DOPAMINE HYDROCHLORIDE S.A.L.F. 40 MG1 ML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DOPAMINE HYDROCHLORIDE

متاح من:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC رمز:

C01CA04

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

DOPAMINE HYDROCHLORIDE 40 MG / 1 ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY

المجال العلاجي:

DOPAMINE

الخصائص العلاجية:

DOPAMINE HYDROCHLORIDE S.A.L.F. is used for the treatment of states of shock of different nature:- post myocardial infarction cardiogenic shock, a shock caused by a heart attack,- surgical shock, caused by a surgical operation,- hypovolemic or haemorrhagic shock, caused by a decrease in blood volume due to a hemorrhage,A shock is characterized by a sharp decrease in blood pressure in response to a reduced blood flow in the organism.

تاريخ الترخيص:

2020-04-07

نشرة المعلومات

Patient leaflet according to Pharmacists' Regulations (Preparations),
1986
This medicine can be sold with a physician's prescription only.
DOPAMINE HYDROCHLORIDE S.A.L.F. 40MG/1ML
CONCENTRATE FOR SOLUTION FOR INFUSION
THE ACTIVE INGREDIENT:
Each 5 ml contain:
Dopamine Hydrochloride 200mg.
The inactive ingredients are listed in section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information about this
medicine. If you have any
further questions, ask the physician or pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may harm them, even if you think that their medical
condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Dopamine hydrochloride S.A.L.F. 40mg/1ml is used for the treatment of
states of shock of different nature:
- Post myocardial infarction cardiogenic shock, a shock caused by a
heart attack.
- Surgical shock, caused by a surgical operation.
- Hypovolemic or haemorrhagic shock, caused by a decrease in blood
volume due to a hemorrhage.
THERAPEUTIC GROUP:
Adrenergic and Dopaminergic agents.
A shock is characterized by a sharp decrease in blood pressure in
response to a reduced blood flow in the organism.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE:
• If you are sensitive (allergic) to the active ingredient or to any
of the other ingredients of this medicine.
• If you have pheochromocytoma (adrenal gland cancer).
• If you suffer from hyperthyroidism (overactive thyroid).
• If you have abnormal heart rate (untreated tachyarrhythmia or
ventricular fibrillation).
• Cyclopropane and halogenated hydrocarbon anesthetics should not be
used together with dopamine during anesthesia.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
Consult your doctor before you start using Dopamine hydrochloride
S.A.L.F. 40mg/1ml.
Take special care in the following cases:
•
If you have a low blood volume (hypovolemia).
• If you have suffered from problems with blood flow and obstructive
bl

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
DOPAMINE HYDROCHLORIDE S.A.L.F. 40 MG/1 ML
1. NAME OF THE DRUG
Dopamine Hydrochloride S.A.L.F. 40 mg/1 ml.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 5ml contains:
_Active ingredient_
: Dopamine hydrochloride 200 mg
Excipients with known effect:
Dopamine Hydrochloride S.A.L.F. 40 mg/1 ml contains 9 mg/ml of sodium
chloride and 1 mg/ml of
potassium metabisulfite.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4. CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
Dopamine Hydrochloride S.A.L.F. 40 mg/1 ml is used for the treatment
of states of shock of different nature:
- Post myocardial infarction cardiogenic shock, a shock caused by a
heart attack,
- Surgical shock, caused by a surgical operation,
- Hypovolemic or haemorrhagic shock, caused by a decrease in blood
volume due to a hemorrhage,
A shock is characterized by a sharp decrease in blood pressure in
response to a reduced blood flow in the
organism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hypovolaemia should be fully corrected, if possible, before dopamine
hydrochloride is used.
Dopamine hydrochloride MUST be diluted before administration to the
patient. Dilution should be made just
prior to administration.
By diluting a 200 mg ampoule to 250 ml with Sodium chloride 0.9%
(saline solution) or Glucose 5% or
Ringer’s lactate, you get a solution which contains 0.8 mg (800
micrograms)/ml of dopamine. The product is
stable for 48 hours after dilution.
Dopamine hydrochloride should be given via an infusion pump or another
suitable metering device to control
the rate of flow in drops per minute. The initial rate is 2 to 5 μg
per kg body mass per minute, gradually
increased by 5 to 10 μg per kg per minute according to the
patient’s blood pressure, cardiac output and urine
output. Up to 20 to 50 μg per kg per minute may be required in
seriously ill patients. A reduction in urine
flow, without hypotension, may indicate a need to reduce the dose. T