MELPHA melphalan (as hydrochloride) 50 mg powder for injection vial with diluent composite pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

melphalan hydrochloride, Quantity: 55.97 mg (Equivalent: melphalan, Qty 50 mg)

Boleh didapati daripada:

Emcure Pharmaceuticals Pty Ltd

Borang farmaseutikal:

Injection, diluent for

Komposisi:

Excipient Ingredients: sodium citrate dihydrate; ethanol; water for injections; propylene glycol

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

1 x 50 mg injection vial and 1 x 10 ml diluent vial

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

For?the?treatment?of?patients?with?multiple?myeloma?for?whom?oral therapy?is?not?appropriate

Ringkasan produk:

Visual Identification: Clear colourless solution supplied in 10 mL clear tubular type-1 lyo glass vial; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Registered

Tarikh kebenaran:

2018-03-15

Risalah maklumat

MELPHA
®
INJECTION
1
MELPHA
®
INJECTION
_Melphalan _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MELPHA
injection. It does not contain all of
the available information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of giving you MELPHA
injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE BEING
TREATED.
You may need to read it again.
WHAT MELPHA
INJECTION IS USED FOR
MELPHA injection contains
melphalan Hydrochloride as the
active ingredient. It belongs to a
group of medicines called
cytotoxics.
MELPHA injection is used to treat
multiple myeloma, a cancer of the
blood.
It is thought to work by stopping
cancer cells from growing and
multiplying.
This medicine may be used in
combination with other medicines to
treat cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MELPHA
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN MELPHA
INJECTION IF YOU HAVE AN ALLERGY TO:
•
melphalan
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
YOU MUST NOT BE GIVEN MELPHA
INJECTION IF YOU HAVE AN INFECTION OR
A HIGH TEMPERATURE.
Your doctor may decide to delay
your treatment until the infection has
gone. A mild illness, such as a cold,
is not usually a reason to delay
treatment.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU ARE TRYING TO
BECOME PREGNANT OR TO FATHER A
CHILD.
MELPHA injection may harm eggs
and sperm. Reliable contra

Ciri produk

Australian PI – MELPHA
®
INJECTION (Melphalan for Injection)
Page 1 of 13
MELPHA Injection – Product Information – V2.1
1
NAME OF THE MEDICINE
Melphalan hydrochloride 50mg powder for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single- use vial contains melphalan hydrochloride equivalent to
50 mg melphalan
and povidone.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
MELPHA for Injection is supplied as a sterile, no pyrogenic,
freeze-dried powder
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
MELPHA Injection is indicated for the treatment of patients with
multiple myeloma for
whom oral therapy is not appropriate
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE:
MELPHA for Injection is reconstituted using the sterile diluent
provided
MELPHA for Injection is administered intravenously. The usual IV dose
is 16 mg/m
2
. The
drug is administered as a single infusion over 15 to 20 minutes.
MELPHA is administered
at 2-week intervals for four doses, then, after adequate recovery from
toxicity, at 4-week
intervals. Available evidence suggests about one third to one half of
the patients with
multiple
myeloma
show
a
favourable
response
to
the
drug.
Experience
with
oral
melphalan suggests that repeated courses should be given since
improvement may
continue slowly over many months, and the maximum benefit may be
missed if treatment
is abandoned prematurely. Dose adjustment on the basis of blood cell
counts at the nadir
and day of treatment should be considered.
PATIENTS WITH RENAL IMPAIRMENT
Melphalan clearance, though variable, is decreased in patients with
renal impairment.
Dosage reduction of up to 50% should be considered in patients with
moderate to severe
renal
impairment
and
subsequent
dosage
determined
according
to
the
degree
of
haematological suppression.
ADMINISTRATION PRECAUTIONS:
As with other toxic compounds, caution should be exercised in handling
and preparing
the solution of MELPHA. Appropriate guidelines for the handling of
cytotoxic compounds
s