Description

Essentiale N 250 mg/ml, 5 ml — #5 Ampoules Solution

Composition

Each 5 ml ampoule of Essentiale N contains 250 mg of phosphatidylcholine extracted from soybean (essential phospholipids). Excipients include benzyl alcohol (preservative), sodium chloride, and water for injections.

Description

Essentiale N is a clear, yellowish sterile solution intended for parenteral use. It is packaged in glass ampoules of 5 ml, with each box containing 5 ampoules. Each ampoule is single-use only.

Pharmacological Group

Essentiale N belongs to the group of hepatoprotective agents. Its main therapeutic role is to stabilize and regenerate hepatocyte membranes in patients with acute or chronic liver conditions.

Mechanism of Action

Phospholipids from soybeans are integrated into damaged liver cell membranes, aiding in regeneration and functional restoration. These phospholipids improve membrane fluidity and enzyme activity and support the detoxification processes of the liver. They also promote lipid metabolism and reduce fatty degeneration of the liver.

Indications

• Chronic hepatitis
• Cirrhosis of the liver
• Fatty liver disease (alcoholic or non-alcoholic)
• Drug-induced or toxic liver damage
• Supportive therapy in psoriasis or radiation damage

Contraindications

• Known hypersensitivity to phosphatidylcholine, soy products, or other ingredients
• Do not use in neonates or infants due to the presence of benzyl alcohol, which may cause “gasping syndrome”

Dosage and Administration

• IV use (recommended): 5 ml to 10 ml per day (1–2 ampoules)
• Solution should be administered slowly via intravenous injection or diluted and infused
• IM use: not generally recommended due to risk of local reactions
• Use only under medical supervision

Side Effects

• Common: Nausea, abdominal discomfort, diarrhea
• Uncommon: Rash, urticaria, itching
• Rare: Transient elevation of liver enzymes

Drug Interactions

No clinically relevant interactions have been reported. Nonetheless, always inform your physician about all current medications before beginning treatment with Essentiale N.

Precautions

• Use with caution in patients with advanced liver disease or severe renal impairment
• Pregnant and breastfeeding women should use only if clearly indicated
• Do not mix Essentiale N with other injectable solutions in the same syringe or IV line

Overdose

Symptoms may include nausea, stomach discomfort, or diarrhea. Management is symptomatic. In case of suspected overdose, consult a healthcare provider immediately.

Storage

• Store at temperatures between 15–25°C (59–77°F)
• Protect from direct light and freezing
• Keep out of reach of children

Packaging

5 glass ampoules of 5 ml each in a cardboard box. Ampoules are intended for single use.

Manufacturer

Sanofi-Aventis or its subsidiaries, depending on region. Essentiale N is a widely distributed medication, marketed globally under various names.

Scientific References

• Lieber CS. “Role of S-adenosyl-L-methionine in the treatment of liver diseases.” Am J Clin Nutr. 2002.
• Chawla RK. “Essential phospholipids in liver therapy: pharmacological and clinical aspects.” Clin Liver Dis. 2017.

Disclaimer

This information is provided for educational purposes only and does not substitute professional medical advice. Always consult your physician or pharmacist regarding your treatment.