Norepinephrine (Concentrate) Instructions for Use
ATC Code
C01CA03 (Norepinephrine)
Active Substance
Norepinephrine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Alpha-, beta-adrenergic agonist
Pharmacotherapeutic Group
Drugs for the treatment of heart diseases. Cardiotonic drugs other than cardiac glycosides. Adrenergic and dopaminergic drugs
Pharmacological Action
Adrenomimetic. It has a pronounced direct effect on α-adrenergic receptors, as well as a weak effect on β1-adrenergic receptors and a minor influence on β2-adrenergic receptors. The predominance of the α-adrenomimetic action leads to vasoconstriction, an increase in systemic vascular resistance (SVR) and systemic blood pressure (BP), and central venous pressure also increases.
Since the stimulating effect on the heart (on the β1-adrenergic receptors of the myocardium) is very weak, compensatory mechanisms associated with vagus nerve excitation in response to increased BP prevail, which ultimately leads to a decrease in heart rate (HR) and the development of bradycardia. However, despite the decrease in HR, the positive inotropic effect on the heart persists, so the cardiac output (CO) decreases insignificantly.
Under the influence of norepinephrine, blood flow in the renal and mesenteric vessels also decreases.
It has a minor effect on myocardial oxygen consumption, and therefore has a less pronounced arrhythmogenic effect than epinephrine.
Unlike epinephrine, it has a stronger (1.5 times) vasoconstrictor and pressor effect, a less pronounced stimulating effect on heart contractions, a weak bronchodilator effect, and a very weak (more than 20 times) hyperglycemic effect.
Pharmacokinetics
Plasma protein binding is 50%.
It is intensively metabolized in adrenergic neurons and in the liver with the participation of MAO by oxidative deamination. It is a metabolic substrate for COMT, which methylates the cyclic part of the molecule in the ortho-position. Inactive metabolites partially form conjugated compounds with glucuronic or sulfuric acid and are excreted by the kidneys in this form.
After administration of norepinephrine, the following most important compounds are detected in the urine: norepinephrine-4 – 4-24%, normetanephrine (o-methyl-norepinephrine) – 21-25%, o-methyl-glycol-derivative – 20-23%, vanillylmandelic acid – 32-35%. Normally, 5 mg/day of vanillylmandelic acid is excreted in the urine (higher rates should raise suspicion of pheochromocytoma).
Norepinephrine does not cross the blood-brain barrier (BBB), but it does cross the placental barrier.
Indications
Rapid restoration of BP during its acute decrease.
ICD codes
| ICD-10 code | Indication |
| I95 | Hypotension |
| ICD-11 code | Indication |
| BA2Z | Hypotension, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer intravenously as a continuous infusion only. Do not administer as a direct intravenous bolus.
Dilute the concentrate before infusion. Add the required quantity to a compatible intravenous solution, typically Dextrose 5% in Water.
Initiate therapy at a rate of 8 to 12 mcg per minute. Titrate the infusion rate to achieve and maintain the desired low-normal blood pressure goal, typically a systolic BP of 80-100 mm Hg or a mean arterial pressure (MAP) of 60-65 mm Hg.
Increase the rate in increments of 2-4 mcg per minute based on blood pressure response. The usual maintenance dose ranges from 2 to 4 mcg per minute.
Monitor blood pressure every 2-3 minutes during initial titration and every 5 minutes once the target pressure is stabilized. Continuously monitor ECG and observe the infusion site for signs of extravasation.
If extravasation occurs, immediately infiltrate the area with phentolamine mesylate. Use a large-bore intravenous catheter, preferably inserted into a large vein, to minimize this risk.
Correct hypovolemia with appropriate fluid and electrolyte solutions concurrently with norepinephrine administration. Discontinue therapy gradually by reducing the infusion rate. Avoid abrupt withdrawal.
Adverse Reactions
With rapid administration, headache, chills, cold extremities, tachycardia are possible.
From the cardiovascular system: arterial hypertension and tissue hypoxia; ischemic disorders, tachycardia, bradycardia, arrhythmia, palpitations, increased contractility of the heart muscle as a result of the β-adrenergic effect on the heart, acute heart failure.
From the nervous system: anxiety, insomnia, headache, mental disorders, weakness, tremor, confusion, decreased attention.
