Ezolong powder for solution for injection or infusion 40mg, 10 vials — Made in Portugal — Free Delivery

Product description

Powder for solution for injection or infusion "Ezolong®" is used for the indications indicated below.

Adults

Antisecretory therapy when it is impossible to use the oral route of administration, for example:

gastroesophageal reflux disease (GERD) in patients with esophagitis and / or severe reflux symptoms;

treatment of stomach ulcers associated with therapy with non-steroidal anti-inflammatory preparations  (NSAIDs);

prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.

Short-term maintenance of hemostasis and prevention of rebleeding in patients after endoscopic treatment of acute bleeding due to gastric or duodenal ulcers.

Children aged 1 to 18 years

Antisecretory therapy when it is impossible to use the oral route of administration, for example, GERD in patients with erosive reflux esophagitis and / or severe reflux symptoms.

Compound

The active ingredient is esomeprazole (1 bottle contains esomeprazole sodium 42.60 mg, which is equivalent to 40 mg esomeprazole).

Excipients: disodium edetate (Trilon B), sodium hydroxide.

Contraindications

Hypersensitivity to esomeprazole, other substituted benzimidazoles, or to any of the excipients.

Ezolong® should not be used concomitantly with nelfinavir, atazanavir.

Mode of application

Adults

Antisecretory therapy in the case when it is impossible to use the oral route of administration. For patients who cannot take the preparation orally, the preparation can be administered parenterally at a dose of 20-40 mg once a day. The dose for patients with reflux esophagitis is 40 mg once a day. The dose for patients receiving symptomatic treatment of reflux disease is 20 mg once a day. When treating stomach ulcers caused by taking NSAIDs, the usual dose is 20 mg once a day. To prevent gastric and duodenal ulcers caused by NSAID therapy, patients at risk are prescribed the preparation at a dose of 20 mg once a day. Usually, treatment with an intravenous preparation is short-lived, and patients should be switched to oral preparation use as soon as possible.

Short-term maintenance of hemostasis and prevention of rebleeding in patients after endoscopic treatment of acute bleeding due to gastric or duodenal ulcers (adults). After therapeutic endoscopy of acute bleeding of a stomach or duodenal ulcer, 80 mg of the preparation is administered as a bolus infusion for 30 minutes, after which the preparation is continued as a long-term intravenous infusion at a rate of 8 mg / hour for 3 days (72 hours). After parenteral treatment, therapy should be continued with oral agents that inhibit acid secretion.

Instructions for preparing the reconstituted solution are provided in this section below (Instructions for Use, Use and Disposal (where applicable)).

Injections.

A dose of 40 mg - 5 ml of the reconstituted solution (8 mg / ml) is administered as an intravenous injection for at least 3 minute

A dose of 20 mg - 2.5 ml or half of the reconstituted solution (8 mg / ml) is administered as an intravenous injection lasting at least 3 minutes. Dispose of unused solution.

Infusion.

Dose 40 mg - the reconstituted solution is administered as an intravenous infusion lasting 10-30 minutes.

Dose 20 mg - half of the reconstituted solution is administered as an intravenous infusion lasting 10-30 minutes. Dispose of unused solution.

Dose 80 mg - the reconstituted solution is administered as a long-term infusion for 30 minutes.

Dose 8 mg / hour - the reconstituted solution is administered as a long-term infusion for 71.5 hours (the infusion rate is calculated to be 8 mg / hour).

Children aged 1 to 18 years

As a means of suppressing gastric secretion in the event that oral administration of the preparation is not possible. For patients who cannot take the preparation orally, within the period of complete cure for GERD, the preparation can be administered parenterally once a day. Typically, treatment with an intravenous preparation should be short-lived and patients should be switched to oral medication as soon as possible.

