natgillin/translations-raw huggingface dataset:
SonoVue can be used in Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions (areas of disease) in the breast or liver.
SonoVue se lahko uporablja pri Dopplerskih preiskavah velikih krvnih žil, npr. v glavi, ki potekajo do glave ali glavne vene do jeter, ali manjših krvnih žil, npr. pri lezijah (območjih bolezni) v prsih ali jetrih.
SonoVue should only be used by doctors who have experience in diagnostic ultrasound imaging.
Zdravilo SonoVue lahko daje samo zdravnik z izkušnjami v diagnostiki z ultrazvokom.
It is injected intravenously (into a vein) before the test is carried out, as a 2- or 2.4-ml dose depending on which test is being carried out.
Injicira se intravensko (v veno) pred izvedbo preiskave v odmerku 2 ali 2, 4 ml, odvisno od vrste preiskave, ki se izvaja.
The dose can be repeated.
Odmerek je mogoče ponoviti.
SonoVue has not been studied in patients aged 18 years or younger and should not be used in this group.
Zdravila SonoVue niso preučevali pri bolnikih, starih 18 let ali mlajših, zato se v tej starostni skupini ne sme uporabljati.
The active substance in SonoVue, sodium hexafluoride, is a gas that is not soluble in the blood.
Zdravilna učinkovina zdravila SonoVue, natrijev heksafluorid, je plin, ki v krvi ni topen.
When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles.
Ko se zdravilo SonoVue pripravi v obliki suspenzije, ostane plin zajet v majhnih mehurčkih, imenovanih mikromehurčki.
After injection, the microbubbles travel in the blood, where they reflect ultrasound waves more than the surrounding tissues.
Po injiciranju potujejo ti mikromehurčki v krvi, kjer odbijajo ultrazvočne valove bolj kot obdajajoča tkiva.
This helps to enhance the results of tests that rely on measuring ultrasound, such as echocardiography and Doppler tests.
To pomaga izboljšati rezultate ultrazvočnih preiskav, kot so ehokardiografija in Dopplerske preiskave.
The gas is removed from the body through the lungs.
Plin se iz telesa izloči skozi pljuča.
(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 How has SonoVue been studied?
(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 Kako je bilo zdravilo SonoVue raziskano?
SonoVue has been studied in a total of 895 patients in six main studies.
Zdravilo SonoVue so preučevali pri skupno 895 bolnikih v šestih glavnih študijah.
These included three studies of echocardiography and three studies of Doppler.
V treh študijah so preučevali učinek pri ehokardiografiji, v drugih treh pa učinek pri Dopplerjevi sonografiji.
The echocardiography studies involved a total of 317 patients, and compared the effects of SonoVue with those of another contrast agent and of placebo (a dummy treatment).
V študije z uporabo ehokardiografije je bilo vključenih skupno 317 bolnikov, primerjali pa so učinke zdravila SonoVue z učinki drugega kontrastnega sredstva in placeba.
The Doppler studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels.
V študije z uporabo Dopplerjeve sonografije je bilo vključenih 361 bolnikov, pri katerih so preučevali nenormalnosti v velikih krvnih žilah, in 217 bolnikov, pri katerih so preučevali nenormalnosti v manjših žilah.
In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared to the ‘ gold standard’, such as angiography (X-rays of blood vessels).
V teh študijah zdravila SonoVue niso primerjali z nobenim drugim zdravilom, vendar pa so rezultate preizkusa z zdravilom SonoVue primerjali z zlatim standardom, kot je npr. angiografija (rentgensko slikanje krvnih žil).
The main measure of effectiveness was how clear the images obtained in the test were.
Glavno merilo učinkovitosti je bila čistost slik, pridobljenih pri preiskavi.
What benefit has SonoVue shown during the studies?
Kakšne koristi je zdravilo SonoVue izkazalo med raziskavami?
In the echocardiography studies, SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.
V študijah z uporabo ehokardiografije je bilo zdravilo SonoVue pri izboljšanju čistosti slike levega prekata in roba levega prekata učinkovitejše od primerjalnega zdravila in placeba.
In the Doppler studies, using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys).
