natgillin/translations-raw huggingface dataset:
20 ml, 50 ml, 100 ml and 250 ml Polyethylene (PET) bottles closed with a rubber stopper and aluminium cap.
20 ml, 50 ml, 100 ml in 250 ml plastenke iz PET plastike, zaprte z gumijastim zamaškom in aluminijasto zaporko.
Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium) DEAE-Dextran
Dodatki: gel aluminijevega hidroksida .......................................................................... 6,4 mg (aluminij)
50 doses (100 ml) 50 doses (100 ml) 125 doses (250 ml)
VELIKOST PAKIRANJA 50 odmerkov (100 ml) 50 odmerkov (100 ml) 125 odmerkov (250 ml)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA
Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed at necropsy in 10% of animals.
Ob obdukciji je možno pri 10 % živali opaziti razbarvanje mišičnih vlaken na mestu inokulacije (0,5 cm širine x 2 cm dolžine).
PACKAGE LEAFLET: RHINISENG suspension for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI RHINISENG suspenzija za injiciranje za prašiče
Allow the vaccine to reach room temperature (15-25˚C) before administration.
Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo (15-25 °C).
Date of first authorisation: 16/09/2010
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 16/09/2010.
To stimulate active immunity in order to provide passive immunity to the progeny against atrophic rhinitis associated with Bordetella bronchiseptica and Pasteurella multocida infections.
Stimuliranje aktivne imunosti za doseganje pasivne imunosti zaroda na atropični rinitis, povezan z okužbami z bakterijama Bordetella bronchiseptica in Pasteurella multocida.
10 doses (20 ml) 25 doses (50 ml)
25 odmerkov (50 ml)
Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Laboratorios Hipra, S.A.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Španija V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov proizvajalca,
1 dose (2 ml):
KOLIČINA UČINKOVIN(E) 1 odmerek (2 ml):
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
For the passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Za pasivno zaščito prašičkov prek kolostruma po aktivni imunizaciji svinj in mladic za zmanjšanje kliničnih znakov in lezij progresivnega in neprogresivnega atrofičnega rinitisa ter za zmanjšanje izgube teže, povezane z okužbo z Bordetella bronchiseptica in s Pasteurella multocida v obdobju pitanja.
Type II colourless glass vials of 50 ml and 100 ml .
20 ml brezbarvne viale iz stekla tipa I 50 ml in 100 ml brezbarvne viale iz stekla tipa II
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 odmerkov (20 ml)
Shelf life after first opening the immediate packaging: 10 hours stored at 15 ºC to 25 ºC.
Rok uporabnosti po prvem odpiranju stične ovojnine: 10 ur shranjeno pri 15 °C do 25 °C.
RHINISENG suspension for injection for pigs.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI RHINISENG suspenzija za injiciranje za prašiče.
In case of accidental self-injection only a minor injection site reaction is expected.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se pričakuje le manjša reakcija na mestu injiciranja.
- Anaphylactic type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Svetuje se primerno simptomatsko zdravljenje.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
RHINISENG suspenzija za injiciranje za prašiče IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
Simethicone
DEAE-dekstran ginseng
- Transient local reactions may occur after the administration of one dose of vaccine.
Pogosti neželeni učinki: - Po uporabi enega odmerka cepiva pride lahko do prehodnih lokalnih reakcij.
4.7 Use during pregnancy, lactation or lay
Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti.
- Cardboard box with 1 PET bottle of 125 doses.
- kartonasta škatla z 1 PET plastenko po 125 odmerkov.
- Cardboard box with 1 or 10 PET bottles of 10 doses.
- kartonasta škatla z 1 ali 10 PET plastenkami po 10 odmerkov.
CONTRAINDICATIONS
NALEPKA
PHARMACEUTICAL FORM
KLINIČNI PODATKI
Pack sizes: - Cardboard box with 1 or 10 glass vials of 10 doses.
- kartonasta škatlaz 1 ali 10 steklenimi vialami po 10 odmerkov.
Name and address of the manufacturer of the biological active substances
Ime in naslov izdelovalca(izdelovalcev) biološke učinkovine (učinkovin) Laboratorios Hipra, S.A.
- Cardboard box with 1 PET bottle of 50 doses.
- kartonasta škatla z 1 PET plastenko po 50 odmerkov.
EXP {month/ year} Once opened, use within a 10-hour period, stored at 15 ºC to 25 ºC.
