natgillin/translations-raw huggingface dataset:
This summary is not intended to provide practical advice on how to use medicines containing ispaghula husk.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo semensko lupino jajčastega trpotca.
By increasing the stool bulk it also increases the tension in the bowel wall which will trigger bowel movements.
S povečanjem prostornine blata poveča tudi napetost črevesne stene, kar sproži odvajanje blata.
Allergic reactions including rhinitis (runny nose), conjunctivitis (reddening and inflammation of the white of the eye), bronchospasm (excessive and prolonged contraction of the airway muscles) and anaphylaxis (severe allergic reaction) may also occur.
Pojavijo se lahko tudi alergijske reakcije, vključno z rinitisom (izcejanjem iz nosu), konjunktivitisom (pordečitvijo in vnetjem očesne beločnice), bronhospazmom (čezmernim in dolgotrajnim krčenjem mišic v dihalnih poteh) in anafilaksijo (hudo alergijsko reakcijo).
Ispaghula husk is the common name for the seed coats of the plant Plantago ovata Forssk.
Semenska lupina jajčastega trpotca je splošno ime za ovojnice semen rastline Plantago ovata Forssk.
Any applications for the licensing of medicines containing ispaghula husk have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
The HMPC also concluded that ispaghula husk can be used in people where an increase in the daily intake of dietary fibre may be advisable, such as patients with irritable bowel syndrome who are suffering from constipation or in combination with diet in patients with hypercholesterolaemia (high blood cholesterol levels).
Odbor HMPC je prav tako zaključil, da se lahko semenska lupina jajčastega trpotca uporablja pri osebah, pri katerih bi bil priporočljiv povečan dnevni vnos prehranskih vlaknin, na primer pri bolnikih s sindromom razdražljivega črevesja, ki trpijo za zaprtostjo, ali v kombinaciji s prehrano pri bolnikih s hiperholesterolemijo (visokimi ravnmi holesterolav krvi).
Further information on the HMPC assessment of ispaghula husk medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo semensko lupino jajčastega trpotca, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ispaghula husk.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo semensko lupino jajčastega trpotca.
Information on the use and licensing of ispaghula husk medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, v državah članicah EU se obrnite na pristojni nacionalni organ.
Its effectiveness in softening stools has been shown in a number of studies comparing ispaghula husk with placebo (a dummy treatment) in patients with haemorrhoids.
Njegova učinkovitost pri mehčanju blata je bila dokazana v številnih študijah, v katerih so semensko lupino jajčastega trpotca primerjali s placebom (zdravilom brez zdravilne učinkovine) pri bolnikih s hemoroidi.
Ispaghula husk is used without further processing or as preparations obtained by powdering the seed coats.
Semenska lupina jajčastega trpotca se uporablja brez nadaljnje obdelave ali v obliki pripravkov, izdelanih z drobljenjem ovojnic semen v prašek.
How are ispaghula husk medicines approved in the EU?
Kako so zdravila, ki vsebujejo semensko lupino jajčastega trpotca, odobrena v EU?
In its assessment of ispaghula husk to treat constipation, the HMPC considered a number of clinical studies involving over 900 patients that showed the effectiveness of ispaghula husk as a mild laxative.
Odbor HMPC je pri oceni semenske lupine jajčastega trpotca za zdravljenje zaprtosti preučil številne klinične študije, v katerih je sodelovalo več kot 900 bolnikov, ki so pokazale učinkovitost semenske lupine jajčastega trpotca kot blagega odvajala.
Several studies investigated the effects of ispaghula husk on blood cholesterol levels and found that treatment with ispaghula husk led to small reductions in blood cholesterol levels.
Učinke semenske lupine jajčastega trpotca na raven holesterola v krvi so preučevali v več študijah in ugotovili, da je zdravljenje s semensko lupino jajčastega trpotca povzročilo manjša znižanja ravni holesterola v krvi.
Detailed instruction on how to take ispaghula husk medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo semensko lupino jajčastega trpotca, in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
The HMPC concluded that ispaghula husk can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Odbor HMPC je zaključil, da se lahko semenska lupina jajčastega trpotca uporablja za zdravljenje habitualne (ponavljajoče) zaprtosti (zaprtost, ki ni posledica organskih sprememb) in pri stanjih, ko je želeno omehčanje blata, da se zmanjša bolečine pri njegovem odvajanju, na primer pri analnih fisurah (zadnjičnih razpokah), hemoroidih (zlati žili) in po kirurškem posegu na anusu (zadnjiku) ali rektumu (danki).