V študijah z uporabo Dopplerjeve sonografije je uporaba zdravila SonoVue pri meritvah toka krvi v velikih krvnih žilah izboljšala kakovost slike pri preiskavah cerebralnih arterij (v glavi), karotid (v vratu) in portalne vene (ki vodi do jeter), ne pa tudi ledvičnih arterij (ki vodijo proti ledvicam).
For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions.
Pri manjših žilah je zdravilo SonoVue izboljšalo kakovost slik toka krvi pri lezijah v prsih in jetrih.
However, this was not observed for lesions in the pancreas, kidney, ovary or prostate gland.
Vendar pa to ni veljalo za lezije v trebušni slinavki, ledvicah, jajčnikih ali prostati.
The most common side effects with SonoVue (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), injection site pain, injection site reactions, including bruising, burning, and paraesthesia (unusual sensations like pins and needles) at the injection site.
Najpogostejši neželeni učinki zdravila SonoVue (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, navzeja (slabost), bolečina in reakcije na mestu injiciranja, vključno s podplutbo, pekočim občutkom in parestezijo (neobičajnimi občutki zbadanja) na mestu injiciranja.
For the full list of all side effects reported with SonoVue, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila SonoVue, glejte Navodilo za uporabo.
SonoVue should not be used in people who may be hypersensitive (allergic) to sulphur hexafluoride or any of the other ingredients.
Zdravila SonoVue se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) žveplov heksafluorid ali katerokoli drugo sestavino zdravila.
SonoVue should also not be used in the following patients: • patients with recent acute coronary syndrome (symptoms involving the heart) or unstable ischaemic cardiac disease (reduced blood supply to the heart), • patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs), • pregnant or breast-feeding women.
Zdravila SonoVue prav tako ne smejo uporabljati naslednji bolniki: • bolniki z nedavnim akutnim koronarnim sindromom (simptomi, zajemajoči srce) ali nestabilno ishemično boleznijo srca (zmanjšanim dotokom krvi v srce), • bolniki z desno- levim šantom (nenormalnim gibanjem krvi po srcu), hudo pulmonalno hipertenzijo (visokim krvnim tlakom v pulmonalni arteriji, žili, ki vodi kri iz srca proti pljučem), nenadzorovano hipertenzijo (visokim krvnim tlakom) ali odrasli bolniki z respiratornim distresnim sindromom (hudim zastajanjem tekočine v obeh pljučnih krilih), • nosečnice ali doječe ženske.
The Committee for Medicinal products for Human Use (CHMP) decided that SonoVue’ s benefits are greater than its risks to enhance the echogenicity (ultrasound contrast) of the blood in echocardiography in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation, and in Doppler of macrovasculature (cerebral arteries, extracranial carotid or peripheral arteries and portal vein) or microvasculature (liver and breast lesions).
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila SonoVue za izboljšanje ehogenosti (ultrazvočnega kontrasta) krvi pri ehokardiografiji pri bolnikih s sumom na ali z dokazano kardiovaskularno boleznijo, z namenom da bi zagotovili opacifikacijo srčnih votlin in izboljšali razmejitev roba endokarda levega prekata, ter pri Dopplerjevi sonografiji velikih žil (cerebralnih arterij, ekstrakranialnih karotidnih arterij ali perifernih arterij in portalne vene) ali majhnih žil (lezij v jetrih in prsih) večje od z njim povezanih tveganj.
The Committee recommended that SonoVue be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo SonoVue odobri dovoljenje za promet.
Other information about SonoVue:
Druge informacije o zdravilu SonoVue:
The European Commission granted a marketing authorisation valid throughout the European Union for SonoVue to Bracco International B. V. on 26 March 2001.
Evropska komisija je dovoljenje za promet z zdravilom SonoVue, veljavno po vsej Evropski uniji, odobrila družbi Bracco International B. V. dne 26. marca 2001.
The marketing authorisation was renewed on 26 March 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 26. marca 2006.
The full EPAR for SonoVue is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo SonoVue je na voljo tukaj.
