natgillin/translations-raw huggingface dataset:
What you need to know before you take <product name> Warnings and precautions
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Opozorila in previdnostni ukrepi
Undesirable effects
Možni neželeni učinki
Ondansetron should not be used during the first trimester of pregnancy.
Ondansteron se ne sme uporabljati v prvem trimesečju nosečnosti.
Parenteral nutrition products2 containing amino acids and/or lipids with or without admixture of vitamins and/or trace elements - Adverse outcomes in neonates treated with solutions not protected from light (EPITT no 19423)
Zdravila za parenteralno prehrano2, ki vsebujejo aminokisline in/ali lipide s primesmi vitaminov in/ali elementov v sledeh ali brez - neželeni učinki pri novorojenčkih, zdravljenih z raztopinami, ki niso zaščitene pred svetlobo (št. EPITT 19423)
Before initiating axitinib therapy in patients with pre-existing aneurysms, this risk should be carefully considered.
Pred uvedbo zdravljenja z aksitinibom pri bolnikih z že obstoječimi anevrizmami je treba skrbno razmisliti o tem tveganju.
Tell your doctor right away if you have any of these symptoms or a serious bleeding problem during treatment with Inlyta: black tarry stools, coughing up of blood or bloody sputum, or change in your mental status.
Nemudoma obvestite zdravnika, če se vam med zdravljenjem z zdravilom Inlyta pojavi katerikoli od naslednjih simptomov ali če imate hude težave, povezane s krvavitvami: črno, lepljivo blato, izkašljevanje krvi ali krvav izpljunek ali spremembe v duševnem stanju.
Special precautions for disposal and other handling:
Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom:
Bleeding.
Krvavitev.
Talk to your doctor or nurse before taking <product name>: - If you have been diagnosed with an enlargement or "bulge" of the large blood aortic vessel known as aortic aneurysm.
Pred začetkom jemanja zdravila <ime zdravila> se posvetujte z zdravnikom ali medicinsko sestro: - Če so vam postavili diagnozo razširitve ali "izbokline" velike krvne žile (aorte), kar imenujemo aortna anevrizma.
Summary of product characteristics (* include neonates and if product is indicated in such population) 4.2.
(* vključiti novorojenčkih in, če je zdravilo indicirano pri tovrstni populaciji) 4.2.
Take care to drink sufficient amount of liquid during treatment with mesalazine.
Med zdravljenjem z mesalazinom poskrbite za zadosten vnos tekočine.
Package leaflet (* include neonates and if product is indicated in such population) [For products used in <neonates and *> children below 2 years] 2.
(* vključiti novorojenčkih in, če je zdravilo indicirano pri tovrstni populaciji) [Za zdravila, indicirana pri <novorojenčkih in *> otrocih, mlajših od 2 let] 2.
Kidney stones may develop with use of mesalazine.
Uporaba mesalazina lahko povzroči nastanek ledvičnih kamnov.
Tell your doctor if you have any bleeding, coughing up of blood or bloody sputum while on treatment with this medicine.
Obvestite zdravnika, če med zdravljenjem s tem zdravilom pride do kakršnekoli krvavitve, izkašljevanja krvi ali krvavega izpljunka.
Section at the end of the package leaflet:
Poglavje na koncu navodila za uporabo
Aneurysms and artery dissections
Anevrizme in arterijske disekcije
An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Special warnings and precautions
4.4 Posebna opozorila in previdnostni ukrepi
Special warnings and precautions for use: [For products indicated in neonates (age up to 28 days)] Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products.
Posebna opozorila in previdnostni ukrepi: [Za zdravila, indicirana pri novorojenčkih (starost do 28 dni)] Izpostavljenost raztopin za intravensko parenteralno prehrano svetlobi, zlasti po mešanju z elementi v sledeh in/ali vitamini, ima lahko zaradi nastajanja peroksidov in drugih razgradnih produktov škodljive učinke na klinični izid pri novorojenčkih.
INSTRUCTIONS ON USE (* include neonates and if product is indicated in such population) When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed.
NAVODILA ZA UPORABO (* vključiti novorojenčkih in, če je zdravilo indicirano pri tovrstni populaciji) Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, je treba raztopino (v vrekah in kompletih za dajanje zdravila) do zaključka dajanja zaščititi pred izpostavljenostjo svetlobi.
An enlargement or "bulge" of the aortic vessel or a tear in the aortic wall (aortic aneurysms and dissections).
Neznana pogostnost razširitev ali "izboklina" aorte ali raztrganje aortne stene (aortne anevrizme in disekcije).