Ispaghula husk contains dietary fibre, which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Semenska lupina jajčastega trpotca vsebuje prehranske vlaknine, ki pomešane z vodo tvorijo gelu podobno zmes, ki deluje kot blago odvajalo (zdravilo za zdravljenje zaprtosti).
The HMPC recommended that ispaghula husk should not be used in patients with a sudden change in bowel habit that persists for more than two weeks, and in patients with undiagnosed bleeding of the rectum and failure to pass stools following the use of a laxative.
Odbor HMPC je priporočil, da se zdravil, ki vsebujejo semensko lupino jajčastega trpotca, ne sme uporabljati pri bolnikih z nenadno spremembo pri odvajanju blata, ki traja več kot dva tedna, ter pri bolnikih z nediagnosticirano krvavitvijo iz rektuma (danke) in nezmožnostjo izločanja blata po jemanju odvajal.
Herbal medicines containing ispaghula husk are usually available in solid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo semensko lupino jajčastega trpotca, so navadno na voljo v trdnih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
For more information about treatment with ispaghula husk medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo semensko lupino jajčastega trpotca, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
It moves down the digestive system and makes the stools softer by increasing their water content.
Zmes se pomika navzdol po prebavilih in poveča vsebnost vode v blatu ter ga tako omehča.
For practical information about using ispaghula husk medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Ispaghula husk should be taken with plenty of liquid.
Semensko lupino jajčastega trpotca je treba zaužiti z veliko tekočine.
Side effects have been reported with ispaghula husk medicines, including flatulence and abdominal distension (swelling of the belly).
Pri zdravilih, ki vsebujejo semensko lupino jajčastega trpotca, so poročali o neželenih učinkih, vključno s flatulenco (nabiranje plinov v želodcu in črevesju, vetrovi) in abdominalno distenzijo (napihnjenostjo trebuha).
How does ispaghula husk work as a medicine?
Kako semenska lupina jajčastega trpotca deluje kot zdravilo?
What are the risks associated with Ispaghula husk medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo semensko lupino
What evidence supports the use of ispaghula husk medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo semensko lupino
At the same time ispaghula husk lubricates the intestine which improves the transit of stools.
Semenska lupina jajčastega trpotca obenem podmaže črevo, s čimer se izboljša prehajanje blata.
Other information about ispaghula husk medicines
Druge informacije o zdravilih, ki vsebujejo semensko lupino jajčastega trpotca
What is Ispaghula husk?
Kaj je lupina jajčastega trpotca?
15 March 2012
15. marec 2012
The withdrawal letter is available here.
Dopis o umiku je na voljo tukaj.
The application was withdrawn after ‘day 90'.
Vlogo so umaknili po „90.
Tyverb has been authorised in the EU since June 2008.
Zdravila Tyverb je v EU odobreno od junija 2008.
A comparative study would have addressed this issue.
To vprašanje bi lahko obravnavali v primerjalni študiji.
The main measure of effectiveness was overall survival (the length of time the patients lived).
Glavno merilo učinkovitosti je bilo celokupno preživetje (koliko časa so bolnice živele).
What was the recommendation of the CHMP at that time?
Kakšno je bilo takrat priporočilo odbora CHMP?
Tyverb is available in all EU Member States.
Zdravilo Tyverb je na voljo v vseh državah članicah EU.
The full European Public Assessment Report for Tyverb 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 Tyverb je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is available as tablets.
Na voljo je v obliki tablet.
It has been granted ‘conditional' marketing authorisation because there is more evidence to come about the medicine.
Zdravilo je pridobilo „pogojno dovoljenje za promet“, ker se pričakujejo dodatni dokazi o njegovem delovanju.
HER2 is a receptor for epidermal growth factor and is involved in stimulating the cells to divide uncontrollably.
HER2 je receptor za epidermalni rastni faktor in sodeluje pri stimulaciji nenadzorovane delitve celic.
‘Advanced' means that the cancer has started to spread and ‘metastatic' means that the cancer has already spread to other parts of the body.
„Napredoval“ pomeni, da se je rak začel širiti, „metastatski“ pa, da se je že razširil na druge dele telesa.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
To pomeni, da je odbor CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
The company presented data from one main study involving a total of 444 patients with metastatic breast cancer that was expressing large quantities of HER2.
Družba je predložila podatke iz ene glavne študije, v kateri je sodelovalo 444 bolnic z metastatskim rakom dojke, ki je izražal velike količine HER2.
What is Tyverb?
Kaj je zdravilo Tyverb?
