ULKOPROL. 40 mg. 5 vial
ULKOPROL. 40 mg. 5 vial
What Ulkoprol and what it is used?
Ulkoprol Ulcer is a product of the so -called proton pump inhibitors in the gastric mucosa. By inhibiting the action of the " proton pump " , it reduces the formation of hydrochloric acid in the cells of the gastric mucosa . Ulkoprol inhibits both basal and stimulated gastric secretion. A single intravenous dose results in an immediate reduction of gastric acid secretion and provides control of the acidity of gastric juice for 24 hours.
Ulkoprol powder for solution for infusion is used for
• Prevention of aspiration (getting in the lung ) of gastric contents in cases where there is such a risk during general anesthesia ( Mendelson 's syndrome ) .
For patients who can not tolerate oral therapy , Ulkoprol used for short-term treatment ( 5 days ) in the following conditions :
• ulcers of stomach and duodenum , including those attributable to " the use of nonsteroidal anti-inflammatory drugs (NSAIDs) ,
- Symptomatic gastroesophageal reflux oesophagitis (inflammation of the esophagus crossing stoashen juice )
• Zollinger - Ellison (multiple recurrent ulcers of the stomach and duodenum, most often caused by a tumor in the pancreas or duodenum and produce excessive amounts of gastrin ) .
2 . BEFORE YOU USE ULKOPROL
Ulkoprol not apply to
Allergy to omeprazole or to any of the excipients .
Take special care with Ulkoprol order to avoid inappropriate treatment needs suspected peptic ulcer disease can be specified at an early stage through the performance of instrumental studies ( x-ray or endoscopic ) .
In the presence of a gastric ulcer or suspected to be in particular when observing any of the following symptoms - significant weight loss , vomiting periodically , odynophagia , bleeding from the gastrointestinal tract , have to be excluded malignancy , as therapy may affect symptoms and delay diagnosis.
Due to the reduction in stomach acidity possible increase in the number of bacteria normally inhabiting the stomach . Treatment with acid- lowering drugs may cause a slight increase in the risk of gastrointestinal infections .
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Due to reduced gastric acidity may change the absorption of some medicines. Absorption of itraconazole and ketoconazole decreases when omeprazole treatment and this reduces their effectiveness. Since omeprazole is metabolised by the liver , it can also prolong the elimination of diazepam , warfarin and phenytoin. This requires careful monitoring of patients treated with these medications and if necessary reduce their doses .
With concomitant administration of erythromycin or clarithromycin and omeprazole plasma concentrations of omeprazole were increased . They are not affected by concomitant treatment with amoxicillin or metronidazole .
Co-administration of omeprazole and digoxin in healthy subjects resulted in an increased content of the latter .
Some drugs ( protease inhibitors , ketoconazole , itraconazole ) may cause an increase in the plasma concentration of omeprazole. No interaction between omeprazole and antacids , theophylline , caffeine , quinidine , lidocaine , propranolol , metoprolol or ethanol.
Ask your doctor or pharmacist before taking any medicine .
Data from preclinical and epidemiological studies have not identified hazard administration of omeprazole during pregnancy with no evidence of toxic or teratogenic effect on the fetus. However, this product should be used during pregnancy only if clearly needed and after careful consideration of the benefit / risk ratio .
Ask your doctor or pharmacist before taking any medicine .
Omeprazole is excreted in breast milk. Although no evidence of adverse effects on the infant when therapeutic doses are not recommended for use of omeprazole during lactation or if it is necessary , breastfeeding should be discontinued.
Driving and using machines
No evidence of effect on ability to drive and use machines
3 . HOW TO USE ULKOPROL ?
Always Ulkoprol exactly as stated in this leaflet. If you are not sure, ask your doctor or pharmacist
Strictly yantravenozno only on prescription !
Preoperative prevent aspiration of gastric contents is recommended the administration of 40 mg of one hour before the operation. If the operation lasted more than two hours , the dose may be repeated.
Gastric ulcer and duodenal ulcer or reflux oesophagitis :
It is used in patients for whom oral therapy is unsuitable or impossible , at a dose of 40 mg once daily . The duration of intravenous administration is 2-3 days , and then switched to oral therapy .
