NORADRENALINA 2 mg /Ml Концентрат Для Инфузионного Раствора

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1. NORADRENALINA TARTRATO GALENICA SENESE 2 mg/ml
2. Noradrenalina tartrato
   1. What is NORADRENALINA TARTRATO GALENICA SENESE and what is it used for
   2. What you need to know before using NORADRENALINA TARTRATO GALENICA SENESE
   3. How to use NORADRENALINA TARTRATO GALENICA SENESE
   4. Possible side effects
   5. How to store NORADRENALINA TARTRATO GALENICA SENESE
   6. Contents of the pack and other information
3. NORADRENALINE TARTRATE GALENICA SENESE 2 mg/ml

NORADRENALINA TARTRATO GALENICA SENESE 2 mg/ml

concentrate for solution for infusion

Noradrenalina tartrato

Generic medicine

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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is NORADRENALINA TARTRATO GALENICA SENESE and what is it used for

NORADRENALINA TARTRATO GALENICA SENESE contains the active ingredient noradrenaline, which
belongs to a group of medicines called adrenergic and dopaminergic agents.
NORADRENALINA TARTRATO GALENICA SENESE is used in emergency situations for
resuscitation in case of cardiac arrest and to restore normal blood pressure in case of a severe and
sudden drop in blood pressure (acute hypotension).

2. What you need to know before using NORADRENALINA TARTRATO GALENICA SENESE

Do not use NORADRENALINA TARTRATO GALENICA SENESE

• if you are allergic to norepinephrine tartrate or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from low blood pressure (hypotension) caused by a low blood volume;
• if you suffer from high blood pressure (hypertension) and if you have chest pain caused by heart problems (Prinzmetal's angina);
• if you are to undergo anesthesia, due to the risk of altered heartbeat (arrhythmias);
• if you are pregnant or breastfeeding (See section Pregnancy and breastfeeding).

Warnings and precautions
Consult your doctor or nurse before NORADRENALINA TARTRATO is administered to you.
This medicine must be administered to you with great care in the following cases:

• if you have recently had a heart attack or if you suffer from heart problems (ischemic heart disease);
• if you have high blood pressure (arterial hypertension);
• if you suffer from a thyroid malfunction (hyperthyroidism);
• if you suffer from diabetes mellitus;
• if you have a low blood volume (hypovolemia) that is not corrected;
• if you are being treated with medicines for depression (tricyclic antidepressants or MAOIs);
• if you are to undergo surgery and will be given anesthesia with halothane or cyclopropane;
• if you suffer from blood circulation problems such as thrombosis, a disease that causes circulation problems due to the formation of blood clots (thrombi);
• if you have low oxygen levels in the blood; or high levels of carbon dioxide in the blood;
• if you are allergic to some food preservatives (sulfites), especially if you suffer from asthma;
• if you are elderly. This medicine will be injected intravenously by a doctor or nurse. The infusion is preferably done in large-caliber veins of the arm or leg, and with attention to the injection site, to avoid leakage of the medicine from the injection site (extravasation) and minimize the risk of tissue damage (tissue necrosis). If you are elderly or have occlusive vascular problems, the medicine should not be injected into the veins of the leg, because there is a risk of developing tissue damage (tissue necrosis).

For athletes: the use of this medicine without actual therapeutic need constitutes
doping and may result in a positive doping test.

Children
There is no experience with the use of norepinephrine in children.

Other medicines and NORADRENALINA TARTRATO GALENICA SENESE
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines.
Norepinephrine should not be administered with the following medicines:

• medicines used during anesthesia such as cyclopropane and halothane;
• medicines for depression such as tricyclic antidepressants and MAO inhibitors, because they can enhance the effects of norepinephrine causing an increase in blood pressure or altered heartbeat (cardiac arrhythmias and tachycardia). Tell your doctor or dentist if you are taking these medicines, in case you need to undergo surgery, including dental surgery. If you experience symptoms of high blood pressure, tell your doctor and stop treatment;
• medicines used for mental disorders (neuroleptics), because they can decrease the effects of norepinephrine; if the two medicines are administered together, it is necessary to adjust the dose to maintain the desired therapeutic effect;
• dihydroergotamine, a medicine used to treat headaches, because it can cause a sharp increase in blood pressure;
• linezolid, an antibiotic used against infections, because it can cause a sharp increase in blood pressure;
• entacapone, a medicine used for Parkinson's disease, because it can cause heart problems (tachycardia, hypertension, arrhythmias);
• guanethidine, a medicine used to treat high blood pressure, because it can cause heart problems (arrhythmias) and increases in blood pressure;

This medicine should not be injected intravenously together with the following medicines:

• some medicines used to treat bacterial infections, called basic buffered antibiotics, because norepinephrine is destroyed at pH greater than 6;
• antibiotics and antibacterials used against bacteria such as cefamandole, cefoxitin, moxalactam, nitrofurantoin;
• medicines used for epilepsy such as secobarbital, phenobarbital, thiopental.

