Melphalan Tillomed 50 mg powder and solvent for solution for injection/infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Melphalan Hydrochloride

Dostupné z:

Tillomed Pharma GmbH

ATC kód:

L01AA; L01AA03

INN (Medzinárodný Name):

Melphalan Hydrochloride

Dávkovanie:

50 milligram(s)

Forma lieku:

Powder and solvent for solution for injection/infusion

Terapeutické oblasti:

Nitrogen mustard analogues; melphalan

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2019-08-19

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MELPHALAN TILLOMED 50 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
melphalan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Melphalan Tillomed is and what it is used for
2.
What you need to know before you are given Melphalan Tillomed
3.
How Melphalan Tillomed will be given
4.
Possible side effects
5.
How to store Melphalan Tillomed
6.
Contents of the pack and other information
1.
WHAT MELPHALAN IS AND WHAT IT IS USED FOR
Melphalan Tillomed contains a medicine called melphalan. This belongs
to a group of
medicines called cytotoxics (also called chemotherapy). Melphalan is
used to treat cancer.
It works by reducing the number of abnormal cells your body makes.
Melphalan Tillomed 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,
•
Childhood neuroblastoma - cancer of the nervous system,
•
Malignant melanoma – skin cancer,
•
Soft tissue sarcoma – cancer of the muscle, fat, fibrous tissue,
blood vessels, or
other supporting tissue of the body.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MELPHALAN TILLOMED
You should not be given Melphalan if any of the following apply to
you. Tell your doctor
if:
•
you are allergic to melphalan or any of the other ingredients of this
medicine listed in
section 6,
•
you are breast-feeding.
WARNINGS AND PRECAUTIONS
Before treatment with melphalan, tell your doctor if any of the
following

Súhrn charakteristických

Health Products Regulatory Authority
06 November 2023
CRN00DMCL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Melphalan Tillomed 50 mg powder and solvent for solution for
injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains melphalan hydrochloride equivalent to 50
mg melphalan.
Each vial of solvent contains 10 ml of solvent.
After reconstitution, each ml of the reconstituted solution contains 5
mg melphalan.
Excipient(s) with known effect:
After reconstitution each vial contains 53.5 mg sodium, 0.4 g ethanol
and 6.2 g propylene glycol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion
Powder: White to pale yellow lyophilized powder
Solvent: A clear colourless solution, free from visible particles
pH of the reconstituted solution is between 6.0 and 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Melphalan, at conventional intravenous dose, is indicated in the
treatment of multiple myeloma and advanced ovarian
cancer.
2. Melphalan, at high intravenous dose, is indicated, with or without
haematopoietic stem cell transplantation, for the
treatment of multiple myeloma and childhood neuroblastoma.
3. Melphalan, 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with melphalan should be supervised by a physician
experienced in the use of anticancer therapies.
General information
Melphalan is for intravenous use and regional arterial perfusion only.
Melphalan should not be given without haematopoietic
stem cell rescue at doses of above 140 mg/m
2
.
For intravenous administration, it is recommended that melphalan is
injected slowly into a fast-running infusion solution via a
swabbed injection port. If direct injection into a fast-running
infusion is not appropriate, melphalan may be admini