DOPAMINA 200 mg /5 Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. DOPAMINA PFIZER 200 mg/5 ml concentrate for solution for infusion
   1. What DOPAMINA PFIZER is and what it is used for
   2. What you need to know before using DOPAMINA PFIZER
   3. How to use DOPAMINA PFIZER
   4. Possible side effects
   5. How to store DOPAMINA PFIZER
   6. Package Contents and Other Information

DOPAMINA PFIZER 200 mg/5 ml concentrate for solution for infusion

Dopamina

Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What DOPAMINA PFIZER is and what it is used for
• 2. What you need to know before you use DOPAMINA PFIZER
• 3. How to use DOPAMINA PFIZER
• 4. Possible side effects
• 5. How to store DOPAMINA PFIZER
• 6. Contents of the pack and other information

1. What DOPAMINA PFIZER is and what it is used for

DOPAMINA PFIZER contains the active substance dopamine, which belongs to a group of medicines called
adrenergic and dopaminergic agents.
DOPAMINA PFIZER is used for the treatment of shock caused by myocardial infarction, surgery,
decreased blood volume, hemorrhage, widespread blood infection, or a severe allergic reaction (anaphylactic shock). This shock is characterized by a significant
drop in blood pressure following a reduction in blood flow throughout the body.
The doctor will also take other measures to restore blood volume and to address the cause of the shock.

2. What you need to know before using DOPAMINA PFIZER

Do not use DOPAMINA PFIZER

• if you are allergic to dopamine or to any of the other ingredients of this medicine (listed in section 6);
• if you have high blood pressure due to a tumor of the adrenal glands (pheochromocytoma);
• if you have a problem of hyperthyroidism (hyperthyroidism);
• if you have an alteration of the heart rhythm (tachyarrhythmias and ventricular fibrillation).

Dopamine should not be administered during anesthesia with cyclopropane or halogenated hydrocarbon anesthetics.

Warnings and precautions
Talk to your doctor or nurse before you are given DOPAMINA PFIZER.
This medicine must be administered to you with great care in the following cases:

• if you have a low blood volume (hypovolemia);
• if you suffer from problems with blood circulation, in this case any changes in color or temperature of the fingers must be carefully monitored;
• if you are being treated with medicines for depression (MAOIs);
• if you have problems with kidney or liver function.

This medicine will be injected into a vein by a doctor or nurse. The infusion is preferably done
in the larger veins, to avoid leakage of the medicine from the veins (extravasation) and to minimize
the risk of tissue damage (tissue necrosis).
During the administration of dopamine, heart parameters (cardiac output
and blood pressure) and kidney function (urine flow) must be continuously monitored.
For those who play sports, the use of this medicine without real therapeutic need constitutes doping
and may result in positive doping tests.

Interference with laboratory tests
The infusion of dopamine suppresses the pituitary secretion of thyroid-stimulating hormone and prolactin.

Children
There are no data on the safety and efficacy of dopamine in children.

Other medicines and DOPAMINA PFIZER
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are using the following medicines:

• medicines for depression such as tricyclic antidepressants or MAO inhibitors;
• medicines used during anesthesia such as cyclopropane and halogenated hydrocarbon anesthetics;
• alpha and beta-blockers used to lower blood pressure, such as propanolol and metoprolol;
• phenytoin, a medicine used for epilepsy;
• medicines used to treat high blood pressure (diuretics, guanethidine);
• some medicines used to treat headaches (ergot alkaloids);

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor or nurse for advice before this medicine is given to you.
This medicine should not be administered during pregnancy unless absolutely necessary under
direct medical supervision.
It is not known whether dopamine passes into breast milk and there are no data available regarding its effect in
the newborn.

Driving and operating machinery
There are no data available to establish the effect of the medicine on the ability to drive vehicles and operate
machinery.

DOPAMINA PFIZER contains potassium metabisulfite
This medicine contains potassium metabisulfite which rarely may cause severe hypersensitivity reactions and
bronchospasm.

3. How to use DOPAMINA PFIZER

This medicine will be administered to you in hospital by qualified healthcare personnel. If you have any doubts, consult your
doctor or nurse.
This medicine is administered by intravenous (IV) infusion after appropriate dilution.
The recommended dose is 5-15 micrograms per kg of body weight per minute through continuous intravenous
infusion. The flow rate and dosage will be adjusted based on your response to therapy.

If you use more DOPAMINA PFIZER than you should
This medicine will be administered by specialized personnel, so it is unlikely that you will be
administered an excessive dose.
In case of overdose, a significant increase in blood pressure may occur, which resolves
by stopping or decreasing the infusion.
Its antidote is phentolamine mesylate.
If you think that you have been administered an excessive amount of this medicine, seek immediate medical
attention from your doctor or nurse.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• alterations of the heartbeat (ectopic beats, tachycardia);
• increased awareness of the heartbeat (palpitations);
• atrial fibrillation;
• conduction disturbances, slow heartbeat (bradycardia), prolongation of the QRS complex on the electrocardiogram and other heart rhythm problems (ventricular arrhythmias);
• chest pain due to heart problems (angina);
• problems with blood circulation caused by narrowing of the blood vessels;
• increase or decrease in blood pressure (hypertension or hypotension);
• nausea and vomiting;
• headache;
• difficulty breathing;
• goosebumps;
• dilation of the pupil of the eye (mydriasis) with vision problems;
• increased levels of nitrogen in the blood;
• tissue damage of the feet (gangrene) which may occur in people with vascular disease;

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DOPAMINA PFIZER

Medical and nursing staff are aware of the methods for storing the medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Store in the original package at a temperature not exceeding 25°C.
After dilution of the vial, the prepared solutions must be kept at a temperature not exceeding
25°C and used within 24 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

WhatDOPAMINE PFIZER contains

• The active ingredient is dopamine hydrochloride. Each vial contains 200 mg of dopamine.
• The other ingredients are: potassium metabisulfite, water for injections.

