Essentiale N ampoules

Product at a Glance

• Product: Essentiale N
• Active component: Essential phospholipids (EPL)
• Strength: 250 mg per 5 ml ampoule
• Concentration: 50 mg/ml
• Dosage form: Solution for injection
• Route: Intravenous
• Package: 5 ampoules × 5 ml
• Supply category: Prescription medicine

Composition

Active substance: essential phospholipids (EPL®), derived from soybean phospholipids with a high phosphatidylcholine content.

Each 1 ml of solution contains 50 mg of essential phospholipids.

Each 5 ml ampoule contains 250 mg of essential phospholipids.

Excipients may include: benzyl alcohol, deoxycholic acid, sodium chloride, sodium hydroxide, riboflavin (E101), and water for injection.

Pharmaceutical Form

Solution for intravenous injection.

Appearance: clear yellow solution.

How Essential Phospholipids Work

Phospholipids are major structural components of hepatocyte membranes and intracellular organelles.

Damage to these membranes can affect membrane-associated enzymes, receptors and normal cellular metabolic processes.

The rationale for essential phospholipid therapy is that phospholipid molecules can become incorporated into cellular membrane structures and support normal membrane function.

Essential phospholipids also participate in lipid and lipoprotein metabolism.

Uses and Clinical Context

Essentiale N is used as supportive therapy in liver and hepatobiliary disorders according to the prescribing information applicable in the country of use.

Clinical use may include supportive treatment in conditions such as:

• Fatty degeneration of the liver
• Acute and chronic hepatitis
• Liver cirrhosis
• Toxic liver injury
• Preoperative and postoperative treatment in hepatobiliary surgery
• Psoriasis as part of combination therapy
• Radiation syndrome

Essentiale N should be regarded as supportive therapy rather than as a standalone cure for liver disease.

The overall management of liver disease may also involve treatment of the underlying cause, dietary changes, metabolic control, alcohol avoidance and other therapies prescribed by a physician.

Clinical Evidence and Scientific Background

Clinical studies have evaluated essential phospholipids and polyenylphosphatidylcholine as supportive therapy in patients with non-alcoholic fatty liver disease and metabolic disorders.

Systematic Review

A 2020 systematic review and network meta-analysis by Dajani and Popovic evaluated essential phospholipids in adults with NAFLD associated with type 2 diabetes and/or obesity.

The authors reported improvements in several biochemical and clinical outcomes while also noting that larger clinical trials were needed.

Observational Clinical Study

A large observational study by Maev and colleagues evaluated polyenylphosphatidylcholine as adjunctive therapy in patients with newly diagnosed NAFLD and metabolic comorbidities.

Reductions in ALT, AST and GGT were reported during follow-up.

These findings relate to essential phospholipid therapy in specific studied patient populations and should not be interpreted as proof that the medicine universally reverses or cures liver disease.

Scientific References

• 
  Dajani AI, Popovic B. Essential phospholipids for nonalcoholic fatty liver disease associated with metabolic syndrome: systematic review and network meta-analysis.
  
• 
  Maev IV et al. Effectiveness of phosphatidylcholine as adjunctive therapy in patients with non-alcoholic fatty liver disease and metabolic comorbidities.
  

Dosage and Administration

Essentiale N solution for injection is intended for intravenous administration only.

The solution should be administered slowly by qualified healthcare personnel.

It should not be administered intramuscularly because of the risk of local irritation.

The exact dosage, duration of treatment and administration schedule should follow the prescribing information supplied with the product and the instructions of the treating physician.

Dilution and Compatibility

Essentiale N should not be mixed in the same syringe with other medicinal products unless compatibility has been specifically established.

If dilution is required, the official product instructions should be followed.

Electrolyte-containing solutions such as sodium chloride or Ringer’s solution should not be used where the prescribing information specifies electrolyte-free dilution.

Important Safety Information

• Do not use in patients with known hypersensitivity to phosphatidylcholine, soy-derived ingredients or other components of the formulation.
• The product contains benzyl alcohol.
• Administration should be performed by qualified healthcare professionals.
• Do not administer intramuscularly.
• Use during pregnancy or breastfeeding should be discussed with a healthcare professional.
• Use only clear solution from undamaged ampoules.

Pregnancy and Breastfeeding

Use during pregnancy should be considered only under medical supervision.

Caution is required because benzyl alcohol may cross the placental barrier.

Because adequate clinical data during breastfeeding are limited, use during breastfeeding should be discussed with a physician.

Adverse Reactions

Possible adverse reactions may include hypersensitivity reactions.

Allergic skin reactions such as rash, urticaria or itching may occur.

If an unexpected or severe reaction occurs, administration should be stopped and medical advice obtained.

Storage Conditions

• Store at 2°C to 8°C.
• Keep the ampoules in the original packaging.
• Protect from inappropriate heat and storage conditions.
• Keep out of the reach of children.

Packaging

Each ampoule contains 5 ml of solution.

Each box contains 5 ampoules.

Use in Aesthetic and Cosmetic Contexts

Phosphatidylcholine has been investigated separately in aesthetic medicine and injection-lipolysis research.

This is a distinct off-label context and should not be confused with the approved intravenous liver-related use of Essentiale N.

This page does not recommend Essentiale N for cosmetic fat reduction or injection lipolysis.

Frequently Asked Questions

What strength is Essentiale N injection?

Each 5 ml ampoule contains 250 mg of essential phospholipids, equivalent to 50 mg/ml.

How many ampoules are in one box?

One box contains 5 ampoules of 5 ml each.

How is Essentiale N administered?

The injectable formulation is intended for slow intravenous administration by qualified healthcare personnel.

Can Essentiale N be injected intramuscularly?

No. The injectable solution should not be administered intramuscularly because of the risk of local irritation.

Can Essentiale N be self-injected?

No. Injectable medicines should be administered according to medical instructions by appropriately trained personnel.

Can essential phospholipids be used for fatty liver disease?

Essential phospholipids have been studied as supportive therapy in patients with non-alcoholic fatty liver disease, including patients with metabolic comorbidities.

Is Essentiale N a “detox” medicine?

It is more accurate to describe Essentiale N as a medicinal essential-phospholipid preparation used as supportive therapy rather than as a general “detox” product.

Why Order from Us?

• Individual and wholesale order options
• Quantity discounts for larger orders
• International delivery information available
• Support for individual and wholesale customers
• Transparent quantity-based pricing

Contact and Wholesale Orders

Looking for wholesale terms?
Contact us here.

You can also review our delivery information before placing an order.