NORADRENALINA 2 mg /Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. noradrenalina (norepinephrine) tartrate
   1. What is Noradrenalina tartrato Laboratoire Aguettant and what is it used for?
   2. What you need to know before you are given Noradrenalina tartrato Laboratoire
   3. How Noradrenalina tartrato Laboratoire Aguettant is administered
   4. Possible side effects
   5. How to store Noradrenalina tartrato Laboratoire Aguettant
   6. Package contents and other information

Noradrenalina tartrato Laboratoire Aguettant 2 mg/ml concentrate for solution for infusion

noradrenalina (norepinephrine) tartrate

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Noradrenalina tartrato Laboratoire Aguettant is and what it is used for
• 2. What you need to know before you are given Noradrenalina tartrato Laboratoire Aguettant
• 3. How Noradrenalina tartrato Laboratoire Aguettant is given
• 4. Possible side effects
• 5. How to store Noradrenalina tartrato Laboratoire Aguettant
• 6. Contents of the pack and other information

1. What is Noradrenalina tartrato Laboratoire Aguettant and what is it used for?

Noradrenalina tartrato Laboratoire Aguettant contains the active ingredient noradrenaline (norepinephrine),
which causes the constriction of blood vessels (vasoconstriction).
Noradrenalina tartrato Laboratoire Aguettant is indicated in adults for the emergency restoration of
blood pressure in cases of acute hypotension (low blood pressure).

2. What you need to know before you are given Noradrenalina tartrato Laboratoire

Aguettant
Noradrenalina tartrato Laboratoire Aguettant must not be given

• if you are allergic to noradrenaline (norepinephrine) tartrate or to any of the other ingredients of this medicine (listed in section 6);
• in case of hypotension (low blood pressure) caused by hypovolemia (low blood volume);
• if you are taking certain anesthetics, such as halothane or cyclopropane (this may increase the risk of irregular heartbeat).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Noradrenalina
tartrato Laboratoire Aguettant if you:

• have severe left ventricular dysfunction (a heart condition);
• suffer from coronary thrombosis (blood clot in a heart blood vessel), mesenteric (blood clot in a vein draining blood from the intestine) or peripheral vascular (blood clot in the arm or leg vein);
• suffer from hypotension (low blood pressure) following myocardial infarction (heart attack);
• have variant or Prinzmetal's angina;
• during treatment, you experience heart rhythm disturbances (in this case, a reduced dose may be necessary);
• suffer from hyperthyroidism (thyroid gland problem);
• diabetes mellitus;
• are elderly.

Additional monitoring tests that you may be required to undergo during treatment:
During treatment, blood pressure and heart rate will be checked
frequently to avoid hypertension (high blood pressure).

Children and adolescents
The safety and efficacy of norepinephrine in children under 18 years of age have not yet been
established. Therefore, use in children is not recommended.

Other medicines and Noradrenalina tartrato Laboratoire
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The following medicines can affect the effect of Noradrenalina tartrato Laboratoire Aguettant:

• Halothane, cyclopropane, chloroform, enflurane or other halogenated anesthetics are contraindicated

given”): these medicines are anesthetics, causing insensitivity to pain and are
used before some operations. Taking these medicines and noradrenaline
(norepinephrine) tartrate can increase the risk of irregular heartbeat.

