Norages 1 mg/ml solution for injection
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORAGES 1 mg/ml injectable solution
L-norepinephrine base
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet.
Leaflet contents:
- What Norages is and what it is used for
- What you need to know before using Norages
- How to use Norages
- Possible side effects
- 5 Storage of Norages
- Contents of the pack and other information
1. What Norages is and what it is used for
Norages is a medicine that belongs to the group of "adrenergic and dopaminergic agents", which works by increasing blood pressure.
Norages is indicated for the treatment of acute hypotension (low blood pressure).
2. What you need to know before using Norages
Do not use Norages:
- if you are allergic (hypersensitive) to L-norepinephrine bitartrate monohydrate or to any of the other components of this medicine
- if you are to be given other medicines such as halothane or cyclopropane during anaesthesia.
- if you have gastrointestinal ulcers or bleeding.
Take special care with Norages if:
- You are diabetic
- You have hyperthyroidism
- Your oxygenation status is inadequate
- You have any occlusive (obstructive) disease such as arteriosclerosis (hardening of the arteries), Buerger's disease (inflammation of a vein with thrombus formation), or diabetes mellitus.
- If you have had thrombosis.
Warnings and precautions
Consult your doctor or pharmacist before starting to use this medicine.
Use of Norages with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Norages, and it may be necessary to adjust the dose of Norages and/or these medicines and to administer them with caution.
It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:
- Organic anaesthetics
- Tricyclic antidepressants (used to treat depression) or maprotiline
- Digitalis glycosides (heart medications)
- Ergoloid mesylates or ergotamine (medicines for headache)
- Levodopa (a medicine for the treatment of Parkinson's disease)
- Cocaine
- Guanadrel and guanethidine (medicines for treating hypertension)
- Hydrochloric chlorpheniramine, hydrochloric tripelennamine (medicines for treating allergies), and desipramine (a medicine for treating depression)
- Antihistamines (medicines for treating allergies)
- Amphetamines (central nervous system stimulants)
- Dihydroergotamine (a medicine for headache), ergometrine, methylergometrine (medicines for treating bleeding after childbirth or abortion), or methysergide (a medicine for headache)
- Doxapram (a respiratory stimulant)
- Mazindol (a medicine for treating obesity)
- Mecamylamine (a medicine to help stop smoking) or methyldopa (a medicine for hypertension)
- Methylphenidate (a central nervous system stimulant)
- Rauwolfia alkaloids (a medicine for hypertension)
- Other sympathomimetics (medicines that increase blood pressure)
- Thyroid hormones (treatment for metabolic disorders)
- Monoamine oxidase inhibitors (MAOIs) (medicines for treating depression)
- Medicines for blood pressure or to increase urine elimination (diuretics)
- Beta-adrenergic blockers (medicines to reduce blood pressure)
- Desmopressin (a medicine used for uncontrolled nighttime urination), lysopressin, or vasopressin (medicines for treating hypotension and antidiuretic effect)
- Lithium (a medicine for treating mental illnesses)
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine, as there may be risks to the unborn child.
It is unknown whether Norages is excreted in breast milk; therefore, your doctor will assess the necessity of its administration.
Norages 1 mg/ml contains sodium.
This medicine contains less than 23 mg (1 mmol) of sodium per 4 ml vial and is therefore considered essentially “sodium-free”.
3. How to use Norages
Follow exactly the administration instructions for Norages 1 mg/ml provided by your doctor. If in doubt, consult your doctor again.
Norages 1 mg/ml is administered intravenously by a healthcare professional.
Adults
The initial dose is administered at a rate of 8 to 12 micrograms (0.008 to 0.012 mg) (base) per minute. For maintenance, the rate is adjusted to 2 to 4 micrograms (0.002 to 0.004 mg) (base) per minute.
In the case of septic shock, doses should be adjusted to approximately 0.5 micrograms per kg per minute (up to a maximum of 1.0 microgram per kg per minute).
Children
Intravenous infusion: 0.1 microgram (base) per kg per minute, up to a maximum of 1 microgram (base) per kg per minute.
If you use more Norages than you should:
A severe increase in blood pressure may occur, accompanied by intense headache, photophobia, acute retrosternal pain (in the chest), pharyngeal pain, pallor and profuse sweating, and vomiting.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 – 5620420.
4. Possible adverse effects
Like all medicines, Norages may cause adverse effects, although not everyone experiences them.
If leakage of the liquid from the vein occurs, destruction of the surrounding tissue may result.
A reduction in heart rate may occur.
Prolonged use may decrease cardiac output.
Prolonged administration of this type of substance may lead to fluid loss from the blood, which, if not corrected, may cause a relapse of low blood pressure when treatment is discontinued.
Severe narrowing of the body's blood vessels and visceral vessels (e.g. reduced blood flow to the kidney) may occur, resulting in decreased blood flow and tissue perfusion, leading to tissue hypoxia, increased blood acidity, and ischemic damage.
Although rare, the following symptoms may appear during administration and require medical attention:
Skin disorders: Pallor along the infused vein, necrosis, cyanosis, flushing or redness of the skin, skin rash, urticaria, or pruritus.
Cardiovascular disorders: Irregular heartbeat, decreased heart rate.
Respiratory disorders: Wheezing or difficulty breathing.
General disorders: Severe dizziness or fainting sensation.
Less frequently, the following symptoms may occur, which require medical attention only if they persist or are bothersome:
Skin disorders: Pallor.
Cardiovascular disorders: Heart palpitations.
Nervous system disorders: Anxiety or restlessness, sleep disturbances, tremors, headache.
General disorders: Dizziness, swelling in the neck.
