FrancophonIA/ELRC3.0 huggingface dataset:
English: Xigduo is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Slovenian: Zdravilo Xigduo je na voljo v obliki tablet, ki vsebujejo bodisi 5 mg dapagliflozina in 850 mg metformina ali 5 mg dapagliflozina in 1 000 mg metformina.
English: • dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Slovenian: • dapagliflozin zavira delovanje beljakovine v ledvicah, imenovane natrij-glukozni soprenašalec 2 (SGLT2).
English: The recommended dose is 1 tablet taken twice a day with a meal; the strength should be chosen so that in total, patients receive 10 mg of dapagliflozin each day and the same (or almost the same) dose of metformin they were taking before starting Xigduo.
Slovenian: Priporočeni odmerek je ena tableta, ki jo je treba vzeti ob obroku dvakrat na dan, pri čemer se jakost odmerka izbere tako, da bolnik prejme skupno 10 mg dapagliflozina na dan in enak (oziroma skoraj enak) odmerek metformina, kot ga je jemal, preden je prešel na jemanje zdravila Xigduo.
English: • patients with reduced liver function;
Slovenian: • bolnikih z okvaro delovanja jeter;
English: It contains the active substances dapagliflozin and metformin.
Slovenian: Vsebuje učinkovini dapagliflozin in metformin.
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Slovenian: Študija je pokazala, da so učinki dapagliflozina skladni z učinki drugih zdravil za zdravljenje sladkorne bolezni, ki prav tako delujejo z zaviranjem soprenašalca SGLT2.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Slovenian: Zaradi hkratnega delovanja obeh učinkovin se raven glukoze v krvi zniža, kar prispeva k uravnavanju sladkorne bolezni tipa 2.
English: Xigduo is a diabetes medicine used, together with diet and exercise in adults with type 2 diabetes.
Slovenian: Xigduo je zdravilo za zdravljenje sladkorne bolezni, ki se skupaj z dieto in telesno vadbo uporablja pri odraslih s sladkorno boleznijo tipa 2.
English: The Agency also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Slovenian: Prav tako je menila, da je kombinacija dapagliflozina in metformina v eni tableti lahko dodatna možnost zdravljenja za bolnike s sladkorno boleznijo tipa 2, ki bi lahko prispevala k temu, da se bodo držali predpisanega zdravljenja.
English: For the full list of side effects of Xigduo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Xigduo glejte navodilo za uporabo.
English: Xigduo is used:
Slovenian: Zdravilo Xigduo se uporablja:
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Slovenian: Dodatne študije so potrdile, da različni odmerki dapagliflozina v kombinaciji z metforminom bolj znižajo ravni HbA1c kot placebo v kombinaciji s primerljivimi odmerki metformina ter da je dapagliflozin v kombinaciji z metforminom vsaj tako učinkovit pri znižanju ravni HbA1c kot zdravilo za zdravljenje sladkorne bolezni, ki vsebuje glipizid (vrsta zdravila, znana kot sulfonilsečnina).
English: The Agency considered Xigduo to be effective for treating type 2 diabetes; it also leads to weight loss, which is considered beneficial in patients with diabetes.
Slovenian: Menila je, da je zdravilo Xigduo učinkovito pri zdravljenju sladkorne bolezni tipa 2; poleg tega pa povzroči zmanjšanje telesne mase, kar je koristno za bolnike s sladkorno boleznijo.
English: A sixth study showed that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had an average reduction in body weight of around 2 kg more than those taking placebo plus metformin.
Slovenian: Šesta študija je pokazala, da se je po 24 tednih zdravljenja pri bolnikih, ki so jemali dapagliflozin skupaj z metforminom, telesna masa v povprečju zmanjšala za približno 2 kg več kot pri bolnikih, ki so jemali placebo v kombinaciji z metforminom.
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40 percentage points more than placebo and metformin when added to sitagliptin, and by 0.61 percentage points more than placebo and metformin when added to insulin.
Slovenian: Dve drugi študiji sta pokazali, da jemanje dapagliflozina v kombinaciji z metforminom in drugim zdravilom za zdravljenje sladkorne bolezni, sitagliptinom ali insulinom, po 24 tednih jemanja dodatno zniža ravni HbA1c: ko so dapagliflozin v kombinaciji z metforminom dodajali sitagliptinu, so se ravni HbA1c znižale za 0,40 odstotnih točk več kot pri dodajanju kombinacije placeba in metformina; ko so ga dodajali insulinu, pa za 0,61 odstotnih točk več kot pri dodajanju kombinacije placeba in metformina.
