MYLOTARG gemtuzumab ozogamicin 5 mg powder for injection vial

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

gemtuzumab ozogamicin, Quantity: 5 mg

Tilgængelig fra:

Pfizer Australia Pty Ltd

Lægemiddelform:

Injection, powder for

Sammensætning:

Excipient Ingredients: sucrose; dextran 40; sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate

Indgivelsesvej:

Intravenous

Enheder i pakken:

1 vial

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

MYLOTARG is indicated for combination therapy with standard anthracycline and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see Section 4.4 Special warnings and precautions for use, and Section 5.1 Pharmacodynamic properties).

Produkt oversigt:

Visual Identification: White to off-white powder cake; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

2020-04-09

Indlægsseddel

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at www.tga.gov.au/
reporting-problems .
MYLOTARG
®
_Gemtuzumab ozogamicin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MYLOTARG. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking MYLOTARG
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MYLOTARG IS
USED FOR
MYLOTARG contains the active
ingredient gemtuzumab ozogamicin.
It belongs to a group of medicines
called antineoplastic agents that
target cancer cells.
MYLOTARG is used to treat patients
aged 15 years and above with acute
myeloid leukaemia (AML). AML is a
cancer of the blood and bone marrow
in which the bone marrow makes
immature white blood cells in high
numbers. These abnormal cells
crowd the bone marrow, preventing it
from making normal blood cells.
This medicine works by stopping the
abnormal growth of these cells and
destroying them.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
MYLOTARG
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT RECEIVE MYLOTARG IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
gemtuzumab ozogamicin
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itch

Produktets egenskaber

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Supersedes: pfpmylov10420
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This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION –
MYLOTARG
® (GEMTUZUMAB OZOGAMICIN)
POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Gemtuzumab ozogamicin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial contains 5 mg gemtuzumab ozogamicin.
After reconstitution, the concentrated solution contains 1 mg/mL
gemtuzumab ozogamicin (see
Section 4.2 Dose and method of administration).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
White to off-white cake or powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYLOTARG is indicated for combination therapy with standard
anthracycline and cytarabine
(AraC) for the treatment of patients age 15 years and above with
previously untreated,
_de novo_
CD33-positive acute myeloid leukaemia (AML), except acute
promyelocytic leukaemia (APL)
(see Section 4.4 Special warnings and precautions for use, and Section
5.1 Pharmacodynamic
properties).
4.2 DOSE AND METHOD OF ADMINISTRATION
MYLOTARG should be administered under the supervision of a physician
experienced in the
use of anticancer medicinal products and in an environment where full
resuscitation facilities
are immediately available.
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Premedication with a corticosteroid, antihistamine, and acetaminophen
(or paracetamol) is
recommended 1 hour prior to MYLOTARG dosing to help ameliorate
infusion-related
symptoms (see Section 4.4 Special warnings and precautions for use).
Appropriate measures to help prevent the development of tumour
lysis-related hyperuricaemia
such as hydration, administration of antihyperuricaemic or other
agents for treatment of
hyperuricaemia must be taken (see Secti