Frequency ‘Not known': Aneurysms and artery dissections Footnotes: hIncluding activated partial thromboplastin time prolonged, anal haemorrhage, aneurysm rupture, arterial haemorrhage...
Opombe: h vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom, krvavitvijo iz anusa, rupturo anevrizme, arterijsko krvavitvijo […]
- If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
- Če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
[For products NOT indicated in neonates BUT in children below 2 years] Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may lead to generation of peroxides and other degradation products.
[Za zdravila, indicirana pri otrocih do 2 let, VENDAR NE pri novorojenčkih] Izpostavljenost raztopin za intravensko parenteralno prehrano svetlobi, zlasti po mešanju z elementi v sledeh in/ali vitamini, lahko povzroči nastajanje peroksidov in drugih razgradnih produktov.
If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
Aortic aneurysms and dissections
Aortne anevrizme in disekcije
Before initiating Inlyta, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila Inlyta je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
Before initiating <product name>, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila <ime zdravila> je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
Frequency ‘Not known': Aortic aneurysms and dissections* Frequency ‘Not known': Aneurysms and artery dissections*
Pogostnost „občasni“: disekcija aorte Neznana pogostnost: anevrizme in disekcije arterij
Before initiating <product name> therapy, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred začetkom zdravljenja s uvedbo zdravila <ime zdravila> je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
Exposure of <product name> to ambient light, especially after admixtures with trace elements and/or vitamins, generates peroxides and other degradation products that can be reduced by protection from light exposure.
Izpostavljenost zdravila <ime zdravila> svetlobi okolice, zlasti po mešanju z elementi v sledeh in/ali vitamini, povzroči nastanek peroksidov in drugih razgradnih produktov.
When used in <neonates and *> children below 2 years, protect from light exposure, until administration is completed.
Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, do zaključka dajanja zaščitite pred izpostavljenostjo svetlobi.
What you need to know before you take Inlyta
Kaj morate vedeti, preden boste vzeli zdravilo Inlyta Opozorila in previdnostni ukrepi
When used in children below 2 years, <product name> should be protected from ambient light until administration is completed (see sections 4.2, 6.3 and 6.6).
Ob uporabi pri otrocih, mlajših od 2 let, je treba zdravilo <ime zdravila> do zaključka dajanja zaščititi pred svetlobo okolice (glejte poglavja 4.2, 6.3 in 6.6).
When used in children below 2 years, <product name> should be protected from ambient light until administration is completed.
Ob uporabi pri otrocih, mlajših od 2 let, je treba zdravilo <ime zdravila> do zaključka dajanja zaščititi pred svetlobo okolice.
When used in neonates and children below 2 years, <product name> should be protected from ambient light until administration is completed.
Ob uporabi pri novorojenčkih in otrocih, mlajših od 2 let, je treba zdravilo <ime zdravila> do zaključka dajanja zaščititi pred svetlobo okolice.
Talk to your doctor or nurse before taking Inlyta:
Pred začetkom jemanja zdravila Inlyta se posvetujte z zdravnikom ali medicinsko sestro: Če imate težave s krvavitvami.
Frequency ‘Not known': Aneurysms and artery dissections
Neznana pogostnost: anevrizme in disekcije arterij
When used in neonates and children below 2 years, <product name> should be protected from ambient light until administration is completed (see sections 4.2, 6.3 and 6.6).
Ob uporabi pri novorojenčkih in otrocih, mlajših od 2 let, je treba zdravilo <ime zdravila> do zaključka dajanja zaščititi pred svetlobo okolice (glejte poglavja 4.2., 6.3. in 6.6).
When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed.
Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, je treba raztopino (v vrečah in kompletih za dajanje zdravila) do zaključka dajanja zaščititi pred izpostavljenostjo svetlobi.
When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see sections 4.4, 6.3 and
Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, je treba raztopino (v vrečah in kompletih za dajanje zdravila) do zaključka dajanja zaščititi pred izpostavljenostjo svetlobi (glejte poglavja 4.4., 6.3 in 6.6).
When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see section 2).
Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, je treba raztopino (v vrečkah in setih za dajanje zdravila) do zaključka dajanja zaščititi pred izpostavljenostjo svetlobi (glejte poglavje 2).
If you have high blood pressure (only applicable for products containing nintedanib and vandetanib as for the rest of the products, this warning is already included) If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Pred začetkom jemanja zdravila <ime zdravila> se posvetujte z zdravnikom ali medicinsko sestro: Če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
Aflibercept (Zaltrap), bevacizumab, cabozantinib, nintedanib, pazopanib, ponatinib, ramucirumab, regorafenib, sorafenib, tivozanib, vandetanib Summary of product characteristics
Aflibercept (Zaltrap); bevacizumab; kabozantinib; nintedanib; pazopanib; ponatinib; ramucirumab; regorafenib; sorafenib; tivozanib; vandetanib Povzetek glavnih značilnosti zdravila
When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see sections 4.2, 4.4 and
Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, je treba raztopino (v vrečah in kompletih za dajanje zdravila) do zaključka dajanja zaščititi pred izpostavljenostjo svetlobi (glejte poglavja 4.2, 4.4 in 6.6).