English: How is Xigduo used?
Slovenian: Kako se zdravilo Xigduo uporablja?
English: By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Slovenian: Dapagliflozin z zaviranjem delovanja soprenašalca SGLT2 povzroči, da ledvice v urin izločijo več glukoze, kar zniža ravni glukoze v krvi.
English: such as heart or lung failure (the heart and lungs not working as well as they should), recent heart attack or shock;
Slovenian: • bolnikih z boleznimi, ki bi lahko povzročile hipoksijo tkiv (zmanjšano vsebnost kisika v telesnih tkivih), kot sta srčno popuščanje ali respiratorna insuficienca (srce in pljuča ne delujejo tako dobro, kot bi morali), nedavni srčni napad ali šok;
English: How does Xigduo work?
Slovenian: Kako zdravilo Xigduo deluje?
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Xigduo), it decreased HbA1c levels by 0.65 percentage points after 16 weeks, compared with a reduction of 0.30 percentage points with placebo (a dummy treatment) and metformin.
Slovenian: V eni glavni študiji je dapagliflozin, ki so ga uporabili v odmerku 5 mg dvakrat na dan v kombinaciji z metforminom (enaka kombinacija kot v zdravilu Xigduo), po 16 tednih znižal ravni HbA1c za 0,65 odstotnih točk, medtem ko sta placebo (zdravilo brez učinkovine) in metformin raven te snovi znižala zgolj za 0,30 odstotnih točk.
English: such as dehydration, severe infection or shock;
Slovenian: • bolnikih s hudo okvaro delovanja ledvic ali z obolenji, ki bi lahko vplivala na delovanje ledvic, kot so na primer dehidracija, huda okužba ali šok;
English: Computers record the activity and translate that into images.
Slovenian: Računalniki zabeležijo dejavnost in to pretvorijo v sliko.
English: Section 4.1 (Indication):
Slovenian: Poglavje 4.1 (Indikacija):
English: In some cases he will check whether your heart and kidneys work properly.
Slovenian: V nekaterih primerih bo preveril, ali srce in ledvice delujejo pravilno.
English: All results are average results obtained in blinded reader studies.
Slovenian: Vsi rezultati so povprečni rezultati, pridobljeni v slepih študijah.
English: Any additional instructions from the respective equipment manufacturer must also be strictly adhered to.
Slovenian: Strogo je treba upoštevati tudi vsa dodatna navodila izdelovalca opreme.
English: Overdosing is unlikely.
Slovenian: Preveliko odmerjanje ni verjetno.
English: After the injection you will be observed for at least 30 minutes.
Slovenian: Po injiciranju vas bodo opazovali vsaj še 30 minut.
English: Severe reactions are possible.
Slovenian: Možne so hude reakcije.
English: Athens 14122
Slovenian: Atene 14122
English: • Paediatric patients
Slovenian: • Pediatrični bolniki
English: This is done by a complex system of magnets and radiowaves.
Slovenian: To se naredi z zapletenim sistemom magnetov in radijskih valov.
English: There are no adequate data from the use of gadobutrol in pregnant women.
Slovenian: Ni ustreznih podatkov o uporabi gadobutrola pri nosečnicah.
English: Within two hours more than 50% and within 12 hours more than 90% (or 92%) of the given dose is eliminated via the urine.
Slovenian: V dveh urah se več kot 50 %, v 12 urah pa več kot 90 % (natančneje 92 %) uporabljenega odmerka izloči v urinu.
English: The potential risk of single administration for humans is unknown.
Slovenian: Morebitno tveganje za ljudi pri enkratni uporabi ni znano.
English: If it does happen, the doctor will treat any symptoms that follow.
Slovenian: Če pride do prevelikega odmerjanja, bo zdravnik zdravil vse simptome, ki sledijo.
English: ATC - Code: V08C A09
Slovenian: Oznaka ATC: V08C A09
English: Before you receive Gadovist, tell your doctor if any of these applies to you.
Slovenian: Preden vam dajo zdravilo Gadovist, obvestite zdravnika, če karkoli od naštetega velja za vas.
English: Physico-chemical properties:
Slovenian: Fizikalne in kemične lastnosti:
English: Your doctor will decide whether the intended examination is possible or not.
Slovenian: Zdravnik se bo odločil, ali je načrtovana preiskava pri vas mogoča.
English: If this should happen to you, tell your doctor or radiologist.
