Leaflet IRINOTECAN AUROBINDO 20mg / ml concentrate for solution for infusion

Product code:
W69253001
Quantity:
1
Indicated for:
colorectal cancer
Route of administration:
infusion
Substance:
irinotecan (topoisomerase inhibitor)
ATC
L01CE02 — Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Topoisomerase 1 (TOP1) inhibitors

Precautions:

Fertility warning

Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling

Cytotoxic / special handling

Handle with special care.

Colitis / severe diarrhea

Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Contraception required

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Severe skin reactions

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

Genetic test recommended

Genetic test recommended

A genetic test may be needed before treatment.

Irinotecan is a chemotherapy medication used to treat metastatic colorectal cancer, usually in combination with other drugs. It works by inhibiting the enzyme topoisomerase I, which is essential for DNA replication in cancer cells, thereby causing their death.

The medication is administered intravenously under the supervision of an oncologist, and the dosage is adjusted based on body weight and the patient's overall condition.

Side effects may include severe diarrhea, nausea, vomiting, decreased blood cell counts, or hair loss. In rare cases, severe allergic reactions or liver toxicity may occur.

Patients should be closely monitored during treatment and inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should not use this medication.

General data about IRINOTECAN AUROBINDO 20mg / ml

Substance:
irinotecan
Date of latest medicines list:
01-12-2022
Product code:
W69253001
Concentration:
20mg / ml
Pharmaceutical form:
concentrate for solution for infusion
Quantity:
1
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
APL SWIFT SERVICES (MALTA) LTD. - MALTA
Holder:
EUGIA PHARMA (MALTA) LTD. - MALTA
Number:
14058/2021/01
Shelf life:
2 years-after packing for marketing;dupa dilutie -it is used immediately

Concentrations available for irinotecan

  • 1.5mg/ml
  • 20mg/ml
  • 4.3mg/ml