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice umika za bolnice, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
There are no consequences on the use of Tyverb in its authorised indications.
Umik nima nobenih posledic za uporabo zdravila Tyverb pri odobrenih indikacijah.
Tyverb in combination with paclitaxel is expected to work in the same way as it does in its existing indication.
Zdravilo Tyverb naj bi v kombinaciji s paklitakselom delovalo enako kot pri obstoječi indikaciji.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Potem ko je ocenil odgovore družbe na vprašanja, so nekatera vprašanja še vedno ostala nerešena.
On 15 February 2012, Glaxo Group Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Tyverb, to add the use in combination with paclitaxel for the treatment of metastatic breast cancer.
Družba Glaxo Group Ltd. je dne 15. februarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Tyverb, s katero bi dodala uporabo zdravila v kombinaciji s paklitakselom za zdravljenje metastatskega raka dojke.
What was Tyverb expected to be used for?
Za kaj naj bi se zdravilo Tyverb uporabljalo?
Tyverb is used when the cancer is advanced or metastatic.
Zdravilo Tyverb se uporablja pri napredovalem ali metastatskem raku.
These compounds work by blocking enzymes known as protein kinases, which can be found in some receptors on the surface of cancer cells including HER2.
Te učinkovine delujejo tako, da zavirajo encime proteinske kinaze, ki jih najdemo v nekaterih receptorjih na površini rakavih celic, vključno s HER2.
Tyverb is a medicine that contains the active substance lapatinib.
Tyverb je zdravilo, ki vsebuje zdravilno učinkovino lapatinib.
In particular, the Committee could not exclude the possibility that Tyverb in combination with paclitaxel is inferior to the standard treatment, trastuzumab plus paclitaxel.
Odbor predvsem ni mogel izključiti možnosti, da je zdravilo Tyverb v kombinaciji s paklitakselom manj učinkovito kot standardno zdravljenje - trastuzumab v kombinaciji s paklitakselom.
The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Zdravilna učinkovina v zdravilu Tyverb, lapatinib, spada v skupino zdravil, ki se imenujejo zaviralci proteinske kinaze.
About a quarter of breast cancers express HER2.
HER2 je izražen pri približno četrtini primerov raka dojke.
What is happening with Tyverb used in combination with capecitabine or with an aromatase inhibitor?
Kakšne so posledice za zdravilo Tyverb v kombinaciji s kapecitabinom ali zaviralcem aromataze?
How is Tyverb expected to work?
Kako naj bi zdravilo Tyverb delovalo?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tyverb at this time.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnice, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Tyverb.
The CHMP was concerned that the main study, which compared Tyverb with placebo, did not allow the Committee to conclude on how Tyverb compares with other authorised treatments.
Odbor CHMP je menil, da na podlagi glavne študije, v kateri so primerjali zdravilo Tyverb s placebom, ni bilo mogoče sklepati o delovanju zdravila Tyverb v primerjavi z drugimi odobrenimi zdravili.
Tyverb is used in combination with capecitabine or with an aromatase inhibitor (other anticancer medicines) to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Zdravilo Tyverb se uporablja v kombinaciji s kapecitabinom ali z zaviralcem aromataze (drugim zdravilom za zdravljenje raka) za zdravljenje bolnic z rakom dojke, za katerega so ugotovili, da „zraža“ velike količine HER2.
In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the CHMP's assessment that the lack of a study comparing Tyverb with another treatment hampered the proper assessment of the benefit-risk balance in European patients in the applied indication.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je odločitev za umik vloge temeljila na oceni odbora CHMP, da zaradi odsotnosti študije, ki bi primerjala zdravilo Tyverb z drugim zdravilom, ni bilo mogoče ustrezno ovrednotiti razmerja med koristmi in tveganji pri evropskih bolnicah za uporabljeno indikacijo.
Tyverb was also expected to be used in combination with paclitaxel (another anticancer medicine) for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2.
Za zdravilo Tyverb so načrtovali tudi uporabo v kombinaciji s paklitakselom (drugim zdravilom za zdravljenje raka) za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji pretirano izražajo HER2.
The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
V času umika je odbor CHMP ocenjeval odgovore družbe na predložena vprašanja.
This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the tumour cells.
To pomeni, da rak na površini tumorskih celic tvori velike količine določene beljakovine HER2 (imenovane tudi ErbB2).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not addressed its concerns and that the benefit-risk balance of Tyverb in combination with paclitaxel for the treatment of metastatic breast cancer could not be properly assessed.