In sensitive individuals, for example those with neurological disorders or hyperthyroidism, the following may occur:
Nervous disorders: Fear, anxiety, pulsating headache, and respiratory difficulty.
Cardiovascular disorders: Pallor, tachycardia, palpitations, and (mild) increase in blood pressure.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Norages
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 packaging after EXP. The expiry date is the last day of the month indicated.
Do not store above 25°C. Keep in the original container to protect from light.
Medicines must not be disposed of via wastewater or household waste. If you have any questions about how to dispose of unwanted medicines and packaging, please consult your pharmacist. This will help protect the environment.
6. Contents of the container and other information
Composition of Norages
The active substance is noradrenaline (L-norepinephrine) base.
Each ml of solution contains 1 mg of noradrenaline (L-norepinephrine) base, equivalent to 2 mg of noradrenaline bitartrate (L-norepinephrine) monohydrate.
Each 4 ml ampoule contains 4 mg of noradrenaline (L-norepinephrine) base, equivalent to 8 mg of noradrenaline bitartrate (L-norepinephrine) monohydrate.
The other components (excipients) are sodium chloride and water for injections.
Appearance of the product and contents of the pack
Norages 1 mg/ml is an injectable solution supplied in packs containing 10 ampoules of 4 ml.
Marketing Authorization Holder and Manufacturer
Altan Pharmaceuticals, S.A.
C/ Cólquide 6, Portal 2, 1st floor, office F
Prisma Building
28230 Las Rozas – Madrid, Spain
Manufacturer:
Laboratorio RENAUDIN
Z.A. Errobi
64250 Itxassou, France
This leaflet was approved in July 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es
This information is intended for healthcare professionals only:
Dosage and method of administration
Norepinephrine must be administered intravenously:
Usual adult dose
The initial dose is administered at a rate of 8 to 12 micrograms (0.008 to 0.012 mg) (base) per minute, adjusting the infusion rate to establish and maintain the desired blood pressure.
For maintenance, the rate is adjusted to 2 to 4 micrograms (0.002 to 0.004 mg) (base) per minute, titrating the dose according to the patient's response.
In septic shock, doses should be adjusted to approximately 0.5 micrograms/kg/min (up to a maximum of 1.0 micrograms/kg/min) to achieve the desired mean arterial pressure. It is recommended to co-administer with dopamine at doses of 2–2.5 micrograms/kg/min, which counteracts vasoconstriction and ensures adequate renal and splanchnic perfusion.
- To prepare the norepinephrine intravenous infusion solution, add 4 mg of L-norepinephrine (base) to 1 liter of 5% glucose solution. The resulting solution will contain 4 micrograms (0.004 mg) of L-norepinephrine (base) per ml. Note that 1 mg of L-norepinephrine bitartrate is equivalent to 0.5 mg of L-norepinephrine base.
Duration of treatment
Infusion should be continued until adequate blood pressure and tissue perfusion are maintained without treatment. Norepinephrine infusion should be tapered gradually, avoiding abrupt discontinuation. In some reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.
Usual pediatric dose
Intravenous infusion: 0.1 micrograms (base) per kg per minute, gradually adjusting the infusion rate to achieve the desired blood pressure, up to a maximum of 1 microgram (base) per kg per minute.
- When added to local anesthetics, these solutions contain a norepinephrine concentration of approximately 1:200,000 (5 micrograms/ml).
Administration should be avoided:
- Norepinephrine should not be used as the sole therapy in hypotensive patients due to hypovolemia, except as an emergency measure to maintain coronary and cerebral arterial perfusion until volume replacement therapy is completed.
- Administration should be avoided in veins of the lower limbs in elderly patients and in patients with occlusive vascular diseases due to the risk of vasoconstriction.
- Accidental extravasation may occur if adequate precautions are not taken, potentially leading to tissue necrosis or even gangrene. To prevent necrosis and tissue scarring at the site of extravasation, the area should be immediately infiltrated with 10 to 15 ml of sodium chloride solution containing 5 to 10 mg of phentolamine. A syringe with a fine hypodermic needle should be used to infiltrate the solution thoroughly throughout the affected area. If infiltration is performed within 12 hours, sympathetic blockade with phentolamine produces immediate and noticeable local hyperemic changes.
- Blood volume should be restored as completely as possible before administering any vasopressor.
Special precautions for use
- Prior to administration, injectable norepinephrine must be diluted with 5% glucose in water or 5% glucose in sodium chloride solution. Sodium chloride solution alone must not be used.
- To prepare the norepinephrine intravenous infusion solution, add 4 mg of L-norepinephrine (base) to 1 liter of 5% glucose solution. The resulting solution will contain 4 micrograms (0.004 mg) of L-norepinephrine (base) per ml. Note that 1 mg of L-norepinephrine bitartrate is equivalent to 0.5 mg of L-norepinephrine base.
- Use an infusion pump or controlled infusion system to ensure accurate measurement of the infusion rate in drops per minute. Infusion should be administered into veins of the upper extremities.
- Catheterization via ligation technique should be avoided if possible, as obstruction of blood flow around the catheter may cause stasis and increased local concentration of norepinephrine.
- Do not use the injectable solution if it is brown in color or contains a precipitate.
Overdose
Symptoms
Overdose causes severe hypertension with intense headache, photophobia, acute retrosternal pain, pharyngeal pain, pallor, profuse sweating, and vomiting.
Emergency treatment, antidotes
Recommended treatment for norepinephrine overdose includes:
- Discontinuation of the medication
- Appropriate fluid and electrolyte replacement therapy
For hypertensive effects: if necessary, an α-adrenergic blocker such as 5 to 10 mg of phentolamine may be administered intravenously.