Noradrenaline hameln

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Noradrenaline hameln, 0.2 mg/ml, solution for infusion
Noradrenalinum
Please read all of this leaflet carefully before receiving the medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• 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 hameln is and what it is used for
2. Important information before receiving Noradrenaline hameln
3. How to use Noradrenaline hameln
4. Possible side effects
5. How to store Noradrenaline hameln
6. Contents of the pack and other information

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

Noradrenaline hameln is used as an emergency treatment to raise blood pressure to normal levels in adults.

2. Important information before receiving Noradrenaline hameln

When not to use Noradrenaline hameln:

• if the patient is allergic (hypersensitive) to products containing noradrenaline or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has high blood pressure, hyperthyroidism (excessive production of thyroid hormones), narrow-angle glaucoma (a condition of increased intraocular pressure), pheochromocytoma (a rare tumour producing catecholamine), severe kidney dysfunction,
• if the patient has palpitations (paroxysmal tachycardia),
• if the patient has sudden, irregular heartbeat (absolute arrhythmia with high frequency),
• if the patient has coronary artery disease or myocardial disease,
• if the patient has vascular calcification (atherosclerotic changes in blood vessels),
• if the patient has benign prostatic hyperplasia with urinary retention,
• if the patient has enlargement of the right side of the heart (right ventricular hypertrophy).

Warnings and precautions
Before starting treatment with Noradrenaline hameln, discuss with your doctor or pharmacist:

• if the patient has diabetes,
• if the patient has elevated calcium levels in the blood (hypercalcaemia) or potassium deficiency (hypokalaemia),
• if the patient has congenital heart defects (patent foramen ovale, atrial septal defect or ventricular septal defect).

During noradrenaline infusion, the doctor or nurse will continuously monitor blood pressure, heart rate (pulse) and the infusion site.
Abuse and doping
Using noradrenaline as a doping agent may pose a health risk and lead to positive doping test results.
Children and adolescents
No available data.
Noradrenaline hameln and other medicines
Inform the doctor or nurse about all medicines currently used or recently used by the patient, including those available without a prescription.
It has been confirmed that certain drugs enhance the toxic effects of noradrenaline, including:

• tricyclic and tetracyclic antidepressants,
• monoamine oxidase inhibitors (e.g. moclobemide or phenelzine) used in the treatment of depression, and catechol-O-methyltransferase inhibitors used in the treatment of Parkinson's disease,
• parasympatholytic drugs (e.g. atropine) used before surgery to reduce salivation,
• certain antihistamines (e.g. diphenhydramine, chlorphenamine) used in the treatment of allergies,
• guanethidine, reserpine, methyldopa used in the treatment of severe hypertension,
• levothyroxine used in the treatment of hypothyroidism,
• carbazochrome and ornipressin used to control bleeding/prevent blood loss,
• alcohol,
• theophylline and its derivatives in high doses used in the treatment of breathing difficulties such as asthma, chronic obstructive pulmonary disease,
• anaesthetic agents (e.g. halothane, enflurane, isoflurane) or other inhaled anaesthetics,
• local anaesthetics (reducing sensation in certain body areas before some surgical procedures),
• digitalis (a cardiac glycoside used to restore normal heart function),
• diuretics (water pills),
• linezolid (an antibiotic used to treat infections),
• methylene blue used in the treatment of methaemoglobinaemia.

Some drugs reduce or weaken the effect of noradrenaline, including:

• β-adrenolytics;
• phenothiazines;
• α-adrenolytics (e.g. phenoxybenzamine).

Noradrenaline reduces the effect of antidiabetic drugs that lower blood glucose levels.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or nurse before using any medicine.
There is no or only limited data available on the use of noradrenaline in pregnant women.
Under certain circumstances, noradrenaline may reduce blood flow through the placenta and cause bradycardia (slow heart rate) in the unborn child. Noradrenaline may constrict blood vessels in the uterus and cause infarction (tissue death) in late pregnancy, during which the foetus does not receive sufficient oxygen.
After careful assessment of benefit versus risk, the doctor should decide whether the use of this medicine is necessary.
There is no available information regarding the use of noradrenaline in breastfeeding women.
However, noradrenaline is not absorbed through the oral cavity; therefore, exposure to the drug via breast milk is not expected to have adverse effects on the breastfed infant.
Noradrenaline hameln contains sodium
One vial containing 50 ml of infusion solution contains 177.5 mg of sodium. This corresponds to 8.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Noradrenaline hameln

Noradrenaline hameln will be administered to the patient in a hospital setting by a doctor or nurse.
Noradrenaline hameln should not be diluted before use. It is a ready-to-administer solution contained in a 50 ml vial.
The medicinal product Noradrenaline hameln should be administered as an intravenous infusion via a central venous port or through a catheter placed in a sufficiently large vein. To determine the dose required to restore normal blood pressure, an infusion syringe pump should be used.
The recommended dose of Noradrenaline hameln depends on the patient's physical condition.
The doctor will determine the appropriate dose for the patient. After the initial dose is given, the doctor will assess the patient's response and adjust the dose accordingly.
The infusion site should be checked frequently.
Administration of too high a dose of Noradrenaline hameln
Administration of a higher or lower dose than recommended is unlikely, as the patient will receive the medicine in a hospital.
If you have any doubts, discuss them with your doctor or nurse.
Systemic (general) symptoms
Symptoms of overdose include: very high blood pressure, slow heart rate, irregular heartbeat, shallow breathing, chest pain, dizziness, loss of consciousness, pale to ashen cold skin, fluid overload in the lungs, complete or severe weakening of respiratory muscles, and gastrointestinal symptoms.
Local symptoms
At or near the infusion site, whitish skin discoloration along the infused vein and necrosis (cell damage leading to cell death in tissue) may occur.
Treatment in case of poisoning:
In case of overdose, treatment should be discontinued and appropriate measures initiated.
In case of vascular tissue damage, the infusion must be stopped immediately. The affected area should be infiltrated with a vasodilating agent.
If you have any further questions about the use of this medicine, please consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, Noradrenaline hameln may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed:

