NORADRENALINE 0.2 mg/ml Solution

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT
   1. You should carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Noradrenaline hameln and what is it used for
3. Important information before receiving Noradrenaline hameln
   1. When not to use Noradrenaline hameln:
   2. Warnings and precautions
   3. Before starting treatment with Noradrenaline hameln, you should discuss with your doctor or pharmacist:
   4. Children and adolescents
   5. Noradrenaline hameln and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Noradrenaline hameln contains sodium
4. How to use Noradrenaline hameln
   1. Using too much Noradrenaline hameln
5. Possible side effects
   1. Reporting side effects
6. How to store Noradrenaline hameln
7. Contents of the packaging and other information
   1. What Noradrenaline hameln contains
   2. What Noradrenaline hameln looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of revision of the leaflet:
   7. Information intended for healthcare professionals only:
   8. Preparation guide
   9. Dosage
   10. Incompatibilities
   11. Special precautions for storage

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Noradrenaline hameln,0.2 mg/ml, solution for infusion
Noradrenalinum

You should carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Noradrenaline hameln and what is it 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 packaging and other information

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

Noradrenaline hameln is used as an emergency measure to increase blood pressure to a normal level 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 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 tumor that produces catecholamine), or severe kidney function disorders,
• if the patient has tachycardia (paroxysmal tachycardia),
• If the patient has sudden, irregular heartbeat (absolute arrhythmia at high frequency),
• if the patient has coronary artery disease or heart muscle disease,
• if the patient has vascular calcification (atherosclerotic changes in blood vessels),
• If the patient has prostate enlargement with urine retention.
• If there is an enlargement of the right part of the heart (right ventricular hypertrophy),

Warnings and precautions

Before starting treatment with Noradrenaline hameln, you should discuss with your doctor or pharmacist:

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

During the infusion of noradrenaline, the doctor or nurse will constantly monitor blood pressure, heart rate (heart rate), and the infusion site.
Overdose and doping
Using noradrenaline as a doping agent can pose a health risk and lead to positive doping test results.

Children and adolescents

No data available.

Noradrenaline hameln and other medicines

You should tell your doctor or nurse about all medicines you are currently taking or have recently taken, including those available without a prescription.
It has been confirmed that some medicines enhance the toxic effects of noradrenaline, including:

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

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

• β-adrenergic blockers;
• phenothiazines;
• α-adrenergic blockers (e.g., phenoxybenzamine).

Noradrenaline reduces the effect of antidiabetic medicines that lower blood sugar levels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or nurse before using any medicine.
There is limited or no data on the use of noradrenaline in pregnant women.
In certain circumstances, noradrenaline may reduce blood flow through the placenta and cause slow heart rate in the unborn child. Noradrenaline may constrict blood vessels in the uterus and cause a condition (fetal distress) in late pregnancy, in which the child does not receive enough oxygen.
After careful assessment of the benefits and risks, the doctor should decide on the need to use this medicine.
There is no available information on the use of noradrenaline in breastfeeding women.
However, noradrenaline is not absorbed in the oral cavity, so it is not expected that exposure to it after breastfeeding will have adverse effects on the breastfed child.

Noradrenaline hameln contains sodium

One vial containing 50 ml of solution for infusion 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 you in a hospital by a doctor or nurse.
Noradrenaline hameln should not be diluted before use. It is a ready-to-use solution in a 50 ml vial.
The medicinal product Noradrenaline hameln should be administered as an intravenous infusion through a central venous port or through a cannula placed in a sufficiently large vein. To determine the dose necessary to restore normal blood pressure, a syringe infusion 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 administering the initial dose, the doctor will assess the patient's response and adjust the dose accordingly.
The infusion site should be frequently checked.

Using too much Noradrenaline hameln

Using a larger or smaller dose than recommended is unlikely, as you will receive the medicine in a hospital.
In case of any doubts, you should consult a doctor or nurse.
Systemic symptoms (general)
Overdose symptoms are as follows: very high blood pressure, slow heart rate, irregular heart rate, shallow breathing, chest pain, dizziness, loss of consciousness, pale to bluish-cold skin, excess fluid in the lungs, complete or severe muscle weakness, and gastrointestinal symptoms.
Local symptoms
Near the infusion site, white skin discoloration along the infusion vein and tissue necrosis (cell damage causing cell death in tissue) may occur.
Treatment in case of poisoning:
In case of overdose, treatment should be discontinued and appropriate treatment should be initiated.
In case of tissue damage, the infusion should be stopped immediately. The affected area should be soaked with a vasodilator.
In case of any further doubts related to the use of this medicine, you should consult a doctor or nurse.