Norepinephrine enhances the action of other drugs such as atropine, used in anesthesia, digitalis, used to treat
heartbeat alterations and antiasthmatics; while antagonizing the action of some medicines used to
lower blood pressure: beta-blockers, thiazide diuretics, furosemide.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast milk
ask your doctor or nurse for advice before this medicine is administered to you.
This medicine should not be administered during pregnancy unless absolutely necessary, for example
in life-threatening emergencies for heart problems. Norepinephrine can cause problems with the fetus.
Use this medicine with caution if you are breastfeeding because it is not known whether norepinephrine passes into
breast milk and no data are available regarding its effect on the newborn.

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

NORADRENALINA TARTRATO GALENICA SENESE contains sodium and sodium metabisulfite
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.
This medicine contains sodium metabisulfite which rarely can cause serious hypersensitivity reactions and
bronchospasm (particularly in people who suffer from asthma).

3. How to use NORADRENALINA TARTRATO GALENICA SENESE

This medicine will be administered to you in hospital by trained healthcare professionals. If you have any doubts, consult your
doctor or nurse.
The dose will be calculated by the doctor based on your health condition.
This medicine is administered by intravenous infusion (intravenous drip) after appropriate
dilution.
The doses reported below are expressed as noradrenaline base:
The initial dose is 8-12 micrograms per minute through intravenous infusion. The flow rate will be
adjusted to maintain blood pressure at normal values (systolic pressure 80-100).
The usual maintenance dose ranges from 2 to 4 micrograms per minute, up to a maximum of 68 mg per day.

Use in the elderly
For elderly patients, infusion should be started with the lowest possible dose, which may then be
increased according to the patient's needs. In the elderly, infusion into the leg veins should be avoided.

If you use more NORADRENALINA TARTRATO GALENICA SENESE than you should
This medicine will be administered by trained personnel, so it is unlikely that you will be
administered an excessive dose.
Symptoms of an overdose may include headache, a significant increase in blood pressure, a decrease in
heart rate (reflex bradycardia), heart and blood circulation problems.
If you experience these symptoms or think you have been given 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, ask 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:

Not known(the frequency of the side effects cannot be estimated from available data)

• increase in blood pressure (hypertension);
• fluid accumulation around the lung (pulmonary edema);
• bleeding in the brain (cerebral hemorrhage);
• slow heartbeat (bradycardia) or irregular heartbeat (arrhythmias, palpitations);
• chest pain due to heart problems (angina), stress cardiomyopathy, cardiac arrest; sudden death
• tissue damage at the injection site if the medicine leaks from the vein (extravasation) during infusion;
• alteration of sugar metabolism;
• nausea, vomiting and excessive saliva production;
• problems with blood circulation caused by the formation of blood clots and impaired blood flow to the limbs (peripheral ischemia);
• fear, anxiety, agitation, tremor, insomnia;
• confusion, irritability, weakness and psychosis;
• convulsions;
• kidney problems with decreased creatinine and insulin clearance;
• difficulty urinating;
• difficulty breathing, including cessation of breathing (apnea);
• severe headache, sensitivity to light, chest pain behind the sternum, paleness, vomiting and profuse sweating may occur in hypersensitive individuals or following an overdose.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. 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 NORADRENALINA TARTRATO GALENICA SENESE

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 “Expiry”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C and in the original package, tightly closed, protected
from light. Do not refrigerate or freeze. The solution must not be used if it has a brown colour or if
a precipitate is present.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NORADRENALINA TARTRATO GALENICA SENESE contains

• The active ingredient is noradrenaline tartrate acid. Each vial contains 2 mg of noradrenaline tartrate acid (corresponding to 1 mg of noradrenaline base).
• The other ingredients are: sodium chloride, sodium metabisulfite, water for injections.

