natgillin/translations-raw huggingface dataset:
The following side effects have occurred rarely (> 1/ 10,000, < 1/ 1,000) after treatment with METALYSE:
Redki (> 1/ 10. 000, < 1/ 1. 000) neželeni učinki, ki so se pojavili po zdravljenju z zdravilom METALYSE:
− bleeding into the area surrounding the heart (haemopericardium) − blood clot in the lung (pulmonary embolism)
− krvavitev v osrčnik (hemoperikardij), − krvni strdek v pljučih (pljučna embolija).
The following side effects have occurred very rarely (< 1/ 10,000) after treatment with METALYSE:
Zelo redki (< 1/ 10. 000) neželeni učinki, ki so se pojavili po zdravljenju z zdravilom METALYSE:
− crystal cholesterol clots − bleeding in the eyes (eye haemorrhage)
- strdki iz kristalov holesterola,
In case of bleeding in the brain events related to the nervous system have been reported e. g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
53 V primerih, ko je prišlo do krvavitve v možganih, so poročali o posameznih dogodkih, povezanih z živčnim sistemom, kot so dremavost (somnolenca), motnje govora, ohromelost telesnih delov (hemipareza) in krče (konvulzije).
Tell your doctor immediately if you think you are experiencing any of these side effects.
Če opazite katerega od naštetih neželenih učinkov, nemudoma obvestite svojega zdravnika.
54 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželen učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE METALYSE
SHRANJEVANJE ZDRAVILA METALYSE
Once METALYSE has been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C.
Pripravljeno zdravilo METALYSE je mogoče hraniti do 24 ur pri 2 do 8 °C in do 8 ur pri 30 °C.
Do not use METALYSE after the expiry date which is stated on the label/ carton.
Zdravila METALYSE ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini / škatli.
What METALYSE contains
Kaj vsebuje zdravilo METALYSE
− The active substance is tenecteplase.
− Zdravilna učinkovina je tenekteplaza.
One vial contains 6,000 units of tenecteplase.
Ena viala vsebuje 6. 000 enot tenekteplaze.
One pre- filled syringe contains 6 ml of water for injections. − The other ingredients are L-arginine, phosphoric acid and polysorbate 20. − The METALYSE solvent is water for injections.
Ena napolnjena injekcijska brizga vsebuje 6 ml vode za injekcije. − Pomožne snovi so L- arginin, fosforjeva kislina in polisorbat 20. − Vehikel zdravila METALYSE je voda za injekcije.
What METALYSE looks like and contents of the pack The folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.
Izgled zdravila METALYSE in vsebina pakiranja Škatla vsebuje eno vialo z liofiliziranim praškom, eno brizgo z vehiklom, pripravljeno za uporabo, en adapter za vialo in eno iglo.
KG Birkendorfer Strasse 65 D-88397 Biberach/ Riss Germany
KG Birkendorferstrasse 65 D- 88397 Biberach/ Riss Nemčija
55 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
54 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
56 Latvija Boehringer Ingelheim Pharma GmbH Pā rstā vniecī ba Latvijā Tel: +371 7 240 068
55 Latvija Boehringer Ingelheim Pharma GmbH Pārstāvniecība Latvijā Tel: +371 7 240 068
This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno {MM/ YYYY}.
INFORMATION FOR THE USER
56 NAVODILO ZA UPORABO
METALYSE 8,000 units powder and solvent for solution for injection Tenecteplase
METALYSE 8. 000 enot prašek in vehikel za raztopino za injiciranje tenekteplaza
− one vial of 8,000 units METALYSE powder and one pre-filled syringe containing 8 ml water for injections
– eno vialo z 8. 000 enotami praška METALYSE in eno napolnjeno brizgo z 8 ml vode za injekcije.
58 inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis);
57 nepravilnosti krvnih žil (npr. anevrizmo), nekatere vrste tumorjev, vnetje osrčnika (perikarditis); vnetje ali okužbo srčnih zaklopk (endokarditis);
− if you are taking tablets/ capsules used to ” thin” the blood, such as warfarin or coumarin (anti- coagulants); − if you have an inflamed pancreas (pancreatitis); − if you have recently had major surgery including surgery to your brain or spine; − if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks.
− če jemljete tablete ali kapsule za "redčenje" krvi, npr. varfarin ali kumarin (antikoagulanse); − če imate vnetje trebušne slinavke (pankreatitis); − če ste pred nedavnim imeli večjo operacijo, tudi možganov ali hrbtenjače; − če so vas v preteklih dveh tednih oživljali z masažo srca in umetnim dihanjem (pritiski na prsni koš) dlje kot 2 minuti.
