DOBUTAMINE SANDOZ dobutamine 250mg/20mL (as hydrochloride) injection ampoule

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

dobutamine hydrochloride, Quantity: 14 mg/mL (Equivalent: dobutamine, Qty 12.5 mg/mL)

Sẵn có từ:

Sandoz Pty Ltd

Dạng dược phẩm:

Injection, concentrated

Thành phần:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium metabisulfite

Tuyến hành chính:

Intravenous Infusion

Các đơn vị trong gói:

5 vials, 1 vial, 10 vials

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.

Tóm tắt sản phẩm:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2003-01-07

Tờ rơi thông tin

______________________________________________________________________________
Dobutamine Sandoz
®
1
DOBUTAMINE SANDOZ®
_Dobutamine hydrochloride Injection _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Dobutamine Sandoz. 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 using Dobutamine Sandoz
against
the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DOBUTAMINE SANDOZ IS USED FOR
The name of your medicine is Dobutamine Sandoz. It contains the active
ingredient dobutamine hydrochloride.
This medicine belongs to a group of medicines called adrenergic
stimulants.
This medicine is used to treat heart failure following a heart attack
or heart surgery_. _Dobutamine Sandoz works by
helping the heart to beat more strongly._ _
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 not addictive.
This medicine is available only with a doctor’s prescription.
DOBUTAMINE SANDOZ IS NOT RECOMMENDED FOR USE IN CHILDREN.
The safety and effectiveness of Dobutamine Sandoz in children have not
been established._ _
BEFORE YOU ARE GIVEN DOBUTAMINE SANDOZ
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE DOBUTAMINE SANDOZ IF YOU HAVE AN ALLERGY TO DOBUTAMINE OR
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,
itching or hives on
the skin.
DO NOT USE DOBUTAMINE SANDOZ IF YOU HAVE A HEART CONDITION KNOWN AS
IDIOPATHIC HYPERTROPHIC SUBAORTIC
STENOSIS_._
THIS MEDICINE SHOULD NOT BE USED AFTER THE EXPIRY

Đặc tính sản phẩm

191120-Dobutamine Sandoz-pi
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
DOBUTAMINE SANDOZ
® (DOBUTAMINE HYDROCHLORIDE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Dobutamine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of DOBUTAMINE SANDOZ
®
250 mg/20 mL (as hydrochloride)
concentrated injection is Dobutamine hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Dobutamine Sandoz 250 mg/20 mL Concentrated Injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Adults who require short-term treatment of cardiac failure secondary
to acute myocardial
infarction, or cardiac surgery.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The rate of infusion needed to increase cardiac output usually ranges
from 2.5 to 10
microgram/kg/minute
(see
Table
1).
On
rare
occasions,
infusion
rates
up
to
40
microgram/kg/minute have been required to obtain the desired effect.
However, the possibility
of intensifying myocardial ischaemia should be borne in mind and the
lowest effective dose
infused.
TABLE 1. RATES OF INFUSION FOR CONCENTRATIONS OF 250, 500 AND 1000
µ
G/ML
DRUG DELIVERY RATE
(
µ
G/KG/MIN)
INFUSION DELIVERY RATE
250
µ
G/ML*
(ML/KG/MIN)
500
µ
G/ML**
(ML/KG/MIN)
1000
µ
G/ML***
(ML/KG/MIN)
2.5
0.01
0.005
0.0025
5.0
0.02
0.010
0.0050
7.5
0.03
0.015
0.0075
10.0
0.04
0.020
0.0100
12.5
0.05
0.025
0.0125
15.0
0.06
0.030
0.0150
* 250 mg/L of diluent
** 500 mg/L or 250 mg/500 mL of diluent
*** 1000 mg/L or 250 mg/250 mL of diluent
The rate of administration and the duration of therapy should be
adjusted according to the
patient's
response,
as
determined
by
the
following
clinical
indicators:
haemodynamic
parameters such as heart rate and rhythm, arterial pressure, and,
whenever possible, cardiac
output and measurements of ventricular filling pressures (central
venous, pulmonary artery
191120-Dobutamine Sandoz-pi
Page 2 of 10
wedge and left atrial), and signs of pulmonary congestion and organ
perfusion (urine flow, skin
temperature and