Slovenian: Če se to zgodi, povejte zdravniku ali radiologu.
English: These include especially medicines that change the rhythm or rate of your heartbeat.
Slovenian: Med njimi so zlasti zdravila, ki spreminjajo srčni ritem ali hitrost srčnega utripa.
English: Schering España, S.A. c/ Mendez Alvaro, 55 28045 Madrid
Slovenian: Schering Espana, S.A. c/ Mendez Alvaro, 55 28045 Madrid
English: Additional safety information:
Slovenian: Dodatne informacije o varnosti:
English: After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.
Slovenian: Po injiciranju je treba bolnika opazovati vsaj 30 minut, ker so izkušnje pokazale, da se večina neželenih učinkov pojavi v tem času.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GADOBUTROL
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA GADOBUTROL
English: A-1121 Wien
Slovenian: A-1121 Dunaj
English: To be able to react immediately to an emergency, medicinal products and equipment (e.g. endotracheal tube and respirator) should be within hand reach.
Slovenian: Da bi se lahko v nujnem primeru takoj odzvali, morajo biti zdravila in oprema (npr. endotrahealni tubus in respirator) pri roki.
English: 1 and 10 vials 1 and 10 bottles
Slovenian: Velikosti pakiranja: 1 in 10 vial 1 in 10 steklenic
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij inkompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
English: Additional adverse reactions from postmarketing spontaneous reporting
Slovenian: Dodatne neželene reakcije, o katerih so v postmarketinškem obdobju poročali spontano
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: [To be completed nationally] Date of last renewal: 24.01.2005
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: [Izpolni država članica] Datum zadnjega podaljšanja: 24. 1. 2005
English: After finalisation of the procedure the Spanish Agency for Medicines and Health Products initiated a referral for Arbitration under Article 36.1 of Directive 2001/83/EC to the CHMP.
Slovenian: Po zaključku postopka je španska agencija za zdravila in medicinske proizvode pri Odboru za zdravila za uporabo v humani medicini (CHMP) uvedla napotitveni postopek za arbitražo po členu 36(1) Direktive 2001/83/ES.
English: The tube from the injector to the patient (patient's tube) must be changed after every examination.
Slovenian: Cev od injektorja do bolnika je treba zamenjati po vsakem pregledu.
English: - If you are younger than 18, the use of Gadovist is not recommended.
Slovenian: - Če ste mlajši od 18 let, uporaba zdravila Gadovist ni priporočena.
English: No metabolites are detected in plasma or urine.
Slovenian: V plazmi ali urinu niso odkrili presnovkov.
English: If you receive more GADOVIST than you should have received:
Slovenian: Če ste prejeli večji odmerek zdravila GADOVIST, kot bi smeli:
English: The MAH submitted its response to the CHMP List of Questions on 29 September 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil odgovore na Seznam vprašanj 29. septembra 2006.
English: Small amounts of gadobutrol enter milk in animals (less than 0.01% of the dose administered).
Slovenian: Pri živalih majhna količina gadobutrola prehaja v mleko (manj kot 0,01 % uporabljenega odmerka).
English: UK - United Kingdom
Slovenian: UK - Združeno kraljestvo
English: Data are too limited to exclude the possibility of renal toxicity or aggravation of renal impairment.
Slovenian: Podatki so preveč omejeni, da bi lahko izključili možnost toksičnosti za ledvice ali poslabšanja ledvične okvare.
English: T1 -weighted scanning sequences are particularly suitable for contrast-enhanced examinations.
Slovenian: T1 - obtežena slikovna zaporedja so zlasti primerna za kontrastne preiskave.
English: The passage of Gadovist into breast milk has not been investigated in humans so far.
Slovenian: Prehajanja zdravila Gadovist v materino mleko pri ljudeh doslej ni bilo raziskano.
English: Tell the MRI department staff immediately if you experience any of these signs or have difficulty in breathing.
Slovenian: Osebju v oddelku za slikanje MRS takoj povejte, če imate katerega koli od teh znakov ali če imate težave pri dihanju.
English: Tell your doctor if you are pregnant or could be pregnant, since Gadovist should not be used during pregnancy unless it is considered absolutely necessary.
Slovenian: Povejte zdravniku, če ste noseči ali bi lahko bili noseči, ker se zdravilo Gadovist med nosečnostjo ne sme uporabljati, razen če je nujno.
English: • General information
Slovenian: • Splošne informacije
English: Gadovist 1.0 mmol/ml (INN gadobutrol) was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” (MRI) in Germany in January 2000 and subsequently in June 2000 in the EU and Norway via the mutual recognition procedure.
