Noradrenaline aguettant

Package leaflet: Information for the user

Noradrenaline Aguettant, 0.08 mg/ml, solution for infusion
Noradrenalinum
Please read all of this leaflet carefully before use, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Noradrenaline Aguettant is and what it is used for
2. Important information before using Noradrenaline Aguettant
3. How to use Noradrenaline Aguettant
4. Possible side effects
5. How to store Noradrenaline Aguettant
6. Contents of the pack and other information

1. What Noradrenaline Aguettant is and what it is used for

Noradrenaline Aguettant contains the active substance noradrenaline, which causes constriction of blood vessels.
This medicine is intended for use in adults only.
Noradrenaline Aguettant is indicated in adults with a body weight greater than 50 kg for the treatment of acute hypotensive states requiring immediate elevation of arterial blood pressure to normal values.

2. Important information before using Noradrenaline Aguettant

When must Noradrenaline Aguettant not be used:

• for administration via peripheral cannula and (or) into a peripheral vein;
• if the patient is allergic to noradrenaline or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heartbeat).

Warnings and precautions
Before starting treatment with Noradrenaline Aguettant, discuss this with your doctor,
pharmacist, or nurse:

• if the patient has severe left ventricular dysfunction (heart disease);
• if the patient has coronary thrombosis (blood clot in a blood vessel of the heart), mesenteric thrombosis (blood clot in the vein draining blood from the intestine), or peripheral vascular thrombosis (blood clot in a vein of the arm or leg);
• if the patient has hypotension (low blood pressure) following a myocardial infarction;
• if the patient has Prinzmetal's angina;
• if the patient develops cardiac arrhythmias during treatment;
• if the patient has hyperthyroidism;
• if the patient has diabetes.

Additional monitoring tests that may be required during treatment:
Blood pressure and pulse will be frequently monitored during treatment to avoid arterial hypertension
(high blood pressure).
If noradrenaline and blood or plasma transfusion are required at the same time,
the blood or plasma will be administered through a separate infusion.

Children and adolescents
The safety and efficacy of noradrenaline in children under 18 years of age have not been established.
Therefore, the use of this medicine in children is not recommended.

Noradrenaline Aguettant with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
The following medicines may affect the action of Noradrenaline Aguettant:

• Halothane, cyclopropane, chloroform, enflurane, or other halogenated anaesthetics are contraindicated (see section 2 of this leaflet, subsection "When must Noradrenaline Aguettant not be used"): these are anaesthetic agents that cause insensitivity to pain and are used before certain surgical procedures. If the patient receives these medicines together with noradrenaline (norepinephrine), the risk of irregular heartbeat may increase.
• Amitriptyline, imipramine, trimipramine, moclobemide, iproniazid, phenelzine, fluoxetine, sertraline, desipramine: these medicines are used to treat depression. Taking any of these medicines together with noradrenaline (norepinephrine) may dangerously increase its blood concentration and thus its pressor effect.
• Cardiac glycosides may sometimes cause irregular heartbeat.
• Levodopa may enhance the effect of noradrenaline (norepinephrine).
• Non-selective MAO inhibitors (or within 14 days after discontinuation of such therapy): increased pressor effect of sympathomimetics, usually moderate. The medicine should be used only under strict medical supervision.
• Selective MAO-A inhibitors: based on conclusions drawn from studies with non-selective MAO inhibitors, there is a risk of increased blood pressure-raising effect. The medicine should be used only under strict medical supervision.
• Linezolid (an antibiotic), (a medicine used to treat infections caused by bacteria and other microorganisms), may dangerously increase the blood concentration of noradrenaline (norepinephrine) and thus its pressor effect when used concomitantly.
• Methylene blue (an antidote for methemoglobinemia).
• Alpha-1 receptor agonists (e.g. midodrine): if the patient takes these medicines with noradrenaline (norepinephrine), this may increase the risk of marked arterial hypertension (high blood pressure).
• Alpha-1 receptor antagonists (e.g. prazosin, terazosin or doxazosin): if the patient takes these medicines simultaneously with noradrenaline (norepinephrine), this may reduce the effect of noradrenaline on blood pressure.
• Beta-blockers: if the patient takes these medicines together with noradrenaline (norepinephrine), this may increase the risk of severe arterial hypertension (high blood pressure).
• Thyroid hormones: if the patient takes these medicines with noradrenaline (norepinephrine), this may intensify the effect on the heart.
• Ergot alkaloids, particularly those with alpha1-agonist activity (e.g. ergotamine, dihydroergotamine, methylergonovine): may enhance the vasoconstrictive and vasopressor (blood pressure-raising) effects.
• Lithium reduces the effect of noradrenaline (norepinephrine).
• Reserpine, amphetamine: may enhance the effect of noradrenaline (norepinephrine).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, she should consult her doctor or nurse before
using this medicine.
If the patient is pregnant, the doctor will decide whether Noradrenaline Aguettant can be administered, as
noradrenaline may be harmful to the unborn child.
There are no data available on the use of noradrenaline in breastfeeding women.

