NORADRENALINA 2 mg /Ml Концентрат И Раствор Для Инфузий

Содержание инструкции

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

NORADRENALINA TARTRATO S.A.L.F. 2 mg/ml concentrate for solution for infusion

Noradrenalina tartrato 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.
• 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is NORADRENALINA TARTRATO S.A.L.F. and what is it used for

NORADRENALINA TARTRATO S.A.L.F. contains the active substance noradrenaline, which belongs to a
group of medicines called adrenergic and dopaminergic agents.
NORADRENALINA TARTRATO S.A.L.F. 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 S.A.L.F.

Do not use NORADRENALINA TARTRATO S.A.L.F.

• if you are allergic to noradrenaline 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 are pregnant or breastfeeding unless after careful evaluation by your doctor (See section Pregnancy and breastfeeding).

Warnings and precautions
Consult your doctor, pharmacist or nurse before you are given NORADRENALINA
TARTRATO S.A.L.F.
This medicine must be administered to you with great care in the following cases:

• if you are being treated with medicines for depression (tricyclic antidepressants or MAOIs);
• if you are going to undergo surgery and you 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 clots (thrombi);
• if you have low oxygen levels in your blood;
• if you are elderly.

This medicine will be injected into a vein by a doctor or a nurse. The infusion is preferably done in veins of large caliber of the arm or leg, taking care at the injection site,
to avoid leakage of the medicine from the injection site (extravasation) and to 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 those who engage in sports, the use of this medicine without actual therapeutic necessity constitutes
doping and may result in positive doping tests.

Other medicines and NORADRENALINA TARTRATO S.A.L.F.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking the following medicines because noradrenaline should not be
administered simultaneously:

• 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 noradrenaline causing an increase in blood pressure or alteration of the 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 noradrenaline; if the two drugs 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 strong increase in blood pressure;
• linezolid, an antibiotic used against infections, because it can cause a strong 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 pressure;

This medicine should not be injected into a vein together with the following medicines:

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

Fertility, Pregnancy and Breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor, pharmacist or nurse for advice before this medicine is given to you.
This medicine should not be administered during pregnancy, unless in case of absolute necessity, for
example as in life-saving emergencies for heart problems. Noradrenaline can cause
problems for the fetus.
Use this medicine with caution if you are breastfeeding because it is not known whether noradrenaline passes
into breast milk and there is no data 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 S.A.L.F. contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of injectable solution, i.e.
essentially ‘sodium-free’.

3. How to use NORADRENALINA TARTRATO S.A.L.F.

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 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 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 S.A.L.F. 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,
decreased 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, 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:

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

• increased 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) and cardiac arrest;
• tissue damage at the injection site if the medicine leaks out of the vein (extravasation) during infusion;
• nausea, vomiting and excessive saliva production;
• problems with blood circulation caused by the formation of blood clots;
• fear, anxiety, agitation, tremor, insomnia;
• confusion, irritability, weakness and psychosis;
• kidney problems with decreased elimination rate of creatinine and insulin;
• difficulty urinating;
• difficulty breathing;
• 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, pharmacist 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 NORADRENALINA TARTRATO S.A.L.F.

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 in the original packaging, 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 dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What NORADRENALINE TARTRATE S.A.L.F. contains

• The active ingredient is noradrenaline tartrate monohydrate. Each vial contains 2 mg of noradrenaline tartrate monohydrate (corresponding to 1 mg of noradrenaline base).
• The other ingredients are: sodium chloride, sodium edetate, sodium citrate dihydrate, citric acid monohydrate, 45% sodium hydroxide or 37% hydrochloric acid (pH adjuster), water for injections.

Description of the appearance of NORADRENALINE TARTRATE S.A.L.F. and package contents
Pack of 5 vials of 1 ml concentrate for solution for infusion.

Marketing Authorisation Holder and manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico
via Marconi, 2 - 24069 Cenate Sotto (BG) Italy
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The following information is intended exclusively for doctors or healthcare professionals
CLINICAL INFORMATION
Dosage and administration
Noradrenaline must be diluted in 5% glucose in water or in physiological saline
(0.9% sodium chloride) because these solutions protect against excessive oxidation and the resulting
loss of potency.
Dilution with saline solution alone is not recommended.
The doses below are expressed as noradrenaline base.
The initial dose of noradrenaline is 8-12 micrograms/min for intravenous infusion. It is necessary
to adjust the flow rate 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).
When possible, noradrenaline infusion should be carried out in large-caliber veins, in
particular 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 to blood flow around the tube
can cause stasis and increased local drug concentration.
In elderly patients and patients with occlusive vascular disease (atherosclerosis, arteriosclerosis,
diabetic endarteritis, Buerger's disease), veins in the leg should be avoided as the infusion site. In
such patients, cases of gangrene in the lower limb have been reported when noradrenaline infusion was done
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 obvious extravasation, has been attributed to constriction of the vessels with increased permeability of the venous bed, allowing some leakage.
This can also lead, in rare cases, to tissue loss, especially during infusion into the veins
of the legs in elderly patients or those suffering from obliterating vascular diseases. Therefore, if
pallor occurs, consideration should be given to changing the infusion site.

Overdose
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,
indicated by an excessive increase in pressure, the administration of
noradrenaline should 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 counteracted 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 potency of the medicine. Therefore, the use of noradrenaline in solutions with
pH>6 (presence of sodium bicarbonate, barbiturates, alkaline antibiotics) is not recommended.
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, see the Summary of Product Characteristics.