natgillin/translations-raw huggingface dataset:
Abdominal pain Pruritus, rash erythematous
abdominalne bolečine pruritus, eritemski osip bolečine v hrbtu
Musculoskeletal, connective tissue and bone disorders
splošne težave in spremembe na mestu aplikacije
General disorders and administration site conditions
bolečine na mestu injiciranja, reakcije na mestu injiciranja, vključno modrice, vnetja in parestezija
Injection site pain, injection site reaction, including bruising, burning and paraesthesia at the injection site
bolečine v prsih, neopredeljena bolečina, astenija
Chest pain, pain no organ system, asthenia
Poročali so o enem pojavu senzorno- motorične pareze.
Post marketing Rare cases suggestive of hypersensitivity, which could include skin erythema, bradycardia, hypotension or anaphylactic shock have been reported following the injection of SonoVue.
Spremljanje izdelka na trgu Redki primeri, ki spominjajo na preobčutljivost in vključujejo: kožna rdečina, bradikardija, hipotenzija ali anafilaktični šok so bili zaznani po injiciranju SonoVue.
In some of these cases, in patients with underlying coronary artery disease, bradycardia and hypotension were accompanied by myocardial ischemia and/ or myocardial infarctions.
Pri nekaterih od teh primerov, pri bolnikih z osnovno boleznijo koronarnih arterij, bradikardijo in hipotenzijo, je bilo zaslediti še miokardno ishemijo in/ ali miokardni infarkt.
In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue.
V zelo redkih primerih so bili zabeleženi smrtni izidi ob dajanju SonoVue.
In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.
Pri vseh teh bolnikih je bila velika verjetnost resnih srčnih zapletov, ki so lahko pripeljali do smrtnega izida.
VO8DA.
Farmakoterapevtska skupina: ultrazvočna kontrastna sredstva Oznaka ATC:
The addition of sodium chloride 9 mg/ ml (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride.
VO8DA Dodatek 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje k liofiliziranemu prašku ob močnem stresanju ustvari mikromehurčke žveplovega heksafluorida.
The microbubbles have a mean diameter of about 2.5 µm, with 90% having a diameter less than 6 µm and 99% having a diameter less than 11 µm.
Mikromehurčki imajo povprečni premer okrog 2, 5 µm, pri tem ima 90% premer manjši od 6 µm in 99% premer manjši od 11 µm.
5 increase in signal intensity of more than 2 minutes for B-mode imaging in echocardiography and of 3 to 8 minutes for Doppler imaging of the macrovasculature and microvasculature.
Pri predlaganih kliničnih odmerkih izkazuje SonoVue znaten porast jakosti signala za več kot 2 minuti pri ehokardiografiji z B- načinom slikanja in za 3 do 8 minut pri dopplerskem slikanju velikih žil in mikrovaskularizacije.
Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions.
5 Žveplov heksafluorid je inertnen, neškodljiv plin, slabo topen v vodnih raztopinah.
After a single intravenous injection of 0.03 or 0.3 ml of SonoVue/ kg (approximately 1 and 10 times the maximum clinical dose) to human volunteers, the sulphur hexafluoride was cleared rapidly.
Po enkratnem intravenskem injiciranju 0, 03 ali 0, 3 ml SonoVue/ kg (približno 1 do 10 kratnik maksimalnega kliničnega odmerka) prostovoljcem, se je žveplov heksafluorid hitro izločil.
Macrogol 4000 Distearoylphosphatidylcholine Dipalmitoylphosphatidylglycerol Sodium Palmitic acid
Prašek: makrogol 4000 distearilfosfatidilholin natrijev fosfatidilglicerildipalmitat palmitinska kislina
Sodium chloride 9 mg/ ml (0.9%) solution for injection
9 mg/ ml (0, 9%) raztopina natrijevega klorida za injiciranje
In the absence of compatibility studies, SonoVue should not be admixed with any other medicinal product except the solvent provided.
Zaradi pomanjkanja študij o kompatibilnosti SonoVue ne smemo mešati z nobenim drugim zdravilom razen s priloženim vehiklom.
Presentation 02 (with separate MiniSpike transfer system):
6 Pakiranje 02 (z ločenim MiniSpike sistemom za prenos)
Type I glass pre-filled syringe containing 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection.
Napolnjena injekcijska brizga iz stekla tipa I s 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje.
SonoVue must be prepared before use by injecting through the septum 5 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to the contents of the vial.
Skozi zamašek k vsebini viale vbrizgajte 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje.
