Adriamycin

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Doxorubicin hydrochloride 2 mg/mL

Доступна с:

Pfizer New Zealand Limited

ИНН (Международная Имя):

Doxorubicin hydrochloride 2 mg/mL

дозировка:

2 mg/mL

Фармацевтическая форма:

Solution for injection

состав:

Active: Doxorubicin hydrochloride 2 mg/mL Excipient: Hydrochloric acid as 0.5M, to pH 3 Sodium chloride Water for injection

Штук в упаковке:

Vial, glass, 5 mL

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Olon SpA

Терапевтические показания :

Doxorubicin has produced significant therapeutic responses in a number of solid tumours and haematologic malignancies, and is commonly used in the treatment of the following tumours: · carcinoma of the breast · carcinoma of the lung · carcinoma of the ovary · transitional bladder cell cancer · neuroblastoma · Wilms' tumour · soft tissue sarcomas · osteosarcoma · acute lymphocytic - lymphoblastic leukaemia · acute myelogenous leukaemia · non-Hodgkin's lymphoma · Hodgkin's disease Doxorubicin has also shown antitumour activity in the following adult and paediatric malignancies: · carcinoma of the thyroid · carcinoma of the endometrium · carcinoma of the head and neck · carcinoma of the stomach · primary hepatocellular carcinoma · non-seminomatous carcinoma of the testis · carcinoma of the prostate · Ewing's sarcoma · rhabdomyosarcoma · multiple myeloma · chronic leukaemias

Обзор продуктов:

Package - Contents - Shelf Life: Vial, plastic, polyprop - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, plastic, polyprop - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, plastic, polyprop - 25 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, plastic, polyprop - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Дата Авторизация:

1990-08-02

тонкая брошюра

New Zealand Consumer Medicine Information
ADRIAMYCIN
®
1
ADRIAMYCIN
®
_Doxorubicin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE TREATMENT WITH
ADRIAMYCIN.
This leaflet answers some common
questions about this medicine.
It does not contain all 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 you taking
ADRIAMYCIN against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
PLEASE KEEP THIS LEAFLET.
You may need to read it again.
WHAT ADRIAMYCIN IS
USED FOR
ADRIAMYCIN is used to treat many
types of cancer. ADRIAMYCIN
works by stopping cancer cells from
growing and multiplying. It contains
the active ingredient doxorubicin
hydrochloride.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ADRIAMYCIN HAS BEEN
PRESCRIBED FOR YOU.
ADRIAMYCIN is to be given only
under the strict supervision of your
doctor.
ADRIAMYCIN is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN _
_ADRIAMYCIN _
DO NOT HAVE ADRIAMYCIN IF YOU
ARE ALLERGIC TO ADRIAMYCIN OR
HAVE HAD AN ALLERGIC REACTION TO
ANY OTHER CANCER MEDICATION E.G.
DAUNORUBICIN, EPIRUBICIN,
MITOZANTRONE.
Symptoms of an allergic reaction to
ADRIAMYCIN 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
•
light-headedness or back pain.
DO NOT HAVE ADRIAMYCIN IF:
•
you have bone marrow
suppression (reduced number of
red or white blood cells or
platelets) caused by previous
treatment with other cancer
medicines or radiation therapy,
symptoms include tiredness,
mouth ulcers or bleeding or
bruising more easily than usual
•
you have a generalised infection
•
you have an irregular heart rate,
poor blood flow to the heart or
had a heart attack
•
you have severe liver problems
•
you have previously rec

Характеристики продукта

Version: pfdadrii11121
Supersedes: pfdadrii10219
Page 1 of 16
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ADRIAMYCIN 2 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of ADRIAMYCIN contains 10 mg, 20 mg, 50 mg and 200 mg of
doxorubicin
hydrochloride as a solution (2 mg/mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxorubicin has produced significant therapeutic responses in a number
of solid tumours and
haematologic malignancies, and is commonly used in the treatment of
the following tumours:

carcinoma of the breast

carcinoma of the lung

carcinoma of the ovary

transitional bladder cell cancer

neuroblastoma

Wilms’ tumour

soft tissue sarcomas

osteosarcoma

acute lymphocytic - lymphoblastic leukaemia

acute myelogenous leukaemia

non-Hodgkin’s lymphoma

Hodgkin’s disease
Doxorubicin
has
also
shown
antitumour
activity
in
the
following
adult
and
paediatric
malignancies:

carcinoma of the thyroid

carcinoma of the endometrium
Version: pfdadrii11121
Supersedes: pfdadrii10219
Page 2 of 16

carcinoma of the head and neck

carcinoma of the stomach

primary hepatocellular carcinoma

non-seminomatous carcinoma of the testis

carcinoma of the prostate

Ewing’s sarcoma

rhabdomyosarcoma

multiple myeloma

chronic leukaemias
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Doxorubicin is a cytotoxic drug that is usually administered to cancer
patients by the
intravenous and, whenever appropriate, intravesical and intra-arterial
routes.
_INTRAVENOUS (IV) ADMINISTRATION_
Dosage is usually calculated on the basis of body surface area (mg/m
2
). The doxorubicin
dose-schedule to be delivered may differ depending on the therapeutic
indication (e.g., solid
tumours or acute leukaemias) as well as on its use within a specific
regimen (e.g., as a single
agent or in combination with other cytotoxics or as a part of
multidisci