• Amitriptyline, imipramine, trimipramine, moclobemide, iproniazide, phenelzine, fluoxetine,sertraline, desipramine: these medicines are used to treat depression. Taking one of these medicines together with noradrenaline (norepinephrine) tartrate can dangerously increase its concentration in the blood and therefore its pressor action.
• Digitalis glycosidescan occasionally cause irregular heartbeat.
• Levodopamay intensify the effects of noradrenaline (norepinephrine) tartrate.
• Antihistamines, because some can block the absorption of catecholamines by peripheral tissues and increase the toxicity of injected noradrenaline (norepinephrine) tartrate.
• Chlorphenamine hydrochloride, tripelennamine hydrochloride: significantly increase the toxicity of noradrenaline (norepinephrine) tartrate.
• Non-selective MAO inhibitors (or within 14 days of stopping such therapy):increased pressor action of the sympathomimetic, which is usually moderate. They should only be used under strict medical supervision.
• -Selective MAO-A inhibitors:by extrapolation from non-selective MAO inhibitors, risk of increased pressor action. They should only be used under strict medical supervision.
• Linezolid, an antibiotic (a medicine used to treat infections caused by bacteria and other microorganisms) that can dangerously increase the concentration of noradrenaline (norepinephrine) tartrate in the blood and therefore its pressor action.
• Alpha and beta-blockers: taking these medicines and noradrenaline (norepinephrine) tartrate can increase the risk of severe hypertension (high blood pressure).
• Thyroid hormones, cardiac glycosides, antiarrhythmics: taking these medicines and noradrenaline (norepinephrine) tartrate can cause a potentiation of cardiac effects.
• Ergot alkaloids or oxytocincan potentiate the vasopressor and vasoconstrictor effects (increasing blood pressure).
• Desmopressin or vasopressin: its antidiuretic effect is reduced.
• Lithiumreduces the effect of noradrenaline (norepinephrine) tartrate.
• Guanethidine, guanadrel, reserpine, methyldopa or tricyclic antidepressants, amphetamine,doxapram, mazindol, Rauwolfia alkaloids: can potentiate the effects of noradrenaline (norepinephrine) tartrate.
• Propofol: concomitant administration can lead to propofol infusion syndrome (PRIS).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine. Noradrenaline
tartrate may cause harm to the unborn child. The doctor will decide whether to give you noradrenaline tartrate.
It is not known whether this medicine is excreted in human breast milk. Because many medicines are
excreted in human breast milk, caution should be exercised when giving norepinephrine to breastfeeding women.

Driving and operating machinery
Because the medicine is administered in hospital, the doctor will tell you when you will be able to
drive or operate machinery.

Noradrenalina tartrato Laboratoire Aguettantcontains sodium
This medicine contains 3.3 mg of sodium (the main component of table salt) per each
ml. This is equivalent to 0.16% of the recommended daily intake of salt with the diet of an
adult.

3. How Noradrenalina tartrato Laboratoire Aguettant is administered

Noradrenalina tartrato Laboratoire Aguettant will be administered to you in hospital by a doctor or a
nurse.

Dose
Noradrenalina tartrato Laboratoire Aguettant is first diluted and then infused into a vein. It must not
be mixed with other medicines. The dose of noradrenalina (norepinephrine) tartrate depends on the
patient's conditions. Your doctor will know which dose to use. The initial dose is 0.8-1.6 mg of
noradrenalina (norepinephrine) tartrate per hour (equivalent to 0.4-0.8 mg of noradrenalina (norepinephrine)
base per hour). The dose can then be controlled using a pump depending on the response to
treatment, with the aim of normalizing blood pressure. The doctor will monitor blood
pressure and blood volume.

If you are given too much noradrenalina (norepinephrine)
It is unlikely that you will receive an excessive dose since this medicine is administered
in hospital. However, contact your doctor or nurse if you have any doubts.
The symptoms that may occur in case of an overdose of noradrenalina
(norepinephrine) tartrate are very high blood pressure, slow heartbeat, severe headache,
sensitivity to light, chest pain, brain hemorrhage, paleness, fever, profuse sweating and vomiting, fluid
in the lungs causing shortness of breath.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the side effects listed is not known (cannot be estimated from the available data).
Tell your doctor or nurse immediatelyif any of the following happen:

• difficulty or irregularity in breathing
• fast, slow or irregular heartbeat, palpitations
• chest or throat pain

Tell your doctor or nurse as soon as possible if any of the following happen:

• anxiety, insomnia, confusion, headache, psychotic state, weakness, tremor, decreased alertness, anorexia, nausea, vomiting;
• high blood pressure,
• paleness (loss of skin color), sweating, sensitivity to light
• gangrene (pain and coldness in the extremities, which may become purple to very dark/black, with tissue death)
• skin necrosis if the infusion is not administered directly into a vein,
• acute glaucoma (eye problem)
• skin scarring, bluish discoloration of the skin, hot flashes or skin redness, rash, hives or itching,
• urinary retention.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Noradrenalina tartrato Laboratoire Aguettant

