Leaflet SINPLATIN 1mg / 1ml concentrate for solution for infusion

Product code:
W52187001
Quantity:
1
Indicated for:
cancer
Route of administration:
infusion
Substance:
cisplatin (antineoplastic agent)
ATC
L01XA01 — Antineoplastic and immunomodulating agents | Other antineoplastic agents | Platinum compounds

Precautions:

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Handle with special care.

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Nephrotoxicity

This medicine may affect the kidneys.

Neuropathy / neurotoxicity

This medicine may affect the nerves or nervous system.

Ototoxicity

This medicine may affect hearing or balance.

Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Cisplatin is a chemotherapy medication used for the treatment of various types of cancer, including testicular, ovarian, bladder, and lung cancer. It works by binding to the DNA of tumor cells, inhibiting their replication and inducing cell death.

The medication is administered intravenously, as directed by a doctor, usually in a hospital or specialized clinic. It is important for patients to be monitored to prevent severe side effects.

Patients should be aware of potential side effects, such as nausea, vomiting, kidney dysfunction, or ototoxicity. It is important to inform the doctor of any unusual symptoms.

Common side effects include nausea, vomiting, and fatigue. In rare cases, severe reactions such as kidney failure or hearing loss may occur. Patients should be informed of these risks before starting treatment.

General data about SINPLATIN 1mg / 1ml

Substance:
cisplatin
Date of latest medicines list:
01-03-2022
Product code:
W52187001
Concentration:
1mg / 1ml
Pharmaceutical form:
concentrate for solution for infusion
Packing volume:
10ml
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer:
SINDAN PHARMA SRL - ROMANIA
Holder:
TEVA PHARMACEUTICALS S.R.L. - ROMANIA
Number:
12451/2019/01
Shelf life:
18 months

Concentrations available for cisplatin

  • 0.5mg/ml
  • 10mg
  • 10mg/20ml
  • 1mg/1ml
  • 1mg/ml
  • 25mg/50ml
  • 50mg
  • 50mg/100ml