Zato je ob umiku menil, da družba ni obravnavala njegovih zadržkov ter da razmerja med koristmi in tveganji pri uporabi zdravila Tyverb v kombinaciji s paklitakselom za zdravljenje metastatskega raka dojke ni bilo mogoče ustrezno oceniti.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Tyverb could not have been approved for use in combination with paclitaxel in the treatment of metastatic breast cancer.
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil, ob umiku izrazil določene zadržke ter začasno menil, da zdravila Tyverb ni mogoče odobriti za uporabo v kombinaciji s paklitakselom za zdravljenje metastatskega raka dojke.
By blocking these receptors, Tyverb helps to control cell division.
Zdravilo Tyverb pomaga nadzorovati delitev celic tako, da te receptorje zavira.
The study compared Tyverb with placebo (a dummy treatment), both of which were taken together with paclitaxel.
V študiji so primerjali zdravilo Tyverb s placebom (zdravilom brez zdravilne učinkovine).
Further information on Dengvaxia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
Nadaljnje informacije o zdravilu Dengvaxia so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
Three studies were carried out in Asia and Latin America involving over 35,000 children aged 2 to 16 years.
Izvedene so bile tri študije v Aziji in Latinski Ameriki, ki so zajele več kot 35 000 otrok, starih od 2 do 16 let.
Additional studies showed that the vaccine is also effective in people aged 16 to 45 years.
Dodatne študije so pokazale, da je cepivo učinkovito tudi pri osebah, starih od 16 do 45 let.
What measures are being taken to ensure the safe and effective use of Dengvaxia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dengvaxia?
Cases of dengue disease were recorded for one year after the last injection.
Primere bolezni denge so spremljali eno leto po zadnji injekciji cepiva.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend the body against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznijo.
There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.
Obstaja več vrst (serotipov) virusa denge, pri čemer cepivo Dengvaxia ščiti pred serotipi 1, 2, 3 in 4.
Allergic reactions, which may be severe, are a very rare side effect of Dengvaxia.
Alergijske reakcije, ki utegnejo biti resne, so zelo redek neželeni učinek zdravila Dengvaxia.
The injection is given under the skin, preferably in the upper arm.
Injekcija se vbrizga pod kožo, po možnosti v nadlaket.
Other information about Dengvaxia
Druge informacije o zdravilu Dengvaxia
Dengvaxia's side effects are usually mild or moderate and do not last longer than three days.
Neželeni učinki cepiva Dengvaxia so običajno blagi ali zmerni in ne trajajo več kot tri dni.
The European Medicines Agency therefore decided that Dengvaxia's benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic.
Evropska agencija za zdravila je zato zaključila, da so koristi cepiva Dengvaxia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU na endemičnih območjih bolezni denge.
Dengvaxia must also not be given to women who are pregnant or breastfeeding.
Zdravila Dengvaxia prav tako ne smejo prejeti ženske, ki so noseče ali dojijo.
Endemic areas are areas where the disease occurs regularly throughout the year.
Endemična območja so predeli, kjer prihaja do rednih izbruhov bolezni.
Dengvaxia contains weakened viruses that do not cause disease.
Cepivo Dengvaxia vsebuje oslabljene viruse, ki ne povzročajo bolezni.
As for all medicines, data on the use of Dengvaxia are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi cepiva Dengvaxia stalno spremljajo.
The most common side effects with Dengvaxia (which may affect more than 1 in 10 people) are headache, injection site pain, malaise (feeling unwell), muscle pain, weakness and fever.
Najpogostejši neželeni učinki cepiva Dengvaxia (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, bolečine na mestu injiciranja, slabo počutje, bolečine v mišicah, oslabelost in povišana telesna temperatura.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dengvaxia have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo cepiva Dengvaxia upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Dengvaxia are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri cepivu Dengvaxia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
In the future, when the person comes into contact with dengue virus, these antibodies together with other components of the immune system will be able to kill the virus and help protect against the disease.
Ob ponovni izpostaviti virusu denge v prihodnosti bodo lahko ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničila virus in pripomogla k zaščiti pred boleznijo.
Why is Dengvaxia authorised in the EU?
Zakaj je zdravilo Dengvaxia odobreno v EU?
For more information about using Dengvaxia, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe cepiva Dengvaxia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Dengvaxia and why it is authorised in the EU
Pregled zdravila Dengvaxia in zakaj je odobreno v EU
However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage.
Toda pri manjšem številu ljudi lahko ta virus povzroči hujšo obliko bolezni z življenjsko nevarnimi krvavitvami in poškodbami organov.