From the digestive system: nausea, vomiting, anorexia.
From the respiratory system: shortness of breath, pain in the sternum and mediastinum, difficulty breathing, respiratory failure.
From the urinary system: urinary retention.
From the organ of vision: acute glaucoma.
From the immune system: allergic reactions and difficulty breathing are possible.
Local reactions: irritation at the injection site, development of necrosis.
Contraindications
Hypersensitivity to norepinephrine; arterial hypotension caused by hypovolemia (except when Norepinephrine is used to maintain cerebral and coronary blood flow until the completion of therapy aimed at replenishing the circulating blood volume); anesthesia with cyclopropane or halothane (risk of arrhythmias); severe hypoxia and hypercapnia.
With caution severe left ventricular failure, acute heart failure, recent myocardial infarction, Prinzmetal’s angina, thrombosis of coronary, mesenteric or peripheral vessels (risk of worsening ischemia and increasing the infarction zone), insufficient circulation, heart rhythm disturbance during infusion, hyperthyroidism, diabetes mellitus; old age.
Use in Pregnancy and Lactation
Norepinephrine should not be used during pregnancy due to the risk of fetal hypoxia. It is believed that use is possible only for vital indications (including collapse, myocardial infarction). Use with caution during lactation (breastfeeding).
Geriatric Use
Use with caution in elderly patients – careful monitoring of BP is necessary in this category of patients.
Special Precautions
Correction of hypovolemia, hypoxia, acidosis, hypercapnia is necessary before starting or during therapy.
Norepinephrine should be used simultaneously with adequate replenishment of the circulating blood volume.
During the infusion of norepinephrine, BP and the rate of administration should be checked frequently every 2 minutes until the desired BP is achieved, and then every 5 minutes throughout the entire infusion time. The patient should not be left unattended during the use of norepinephrine. Headache may be a symptom of arterial hypertension due to an overdose of norepinephrine.
Long-term administration of any potent vasopressor (including Norepinephrine) can lead to a decrease in plasma volume, which must be continuously corrected by appropriate administration of fluids and electrolytes. If the plasma volume is not corrected, after discontinuation of the norepinephrine infusion, arterial hypotension may develop again, or maintaining BP may be associated with the risk of severe peripheral and visceral vasoconstriction with reduced blood flow and tissue perfusion (e.g., decreased renal perfusion) with subsequent tissue hypoxia, lactic acidosis, and possible ischemic tissue damage.
Elderly patients may be particularly sensitive to the effects of norepinephrine. If cardiac arrhythmias occur during the infusion, the dose should be reduced.
Norepinephrine therapy should be reduced gradually, as abrupt withdrawal can lead to acute arterial hypotension.
Effect on the ability to drive vehicles and operate machinery
During the treatment period, patients are prohibited from driving any vehicles and engaging in other activities that require high concentration and speed of psychomotor reactions.
Drug Interactions
With simultaneous use with MAO inhibitors, a slight enhancement of the pressor effects of norepinephrine is possible.
Alpha-blockers (doxazosin, labetalol, phenoxybenzamine, prazosin, terazosin) and other drugs with alpha-blocking activity (haloperidol, loxapine, phenothiazines, thioxanthenes) reduce the vasoconstrictor effect of norepinephrine.
With simultaneous use of agents for inhalation general anesthesia (chloroform, enflurane, halothane, cyclopropane, isoflurane and methoxyflurane), the risk of developing ventricular arrhythmias increases. Halothane and cyclopropane increase the autonomic excitability of the heart and, thus, can increase the sensitivity of the myocardium to the effects of intravenously administered sympathomimetics, such as epinephrine or Norepinephrine.
When norepinephrine is used simultaneously with cardiac glycosides, quinidine, tricyclic antidepressants, the risk of developing arrhythmias increases.
With simultaneous use with hypotensive drugs and diuretics, a decrease in the effectiveness of norepinephrine is possible.
With simultaneous use with adrenergic blockers, mutual weakening of the action occurs.
With simultaneous use with cocaine, doxapram, mutual enhancement of the hypertensive action occurs.
With simultaneous use of MAO inhibitors (linezolid, furazolidone, procarbazine, selegiline), prolongation and enhancement of the pressor effect are possible.
