Noradrenaline Normon 0.5 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Noradrenalina Normon 0.5 mg/ml concentrate for solution for infusion EFG

norepinephrine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Noradrenalina Normon is and what it is used for

Noradrenaline (norepinephrine) belongs to a group of medicines called "adrenergic and dopaminergic agents", which work by increasing blood pressure.

Noradrenaline is used for the treatment of acute drops in blood pressure (acute hypotension).

2. What you need to know before using Noradrenalina Normon

Do not use Noradrenalina Normon

• If you are allergic to noradrenaline bitartrate or to any of the other ingredients of this medicine (listed in section 6).
• As sole therapy if you have low blood pressure due to decreased blood volume.
• If you are receiving the anaesthetic gases halothane or cyclopropane, as they may increase the risk of irregular heartbeats.

Warnings and precautions

Consult your doctor before starting Noradrenalina Normon 0.5 mg/ml.

Inform your doctor of any allergies or medical conditions you currently have or have had, especially if:

• you have diabetes
• you have liver or kidney impairment
• you suffer from hypertension
• you have hyperthyroidism
• you have low levels of oxygen in the blood
• you have high levels of carbon dioxide in the blood
• you have increased pressure inside the skull (intracranial pressure)
• you have blood clots or blockages in blood vessels supplying the heart, intestines, or other parts of the body
• you have hypotension following a heart attack
• you have angina pectoris (chest pain), particularly Prinzmetal's angina
• you have significant left ventricular dysfunction
• you have recently had a myocardial infarction (heart attack)
• you have cardiac arrhythmias (your heart beats too fast, too slow, or irregularly); you will require a reduced dose
• you are elderly

During noradrenaline infusion, your doctor will continuously monitor your blood pressure, heart rate, and the infusion site.

Other medicines and Noradrenalina Normon

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Medicines used to treat depression called "monoamine oxidase inhibitors" (MAOIs), if you are currently taking them or have taken them within the last 14 days
• Medicines used to treat depression called "tricyclic antidepressants" (e.g., imipramine or desipramine)
• Adrenergic-serotonergic medicines, for example, used in the treatment of asthma and heart diseases
• Linezolid (an antibiotic)
• Anaesthetics (especially anaesthetic gases such as cyclopropane, halothane, chloroform, enflurane)
• Medicines used to treat hypertension (e.g., guanethidine, guanadrel, reserpine, methyldopa, alpha- and beta-blockers)
• Medicines used to treat cardiac arrhythmias
• Cardiac glycosides (used to treat heart diseases)
• Levodopa (used to treat Parkinson's disease)
• Thyroid hormones
• Oxytocin (used to enhance uterine contractions)
• Antihistamines (used to treat allergies)
• Amphetamines
• Doxapram (used for respiratory disorders)
• Mazindol (used to treat obesity)
• Medicines used to treat migraine (ergot alkaloids)
• Lithium (used to treat certain mental disorders)
• Vasopressin, desmopressin (antidiuretics, to reduce urine production)

The use of noradrenaline with propofol (an anaesthetic) may cause propofol infusion syndrome (PRIS), a serious condition affecting patients receiving sedation with propofol in intensive care units. In such cases, the doctor may observe metabolic disturbances in blood tests, which could lead to renal failure, cardiac failure, and death.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine. Noradrenaline (Norepinephrine) may harm the fetus. It is unknown whether this medicine is excreted in breast milk. Your doctor will decide whether Noradrenaline (Norepinephrine) should be administered to you.

Driving and using machines

You should not drive or operate machinery if you are affected by administration of this medicine.

Noradrenalina Normon 0.5 mg/ml concentrate for solution for infusion contains sodium metabisulfite (E-223) and sodium.

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite (E-223).

This medicine contains 34.82 mg of sodium (a main component of table/cooking salt) per ampoule. This corresponds to 1.74% of the maximum recommended daily intake of sodium for an adult.

3. How to use Noradrenalina Normon

Noradrenaline is administered intravenously.

This medicine will always be administered by healthcare personnel.

Your doctor will decide the dose and frequency at which the medicine will be administered.

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor again.

If you use more Noradrenalina Normon than you should:

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91 562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

It is unlikely that this will occur, as your doctor will determine your daily doses. However, if you were to receive more noradrenaline than you should, this could cause you:

Severe increase in blood pressure with intense headache, light sensitivity, acute pain behind the sternum (in the chest), throat pain, pallor and intense sweating, and vomiting.

