Omzol time. for solution for inf. 40 mg fl. No. 10

Powder for infusions of Omzol is applied to solution at the following indications:

• treatment of an ulcer of a duodenum;
• prevention of a recurrence of an ulcer of a duodenum;
• treatment of stomach ulcer;
• prevention of a recurrence of stomach ulcer;
• in combination with the corresponding antibiotics, for an eradikation of Helicobacter pylori (H. Pylori), which associated with a peptic ulcer;
• treatment of the stomach ulcers and a duodenum tied with intake of non-steroidal anti-inflammatory medicaments (NPVS);
• prevention of the stomach ulcers and a duodenum tied with reception of NPVS at predisposed patients is risk groups;
• treatment reflux esophagitis;
• maintenance therapy at patients after treatment a reflux esophagitis;
• symptomatic treatment of a gastroesophageal reflux disease (GERD);
• treatment of a syndrome of Zollingera-Ellison.

Structure

Active ingredient - omeprazole (1 bottle contains omeprazolum of sodium 42.6 mg in terms of omeprazolum of 40 mg).

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

Contraindication

Hypersensitivity to omeprazolum, to other substituted benzimidazoles or to any of medicine excipients.

Omzol, as well as other IPP, it is not necessary to apply along with nelfinaviry or atazanaviry.

Route of administration

Dosage

Alternative of oral therapy. To patients for whom the oral form of medicine is unacceptable, recommend to apply omeprazolum of 40 mg of 1 times a day. For patients with Zollingera-Ellison's syndrome the recommended initial dose of medicament which is administered intravenously makes 60 mg a day. There can be a need for higher daily doses therefore the dose should be selected individually. If the dose exceeds 60 mg, it should be divided into two equal parts and to enter 2 times a day. Drug should be used only intravenously, it cannot be entered in any other way. Solution needs to be used right after preparation, but not later than in 3 hours. Divorced solution of omeprazolum cannot be stored in the fridge. Unused solution should be destroyed.

Instruction for restoration of medicine before introduction

At intravenous infusions contents of each bottle of omeprazolum which contains 40 mg of omeprazolum is restored in 10 ml and bring to 100 ml 0.9% solution of sodium of chloride or 5% glucose solution. Stability of omeprazolum depends from rn solution for infusions therefore for cultivation it is necessary to use other solvents or other their quantities.

Drug in the form of infusion is administered within 20-30 minutes.

At intravenous injections contents of one bottle of omeprazolum which contains 40 mg of omeprazolum is dissolved in 10 ml of water for injections. Means in the form of intravenous injections should be entered slowly (within 5 minutes).

Solution needs to be used right after preparation, but not later than in 3 hours. Divorced solution of omeprazolum cannot be stored in the fridge.

according to local requirements.

Dose adjustment is not required by

to patients with renal failures.

to Patients with abnormal liver functions sufficient.

Dose adjustment is not required by

to patients of advanced age (> 65 years).

Pregnant

Results of researches indicate

Feature of application

lack of undesirable impact of omeprazolum on pregnancy or health of the fruit/newborn. Omeprazolum can be applied during pregnancy.

Omeprazolum is removed by

in breast milk, however hardly influences the child if it is applied in therapeutic doses.

Children

Experience of use of medicine for intravenous administration in pediatric practice is limited to

therefore this category of patients should not appoint.

Drivers

It is improbable

that medicine affects ability to drive the car or to work with other mechanisms. Considering that sensitive patients at use of medicine can have side reactions (dizziness, drowsiness, hallucinations, reversible confusion of consciousness), such patients for administration of medicament should refrain from control of motor transport and work with the mechanisms demanding concentration of attention.

Overdose

Exists the limited volume of information on consequences of overdose of omeprazolum at the person. Cases of use of medicine in a dose to 560 mg were described; also separate messages about oral application of single doses of omeprazolum which reached 2400 mg (120 times higher than the usual recommended clinical dose) were received. Cases of nausea, vomiting, dizziness, an abdominal pain, diarrhea and headache were registered. It was also in rare instances reported about apathy, a depression and confusion of consciousness. The described symptoms were temporary, messages about serious consequences did not arrive. Clearance rate of medicine did not change (kinetics of the first order) with increase in doses of medicine.

symptomatic treatment. At conduct of clinical trials applied intravenous administration of medicine in a dose to 270 mg within one day and to 650 mg within three days that did not lead to what emergence of dose-dependent undesirable reactions.

Side effects

Most frequent side effects are a headache, an abdominal pain, a lock, diarrhea, a meteorism, nausea/vomiting.

Storage conditions

to Keep a bottle in an external box at a temperature not above 25 °C. To store out of children's reach.

Expiration date - 2 years.

Period of storage after solution preparation: stability of chemical physical properties of the prepared solution was shown within 12 hours at 25 °C after dissolution of 0.9% by solution of sodium chloride and within 6 hours after dissolution of 5% glucose solution. From the microbiological point of view, the received solution should be used immediately, except cases when restoration of medicine happens in the controlled and aseptic conditions confirmed with validation methods.