Dobutamine 250mg/20ml concentrate for solution for infusion ampoules

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Dobutamine hydrochloride

Sẵn có từ:

hameln pharma Ltd

Mã ATC:

C01CA07

INN (Tên quốc tế):

Dobutamine hydrochloride

Liều dùng:

12.5mg/1ml

Dạng dược phẩm:

Solution for infusion

Tuyến hành chính:

Intravenous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02070100; GTIN: 5016386005459 5016386000225

Tờ rơi thông tin

PATIENT INFORMATION LEAFLET
DOBUTAMINE CONCENTRATE
1. What
Dobutamine
Concentrate
is
and
what it is used for
Dobutamine Concentrate belongs to a group of
medicines known as INOTROPES
, which make
your heart beat more strongly.
In
ADULTS
it is used:
• in open heart
SURGERY
• to treat heart
DISEASE
• to treat heart
FAILURE
• in
SHOCK
• as an alternative to exercise for stress
TESTING
the heart.
Paediatric population
Dobutamine is indicated in all paediatric age groups
(from neonates to 18 years of age) as inotropic
support in low cardiac output hypoperfusion states
resulting
from
decompensated
heart
failure,
following cardiac surgery, cardiomyopathies and
in cardiogenic or septic shock.
2. What you need to know before you use
Dobutamine Concentrate
DO NOT USE DOBUTAMINE CONCENTRATE IF
YOU:
• Are
SENSITIVE
or
ALLERGIC
to
Dobutamine
Concentrate,
SODIUM METABISULFITE
or any
of the other ingredients in this injection.
• suffer
from
HIGH
BLOOD
PRESSURE
due
to
a
tumour
near
the
kidney
(
PHAEOCROMOCYTOMA
).
• have certain heart or blood vessel disorders.
Dobutamine
should
not
be
used
to
detect
poor
blood
supply
to
your
heart
(a
cardiac
stress test known as
DOBUTAMINE STRESS
ECHOCARDIOGRAPHY)
WARNINGS AND PRECAUTIONS:
Talk to your doctor or nurse if you have any of the
following conditions:
• have recently had a
HEART ATTACK
• have had a
HEART TRANSPLANT
• are
ASTHMATIC
• have unstable
ANGINA
• have
HEART
disease
• have
HIGH BLOOD PRESSURE
• have any condition that would make
EXERCISE
dangerous for you.
Important information about your medicine
►
Your doctor or nurse will give you the injection
►
If this injection causes you any problems talk to your doctor, nurse
or pharmacist
►
Please tell your doctor or pharmacist, if you have any other medical
conditions or have an allergy to
any of the ingredients of this medicine
►
Please tell your doctor or pharmacist, if you are taking any other
medicines
•
READ ALL OF THIS LEAFLET CAREFULLY
before you start using this medicine because it con

Đặc tính sản phẩm

OBJECT 1
DOBUTAMINE CONCENTRATE 250MG/20ML
Summary of Product Characteristics Updated 11-Aug-2015 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Dobutamine Concentrate 250 mg/20 ml.
2. Qualitative and quantitative composition
Each ml contains Dobutamine Hydrochloride USP equivalent to Dobutamine
12.5 mg.
3. Pharmaceutical form
Sterile Injection.
4. Clinical particulars
4.1 Therapeutic indications
_ADULT POPULATION_
Dobutamine Concentrate is indicated in adults who require inotropic
support in the treatment of low
output cardiac failure associated with myocardial infarction, open
heart surgery, cardiomyopathies, septic
shock and cardiogenic shock. Dobutamine Concentrate can also increase
or maintain cardiac output
during positive end expiratory pressure (PEEP) ventilation.
_DOBUTAMINE STRESS ECHOCARDIOGRAPHY_ _(Adult population only)_
Dobutamine Concentrate may also be used for cardiac stress testing as
an alternative to exercise in
patients for whom routine exercise cannot be satisfactorily performed.
This use of dobutamine should
only be undertaken in units which already perform exercise stress
testing and all normal care and
precautions required for such testing are also required when using
dobutamine for this purpose.
_PAEDIATRIC POPULATION_
Dobutamine is indicated in all paediatric age groups (from neonates to
18 years of age) as inotropic
support in low cardiac output hypoperfusion states resulting from
decompensated heart failure, following
cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.
4.2 Posology and method of administration
Route of Administration: For intravenous use only.
_ADULT POPULATION_
Dobutamine Concentrate must be diluted to at least 50 ml prior to
administration in an IV container with
one of the intravenous solutions listed below:
Sodium Chloride Intravenous Infusion BP
5% Dextrose Intravenous Infusion BP
5% Dextrose + 0.9% Sodium Chloride Intravenous Infusion BP
5% Dextrose + 0.45% Sodium Chloride Intravenous Infusion BP
Sodium Lactate Intravenous Infusi