The vial is then shaken vigorously for twenty seconds after which the desired volume of the dispersion can be drawn into a syringe as follows, depending on the presentation:
Nato vialo močno stresajte 20 sekund, nato pa z injekcijsko brizgo odvzamite želeni volumen disperzije po sledečem postopku, odvisno od pakiranja:
Open the MiniSpike transfer system blister and remove syringe tip cap.
Odprite pokrovček sistema za prenos in namestite injekcijsko brizgo na sistem za prenos s privijanjem v smeri gibanja urnega kazalca.
Remove Flipcap glass protective disk from the vial.
Z viale odstranite stekleno zaščitno ploščico.
Shake vigorously for 20 seconds to mix all the contents in the vial (white milky liquid).
Močno stresajte 20 sekund, da se vsebina viale premeša (nastane mlečna tekočina).
SonoVue should be administered immediately by injection into a peripheral vein.
SonoVue morate aplicirati takoj z injiciranjem v periferno veno.
After reconstitution, a homogeneous white milky liquid is obtained.
Če so vidni trdi delci ali če disperzija ni homogena se mora izdelek zavreči.
If solid parts of the lyophilisate are seen or the suspension is not homogeneous, the product should be discarded.
Če se zdravila SonoVue ne porabi takoj po rekonstituiranju se mora disperzijo ponovno pretresti predno se jo posesa v injekcijsko brizgo.
If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe.
Če SonoVue ne uporabite takoj po pripravi, morate disperzijo mikromehurčkov ponovno pretresti preden jo potegnete v injekcijsko brizgo.
Any unused dispersion remaining at the end of an examination or waste material must be discarded in accordance with local requirements.
Vso neuporabljeno disperzijo, ki je ostala po pregledu in odpadni material, zavrzite v skladu z lokalnimi predpisi.
Strawinskylaan 3051 NL - 1077 ZX Amsterdam The Netherlands
Strawinskylaan 3051 NL - 1077 ZX Amsterdam Nizozemska
26 March 2001 / 24 April 2006
26/ 03/ 2001 / 24 April 2006
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Via Ribes 5, Biondustry Park Colleretto Giacosa - 10010 (TO) Italy
Bracco Imaging S. p. A Via Ribes 5, Biondustry Park Colleretto Giacosa - 10010 (TO) Italija
Not applicable.
Navedba smiselno ni primerna.
The MAH will provide a PSUR covering the period 01/ 10/ 2005 to 30/ 09/ 2006 and continue with yearly PSURs unless otherwise agreed with CHMP.
Imetnik dovoljenja za promet bo zagotavljal Redna poročila o neželenih škodljivih učinkih (PSUR - Periodic Safety Update Report) za obdobje 01/ 10/ 2005 do 30/ 09/ 2006.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
12 PODATKI NA ZUNANJI IN PRIMARNI OVOJNINI
SonoVue sulphur hexafluoride microbubbles 8 microlitres/ ml Powder and solvent for dispersion for injection
SonoVue, žveplov heksafluorid v obliki mikromehurčkov 8 mikrolitrov/ ml. prašek in vehikel za disperzijo za injiciranje.
Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol sodium, palmitic acid.
Vehikel:
Solvent: sodium chloride 9 mg/ ml (0.9%) solution for injection.
9 mg/ ml (0, 9%) raztopina natrijevega klorida za injiciranje.
1 vial containing 25 mg lyophilized powder to be reconstituted with 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection 1 pre-filled syringe containing sodium chloride 9 mg/ ml (0.9%) solution for injection 1 Mini-Spike Plus 6/ 8 (CE 0123) transfer system.
1 Mini- Spike Plus 6/ 8 (CE 0123) sistem za prenos.
Intravenous use Read carefully the package leaflet before use.
Intravenska uporaba Pred uporabo preberite priloženo navodilo.
Exp:
Uporabno do:
For single use only, discard any unused portion
Neuporabljeno zdravilo zavrzite.
Bracco International B. V., Strawinskylaan 3051, NL - 1077 ZX Amsterdam, The Netherlands
Bracco International B. V., Strawinskylaan 3051, NL - 1077 ZX Amsterdam, Nizozemska
EU/ 1/ 01/ 177/ 002
EU/ 1/ 01/ 177/ 02
SonoVue 8 microlitres/ ml powder for dispersion for injection
SonoVue, 8 mikrolitrov/ ml prašek in vehikel za disperzijo za injiciranje
25 mg lyophilised powder to be reconstituted with 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection before administration.
Pred dajanjem 25 mg liofiliziranega praška rekonstituiramo s 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje.