Noradrenaline Aguettant contains sodium
The medicine contains 177.3 mg of sodium (main component of table salt) in each 50 ml vial. This corresponds to
8.9% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Noradrenaline Aguettant

Dosage
Noradrenaline Aguettant will be administered by a doctor or nurse in a hospital.
This medicine is given as an intravenous infusion (into a vein).
The dose of the medicine depends on the patient's condition. The doctor will determine the dose appropriate for the patient.
Use of more than the recommended dose of Noradrenaline Aguettant
It is unlikely that a patient would receive too high a dose of the medicine, as this medicine will be administered in a hospital. However, if there are any concerns, please consult a doctor or nurse.
Symptoms which may occur if too high a dose of noradrenaline is given include: severe arterial hypertension, slowed heart rate, severe headache, sensitivity to light, chest pain, brain hemorrhage, pallor, fever, intense sweating, vomiting, and fluid in the lungs causing breathlessness.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of occurrence of the listed adverse reactions is unknown (frequency cannot be determined from the available data).
You should inform your doctor or nurse immediately if any of the following occur:

• difficulty breathing or irregular breathing,
• rapid, slow or irregular heartbeat, palpitations,
• chest or throat pain.

You should inform your doctor or nurse as soon as possible if any of the following occur:

• anxiety,
• headache, tremor,
• vomiting,
• high blood pressure,
• pallor (loss of skin color), sweating, light sensitivity,
• gangrene (painful and cold limbs which may become purple or very dark/black, with tissue death),
• skin necrosis, if the infusion is not administered directly into the vein,
• acute glaucoma (eye problems),
• urinary retention.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Noradrenaline Aguettant

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the
carton after: EXP. The expiry date refers to the last day of the stated month.
After first opening, the medicine must be used immediately.
Do not store above 25°C. Keep the vial in the outer packaging (cardboard carton) to protect from light.

Do not use the medicine if the solution is darker than slightly yellowish or pinkish, or if it contains a precipitate.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Noradrenaline Aguettant contains:

• The active substance is noradrenaline (Noradrenalinum). Each ml of solution contains 0.16 mg of noradrenaline tartrate, equivalent to 0.08 mg of noradrenaline. Each 50 ml vial contains 8 mg of noradrenaline tartrate, equivalent to 4 mg of noradrenaline.
• The other components are: sodium chloride, disodium edetate, hydrochloric acid or sodium hydroxide (for pH adjustment), and water for injections.

What Noradrenaline Aguettant looks like and contents of the pack:
A clear, colourless, slightly yellow infusion solution contained in a transparent glass vial with a volume of 50 ml.
Pack of 10 vials in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Noradrenalin Aguettant
Germany: Noradrenalin Aguettant
Denmark: Noradrenalin Aguettant
Finland: Noradrenalin Aguettant
Norway: Noradrenalin Aguettant
Ireland: Noradrenaline (Norepinephrine)
United Kingdom: Noradrenaline (Norepinephrine)
Italy: Noradrenalina tartrato Aguettant
Poland: Noradrenalina Aguettant

The following information is intended exclusively for healthcare professionals

medical
The following information is an extract from the Summary of Product Characteristics, to be used
when administering Noradrenaline Aguettant 0,08 mg/ml, solution for infusion. The prescribing
physician should consult the full Summary of Product Characteristics to determine whether this
medicinal product is appropriate for a given patient.
Indications
The medicinal product is indicated for the treatment of acute hypotensive states in adults with a body weight greater than 50 kg.
Dosage and administration
Noradrenaline must be administered exclusively by intravenous infusion via a central venous catheter. The medicinal product must be administered at a controlled rate using an infusion pump or syringe pump, without dilution: it is supplied ready for use.
Arterial pressure must be closely monitored during treatment.
Dosage
Initial dose:
The initial dose of noradrenaline is typically between 0.05 and 0.15 microgram/kg body weight/min.
Recommended maintenance dose:
The recommended maintenance dose of noradrenaline ranges from 0.05 to 1.5 microgram/kg body weight/min.
Gradual dose titration:
After starting the infusion, the dose of noradrenaline should be gradually increased by 0.05–0.1 microgram/kg body weight/min according to the observed pressor response. The therapeutic goal should be to achieve a low-normal systolic blood pressure (100–120 mm Hg) or an appropriate mean arterial pressure (above 65 mm Hg—depending on the patient's condition).
Duration of treatment
Treatment should be continued until there is no longer a need for high-dose vasoactive drug therapy. From that point, the infusion should be gradually tapered and then replaced with an infusion containing a lower concentration of noradrenaline. Abrupt discontinuation of the drug may result in acute hypotension.
Overdose
Symptoms
Overdose may cause headache, severe arterial hypertension, reflex bradycardia, and reduced cardiac output.
These symptoms may be accompanied by severe headache, photophobia, retrosternal pain, pallor, fever, profuse sweating, pulmonary oedema, and vomiting.
Skin vasoconstriction and pressure ulcers may also occur.
Management
In case of accidental overdose manifesting as excessive increase in blood pressure, administration of the drug should be discontinued until the patient's condition stabilizes.
Instructions for use and disposal
Do not use the medicinal product if the solution is darker than slightly yellow or pink, or if it contains a precipitate.
Do not use the solution if it is not clear and contains particles, or if the vial's tamper-evident seal is broken.
Do not mix this medicinal product with other medicinal products.
For single use only.
The medicinal product is a ready-to-use diluted infusion solution. It must not be diluted prior to use.
The infusion should be administered using an appropriate infusion pump or syringe pump capable of delivering small, precise volumes at a strictly controlled and monitored infusion rate, in accordance with the instructions for gradual dose titration.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.