Examples of using Lisonorm in English and their translations into Polish
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Computer
What LISONORM contains.
How to store Lisonorm 6.
Consequently, Lisonorm is contraindicated in pregnancy see section 4.3.
The gastrointestinal absorption of Lisonorm is not influenced by food.
Lisonorm is a fixed dose combination containing the active substances lisinopril and amlodipine.
Pregnancy and breast-feeding Lisonorm must not be taken during pregnancy and breast-feeding.
Lisonorm(see Annex I) 10/ 5 mg tablets[See Annex I- To be completed nationally] lisinopril/ amlodipine.
Gedeon Richter Plc obtained a national marketing authorisation for Lisonorm which was authorised in Bulgaria on 29 December 2006, before Bulgaria joined the European Union.
Lisonorm may influence the ability to drive and operate machines particularly during the initial period of treatment.
Potassium-sparing diuretics(such as spironolactone, amiloride, triamterene, used to reduce fluid retention)may only be taken together with Lisonorm under close medical supervision.
Driving and using machines Lisonorm can affect your ability to drive and use machinery safely.
During their July 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee,was of the opinion that the benefit/ risk ratio is favourable for Lisonorm, that the objections raised by Czech Republic and Latvia should not prevent the granting of a Marketing Authorisation.
Lisonorm and associated names(see Annex I) 10 mg/ 5mg tablets[See Annex I- To be completed nationally] Lisinopril/ Amlodipine.
Therefore, the Applicant acknowledged the limitations arising from the product selection in the initial pivotal BE study and performed a study(Protocol No 67289)to investigate bioequivalence of LISONORM FORTE(fixed-combination of amlodipine 10 mg and lisinopril 20 mg), co-administration of NORVASC 10 mg(containing amlodipine 10 mg) and PRINIVIL 20 mg(containing lisinopril 20 mg), and LISONORM(fixed-combination of amlodipine 5 mg and lisinopril 10 mg) under fasting conditions.
Lactation Lisonorm is not recommended for breast-feeding mothers, as lisinopril may be excreted in human milk see section 4.3.
In the case of renal function deterioration, Lisonorm should be withdrawn and replaced by the therapy with individual components adequately adjusted.
Taking Lisonorm with food and drink Lisonorm can be taken with or without food, but alcohol should be avoided during treatment.
Common side effects in a clinical trial with Lisonorm tablets were: headache, cough, dizziness, palpitations(a quicker or irregular heart beat), and pruritus.
In such cases, Lisonorm should be discontinued immediately and the patient kept under close medical supervision until complete and sustained resolution of symptoms has occurred.
Children and adolescents Lisonorm is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
If Lisonorm is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
Patients planning pregnancy Lisonorm should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Lisonorm is indicated only for patients in whom the optimal maintenance dose of lisinopril and amlodipine has been titrated to 10 mg and 5 mg, respectively.
Patients receiving Lisonorm tabletswho develop jaundice or marked elevations of hepatic enzymes should discontinue Lisonorm and receive appropriate medical follow-up.
Lisonorm is indicated as substitution therapy of patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Lisonorm tablet contains 5mg amlodipine/ 10mg lisinopril and is an anti-hypertensive indicated in patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Lisonorm should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function.