Tabulated list of adverse reactions
Seznam neželenih učinkov Žilne bolezni
Frequency Uncommon: Aortic Dissection
Neznana pogostnost: aortne anevrizme in disekcije*
Patients should be monitored at least every six months.
Bolnike je treba pregledati vsaj vsakih šest mesecev.
These amino acids are normally found in proteins in foods and drinks.
Te aminokisline so običajno prisotne v beljakovinah v hrani in pijači.
Nitisinone MDK is available as capsules (2 mg, 5 mg and 10 mg).
Zdravilo Nitizinon MDK je na voljo v obliki kapsul (2 mg, 5 mg in 10 mg).
The full EPAR for Nitisinone MDK 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 Nitizinon MDK je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tyrosine is broken down in the body by a number of enzymes.
Tirozin v telesu razgrajujejo številni encimi.
The European Commission granted a marketing authorisation valid throughout the European Union for Nitisinone MendeliKABS on 24 August 2017.
Evropska komisija je dovoljenje za promet z zdravilom Nitizinon MendeliKABS, veljavno po vsej Evropski uniji, izdala 24. avgusta 2017.
This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and harmful substances are formed, causing serious liver problems and liver cancer.
To je redka bolezen, pri kateri telo ni sposobno popolnoma razgraditi aminokisline tirozin, zaradi česar nastajajo škodljive snovi, ki povzročajo hude težave z jetri, vključno z rakom jeter.
Previously known as Nitisinone MendeliKABS
Prej znano kot Nitizinon MendeliKABS
This is a summary of the European public assessment report (EPAR) for Nitisinone MDK.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nitizinon MDK.
Because Nitisinone MDK is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Nitizinon MDK generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What measures are being taken to ensure the safe and effective use of Nitisinone MDK?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nitizinon MDK?
As for every medicine, the company provided studies on the quality of Nitisinone MDK.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Nitizinon MDK.
The name of the medicine was changed to Nitisinone MDK on 3 October 2017.
Ime zdravila je bilo 3. oktober 2017 spremenjeno v Nitizinon MDK.
The European Medicines Agency concluded that, in accordance with EU requirements, Nitisinone MDK has been shown to have comparable quality and to be bioequivalent to Orfadin.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Nitizinon MDK primerljivo raven kakovosti kot referenčno zdravilo Orfadin ter da mu je biološko enakovredno.
Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is transformed into harmful substances.
Bolniki z dedno tirozinemijo tipa 1 nimajo enega od teh encimov, zato se tirozin v njihovem telesu ne razgradi ustrezno, ampak se pretvori v škodljive snovi.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nitisinone MDK.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih načinih uporabe so že bile izvedene z referenčnim zdravilom Orfadin, zato jih ni treba ponoviti za zdravilo Nitizinon MDK.
This means that Nitisinone MDK contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Orfadin.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Orfadin.
The Agency recommended that Nitisinone MDK be approved for use in the EU.
Priporočila je, da se zdravilo Nitizinon MDK odobri za uporabo v EU.
For more information about treatment with Nitisinone MDK, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Nitizinon MDK preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nitisinone MDK 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 zdravila Nitizinon MDK upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Nitisinone MDK
Nitizinon MDK1
What are the benefits and risks of Nitisinone MDK?
Kakšne so koristi in tveganja, povezani z zdravilom Nitizinon MDK?
The capsules are usually swallowed whole, but they may be opened and their contents mixed into a small amount of water or formula just before swallowing.
Priporočeni začetni odmerek znaša 1 mg na kilogram telesne mase na dan. Kapsule se navadno pogoltnejo cele, vendar se lahko odprejo, da se vsebina tik pred zaužitjem zmeša z manjšo količino vode ali formule.
Therefore, the Agency's view was that, as for Orfadin, the benefit outweighs the identified risk.
Zato je menila, da njegove koristi enako kot pri zdravilu Orfadin odtehtajo znana tveganja.
Nitisinone MDK is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Zdravilo Nitizinon MDK se uporablja za zdravljenje dedne tirozinemije tipa 1 (HT-1).
However, as the unconverted tyrosine remains in the body during Nitisinone MDK treatment, patients need to eat a special diet low in tyrosine.