If this were to happen, your doctor must immediately stop treatment and, depending on the severity of the situation, administer:

• appropriate fluid and electrolyte replacement therapy
• a medicine given intravenously to lower blood pressure (antihypertensive), if necessary, to counteract the effects of the increased blood pressure.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The frequency of the adverse effects mentioned is unknown (cannot be estimated from the available data).

Inform your doctor or nurse immediately if you experience:

• sudden itchy rash (urticaria), swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), feeling of fainting,
• pain or swelling at the injection site.

Inform your doctor or nurse as soon as possible if you experience:

• anxiety, insomnia, confusion, weakness, psychotic state
• headaches, tremor
• increased intraocular pressure (acute glaucoma)
• decreased or increased heart rate
• abnormal heart rhythm
• electrocardiogram abnormalities
• a potentially life-threatening type of circulatory failure called "cardiogenic shock"
• heart muscle weakness due to intense physical or emotional stress, palpitations, increased cardiac contractility, acute heart failure
• hypertension, reduced oxygen supply to an organ (hypoxia)
• poor blood flow to hands and feet (may cause coldness, paleness and/or pain in the extremities)
• gangrene (tissue death)
• reduction in blood plasma volume
• difficulty breathing
• pallor, skin sloughing, bluish discoloration of the skin, hot flushes or skin redness, skin rash, urticaria or itching
• nausea, vomiting
• urinary retention
• irritation and necrosis (cellular injury leading to cell death in tissue) at the injection site

Your doctor will monitor your blood pressure and blood volume.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nursing staff, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Noradrenaline Normon 0.5 mg/ml concentrate for solution for infusion

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C. Store in the original packaging.

Do not use this medicine after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Noradrenalina Normon contains

The active substance is norepinephrine bitartrate. Each ml of solution contains 1 mg of norepinephrine bitartrate (10 mg per 10 ml vial), equivalent to 0.5 mg of norepinephrine base.

The other components (excipients) are: sodium chloride, sodium metabisulfite (E-223), hydrochloric acid or sodium hydroxide, and water for injection.

Appearance of the product and contents of the pack

The solution contained in the Noradrenalina Normon 0.5 mg/ml vials is transparent, colorless or practically colorless. The packs contain 10 vials.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was approved in June 2018.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS):
http://www.aemps.es/”*

This information is intended for healthcare professionals only:

Noradrenalina Normon 0.5 mg/ml concentrate for solution for infusion must be administered intravenously:

The initial dose should be administered at a rate of 8 to 12 micrograms (0.008 to 0.012 mg) (base) per minute, adjusting the infusion rate to achieve and maintain the desired blood pressure.

For maintenance, the rate should be adjusted to 2 to 4 micrograms (0.002 to 0.004 mg) (base) per minute, titrating the dose according to the patient's response.

In cases of septic shock, doses should be adjusted to approximately 0.5 µg/kg/min (up to a maximum of 1.0 µg/kg/min) to achieve the desired mean arterial pressure. It is recommended to co-administer dopamine at doses of 2–2.5 µg/kg/min, which counteracts vasoconstriction and ensures adequate renal and splanchnic circulation.

To prepare the intravenous infusion solution of norepinephrine, add 4 mg of norepinephrine (base) to 1 liter of 5% glucose solution. The resulting solution will contain 4 micrograms (0.004 mg) of norepinephrine (base) per ml. Note that 1 mg of norepinephrine bitartrate is equivalent to 0.5 mg of norepinephrine base.

Noradrenalina Normon 0.5 mg/ml concentrate for solution for infusion may be used as an emergency measure to maintain coronary and cerebral perfusion until volume replacement therapy is completed.

Duration of treatment

The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without treatment. Norepinephrine infusion should be gradually reduced, avoiding abrupt discontinuation. In some reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.

Usual pediatric dose

Intravenous infusion: 0.1 microgram (base) per kg per minute, gradually adjusting the infusion rate to achieve the desired blood pressure, up to a maximum of 1 microgram (base) per kg per minute.

When added to local anesthetics, these solutions contain a norepinephrine concentration of approximately 1:200,000 (5 µg/ml).