NORADRENALINE TARTRATE MONICO

Package leaflet: Information for the user

NORADRENALINA TARTRATO MONICO

2 mg/ml concentrate for solution for infusion
Equivalent medicine
Read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What NORADRENALINA TARTRATO MONICO is and what it is used for

NORADRENALINA TARTRATO MONICO contains the active substance noradrenaline, which belongs to a group of medicines called adrenergic agonists.
NORADRENALINA TARTRATO MONICO is used in emergency situations for resuscitation in cardiac arrest and to restore normal blood pressure in cases of severe and sudden drop in blood pressure (acute hypotension).

2. What you need to know before using NORADRENALINA TARTRATO MONICO

Do not use NORADRENALINA TARTRATO MONICO

• if you are allergic to noradrenaline tartrate or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (hypotension) caused by low circulating blood volume;
• if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding).

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

• if you are being treated with medicines for depression (tricyclic antidepressants or MAO inhibitors);
• if you are undergoing surgery and will receive anaesthesia with halothane or cyclopropane;
• if you have circulatory problems such as thrombosis, a disease causing circulatory problems due to blood clot formation (thrombi);
• if you have low oxygen levels or high carbon dioxide levels in the blood;
• if you are allergic to certain food preservatives (sulphites), especially if you suffer from asthma;
• if you are elderly.

This medicine will be administered intravenously by a doctor or nurse. The infusion should preferably be given into large-caliber veins in the arm or leg, with careful attention to the injection site to prevent 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 disorders, the medicine must not be injected into leg veins, as there is a risk of tissue damage (tissue necrosis).
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
There is no experience with the use of noradrenaline in children.
Other medicines and NORADRENALINA TARTRATO MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Noradrenaline must not be administered together with the following medicines:

• medicines used during anaesthesia such as cyclopropane and halothane;
• medicines for depression such as tricyclic antidepressants and MAO inhibitors, because they may enhance the effects of noradrenaline, causing increased blood pressure or changes in heart rhythm (cardiac arrhythmias and tachycardia); inform your doctor or dentist if you are taking these medicines, especially if you are undergoing surgery, including dental procedures; if you experience symptoms of high blood pressure, inform your doctor and stop treatment;
• medicines used for mental disorders (neuroleptics), because they may reduce the effects of noradrenaline; if both medicines are administered together, the dose may need to be adjusted to maintain the desired therapeutic effect;
• dihydroergotamine, a medicine used to treat headache, because it may cause a marked increase in blood pressure;
• linezolid, an antibiotic used to treat infections, because it may cause a marked increase in blood pressure;
• entacapone, a medicine used for Parkinson's disease, because it may cause heart problems (tachycardia, hypertension, arrhythmias);
• guanethidine, a medicine used to treat high blood pressure, because it may cause heart problems (arrhythmias) and increased blood pressure.

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

• certain antibiotics known as 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, thiopentone.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before this medicine is administered.
This medicine must not be administered during pregnancy unless absolutely necessary, for example in life-saving emergency situations related to heart problems. Noradrenaline may cause harm to the fetus.
Use this medicine with caution if you are breastfeeding, as it is unknown whether noradrenaline passes into breast milk and there are no available data on its effects in the newborn.
Driving and using machines
Not applicable.
NORADRENALINA TARTRATO MONICO contains sodium and sodium metabisulphite
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically 'sodium-free'.
This medicine contains sodium metabisulphite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use NORADRENALINE TARTRATE MONICO

