natgillin/translations-raw huggingface dataset:
COMMON side effects (affects 1 to 10 users in 100): − Abnormal liver function tests; − Changes in body shape due to changes in fat distribution; − Headache; − Increased glucose, increased amylase (a digestive enzyme), increased liver enzymes; − Difficulty in sleeping; − Lack of strength and energy; − Nausea, vomiting, abdominal pain, abnormal stools, indigestion, wind, problems with your digestive system; − Pain; − Rash, acne; − Tingling, prickling or numbness of the skin.
- ebanormaalsed unenäod, rahutus, ärevus, segasus, depressioon, liigutuste kontrollivõime
Further information about nausea, vomiting or abdominal pain Tell your doctor if you experience nausea, vomiting or abdominal pain as these may be suggestive of pancreatitis.
kahjustus, emotsionaalne labiilsus, seksuaaltungi vähenemine, närvilisus, ebanormaalne mõtlemine;
Changes in body shape due to changes in fat distribution Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
- ebanormaalne ejakulatsioon, rindade suurenemine, rindade suurenemine meestel, impotentsus,
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’).
ebanormaalselt vererohke või pikaajaline menstruatsioon;
The cause and long-term health effects of these conditions are not known at this time.
- hingeldus, ninaärritus ja - põletik, suurenenud köha;
Tell your doctor if you notice any changes in your body shape due to changes in fat distribution.
- juuksekadu, nahakuivus, ekseem, soomuseline nahk, madal punane lööve vistrike ja laikudega,
UNCOMMON side effects (affects 1 to 10 users in 1,000):
küünte kahjustus, sügelemine, rasuse naha soomusjad kogumid, naha värvus muutus, nahahaavand, näoturse, higistamine, striiad;
- Low number of red blood cells, low number of white blood cells, enlargement of the lymph
- healoomuline nahakasvaja, tsüst;
nodes; − A sound in one ear or both ears, such as buzzing, ringing or whistling; − Abnormal vision, eye disorder; − Feeling the heart racing, ‘skipping a beat’ or pounding, heart attack, swelling and/or fluid accumulation in the lungs; − Enlarged abdomen, constipation, dry mouth, difficulty swallowing, inflammation of the small and large intestine, burping, inflammation of the food pipe, inability to control your bowels, inflammation of the stomach and intestine, bloody diarrhoea, mouth ulcerations, inflammation of the pancreas; inflammation of a salivary gland, inflammation in the mouth, mouth ulcer, inflammation of the gums; − Chest pain, chest pain beneath the sternum, chills, fever, flu-like symptoms, vague feeling of bodily discomfort, accumulation of fluid in your legs or around your ankles, interactions with other medicines; − Lack of functioning of the testes, Cushing syndrome (a condition caused by high levels of cortisol in the blood), under-active thyroid gland; − Inflammation of the middle ear, inflammation of the bronchi, inflammation of the sinuses, recurring boils, bacterial infection, viral infection; 149 − Decreased glucose tolerance, weight gain, weight loss, increased bilirubin (a bile pigment), hormone level altered, lab test abnormal; − Kidney stones, urine abnormality, albumin in the urine, high levels of calcium in the urine, excess uric acid in the blood; − Inflammation of the gall bladder, inflammation of the liver, enlarged liver, fatty deposits in the liver, liver tenderness; − Deficiency of one or more essential vitamins, dehydration, accumulation of fluid in the cells or tissues, increased appetite, excess lactic acid in the blood, obesity, anorexia, diabetes mellitus, high glucose in the blood, low cholesterol in the blood; − Painful joints, inflammation in the joints, muscle pain, back pain, joint disorder; − Dizziness, loss or impairment of memory, loss in the ability to co-ordinate muscular movement, degenerative brain disease, loss of power of voluntary movement in the facial muscles, increased muscle tension, disease or abnormality of the nervous system, damage to nerves of the peripheral nervous system, sleepiness, tremor, altered sense of taste, migraine, abnormal involuntary movements; − Abnormal dreams, agitation, anxiety, confusion, depression, impairment in the ability to control movements, emotional instability, decreased sexual desire, nervousness, abnormal thinking; − Abnormal ejaculation, breast enlargement, enlargement of male breasts, impotence, abnormally heavy or extended menstrual flow; − Shortness of breath, irritation and inflammation of the nose, increased cough; − Hair loss, dry skin, eczema, scaling of the skin, flat red rash with pimples or spots, nail disorder, itching, accumulation of scales of greasy skin, skin discoloration, skin ulcer, facial swelling, sweating, stretch marks; − Benign skin tumour, cyst; − High blood pressure, vein inflammation related to a blood clot, inflammation of the blood vessels, varicose vein, deep vein inflammation related to a blood clot, vascular disorder.