Sodium chloride 9 mg/ ml solution for injection
9 mg/ ml (0, 9%) raztopina natrijevega klorida za injiciranje
SonoVue 8 microlitres/ ml powder and solvent for dispersion for injection sulphur hexafluoride
17 NAVODILO ZA UPORABO SonoVue, 8 mikrolitrov/ ml, prašek in vehikel za disperzijo za injiciranje žveplov heksafluorid
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 neželeni ulčinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
In this leaflet:
Vsebina navodila:
What SonoVue is and what it is used for Before you use SonoVue How to use SonoVue Possible side effects How to store SonoVue Further information
Kaj je SonoVue in za kaj ga uporabljamo Kaj morate vedeti predno boste uporabili SonoVue Kako uporabljati SonoVue Možni neželeni učinki Shranjevanje zdravila SonoVue Dodatne informacije
WHAT SONOVUE IS AND WHAT IT IS USED FOR
KAJ JE SONOVUE IN ZA KAJ GA UPORABLJAMO
SonoVue is a contrast agent for ultrasound scans of blood vessels and tissues of the body.
SonoVue je kontrastno sredstvo za ultrazvočni pregled ožilja in telesnih tkiv.
SonoVue is a dispersion containing millions of tiny bubbles (microbubbles).
SonoVue je disperzija, ki vsebuje milijone drobnih mehurčkov (mikromehurčki).
Each of these bubbles is smaller than a red blood cell.
Vsak mehurček je manjši od rdečih krvnih telesc.
The bubbles act as a reflector of the ultrasound beam and provide a better echo than the tissues of the body.
Mehurčki delujejo kot reflektorji za ultrazvočni snop in zagotavljajo boljši odboj kot pa telesna tkiva.
SonoVue is a contrast agent that reflects ultrasound waves differently from the tissues of the body and improves the picture from the scan.
SonoVue je kontrastno sredstvo, ki odbija ultrazvočne valove različno od telesnih tkiv in tako izboljša sliko pri pregledu.
This helps your doctor to identify the part of your body or blood vessel and to see any abnormalities.
To pomaga zdravniku, da pregleda del telesa ali del krvnih žil in ugotovi kakršnokoli nepravilnost.
SonoVue can be used for scans of the chambers of the heart, scans of large blood vessels and scans to assess lesions in the breast and the liver.
SonoVue uporabljamo pri pregledu srčnih komor, velikih krvnih žil in za oceno lezij v prsih in jetrih.
BEFORE YOU USE SONOVUE
KAJ MORATE VEDETI PREDEN BOSTE UPORABILI SONOVUE
Do not use SonoVue:
Ne uporabljajte SonoVue:
If you are allergic (hypersensitive) to sulphur hexafluoride or any of the other ingredients of SonoVue or if you have:
če ste alergični (preobčutljivi) na žveplov heksafluorid ali na katerokoli drugo sestavino SonoVue.
had a myocardial infarction and you still suffer from frequent and/ or repeated angina or chest pain,
če ste imeli miokardni infark in imate še vedno pogoste ali ponavljajoče bolečine v prsih ali angino,
had a recent coronary artery intervention, recent changes in your electrocardiogram, frequent and/ or repeated angina or chest pain in the past 7 days, heart failure, severe heart rhythm disorders, right-to-left shunts of the heart, severe increase in pulmonary artery blood pressure, uncontrolled hypertension, adult respiratory distress syndrome.
če ste imeli nedavno poseg na koronarnih arterijah, nedavno spremembo EKG pogosto ali ponavljajočo se angino ali bolečine v prsnem košu v zadnjih sedmih dneh, odpoved srca hudo aritmijo desno- levi šant, hudo zvišanje pljučnega arterijskega tlaka, nenadzorovano hipertenzijo, respiratorni distresni sindromom
had frequent and/ or repeated angina or chest pain, especially if you have history of heart disease,
pogosto ali ponavljajočo se angino ali bolečine v prsnem košu, predvsem če ste imeli v preteklostiodpoved srca
recent electrocardiography changes.
nedavno spremembo EKG
Take special care with SonoVue:
Bodite posebno pozorni pri uporabi zdravila SonoVue:
during SonoVue-enhanced echocardiography examination with a pharmacological stress, when ECG and blood pressure should be carefully monitored,
med uporabo zdravila SonoVue pri ehokardiografiji s farmakološko obremenitvijo, pri kateri moramo snemati EKG in nadzorovati krvni tlak,
in case you have severe lung disease and shortage of breath, in case you have a neurological illness which is unstable, respiratory ventilation, acute endocarditis, artificial heart valves, acute systemic inflammation and/ or sepsis, hyperactive coagulation states and/ or recent thromboembolism, advanced kidney or liver diseases.
v primeru, če imete težko pljučno obolenje in kratko sapo, v primeru, če imete nestabilne nevrološke bolezni, umetno ventilacijo, akutnim endokarditisom, umetne srčne zaklopke, akutno sistemsko vnetje in/ ali sepso, hiperaktivne motnje koagulacije in/ ali nedavno trombembolijo, odpoved jeter ali ledvic.
