natgillin/translations-raw huggingface dataset:
METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
NAČIN IN POT(I) UPORABE
However, no specific efficacy studies were conducted in pregnant mares.
Pri brejih kobilah niso bile narejene študije učinkovitosti zdravila.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single dose syringe
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE(ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
PACKAGE LEAFLET FOR: Equip WNV emulsion for injection for horses
NAVODILO ZA UPORABO: Equip WNV emulzija za injiciranje za konje
Incompatibilities: Do not mix with any other veterinary medicinal product.
fosfatni pufer s soljo 6.2 Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij:
NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV emulsion for injection for horses
Equip WNV emulzija za injiciranje za konje
NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV injection for horses
Equip WNV injekcija za konje
This will help to protect against the disease caused by the virus.
To pripomore k zaščiti pred boleznijo, ki jo povzroča virus.
A second dose may be given after an interval of at least three weeks, particularly in children from six months to nine years of age.
Drugi odmerek se lahko injicira v presledku vsaj treh tednov po prvem odmerku, zlasti pri otrocih, starih od šest mesecev do devet let.
This means that there is more evidence to come about the medicine, in particular the results of further clinical studies in children, adolescents and adults.
To pomeni, da pričakujemo še več dokazov o zdravilu, zlasti rezultati nadaljnjih kliničnih študij pri otrocih, mladostnikih in odraslih.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
It should only be used for the influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009.
Uporablja se lahko samo proti pandemski gripi A (H1N1), ki jo je Svetovna zdravstvena organizacija uradno razglasila 11. junija 2009.
In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection.
V skladu z merili, ki jih je določil CHMP, je iz tega razvidno, da je cepivo vzpostavilo ustrezno raven zaščite.
This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Te bodo obsegale informacije o njegovih neželenih učinkih ter varnosti pri otrocih, starostnikih, nosečnicah, bolnikih s hudimi boleznimi in osebah, ki imajo težave z imunskim sistemom.
The European Commission granted a marketing authorisation valid throughout the European Union for Arepanrix to GlaxoSmithKline Biologicals s.a. on on 23 March 2010.
Evropska komisija je dovoljenje za promet z zdravilom Arepanrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 23. marca 2010.
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Vendar pa bo med pandemijo cepljenje takih oseb morda vseeno upravičeno, če bo na voljo oprema za oživljanje.
It contains parts of influenza (flu) viruses that have been inactivated (killed).
Vsebuje delce virusov influence (gripe), ki so inaktivirani (uničeni).
This document is a summary of the European Public Assessment Report (EPAR) for Arepanrix.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Arepanrix.
The percentage of subjects who had a level of antibodies in their blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 100%.
Odstotek oseb, ki so imele v svoji krvi dovolj visoko raven protiteles za nevtralizacijo virusa H1N1 (delež serološke zaščite), je bil 100 %.
The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Vehikel vsebuje „adjuvans“ (sestavino, ki vsebuje olje) za okrepitev imunskega odziva.
Arepanrix is very similar to another pandemic vaccine called Pandemrix, which has been available in the European Union (EU) since September 2009.
Zdravilo Arepanrix je zelo podobno drugemu cepivu proti pandemski gripi, imenovanemu Pandemrix, ki je v Evropski uniji (EU) na voljo od septembra 2009.
The resulting ‘emulsion' is then injected.
Nastala „emulzija“ se nato injicira.
The CHMP noted that Arepanrix had already been marketed in Canada and used to vaccinate over 5 million people with no safety concerns.
Odbor CHMP je upošteval, da je bilo zdravilo Arepanrix že na trgu v Kanadi in je bilo uporabljeno kot cepivo pri več kot 5 milijonih ljudi brez pomislekov glede njegove varnosti.
Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with a solvent.
Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje virusne delce, in vehikla.
The studies of Arepanrix H5N1 showed that the vaccine was able to bring about protective levels of antibodies in at least 70% of people in which it was studied.
Študije zdravila Arepanrix H5N1 so pokazale, da je cepivo uspelo vzpostaviti zaščitne ravni protiteles pri najmanj 70 % oseb, pri katerih je bilo proučevano.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arepanrix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila Arepanrix.
For more information about treatment with Arepanrix, read the Package Leaflet (also part of the EPAR).
Za več informacij o zdravljenju z zdravilom Arepanrix preberite navodilo za uporabo (ki je prav tako del EPAR).