- kõrge vererõhk, veenipõletik, mis on tingitud verehüübest, veresoonte põletik, varikoosne
− Keep out of the reach and sight of children. − Do not use Kaletra after the expiry date which is stated on the pack. − This medicinal product does not require any special storage conditions.
- Ärge kasutage Kaletra’ t pärast kõlblikkusaega, mis on märgitud pakendil.
How should I dispose of any unused Kaletra?
- See ravimpreparaat ei vaja säilitamisel eritingimusi.
− Medicines should not be disposed of via wastewater or household waste. − Ask your pharmacist how to dispose of medicines not longer required.
- Ravimeid ei tohi ära visata kanalisatsiooni kaudu ega koos majapidamisprügiga.
These measures will help protect the environment.
- Küsige oma apteekrilt, kuidas hävitatakse ravimeid, mida enam ei vajata.
FURTHER INFORMATION
Need meetmed aitavad kaitsta keskkonda.
What Kaletra contains
LISAINFO
The active substances are lopinavir and ritonavir.
Mida Kaletra sisaldab Toimeained on lopinaviir ja ritonaviir.
Tablet Colloidal anhydrous silica, copovidone, sodium stearyl fumarate, sorbitan laurate.
Tablett Kolloidne veevaba räni, kopovidoon, naatriumstearüülfumaraat, sorbitaanlauraat.
Tablet coating Polyvinyl alcohol, talc, titanium dioxide, macrogols type 3350, yellow ferric oxide E172.
Tableti kate Polüvinüülalkohol, talk, titaandioksiid, tüüp 3350 makrogoolid, kollane raudoksiid E172.
What Kaletra looks like and contents of the pack
153 Kuidas Kaletra välja näeb ja pakendi sisu
− Kaletra film-coated tablets come in a plastic bottle containing 60 tablets. − The tablets are pale yellow debossed with [Abbott logo] and “KC”. − One bottle of 60 tablets is provided in one package.
- Kaletra õhukese polümeerikattega tabletid on saadaval plastikpurgis, mis sisaldab 60 tabletti.
Marketing Authorisation Holder
- Ühes pakendis on 1 purk 60 tabletiga.
151 Danmark Abbott Laboratories A/S Emdrupvej 28C DK-2100 København Ø Tlf: + 45 39 77-00-00
Danmark Abbott Laboratories A/ S Emdrupvej 28C DK- 2100 København Ø Tlf: + 45 39 77- 00- 00
Eesti Österreich Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
Eesti Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Läti Tel: + 371 67605580
Abbott Ges.m.b.H.
Österreich Abbott Ges. m. b. H.
Perfektastrasse 86 A-1230 Wien Tel: + 43 1 891-22
Perfektastrasse 86 A- 1230 Wien Tel: + 43 1 891- 22
Ελλάδα Abbott Laboratories (ΕΛΛΑΣ) Α.Β.Ε.Ε.
154 Ελλάδα Abbott Laboratories (ΕΛΛΑΣ) Α. Β. Ε. Ε.
152 Italia Abbott S.r.l.
Italia Abbott S. r. l.
Lietuva Abbott Laboratories Baltics Vienības 87h Rīga, LV-1004 Latvija Tel: + 371 67605580
155 Lietuva Abbott Laboratories Baltics Vienības 87h Rīga, LV- 1004 Latvija Tel: + 371 67605580
This leaflet was last approved on:
Infoleht on kooskõlastatud:
153
156
Karvea is used in patients who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Essentsiaalne tähendab, et seda ei põhjusta ükski teine haigus.