Like all medicines, METALYSE can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravila METALYSE neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
59 The following side effects are very common (> 1/ 10) with METALYSE:
Zelo pogosti (> 1/ 10) neželeni učinki zdravila METALYSE:
In case of bleeding in the brain events related to the nervous system have been reported e. g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
59 V primerih, ko je prišlo do krvavitve v možganih, so poročali o posameznih dogodkih, povezanih z živčnim sistemom, kot so dremavost (somnolenca), motnje govora, ohromelost telesnih delov (hemipareza) in krče (konvulzije).
60 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželen učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
One vial contains 8,000 units of tenecteplase.
Ena viala vsebuje 8. 000 enot tenekteplaze.
One pre- filled syringe contains 8 ml of water for injections. − The other ingredients are L-arginine, phosphoric acid and polysorbate 20. − The METALYSE solvent is water for injections.
Ena napolnjena injekcijska brizga vsebuje 8 ml vode za injekcije. − Pomožne snovi so L- arginin, fosforjeva kislina in polisorbat 20. − Vehikel zdravila METALYSE je voda za injekcije.
61 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
60 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
62 Latvija Boehringer Ingelheim Pharma GmbH Pā rstā vniecī ba Latvijā Tel: +371 7 240 068
61 Latvija Boehringer Ingelheim Pharma GmbH Pārstāvniecība Latvijā Tel: +371 7 240 068
METALYSE 10,000 units powder and solvent for solution for injection Tenecteplase
METALYSE 10. 000 enot prašek in vehikel za raztopino za injiciranje tenekteplaza
− one vial of 10,000 units METALYSE powder and one pre-filled syringe containing 10 ml water for injections.
– eno vialo z 10. 000 enotami praška METALYSE in eno napolnjeno brizgo z 10 ml vode za injekcije.
64 inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis);
63 nepravilnosti krvnih žil (npr. anevrizmo), nekatere vrste tumorjev, vnetje osrčnika (perikarditis); vnetje ali okužbo srčnih zaklopk (endokarditis);
65 The following side effects are very common (> 1/ 10) with METALYSE:
Zelo pogosti (> 1/ 10) neželeni učinki zdravila METALYSE:
The following side effects have occurred very rarely (< 1/ 10,000) after treatment with METALYSE:
Zelo redki (< 10. 000) neželeni učinki, ki so se pojavili po zdravljenju z zdravilom METALYSE:
In case of bleeding in the brain events related to the nervous system have been reported e. g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
65 V primerih, ko je prišlo do krvavitve v možganih, so poročali o posameznih dogodkih, povezanih z živčnim sistemom, kot so dremavost (somnolenca), motnje govora, ohromelost telesnih delov (hemipareza) in krče (konvulzije).
66 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če postane katerikoli neželen učinek resen ali če opazite katerikoli neželen učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
One vial contains 10,000 units of tenecteplase.
Ena viala vsebuje 10. 000 enot tenekteplaze.
One pre- filled syringe contains 10 ml of water for injections. − The other ingredients are L-arginine, phosphoric acid and polysorbate 20. − The METALYSE solvent is water for injections.
Ena napolnjena injekcijska brizga vsebuje 10 ml vode za injekcije. − Pomožne snovi so L- arginin, fosforjeva kislina in polisorbat 20. − Vehikel zdravila METALYSE je voda za injekcije.
67 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
66 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
68 Latvija Boehringer Ingelheim Pharma GmbH Pā rstā vniecī ba Latvijā Tel: +371 7 240 068
67 Latvija Boehringer Ingelheim Pharma GmbH Pārstāvniecība Latvijā Tel: +371 7 240 068
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC) blister (PA/ alu/ PVC)
pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) prestisni omot( PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC)
14 tablets 28 tablets 56 tablets 98 tablets 14 tablets 28 tablets 56 tablets 98 tablets 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 28 x 1 tablets 84 tablets 84 tablets 30 tablets 30 tablets 90 tablets 90 tablets
14 tablet 28 tablet 56 tablet 98 tablet 14 tablet 28 tablet 56 tablet 98 tablet 14 tablet 28 tablet 56 tablet 98 tablet 28 x 1 tableta 28 x 1 tableta 84 tablet 84 tablet 30 tablet 30 tablet 90 tablet 90 tablet
Micardis is used in adults who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
Zdravilo Micardis se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
Micardis is taken by mouth, with or without food.