With simultaneous use of nitrates, a weakening of the antianginal action is possible.
With simultaneous use of ergot alkaloids or oxytocin, vasopressor and vasoconstrictor effects may be enhanced.
With simultaneous use of thyroid hormones, the risk of coronary insufficiency against the background of angina pectoris increases.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Concentrate for solution for intravenous administration 2 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5, 10, or 20 pcs.
Marketing Authorization Holder
B-PHARM, LLC (Russia)
Manufactured By
Bryntsalov-A, JSC (Russia)
Dosage Form
 |
Norepinephrine | Concentrate for solution for intravenous administration 2 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5, 10, or 20 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration in the form of a clear, colorless or brownish-yellow liquid.
| 1 ml | |
| Norepinephrine hydrotartrate (in the form of monohydrate) recalculated as norepinephrine bitartrate | 2 mg |
Excipients: sodium chloride – 8.4 mg, hydrochloric acid or sodium hydroxide – to pH 3.0-4.5, water for injection – up to 1 ml.
2 ml – ampoules (5) – blister packs (1) – cardboard packs.
2 ml – ampoules (5) – blister packs (2) – cardboard packs.
4 ml – ampoules (5) – blister packs (1) – cardboard packs.
4 ml – ampoules (5) – blister packs (2) – cardboard packs.
8 ml – ampoules (5) – blister packs (1) – cardboard packs.
8 ml – ampoules (5) – blister packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 1 mg/1 ml: amp. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml 5 or 10 pcs.
Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml 5 or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
|
Norepinephrine | Concentrate for solution for intravenous administration 1 mg/1 ml: amp. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml 5 or 10 pcs. |
| Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration in the form of a clear, colorless or slightly brownish-yellow liquid.
| 1 ml | |
| Norepinephrine bitartrate monohydrate | 1.056 mg, |
| Which corresponds to the content of norepinephrine bitartrate | 1 mg |
Excipients: sodium chloride, sodium hydroxide solution 1M or hydrochloric acid solution 1M, water for injection.
1 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
1 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
2 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
2 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
4 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
4 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
5 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
5 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
8 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
8 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
10 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
10 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
Concentrate for solution for intravenous administration in the form of a clear, colorless or slightly brownish-yellow liquid.
| 1 ml | |
| Norepinephrine bitartrate monohydrate | 2.112 mg, |
| Which corresponds to the content of norepinephrine bitartrate | 2 mg |
Excipients: sodium chloride, sodium hydroxide solution 1M or hydrochloric acid solution 1M, water for injection.
1 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
1 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
2 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
2 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
4 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
4 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
5 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
5 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
8 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
8 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
10 ml – ampoules of light-protective glass (5) – blister packs (1) – cardboard packs.
10 ml – ampoules of light-protective glass (5) – blister packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/1 ml: 4 ml amp. 10 pcs.
Marketing Authorization Holder
R-Pharm JSC (Russia)
Manufactured By
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Norepinephrine | Concentrate for solution for intravenous administration 2 mg/1 ml: 4 ml amp. 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration in the form of a clear, colorless or slightly yellowish liquid.
| 1 ml | |
| Norepinephrine bitartrate | 2 mg |
Excipients: sodium chloride – 8.4 mg, sodium disulfite – 0.5 mg, water for injection – up to 1 ml.
Each ml of Norepinephrine concentrate for solution for intravenous administration 2 mg/ml contains 2 mg of norepinephrine bitartrate, which is equivalent to 1 mg of norepinephrine base.
4 ml – ampoules of colorless glass (5) – blister packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/ml: 4 ml or 8 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Norepinephrine | Concentrate for solution for intravenous administration 2 mg/ml: 4 ml or 8 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration in the form of a clear, colorless or yellowish-tinged liquid.
| 1 ml | |
| Norepinephrine hydrotartrate (in the form of monohydrate) | 2 mg |
Excipients: sodium chloride, sodium tartrate dihydrate, sodium disulfite, tartaric acid, sodium hydroxide solution 0.1 M – to pH 3.0-4.5, water for injection.
Each ml of Norepinephrine concentrate for solution for intravenous administration 2 mg/ml contains 2 mg of norepinephrine bitartrate, which is equivalent to 1 mg of norepinephrine base.