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or
nurse.
The dose will be calculated by the doctor according to your health condition.
This medicine is administered by intravenous infusion (intravenous infusion) after appropriate
dilution.
The doses reported below are expressed as noradrenaline base.
The initial dose of Noradrenaline Base is 8–12 micrograms per minute via intravenous infusion. The infusion rate
will be adjusted to maintain blood pressure at normal values (systolic pressure 80–100 mmHg).
The maintenance dose of Noradrenaline Base 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 start at the lowest possible dose, which may be subsequently increased
according to the patient's needs. Intravenous infusions should be avoided in leg veins in the elderly.
If you use more NORADRENALINE TARTRATE MONICO than you should
Symptoms of overdose may include headache, marked increase in blood pressure,
decrease in heart rate (reflex bradycardia), and heart or circulatory problems.
If you experience these symptoms or think you have been given too much of this medicine, contact your doctor or
nurse immediately.
If you have any doubts about how to use 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 (frequency 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 changes in heartbeat (arrhythmias, palpitations);
• chest pain due to heart problems (angina), cardiac arrest, sudden death;
• tissue damage at the injection site if the medicine leaks out of the veins (extravasation) during infusion;
• alteration in sugar metabolism;
• nausea, vomiting, and excessive salivation;
• circulation problems caused by blood clot formation;
• fear, anxiety, agitation, tremor, insomnia;
• confusion, irritability, weakness, and psychosis;
• kidney problems with reduced elimination rate of creatinine and insulin;
• difficulty urinating;
• breathing difficulties;
• severe headaches, light sensitivity, chest pain behind the sternum, pallor, vomiting, and intense sweating may occur in hypersensitive individuals or following an overdose.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NORADRENALINA TARTRATO MONICO

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 packaging after “EXP.”.
The expiry date refers to the last day of that month.
Store below 25°C and in the original packaging, to protect from light. Do not freeze. The solution must not be used if it has turned brown or if a precipitate is present.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NORADRENALINA TARTRATO MONICO contains

• The active substance is acid tartrate of noradrenaline. Each vial contains 2 mg of acid noradrenaline tartrate (equivalent to 1 mg of Noradrenaline Base).
• The other components are: sodium chloride, sodium metabisulfite, water for injections.

Description of the appearance of NORADRENALINA TARTRATO MONICO and contents of the pack
Pack containing 5 vials of 1 ml concentrate for solution for infusion.

Marketing Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

The following information is intended for healthcare professionals only

Instructions for use

Noradrenaline must be diluted in 5% glucose solution in water or in physiological saline (sodium chloride 0.9%) because these solutions protect against excessive oxidation and the consequent loss of potency.
Dilution with saline solution alone is not recommended.
Before administering noradrenaline, blood volume depletion should 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 (e.g., using a Y-tube and separate containers if administered simultaneously).
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 vasoconstrictive action of the drug. If such an event occurs, infiltration with 10–15 ml of saline solution containing 5 to 10 mg of phentolamine should be performed to attempt to prevent tissue necrosis and tissue loss.

Incompatibilities
There are conflicting opinions regarding the compatibility of noradrenaline with 0.9% sodium chloride. Indeed, noradrenaline is physically compatible with 0.9% sodium chloride; however, administration of a mixture of noradrenaline diluted solely with saline solution is not recommended because it does not protect the active substance from oxidation.
Noradrenaline is stable within a pH range of 3.6 to 6.0; above this range, loss of medicinal potency may occur. Therefore, the use of noradrenaline in solutions with pH > 6 (e.g., containing sodium bicarbonate, barbiturates, alkaline antibiotics) is not recommended.
Noradrenaline is physically incompatible with whole blood; therefore, when a patient is receiving blood transfusions, noradrenaline must be administered separately.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
This medicinal product must not be mixed with other products except glucose solutions and sodium chloride solutions.
Avoid contact with iron salts, alkalis, or oxidizing agents.

Special warnings and precautions for use
Whenever possible, noradrenaline infusion should be administered into large-caliber veins, particularly in the antecubital area, because when administered at this site, the risk of tissue necrosis appears to be minimal. The femoral vein also seems to be an acceptable infusion site. The use of a catheter should be avoided if possible, as obstruction to blood flow around the tube may cause stasis and increased local concentration of the drug.
In elderly patients and in patients with occlusive vascular diseases (atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger's disease), leg veins should be avoided as infusion sites. In such patients, cases of gangrene in the lower extremities have been reported when noradrenaline infusion was administered via an ankle vein.
Blanching during infusion, sometimes without evident extravasation, has been attributed to vasoconstriction with increased permeability of the venous bed, allowing some leakage. This may also lead, rarely, to tissue loss, particularly during infusion into leg veins in elderly patients or in those suffering from obliterative vascular diseases. Therefore, if blanching occurs, changing the infusion site should be considered.