Doxorubicin Ebewe

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Doxorubicin hydrochloride 2 mg/mL;  

Διαθέσιμο από:

Sandoz New Zealand Limited

INN (Διεθνής Όνομα):

Doxorubicin hydrochloride 2 mg/mL

Δοσολογία:

2 mg/mL

Φαρμακοτεχνική μορφή:

Concentrate for injection

Σύνθεση:

Active: Doxorubicin hydrochloride 2 mg/mL   Excipient: Hydrochloric acid Sodium chloride Water for injection

Μονάδες σε πακέτο:

Vial, glass, 50mg/25mL, 1 dose unit

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Microbiopharm Japan Co Ltd

Θεραπευτικές ενδείξεις:

Doxorubicin has been used successfully to produce regression in neoplastic conditions, e.g. acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma etc. Doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (Tis, T1, T2) by intravesical administration.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Vial, glass, amber, 50mg/25mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, amber, 10mg/5mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, amber, 10mg/5mL - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, amber, 100mg/50mL - 50 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, amber, 200mg/100mL - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Ημερομηνία της άδειας:

2004-07-26

Φύλλο οδηγιών χρήσης

Doxorubicin Ebewe
2303-cmi-clean-doxorubicin-ebewe.doc
Page 1 of 8
DOXORUBICIN EBEWE
Doxorubicin hydrochloride Injection
_(Dox-oh-roo-bi-sin) _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Doxorubicin Ebewe
Injection.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 or
pharmacist has weighed the
risks of you taking Doxorubicin Ebewe injection against the benefits
they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. YOUR
DOCTOR OR PHARMACIST CAN PROVIDE YOU WITH MORE INFORMATION ABOUT
DOXORUBICIN EBEWE.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
_ _
WHAT DOXORUBICIN EBEWE INJECTION IS USED FOR
Doxorubicin Ebewe Injection is used to treat certain
cancers.Doxorubicin Ebewe belongs to a
group of medicines called antineoplastic or cytotoxic medicines. You
may also hear of these
being called chemotherapy medicines.Doxorubicin Ebewe is thought to
work by killing cancer
cells, and stopping cancer cells from growing and multiplying.Your
doctor may have prescribed
Doxorubicin Ebewe injection for another reason. Ask your doctor if you
have any questions about
why Doxorubicin Ebewe injection has been prescribed for you.
Doxorubicin Ebewe is not addictive.
This medicine is available only with a doctor's prescription.
_ _
BEFORE YOU ARE GIVEN DOXORUBICIN EBEWE INJECTION
_WHEN YOU MUST NOT BE GIVEN IT _
You must not be given Doxorubicin Ebewe if you have an allergy to
Doxorubicin or any of the
ingredients listed at the end of this leaflet
Symptoms of an allergic reaction to Doxorubicin Ebewe Injection 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.
Doxorubicin Ebewe
2303-cmi-clean-doxorubicin-ebewe.doc
Page 2 of 8
•
YOU MUST NOT BE

Αρχείο Π.Χ.Π.

230320-Doxorubicin Ebewe-ds
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NEW ZEALAND DATA SHEET
DOXORUBICIN EBEWE (DOXORUBICIN)
1.
PRODUCT NAME
Doxorubicin Ebewe concentrate for injection 2 mg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: Doxorubicin hydrochloride
Each vial of Doxorubicin Ebewe contains 10 mg, 20 mg, 50 mg and 200 mg
of doxorubicin
hydrochloride as a solution (2 mg/mL).
It is soluble in water and slightly soluble in methanol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Doxorubicin hydrochloride solution for injection is red in colour.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Doxorubicin has been used successfully to produce regression in
neoplastic conditions, e.g.
acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone
sarcomas, breast
carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type,
bronchogenic (lung)
carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma etc. The
main antitumour
activities are listed in Table 1.
Doxorubicin is also indicated in the primary management of
nonmetastatic carcinoma of the
bladder (Tis, T
1
, T
2
) by intravesical administration.
TABLE 1 DOXORUBICIN ANTITUMOUR ACTIVITY
TUMOUR TYPE
RESPONSE
RATE
(%)
MEDIAN
DURATION
(MONTH)
FIRST LINE
CHEMOTHERAPY
Established
Activity
Breast
35
3-6
Yes
Ovary
38
3-6
?
Lung
30
3
?
Sarcoma
30
4
Yes
Wilms’
66
4
Yes
Bladder
28
4-6
?
Neuroblastoma
41
4
Yes
Hodgkin’s
36
4-6
?
Non-Hodgkin’s Lymphoma
40
4-6
Yes
Acute Leukaemia
35
3
?
Hepatoma
32
4-6
Yes
Thyroid
30
6-10
Yes
Some
Response
Stomach
30
2-4
?Yes
Cervix
32
2-6
?
Head & Neck
19
2-4
230320-Doxorubicin Ebewe-ds
Page 2 of 19
TUMOUR TYPE
RESPONSE
RATE
(%)
MEDIAN
DURATION
(MONTH)
FIRST LINE
CHEMOTHERAPY
Testicle
20
3-6
Myeloma
33
3
Endometrial
36
4-6
?Yes
Unresponsive
Colorectal
Pancreas
Renal
Melanoma
Brain
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dosage schedule is 60 to 75 mg/m
2
body surface area, as a single intravenous
injection administered at 21-day intervals. The lower dose should b