4 ml – ampoules of colorless glass (5) – blister packs (1) – cardboard packs.
4 ml – ampoules of colorless glass (5) – blister packs (2) – cardboard packs.
8 ml – ampoules of colorless glass (5) – blister packs (1) – cardboard packs.
8 ml – ampoules of colorless glass (5) – blister packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 4 ml or 8 ml 5 or 10 pcs.
Marketing Authorization Holder
Pharmalab, LLC (Russia)
Manufactured By
Ferment Firm, LLC (Russia)
Packaging and Quality Control Release
Ferment Firm, LLC (Russia)
Or
OHFK, JSC (Russia)
Dosage Form
|
Norepinephrine | Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 4 ml or 8 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration as a clear, colorless or yellowish liquid.
| 1 ml | |
| Norepinephrine hydrotartrate monohydrate | 2.1 mg, |
| Equivalent to norepinephrine hydrotartrate content | 2 mg* |
*Each ml of Norepinephrine, concentrate for solution for intravenous administration 2 mg/1 ml, contains 2 mg of norepinephrine hydrotartrate, equivalent to 1 mg of norepinephrine base.
Excipients: sodium chloride – 8 mg, sodium tartrate dihydrate – 30 mg, sodium disulfite – 1 mg, tartaric acid – 6 mg, sodium hydroxide solution 0.1 M – to pH 3.0-4.5, water for injections – to 1 ml.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 4 ml or 8 ml 3, 5, 10, or 20 pcs.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Manufactured By
Kontsern “MIR”, LLC (Russia)
Dosage Form
|
Norepinephrine | Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 4 ml or 8 ml 3, 5, 10, or 20 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration as a clear, colorless or slightly yellowish liquid.
| 1 ml | |
| Norepinephrine bitartrate monohydrate | 2.11 mg, |
| In terms of norepinephrine bitartrate | 2 mg |
Excipients: sodium chloride, hydrochloric acid solution 1M or sodium hydroxide solution 1M, water for injections.
4 ml – glass ampoules (3) – contour cell packs (1) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – glass ampoules (5) – contour cell packs (4) – cardboard packs.
4 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
4 ml – glass ampoules (10) – contour cell packs (2) – cardboard packs.
4 ml – glass ampoules (10) – cardboard packs.
8 ml – glass ampoules (3) – contour cell packs (1) – cardboard packs.
8 ml – glass ampoules (5) – contour cell packs (1) – cardboard packs.
8 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
8 ml – glass ampoules (5) – contour cell packs (4) – cardboard packs.
8 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
8 ml – glass ampoules (10) – contour cell packs (2) – cardboard packs.
8 ml – glass ampoules (10) – cardboard packs.
Concentrate for solution for intravenous administration 1 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5, 10, or 20 pcs.
Concentrate for solution for intravenous administration 2 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5, 10, or 20 pcs.
Marketing Authorization Holder
Ecofarmplus, JSC (Russia)
Dosage Forms
|
Norepinephrine | Concentrate for solution for intravenous administration 1 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5, 10, or 20 pcs. |
| Concentrate for solution for intravenous administration 2 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5, 10, or 20 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration as a clear, colorless or brownish-yellow liquid.
| 1 ml | |
| Norepinephrine hydrotartrate monohydrate | 1.056 mg, |
| Equivalent to norepinephrine hydrotartrate content | 1 mg |
Excipients: sodium chloride – 8.4 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH from 3.0 to 4.5, water for injections – to 1 ml.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
Concentrate for solution for intravenous administration as a clear, colorless or brownish-yellow liquid.
| 1 ml | |
| Norepinephrine hydrotartrate monohydrate | 2.112 mg, |
| Equivalent to norepinephrine hydrotartrate content | 2 mg |
Excipients: sodium chloride – 8.4 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH from 3.0 to 4.5, water for injections – to 1 ml.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/ml: 4 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Ellara, LLC (Russia)
Dosage Form
|
Norepinephrine | Concentrate for solution for intravenous administration 2 mg/ml: 4 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration as a clear, colorless or slightly yellowish liquid.
| 1 ml | |
| Norepinephrine hydrotartrate (as monohydrate) | 2 mg |
Excipients: sodium chloride – 8.4 mg, sodium metabisulfite (sodium disulfite) – 1 mg, sodium hydroxide 1M or hydrochloric acid 1M – to pH 3.0-4.5, water for injections – to 1 ml.
