Medicinal Products

AMETYCIN 40 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Mitomycin
laboratory: Kyowa Kirin Pharma

Powder for solution for bladder irrigation
box of 1 vial of powder + 40 mg syringe
All forms

Indication

Tumor of the bladder (see section Warnings and precautions for use ).

Dosage AMETYCIN 40 mg powder for solution for bladder irrigation box of 1 vial of powder + 40 mg syringe

Tumor of the bladder (see section Warnings and precautions for use ).

Against indications

This medicine is contraindicated:

· If hypersensitivity to mitomycin C,

· In pregnant or lactating women (see section on Pregnancy and lactation ),

· In case of traumatic probing (see section Warnings and Precautions ).

Adverse effects Ametycine

· Pollakiuria, dysuria, hematuria, urethritis as a rule transient.

· Sometimes calcific cystitis that can progress to fibrosis.

· Some rare cases of vesical necrosis have been observed.

Very rare cases of necrosis of the glans and erectile bodies, usually after traumatic urethral sounding, which can lead to urogenital sequelae (see Warnings and precautions for use ).

· Skin reactions: palmar-plantar erythema and localized genitals, palmar-plantar erythrodysaesthesia (PIP), more rarely generalized rash, eczema.

· Cases of pulmonary arterial hypertension and pulmonary veno-occlusive disease (MVOP) have been reported.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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