Omenax powder for solution for injection 40mg, 1 pc — Made in Greece — Free Delivery

Product description

Powder for preparation of Omenax® solution for injection for intravenous use is indicated as an alternative to oral therapy for the following indications (adults):

• treatment of duodenal ulcers;
• prevention of recurrence of duodenal ulcers;
• treatment of stomach ulcers;
• prevention of relapse of stomach ulcers;
• in combination with appropriate antibiotics for the eradication of Helicobacter pylori (H. pylori) in peptic ulcer disease;
• treatment of stomach and duodenal ulcers associated with the use of non-steroidal anti-inflammatory preparations (NSAIDs);
• prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk;
• reflux esophagitis treatment;
• long-term treatment of patients with inactive reflux esophagitis;
• treatment of symptomatic gastroesophageal reflux disease;
• treatment of Zollinger-Ellison syndrome.

Compound

The active ingredient is omeprazole (1 bottle contains omeprazole sodium equivalent to omeprazole 40 mg).

The excipient is sodium hydroxide.

Contraindications

hypersensitivity to omeprazole, substituted benzimidazoles, or to any of the excipients;

omeprazole, like other proton pump inhibitors (PPIs), should not be used concomitantly with nelfinavir;

concomitant use with atazanavir is contraindicated.

Mode of application

Dosage

Alternative to oral therapy. For patients for whom the oral form of the preparation is unacceptable, it is recommended to use Omenax® 40 mg 1 time per day. For patients with Zollinger-Ellison syndrome, the recommended initial dose of Omenax®, administered intravenously, is 60 mg per day. There may be a need for higher daily doses, so the dose should be selected individually. If the dose exceeds 60 mg, it should be divided equally into two parts and taken 2 times a day.

Omenax® should be administered as an infusion over 20-30 minutes.

For intravenous injections, the content of each vial of omeprazole is dissolved in 10 ml of water (or 0.9% sodium chloride solution) for injection. The injection should be administered slowly (over 5 minutes).

Instructions for reconstitution of the preparation before administration

The entire contents of each bottle should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. You must use 0.9% sodium chloride solution or 5% glucose solution. The stability of omeprazole depends on the pH of the infusion solution, so a different solvent or a different amount should be used for dilution.

Training:

Using a syringe, draw 5 ml of infusion solution from a 100-liter bottle or infusion bag.

Add this volume to the vial with lyophilized omeprazole, mix thoroughly, making sure that all the preparation is dissolved.

Draw the omeprazole solution back into the syringe.

Transfer the solution to an infusion bag or bottle.

Repeat steps 1-4 to ensure that the entire volume of omepraz

Alternative method of preparing solution for infusion in a flexible container:

Attach the reversible adapter needle to the injection membrane of the infusion bag. The other end of the needle is placed in a vial with a lyophilized preparation.

Dissolve the omeprazole substance by pumping the infusion solutions back and forth between the infusion bag and the bottle.

Make sure all of the preparation is dissolved.

The resulting solution must be used for infusion within 20-30 minutes.

Dispose of any unused product or waste in accordance with local regulations.

Application features

Pregnant

The efficacy and safety of using omeprazole for pregnant women have not been established, therefore, the preparation is not recommended to be prescribed during pregnancy.

Omeprazole is excreted in breast milk, but its effect on the child is unknown, therefore it is not recommended to use the preparation during breastfeeding.

Children

The experience of using omeprazole for administration in pediatric practice is limited, so the preparation should not be prescribed to this age group of patients.

Drivers

It is unlikely that omeprazole affects the ability to drive vehicles or other mechanisms. Adverse reactions to the use of the preparation, such as dizziness and visual impairment, may occur. If such disorders are observed, patients should not drive vehicles or other mechanisms.

Overdose

Information on the consequences of an overdose of omeprazole in humans is limited. Cases of the use of the preparation at a dose of up to 560 mg are described; there have also been isolated reports of single oral doses of omeprazole reaching 2400 mg (120 times the usual recommended dose). Cases of nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported. Apathy, depression, and confusion have also been reported on rare occasions.

The symptoms described were temporary and no serious effects were reported. The preparation excretion rate did not change (first-order kinetics) with increasing doses of the preparation. If necessary, symptomatic treatment is carried out.

When conducting clinical studies, intravenous administration of the preparation was used at a dose of up to 270 mg for one day and up to 650 mg for 3 days, which did not lead to the appearance of any dose-dependent adverse reactions.

Side effects

The most common side effects are headache, abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting.

Storage conditions

Store in its original packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 2 years.

The shelf life of the powder after opening is up to 24 hours at a temperature not exceeding 25 ° C.

The shelf life of the reducing solution is up to 4 hours at a temperature not exceeding 25 ° C.