Leunase

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Asparaginase 10000 [iU] (Derived from cultures of E.coli HAP ex Japan, expressed as 10,000KU)

Disponível em:

sanofi-aventis new zealand limited

DCI (Denominação Comum Internacional):

Asparaginase 10000 IU (Derived from cultures of E.coli HAP ex Japan, expressed as 10,000KU)

Dosagem:

10,000KU

Forma farmacêutica:

Powder for injection

Composição:

Active: Asparaginase 10000 [iU] (Derived from cultures of E.coli HAP ex Japan, expressed as 10,000KU)

Unidades em pacote:

Vial, 10,000KU, 1 dose unit

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Kyowa Hakko Bio Co., Ltd

Indicações terapêuticas:

Treatment of acute lymphoblastic leukaemia

Resumo do produto:

Package - Contents - Shelf Life: Vial, 10,000KU - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, 5 x 10,000KU - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorização:

1978-02-16

Folheto informativo - Bula

LEUNASE(R) leunase-ccdsv7-cmiv1-25oct16
1
LEUNASE(R)
_asparaginase (colaspase) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LEUNASE.
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 being given LEUNASE against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT LEUNASE IS USED
FOR
LEUNASE is used to treat leukaemia
and some types of cancer.
LEUNASE works by slowing or
stopping the growth of cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LEUNASE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
LEUNASE for another reason.
LEUNASE is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
LEUNASE
_WHEN YOU MUST NOT BE GIVEN _
_LEUNASE _
YOU MUST NOT BE GIVEN LEUNASE
IF YOU HAVE AN ALLERGY TO:
*
Asparaginase (colaspase), the
drug known as LEUNASE
Symptoms of an allergic reaction to
LEUNASE may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN LEUNASE
IF YOU HAVE OR HAVE HAD
PANCREATITIS, AN INFECTION OR
INFLAMMATION OF THE PANCREAS.
YOU MUST NOT BE GIVEN LEUNASE
IF YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
LEUNASE may affect your
developing baby if you take it during
pregnancy.
DO NOT BREAST-FEED WHILE YOU ARE
BEING GIVEN LEUNASE.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START BEING GIVEN
LEUNASE, TALK TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN _
_LEUNASE _
TELL YOUR DOCTOR IF YOU HAVE HAD
LEUNASE BEFORE.
Your doctor may test you for an
allergic reaction to LEUNASE. A
small test dose is injected under the
skin and observed for several hours
to see if you have a reaction to
LEUNASE.
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO:
*
any oth

Características técnicas

New Zealand Data Sheet
02 August 2017
Leunase
leunase-ccdsv7-dsv3-02aug17
Page 1
DATA SHEET
1
PRODUCT NAME
Leunase powder for infusion, 10,000KU.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 10,000 KU of asparaginase (colaspase).
After reconstitution, 1 mL of solution contains 2,000KU of
asparaginase (colaspase).
Asparaginase (colaspase) is L-asparaginase, or L-asparagine
amidohydrolase. It is an enzyme
produced from cultures of
_Escherichia coli_
HAP. Asparaginase (colaspase) is a monomer thought
to consist of four subunits of molecular weight about 33,000 each, for
a unit molecular weight of
133,000
±
5,000.
3
PHARMACEUTICAL FORM
Leunase is a lyophilised powder, which consists of white columnar or
needle shaped monoclinic
crystals, is readily soluble in water, but insoluble in ethanol and
other organic solvents.
Aqueous solutions of Leunase are most stable in the pH range 6.5 to
7.5.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asparaginase (colaspase) is indicated for the
t
reatment of acute lymphoblastic leukaemia, myeloid
leukaemia or malignant lymphoma.
New Zealand Data Sheet
02 August 2017
Leunase
leunase-ccdsv7-dsv3-02aug17
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
Asparaginase (colaspase) should only be used by physicians experienced
in the use and
management of cytotoxic therapy. It should be used in a hospital
environment, where there are
adequate facilities to monitor and manage the possible short and
longer term complications of
therapy.
TEST DOSE
Before treatment is started a test dose of 1 to 10 KU of asparaginase
(colaspase) in 0.1 mL of
distilled water should be injected subcutaneously and the injection
site observed for several hours
for evidence of primary hypersensitivity. Serious allergic reactions
can occur following
administration of a test dose; patients should be observed in a
hospital setting. A negative skin
reaction does not preclude the development of an allergic reaction.
DOSE
The usual dosage range for asparaginase (colaspase) is 50 to 200 KU/kg
bodyweight