In patients with syndrome Tsaolinger - Ellison :
Recommended starting dose - 60 mg once daily as an intravenous infusion. Possibly require higher doses , they are determined individually . Where necessary , the dose is greater than 60 mg per day , it must be split in two intravenous infusions.
Impaired renal function:
No dose adjustment is required in patients with impaired renal function.
Impaired hepatic function:
As hepatic degradation in these patients is strongly reduced , and stay active substance in the body is increased to dose reduction , usually daily dose of 10 mg -20 mg is sufficient.
No adjustment of dosage.
This product is not recommended for children. Its safety and efficacy have not been established.
Method of administration :
Ulkoprol for infusion administration should be given slowly intravenously ( over 20-30 minutes). The content of each vial must be reconstituted with 100 ml of physiological solution for infusion or 5% glucose solution. It is recommended that the application of the so prepared solution to start immediately , it should be used within 6 hours.
For preparation of the solution must first be added to the contents of the vial sufficient saline or 5% glucose solution to completely dissolve the dry substance , after which the thus prepared solution must be transferred to the infusion system .
If you use more than the prescribed dose Ulkoprol
Upon application of a higher than the prescribed dose is required to be informed of the doctor!
Overdose can occur following symptoms : blurred vision , confusion, drowsiness , dry mouth , headache, malaise , nausea, vomiting, diarrhea , palpitations .
In manifestations of overdose Immediate discontinuation of the product. Due to the lack of a specific antidote treatment is symptomatic and supportive.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Ulkoprol can cause side effects, although not everybody gets them
Treatment with omeprazole was well tolerated .
Adverse reactions :
Common ( > 1/100 , <1 /10):
• Gastrointestinal disorders - diarrhea , nausea, vomiting, constipation ; abdominal pain, flatulence .
• Nervous system - headaches.
Uncommon (> 1/1000 , <1/ 100)
• General disorders - fatigue.
- Hepatobiliary disorders - increases in some liver tests (ALT , AST , GGT , alkaline phosphatase, bilirubin) .
- Skin and subcutaneous tissue disorders - rash , pruritus, urticaria.
- Nervous System - paresthesia , dizziness, drowsiness or sleep disorders.
Rare (> 1/10000 , < 1/1000 ):
- General disorders - increased sweating , peripheral edema
- Immune System - Allergic skin rashes , fever ( fever) , anaphylactic shock
- Gastrointestinal disorders - dry mouth, dysgeusia, candidiasis ,
pancreatitis, hepatitis - liver failure and hepatic encephalopathy (affecting brain function )
- Respiratory disorders - bronchospasm (narrowing of the bronchi )
- Metabolism and nutrition - hyponatremia (low sodium content).
Cardiac disorders - chest pain, fast or slow heartbeat , palpitations, peripheral edema .
is Musculo -skeletal - muscle cramps, muscle pain , weakness , joint God .
- Skin and subcutaneous tissue - hair loss , photosensitivity , very rarely - generalized skin reactions ( including toxic epidermal necrolysis , Stevens -Johnson syndrome, erythema multiforme) .
- Renal and urinary disorders - interstitial nephritis,
- Blood and lymphatic - system - changes in the blood ( leucopenia , thrombocytopenia , agranulocytosis , pancytopenia ) .
- Psychiatric - confusion, depression , hallucinations , apathy , aggression, anxiety.
- Endocrine disorders - gynecomastia ( breast enlargement in men ) .
- Eye disorders - blurred vision .
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . STORAGE
Keep out of reach of children .
Vials Ulkoprol 40 mg powder for solution for infusion should be stored protected from light ( in a box ) at a temperature below 30 ° C. The reconstituted solution should be used within 6 hours. Shelf life : two (2 ) years from date of manufacture. Do not use after the expiry date stated on the package ! Do not use " Ulkoprol after the expiry date stated on the carton . Expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . Such measures will help to protect the environment.
6 . FURTHER INFORMATION
What does Ulkoprol
- The active ingredient in a vial : omeprazole 40 mg (as omeprazole sodium 42.6 mg).
The other ingredients are disodium edetate , Sodium hydroxide
Ulkoprol looks like and contents of pack
Ulkoprol powder for solution for infusion is a white or almost white powder. Ulkoprol comes in vials of 15 ml colorless silicate glass with chlorobutyl stopper and cap of two parts - aluminum seal and plastic lid .
5 vials are placed in a cardboard box with leaflet.