Powder to injections or infusions "Ezolong of ^® " is applied to solution at indications which are provided below.

Adult

Anti-secretory therapy in case it is impossible to apply an oral way of introduction, for example:

• a gastroesophageal reflux disease (GERD) at patients with an esophagitis and/or heavy symptoms of a reflux;
• treatment of the stomach ulcers connected with therapy by non-steroidal anti-inflammatory medicaments (NPVS);
• prevention of the stomach ulcers and a duodenum tied with therapy of NPVP at patients who enter into risk group.

Short-term maintenance of a hemostasis and prevention of repeated bleeding at patients after endoscopic treatment of acute bleeding owing to stomach ulcer or a duodenum.

Children aged from the 1st year up to 18 years

Anti-secretory therapy in case it is impossible to apply an oral way of introduction, for example, of GERD at patients with an erosive reflux esophagitis and/or heavy symptoms of a reflux.

Structure

Active ingredient - esomeprazole (1 bottle contains esomeprazole of sodium 42.60 mg that is equivalent to esomeprazole of 40 mg).

Excipients: dinatrium edetat (Trilonum B), sodium hydroxide.

Contraindication

1. Hypersensitivity to esomeprazole, others to the substituted benzimidazoles or to any of excipients.
2. "Ezolong of ^® " should not be applied along with nelfinaviry, atazanaviry.

Route of administration

Adult

Anti-secretory therapy in case it is impossible to apply an oral way of introduction. Patients who cannot take the medicament orally can administer the medicament parenterally in a dose of 20-40 mg of 1 times a day. The dose for patients with a reflux esophagitis makes 40 mg of 1 times a day. The dose for patients who receive symptomatic treatment of a reflux disease makes 20 mg of 1 times a day. At treatment of the stomach ulcers caused by reception NPVS, the usual dose makes 20 mg of 1 times a day. For prevention to ulcers of stomach and duodenum, NPVP caused by therapy to patients of risk group appoint medicament in a dose of 20 mg of 1 times a day. Usually treatment by means of medicine for intravenous administration is short-term, it is necessary to transfer patients to oral administration of medicine as soon as possible.

Short-term maintenance of a hemostasis and prevention of repeated bleeding at patients after endoscopic treatment of acute bleeding owing to stomach ulcer or a duodenum (adults). After therapeutic endoscopy of acute bleeding of stomach ulcer or a duodenum enter 80 mg of medicine in the form of bolyusny infusion lasting 30 minutes then continue administration of medicament in the form of long intravenous infusion with a speed of 8 mg/hour within 3 days (72 hours). After parenteral treatment the therapy should be continued by means of the oral means oppressing acid secretion.

Instruction for preparation of the restored solution is given in this section below ("To the instruction for use, use and utilization (in appropriate cases)").

Injection.

Dose of 40 mg - 5 ml of the restored solution (8 mg/ml) enter in the form of an intravenous injection lasting not less than 3 minutes.

Dose of 20 mg - 2.5 ml or a half of the restored solution (8 mg/ml) enter in the form of an intravenous injection lasting not less than 3 minutes. Unused solution is utilized.

Infusion.

Dose of 40 mg - the restored solution is entered in the form of intravenous infusion lasting 10-30 minutes.

Dose of 20 mg - a half of the restored solution is entered in the form of intravenous infusion lasting 10-30 minutes. Unused solution is utilized.

Dose of 80 mg - the restored solution is entered in the form of long infusion within 30 minutes.

Dose of 8 mg/hour - the restored solution is entered in the form of long infusion within 71.5 hours (speed of infusion of 8 mg/hour is calculated).

Children aged from the 1st year up to 18 years

As means for suppression of gastric secretion if oral administration of medicament is impossible. Patients who cannot take the medicament orally within the period of full treatment of GERD can administer the medicament parenterally 1 time a day. Usually treatment by means of medicament for intravenous administration has to continue not for long and it is necessary to transfer patients to oral administration of medicine as soon as possible.

