VIPRANOP 10 MICROGRAMMI/ML Injectable or infusion solution

Зміст інструкції

1. Vipranop 10 micrograms/ml injectable solution or infusion
   1. What is Vipranop and what is it used for
   2. What you need to know before you are given Vipranop
   3. How Vipranop is administered
   4. Possible side effects
   5. How to store Vipranop
   6. Contents of the pack and other information

Vipranop 10 micrograms/ml injectable solution or infusion

noradrenaline tartrate

Read this leaflet carefully before you are given 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.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Vipranop and what is it used for

This medicine contains the active substance norepinephrine (as norepinephrine tartrate) and acts as a
vasoconstrictor (narrows blood vessels).
The use of this medicine is only for adults.
This medicine is used during surgery to restore and maintain stable
blood pressure, following the decrease induced by anesthesia.

2. What you need to know before you are given Vipranop

Do not receive Vipranop:

• if you are allergic to norepinephrine or to any of the other ingredients of this medicine (listed in section 6);
• during anesthesia with cyclopropane or halothane.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Vipranop:

• if you have ischemic heart disease (disease caused by the narrowing or blockage of the blood vessels that supply the heart muscle),
• if you have angina (chest pain),
• if you have recently had a myocardial infarction (heart attack),
• if you have blood clots or obstructions in the blood vessels that supply the heart, intestines or other parts of the body (vascular disease),
• if you have hypertension (high blood pressure),
• if you have hypotension (low blood pressure) due to hypovolemia (low blood volume),
• if you have hyperthyroidism (your thyroid is overactive),
• if you have increased intracranial pressure (high pressure in the brain),
• if you have diabetes (disease characterized by a high level of sugar in the blood for a prolonged period of time),
• if you are elderly,
• if you have liver problems or serious kidney problems.

During the infusion of norepinephrine, the doctor will continuously monitor your blood pressure, your
heart rate (heart rhythm) and the infusion site.
In cases where it is necessary to administer norepinephrine simultaneously with blood or
plasma transfusions, norepinephrine will be administered in a separate intravenous line.

Children and adolescents
Vipranop is indicated only for adults. This medicine is not recommended in children and
adolescents under the age of 18 years.

Other medicines and Vipranop
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Vipranop can influence or be influenced by other medicines.
A number of medicines are known to increase the toxic effects of norepinephrine:

• Some anesthetics such as halothane, cyclopropane (anesthetic gases) and propofol (injection anesthetic);
• Antidepressants, so-called serotonergic-adrenergic antidepressants (such as fluoxetine, sertraline), or MAO inhibitors (such as moclobemide), or imipramine antidepressants (such as imipramine, trimipramine), or non-selective MAO inhibitors (such as amitriptyline, iproniazide, phenelzine);
• Linezolid (an antibiotic) (medicine used to treat infections caused by bacteria and other microorganisms);
• Methylene blue (an antidote);
• Medicines to lower blood pressure (such as guanethidine, reserpine, beta-blockers (for example propranolol));
• Thyroid hormones, cardiac glycosides (a class of medicines that increase the pumping force of the heart and increase the frequency of its contractions) and antiarrhythmics (medicines used to suppress abnormal heart rhythms) (such as digitalis);
• Ergot alkaloids (such as bromocriptine);
• Medicines that induce contractions (such as oxytocin).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor, pharmacist or nurse for advice before you are given this
medicine.

Pregnancy
Data relating to the use of norepinephrine in pregnant women are limited. Norepinephrine can
pass through the placenta, cause strong uterine contractions and reduce blood flow to the placenta,
causing insufficient oxygen supply to the fetus. For this reason, the use of norepinephrine during
pregnancy is not recommended unless the benefits to the mother outweigh the potential risks to the fetus. If
you are pregnant, your doctor will decide whether you should be given this medicine, as norepinephrine can
harm the unborn baby.

Breastfeeding
It is not known whether norepinephrine passes into breast milk. Despite the fact that Norepinephrine is not absorbed
orally, this medicine should be used with caution during breastfeeding.

Vipranop contains sodium
This medicine contains 71 mg of sodium (the main component of table salt) per each vial
of 20 ml. This is equivalent to 3.6% of the recommended maximum daily intake with the diet of an
adult.

3. How Vipranop is administered

This medicine will be administered to you in hospital, by a doctor or a nurse.
This medicine is administered by intravenous infusion (into a vein). An initial bolus of the
medicine may be injected into a vein before the start of the infusion.
During treatment, you will be constantly monitored, and blood pressure and the infusion rate
will be carefully controlled.
The recommended dose of Vipranop depends on your medical condition. Your doctor will determine the dose
suitable for you.

If you are given too much Vipranop
Since this medicine will be administered to you during surgery by a
trained healthcare professional, it is unlikely that you will be given an excessive amount of Vipranop.
However, if you think you have received an excessive amount of the medicine, contact a
doctor or nurse immediately.
In case of overdose, the following symptoms may be observed: headache, hypertension (severe high
blood pressure), slow heartbeat, cutaneous vasoconstriction (blood vessels constrict), circulatory collapse
(poorly functioning circulation), cerebral haemorrhage (bleeding in the brain), sensitivity to light,
chest pain, pale skin, fever, excessive sweating, pulmonary oedema (excess fluid in the
lungs) and vomiting.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

• Anxiety
• Insomnia
• Headache
• Tremor (involuntary muscle contraction)
• Dizziness
• Acute glaucoma (condition caused by a rapid or sudden increase in pressure inside the eye)
• Tachycardia (fast heart rate), bradycardia (slow heart rate), arrhythmia (irregular heartbeat), changes in the electrocardiogram (a test of heart activity), cardiogenic shock (a severe drop in blood pressure in the heart area), stress cardiomyopathy (damage to the heart muscle)
• Arterial hypertension (high blood pressure) and tissue hypoxia (decreased oxygen supply to an organ), coldness and pallor of the limbs and face, painful and cold extremities (gangrene), depletion of plasma volume (reduced amount of plasma (the liquid part of the blood) in the body)
• Dyspnea (difficulty breathing)
• Nausea and vomiting
• Urinary retention
• Locally: possibility of irritation and necrosis (cell damage, causing the death of tissue cells) at the injection site.