Odprto zdravilo shranjujte pri temperaturah od 15 °C do 25 °C in ga uporabite v naslednjih 10 urah.
HIPRA DEUTSCHLAND GmbH Tel. (+49) 211 698236 - 0
Tel. (+49) 211 698236 - 0
- Cardboard box with 1 PET bottle of 25 doses.
- kartonasta škatla z 1 PET plastenko po 25 odmerkov.
Fax.
Rp-Vet.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE AND VIAL LABEL
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI NALEPKA PLASTENKE IN VIALE
Adjuvants:
Avda.
- Cardboard box with 1 glass vial of 50 doses.
- kartonasta škatla z 1 vialo po 50 odmerkov.
Aluminium hydroxide DEAE-dextran
Seznam pomožnih snovi gel aluminijevega hidroksida
- Cardboard box with 1 glass vial of 25 doses.
- kartonasta škatla z 1 vialo po 25 odmerkov.
Formaldehyde .................................................................................................................. 0.8 mg White homogeneous suspension.
Pomožna snov: formaldehid ..................................................................................................................... 0,8 mg
If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the clinical trial.
Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
It was to be used in adults admitted to hospital for the treatment of a recent medical illness.
Uporabljalo naj bi se pri odraslih, sprejetih v bolnišnico zaradi zdravljenja nedavne bolezni.
After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 26 July 2018.
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in 26. julija 2018 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
The company presented the results of one main study involving over 7,500 adults who had been admitted to hospital for a recent medical illness.
Družba je predložila rezultate glavne študije, ki je vključevala več kot 7 500 odraslih, ki so jih zaradi nedavne bolezni sprejeli v bolnišnico.
Blood clots that start off in the veins can move to another part of the body such as the lungs and the brain where they can cause severe problems with breathing or stroke.
Krvni strdki, ki nastanejo v venah, se lahko premaknejo v drug del telesa, na primer pljuča in možgane ter tam povzročijo hude težave z dihanjem ali možgansko kap.
The company that applied for authorisation is Portola Pharma UK Limited.
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Portola Pharma UK Limited.
Thrombin is needed for blood to clot.
Trombin je potreben za strjevanje krvi.
On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience, intended for the prevention of venous thromboembolism.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 22. marca 2018 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Dexxience, namenjenim preprečevanju venske trombembolije.
This means that it blocks factor Xa, a protein which is involved in the production of thrombin.
To pomeni, da zavira faktor Xa, tj. beljakovino, ki sodeluje pri tvorbi trombina.
The CHMP considered that the main study did not satisfactorily show Dexxience's effectiveness when used for preventing blood clots in patients admitted to hospital for recent medical illness.
Odbor CHMP je menil, da glavna študija ni zadovoljivo dokazala učinkovitosti zdravila Dexxience pri preprečevanju krvnih strdkov pri bolnikih, sprejetih v bolnišnico zaradi nedavne bolezni.
The main measure of effectiveness was the occurrence of deep vein thrombosis (blood clot in a deep vein, usually in the leg), or of pulmonary embolism (blood clot in the lung), or death from a blood clot.
Glavno merilo učinkovitosti je bil pojav globoke venske tromboze (krvnega strdka v globoki veni, običajno v nogi) ali pljučne embolije (krvnega strdka v pljučih) ali smrti zaradi krvnega strdka.
These patients may be at high risk of blood clots because of reduced mobility during their hospital treatment as well as other underlying conditions that increase the risk.
Pri teh bolnikih lahko obstaja večje tveganje za nastanek krvnih strdkov, in sicer zaradi zmanjšane mobilnosti v času bolnišničnega zdravljenja in drugih osnovnih boleznih, ki povečujejo tveganje.
This was considered an important concern given that the medicine was expected to be used in patients with serious underlying conditions for whom any episode of bleeding could have serious consequences, and Dexxience's long persistence in the body could complicate management of bleeding.
Ocenili so, da je to pomemben zadržek, saj naj bi se zdravilo uporabljalo pri bolnikih z resnimi osnovnimi boleznimi, pri katerih ima vsaka krvavitev lahko resne posledice, dolgotrajno zadrževanje zdravila Dexxience v telesu pa bi lahko zapletlo obvladovanje krvavitve.
Also, patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine.
