Paclitaxel Injection USP 6mg/ml (260mg/43.3ml) Technical Specification:
| Product Name: | Paclitaxel Injection USP 6mg/ml (260mg/43.3ml) |
| Brand Name: | Generics |
| Strength: | 6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml) |
| Dosage Form: | Liquid Injection |
| Packing: | MULTI DOSE VIAL |
| Route of Administration: | For I.V. Infusion after dilution |
| 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: | Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer, and non-small cell lung cancer (NSCLC). |
| Storage: | Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Paclitaxel Injection USP 6mg/ml (260mg/43.3ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Paclitaxel Injection USP 6mg/ml (260mg/43.3ml)
Each ml contains:
Paclitaxel USP……………………………6mg
Polyoxyl 35 Castor oil USNF………527mg
Anhydrous Citric Acid USP……….2mg
Dehydrated alcohol USP…………..49.7%v/v
THERAPEUTIC INDICATION:
Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer, and non-small cell lung cancer (NSCLC).
PACKING:
6mg/ml
- 30mg/5ml
- 100mg/16.7ml
- 150mg/25ml
- 260mg/43.3ml
- 300mg/50ml
DIRECTION OF USE:
For Intravenous Infusion after dilution.
See 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 dilution. Fatal if given Intrathecally for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
CAUTION: Cytotoxic agent special Handling
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution only.
NOTE: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
IMPORTANT WARNING
Paclitaxel injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer. Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell that is needed to fight infection) in your blood. This increases the risk that you will develop a serious infection. You should not receive paclitaxel if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood.
Paclitaxel is given as an injection or infusion into the vein (intravenous, IV).
Paclitaxel is an irritant. An irritant is a chemical that can cause inflammation of the vein through which it is given. If the medication escapes from the vein it can cause tissue damage. If you experience pain or notice redness or swelling at the IV site while you are receiving Paclitaxel, alert your health care professional immediately.
Dilution Required Prior to Intravenous Infusion.
Wear gloves at all times when handling containers.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Paclitaxel Injection USP 6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Paclitaxel Injection USP 6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml)
Each ml contains:
Paclitaxel USP……………………………6mg
Polyoxyl 35 Castor oil USNF………527mg
Anhydrous Citric Acid USP……….2mg
Dehydrated alcohol USP…………..49.7%v/v
Each ml contains:
Paclitaxel USP……………………………6mg
Polyoxyl 35 Castor oil USNF………527mg
Anhydrous Citric Acid USP……….2mg
Dehydrated alcohol USP…………..49.7%v/v
THERAPEUTIC INDICATIONS:
Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer, and non-small cell lung cancer (NSCLC).
PACKING:
6mg/ml
1) 30mg/5ml
2) 100mg/16.7ml
3) 150mg/25ml
4) 260mg/43.3ml
5) 300mg/50ml
1) 30mg/5ml
2) 100mg/16.7ml
3) 150mg/25ml
4) 260mg/43.3ml
5) 300mg/50ml
DIRECTION OF USE:
For Intravenous Infusion after dilution.
See insert for detailed dosage, directions for use and precautions.
See insert for detailed dosage, directions for use and precautions.
CAUTION AND WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after dilution. Fatal if given Intrathecally for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
CAUTION: Cytotoxic agent special Handling
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution only.
NOTE: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
IMPORTANT WARNING Paclitaxel injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer. Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell that is needed to fight infection) in your blood. This increases the risk that you will develop a serious infection. You should not receive paclitaxel if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood.
Paclitaxel is given as an injection or infusion into the vein (intravenous, IV).
Paclitaxel is an irritant. An irritant is a chemical that can cause inflammation of the vein through which it is given. If the medication escapes from the vein it can cause tissue damage. If you experience pain or notice redness or swelling at the IV site while you are receiving Paclitaxel, alert your health care professional immediately.
Dilution Required Prior to Intravenous Infusion.
Wear gloves at all times when handling containers.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep medicine out of reach of children.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
CAUTION: Cytotoxic agent special Handling
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution only.
NOTE: Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
IMPORTANT WARNING Paclitaxel injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer. Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell that is needed to fight infection) in your blood. This increases the risk that you will develop a serious infection. You should not receive paclitaxel if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood.
Paclitaxel is given as an injection or infusion into the vein (intravenous, IV).
Paclitaxel is an irritant. An irritant is a chemical that can cause inflammation of the vein through which it is given. If the medication escapes from the vein it can cause tissue damage. If you experience pain or notice redness or swelling at the IV site while you are receiving Paclitaxel, alert your health care professional immediately.
Dilution Required Prior to Intravenous Infusion.
Wear gloves at all times when handling containers.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE AND DOSAGE:
Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
Protect from light.
Dosage: As directed by the Physician.
Protect from light.
Dosage: As directed by the Physician.
