GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml contains
Irinotecan Hydrochloride trihydrate…….20mg
Sorbitol………………………………………………..45mg
Lactic acid…………………………………………….0.9mg
Water for injection……………………………….q.s.
When necessary, PH was adjusted with sodium hydroxide and/or hydrochloric acid
THERAPEUTIC INDICATION:
PACKING:
1) 40mg/2ml
2) 100mg/5ml
3) 300mg/15ml
4) 500mg/25ml
DIRECTION OF USE:
For Intravenous use only must be diluted with 5% dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP before use.
Read accompanying package insert for detailed information of dosage, directions for use, Reconstitution, storage and precautions.
CAUTION & WARNING:
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: For Intravenous use only. Must be diluted before use.
CONTRAINDICATIONS: Irinotecan Hydrochloride trihydrate for Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. *Antineoplastic Agent
WARNING: You will be closely monitored (e.g. – blood test) by your doctor while using this medication. Keep all medical and laboratory appointments. Irinotecan may cause severe diarrhea, which can occur during or right after you receive this medication and/or more than 24 hours afterwards. If the diarrhea starts immediately, you may also have other side effects such as runny nose, increased saliva, watery eyes, sweating, stomach cramps or flushing. If the diarrhea starts later, it could be a different type that may be persistent and can cause serious (possibly fatal) loss of too much body water (dehydration).
IF CONTENTS ARE DAMAGED AND/OR LEAKING INCINERATE ENTIRE PACKAGE.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.
Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml) Technical Specification:
| Product Name: | Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml) |
| Brand Name: | Irinotecan |
| Strength: | 20mg/ml (40mg/2ml, 100mg/5ml, 300mg/15ml, 500mg/25ml) |
| Dosage Form: | Liquid Injection |
| Packing: | SINGLE 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: | Irinotecan is a medication used to treat colon cancer and small cell lung cancer. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml)
Each ml contains
Irinotecan Hydrochloride trihydrate…….20mg
Sorbitol………………………………………………..45mg
Lactic acid…………………………………………….0.9mg
Water for injection……………………………….q.s.
When necessary, PH was adjusted with sodium hydroxide and/or hydrochloric acid.
THERAPEUTIC INDICATION:
Irinotecan is a medication used to treat colon cancer and small cell lung cancer.
PACKING:
20mg/ml
- 40mg/2ml
- 100mg/5ml
- 300mg/15ml
- 500mg/25ml
DIRECTION OF USE:
For Intravenous use only. Must be diluted before use.
For Intravenous use only must be diluted with 5% dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP before use.
Read accompanying package insert for detailed information of dosage, directions for use, Reconstitution, storage and precautions.
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.
WARNING: For Intravenous use only. Must be diluted before use.
CONTRAINDICATIONS: Irinotecan Hydrochloride trihydrate for Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. *Antineoplastic Agent
WARNING: You will be closely monitored (e.g. – blood test) by your doctor while using this medication. Keep all medical and laboratory appointments. Irinotecan may cause severe diarrhea, which can occur during or right after you receive this medication and/or more than 24 hours afterwards. If the diarrhea starts immediately, you may also have other side effects such as runny nose, increased saliva, watery eyes, sweating, stomach cramps or flushing. If the diarrhea starts later, it could be a different type that may be persistent and can cause serious (possibly fatal) loss of too much body water (dehydration).
IF CONTENTS ARE DAMAGED AND/OR LEAKING INCINERATE ENTIRE PACKAGE.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.