Each ml of Norepinephrine concentrate for solution for intravenous administration 2 mg/ml contains 2 mg of norepinephrine bitartrate, equivalent to 1 mg of norepinephrine base.
4 ml – colorless glass ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – colorless glass ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – colorless glass ampoules (10) – contour cell packs (1) – cardboard packs.
4 ml – colorless glass ampoules (10) – contour cell packs (2) – cardboard packs.
4 ml – colorless glass ampoules (5) – contour cell packs (4) – cardboard packs.
4 ml – colorless glass ampoules (5) – contour cell packs (5) – cardboard packs.
4 ml – colorless glass ampoules (5) – contour cell packs (10) – cardboard packs.
4 ml – colorless glass ampoules (5) – contour cell packs (50) – cardboard boxes (for hospitals).
4 ml – colorless glass ampoules (5) – contour cell packs (100) – cardboard boxes (for hospitals).
4 ml – colorless glass ampoules (10) – contour cell packs (4) – cardboard packs.
4 ml – colorless glass ampoules (10) – contour cell packs (5) – cardboard packs.
4 ml – colorless glass ampoules (10) – contour cell packs (10) – cardboard packs.
4 ml – colorless glass ampoules (10) – contour cell packs (50) – cardboard boxes (for hospitals).
4 ml – colorless glass ampoules (10) – contour cell packs (100) – cardboard boxes (for hospitals).
Concentrate for solution for intravenous administration 1 mg/1 ml: amp. 4 ml or 8 ml 5, 10, 20, or 25 pcs.
Marketing Authorization Holder
Ellara, LLC (Russia)
Dosage Form
|
Norepinephrine | Concentrate for solution for intravenous administration 1 mg/1 ml: amp. 4 ml or 8 ml 5, 10, 20, or 25 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration as a clear, colorless or slightly yellowish solution.
| 1 ml | |
| Norepinephrine bitartrate monohydrate (calculated as anhydrous substance) | 1 mg |
Excipients: sodium chloride, sodium metabisulfite (sodium disulfite), sodium hydroxide solution 1M or hydrochloric acid solution 1M (to adjust pH), water for injections.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (4) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (5) – cardboard packs.
4 ml – ampoules (5) – cardboard packs.
4 ml – ampoules (10) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (4) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (5) – cardboard packs.
8 ml – ampoules (5) – cardboard packs.
8 ml – ampoules (10) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml 5 or 10 pcs.
Marketing Authorization Holder
Kalcex JSC (Latvia)
Manufactured By
HBM Pharma, s.r.o. (Slovakia)
Quality Control Release
KALCEX JSC (Latvia)
Dosage Form
|
Norepinephrine Kalceks | Concentrate for solution for intravenous administration 2 mg/1 ml: amp. 1 ml, 2 ml, 4 ml, 5 ml, 8 ml, or 10 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration as a clear, colorless or yellowish solution.
| 1 ml | |
| Norepinephrine hydrotartrate monohydrate (in terms of norepinephrine hydrotartrate) | 2 mg |
| In terms of Norepinephrine | 1 mg |
Excipients: sodium chloride, hydrochloric acid, water for injections.
1 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
2 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
8 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
Concentrate for solution for intravenous administration 2 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5 or 10 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Norepinephrine Velpharm | Concentrate for solution for intravenous administration 2 mg/ml: 2 ml, 4 ml, or 8 ml amp. 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Concentrate for solution for intravenous administration clear, colorless or slightly brownish-yellow.
| 1 ml | |
| Norepinephrine bitartrate monohydrate | 2.11 mg, |
| Equivalent to norepinephrine bitartrate content | 2 mg |
Excipients: sodium chloride, hydrochloric acid solution 1M or sodium hydroxide solution 1M, water for injections.
2 ml – ampoules (5) – cardboard packs.
2 ml – ampoules (10) – cardboard packs.
4 ml – ampoules (5) – cardboard packs.
4 ml – ampoules (10) – cardboard packs.
8 ml – ampoules (5) – cardboard packs.
8 ml – ampoules (10) – cardboard packs.
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