0.08 mg / ml solution for infusion
noradrenaline
What Noradrenaline Aguettant is and what it is used for
The drug contains the active substance norepinephrine, which causes the blood vessels to constrict ( vasoconstriction ).
The drug is only intended for adults weighing more than 50 kg. The drug is used for the treatment of acute low blood pressure in emergencies that require immediate normalization of blood pressure, and where rising noradrenaline doses are necessary.
Noradrenaline contained in Noradrenaline Aguettant may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Noradrenaline Aguettant
Do not use Noradrenaline Aguettant
- administered via peripheral cannula and / or peripheral vein
- if you are allergic to norepinephrine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or nurse before using Noradrenaline Aguettant
- if you have severe left ventricular dysfunction (a heart defect)
- if you have recently had a heart attack
- if you have an irregular heartbeat (your heart beats too fast, too slow or irregularly)
- if you have hyperthyroidism (your thyroid gland is overactive)
- if you have diabetes
- if you have low blood pressure caused by low blood volume ( hypovolemia )
- if you have angina or a blockage of blood vessels in the arms / legs or abdomen ( acute difficulty for the blood to circulate normally).
During infusion one of norepinephrine, your doctor will continuously monitor your blood pressure, your heart rate (heart rate), and the infusion site.
In cases where it is necessary to give norepinephrine at the same time as a blood or plasma transfusion, it will later be given as a separate drip.
Children and young people
The drug is intended for adults only.
Other medicines and Noradrenaline Aguettant
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as:
- certain anesthetic gas (halogen)
- certain antidepressants (imipramine, serotonergic-adrenergic agents such as venlafaxine or duloxetine, monoamine oxidase inhibitors such as moclobemide or phenelzine)
- linezolid (an antibiotic )
- methylene blue (antidote to methemoglobinemia).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, talk to your doctor or nurse before using this medicine. If you are pregnant, your doctor will decide if you should receive the medicine, as norepinephrine can harm the fetus.
There is no information on the use of norepinephrine during breastfeeding.
Noradrenaline Aguettant contains sodium
This medicine contains 177.3 mg sodium (the main ingredient in table salt/table salt) per 50 ml vial. This corresponds to 8.9% of the highest recommended daily intake of sodium for adults.
How to use Noradrenaline Aguettant
This medicine is given in a hospital by a doctor or nurse.
This medicine is given by intravenous infusion (into a vein) and only through a central venous catheter.
The dose of one of these drugs depends on your condition. Your doctor will decide which dose is best for you.
This medicine should not be used to start treatment with vasoconstrictors (vasopressor treatment) but may be considered for patients who are already receiving norepinephrine and who need increasing doses (clinically confirmed).
If you use more Noradrenaline Aguettant then you should
In case of overdose, the following symptoms may be observed: contraction of vessels in the skin (blood vessels become narrower), pressure ulcers (skin ulcers), shock ( circulatory failure ), and high blood pressure.
If you get any side effects associated with an overdose, contact your doctor immediately. Dose one should be reduced, if possible.
If you have any further questions on the use of this product, ask your doctor or nurse.
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
- headaches, tremors
- acute glaucoma (increased pressure in the eye)
- tachycardia (fast heartbeat), bradycardia (slow heartbeat), arrhythmia (irregular heartbeat), palpitations, heavier heart muscle contractions, acute heart failure
- arterial hypertension (high blood pressure ) and tissue hypoxia (decreased oxygen supply to certain organs); cold and pallor in limbs and face, painful and cold hands / feet (cold sores),
- difficulty breathing, dyspnoea (shortness of breath)
- vomiting
- urinary retention (difficulty emptying the bladder)
- local: possible irritation and necrosis (cell damage, causing cell death in tissue ) in the injection site.
Continuous administration of Noradrenaline Aguettant (to maintain blood pressure in the absence of blood volume replacement) may cause the following symptoms:
- severe peripheral and internal vasoconstriction ( vasoconstriction )
- decreased blood flow to the kidneys
- decreased urine production
- hypoxia (too low oxygenation)
- increased serum lactate levels .
In case of hypersensitivity or overdose, the following side effects may occur more frequently: arterial hypertension (high blood pressure ), photophobia (eyes abnormally sensitive to light), retrosternal pain (pain behind the sternum), pharyngeal pain (sore throat), pallor, intense sweating, and vomiting.
Reporting of side effects ar
If you get any side effects, talk to your doctor or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see address below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
How to store Noradrenaline 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 vial label and the carton after EXP. The expiration date is the last day of the specified month.
After the first opening, the product should be used immediately.
Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light.
Do not use this medicine if the solution is darker than slightly yellowish or pink in color or if it contains precipitates.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is norepinephrine . Each ml of solution contains 0.08 mg of noradrenaline (as noradrenaline tartrate). Each 50 ml vial contains 4 mg of noradrenaline (as noradrenaline tartrate).
- The other ingredients are sodium chloride, disodium edetate, hydrochloric acid or sodium hydroxide (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Clear, colorless, or slightly yellowish infusion solution in a clear glass vial. Each vial contains 50 ml of solution for infusion. Pack sizes: 1, 10, and 25 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
AGUETTANT Laboratory
1, rue Alexander Fleming
69007 LYON
FRAN