There are no reports of reactions between SonoVue and other medicines.
Ni poročil o medsebojnem delovanju med zdravilom SonoVue in drugimi zdravili.
However, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Vendar obvestite svojega zdravnika, če jemljete katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Pregnancy and breast-feeding SonoVue has not been studied in pregnant women.
Študije o uporabi zdravila SonoVue pri nosečnicah niso bile izvedene.
Danger to a developing baby is not expected.
Ni pričakovati nevarnosti za razvoj otroka.
If you are pregnant, or think that you might be pregnant tell your doctor.
Če ste noseči, ali mislite da ste noseči, povejte to svojemu zdravniku.
If you are breast feeding tell your doctor.
Če dojite, povejte to svojemu zdravniku.
It is not known if SonoVue passes into breast milk.
Ni znano ali SonoVue prehaja v materino mleko.
Your doctor will advise you if you should stop feeding for a short time after your ultrasound examination.
Zdravnik bo odločil, če je potrebno prekiniti dojenje za kratek čas po ultrazvočni preiskavi.
Ask your doctor for advice before taking any medicine.
Posvetujte se z zdravnikom preden vzamete katerokoli zdravilo.
HOW TO USE SONOVUE
KAKO UPORABLJATI SONOVUE
After reconstitution, SonoVue is a homogeneous white milky dispersion.
Po rekonstituiranju je SonoVue homogena belomlečna disperzija.
If solid parts are seen or the dispersion is not homogeneous, the product will be discarded.
Če so vidni trdi delci ali če disperzija ni homogena se mora izdelek zavreči.
If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
Če se zdravila SonoVue ne porabi takoj po rekonstituiranju se mora disperzijo ponovno pretresti predno se jo posesa v injekcijsko brizgo.
SonoVue is injected into a vein, usually in your arm.
SonoVue injiciramo v veno, običajno na roki.
The amount that you will be given depends on which part of your body is being scanned.
Količina zdravila, ki ga boste prejeli, je odvisna od tega, kateri del telesa bo pregledan.
The usual dose is 2 or 2.4 ml of the dispersion.
Običajni odmerek znaša 2 ali 2, 4 ml disperzije.
This dose might be repeated.
Ta odmerek se lahko ponovi.
The medical staff supervising your scan will administer the injection of SonoVue to you.
Injekcijo SonoVue vam bo dala oseba, ki nadzira preiskavo.
The dose is the same in adult and elderly patients, however SonoVue should not be given to patients under 18 years old.
Odmerek je enak pri odraslih osebah in starejših bolnikih, vendar se SonoVue ne sme dati bolnikom, ki so mlajši od 18 let.
You will be monitored for 30 minutes after your examination.
Opazovani boste 30 minut po pregledu.
The product is for a single examination only.
Zdravilo je namenjeno samo enkratni uporabi.
Any unused liquid remaining at the end of an examination must be discarded.
Neuporabljena količina tekočine ob koncu preiskave se mora zavreči.
If you have any further questions on the use of this product, ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila se posvetujte z zdravnikom.
Like all medicines, SonoVue can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi SonoVue neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
There is a risk of severe allergy-like reactions, including anaphylactic shock.
Obstoja tveganje za resne, alergijam podobne reakcije vključno z anafilaktičnim šokom.
Most of the side effects that have been reported with SonoVue during clinical trials have been mild and were not prolonged.
Večina neželenih učinkov, o katerih so poročali pri uporabi zdravila SonoVue v kliničnih preskušanjih je blagih in kratkotrajnih.
The commonly reported side effects include: headache; nausea; pain, burning, bruising or numbness where the injection was given.
Pogosto navajani neželeni učinki so: glavobol, navzea, bolečina, pekoč občutek, modrica ali otrplost na mestu injiciranja.
19 Side effects less commonly reported include: itching; rash; abdominal, chest or back pain and pain in general; vasodilatation; increase in blood sugar levels; blurred vision; irritation in the throat; sinus pressure; numbness in part of the body; dizziness; difficulty in sleeping; feeling weak; a strange taste.
