Alkeran 50mg powder and solvent for solution for injection vials

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Melphalan hydrochloride

Pieejams no:

Aspen Pharma Trading Ltd

ATĶ kods:

L01AA03

SNN (starptautisko nepatentēto nosaukumu):

Melphalan hydrochloride

Deva:

50mg

Zāļu forma:

Powder and solvent for solution for injection

Ievadīšanas:

Regional perfusion; Intravenous

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 08010100; GTIN: 5010706004672

Lietošanas instrukcija

- 1 -
ASPEN LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
MELPHALAN 50 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION /
INFUSION
MELPHALAN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions about your illness or your medicine,
ask your doctor or
nurse.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
IN THIS LEAFLET:
1
What Melphalan is and what it is used for
4
Possible side effects
2
Before you have Melphalan
5
How to store Melphalan
3
How to have Melphalan
6
Further information
1
WHAT MELPHALAN IS AND WHAT IT IS USED FOR
Melphalan injection 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 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
Ask your doctor if you would like more explanation about these
diseases.
2
BEFORE YOU HAVE MELPHALAN
DO NOT HAVE MELPHALAN IF:
•
You are allergic (hypersensitive) to melphalan or any of the other
ingredients of
Melphalan injection (See section 6: Further information)
Do not have Melphalan if the above applies to you. If you are not
sure, talk to your doctor or
nurse before having Melphalan.
TAKE SPECIAL CARE WITH MELPHALAN
Before you use Melphalan, tell your doctor or nurse if:
•
you have had radiotherapy or chemotherapy, now or recently
•
you have a kidney problem.
If you are not s

Produkta apraksts

OBJECT 1
MELPHALAN 50 MG POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 09-Dec-2014 | Aspen
1. Name of the medicinal product
Melphalan 50 mg Powder and Solvent for Solution for Injection/Infusion
2. Qualitative and quantitative composition
Melphalan Hydrochloride BP equivalent to 50 mg mephalan per vial.
3. Pharmaceutical form
Freeze-dried powder for injection.
4. Clinical particulars
4.1 Therapeutic indications
Melphalan Injection, at conventional intravenous dosage, is indicated
in the treatment of multiple
myeloma and ovarian cancer.
Melphalan Injection, at high intravenous dosage, is indicated, with or
without haematopoietic stem cell
transplantation, for the treatment of multiple myeloma and childhood
neuroblastoma.
Melphalan 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.
In the above indications, Melphalan may be used alone or in
combination with other cytotoxic drugs.
4.2 Posology and method of administration
Parenteral administration:
Melphalan Injection is for intravenous use and regional arterial
perfusion only. Melphalan Injection
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
Injection solution 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 Injection solution may be
administered diluted in an infusion bag.
Melphalan is not compatible with infusion solutions containing
dextrose and it is recommended that only
sodium chloride intravenous infusion 0.9% w/v is used.
When further diluted in an infusion solution, Melphalan has reduced
stability and the rate of degradation
increases rapidly with rise in temperature. If Melphalan is infused at
a room temperature of approximately
25°C, the tota