4. Possible side effects

Like all medicines, Noradrenaline hameln can cause side effects, although not everybody gets them.
The following side effects have been observed:

• Increased blood sugar levels (hyperglycemia), decreased blood pH (metabolic acidosis),
• Headache, feeling of uncertainty and anxiety, tremors, nervousness, confusion, and psychosis
• Palpitations, rapid heart rate, chest pain,
• Increased blood pressure, slow heart rate (bradycardia), irregular heart rate;
• Tissue damage and decreased blood flow to the limbs, especially in the skin, mucous membranes, and kidneys;
• Feeling of cold in the limbs;
• Shortness of breath and difficulty breathing;
• Salivation, nausea, vomiting;
• Pallor, sweating;
• Decreased or stopped urine production;
• Tissue damage caused by reduced blood flow at the infusion site (skin).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help gather more information on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Noradrenaline hameln

The medicine should be stored out of sight and reach of children.
Do not use Noradrenaline hameln after the expiry date stated on the outer packaging and vial after the abbreviation EXP. The expiry date refers to the last day of the 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 up to 25°C.
Storage outside the refrigerator:
Noradrenaline hameln can be stored outside the refrigerator at a temperature up to 25°C for a maximum of 6 months. After this period, the medicine should be discarded.
When storing outside the refrigerator, the medicine should not be put back in the refrigerator.
The storage time should not exceed the shelf life.
For single use only. After the first opening, the product should be used immediately.
Do not use this medicine if it is not clear, contains solid particles, or the vial is damaged.
Medicines should not be disposed of via wastewater. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Noradrenaline hameln contains

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

What Noradrenaline hameln looks like and what the packaging contains

This medicine is provided as a ready-to-use solution for infusion. The solution is clear and colorless or almost colorless, without visible particles, in a 50 ml glass vial, made of neutral glass type I, closed with a gray rubber stopper and an aluminum cap of the "tear-off" type.
The packaging contains 1, 5, or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

hameln pharma gmbh
Inselstrasse 1
31787 Hameln
Germany

Manufacturer:

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

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

Date of revision of the leaflet:

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Information intended for healthcare professionals only:

Preparation guide

Noradrenaline hameln, 0.2 mg/ml, solution for infusion.
To obtain detailed information, please refer to the Summary of Product Characteristics.
For intravenous infusion only.
pH 3.2-4.2
Osmolality 270-310 mOsmol/kg.

Dosage

All dosage recommendations are given in terms of noradrenaline.

The best way to achieve blood pressure stabilization is by administering the infusion intravenously, e.g., using a syringe infusion pump. Depending on the current state of the circulatory system, the infusion pump should be set to an infusion rate of 0.3 ml/hour (which corresponds to 1 microgram/minute) to 6 ml/hour (which corresponds to 20 micrograms/minute).
Dose
is
dependent
on
the
current
hemodynamic
situation
of
the
patient
and
usually
ranges
from
1-20 micrograms/minute in adult patients, which corresponds to 0.014-0.28 micrograms/kg body weight/minute. Depending on the clinical situation, it may be necessary to use higher doses.
Reduced blood volume (hypovolemia) and acidosis (acidosis) reduce the effectiveness of noradrenaline, which should be compensated for as soon as possible.
The medicinal product Noradrenaline hameln should not be diluted before use. It is provided in a ready-to-use form. Accidental dilution of the medicinal product Noradrenaline hameln may lead to the administration of too small a dose to patients and persistent, life-threatening hypotension.
Noradrenaline hameln should be administered as an intravenous infusion through a central venous port or through a cannula placed in a sufficiently large vein to minimize the risk of extravasation and subsequent tissue necrosis.
Manual bolus administration is not recommended to prepare the infusion.
Caution should be exercised when changing syringes to avoid hemodynamic instability. It is recommended to use a double-pump system with an extension to reduce the volume of dead space.

Incompatibilities

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

Special precautions for storage

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 up to 25°C.
Storage outside the refrigerator:
Noradrenaline hameln can be stored outside the refrigerator at a temperature up to 25°C for a maximum of 6 months. After this period, the product should be discarded.
When storing outside the refrigerator, the medicinal product should not be put back in the refrigerator.
The storage time should not exceed the shelf life.