Description of the appearance of DOPAMINE PFIZER and contents of the pack
Pack of 10 vials or 100 vials of 5 ml concentrate for solution for intravenous infusion.
Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina

Manufacturer
Biologici Italia Laboratories S.r.l., Via Filippo Serpero 2, Masate (MI) - Italy

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The following information is intended for physicians or healthcare professionals only
CLINICAL INFORMATION
Dosage and administration
Dilute 2 vials of 200 mg in 500 ml of physiological saline, glucose or Ringer-lactate
(or dilute one 200 mg vial in 250 ml). The resulting solution will contain 0.8 mg (800 mcg) of
dopamine per ml. Since common drip sets deliver 1 ml equivalent to 20 drops, each drop will contain 40
mcg of dopamine. Generally, doses of 5-15 mcg/kg/min are sufficient, but in some cases it may be necessary
to reach 20 or more mcg/kg/min. Once a satisfactory increase in blood pressure and diuresis and an
improvement in general circulatory conditions have been achieved, the infusion should be continued with the dosage
proven effective. In patients of varying body weight, the number of drops of dopamine solution (2 vials of 200 mg
in 500 ml or 1 vial of 200 mg in 250 ml) to be infused when using dosages of 5 to 15
mcg/kg/min is as follows:

Special warnings and precautions for use
Excessive administration of potassium-free solutions can cause significant hypokalemia. Intravenous administration of these solutions can cause fluid and/or solute overload with
resulting dilution of serum electrolyte concentrations, hyperhydration, congestive states or pulmonary edema.
Before treatment with dopamine, hypovolemia must be corrected with appropriate amounts of blood or
plasma as indicated.
During therapy with dopamine, monitor: urine output, cardiac output, blood pressure.
If a disproportionate increase in diastolic pressure is encountered (i.e., a significant
decrease in pulse pressure), the infusion should be reduced and the patient carefully observed to avoid the vasoconstrictor activity becoming predominant, unless this is the desired effect.
Dopamine should be infused into larger veins, if possible, to avoid extravasation into adjacent tissues.
Extravasation can cause necrosis and ulcers. It is therefore necessary to continuously monitor the regularity of the infusion. Ischemia is reversible by infiltrating the affected area with
10 ml - 15 ml of saline solution containing 5 mg to 10 mg of phentolamine mesylate. At the onset of
extravasation, a syringe with a small-diameter hypodermic needle should be used to allow free
infiltration of phentolamine into the ischemic area.
Patients with a history of occlusive vascular disease (atherosclerosis, arterial embolism, Raynaud's disease,
cold injuries, diabetic endarteritis and Buerger's disease) should be carefully observed for any
changes in skin color or temperature in the extremities. If any changes occur and are thought to
be the result of impaired circulation in the extremities, the benefits of continuing dopamine infusion and the risks of possible necrosis should be assessed. This condition can be
reversed by either decreasing or stopping the perfusion. The antidote to peripheral ischemia to prevent ulcers and
necrosis will be infiltration as quickly as possible of the affected areas with 10 or 15 ml of physiological saline
containing 5 or 10 mg of phentolamine.
Patients treated with monoamine oxidase inhibitors (MAOIs) require a substantial reduction in dosage
(at least 1/10 of the normal dose).
Do not add alkaline solutions to dopamine.
Glucose solutions should be used with caution in patients with a history of subclinical or overt diabetes mellitus.
To avoid inappropriate hypotension, dopamine infusion should be discontinued gradually.
The safety and efficacy of dopamine in pediatric patients have not been established.

Interference with laboratory tests
Dopamine infusion suppresses pituitary secretion of thyroid-stimulating hormone and prolactin.

Overdose
In case of accidental overdose, indicated by excessive elevation of blood pressure, reduce the
infusion rate or suspend it temporarily until conditions stabilize. Since dopamine activity is extremely short, normally no further measures are necessary.
Excessive increase in blood pressure and vasoconstriction may occur due to the alpha-adrenergic effects of dopamine, particularly in patients with a history of
occlusive vascular disease. If necessary, these effects can be rapidly resolved by decreasing the dose or interrupting
the infusion, as dopamine in humans has a half-life of less than 2 minutes.
If the measures taken are not sufficient, treatment with a short-acting alpha-adrenergic blocker such as phentolamine mesylate should be considered.
Dopamine can cause local vasoconstriction at the infusion site, so a large-caliber vein should be chosen for
infusion. The resulting ischemia is reversible by infiltrating the affected area with 10
ml - 15 ml of saline solution containing 5 mg to 10 mg of phentolamine mesylate. At the onset of

extravasation, a syringe with a small-diameter hypodermic needle should be used to allow free
infiltration of phentolamine into the ischemic area.

Incompatibilities
Dopamine is inactivated in alkaline solutions, such as 5% bicarbonate, and is incompatible with
alkaline drugs, such as furosemide and thiopental sodium. Incompatibility has also been reported with insulin,
ampicillin, amphotericin B, gentamicin sulfate, cephalothin sodium, oxacillin sodium, and therefore mixtures with
the aforementioned drugs should be avoided.

Shelf life after dilution
Once diluted in physiological saline, glucose, or Ringer-lactate, DOPAMINE PFIZER
should be kept at a temperature not exceeding 25°C and used within 24 hours.

For further information, see the Summary of Product Characteristics.