• Increased blood glucose levels (hyperglycaemia), decreased blood pH (metabolic acidosis),
• Headache, feeling of restlessness and anxiety, tremor, nervousness, confusion and psychosis,
• Palpitations, rapid heartbeat, chest pain,
• Increased blood pressure, slow heartbeat (bradycardia), irregular heartbeat,
• Tissue and skin damage in the extremities due to reduced blood flow, especially affecting the skin, mucous membranes and kidneys,
• Cold sensation in the extremities,
• Shortness of breath and breathing difficulties,
• Salivation, nausea, vomiting,
• Pallor, sweating,
• Decreased or cessation of urine output,
• Tissue damage at the site of administration due to reduced blood flow (skin).

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

5. How to store Noradrenaline hameln

Keep this medicine out of sight and reach of children.
Do not use Noradrenaline hameln after the expiry date stated on the outer packaging and vial following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Before administration, the medicinal product should be removed from the refrigerator to reach a temperature of up to 25°C.
Storage outside the refrigerator:
Noradrenaline hameln may be stored outside the refrigerator at a temperature up to 25°C for a maximum of 6 months. After this period, the medicine must be destroyed.
When stored outside the refrigerator, the medicine must not be returned to the refrigerator.
The storage period must not exceed the expiry date.
For single use only. After first opening, the product must be used immediately.
Do not use this medicine if it is not clear, contains particulate matter, or if the vial is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Noradrenaline hameln contains

• The active substance is noradrenaline (Noradrenalinum) (in the form of noradrenaline tartrate). Each ml of infusion solution contains 0.4 mg of noradrenaline tartrate, equivalent to 0.2 mg of noradrenaline. Each 50 ml vial contains 20 mg of noradrenaline tartrate, equivalent to 10 mg of noradrenaline.
• The other components are: disodium edetate, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.

What Noradrenaline hameln looks like and contents of the pack
This medicine is supplied as a ready-to-use infusion solution. The solution is clear and colourless or almost colourless, free from visible particles, contained in a 50 ml glass vial made of colourless, transparent, neutral glass of type I, stoppered with a grey bromobutyl rubber closure and sealed with an aluminium "tear-off" cap.
The pack contains 1, 5 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
hameln pharma gmbh
Inselstrasse 1
31787 Hameln
Germany

Manufacturer:
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestraße 3
34212 Melsungen
Germany
hameln rds s.r.o.
Horná 36
90001 Modra
Slovakia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended exclusively for medical professionals:

Preparation Guide
Noradrenaline hameln, 0.2 mg/ml, solution for infusion.
For detailed information, please refer to the Product Characteristics.
For intravenous infusion only.
pH 3.2–4.2
Osmolality 270–310 mOsmol/kg.

Dosage
All dosage recommendations are expressed in terms of noradrenaline.
The optimal method to achieve hemodynamic stabilization is administration via intravenous infusion, e.g., using a syringe pump. Depending on the patient's current circulatory status, the syringe pump should be set to deliver between 0.3 ml/hour (equivalent to 1 microgram/minute) and 6 ml/hour (equivalent to 20 micrograms/minute).
The dose depends on the patient's current hemodynamic condition and typically ranges from 1–20 micrograms/minute in adult patients, corresponding to 0.014–0.28 micrograms per kg of body weight per minute. Higher doses may be required depending on the clinical situation.
Hypovolemia and acidosis reduce the effectiveness of noradrenaline and should be corrected as early as possible.

Noradrenaline hameln must not be diluted prior to use. It is supplied ready for administration. Accidental dilution of Noradrenaline hameln may result in subtherapeutic dosing and persistent, life-threatening hypotension.

Noradrenaline hameln should be administered as an intravenous infusion via a central venous port or through a catheter placed in a sufficiently large vein to minimize the risk of extravasation and subsequent tissue necrosis.

Manual bolus administration is not recommended to initiate the infusion.

Extreme caution must be exercised when changing syringes to avoid hemodynamic instability. Continuous administration using a dual-pump set with a low-dead-space connector is recommended.

Pharmaceutical incompatibilities
This medicinal product must not be mixed with other medicinal products.
Pharmaceutical incompatibilities have been reported between infusion solutions containing noradrenaline bitartrate and the following substances: alkaline agents or oxidizing agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, and streptomycin.

Special precautions during storage
Store in a refrigerator (2°C–8°C). Do not freeze.
Before administration, remove the medicinal product from the refrigerator and allow it to reach room temperature (up to 25°C).

Storage outside the refrigerator:
Noradrenaline hameln may be stored outside the refrigerator at temperatures up to 25°C for a maximum of 6 months. After this period, the product must be discarded.
Once removed from refrigeration, the product must not be returned to the refrigerator.
The storage period must not exceed the product's expiry date.