Description of the appearance of NORADRENALINA TARTRATO GALENICA SENESE and contents of the pack
Pack of 5 and 10 vials of 1 ml concentrate for solution for infusion

Marketing Authorisation Holder and manufacturer
Industria farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351, Monteroni d’Arbia (SI), Italy

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NORADRENALINE TARTRATE GALENICA SENESE 2 mg/ml

concentrate for solution for infusion
Noradrenaline tartrate
The following information is intended exclusively for physicians or healthcare professionals
CLINICAL INFORMATION
Dosage and administration
Noradrenaline must be diluted in a 5% glucose solution in water or in physiological saline (sodium
chloride 0.9%) because these solutions protect against excessive oxidation and the resulting loss of
potency. Dilution with saline solution alone is not recommended.
The doses reported below are expressed as noradrenaline base.
The initial dose of noradrenaline is 8-12 micrograms/min for intravenous infusion.
The flow rate must be adjusted to establish and maintain a normal blood pressure (systolic
80-100 mmHg).
The usual maintenance dose ranges from 2 to 4 micrograms/min.
Daily doses up to 68 mg may be necessary.
Before administering noradrenaline, the blood volume depletion must be corrected as
completely as possible. When, as an emergency measure, intra-aortic pressure must be
maintained to prevent cerebral or coronary arterial ischemia, noradrenaline may be administered
before or concurrently with blood volume restoration.
Any transfusions of whole blood or plasma, if indicated to increase blood volume, must be
administered separately from the solution containing noradrenaline (for example, using a Y-tube and
separate containers if administered simultaneously).

Monitor blood pressure, heart rate and electrocardiogram.
Elderly patients
In general, the dose for the elderly should be chosen with caution, usually starting with the lowest dose
within the dosage range. In elderly patients, noradrenaline infusion should not be performed in the veins of the
legs (see section “Special warnings and precautions for use”).

Special warnings and precautions for use
Use with caution after myocardial infarction, in the presence of ischemic heart disease, arterial hypertension,
hyperthyroidism, diabetes mellitus, uncorrected hypovolemia and in advanced age.
When possible, noradrenaline infusion should be performed in veins of large caliber, particularly
in the antecubital area, because, when administered in this area, the risk of tissue necrosis is
apparently minimal. The femoral vein appears to be another acceptable infusion site. The use of a
catheter, if possible, should be avoided as obstruction of blood flow around the tube can cause
stasis and increased local concentration of the drug.
In elderly patients and patients with occlusive vascular disease (atherosclerosis, arteriosclerosis, diabetic
endarteritis, Buerger's disease), veins in the leg should be avoided as an infusion site. In these patients,
cases of lower limb gangrene have been reported when noradrenaline infusion was performed at the
level of an ankle vein.
The infusion site must be checked frequently. Care must be taken to avoid extravasation of
noradrenaline into the tissues, as tissue necrosis may occur due to the vasoconstrictor action of the
drug.
Pallor during infusion, sometimes without an evident extravasation, has been attributed to constriction of the
vessels with an increase in the permeability of the venous bed, allowing some leakage. This
can also lead, in rare cases, to tissue loss, particularly during infusion into the leg veins
in elderly patients or those suffering from obliterating vascular pathologies. Therefore, if
pallor occurs, consideration should be given to changing the infusion site.

The solution must be appropriately diluted before intravenous administration.The
solution must be used only if clear, colorless and free from visible particles. It is intended for single and
uninterrupted administration and any residue cannot be used.

Overdosage
An overdose of noradrenaline can cause headache, severe hypertension, reflex bradycardia, marked increase in
peripheral resistance and decreased cardiac output. In case of accidental overdose,
shown by an excessive increase in pressure, the administration of noradrenaline must be
suspended until the patient's condition has stabilized.
Bradycardia from noradrenaline can be treated with the administration of atropine while hypertensive effects can be countered with the administration of phentolamine.

Incompatibilities
There are conflicting opinions regarding the compatibility of noradrenaline with 0.9% sodium chloride. In fact,
noradrenaline is physically compatible with 0.9% sodium chloride but the administration of a
mixture of noradrenaline diluted only with saline solution is not recommended as it does not protect the active
ingredient from oxidation.
Noradrenaline is stable in a pH range of 3.6 – 6.0; above this range there may be a
loss of drug potency. Therefore, the use of noradrenaline in solutions with pH > 6 is not recommended
(presence of sodium bicarbonate, barbiturates, alkaline antibiotics).
Noradrenaline is physically incompatible with whole blood, therefore if the patient receives
transfusions, noradrenaline must be administered separately.
In the absence of incompatibility studies, this medicine should not be mixed with other medicines.
This medicine should not be mixed with other products except glucose or sodium
chloride solutions.

For further information consult the Summary of Product Characteristics.