Slovenian: Gadograf 1,0 mmol/ml (mednarodno nelastniško ime: gadobutrol) je bilo odobreno za „izboljšanje kontrasta pri magnetnem resonančnem slikanju (MRI) lobanje in hrbtenjače“ januarja 2000 v Nemčiji in nato še junija 2000 v EU in na Norveškem v postopku medsebojnega priznavanja.
English: Gadovist should not be used in patients with uncorrected hypokalemia.
Slovenian: Zdravilo Gadovist se ne sme uporabljati pri bolnikih z nekorigirano hipokaliemijo.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: The contents of the packs are:
Slovenian: Vsebina pakiranj je:
English: One of the requirements for a diagnostic agent to be authorised is to demonstrate relevant impact on diagnostic thinking in the clinical context in which the test is to be used, unless such impact can be shown indirectly or historically.
Slovenian: Ena od zahtev za odobritev diagnostičnega sredstva je dokaz relevantnega vpliva na diagnostično miselnost v kliničnem kontekstu, kjer bi se naj preiskava uporabljala, razen če je možno takšen vpliv dokazati posredno ali zgodovinsko.
English: - Before injection
Slovenian: - Pred injiciranjem
English: CNS indications:
Slovenian: Indikacije za CŽS:
English: Delayed reactions have been observed (after hours or days) (see section 4 “Possible Side Effects”).
Slovenian: Opazili so zapoznele reakcije (po več urah ali dneh) (glejte poglavje 4 "Možni neželeni učinki").
English: Any contrast medium solution left over in the bottle, the connecting tubes and all disposable parts of the injector system must be discarded within 8 hours.
Slovenian: Kontrastno sredstvo, ki ostane v steklenici, povezovalne cevi in vse dele injektorskega sistema za enkratno uporabo je treba zavreči v 8 urah.
English: - Tell your doctor if you have a heart pacemaker or if there are any implants or clips containing iron in your body.
Slovenian: - Zdravniku povejte, če imate srčni spodbujevalnik ali če imate v telesu vsadke ali spojke, ki vsebujejo železo.
English: Having considered the grounds for the referral, the CHMP, during its May 2006 plenary meeting, requested the MAH to address the major objection to public health and adopted a List of Questions.
Slovenian: Po preučitvi podlage za napotitveni postopek je CHMP na plenarnem zasedanju maja 2006 zaprosil imetnika dovoljenja za promet z zdravilom (MAH), da razjasni pomemben zadržek v zvezi z javnim zdravjem, in sprejel seznam vprašanj.
English: The following applies to the use of the infusion bottle containing 65 ml: After opening of the infusion bottle under aseptic conditions Gadovist remains stable for at least 8 hours at room temperature.
Slovenian: Naslednja izjava velja za uporabo infuzijske steklenice, ki vsebuje 65 ml: Po odprtju infuzijske steklenice v aseptičnih pogojih ostane zdravilo Gadovist stabilno vsaj 8 ur pri sobni temperaturi.
English: The MRP procedure was finalised on Day 221 of the procedure on 09.05.2006 with approval of the proposed indication and inclusion of the liver and kidney imaging studies' results under Section 5.1.
Slovenian: Postopek medsebojnega priznavanja je bil končan na 221. dan postopka, dne 9. maja 2006, z odobritvijo predlagane indikacije in vključitve rezultatov študij slikovnih preiskav jeter in ledvic v razdelek 5.1.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni:
English: In patients with severe cardiovascular disease Gadovist should only be administered after careful risk benefit assessment because only limited data are available so far.
Slovenian: Pri bolnikih s hudimi kardiovaskularnimi boleznimi se lahko zdravilo Gadovist uporablja samo po skrbni oceni razmerja tveganja in koristi, ker so za zdaj na voljo le omejeni podatki.
English: Tissue enhancement generally lasts up to 45 minutes after injection of Gadovist.
Slovenian: Povečanje kontrasta tkiva traja na splošno do 45 minut po injiciranju zdravila Gadovist.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINOV UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH
English: It is not known whether these effects can also be induced by a single administration.
Slovenian: Ni znano, ali enkratno odmerjanje lahko povzroči te učinke.
English: With high local tissue concentrations of gadobutrol the T2 effect results in a lessening of signal intensity.
Slovenian: V primeru velikih koncentracij gadobutrola v lokalnem tkivu T2 efekt povzroči zmanjševanje intenzivnosti signala.