Other information about Arepanrix:
Druge informacije o zdravilu Arepanrix:
The most common side effects with Arepanrix (seen with more than 1 in 10 doses of the vaccine) are headache, joint pain, muscle aches, pain at the site of the injection and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Arepanrix (opaženi pri več kot 1 odmerku cepiva od 10) so glavobol, bolečine v sklepih, bolečine v mišicah, bolečina na mestu injiciranja ter utrujenost.
Arepanrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate.
Cepivo Arepanrix se ne sme dajati osebam, ki so kdaj imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva ali katero koli snov, ki je v cepivu v sledeh, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid in natrijev deoksiholat.
This study looked at the immunogenicity against influenza A(H1N1)v.
V tej študiji so proučevali imunogenost proti gripi A(H1N1)v.
Because Arepanrix is similar to Pandemrix, the company used the data on the use of Pandemrix in children to support the use of Arepanrix in children.
Ker je zdravilo Arepanrix podobno zdravilu Pandemrix, je družba podatke o uporabi zdravila Pandemrix pri otrocih uporabila v podporo uporabe zdravila Arepanrix pri otrocih.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se hitro širi med ljudmi, ker proti njemu ljudje nimajo imunosti (zaščite).
Which measures are being taken to ensure the safe use of Arepanrix?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Arepanrix?
Arepanrix is given as one dose, injected into the shoulder muscle.
Zdravilo Arepanrix se daje v enkratnem odmerku, ki se injicira v ramensko mišico.
When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Ko osebo cepimo, imunski sistem prepozna virus kot „tujek“, zato proti njemu tvori protitelesa.
Arepanrix is given according to official recommendations.
Zdravilo Arepanrix se daje v skladu z uradnimi priporočili.
The Committee decided that Arepanrix's benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Odbor je odločil, da so koristi zdravila Arepanrix za preprečevanje gripe v primeru uradne razglasitve pandemije H1N1 večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Arepanrix shown during the studies?
Kakšne koristi je zdravilo Arepanrix izkazalo med študijami?
Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Arepanrix cepivo proti pandemski gripi (H1N1)v (z delci virionov, inaktivirano, z adjuvansom)
Arepanrix has been given ‘Conditional Approval'.
Zdravilo Arepanrix je „pogojno odobreno“.
Arepanrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).
Zdravilo Arepanrix vsebuje sev virusa gripe A/California/7/2009 (X-179A), ki je podoben sevu A/California/7/2009 (H1N1)v.
The company that makes Arepanrix will collect information on the safety of the vaccine while it is being used.
Družba, ki izdeluje zdravilo Arepanrix, bo med uporabo tega cepiva zbirala informacije o njegovi varnosti.
Arepanrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic.
Zdravilo Arepanrix vsebuje majhne količine hemaglutininov (beljakovin s površine) virusa, imenovanega A(H1N1)v, ki povzroča trenutno pandemijo.
This included one study in 4,561 adults, which looked at the ability of Arepanrix H5N1 to trigger the production of antibodies (‘immunogenicity') against this H5N1 strain, and one study comparing it with Pandemrix H5N1.
V eno študijo je bilo vključenih 4 561 odraslih, v kateri so proučevali sposobnost zdravila Arepanrix H5N1 za sprožitev tvorbe protiteles („imunogenost“) proti temu sevu H5N1, v drugi študiji pa so ga primerjali z zdravilom Pandemrix H5N1.
The company presented information from studies carried out with an earlier version of Arepanrix, containing the ‘bird flu' strain H5N1.
Družba je predložila podatke iz študij, izvedenih s starejšo različico zdravila Arepanrix, ki vsebuje sev H5N1 „ptičje gripe“.
The company that makes Arepanrix will provide data collected in clinical trials of Arepanrix in adults and children, as well as information collected on the safety and effectiveness of the vaccine, to the CHMP for evaluation.
Družba, ki izdeluje zdravilo Arepanrix, bo odboru CHMP v oceno predložila zbrane podatke iz kliničnih preskušanj zdravila Arepanrix pri odraslih in otrocih ter zbrane informacije o varnosti in učinkovitosti cepiva.
A further study compared Arepanrix containing the pandemic flu strain H1N1 with Pandemrix H1N1 in 334 adults.
