Leaflet ALDESTA 17.5mg 17.5mg / ml solution for injection in pre-filled syringe

Product code:
W66411001
Quantity:
1
Indicated for:
cancer; autoimmune inflammatory diseases
Route of administration:
injectable
Substance:
methotrexate (antimetabolite antineoplastic)
ATC
L04AX03 — Antineoplastic and immunomodulating agents | Immunosuppressants | Immunosuppressants | Other immunosuppressants

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.

Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Hepatotoxicity

This medicine may affect the liver.

Immunosuppression / infection risk

This medicine may increase the risk of infections.

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.

Severe skin reactions

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

Teratogenic / fetal risk

This medicine may affect fetal development.

Methotrexate is a medication used to treat various conditions, including autoimmune diseases and certain types of cancer. It is commonly prescribed for rheumatoid arthritis, severe psoriasis, psoriatic arthritis, and other chronic inflammatory diseases. It is also used in chemotherapy to treat leukemia, lymphomas, and other cancers.

Methotrexate works by inhibiting an enzyme called dihydrofolate reductase, which is essential for DNA synthesis and cell division. In autoimmune diseases, this mechanism helps reduce inflammation and immune system activity, while in cancer, it slows the growth of tumor cells.

Side effects may include nausea, vomiting, fatigue, mouth ulcers, hair loss, and a decrease in blood cell counts. In rare cases, more serious reactions can occur, such as liver damage, lung problems, or bone marrow suppression. It is crucial to take methotrexate as prescribed by a doctor, with regular blood tests to monitor for potential complications.

General data about ALDESTA 17.5mg 17.5mg / ml

Substance:
methotrexate
Date of latest medicines list:
01-03-2020
Product code:
W66411001
Concentration:
17.5mg / ml
Pharmaceutical form:
solution for injection in pre-filled syringe
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:
ACTAVIS ITALY S.P.A - ITALIA
Holder:
ADDENDA PHARMA S.R.L. - ITALIA
Number:
12256/2019/01
Shelf life:
2 years

Concentrations available for methotrexate

  • 100mg/ml
  • 10mg
  • 10mg/ml
  • 12.5mg
  • 12.5mg/ml
  • 15mg
  • 15mg/ml
  • 17.5mg
  • 17.5mg/ml
  • 2.5mg
  • 2.5mg/ml
  • 20mg
  • 20mg/ml
  • 22.5mg
  • 22.5mg/ml
  • 25mg
  • 25mg/ml
  • 27.5mg
  • 27.5mg/ml
  • 2mg/ml
  • 30mg
  • 30mg/ml
  • 50mg
  • 50mg/ml
  • 5mg
  • 5mg/ml
  • 7.5mg
  • 7.5mg/ml