EU Number
< Številka EU >
Invented name
< ime >
Content
(koncentracija) >
8 µl/ ml
8µl/ ml
powder: vial (glass); solvent: pre-filled syringe (glass)
Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
solvent:
Vehikel:
1 vial + 1 pre-filled syringe + 1'MiniSpike 'rec. device
1 viala + 1 napolnjena injekcijska brizga + ločen MiniSpike sistem za prenos
SonoVue 8 microlitres / ml powder and solvent for dispersion for injection
SonoVue, 8 mikrolitrov/ ml, prašek in vehikel za disperzijo za injiciranje
One ml contains 8 µl of sulphur hexafluoride microbubbles On reconstitution as directed, 1 ml of the resulting dispersion contains 8 µl sulphur hexafluoride in the microbubbles, equivalent to 45 microgrammes.
1 ml vsebuje 8 µl žveplovega heksafluorida v obliki mikromehurčkov Po pripravi po navodilih vsebuje 1 ml pripravljene disperzije 8 µl žveplovega heksafluorida v obliki mikromehurčkov kar ustreza 45 microgramov.
SonoVue is a kit including 1 vial containing 25 mg of lyophilised powder 1 pre-filled syringe containing 5 ml sodium chloride 1 Mini-Spike transfer system
Prašek in vehikel za disperzijo za injiciranje SonoVue je komplet, ki vsebuje 1 vialo, ki vsebuje 25 mg liofiliziranega praška 1 napolnjeno injekcijsko brizgo s 5 ml natrijevega klorida 1 Mini- Spike sistem za prenos.
Information on the appearance of the reconstituted solution is given in section 6.6.
Podatek o videzu rekonstituirane raztopine je v poglavju 6. 6.
SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, which results in an improved signal to noise ratio.
SonoVue uporabljamo pri ultrazvočnih preiskavah kjer poveča ehogenost krvi, kar se pokaže z izboljšanim razmerjem med signalom in šumom.
SonoVue should only be used in patients where study without contrast enhancement is inconclusive.
SonoVue lahko uporabljamo samo pri bolnikih kjer je preiskava brez kontrastnega sredstva neuspešna.
SonoVue is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
SonoVue je transpulmonalno ehokardiografsko kontrastno sredstvo, ki se uporablja pri bolnikih s sumom na ali z dokazanim kardiovaskularnim obolenjem, da zagotovi opacifikacijo srčnih votlin in izboljša razmejitev konture epikarda levega ventrikla.
SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries by improving the Doppler signal to noise ratio.
SonoVue poveča natančnost pri zaznavanju ali izključitvi anomalij v cerebralnih arterijah in v ekstrakranialnih karotidnih arterijah ali perifernih arterijah z izboljšanjem dopplerjevega razmerja med signalom in šumom.
SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment.
SonoVue poveča kakovost dopplerskega posnetka pretoka in trajanje klinično uporabnega pojačanega signala za preiskavo portalne vene.
SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography, leading to more specific lesion characterisation.
SonoVue izboljša prikaz vaskularnosti lezij v jetrih in dojkah pri dopplerski sonografiji, kar daje bolj specifične podatke o lezijah.
2 The recommended doses of SonoVue are:
2 Zdravilo lahko daje samo zdravnik z izkušnjami v diagnostiki z ultrazvokom.
B-mode imaging of cardiac chambers, at rest or with stress:
Preiskava srčnih prekatov način- B, pri mirovanju ali pri obremenitvi:
Vascular Doppler imaging:
2 ml Vaskularno dopplersko slikanje:
2.4 ml.
2, 4 ml
Elderly Patients The dosage recommendations also apply to elderly patients.
Starejši bolniki Priporočeni odmerki so primerni tudi za starejše bolnike.
Paediatric Patients The safety and effectiveness of SonoVue in patients under 18 years old has not been established and the product should not be used in these patients.
Otroci Varnost in učinkovitost zdravila SonoVue pri bolnikih mlajših od 18 let ni bila ugotovljena, zato zdravila ne smemo uporabljati pri teh bolnikih.
The microbubble dispersion is 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.
Disperzijo mikromehurčkov pripravimo neposredno pred uporabo z vbrizganjem 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje skozi zamašek k vsebini v viali.
The vial is then shaken vigorously for a few seconds until the lyophilisate is completely dissolved.
Vialo nato dobro pretresamo nekaj sekund dokler se liofilizat popolnoma ne raztopi.
SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.
SonoVue moramo dati bolniku v periferno veno takoj, ko potegnemo disperzijo v brizgo.
Every injection should be followed by a flush with 5 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection.
Vsakemu injiciranju sledi izpiranje s 5 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje.
For instructions for preparation see section 6.6.
Navodilo za pripravo zdravila glejte poglavje 6. 6.
SonoVue should not be administered to patients with known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
SonoVue ne smemo dajati bolnikom z znano preobčutljivostjo za žveplov heksafluorid ali za katerokoli sestavino zdravila.
SonoVue is contraindicated for use in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/ IV cardiac failure, or severe rhythm disorders.
SonoVue je kontraindiciran pri bolnikih z nedavnim akutnim koronarnim sindromom ali klinično nestabilno ishemično boleznijo srca vštevši razvijajoči se ali že obstoječi miokardni infarkt, tipično angino v mirovanju v zadnjih sedmih dneh, s pomembnim slabšanjem srčnih simptomov v zadnjih sedmih dneh, z nedavnim posegom na koronarnih arterijah ali z drugimi faktorji, ki bi kazali klinično nestabilnost (npr. nedavno poslabšanje EKG, laboratorijskih ali kliničnh izvidov), z akutno srčno odpovedjo, s srčno odpovedjo klase III/ IV ali hudo aritmijo.
SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
SonoVue je kontraindiciran pri bolnikih ter pri bolnikih z desno- levim šantom, akutnim endokarditisom, umetnimi srčnimi zaklopkami, s hudo pulmonalno hipertenzijo (pulmonalni arterijski tlak > 90 mm Hg), nenadzorovano hipertenzijo in pri odraslih bolnikih z respiratornim distresnim sindromom.
The safety and efficacy of SonoVue have not been established in pregnant and lactating women therefore, SonoVue should not be administered during pregnancy and lactation (see Section 4.6).
Varnost in učinkovitost zdravila SonoVue pri nosečnicah in pri doječih ženskah, ni bila ugotovljena, zato zdravila SonoVue ne smemo dajati med nosečnostjo in dojenjem (glejte poglavje 4. 6).
It should be emphasised that stress echocardiography, which can mimic an ischaemic episode, could potentially increase the risk of SonoVue utilisation.
Potrebno je poudariti, da lahko ehokardiografski stres, ki lahko oponaša ishemično epizodo, potencialno poveča tveanje uporabe SonoVue- a.
Therefore, if SonoVue is to be used in conjunction with stress echocardiography patients must have a stable condition verified by absence of chest pain or ECG modification during the two preceding days.
Zatorej, če je SonoVue uporabljen v povezavi z ehokardiografskim stresom, morajo biti bolniki v preteklih dveh dneh brez bolečin v prsnem košu ali brez EKG sprememb.
Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e. g. with dobutamine).
Kadar Sono Vue uporabljamo za ehokardiografijo s farmakološko obremenitvijo (npr z dobutaminom) pri bolnikih z visoko stopnjo kliničnega tveganja, moramo snemati EKG in nadzorovati krvni tlak.
3 Care should be taken in patients with ischaemic cardiac disease because in these patients allergy-like and/ or vasodilatory reactions may lead to life-threatening conditions.
Previdnost mora biti posvečena bolnikom z ishemično boleznijo srca, kajti alergijam podobne in/ ali vazodilatatorne reakcije lahko vodijo v okoliščine, ki bi utegnile ogroziti življenje.
Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease.
3 Svetujemo previdnost pri dajanju zdravila SonoVue bolnikom s klinično pomembnimi pljučnimi obolenji, vključno pri bolnikih s hudo kronično obstrukcijsko pljučno boleznijo Priporočljivo je najmanj 30 minutno opazovanje bolnika po uporabi SonoVue- a.
It is recommended to keep the patient under close medical supervision during and for at least 30 minutes following the administration of SonoVue.
Število bolnikov, ki so prejeli SonoVue v kliničnih preskušanjih in so imeli eno od v nadaljevanju naštetih stanj, je bilo omejeno.
Numbers of patients with the following conditions who were exposed to SonoVue in the clinical trials were limited, and therefore, caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/ or sepsis, hyperactive coagulation states and/ or recent thromboembolism, and end-stage renal or hepatic disease.