V nadaljnji študiji so primerjali zdravilo Arepanrix, ki vsebuje sev H1N1 pandemske gripe, z zdravilom Pandemrix H1N1 pri 334 odraslih.
The study comparing Arepanrix H1N1 with Pandemrix H1N1 showed that one dose was able to trigger immunity to a satisfactory level.
Študija, v kateri so primerjali zdravilo Arepanrix H1N1 z zdravilom Pandemrix H1N1, je pokazala, da je enkratni odmerek zagotovil zadostno raven imunosti.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Ob ponovni izpostavitvi virusu bo imunski sistem sposoben hitreje tvoriti protitelesa.
For the full list of all side effects reported with Arepanrix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Arepanrix, glejte navodilo za uporabo.
Arepanrix is a vaccine.
Zdravilo Arepanrix je cepivo.
What information is still awaited for Arepanrix?
Katere informacije o zdravilu Arepanrix še pričakujemo?
Arepanrix is a vaccine to protect against ‘pandemic' flu.
Zdravilo Arepanrix je cepivo proti „pandemski“ gripi.
What is the risk associated with Arepanrix?
Kakšna tveganja so povezana z zdravilom Arepanrix?
Why has Arepanrix been approved?
Zakaj je bilo zdravilo Arepanrix odobreno?
The same level of protection was obtained with Arepanrix as with Pandemrix.
Zdravili Arepanrix in Pandemrix sta vzpostavili enako raven zaščite.
Both contain the same adjuvant, In Arepanrix, a different method is used to prepare the haemagglutinins used in the vaccine.
Pri zdravilu Arepanrix se za pripravo hemaglutininov v cepivu uporablja drugačna metoda.
Arepanrix is a vaccine that is given by injection.
Arepanrix je cepivo za injiciranje.
The full EPAR for Arepanrix can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Arepanrix je na voljo tukaj.
What is Arepanrix used for?
Za kaj se zdravilo Arepanrix uporablja?
How has Arepanrix been studied?
Kako je bilo zdravilo Arepanrix raziskano?
How does Arepanrix work?
Kako zdravilo Arepanrix deluje?
What is Arepanrix?
Kaj je zdravilo Arepanrix?
How is Arepanrix used?
Kako se zdravilo Arepanrix uporablja?
This summary was last updated in July-2015.
Povzetek je bil nazadnje posodobljen julija 2015.
Pregabalin Zentiva is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Zdravilo Pregabalin Zentiva je na voljo v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg) in se izdaja le na recept.
The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Zentiva on 17 July 2015.
Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Zentiva, veljavno po vsej Evropski uniji, izdala 17. julija 2015.
The full EPAR and risk management plan summary for Pregabalin Zentiva 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 Pregabalin Zentiva 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 Pregabalin Zentiva?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Zentiva?
Pregabalin Zentiva is a medicine used to treat adults with the following conditions:
Pregabalin Zentiva je zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Natančno delovanje pregabalina ni popolnoma jasno, vendar pa naj bi vplival na način vstopanja kalcija v živčne celice.
This means that Pregabalin Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Lyrica.
What are the benefits and risks of Pregabalin Zentiva?
Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Zentiva?
This is a summary of the European public assessment report (EPAR) for Pregabalin Zentiva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Zentiva.
A risk management plan has been developed to ensure that Pregabalin Zentiva is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pregabalin Zentiva je bil pripravljen načrt obvladovanja tveganj.
The Committee recommended that Pregabalin Zentiva be approved for use in the EU.
Priporočil je, da se zdravilo Pregabalin Zentiva odobri za uporabo v EU.
The active substance in Pregabalin Zentiva, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Zdravilna učinkovina v zdravilu Pregabalin Zentiva, pregabalin, ima podobno strukturo kot telesu lastni živčni prenašalec („nevrotransmitor“) gama-aminomaslena kislina (GABA), vendar pa ima bistveno drugačne biološke učinke.
Because Pregabalin Zentiva 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 Pregabalin Zentiva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva has been shown to have comparable quality and to be bioequivalent to Lyrica.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Zentiva primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
What is Pregabalin Zentiva and what is it used for?
Kaj je zdravilo Pregabalin Zentiva in za kaj se uporablja?
For more information about treatment with Pregabalin Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pregabalin Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Pregabalin Zentiva is a ‘generic medicine'.
Zdravilo Pregabalin Zentiva je „generično zdravilo“.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Zentiva, 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.