Ker pa tirozin med zdravljenjem z zdravilom Nitizinon MDK ostane v telesu, bolniki potrebujejo posebno dieto z nizko vsebnostjo tirozinov.
The diet also needs to be low in phenylalanine, as this is converted into tyrosine in the body.
Dieta mora vsebovati tudi čim manj fenilalanina, saj se ta v telesu pretvori v tirozin.
The active substance in Nitisinone MDK, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Zdravilna učinkovina v zdravilu Nitizinon MDK, nitizinon, zavira encim, ki pretvarja tirozin v škodljive snovi.
For practical information about using Nitisinone MDK, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Nitizinon MDK naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Nitisinone MDK is a ‘generic medicine'.
Zdravilo Nitizinon MDK je „generično zdravilo“.
Nitisinone MDK is intended for long-term use.
Zdravilo Nitizinon MDK je namenjeno za dolgotrajno uporabo.
Other information about Nitisinone MDK
Druge informacije o zdravilu Nitizinon MDK
Nitisinone MDK can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z dedno tirozinemijo tipa 1.
Nitisinone MDK is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Zdravilo Nitizinon MDK se uporablja skupaj z dieto, ki omejuje vnos aminokislin tirozin in fenilalanin.
be started as early as possible and the dose of Nitisinone MDK adjusted according to the patient's response and body weight.
Zdravljenje je treba začeti čim prej, odmerek zdravila pa je treba prilagoditi bolnikovemu odzivu in telesni masi.
What is Nitisinone MDK and what is it used for?
Kaj je zdravilo Nitizinon MDK in za kaj se uporablja?
Why is Nitisinone MDK approved?
Zakaj je bilo zdravilo Nitizinon MDK odobreno?
It is not intended to provide practical advice on how to use Nitisinone MDK.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Nitisinone MDK contains the active substance nitisinone.
Zdravilo Nitizinon MDK vsebuje zdravilno učinkovino nitizinon.
How does Nitisinone MDK work?
Kako zdravilo Nitizinon MDK deluje?
How is Nitisinone MDK used?
Kako se zdravilo Nitizinon MDK uporablja?
How has Nitisinone MDK been studied?
Kako je bilo zdravilo Nitizinon MDK raziskano?
Final study report by:
Končno poročilo o študiji:
Timetable for the implementation of the position
Časovnica za uveljavitev stališča
The final results of the complementary drug utilization study using databases, which allows a dual approach to assessing the effectiveness of the risk minimisation measures imposed on thiocolchicoside containing medicinal products, are expected in 2019, and this new due date should be reflected in the conditions of the Marketing Authorisation.
Končni rezultati dopolnilne študije o uporabi zdravil na podlagi podatkovnih zbirk, kar omogoča dvojni pristop k ocenjevanju učinkovitosti ukrepov za zmanjševanje tveganj, ki je bila odrejena za zdravila, ki vsebujejo tiokolhikozid, so pričakovani leta 2019, ta novi rok pa se mora odražati v pogojih dovoljenja za promet z zdravilom.
February 2018 CMDh meeting
Zasedanje skupine CMDh februarja 2018
The MAH(s) should provide within the risk management plan submission, a protocol for results of the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Imetniki dovoljenja za promet z zdravilom morajo v načrtu za obvladovanje tveganja, protokolu za predložiti rezultate študije o uporabi zdravil za opredelitev prakse predpisovanja zdravil pri običajni klinični uporabi v reprezentativni skupini zdravnikov, ki predpisujejo zdravilo, in za oceno glavnih razlogov za predpisovanje zdravil.
06 June 2018
6. junij 2018
The marketing authorisation holder(s) shall change the following condition(s) (new text underlined and in bold, deleted text strike through)
Imetnik (imetniki) dovoljenja za promet z zdravilom mora (morajo) spremeniti naslednji pogoj (naslednje pogoje) (novo besedilo je podčrtano in označeno krepko, izbrisano besedilo prečrtano)
On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov o rezultatih študije za zdravilo (zdravila), ki vsebujejo zdravilno učinkovino tiokolhikozid, in ob izraženi zaskrbljenosti zaradi končnega poročila študije PASS skupina CMDh meni, da je razmerje med koristjo in tveganjem zgoraj navedenih zdravil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Annex III Timetable for the implementation of this position>
Časovnica za uveljavitev tega stališča
Therefore, in view of available data regarding the PASS survey final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Zato je odbor PRAC ob upoštevanju vseh razpoložljivih podatkov v povezavi s končnim poročilom študije PASS menil, da so potrebne spremembe v informacijah o zdravilu.