Ezonexa (esomeprazole) lyophilisate for injections and infusions 40 mg. vial №1

Description

Ezonexa for injections Dosage form:

Lyophilisate for solution for injection and infusion. Main physical and chemical properties: porous lyophilized powder of white or almost white color.
Packaging: 10 ml in a bottle. 1, 5 or 10 vials in a pack (production in bulk packaging of the manufacturer Laboratorios Normon SA, Spain). 10 ml in a bottle. 1, 5 or 10 vials per pack (manufactured from in bulk packaging by Laboratorios Normon SA, Spain). Vacation category. According to the recipe. Manufacturer. Farmak JSC. Location of the manufacturer and his address of the place of activity. Ukraine, 04080, Kyiv, st. Kirillovskaya, 74.
Pharmaceutical group: Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease.
ATX code: A02B C05.

EZONEXA FOR INJECTIONS CONTRAINDICATION

Hypersensitivity to the active substance of esomeprazole, other substituted benzimidazoles or to any of the excipients of this medicinal product.
Esomeprazole should not be used concomitantly with atazanavir, nelfinavir (see section “Interaction with other medicinal products and other forms of interaction”).

EZONEXA FOR INJECTIONS APPLICATION

Dosage Adults Antisecretory therapy in case of impossibility of oral administration. Patients who cannot take the drug orally 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 daily. In the treatment of gastric ulcers caused by 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 a drug at a dose of 20 mg once a day. Treatment with intravenous drugs is usually short-term, and patients should be switched to oral administration as soon as possible. Short-term maintenance of hemostasis and prevention of re-bleeding in patients after endoscopic treatment of acute bleeding due to gastric or duodenal ulcer After therapeutic endoscopy of acute bleeding of gastric or duodenal ulcers, 80 mg 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. Method of administration Instructions for reconstitution are given in this section below (“Instructions for use, use and disposal (if applicable)”). Injections A dose of 40 mg 5 ml of reconstituted solution (8 mg / ml) is given as an intravenous injection lasting at least 3 minutes. A dose of 20 mg of 2.5 ml or half of the reconstituted solution (8 mg / ml) is given as an intravenous injection of at least 3 minutes. The unused solution is disposed of. Infusions A dose of 40 mg of reconstituted solution is administered as an intravenous infusion lasting 10 to 30 minutes. Dose 20 mg Half of the reconstituted solution is administered as an intravenous infusion lasting 10-30 minutes. The unused solution is disposed of. A dose of 80 mg of reconstituted solution is administered as a long-term intravenous infusion over 30 minutes. The dose of 8 mg / h reconstituted solution is administered as a long-term intravenous infusion over 71.5 hours (calculated infusion rate 8 mg / hour; the shelf life of the reconstituted solution is indicated in the section “Shelf life”). Renal impairment No dose adjustment is required for patients with renal impairment. Because experience with patients with severe renal impairment is limited, caution should be exercised in such patients (see Pharmacokinetics). Hepatic impairment GERD: No dose adjustment is required in patients with mild or moderate hepatic impairment.