TAKEDA PHARMA #Digestive_system #Stomach_ulcers_heartburn_acid_reflux #HEALTH_CARE
Indications
- reflux esophagitis.
- duodenal ulcer.
- gastric ulcer.
- Zollinger-Ellison syndrome and other hypersecretory pathological conditions.
Contraindications
Hypersensitivity to the active substance, benzimidazole derivatives and any component of the preparation.
Compound
active ingredient: pantoprazole;
1 vial contains 42.3 mg of pantoprazole sodium (equivalent to 40.0 mg of pantoprazole);
other components: disodium edetate, sodium hydroxide.
Dosage and administration
The preparation is used as prescribed by a doctor and under proper supervision.
Intravenous use of the preparation is recommended only if oral administration is not possible. There are data on the duration of intravenous treatment up to 7 days. Therefore, as soon as oral administration of pantoprazole becomes possible, a transition is made from intravenous administration of Controloc to oral administration of pantoprazole at a dose of 40 mg.
Reflux esophagitis, duodenal ulcer, stomach ulcer.
The recommended dose is 40 mg pantoprazole (1 vial) per day intravenously.
Treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions.
For long-term treatment of Zollinger-Ellison syndrome and other hypersecretory pathological conditions, the recommended initial dose of Controloc is 80 mg per day. If necessary, the dose can be titrated, increasing or decreasing, depending on the indicators of acid secretion in the stomach. Doses exceeding 80 mg/day should be divided into two doses. It is possible to temporarily increase the dose of pantoprazole to more than 160 mg, but the duration of use should be limited only to the period necessary for adequate control of acid secretion.
In the event that a rapid decrease in acidity is required, for most patients an initial dose of 2 x 80 mg is sufficient to achieve the desired level (< 10 mEq / h) within 1 hour.
Preparation for use.
The powder is dissolved in 10 ml of 0.9% sodium chloride solution added to the vial. The solution can be administered directly or after mixing with 100 ml of 0.9% sodium chloride solution or 5% glucose solution in plastic or glass vials.
After dilution, the chemical and physical stability of the preparation is maintained for 12 hours at a temperature of 25 ° C. From a microbiological point of view, the diluted preparation must be used immediately.
Controloc must not be prepared or mixed with solvents other than those specified above.
Intravenous administration of the preparation should be carried out within 2-15 minutes.
The bottle is for single use only. Residues of the preparation or the preparation, the physico-chemical properties of which have changed (in particular, the color has changed, a precipitate has appeared), must be disposed of in accordance with the requirements of local legislation.
The diluted solution should have a clear yellowish color.
Liver failure. Patients with severely impaired liver function should not exceed a daily dose of 20 mg (½ vial of Controloc, powder 40 mg) (see section "Peculiarities of use").
Renal failure. Patients with impaired renal function do not require dose adjustment.
Elderly patients do not need dose adjustment.
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