Cisplatin Injection BP 1mg/ml (10mg/10ml) Technical Specification:

Product Name:Cisplatin Injection BP 1mg/ml (10mg/10ml)
Brand Name:Cisplatin
Strength:1mg/ml (10mg/10ml, 50mg/50ml, 100mg/100ml, 200mg/200ml), 0.5mg/ml (10mg/20ml, 50mg/100ml)
Dosage Form:Liquid Injection
Packing:SINGLE USE VIAL
Route of Administration:For Intravenous 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: Cisplatin is a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.
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). Do not refrigerate. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Cisplatin Injection BP 1mg/ml (10mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cisplatin Injection BP 1mg/ml (10mg/10ml)
    Each ml contains:
    Cisplatin BP……………………………..1 mg
    Sodium Chloride………………………9mg
    Sodium Hydroxide……………………q.s.
    Hydrochloric Acid…………………….q.s.
    Water for Injection…………………..q.s.

THERAPEUTIC INDICATION:

Cisplatin is a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.

PACKING:

1mg/ml

  • 10mg/10ml
  • 50mg/50ml
  • 100mg/100ml
  • 200mg/200ml

0.5mg/ml

  • 10mg/20ml
  • 50mg/100ml

DIRECTION OF USE:

For Intravenous Infusion only.

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.

NOTE: Cisplatin Injection should not be administered with needles or intravenous sets containing aluminum components.

Does not move the needle, aspirate and wash extravazatul tissue with saline solution 0.9%

(If the solution concentration of CISPLATIN is higher than recommended).

Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See package insert.

Nonpyrogenic, Preservative free, the container closure is not made with natural rubber latex.

DO NOT USE AFTER THE EXPIRY DATE STATED ON THE LABEL AFTER DILUTION.

Use the solution within 8 hours of opening.

Handle injection with great care, since it is a potent cytotoxic agent.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

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). Do not refrigerate. Protect from light.

Dosage: As directed by the Oncologist.

Adults and children:

CISPLATIN dose depends on the underlying disease, the response followed by the use of chemotherapy alone or in combination, Instructions for use are applicable to both adults and children.

Recommended doses alone:

Single dose 50-120 mg/m2 body surface area every three to four weeks.

15 to 20 mg/m2/day for five days, three to four weeks

 

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Cisplatin Injection BP 1mg/ml (10mg/10ml, 50mg/50ml, 100mg/100ml, 200mg/200ml)
b) Cisplatin Injection BP 0.5mg/ml (10mg/20ml, 50mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Cisplatin Injection BP 1mg/ml (10mg/10ml, 50mg/50ml, 100mg/100ml, 200mg/200ml)
Each ml contains:
Cisplatin BP……………………………..1 mg
Sodium Chloride………………………9mg
Sodium Hydroxide……………………q.s.
Hydrochloric Acid…………………….q.s.
Water for Injection…………………..q.s.


b) Cisplatin Injection BP 0.5mg/ml (10mg/20ml, 50mg/100ml)
Each ml contains:
Cisplatin BP……………………………0.5mg
Sodium Chloride………………………9mg
Sodium Hydroxide……………………q.s.
Hydrochloric Acid…………………….q.s.
Water for Injection…………………..q.s.

THERAPEUTIC INDICATION:

Cisplatin is a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.

PACKING:

1mg/ml
1) 10mg/10ml
2) 50mg/50ml
3) 100mg/100ml
4) 200mg/200ml

0.5mg/ml
1) 10mg/20ml
2) 50mg/100ml

DIRECTION OF USE:

For Intravenous Infusion only.

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.
NOTE: Cisplatin Injection should not be administered with needles or intravenous sets containing aluminum components.
Does not move the needle, aspirate and wash extravazatul tissue with saline solution 0.9% (If the solution concentration of CISPLATIN is higher than recommended).
Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See package insert.
Nonpyrogenic, Preservative free, the container closure is not made with natural rubber latex.
DO NOT USE AFTER THE EXPIRY DATE STATED ON THE LABEL AFTER DILUTION.
Use the solution within 8 hours of opening.
Handle injection with great care, since it is a potent cytotoxic agent.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
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). Do not refrigerate. Protect from light.
Dosage: As directed by the Oncologist.
Adults and children:
CISPLATIN dose depends on the underlying disease, the response followed by the use of chemotherapy alone or in combination, Instructions for use are applicable to both adults and children.
Recommended doses alone:
Single dose 50-120 mg/m2 body surface area every three to four weeks.
15 to 20 mg/m2/day for five days, three to four weeks