Karvea is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Karveat kasutatakse ka neeruhaiguste raviks hüpertensiooniga ja II tüüpi diabeediga (insuliinisõltumatu suhkurtõvega) patsientidel.
Karvea is not recommended for use in patients below 18 years of age.
Karveat ei soovitata kasutada alla 18- aastastel patsientidel.
Karvea is taken by mouth, with or without food.
Karveat manustatakse suu kaudu, koos söögiga või ilma.
In patients with hypertension and type 2 diabetes, Karvea is added to other treatments for hypertension.
Kõrgvererõhuga ja II tüüpi diabeediga patsientidel kasutatakse Karveat lisaks teistele kõrgvererõhu ravimitele.
The active substance in Karvea, irbesartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Karvea toimeaine irbesartaan on angiotensiin II retseptori antagonist, mis blokeerib organismi hormooni angiotensiin II toime.
Karvea was compared with placebo (a dummy treatment) in 712 patients, and with other medicines for hypertension (atenolol, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Its use in combination with hydrochlorothiazide was also examined in 1,736 patients).
Reproduction is authorised provided the source is acknowledged. põhinäitajaks oli diastoolse vererõhu (mõõdetakse kahe südamelöögi vahelises puhkefaasis) langemine.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Karvea toimet neeruhaiguste ravis uuriti kahes ulatuslikus uuringus, milles osales 2326 patsienti, kes põdesid II tüüpi diabeeti.
Karvea was used for two years or more.
Neile manustati Karveat kahe või enama aasta jooksul.
The second study looked at whether Karvea increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Teises uuringus jälgiti, kas Karvea pikendab aega, mille jooksul patsiendil vere kreatiniinisisaldus (neeruhaiguse marker) kahekordistub, või kuni patsient vajab neerusiirdamist või dialüüsi, või aega patsiendi surmani.
In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Vererõhku käsitlevates uuringutes täheldati, et Karvea alandab diastoolset vererõhku tunduvalt paremini kui platseebo ning tema toime on samalaadne teiste kõrgvererõhu ravimite toimega.
When used with hydrochlorothiazide, the effects of the two medicines were additive.
Kui Karveat kasutati koos hüdrokloortiasiidiga, olid nende kahe ravimi toimed aditiivsed.
In the first kidney disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Esimeses neeruhaiguste uuringus oli Karvea neerukahjustuse (hinnati valgueritumise alusel) tekkeriski vähendamisel tõhusam kui platseebo.
In the second kidney disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo.
Teises neeruhaiguste uuringus vähendas Karvea suhtelist riski, mille korral vere kreatiniinisisalduse kahekordistub, tekib neerusiirdamise või dialüüsi vajadus või surmajuhtumid, platseeboga võrreldes 20%.
The most common side effects with Karvea (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase (an enzyme found in muscles).
Karvea kõige sagedamad kõrvalnähud (esinenud ühel kuni kümnel patsiendil sajast) on peapööritus, iiveldus või oksendamine, väsimus ja vere kreatiinkinaasi (lihastes leiduv ensüüm) sisalduse suurenemine.
For the full list of all side effects reported with Karvea, see the Package Leaflet.
Karvea kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
Karvea should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Karveat ei tohi kasutada patsiendid, kes võivad olla irbesartaani või Karvea mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
It must not be used in women who are more than three months pregnant or who are breast-feeding.
Karveat ei tohi kasutada üle kolme kuu rasedatel või last rinnaga toitvatel naistel.
The Committee for Medicinal Products for Human Use (CHMP) decided that Karvea’ s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Inimravimite komitee jõudis otsusele, et Karvea kasulikkus essentsiaalse hüpertensiooni ning hüpertensiooniga ja II tüüpi diabeediga neeruhaigete ravis on suurem kui ravimiga kaasnevad riskid.
The Committee recommended that Karvea be given marketing authorisation.
Komitee soovitas anda Karveale müügiloa.
The European Commission granted a marketing authorisation valid throughout the European Union for Karvea to Bristol-Myers Squibb Pharma EEIG on 27 August 1997.
Muu teave Karvea kohta Euroopa Komisjon andis Karvea müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Bristol- Myers Squibb Pharma EEIG 27. augustil 1997.