Manj običajno navajani neželeni učinki vključujejo: srbečico, izpuščaj, bolečine v trebuhu, bolečine v prsih in hrbtu in splošne bolečine, vazodilatacijo, zvišan nivo sladkorja v krvi, zamegljen vid, draženje v grlu, pritisk v sinusih, otrplost v delu telesa, vrtoglavica, motnje spanja, slabotnost, nenavaden okus.
If you think that you notice any side effects after receiving an injection of SonoVue, tell the medical staff supervising your scan.
Če mislite, da so se pri vas pojavili neželeni učinki po prejetju injekcije SonoVue, povejte to osebi, ki izvaja pregled z ultrazvokom.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
19 Če katerikoli neželeni učinek postane resen ali če opazite neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE SONOVUE
SHRANJEVANJE ZDRAVILA SONOVUE
SonoVue dispersion should be administered to you within six hours of its preparation.
Disperzija zdravila SonoVUe mora biti porabljena v roku šestih ur po pripravi.
The active substance is sulphur hexafluoride in the form of microbubbles.
Kaj vsebuje SonoVue Zdravilna učinkovina je žveplov heksafluorid v obliki mehurčkov.
The glass syringe contains sodium chloride 9 mg/ ml (0.9%) solution for injection.
Pomožne snovi: makrogol 4000, distearilfosfatidilholin, natrijev fosfatidilglicerildipalmitat, palmitinska kislina Steklena injekcijska brizga vsebuje 9 mg/ ml (0, 9%) raztopino natrijevega klorida za injiciranje.
What SonoVue looks like and content of the pack
Izgled zdravila SonoVue in vsebina pakiranja:
SonoVue is a kit which includes a glass vial containing white powder, a glass syringe containing the solvent and a transfer system.
SonoVue je pakiran v kompletu, ki vsebuje bel prašek, stekleno injekcijsko brizgo s topilom in sistem za prenos.
Bracco International B. V.
Imetnik dovoljenja za promet z zdravilom Bracco International B. V.
Strawinskylaan 3051 NL - 1077 ZX Amsterdam The Netherlands
Stawinskylaan 3051 1077ZX Amsterdam Nizozemska
Via Ribes 5, Biondustry Park Colleretto Giacosa - 10010 (TO) Italy
Izdelovalec Bracco Imaging S. p. A Via Ribes 5, Biondustry Park Colleretto Giacosa - 10010 (TO) Italija
20 The following information is intended for medical or healthcare professionals only:
20 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Presentation 02 (with separate MiniSpike transfer system (CE 0123))
Pakiranje 02 (z ločenim MiniSpike sistemom za prenos (CE0123))
Sprimeo is a medicine containing the active substance aliskiren.
Sprimeo je zdravilo, ki vsebuje zdravilno učinkovino aliskiren.
Sprimeo is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Zdravilo Sprimeo se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka).
The recommended dose of Sprimeo is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Priporočeni odmerek zdravila Sprimeo znaša 150 mg enkrat dnevno, bodisi samostojno ali v kombinaciji z drugimi zdravili za zdravljenje hipertenzije.
Sprimeo is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Zdravilo Sprimeo ni priporočeno za otroke, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej skupini.
The effects of Sprimeo were first tested in experimental models before being studied in humans.
Učinki zdravila Sprimeo so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Sprimeo was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Zdravilo Sprimeo so raziskali v 14 glavnih študijah, ki so vključevale preko 10. 000 bolnikov z esencialno hipertenzijo.
Sprimeo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Zdravilo Sprimeo so, bodisi kot samostojno zdravilo ali v kombinaciji z drugimi zdravili, primerjali tudi z drugimi zdravili za zdravljenje hipertenzije.
Combination studies looked at Sprimeo used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V študijah kombinacij zdravil so raziskovali 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diuretic (hydrochlorothiazide).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged zdravilo Sprimeo v kombinaciji z zaviralcem angiotenzinske konvertaze (ramipril), zaviralcem angiotenzinskih receptorjev (valsartan), zaviralcem receptorjev beta (atenolol), zaviralcem kalcijevih kanalčkov (amlodipin) in diuretikom (hidroklorotiazid).
Sprimeo on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Zdravilo Sprimeo kot samostojno zdravilo je bilo pri zdravljenju visokega krvnega tlaka bolj učinkovito kot placebo in enako učinkovito kot zdravljenja s primerljivimi zdravili.