Recommended esomeprazole doses for intravenously introduction:

• treatment of an erosive reflux esophagitis:
  • 1-11 years body weight <20 kg - 10 mg of 1 times a day;
  • 1-11 years body weight ≥ 20 kg - 10 or 20 mg of 1 times a day;
  • 12-18 years - 40 mg once a day;
• symptomatic treatment of GERD
  • 1-11 years - 10 mg of 1 times a day;
  • 12-18 years - 20 mg of 1 times a day.

Instruction for preparation of the restored solution is given in this section below ("To the instruction for use, use and utilization (in appropriate cases)").

Injection.

Dose of 40 mg - 5 ml of the restored solution (8 mg/ml) enter in the form of an intravenous injection lasting not less than 3 minutes.

Dose of 20 mg - 2.5 ml or a half of the restored solution (8 mg/ml) enter in the form of an intravenous injection lasting not less than 3 minutes. Unused solution is utilized.

Dose of 10 mg - 1.25 ml of the restored solution (8 mg/ml) enter in the form of an intravenous injection lasting not less than 3 minutes. Unused solution is utilized.

Infusion.

Dose of 40 mg - the restored solution is entered in the form of intravenous infusion lasting 10-30 minutes.

Dose of 20 mg - a half of the restored solution is entered in the form of intravenous infusion lasting 10-30 minutes. Unused solution is utilized.

Dose of 10 mg - a quarter of the restored solution is entered in the form of intravenous infusion lasting 10-30 minutes. Unused solution is utilized.

Instruction for use, to use and utilization (in appropriate cases)

Before use visually on existence of particles and change of coloring. It is necessary to use only transparent solution. Solution is intended only for single application.

If all restored contents of a bottle it is not necessary, unused solution should be utilized according to local requirements.

Solution for injections of 40 mg: prepare solution for an injection (8 mg/ml), adding 5 ml of 0.9% of sodium of chloride for use to a bottle of esomeprazole of 40 mg. The restored solution for injections transparent and colourless or slightly yellowish color.

Solution for infusions of 40 mg: prepare solution for infusions, dissolving contents of a bottle of esomeprazole of 40 mg in 100 ml of 0.9% of sodium chloride for intravenous use.

Solution for infusions of 80 mg: prepare solution for infusions, dissolving contents of two bottles of esomeprazole of 40 mg in 100 ml of 0.9% of sodium chloride for intravenous use.

Restored solution for infusions transparent and colourless or slightly yellowish color.

Feature of use

Pregnant

"Ezolong of ^® " to pregnant women with care.

whether esomeprazole with breast milk gets. Researches with the assistance of women who nurse were not conducted. Therefore "Ezolong of ^® " should not be applied during feeding by a breast.

It is improbable

that "Ezolong of ^® " affected ability to drive the car and to work with other mechanisms. During treatment, side reactions from nervous system or organs of sight can be observed.

Overdose

Experience of deliberate overdose is very limited to

now. Manifestations from digestive tract and weakness were symptoms which resulted from oral administration of a dose of 280 mg. Single oral administration of 80 mg of esomeprazole and introduction of 308 mg of esomeprazole within 24 hours of consequences did not cause. Specific antidote is unknown. Esomeprazole considerably contacts proteins of blood plasma and therefore it is badly removed by means of dialysis. As well as in case of any overdose, it is necessary to provide symptomatic treatment and to take the general supporting measures.

Side effects

Following side reactions on medicament were found by

or were suspected of the program of clinical trials of esomeprazole at its oral or intravenous administration and also during post-marketing observation of oral administration of drug. Side reactions which arose with a frequency "often" (≥ 1/100 – <1/10):

• from nervous system: headache;
• from digestive system: abdominal pain, constipation, diarrhea, meteorism, nausea/vomiting;
• from skin and hypodermic cellulose: reactions in the injection site.

Storage conditions

to Keep a bottle in external packing at a temperature not above 25 °C. Bottles can be stored without secondary packing under the influence of usual room lighting till 24 o'clock.

out of children's reach.

Expiration date - 2 years.

Period of storage after solution preparation: stability of physical and chemical properties of the prepared solution was shown within 12 hours at 25 °C. However, in terms of microbiology, solution should be used immediately.