Noradrenaline Equity 1 mg Solution

NORADRENALINE (NOREPINEPHRINE) EQUITY 1 mg/1 mL concentrate for solution for infusion is a medicine that belongs to the group of adrenergic and dopaminergic medicines and acts by narrowing the blood vessels. NORADRENALINE (NOREPINEPHRINE) EQUITY is indicated for the emergency restoration of blood pressure in cases of acute hypotension (decreased blood pressure).

NORADRENALINE (NOREPINEPHRINE) EQUITY should not be administered to you:

• if you are hypersensitive (allergic) to noradrenaline (norepinephrine) or any of the other ingredients of NORADRENALINE (NOREPINEPHRINE) EQUITY (listed in section 6).
• if you are hypotensive (have low blood pressure) that has been caused by hypovolaemia (low blood volume).
• if you are going to receive anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heartbeat).

Warnings and precautions

Tell your doctor or health care provider before being given the injection: Special care should be taken with NORADRENALINE (NOREPINEPHRINE) EQUITY:

• tell your doctor if you experience any pain, stinging or burning at the injection site
• if you have major left ventricular dysfunction (a heart condition)
• if you suffer from clots or obstructions in your blood vessels
• if you have hypotension following a heart attack
• if you have Prinzmetal’s variant angina (causes chest pain)
• if you have heart rhythm disorders during your treatment – you will need a reduced dose
• if you have hyperthyroidism (an overactive thyroid gland) or diabetes mellitus
• if you are elderly.

Your blood pressure and heart rate will be checked frequently during your treatment to avoid hypertension (high blood pressure).

Children and adolescents

The safety and efficacy of NORADRENALINE (NOREPINEPHRINE) EQUITY in children and adolescents have not been established.

Other medicines and NORADRENALINE (NOREPINEPHRINE) EQUITY

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

• Halothane, cyclopropane, chloroform, enflurane or other halogenated anaesthetics are contraindicated (see section 2 of this leaflet, subsection “NORADRENALINE (NOREPINEPHRINE) EQUITY should not be administered to you”): these medicines are anaesthetics, they cause insensibility to pain and are used before some operations. If you are receiving these medicines as well as NORADRENALINE (NOREPINEPHRINE) EQUITY, this may increase the risk of irregular heartbeat.
• Amitriptyline, imipramine, trimipramine, moclobemide, iproniazide, phenelzine, fluoxetine, sertraline, desipramine: these medicines are used for treatment of depression. Taking any of these medicines together with NORADRENALINE (NOREPINEPHRINE) EQUITY can dangerously increase its concentration in the blood and therefore its pressor action (causing increase in blood pressure).
• Digitalis glycosides (used to treat heart failure and irregular heartbeat) may occasionally cause irregular heartbeat.
• Levodopa (used to treat Parkinson’s disease) may enhance the effects of NORADRENALINE (NOREPINEPHRINE) EQUITY.
• Antihistamines (used to treat allergies), as some may block the intake of catecholamines by peripheral tissues and increase the toxicity of NORADRENALINE (NOREPINEPHRINE) EQUITY.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself NORADRENALINE (NOREPINEPHRINE) EQUITY. It will be given to you by a person who is qualified to do so. The dose of NORADRENALINE (NOREPINEPHRINE) EQUITY depends on the condition of the patient. Your doctor will know the best dose to use. NORADRENALINE (NOREPINEPHRINE) EQUITY is first diluted and then usually infused into a vein. The dose can then be adjusted using a pump according to the response to treatment, with the aim to establish a normal blood pressure.

If you are given more NORADRENALINE (NOREPINEPHRINE) EQUITY than you should Since a health care provider will administer NORADRENALINE (NOREPINEPHRINE) EQUITY, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Symptoms that may occur if you are given too much NORADRENALINE (NOREPINEPHRINE) EQUITY are severe high blood pressure, slow heartbeat, violent headache, light sensitivity, pain in the chest, bleeding in the brain, pallor, fever, intense sweating and vomiting, fluid in the lungs causing breathlessness.

If you forget to use NORADRENALINE (NOREPINEPHRINE) EQUITY Since a health care provider will administer NORADRENALINE (NOREPINEPHRINE) EQUITY, it is unlikely that the dose will be missed.

NORADRENALINE (NOREPINEPHRINE) EQUITY can have side effects. Not all side effects reported for NORADRENALINE (NOREPINEPHRINE) EQUITY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using NORADRENALINE (NOREPINEPHRINE) EQUITY, please consult your health care provider for advice. If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• severe headaches, dizziness, intense sweating, vomiting, pain in the chest or throat, paleness or loss of skin colour (pallor), abnormal sensitivity to light especially of the eyes.

These are all very serious side effects. If you have them, you may have had a serious reaction to NORADRENALINE (NOREPINEPHRINE) EQUITY. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: Side effects with unknown frequency:

• feeling anxious, weak, less alert
• problems with falling and staying asleep (insomnia)
• hallucinating, hearing voices, not thinking clearly, which may be signs of a psychotic state
• restricting your food intake (anorexia)
• headaches
• shaking or trembling movements in one or more parts of the body (tremor)
• changes in vision, blurred vision
• fast or slow heart rate
• breathlessness, swollen legs and feet and a bloated stomach, which may be early symptoms of a disease of the heart muscle
• confusion, restlessness, which may be caused by lower levels of oxygen
• gangrene (painful and cold extremities that may become purple to very dark/black, with tissue death)
• scarification of the skin (marking or damage to the skin that causes scars), bluish skin colour, hot flushes or skin redness, skin rash, hives or itching
• feeling sick (nausea)
• difficulty or increased frequency in passing urine
• pain, stinging, burning or swelling, redness, peeling skin, or liquid forming at the injection site.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of NORADRENALINE (NOREPINEPHRINE) EQUITY.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original package to protect from light. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

After dilution: The physicochemical stability of diluted product (in 5 % dextrose, sodium chloride 9 mg/mL (0,9 %), or isotonic dextrose saline) has been demonstrated for 48 hours at 30 °C. However, from a microbiological point of view, the diluted product should be used immediately. If the product is not used immediately, the duration and conditions of use are the sole responsibility of the user. This product should be visually inspected prior to administration. Only a clear, colourless or slightly yellowish solution, free of particles or precipitates should be used. Do not use ampoules with a pink colour or darker than pale yellow, or containing a precipitate. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.