg
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1000mg
Excipients……………………………….q.s.
c) Gemcitabine for Injection USP 1.4gm
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..1.4gm
Excipients……………………………….q.s.
d) Gemcitabine for Injection USP 2gm
Each sterile lyophilized vial contains
Gemcitabine Hydrochloride USP
Equivalent to Gemcitabine……..2gm
Excipients……………………………….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.
DIRECTION OF USE:
For Intravenous infusion only.
Reconstitution for 1000mg: Reconstitute with 25ml Sodium Chloride injection IP (0.9% w/v) and shake gently to make a clear solution
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
Reconstitution for 1000mg: Reconstitute with 25ml Sodium Chloride injection IP (0.9% w/v) and shake gently to make a clear solution
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
Patients receiving therapy with Gemcitabine for Injection should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Solutions of reconstituted Gemcitabine for Injection should not be refrigerated, as crystallization may occur.
Gemcitabine Hydrochloride is potentially cytotoxic. Great care should be taken to prevent inhaling particles and exposing the skin to it.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Infusion time and dose frequency: Increased toxicity with infusion time >60 minutes or dosing more frequently than once weekly.
WARNINGS AND PRECAUTIONS
Gemcitabine is used with cisplatin is indicated at first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
CONTRAINDICATIONS
Gemcitabine for Injection is contraindicated in those patients with a known hypersensitivity to the drug.
Administer solution within 24 hours.
Do not refrigerate after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of the reach of the children.
Patients receiving therapy with Gemcitabine for Injection should be monitored closely by a physician experienced in the use of cancer chemotherapeutic agents. Solutions of reconstituted Gemcitabine for Injection should not be refrigerated, as crystallization may occur.
Gemcitabine Hydrochloride is potentially cytotoxic. Great care should be taken to prevent inhaling particles and exposing the skin to it.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Infusion time and dose frequency: Increased toxicity with infusion time >60 minutes or dosing more frequently than once weekly.
WARNINGS AND PRECAUTIONS
Gemcitabine is used with cisplatin is indicated at first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
CONTRAINDICATIONS
Gemcitabine for Injection is contraindicated in those patients with a known hypersensitivity to the drug.
Administer solution within 24 hours.
Do not refrigerate after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Do not refrigerate after reconstitution.
Dosage: As directed by an Oncologist.
Do not refrigerate after reconstitution.
Dosage: As directed by an Oncologist.
