Leaflet MITOMICINA MEDAC 1mg / ml powder for solution for injection / infusion or intravesical solution

Product code:
W62643001
Quantity:
1
Indicated for:
cancer
Route of administration:
infusion / intravesical
Substance:
mitomycin (antineoplastic agent)
ATC
L01DC03 — Antineoplastic and immunomodulating agents | Cytotoxic antibiotics and related substances | Other cytotoxic antibiotics

Precautions:

Fertility warning

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Cytotoxic / special handling

Handle with special care.

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.

Mitomycin is a chemotherapy drug used for the treatment of certain types of cancer, including gastric cancer, pancreatic cancer, and bladder cancer. It acts as an alkylating agent, interfering with DNA synthesis in cancer cells and inhibiting their division.

The medication is administered intravenously or intravesically, depending on the type and location of the cancer. It is effective in reducing tumor size and slowing disease progression.

Side effects may include nausea, vomiting, bone marrow suppression, increased risk of infections, and, in rare cases, pulmonary or renal toxicity. Close monitoring is essential during treatment.

Consult your doctor to discuss the benefits and risks of treatment with Mitomycin. This medication must be administered under the supervision of an oncology specialist.

General data about MITOMICINA MEDAC 1mg / ml

Substance:
mitomycin
Date of latest medicines list:
01-06-2016
Product code:
W62643001
Concentration:
1mg / ml
Pharmaceutical form:
powder for solution for injection / infusion or intravesical solution
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:
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE - GERMANIA
Holder:
MEDAC GMBH - GERMANIA
Number:
8664/2016/01
Shelf life:
18 months-after packing for marketing;after reconstitution-it is used immediately

Concentrations available for mitomycin

  • 1mg/ml
  • 20mg
  • 40mg