The full EPAR for Karvea is available here.
Euroopa avaliku hindamisaruande täisteksti Karvea kohta siit.
Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Karvea annuses 150 mg üks kord ööpäevas annab üldiselt parema 24- tunnise kontrolli vererõhu üle kui 75 mg.
In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other anti-hypertensive agents can be added.
Patsientidele, kellel 150 mg 1 kord ööpäevas ei taga rahuldavat vererõhu langust, võib Karveai annust suurendada kuni 300 mg- ni või lisada raviskeemi teise antihüpertensiivse ravimi.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).
Diureetikumi, nt hüdroklorotiasiidi lisamine on näidanud aditiivset toimet Karveaiga (vt lõik 4. 5).
The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Karveai soodne toime teist tüüpi diabeediga haigete neeruhaigusele põhineb uuringutel, kus irbesartaani kasutati lisaks teistele antihüpertensiivsetele ravimitele, et saavutada vajalikku vererõhu väärtust (vt lõik 5. 1).
While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Kuigi seda ei ole dokumenteeritud Karveai puhul, tuleb arvestada angiotensiin- II retseptorite antagonistide samasuguse toimega.
Renal impairment and kidney transplantation: when Karvea is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Karveai manustamisel neerufunktsiooni häirega patsientidele on soovitatav perioodiliselt kontrollida kaaliumi ja kreatiniini sisaldust seerumis.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Karvea, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
Hüperkaleemia: nagu ka teiste ravimitega, mis mõjutavad reniin- angiotensiin- aldosterooni süsteemi, võib Karvea ravi ajal tekkida hüperkaleemia, eriti neerupuudulikkuse, diabeetilisest neeruhaigusest tingitud väljendunud proteinuuria ja/ või südamepuudulikkuse esinemisel.
Lithium: the combination of lithium and Karvea is not recommended (see section 4.5).
Liitium: liitiumi ja Karveai kombinatsioon ei ole soovitatav (vt lõik 4. 5).
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Karvea has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Kuid Karveai on siiski ohutult kasutatud koos teiste antihüpertensiivsete ravimitega, nt beeta- adrenoblokaatorite, kaltsiumikanalite prolongeeritud toimega blokaatorite ja tiasiiddiureetikumidega.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Karvea (see section 4.4).
Eelnev ravi diureetikumi suurte annustega võib põhjustada vedeliku mahu vähenemist ja hüpotensiooni ohtu Karveaiga ravi alustamisel (vt lõik 4. 4).
Karvea is contraindicated (see section 4.3) during breast-feeding.
Karvea on rinnaga toitmise ajal vastunäidustatud (vt lõik 4. 3).
The blood pressure lowering effect of Karvea is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
7 manustamisel oli vererõhu langus kõige madalama kontsentratsiooni korral ja keskmine langus 24 tunni jooksul sarnane 2 korda ööpäevas manustamisele samas koguannuses.
The antihypertensive effects are maintained during long term therapy.
Karveai vererõhku langetav toime ilmneb 1… 2 nädala jooksul, maksimaalne toime ilmneb 4… 6 nädalal ravi alustamisest.
Hypertension and type 2 diabetes with renal disease The “ Irbesartan Diabetic Nephropathy Trial (IDNT) ” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
"Irbesartan Diabetic Nephropathy Trial (IDNT)" uuring näitas, et irbesartaan vähendab kroonilise neerupuudlikkusega neeruhaigetel haiguse progresseerumist ja proteinuuriat.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Karvea, amlodipine and placebo.
IDNT oli topeltpime, kontrollgrupiga, haigestumuse ja suremuse uuring, kus võrreldi Karveai, amlodipiini ja platseebot.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Karvea on the progression of renal disease and all-cause mortality were examined.
1715 patsiendil, kellel esinesid hüpertensioon, teist tüüpi diabeet, proteinuuria (≥ 900 mg/ päevas) ja seerumi kreatiniini kontsentratsioon oli vahemikus 1… 3 mg/ dl (IDNT), uuriti Karveai pikaajalist (keskmine 2, 6 aastat) toimet neeruhaiguse progresseerumisele ja üldsuremusele.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Karvea, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Karveai annused tiitriti 75- lt 300 mg- ni, amlodipiini annused 2, 5- lt 10 mg- ni, või kasutati platseebot.