Stopping treatment with Pregabalin Zentiva should also be done gradually, over at least a week.
Največji odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Pregabalin Zentiva mora potekati postopno in mora trajati najmanj en teden.
Other information about Pregabalin Zentiva
Druge informacije o zdravilu Pregabalin Zentiva
It is not intended to provide practical advice on how to use Pregabalin Zentiva.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For practical information about using Pregabalin Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pregabalin Zentiva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
• epilepsijo, pri čemer se uporablja kot „dodatek“ obstoječemu zdravljenju pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
Because Pregabalin Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Ker je zdravilo Pregabalin Zentiva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Lyrica.
Why is Pregabalin Zentiva approved?
Zakaj je bilo zdravilo Pregabalin Zentiva odobreno?
How has Pregabalin Zentiva been studied?
Kako je bilo zdravilo Pregabalin Zentiva raziskano?
How is Pregabalin Zentiva used?
Kako se zdravilo Pregabalin Zentiva uporablja?
Pregabalin Zentiva contains the active substance pregabalin.
Zdravilo Pregabalin Zentiva vsebuje zdravilno učinkovino pregabalin.
How does Pregabalin Zentiva work?
Kako zdravilo Pregabalin Zentiva deluje?
CONCLUSIONS ON <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
SKLEPNE UGOTOVITVE O <PODOBNOSTI> <IN> <ODSTOPANJU> <IN> <ZAHTEVKU ZA ENOLETNO <TRŽNO ZAŠČITO> <EKSKLUZIVNOST PODATKOV>>, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
<the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>.
<predlagatelj je v svoji vlogi lahko utemeljil, da je zdravilo, čeprav je podobno <odobrenemu zdravilu siroti,>, varnejše, učinkovitejše ali kako drugače klinično boljše (kot je opredeljeno v členu 3 Uredbe Komisije (ES) št. 847/2000) za isto terapevtsko indikacijo>; <in>
[Art 74(a)- legal status switch]<Furthermore, the CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 74(a) of Directive 2001/83/EC, and considers that the data submitted in support of the classification of {specify medicinal product name} as ‘medicinal product not subject to medical prescription' were significant as further explained in the European Public Assessment Report.>
[Art 74(a)- legal status switch] <Odbor za zdravila za uporabo v humani medicini (CHMP) je prav tako pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe iz člena 74(a) Direktive 2001/83/ES), in meni, da so bili podatki, posredovani v podporo razvrstitvi zdravila {navedite ime zdravila} kot „zdravila, ki se izdaja brez recepta“ pomembni, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.
Patients should be closely monitored.
Bolnike je treba skrbno spremljati.
This change may have led to the development of melanoma.
Ta sprememba je morda povzročila nastanek vašega melanoma.
On average, 94% of the dose was recovered within 17 days.
V povprečju se je v 17 dneh pojavilo 94 % odmerka.
Efficacy results are summarized in Table 5.
Rezultati o učinkovitosti so povzeti v preglednici 5.
The majority of events were Grade 1 or 2 and non-serious.
Večina dogodkov je bila stopnje 1 ali 2 in niso bili resni.
Continue at current dose
Nadaljujte s trenutnim odmerkom
Study NO25395 (BRIM7)
Študija NO25395 (BRIM7)
Grade (CTC-AE)*
Stopnja (CTC-AE)*
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1048/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1048/001
· Take the tablets every day for 21 days (called a “treatment period”).
• Tablete jemljite vsak dan 21 dni (to imenujemo "obdobje zdravljenja").
Grade 4:
Stopnja 4:
Once the dose has been reduced, it should not be increased at a later time.
Ko je bil odmerek enkrat zmanjšan, se ga kasneje ne sme več povečati.
No dose reduction.
Brez zmanjšanja odmerka.
Symptomatic regardless of LVEF Permanent discontinuation
Simptomatski ne glede na LVEF Trajno prenehanje
They can be taken with or without food.
Lahko se jemljejo skupaj s hrano ali brez nje.
Cotellic is not recommended for children and adolescents.
Zdravilo Cotellic ni priporočljivo za otroke in mladostnike.
Before starting treatment, your doctor will test for this mutation.
Pred začetkom zdravljenja vam bo zdravnik opravil test za to mutacijo.
If doses are omitted for toxicity, these doses should not be replaced.
Če so odmerki izpuščeni zaradi toksičnosti, se teh odmerkov ne sme nadomeščati.