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the label of the
vial after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Keep the vial in the outer carton to protect the
medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Noradrenalina tartrato Laboratoire Aguettant contains

• The active ingredient is noradrenaline (norepinephrine) tartrate. Each ml of concentrate for solution for infusion contains 2 mg of noradrenaline (norepinephrine) tartrate, equivalent to 1 mg of noradrenaline (norepinephrine). Each vial of 4 ml contains 8 mg of noradrenaline (norepinephrine) tartrate, equivalent to 4 mg of noradrenaline (norepinephrine). Each vial of 8 ml contains 16 mg of noradrenaline (norepinephrine) tartrate, equivalent to 8 mg of noradrenaline (norepinephrine).
• The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

Description of the appearance of Noradrenalina tartrato Laboratoire Aguettant and package contents
Clear, colorless to slightly yellowish solution with a pH of 3.0‑4.0 packaged in a transparent glass vial of 4 ml or 8 ml.
Cartons of 10, 50 or 100 vials.
Not all pack sizes may be marketed.

Marketing authorisation holder
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France
or
Delpharm Tours
Rue Paul Langevin
37 170 Chambray-Les-Tours
France
or
Haupt Pharma Livron
1 rue Comte de Sinard,
26250 Livron Sur Drome
France

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
BE, LU: Noradrenaline (Norepinephrine) Aguettant
NL: Noradrenaline Aguettant
ES: Noradrenalina Aguettant
BG, Noradrenalin Aguettant
DK, FI, IS, NO, SE: Noradrenalin Laboratoire Aguettant
AT, DE: Norepinephrin Aguettant
UK (NI), IE: Noradrenaline (Norepinephrine)
PT: Noradrenalina Aguettant
IT: Noradrenalina tartrato Laboratoire Aguettant

The following information is intended exclusively for doctors or healthcare professionals
Method of administration
For intravenous use only, after dilution. For single use.
The infusion must be administered at a controlled rate, using a syringe pump, an infusion pump or a drip device.

Instructions for dilution
This product must be visually inspected before administration. Use only if the solution is clear and colorless or slightly yellowish, free from particles or precipitates. Do not use vials that are pink in color or darker than pale yellow, or that contain a precipitate.
Add 2 ml of Noradrenalina tartrato Laboratoire Aguettant to 48 ml of 5% glucose solution (or 9 mg/ml (0.9%) sodium chloride or physiological saline solution) for administration using a syringe pump.
Or add 20 ml of Noradrenalina tartrato Laboratoire Aguettant to 480 ml of 5% glucose solution (or 9 mg/ml (0.9%) sodium chloride or physiological saline solution) for administration using a drip device.
When diluted, the final concentration of the infusion solution is generally 80 mg/l of noradrenaline (norepinephrine) tartrate (equivalent to 40 mg/litre of noradrenaline (norepinephrine)).
If other dilutions are used, carefully check the calculation before starting treatment.
In the absence of specific data, this medicinal product must not be mixed with other medicinal products.
After dilution: The physicochemical stability of the diluted product (in 5% dextrose, in 9 mg/ml (0.9%) sodium chloride or in physiological saline solution) has been demonstrated for 48 hours at 30 °C.
However, from a microbiological point of view, the diluted product must be used immediately. If the product is not used immediately, the duration and conditions of use are the responsibility of the user.

Dosage
Initial infusion rate:
The initial infusion rate should be between 10 ml/hour and 20 ml/hour (0.16 ml/min to 0.33 ml/min). This is equivalent to 0.8‑1.6 mg/hour of noradrenaline (norepinephrine) tartrate (equivalent to 0.4-0.8 mg/hour of noradrenaline (norepinephrine) base).
Dose titration:
Once the noradrenaline (norepinephrine) tartrate infusion has been established, the dose should be titrated according to the observed pressor effect. The dose required to achieve and maintain normotension can vary greatly from individual to individual. The goal should be to establish a low normal systolic blood pressure (100‑120 mmHg) or to achieve an adequate mean arterial pressure (greater than 65‑80 mmHg, depending on the patient's condition).