8 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2) ” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Uuring “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2) ” näitas, et 300 mg irbesartaani lükkab mikroalbuminuuriaga patsientidel edasi proteinuuria avaldumist.
The study examined the long-term effects (2 years) of Karvea on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/ day, and an increase in UAER of at least 30% from baseline).
Uuring käsitles Karveai pikaajalist (2 aastat) toimet kliinilise (manifesteerunud) proteinuuria (uriini albumiini ekskretsiooni määr (urinary albumin excretion rate, UAER) > 300 mg/ ööpäevas ja UAER suurenemine vähemalt 30% algväärtusest) tekkele.
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the Karvea 300 mg group (34%) than in the placebo group (21%).
Normoalbuminuuria (< 30 mg/ ööpäevas) tekkis sagedamini Karvea 300 mg grupis (34%) kui platseebogrupis (21%).
EU/ 1/ 97/ 049/ 001-003 EU/ 1/ 97/ 049/ 010 EU/ 1/ 97/ 049/ 013
EU/ 1/ 97/ 049/ 001- 003 EU/ 1/ 97/ 049/ 010 EU/ 1/ 97/ 049/ 013
The blood pressure lowering effect of Karvea is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
17 manustamisel oli vererõhu langus kõige madalama kontsentratsiooni korral ja keskmine langus 24 tunni jooksul sarnane 2 korda ööpäevas manustamisele samas koguannuses.
18 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2) ” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Uuring “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2) ” näitas, et 300 mg irbesartaani lükkab mikroalbuminuuriaga patsientidel edasi proteinuuria avaldumist.
EU/ 1/ 97/ 049/ 004-006 EU/ 1/ 97/ 049/ 011 EU/ 1/ 97/ 049/ 014
EU/ 1/ 97/ 049/ 004- 006 EU/ 1/ 97/ 049/ 011 EU/ 1/ 97/ 049/ 014
The blood pressure lowering effect of Karvea is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
27 manustamisel oli vererõhu langus kõige madalama kontsentratsiooni korral ja keskmine langus 24 tunni jooksul sarnane 2 korda ööpäevas manustamisele samas koguannuses.
28 The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2) ” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Uuring “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2) ” näitas, et 300 mg irbesartaani lükkab mikroalbuminuuriaga patsientidel edasi proteinuuria avaldumist.
EU/ 1/ 97/ 049/ 007-009 EU/ 1/ 97/ 049/ 012 EU/ 1/ 97/ 049/ 015
EU/ 1/ 97/ 049/ 007- 009 EU/ 1/ 97/ 049/ 012 EU/ 1/ 97/ 049/ 015
Karvea 75 mg film-coated tablets.
Karvea 75 mg õhukese polümeerikilega kaetud tabletid.
In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other anti-hypertensive agents can be added.
Patsientidele, kellel 150 mg 1 kord ööpäevas ei taga rahuldavat vererõhu langust, võib Karvea' i annust suurendada kuni 300 mg- ni või lisada raviskeemi teise antihüpertensiivse ravimi.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).
Diureetikumi, nt hüdroklorotiasiidi lisamine on näidanud aditiivset toimet Karvea' iga (vt lõik 4. 5).
The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Karvea' i soodne toime teist tüüpi diabeediga haigete neeruhaigusele põhineb uuringutel, kus irbesartaani kasutati lisaks teistele antihüpertensiivsetele ravimitele, et saavutada vajalikku vererõhu väärtust (vt lõik 5. 1).
Such conditions should be corrected before the administration of Karvea.
Sellised seisundid tuleb korrigeerida enne ravi alustamist Karvea' iga.
While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Kuigi seda ei ole dokumenteeritud Karvea' i puhul, tuleb arvestada angiotensiin- II retseptorite antagonistide samasuguse toimega.
Renal impairment and kidney transplantation: when Karvea is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Karvea' i manustamisel neerufunktsiooni häirega patsientidele on soovitatav perioodiliselt kontrollida kaaliumi ja kreatiniini sisaldust seerumis.