Recommended doses of esomeprazole for intravenous administration:

Erosive reflux esophagitis treatment:

1-11 years old, body weight <20 kg - 10 mg once a day;

1-11 years old body weight ≥ 20 kg - 10 or 20 mg 1 time per day;

12-18 years old - 40 mg once a day;

symptomatic treatment of GERD

1-11 years old - 10 mg once a day;

12-18 years old - 20 mg once a day.

Instructions for preparing the reconstituted solution are provided in this section below (Instructions for Use, Use and Disposal (where applicable)).

Injections.

A dose of 40 mg - 5 ml of the reconstituted solution (8 mg / ml) is administered as an intravenous injection for at least 3 minutes.

A dose of 20 mg - 2.5 ml or half of the reconstituted solution (8 mg / ml) is administered as an intravenous injection lasting at least 3 minutes. Dispose of unused solution.

A dose of 10 mg - 1.25 ml of the reconstituted solution (8 mg / ml) is administered as an intravenous injection for at least 3 minutes. Dispose of unused solution.

Infusion.

Dose 40 mg - the reconstituted solution is administered as an intravenous infusion lasting 10-30 minutes.

Dose 20 mg - half of the reconstituted solution is administered as an intravenous infusion lasting 10-30 minutes. Dispose of unused solution.

A dose of 10 mg - a quarter of the reconstituted solution is administered as an intravenous infusion lasting 10-30 minutes. Dispose of unused solution.

Instructions for use, use and disposal (where applicable)

The reconstituted solution should be visually inspected for particles and discoloration prior to use. Only clear solution should be used. The solution is intended for single use only.

If all of the reconstituted vial contents are not needed, the unused solution should be disposed of in accordance with local regulations.

Solution for injection 40 mg: Prepare a solution for injection (8 mg / ml) by adding 5 ml of 0.9% sodium chloride for use in a vial of esomeprazole 40 mg. The reconstituted solution for injection is clear and colorless or slightly yellowish.

Solution for infusion 40 mg: prepare a solution for infusion by dissolving the contents of a vial of esomeprazole 40 mg in 100 ml of 0.9% sodium chloride for intravenous use.

Solution for infusion 80 mg: prepare a solution for infusion by dissolving the contents of two vials of esomeprazole 40 mg in 100 ml of 0.9% sodium chloride for intravenous use.

The reconstituted solution for infusion is clear and colorless or slightly yellowish.

Application features

Pregnant

Ezolong® should be prescribed to pregnant women with caution.

It is not known whether esomeprazole is excreted in breast milk. There have been no studies involving women who are breastfeeding. Therefore, "Ezolong®" should not be used during breastfeeding.

Drivers

It is unlikely that Ezolong® would affect the ability to drive and operate other machinery. During treatment, adverse reactions from the nervous system or organs of vision may occur.

Overdose

Experience with deliberate overdose is currently very limited. Symptoms that resulted from the 280 mg oral dose were gastrointestinal symptoms and weakness. A single oral dose of 80 mg of esomeprazole and the administration of 308 mg of esomeprazole for 24 hours did not cause any consequences. The specific antidote is unknown. Esomeprazole binds significantly to blood plasma proteins and is therefore poorly eliminated by dialysis. As with any overdose, symptomatic treatment and general supportive measures should be taken.

Side effects

The following adverse reactions to the preparation  have been detected or suspected in the clinical trials program for esomeprazole when administered orally or intravenously, as well as during post-marketing surveillance of oral administration of the preparation. Adverse reactions that occurred with a frequency of "often" (≥ 1/100 - <1/10):

from the nervous system: headache;

from the digestive system: abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting;

from the skin and subcutaneous tissue: reactions at the injection site.

Storage conditions

Keep the bottle in outer packaging at a temperature not exceeding 25 ° C. The vials can be stored unpackaged under normal room lighting for up to 24 hours.

Keep out of the reach of children.

Shelf life is 2 years.

Shelf life after preparation of the solution: the stability of the physicochemical properties of the prepared solution was demonstrated for 12 hours at 25 ° C. However, from a microbiological point of view, the solution should be used immediately.