Alkeran 50mg, Powder and Solvent for Solution for Infusion

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Melphalan

Disponible des:

Aspen Pharma Trading Limited

Codi ATC:

L01AA; L01AA03

Designació comuna internacional (DCI):

Melphalan

Dosis:

50 milligram(s)

formulario farmacéutico:

Powder and solvent for solution for infusion

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Nitrogen mustard analogues; melphalan

Estat d'Autorització:

Marketed

Data d'autorització:

2002-10-25

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALKERAN 50MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
melphalan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alkeran is and what it is used for
2.
What you need to know before Alkeran is given
3.
How Alkeran is given
4.
Possible side effects
5.
How to store Alkeran
6.
Contents of the pack and other information
1.
WHAT ALKERAN IS AND WHAT IT IS USED FOR
Alkeran injection contains a medicine called melphalan which belongs
to a group of medicines called
cytotoxics (also called chemotherapy) and is used to treat certain
types of cancer. It works by reducing
the number of abnormal cells your body makes.
Alkeran injection is used for:
•
MULTIPLE MYELOMA
- a type of cancer that develops from cells in the bone marrow called
plasma
cells. Plasma cells help to fight infection and disease by producing
antibodies
•
Advanced
CANCER OF THE OVARIES
•
ADVANCED NEUROBLASTOMA (STAGE 4)
- (a type of cancer affecting the nervous system) in
children
•
MALIGNANT MELANOMA
– a type of skin cancer
•
SOFT TISSUE SARCOMA
- cancer of the muscle, fat, fibrous tissue, blood vessels, or other
supporting tissue of the body
Ask your doctor if you would like more explanation about these
diseases.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE ALKERAN IS GIVEN
YOU WILL NOT BE GIVEN ALKERAN IF:
•
You are allergic to melphalan or any of the other ingredients of this
medicine (listed in section
6).
•
You are breas

Fitxa tècnica

Health Products Regulatory Authority
08 June 2023
CRN00DJR9
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alkeran 50mg, Powder and Solvent for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alkeran Injection is supplied as a unit pack comprising of a vial of
powder containing 50 mg sterile, anhydrous melphalan, with
a vial of solvent containing 10 ml of solvent.
Where a pack is reconstituted with 10 ml of the solvent, the resultant
solution contains 5 mg/ml anhydrous melphalan.
Excipients: When reconstituted each vial contains 53.24 mg of Sodium,
0.52 ml (0.4 g) of Ethanol and 6.0 ml of Propylene Glycol
(E1520).
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for infusion
Powder: A white to off-white freeze-dried powder.
Solvent: A clear, colourless solution (10ml)
The pH of the reconstituted solution is 6.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alkeran Injection, administered by regional arterial perfusion, is
indicated in the treatment of localised malignant melanoma of
the extremities and localised soft tissue sarcoma of the extremities.
Alkeran Injection may be used alone or in combination with other
cytotoxic drugs in the therapy of advanced ovarian
carcinoma, multiple myeloma and stage IV neuroblastoma.
Alkeran Injection may be used alone or in combination with other
cytotoxic drugs in high-dose therapy for patients with
multiple myeloma. Where oral melphalan is not appropriate, intravenous
melphalan may be used at conventional doses for
treatment of multiple myeloma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
General
Alkeran is a cytotoxic drug which falls into the general class of
alkylating agents. It should be prescribed only by physicians
experienced in the management of malignant disease with such agents.
In view of the hazards involved and the level of
supportive care required, the administration of high‑dose Alkeran
Injection should be confined to specialist centres, with the
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