Poleg tega so bolniki, zdravljeni z zdravilom Dexxience, doživeli več krvavitev kot bolniki, zdravljeni s primerjalnim zdravilom.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Dexxience did not outweigh its risks and recommended that it be refused marketing authorisation.
Posledično je odbor CHMP tedaj menil, da koristi zdravila Dexxience ne odtehtajo z njim povezanih tveganj in priporočil, da se vloga za pridobitev dovoljenja za promet z njim zavrne.
The CHMP refusal was confirmed after re-examination.
Zavrnitev odbora CHMP glede izdaje dovoljenja za promet je bila po ponovni presoji potrjena.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Dexxience.
Družba je odbor CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Dexxience.
Treatment with Dexxience was compared with enoxaparin, another medicine for preventing blood clots.
Zdravljenje z zdravilom Dexxience so primerjali z enoksaparinom, drugim zdravilom za preprečevanje krvnih strdkov.
What was Dexxience expected to be used for?
Za kaj naj bi se zdravilo Dexxience uporabljalo?
By blocking factor Xa, the medicine reduces the levels of thrombin in the blood and this reduces the risk of blood clots forming in blood vessels.
Z zaviranjem faktorja Xa zdravilo zmanjšuje količino trombina v krvi in s tem zmanjšuje tveganje za nastanek krvnih strdkov v žilah.
The patients were at high risk of venous thromboembolism because of their age, presence of a protein indicating a blood clot, previous blood clots, cancer and lack of mobility during hospital treatment.
Pri teh bolnikih je obstajalo povečano tveganje za vensko trombembolijo, in sicer zaradi njihove starosti, prisotnosti beljakovine, ki kaže na krvni strdek, predhodnih krvnih strdkov, raka in zmanjšane mobilnosti v času bolnišničnega zdravljenja.
Dexxience was expected to be used to prevent venous thromboembolism (formation of blood clots in veins).
Zdravilo Dexxience naj bi se uporabljalo za preprečevanje venske trombembolije (nastajanja krvnih strdkov v venah).
How does Dexxience work?
Kako zdravilo Dexxience deluje?
What is Dexxience?
Kaj je zdravilo Dexxience?
Dexxience is a medicine that contains the active substance betrixaban.
Zdravilo Dexxience vsebuje učinkovino betriksaban.
The active substance in Dexxience, betrixaban, is a ‘factor Xa inhibitor'.
Učinkovina v zdravilu Dexxience, betriksaban, je zaviralec faktorja Xa.
The full EPAR and risk management plan summary for Pemetrexed Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pemetreksed Accord sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Pemetrexed Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetreksed Accord?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Accord has been shown to be comparable to Alimta.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetreksed Accord primerljivo z zdravilom Alimta.
This means that Pemetrexed Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
What is Pemetrexed Accord and what is it used for?
Kaj je zdravilo Pemetreksed Accord in za kaj se uporablja?
Because Pemetrexed Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pemetreksed Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Pemetrexed Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetreksed Accord.
What are the benefits and risks of Pemetrexed Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Pemetreksed Accord?
A risk management plan has been developed to ensure that Pemetrexed Accord is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pemetreksed Accord je bil pripravljen načrt obvladovanja tveganj.
The Committee recommended that Pemetrexed Accord be approved for use in the EU.
Priporočil je, da se zdravilo Pemetreksed Accord odobri za uporabo v EU.
Pemetrexed Accord is a cancer medicine used to treat two types of lung cancer:
Zdravilo Pemetreksed Accord je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
Other information about Pemetrexed Accord
Druge informacije o zdravilu Pemetreksed Accord
It is not intended to provide practical advice on how to use Pemetrexed Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Pemetrexed Accord is a ‘generic medicine'.
Zdravilo Pemetreksed Accord je „generično zdravilo“.
For practical information about using Pemetrexed Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pemetreksed Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Accord.
Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Pemetreksed Accord jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
For more information about treatment with Pemetrexed Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pemetreksed Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
When Pemetrexed Accord is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Kadar se zdravilo Pemetreksed Accord daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem bolniku dati tudi „antiemetično“ zdravilo (za preprečevanje bruhanja) in tekočino (za preprečevanje dehidracije).
The active substance in Pemetrexed Accord, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Zdravilna učinkovina v zdravilu Pemetreksed Accord, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
Why is Pemetrexed Accord approved?
Zakaj je bilo zdravilo Pemetreksed Accord odobreno?
Pemetrexed Accord is available as a powder that is made up into a solution for infusion (drip) into a vein.