English: The pharmacokinetics of gadobutrol in humans are dose proportional.
Slovenian: Farmakokinetika gadobutrola pri ljudeh je bila sorazmerna odmerku.
English: Gadobutrol does not cross an intact blood-brain barrier and therefore does not accumulate in healthy brain tissue or in lesions featuring an intact blood-brain barrier.
Slovenian: Gadobutrol ne prehaja skozi nepoškodovano krvnomožgansko pregrado, zato se ne kopiči v zdravem možganskem tkivu ali v lezijah v katerih krvnomožganska pregrada ni poškodovana.
English: Contrast-enhanced MRI can commence immediately afterwards (shortly after the injection depending on the pulse sequences used and the protocol for the examination).
Slovenian: Kontrastno MRS se lahko začne takoj zatem (kmalu po injiciranju, odvisno od uporabljenega zaporedja pulzov in protokola preiskave).
English: Adverse reactions from clinical trial data (experience in more than 2900 patients)
Slovenian: Neželeni učinki iz podatkov, pridobljenih pri kliničnih preskušanjih (ki so se pojavili pri več kot 2900 bolnikih)
English: As with other gadolinium containing contrast media, in rare cases allergy-like reactions (hypersensitivity and anaphylaxis) may occur, including severe reactions (shock) that may need immediate medical intervention.
Slovenian: Kot pri drugih kontrastnih sredstvih, ki vsebujejo gadolinij, se v redkih primerih lahko pojavijo reakcije, podobne alergijam (preobčutljivost in anafilaksa), vključno s hudimi reakcijami (šok), pri katerih je potrebna takojšnja zdravniška pomoč.
English: The MAH is asked to provide information on the clinical utility of this product for the requested indication (directly or indirectly), according to the Points of Consider on the evaluation of diagnostic agents (CPMP/EWP/1119/98).
Slovenian: Odbor je prosil imetnika dovoljenja za promet z zdravilom, da predloži podatke o klinični uporabnosti tega zdravila za želeno indikacijo (neposredno ali posredno) v skladu s Ključnimi vprašanji pri vrednotenju diagnostičnih sredstev (CPMP/EWP/1119/98).
English: Schering Lusitana, Lda Estrada Nacional 249, km 15, P.O.
Slovenian: Schering Lusitana, Lda Estrada Nacional 249, km 15, P.O. Box 16
English: 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 radiologist.
Slovenian: Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali radiologa.
English: CE-MRA:
Slovenian: Slikanje CE-MRA:
English: Shelf life after first opening of the container:
Slovenian: Rok uporabnosti po prvem odprtju vsebnika:
English: Osmolality at 37°C: 1603 mOsm/kg H2O Viscosity at 37°C: 4.96 mPa·s
Slovenian: Osmolalnost pri 37 °C: 1603 mOsm/kg H2O Viskoznost pri 37 °C: 4,96 mPa·s
English: In particularly severe cases, it is advisable to remove Gadovist from the body by extracorporeal haemodialysis: For removal of the agent from the body, at least 3 dialysis sessions within 5 days of the injection should be performed.
Slovenian: V posebno hudih primerih se priporoča odstranjevanje zdravila Gadovist iz telesa z zunajtelesno hemodializo: za odstranjevanje zdravila iz telesa je treba v petih dneh od injiciranja opraviti vsaj tri dialize.
English: The actual dosage of Gadovist that is right for you will depend on your body weight and on the region of examination:
Slovenian: Dejanski odmerek zdravila Gadovist, ki je primeren za vas, bo odvisen od vaše telesne mase in mesta preiskave.
English: This medicine is for diagnostic use only.
Slovenian: Zdravilo je samo za diagnostično uporabo.
English: Mild swelling of the face, lips, tongue or throat, coughing, itching, runny nose, sneezing and hives (nettle-type rash) may be the first signs that a severe reaction is happening.
Slovenian: Blago otekanje obraza, ustnic, jezika ali grla, kašljanje, srbenje, izcedek iz nosu, kihanje in koprivnica so lahko prvi znaki, da je prišlo do hude reakcije.
English: The possibility that Gadovist may cause torsade de pointes arrhythmias in an individual patient cannot be excluded (see section 5.3 Preclinical safety data).
Slovenian: Možnosti, da lahko zdravilo Gadovist pri posameznih bolnikih povzroči aritmijo torsade de pointes, ni mogoče izključiti (glejte poglavje 5.3 Predklinični podatki o varnosti).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA