natgillin/translations-raw huggingface dataset:
SonoVue must not be injected into a vein in 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).
Zdravilo SonoVue ne sme biti injicirano v veno pri bolnikih z desno-levim šantom (nenormalnim pretokom krvi v srcu), hudo pljučno hipertenzijo (visokim krvnim tlakom v pljučni arteriji, tj. žili, ki vodi od srca do pljuč), nenadzorovano hipertenzijo (visokim krvnim tlakom) ali sindromom dihalne stiske pri odraslih (obilnega kopičenja tekočine v obeh pljučnih krilih).
When used to detect vesicoureteral reflux in children, 1 ml of SonoVue is given by a catheter into the bladder, which is then filled with saline (salt) solution until the patient feels the need to empty their bladder.
Kadar se zdravilo SonoVue uporablja za odkrivanje refluksa sečnega mehurja, se 1 ml zdravila s katetrom da v mehur, ki je nato polnjen s fiziološko raztopino (raztopino soli), dokler bolnik ne zazna, da mora izprazniti mehur.
However, this was not observed in the pancreas, kidney, ovary or prostate gland.
Vendar tega pri trebušni slinavki, v ledvicah, jajčnikih in prostati ni bilo opaziti.
SonoVue has been shown to be effective in improving ultrasound scans of the heart in adults and the bladder in children, and in measurements of blood flow.
Dokazano je, da je zdravilo SonoVue učinkovito pri izboljšanju ultrazvočnih preiskav srca pri odraslih in mehurja pri otrocih ter merjenja pretoka krvi.
SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability to create an echo.
Uporablja se pri preiskavah, s katerimi se ugotavlja, kako ultrazvok potuje po telesu, saj poveča sposobnost nastajanja odboja.
SonoVue can be used in adults for 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;
Zdravilo SonoVue se lahko uporablja pri odraslih za Dopplerjeve preiskave velikih krvnih žil, kot so žile v glavi, žile, ki potekajo do glave, ali glavna vena do jeter, ali manjših krvnih žil, na primer pri lezijah (območjih bolezni) v prsih ali jetrih;
However, the results were not sufficient to state that a negative result following ultrasound with Sonovue allows the practitioner to exclude a diagnosis of vesicoureteral reflux.
Vendar rezultati niso bili zadostni za trditev, da zdravnik lahko izključi diagnozo refluksa sečnega mehurja, če je bil rezultat po ultrazvoku z zdravilom SonoVue negativen.
The gas is removed naturally from the blood through the lungs or passed out in the urine after bladder scans.
Plin se iz mehurja naravno odstrani prek pljuč ali pa po preiskavah mehurja preide v urin.
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.
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).
Uporaba zdravila SonoVue je pri meritvah pretoka 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 do ledvic).
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.
Zdravilo SonoVue je bilo pri izboljšanju jasnosti slike levega prekata in roba levega prekata učinkovitejše od primerjalnega zdravila in placeba.
When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles.
Ko se zdravilo pripravi v obliki suspenzije, ostane plin ujet v majhnih mehurčkih, imenovanih mikromehurčki.
How is SonoVue used?
Kako se zdravilo SonoVue uporablja?
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 bila zaradi zdravila SonoVue kakovost preiskav med opazovanjem pretoka krvi v lezijah prsi in jeter boljša.
When made up into a solution, SonoVue contains sulphur hexafluoride gas as ‘microbubbles' in suspension in a liquid.
Ko se zdravilo SonoVue pripravi v obliki raztopine, vsebuje plin žveplovega heksafluorida v obliki mikromehurčkov v tekoči suspenziji.
It is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, in adults with suspected or confirmed coronary artery disease;
• ehokardiografiji (diagnostični preiskavi, pri kateri se slika srce), da bi dobili jasnejšo sliko srčnih votlin, zlasti levega prekata, pri odraslih z dokazano boleznijo koronarnih arterij ali sumom nanjo;
No side effects attributable to the medicine have been reported in children given SonoVue into the bladder.
Pri otrocih, ki jim je bilo zdravilo SonoVue dano v mehur, niso poročali o neželenih učinkih, ki bi jih bilo mogoče pripisati zdravilu.
How does SonoVue work?
Kako zdravilo SonoVue deluje?
They may also be given a repeat dose after one hour.
Tudi pri njih se lahko po eni uri odmerek ponovi.
It must not be used in patients with the following conditions:
Ne smejo ga uporabljati bolniki z naslednjimi vrstami obolenj:
This means that it is similar to a reference medicine, containing the same active substance but in a different concentration.
To pomeni, da je podobno referenčnemu zdravilu in vsebuje enako zdravilno učinkovino, vendar v drugačni koncentraciji.
• glucose-6-phosphate dehydrogenase deficiency (G6PD),
• pomanjkanjem glukoza-6-fosfat-dehidrogenaze (G6PD),
The dose in children aged three months or less is 0.3 to 0.5 mg/kg.
Odmerek pri otrocih, starih tri mesece ali manj, znaša med 0,3 in 0,5 mg/kg.
• deficiency in the enzyme NADPH reductase.
• pomanjkanjem encima NADPH reduktaze.
The usual dose for adults and children aged above three months is 1 to 2 mg per kilogram (kg) body weight.
Običajni odmerek za odrasle in otroke, starejše od treh mesecev, je od 1 do 2 mg na kilogram (kg) telesne mase.
The CHMP decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila večje od z njim povezanih tveganj, zato je priporočil, da se zanj izda dovoljenje za promet.
Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.
Snovi, ki lahko povzročijo methemoglobinemijo, so nekateri antibiotiki, lokalni anestetiki, nitrati v pitni vodi in pesticidi.
The full EPAR for Methylthioninium chloride Proveblue 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) za zdravilo Metiltioninijev klorid Proveblue je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Methylthioninium chloride Proveblue on 6 May 2011.
Evropska komisija je dovoljenje za promet z zdravilom Metiltioninijev klorid Proveblue, veljavno po vsej Evropski uniji, izdala 6. maja 2011.
It can only be obtained with a prescription and must be given by a healthcare professional.
Predpisovanje in izdaja zdravila je le na recept, daje pa ga lahko samo strokovni zdravstveni delavec.
The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.
Elektroni se nato prenesejo na atome železa v nenormalnem hemoglobinu in jih spremenijo v normalno obliko železa.
Methylthioninium chloride Proveblue is available as a solution for injection (5 mg/ml), which is injected slowly into a vein over a period of five minutes.
Zdravilo Metiltioninijev klorid Proveblue je na voljo kot raztopina za injiciranje (5 mg/ml), ki se v veno injicira počasi v obdobju petih minut.
This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Metiltioninijev klorid Proveblue.
Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by the use of certain medicines or chemicals.
Zdravilo Metiltioninijev klorid Proveblue se uporablja pri odraslih in otrocih vseh starosti kot antidot za zdravljenje simptomov methemoglobinemije, ki jo povzroča uporaba določenih zdravil ali kemikalij.
Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on its use from the published literature, which confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.
Ker se metiltioninijev klorid v Evropski uniji za zdravljenje methemoglobinemije uporablja že nekaj desetletij, je družba predstavila podatke o njegovi uporabi iz objavljene literature, ki potrjujejo, da je metiltioninijev klorid učinkovit pri zdravljenju methemoglobinemije, ki jo pri odraslih in otrocih povzroča izpostavljenost zdravilom ali kemikalijam.
The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles'), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine), sweating and pain at the site of injection or in a limb.
Najpogostejši neželeni učinki metiltioninijevega klorida so omotica, parestezija (neobičajni občutki zbadanja), disgevzija (motnje okušanja), navzeja (slabost), sprememba barve kože, kromaturija (neobičajna obarvanost urina), potenje in bolečina na mestu injiciranja ali v okončinah.
What measures are being taken to ensure the safe and effective use of Methylthioninium chloride Proveblue?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Metiltioninijev klorid Proveblue?
• methaemoglobinaemia caused by nitrite during treatment of cyanide poisoning,
• methemoglobinemijo, povzročeno z nitritom med zdravljenjem zastrupitve s cianidom,
To carry oxygen in the blood, haemoglobin needs to contain an atom of iron in the ‘ferrous' form (Fe2+).
Za prenašanje kisika po krvi mora hemoglobin vsebovati atom železa v dvovalentni obliki (Fe2+).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Methylthioninium chloride Proveblue have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Exposure to certain medicines or chemicals can cause the iron in the haemoglobin to change to the ‘ferric' form (Fe3+) seen in methaemoglobinaemia which is less able to transport oxygen.
Izpostavljenost nekaterim zdravilom ali kemičnim snovem lahko povzroči, da se železo v hemoglobinu spremeni v trivalentno obliko (Fe3+), kar se zgodi tudi pri methemoglobinemiji, ki je manj zmožna za prenos kisika.
Methylthioninium chloride Proveblue must not be used in people who are hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (the group to which methylthioninium chloride belongs).
Zdravila Metiltioninijev klorid Proveblue ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) metiltioninijev klorid ali katera koli tiazinska barvila (skupina, v katero spada metiltioninijev klorid).
For more information about treatment with Methylthioninium chloride Proveblue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Metiltioninijev klorid Proveblue preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue), helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin.
Zdravilna učinkovina v zdravilu Metiltioninijev klorid Proveblue, metiltioninijev klorid (imenovan tudi metilenska modra), pomaga pospeševati spreminjanje nenormalnega hemoglobina v normalnega.
For practical information about using Methylthioninium chloride Proveblue, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Metiltioninijev klorid Proveblue naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Methaemoglobinaemia is a condition where there is too much of an abnormal form of haemoglobin (called methaemoglobin) in the blood that is not able to transport oxygen effectively.
Methemoglobinemija je bolezen, pri kateri je v krvi preveč nenormalnih oblik hemoglobina (imenovanega methemoglobin), ki ne more učinkovito prenašati kisika.
It does this by accepting negatively charged electron particles through an enzyme called ‘NADPH methaemoglobinaemia reductase'.
To poteka tako, da prek encima, imenovanega „NADPH-methemoglobin reduktaza“, sprejema negativno nabite elektronske delce.
A repeat dose may be given one hour after the first dose if symptoms persist or come back, or if the level of methaemoglobin in the blood stays higher than normal.
V primeru trdovratnih ali ponavljajočih se simptomov ali če ravni methemoglobina v krvi ostanejo višje od običajnih vrednosti, se lahko eno uro po prvem odmerku injicira še en odmerek.
• methaemoglobinaemia caused by chlorate poisoning,
• methemoglobinemijo zaradi zastrupitve s kloratom,
The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.
Referenčno zdravilo za Metiltioninijev klorid Proveblue je zdravilo Metiltioninijev klorid injekcija USP 1 % m/m.
For the full list of all side effects reported with methylthioninium chloride, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi metiltioninijevega klorida, glejte navodilo za uporabo.
Methylthioninium chloride Proveblue is a ‘hybrid medicine'.
Zdravilo Metiltioninijev klorid Proveblue je „ hibridno zdravilo “.
Other information about Methylthioninium chloride Proveblue
Druge informacije o zdravilu Metiltioninijev klorid Proveblue
What is Methylthioninium chloride Proveblue and what is it used for?
Kaj je zdravilo Metiltioninijev klorid Proveblue in za kaj se uporablja?
The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia.
Odbor CHMP je sklenil, da dolgoročne izkušnje z uporabo zdravilne učinkovine, metiltioninijevega klorida, kažejo, da je učinkovita pri zdravljenju methemoglobinemije.
What benefits of Methylthioninium chloride Proveblue have been shown in studies?
Kakšne koristi je zdravilo Metiltioninijev klorid Proveblue izkazalo v študijah?
What are the risks associated with Methylthioninium chloride Proveblue?
Kakšna tveganja so povezana z zdravilom Metiltioninijev klorid Proveblue?
Methylthioninium chloride Proveblue methylthioninium chloride
Metiltioninijev klorid Proveblue metiltioninijev klorid
Methylthioninium chloride Proveblue contains the active substance methylthioninium chloride.
Zdravilo Metiltioninijev klorid Proveblue vsebuje aktivno učinkovino metiltioninijev klorid.
How does Methylthioninium chloride Proveblue work?
Kako zdravilo Metiltioninijev klorid Proveblue deluje?
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu lahko ustrezni organi države članice naknadno posodobijo, v sodelovanju z referenčno državo članico, kot je primerno, v skladu s postopki, opisanimi v poglavju 4, naslovu III direktive 2001/83/EC.
How {invented name} is given
Kako se zdravilo {izmišljeno ime} daje
By reporting side effects you can help provide more information on the safety of this medicine.
S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotoviti več informacij o varnosti tega zdravila.
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron.
Pomanjkanje železa v prvem trimesečju nosečnosti je v mnogih primerih mogoče zdraviti s peroralnim jemanjem železa.
Treatment with {invented name} should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Zdravljenje z zdravilom {izmišljeno ime} je treba omejiti na drugo in tretje trimesečje nosečnosti, če se oceni, da koristi odtehtajo možna tveganja tako za mater kot za plod.
{invented name} has not been tested in pregnant women.
Zdravilo {izmišljeno ime} ni bilo preskušeno pri nosečnicah.
If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Če se med injiciranjem pojavijo preobčutljivostne reakcije ali znaki intolerance, je potrebno zdravljenje takoj ustaviti.
This summary of product characteristics, labelling and package leaflet is the outcome of the referral procedure.
Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo je rezultat postopka napotitve.
Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
Po potrebi je treba izvesti dodatno zdravljenje z antihistaminiki in/ali kortikosteroidi.
The current information on subsequent doses/administration of the product, including for example slower initial rate of administration, should remain unchanged]
Aktualne informacije o poznejših odmerkih/apliciranju izdelka se ne smejo spreminjati, kar velja na primer tudi za začetno hitrost apliciranja]
Your doctor will decide whether or not you should be given this medicine.