Zato svetujemo previdnost pri dajanju zdravila bolnikom z: akutnim endokarditisom, umetnimi zaklopkami, akutnim sistemskim vnetjem in/ ali sepso, s hiperaktivnimi motnjami koagulacije in/ ali nedavno tromboembolijo in odpovedjo jeter ali ledvic.
SonoVue is not suitable for use in ventilated patients, and those with unstable neurological diseases.
SonoVue ni primeren za bolnike, ki so umetno ventilirani in za bolnike z nestabilnimi nevrološkimi boleznimi.
In animal studies, the application of echo-contrast agents revealed biological side effects (e. g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Študije na živalih so pokazale, da je aplikacija echo- kontrastnega sredstva privedla do bioloških neželenih učinkov (npr. poškodba endotelijskih celic, ruptura kapilar) pri interakciji z ultrazvočnimi valovi.
No specific interaction studies have been performed.
Posebne študije interakcij niso bile izvedene.
There was no apparent relationship with respect to occurrence of adverse events in the clinical studies for patients receiving various categories of the most common concomitant medications.
V kliničnih preskušanjih pri bolnikih, ki so sočasno prejemali običajno najbolj predpisovane kombinacije zdravil, niso ugotovili očitne povezave s pojavom neželenih učinkov.
No clinical data on exposed pregnancies are available.
Kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu, ni.
Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data).
Študije na živalih ne kažejo na škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3 Predklinični podatki o varnosti).
Caution should be exercised when prescribing to pregnant women.
Potrebna je previdnost pri predpisovanju zdravila nosečnicam.
Therefore, caution should be exercised when SonoVue is administered to breast-feeding women.
Ni znano, ali se žveplov heksafluorid izloča v materino mleko, zato je potrebna previdnost pri doječih ženskah, ki so prejele SonoVue.
On the basis of the pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of SonoVue on the ability to drive or use machines.
Na osnovi farmakokinetičnih in farmakodinamičnih lastnosti ni pričakovati vpliva zdravila SonoVue na sposobnost vožnje in upravljanja s stroji, ali pa je le- ta zanemarljiv.
The undesirable effects reported with SonoVue were, in general, non-serious, transient and resolved spontaneously without residual effects.
Neželeni učinki zdravila SonoVue so na splošno blagi, prehodnega značaja in izginejo spontano brez posledic.
In clinical trials, the most commonly reported adverse reactions are headache (2.3%), injection site reaction including bruising, burning and paraesthesia at the injection site (1.7%) and injection site pain (1.4%).
V kliničnih preskušanjih so najpogosteje poročali o naslednjih neželenih učinkih: glavobol (2, 3%), bolečina na mestu injiciranja (1, 4%), reakcija na mestu injiciranja vključno z modrico, vnetjem in parestezijo (1, 7%).
There were changes in ECG, blood pressure and in some laboratory parameters measured, but these were not deemed to be of clinical significance.
Zabeležili so spremembe EKG, krvnega tlaka in nekaterih laboratorijskih parametrov, vendar se domneva, da klinično niso pomembni.
4 The adverse reactions reported among 1788 adult patients in clinical studies are:
4 Neželeni učinki, o katerih so poročali pri 1788 odraslih bolnikih, vključenih v klinično preskušanje, so:
Body system Metabolism and nutrition disorders
organski sistem presnovne in prehranske motnje
Common (> 1/ 100, < 1/ 10)
pogosti (> 1/ 100, < 1/ 10)
Uncommon (> 1/ 1,000- < 1/ 100) Hyperglycaemia
občasni (> 1/ 1. 000 - < 1/ 100) hiperglikemija
Paraesthesia, dizziness, insomnia, taste perversion
parestezija, omotica, nespečnost, sprememba okusa
Eye disorders Vascular disorder Respiratory, thoracic and mediastinal disorders
očesne bolezni žilne bolezni bolezni dihal, prsnega koša in mediastinalnega prostora
Vision blurred Vasodilatation Pharyngitis, sinus pain
zamegljen vid vazodilatacija faringitis, sinusna bolečina
Gastrointestinal disorders Skin and subcutaneous tissue disorders
bolezni prebavil bolezni kože in podkožja bolezni mišično- skeletnega sistema in vezivnega tkiva