Zdravilo Pemetreksed Accord je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
How has Pemetrexed Accord been studied?
Kako je bilo zdravilo Pemetreksed Accord raziskano?
No additional studies were needed as Pemetrexed Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Ker je zdravilo Pemetreksed Accord generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile potrebne nobene dodatne študije.
How is Pemetrexed Accord used?
Kako se zdravilo Pemetreksed Accord uporablja?
How does Pemetrexed Accord work?
Kako zdravilo Pemetreksed Accord deluje?
Pemetrexed Accord contains the active substance pemetrexed.
Zdravilo Pemetreksed Accord vsebuje zdravilno učinkovino pemetreksed.
Pemetrexed Accord pemetrexed
Pemetreksed Accord pemetreksed
Commission decision date: 23/11/2017.
Datum sklepa Komisije: 23. 11. 2017
Following a request from companies concerned, the PRAC re-examined its initial recommendation.
Po zahtevi zadevnih družb je odbor PRAC ponovno proučil svoja začetna priporočila.
The review of gadolinium contrast agents was initiated on 17 March 2016 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Pregled kontrastnih sredstev z gadolinijem se je začel 17. marca 2016 na zahtevo Evropske komisije v skladu s členom 31 Direktive 2001/83/ES.
• If you have any questions about your scan, speak to your doctor.
• Če imate kakršna koli vprašanja o slikanju, se posvetujte z zdravnikom.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations in March 2017.
Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in marca 2017 podal več priporočil.
The final recommendations have been sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Končna priporočila je poslala Evropski komisiji, ki je izdala končni pravno zavezujoči sklep, ki velja v vseh državah članicah EU.
• Healthcare professionals should always use the lowest dose that provides sufficient enhancement for diagnosis.
• Zdravstveni delavci morajo vedno uporabljati najmanjši odmerek, ki še zagotavlja zadosten kontrast za diagnostiko.
As a result of this interaction, the water molecules give a stronger signal, helping to obtain a brighter image.
Zaradi tega vpliva začnejo vodne molekule oddajati močnejši signal, kar omogoča jasnejšo sliko.
These body scans rely on the magnetic fields produced by water molecules in the body.
Tovrstna slikanja telesa temeljijo na magnetnih poljih, ki jih ustvarijo vodne molekule v telesu.
The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Končni izid postopka pregleda je pravno zavezujoč sklep, ki ga sprejme Evropska komisija in velja v vseh državah članicah EU.
These products can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.
Ta zdravila se lahko še naprej uporabljajo pri trenutno veljavnih indikacijah, vendar v najmanjšem odmerku, ki še dovolj izboljša kontrast slik, in le v primerih, kadar slikanje telesa brez kontrasta ni primerno.
• Gadolinium deposition in the brain has been confirmed by mass spectrometry and increases in signal intensity in brain tissue.
• Odlaganje gadolinija v možganih so potrdili z masno spektrometrijo in povečanjem intenzitete signala v možganskem tkivu.
• As a precaution, doctors will stop using some contrast agents given into the vein while some others will only be used when other agents are not suitable (e.g. for liver scans).
• Zaradi previdnosti bodo zdravniki prenehali uporabljati nekatera kontrastna sredstva, ki se dajejo v veno, nekatera pa bodo uporabljali le, kadar druga kontrastna sredstva ne bodo primerna (npr. za slikanje jeter).
This review covers agents containing the following active substances: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Ta pregled zajema kontrastna sredstva, ki vsebujejo naslednje zdravilne učinkovine: gadobensko kislino, gadobutrol, gadodiamid, gadopentetno kislino, gadoterno kislino, gadoteridol, gadoversetamid in gadoksetinsko kislino.
• It is known that small amounts of gadolinium may remain in the brain after a scan with these agents, although there is currently no evidence that these small amounts cause any harm.
• Znano je, da lahko po slikanju s temi kontrastnimi sredstvi v možganih ostane manjša količina gadolinija, vendar trenutno ni dokazov, da bi takšne majhne količine povzročile kakršno koli škodo.
restrict use to liver scans
omejitev uporabe na slikanje jeter
• Healthcare professionals in the EU will be sent a letter with information about EMA's review of gadolinium contrast agents.
• Zdravstveni delavci v EU bodo prejeli dopis z informacijami o pregledu kontrastnih sredstev z gadolinijem, ki ga je opravila agencija EMA.