Zdravnik bo presodil, ali zdravilo smete prejeti.
There are no adequate and well-controlled trials of {invented name} in pregnant women.
Ustreznih in dobro kontroliranih preskušanj o uporabi zdravila {izmišljeno ime} pri nosečnicah ni na voljo.
You must not receive {invented name}: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
Ne smete prejeti zdravila {izmišljeno ime}: - če ste alergični na (preobčutljivi za) zdravilo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Talk to your doctor or nurse before receiving {invented name}: - if you have a history of medicine allergy - if you have systemic lupus erythematosus - if you have rheumatoid arthritis - if you have severe asthma, eczema or other allergies
Preden boste prejeli zdravilo {izmišljeno ime} se posvetujte z zdravnikom ali medicinsko sestro: - če ste v preteklosti že imeli alergične reakcije, - če imate sistemski eritematozni lupus, - če imate revmatoidni artritis, - če imate hudo astmo, ekcem ali drugo atopično alergijo.
[All references to the recommendation for an initial test dose before the administration of the first dose to a new patient should be removed in section 4.2 and in any other sections of the SmPC where applicable.
[V razdelku 4.2 in vseh drugih razdelkih povzetka glavnih značilnosti zdravila, kjer je to potrebno, je treba odstraniti vsa sklicevanja na priporočilo o začetnem preskusnem odmerku pred apliciranjem prvega odmerka novemu bolniku.
The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
Tveganje je večje pri bolnikih z znanimi alergijami, vključno z alergijami na zdravila, in pri bolnikih s hudo astmo, ekcemom ali drugo atopično alergijo.
- if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.
- če ste imeli hudo alergično (preobčutljivostno) reakcijo na druga zdravila za injiciranje, ki vsebujejo železo.
If you become pregnant during treatment, you must ask your doctor for advice.
Če med zdravljenjem zanosite, se morate za nasvet obrniti na svojega zdravnika.
{Invented name} should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Zdravilo {izmišljeno ime} se lahko uporablja le, če je takoj na voljo osebje, ki je usposobljeno za prepoznavanje anafilaktičnih reakcij in zna ustrezno ukrepati v okolju, kjer je zagotovljena vsa oprema za oživljanje.
Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution.
Na voljo mora biti oprema za kardiopulmonalno oživljanje in za ravnanje z akutnimi anafilaktičnimi/anafilaktoidnimi reakcijami, vključno z injekcijo raztopine adrenalina v razmerju 1:1000.
• Known serious hypersensitivity to other parenteral iron products.
• Znana huda preobčutljivost na druga parenteralna zdravila, ki vsebujejo železo.
There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Tveganje za preobčutljivostne reakcije na parenteralno dane komplekse železa je povečano tudi pri bolnikih z imunskimi ali vnetnimi stanji (npr. sistemski eritematozni lupus, revmatoidni artritis).
It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom.
What you need to know before you receive {invented name} [the wording below should be inserted in the relevant section]
Kaj morate vedeti, preden boste prejeli zdravilo {izmišljeno ime} [spodnje besedilo je treba vključiti v ustrezno poglavje]
• Hypersensitivity to the active substance, to {invented name} or any of its excipients listed in section 6.1.
• Preobčutljivost za zdravilno učinkovino zdravila {izmišljeno ime} ali katero koli pomožno snov, navedeno v poglavju 6.1.
You will be observed for at least 30 minutes by your doctor or nurse after each administration.
Po vsakem injiciranju vas bo zdravnik ali medicinska sestra opazovala še 30 minut.
Each patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection.
Zaradi morebitnega pojava neželenih učinkov je treba vsakega bolnika opazovati vsaj 30 minut po injiciranju zdravila {izmišljeno ime}.
Your doctor or nurse will administer {invented name} by {route of administration defined in posology section of SmPC}; the {invented name} will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.
Zdravnik ali medicinska sestra vam bosta dala zdravilo {izmišljeno ime} {pot, določena v poglavju o odmerjanju v povzetku glavnih značilnosti zdravila}; zdravilo {izmišljeno ime} vam bodo dali v okolju, kjer je mogoče ustrezno in hitro zdraviti imunoalergijske dogodke.
The patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection (see section 4.4).
Zaradi morebitnega pojava neželenih učinkov je treba bolnika opazovati vsaj 30 minut po injiciranju zdravila {izmišljeno ime} (glejte poglavje 4.4).
You can also report side effects directly via {the national reporting system listed in Appendix V}*.
O neželenih učinkih lahko poročate neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V*.