Zdravilo Micardis se zaužije peroralno, s hrano ali brez nje.
The recommended dose is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Priporočeni odmerek znaša 40 mg enkrat dnevno, toda za nekatere bolnike zadostuje že 20- miligramski odmerek.
The active substance in Micardis, telmisartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Micardis, telmisartan, je „ antagonist receptorjev angiotenzina II “, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Posledica tega je znižanje krvnega tlaka in zmanjšanje tveganja za poškodbe, ki jih povzroča visok krvni tlak, kot je denimo kap.
Micardis has been studied in 1,647 patients who were treated with telmisartan either alone or in combination with hydrochlorothiazide.
Zdravilo Micardis so raziskali pri 1 647 bolnikih, ki so bili zdravljeni bodisi samo s telmisartanom ali pa s telmisartanom v kombinaciji s hidroklorotiazidom.
Micardis was compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Zdravilo Micardis so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenolol, lizinopril, enalapril in amlodipin).
Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Zdravilo Micardis je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje povišanega krvnega tlaka.
However, the following side effects are seen in between 1 and 10 patients in 1,000: hyperkalaemia (high blood potassium levels), syncope (fainting), insomnia (difficulty sleeping), vertigo (a spinning sensation), hypotension (low blood pressure), dyspnoea (difficulty breathing), abdominal (tummy) pain, diarrhoea, dry mouth, dyspepsia (heartburn), flatulence (gas), hyperhidrosis (excessive sweating), pruritus (itching), myalgia (muscle pain), renal impairment (kidney problems) including renal failure (kidney failure), and chest pain.
Pri 1 do 10 bolnikih izmed 1 000 so bili opaženi naslednji neželeni učinki: hiperkaliemija (visoke ravni kalija v krvi), sinkopa (kratkotrajna izguba zavesti), nespečnost, vrtoglavica, hipotenzija (nizek krvni tlak), dispneja (oteženo dihanje), bolečine v trebuhu, driska, suha usta, dispepsija (slaba prebava in zgaga), napenjanje, hiperhidroza (prekomerno potenje), pruritus (srbenje), miaglija (bolečine v mišicah), okvara ledvic, vključno z odpovedjo ledvic, in bolečine v prsnem košu.
For the full list of all side effects reported with Micardis, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Micardis, glejte navodilo za uporabo.
Micardis should not be used in people who may be hypersensitive (allergic) to telmisartan or any of the other ingredients.
Zdravila Micardis ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Micardis’ s benefits are greater than its risks for the treatment of essential hypertension in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Micardis pri zdravljenju esencialne hipertenzije pri odraslih večje od z njim povezanih tveganj.
The Committee recommended that Micardis be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Micardis odobri dovoljenje za promet.
Other information about Micardis:
Druge informacije o zdravilu Micardis:
The European Commission granted a marketing authorisation valid throughout the European Union for Micardis to Boehringer Ingelheim International GmbH on 16 December 1998.
Evropska komisija je dovoljenje za promet z zdravilom Micardis, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim International GmbH dne 16. decembra 1998.
The full EPAR for Micardis is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Micardis je na voljo tukaj.
In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see section 4.4).
Odmerek za bolnike z blago do zmerno jetrno okvaro ne sme prekoračiti 40 mg 1- krat na dan (glejte poglavje 4. 4).
Paediatric patients Micardis is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Pediatrični bolniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba Micardisa pri otrocih pod 18 let ni priporočljiva.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1)
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1) • drugo in tretje trimesečje nosečnosti (glejte poglavji 4. 4 in 4. 6) • dojenje (glejte poglavje 4. 6)
2 • Second and third trimester of pregnancy (see sections 4.4 and 4.6) • Lactation (see section 4.6) • Biliary obstructive disorders • Severe hepatic impairment
2 • obolenja z zaporo žolčevoda • huda jetrna okvara
Micardis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Micardisa ne dajemo bolnikom, ki imajo holestazo, obolenja z zaporo žolčevoda ali hudo jetrno okvaro (glejte poglavje 4. 3), ker se telmisartan pretežno izloča z žolčem.
Micardis should be used only with caution in patients with mild to moderate hepatic impairment.
Micardis moramo previdno dajati bolnikom z zmerno hudo do hudo jetrno okvaro.
When Micardis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Kadar bolnike z ledvično okvaro zdravimo z Micardisom, moramo periodično nadzorovati serumski ravni kalija in kreatinina.
There is no experience regarding the administration of Micardis in patients with recent kidney transplantation.
Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo Micardisa.
Symptomatic hypotension, especially after the first dose of Micardis, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pri bolnikih z zmanjšanim volumnom krvi in/ ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku Micardisa lahko pojavi simptomatična hipotenzija.
Such conditions should be corrected before the administration of Micardis.
Tovrstna stanja moramo uravnati pred zdravljenjem z Micardisom.
Volume and/ or sodium depletion should be corrected prior to administration of Micardis.
Pomanjkanje volumna ali natrija ali obe stanji moramo uravnati pred začetkom zdravljenja z Micardisom.
Hyperkalaemia:
3 Hiperkaliemija:
Patients with rare hereditary problems of fructose intolerance should not take Micardis.
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati Micardisa.
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Telmisartan lahko tako kot druga zdravila, ki delujejo na renin- angiotenzin- aldosteronski sistem, povzroči hiperkaliemijo (glejte poglavje 4. 4).
A
Zlasti veliko je pri kombinaciji z diuretiki, ki zadržujejo kalij, in če jih kombiniramo z nadomestki soli s kalijem.
4 combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Na primer kombinacija z zaviralci ACE ali nesteroidnimi protivnetnimi zdravili je manj tvegana, če natančno upoštevamo previdnostne ukrepe za uporabo.
Potassium sparing diuretics e. g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Diuretiki, ki zadržujejo kalij, na primer spironolakton, eplerenon, triamteren ali
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Med sočasnim dajanjem litija in zaviralcev angiotenzin- konvertaze ter, antagonistov receptorjev angiotenzina II, vključno s telmisartanom, so poročali o reverzibilnem povečanju ravni litija v serumu in toksičnih pojavih.
Pregnancy (see section 4.3 and 4.4):
Uporaba med nosečnostjo (glejte poglavje 4. 3 in 4. 4):
There are no adequate data from the use of Micardis in pregnant women.
Ni zadostnih podatkov o uporabi Micardisa pri nosečnicah.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z
Telmisartan is contraindicated during lactation since it is not known whether it is excreted in human milk.
Telmisartan je kontraindiciran med dojenjem, ker ni znano, ali se izloča z materinim mlekom.
Upper respiratory tract infection including pharyngitis and sinusitis Urinary tract infection including cystitis
okužba zgornjih dihal, tudi faringitis in sinuzitis okužba sečil, tudi cistitis
Metabolism and nutrition disorders
Presnovne
Uncommon:
in prehranske motnje Občasni:
Abdominal pain, diarrhoea, dry mouth, dyspepsia, flatulence Stomach upset, vomiting
želodčne težave, bruhanje
Hyperhidrosis, pruritus Erythema, angioedema, urticaria Drug eruption, toxic skin eruption, rash, eczema
hiperhidroza, pruritus eritem, angioedem, urtikarija medikamentni izpuščaj, toksični kožni izpuščaj, izpuščaj, ekcem
Haemoglobin decreased
zvišana raven sečne kisline v krvi, zvišana raven kreatinina v krvi, zvišana raven jetrnih encimov, zvišana raven kreatin- fosfokinaze v krvi znižana raven hemoglobina
There is limited information available with regard to overdose in humans.
7 O prevelikem odmerjanju pri ljudeh je na voljo malo podatkov.
8 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Telmisartan pri hipertenzivnih bolnikih znižuje sistolični in diastolični krvni tlak, ne da bi vplival na srčni utrip.
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
8 Pogostnost suhega kašlja je bila med bolniki, ki so se zdravili s telmisartanom, pomembno manjša kot pri tistih, ki so jemali zaviralce angiotenzinske konvertaze, kar dokazujejo rezultati kliničnih preskušanj, v katerih so neposredno primerjali obe vrsti antihipertenzivov.
9 Elderly patients:
Starejši bolniki:
Telmisartan is highly bound to plasma protein in renal-insufficient patients and cannot be removed by dialysis.
Telmisartan se pri bolnikih z ledvično okvaro obsežno veže na plazemske
Aluminium/ aluminium blisters (PA/ Al/ PVC/ Al or PA/ PA/ Al/ PVC/ Al).
10 Pretisni omoti iz aluminija/ aluminija (PA/ Al/ PVC/ Al ali PA/ PA/ Al/ PVC/ Al).
Blister with 14, 28, 56, or 98 tablets.
Velikost pakiranja: pretisni omot po 14, 28, 56 ali 98 tablet.
173 D-55216 Ingelheim am Rhein Germany
173 D- 55216 Ingelheim am Rhein Nemčija