In case of hypersensitivity (allergy) or overdose, the following effects may occur more frequently
in association with arterial hypertension (high blood pressure): severe headache, photophobia (abnormal
intolerance to visual perception of light), retrosternal pain (chest pain), pallor (pale skin), fever,
profuse sweating, vomiting, pulmonary edema (difficulty breathing), arrhythmia (irregular heartbeat) or
cardiac arrest.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 to provide more information on the safety of
this medicine.

5. How to store Vipranop

Keep this medicine out of the sight and reach of children.
Keep the vial in the outer packaging to protect the medicine from light. Do not freeze.
Do not use this medicine after the expiry date which is stated on the vial label after Exp.
The expiry date refers to the last day of that month. Your doctor or nurse will check it.
For single use only.
Chemical and physical stability during use has been demonstrated for 24 hours at 30 °C in a syringe made of
polypropylene. From a microbiological point of view, the product must be used immediately. If not
used immediately, the storage times and conditions before use are the responsibility of
the user and should normally not exceed 24 hours at 2-8 °C, unless the
handling has taken place under controlled and validated aseptic conditions.
This medicine is a clear and colourless solution, practically free from visible particles. The
solution should not be used if it appears slightly yellow or pink, or has a brown colour, or if it contains
particles or a precipitate.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.

6. Contents of the pack and other information

What Vipranop contains

• The active ingredient is norepinephrine (as norepinephrine tartrate). Each ml of solution contains 10 micrograms of norepinephrine tartrate equivalent to 5 micrograms of norepinephrine. Each 20 ml vial contains 200 micrograms of norepinephrine tartrate, equivalent to 100 micrograms of norepinephrine.
• The other ingredients are: sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment) and water for injections.

Description of the appearance of Vipranop and contents of the pack
This medicine is a clear, colorless solution for injection and intravenous infusion, practically
free from visible particles, packaged in a 20 ml transparent glass vial closed with a chlorobutyl rubber stopper and an aluminum cap.
Vipranop is available in packs of 1 and 10 vials.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Laboratoire AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency.
The following information is intended exclusively for healthcare professionals:

Qualitative and quantitative composition:
Each ml of solution for injection or infusion contains 10 micrograms of norepinephrine tartrate
monohydrate, equivalent to 5 micrograms of anhydrous norepinephrine.
Each 20 ml vial contains 200 micrograms of norepinephrine tartrate monohydrate, equivalent to 100
micrograms of anhydrous norepinephrine.

Therapeutic indications:
Restoration and maintenance of peri-operative blood pressure in adults following hypotension
induced by spinal or general anesthesia.

Posology:
This formulation is suitable for a peri-operative setting; the concentration is not suitable for an intensive care setting.
The infusion can be administered through a peripheral venous line as a bolus injection or
continuous infusion using a syringe pump, an infusion pump or a drip chamber.
This medicine must not be diluted before use: it is supplied ready for use and must not be
mixed with other medicines.
The patient must be carefully monitored and must always be supervised during the administration of norepinephrine.
Extravasation must be avoided. To prevent the formation of eschars and necrosis in the areas where
extravasation has occurred, the area must be infiltrated as soon as possible with 10 ml - 15 ml of saline solution containing 5 mg to 10 mg of phentolamine. The norepinephrine infusion must be stopped.

Initial rate
The initial infusion dose is between 0.04 µg/kg/min and 0.1 µg/kg/min of norepinephrine tartrate
(equivalent to 0.02 µg/kg/min and 0.05 µg/kg/min of norepinephrine). An initial intravenous bolus of
10 µg - 20 µg of norepinephrine tartrate (5 µg - 10 µg of norepinephrine) can be administered before
the start of the infusion, after spinal anesthesia or the induction of general anesthesia.

Dose titration
Once the norepinephrine infusion has started, the dose can be increased or decreased to maintain
adequate target blood pressure during the peri-operative period. The dose must be adjusted according to
the patient's age, weight and clinical condition.
If blood pressure needs to be increased rapidly, an intravenous bolus of 10 µg - 20 µg of norepinephrine tartrate (5 µg - 10 µg of norepinephrine) can be administered.

Duration of treatment and monitoring
The administration of norepinephrine must be continued for the entire duration of the peri-operative period
until it is deemed necessary to maintain adequate blood pressure and tissue perfusion.

Discontinuation of therapy
Infusions must be reduced gradually, avoiding abrupt discontinuations that could cause
acute hypotension.

Elderly patients
In general, the dose for an elderly patient should be chosen with caution, starting at the lower end
of the dosage range in order to reflect the increased frequency of decreased hepatic, renal or cardiac function and concomitant diseases or other drug therapies.

For complete information on the indication and use, refer to the summary of product characteristics.