natgillin/translations-raw huggingface dataset:
If someone accidentally injects themselves with the medicine, the person should seek medical advice immediately and show the package leaflet or label to the doctor.
Ob nenamernem samoinjiciranju zdravila se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to West Nile virus, and this helps to protect against mortality due to West Nile disease.
Ob ponovni izpostavitvi virusu West Nile v prihodnosti bo imunski sisteme hitreje izdelal protitelesa, kar bo prispevalo k zaustavitvi smrtnosti zaradi bolezni West Nile.
What is the risk associated with Proteq West Nile?
Kakšna tveganja so povezana z zdravilom Proteq West Nile?
Proteq West Nile is used to protect horses from 5 months of age against West Nile disease.
Zdravilo Proteq West Nile se uporablja za zaščito konj, starih pet mesecev ali več, pred boleznijo West Nile.
Proteq West Nile is a vaccine that contains West Nile recombinant canarypox virus (vCP2017 virus).
Zdravilo Proteq West Nile je cepivo, ki vsebuje West Nile rekombinantni Canarypox virus (virus vCP2017).
Why has Proteq West Nile been approved?
Zakaj je bilo zdravilo Proteq West Nile odobreno?
West Nile disease is a mosquito-borne viral disease that can cause encephalitis (inflammation of the brain) and meningitis (inflammation of the lining of the brain and spinal cord).The vaccine is used to reduce the number of horses with the West Nile virus in their blood (viraemia) or with clinical signs of the disease.
Bolezen West Nile je virusna bolezen, ki jo prenašajo komarji ter lahko povzroča encefalitis (vnetje možganov) in meningitis (vnetje ovojnice možganov in hrbtenjače).
How has Proteq West Nile been studied?
Kako je bilo zdravilo Proteq West Nile raziskano?
What is Proteq West Nile?
Kaj je zdravilo Proteq West Nile?
What is Proteq West Nile used for?
Za kaj se zdravilo Proteq West Nile uporablja?
How does Proteq West Nile work?
Kako zdravilo Proteq West Nile deluje?
Note: P values in the table are nominal.
Opomba: vrednosti P v preglednici so nominalne.
(See the end of section 2 - Important information about the contents of Orkambi.)
(Glejte konec poglavja 2 - Pomembne informacije o vsebini zdravila Orkambi.)
As such, risks to the suckling child cannot be excluded.
Tveganja za dojenega otroka ne moremo izključiti.
The Applicant should submit yearly analyses from December 2017 to 2020 and the final CSR by December 2021.
Predlagatelj naj predloži letne analize od decembra 2017 do 2020 in končno CSR do decembra 2021.
The apparent terminal half-life is approximately 26 hours.
Navidezni končni razpolovni čas je približno 26 ur.
If this is not possible, give it within the hour after mixing.
Če to ni možno, mu jo dajte znotraj ene ure po pripravi mešanice.
Juvenile animals
Mlade živali
† Indicates statistical significance confirmed in the hierarchical testing procedure.
†Pomeni statistično signifikantnost, potrjeno s hierarhičnim postopkom testiranja.
No data are available (see section 5.1).
Podatkov ni na voljo (glejte poglavje 5.1).
Following this period, the recommended daily dose should be continued.
Po tem obdobju se mora nadaljevati priporočeni dnevni odmerek.
Respiratory events
Respiratorni dogodki
Majority of patients discontinued for reasons other than safety.
Večina bolnikov je izstopila iz študije zaradi drugih razlogov, ne zaradi varnosti.
The significance of these findings for humans is unknown.
Pomen teh ugotovitev za ljudi ni znan.
Make sure that the mixture is consumed immediately and completely.
Zagotovite, da bo otrok mešanico zaužil v celoti in takoj.
Approximately three-quarters of the events began during the first week of treatment, and in most patients the events resolved without dosing interruption.
Približno tri četrtine dogodkov se je začelo med prvim tednom zdravljenja in pri večini bolnikov so se dogodki razrešili brez prekinitve odmerjanja.
Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Zdravljenje prevelikega odmerka sestavljajo splošni podporni ukrepi, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
1 sachet per day or less frequently
1 vrečica na dan ali manj pogosto
All other drug interactions shown are predicted.
Vse druge interakcije med zdravili so napovedane.
* Trial included key secondary and other secondary endpoints.
* Preskušanje je vključevalo ključne sekundarne in druge sekundarne cilje.
An alternative confirmatory method should be considered to verify results.
Za preverjanje rezultatov premislite o alternativni potrditveni metodi.
† From Trials 1, 2 and 3.
† Iz preskušanj 1, 2 in 3.
In some instances, these elevations have been associated with concomitant elevations in total serum bilirubin.
V nekaterih primerih so bila ta zvišanja povezana s sočasnim zvišanjem celotnega serumskega bilirubina.
Patients from these trials were eligible to roll over into a blinded extension study.
Bolniki iz teh preskušanj so lahko prešli v slepo podaljšano študijo.
Use all 7 days' doses before starting a new wallet.
Uporabite vse odmerke za 7 dni, preden odprete novo zloženko.
Improvements in ppFEV1 were observed regardless of age, disease severity, sex and geographic region.
Izboljšanje ppFEV1 so ugotovili ne glede na starost, izraženost bolezni, spol in zemljepisno območje.
Your child's doctor will determine the correct dose for your child.
Otrokov zdravnik bo določil pravilni odmerek za vašega otroka.
† 1 patient out of 738 ‡ 2 patients out of 738
† 1 bolnik od 738 ‡ 2 bolnika od 738
The post-dose decline was resolved by Week 16.
Zmanjšanje po odmerku je do 16. tedna izginilo.
Lift here to open
Tu privzdignite in odprite.
Check you have been given the right tablet (below).
Preverite, ali so vam dali pravo tableto (v nadaljevanju).
Examples of other fat-containing foods are:
Primeri drugih mastnih vrst hrane so:
It may be better to avoid using Orkambi during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Mogoče bo bolje, če se boste uporabi zdravila Orkambi v nosečnosti po možnosti izogibali, zdravnik pa vam bo pomagal pri odločitvi, kaj je najboljše za vas in vašega otroka.
If more than 6 hours have passed, the patient should be instructed to wait until the next scheduled dose.
Če je minilo več kot 6 ur, bolniku naročite, naj počaka do naslednjega načrtovanega odmerka.
False Positive Urine Tests for THC
Lažno pozitivni urinski testi za THC
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Datum prve odobritve: 19. november 2015.
Most of these reactions were mild or moderate in severity and non-serious.
Večina teh učinkov je bila po izraženosti blagih ali zmernih in niso bili resni.
That is a total of four tablets per day, to be taken with food containing fat.
To je skupaj štiri tablete na dan, jemlje naj jih z mastno hrano.
* A total of 82% (421 of 516 eligible patients) completed 72 weeks of this study; 42% completed 96 weeks.
*Vsega skupaj 82 % (421 od 516 primernih bolnikov) je dokončalo 72 tednov te študije; 42 % je dokončalo 96 tednov.
Percent predicted FEV1 was also evaluated as a clinically meaningful other secondary endpoint.
Napovedani FEV1 v odstotkih je bil tudi ocenjen kot klinično pomemben drug sekundarni cilj.
Meals and snacks recommended in CF guidelines or meals recommended in standard nutritional guidelines contain adequate amounts of fat.
Obroki in prigrizki, ki jih priporočajo smernice za CF, in obroki, ki jih priporočajo standardne prehranske smernice, vsebujejo dovolj maščob.
Drug interactions that have the most clinical relevance are listed first.
Interakcije med zdravili, ki so klinično najpomembnejše, so navedene najprej.
Effects on sweat chloride
Učinki na kloride v znoju
Based on exposure and indicated doses, the interaction profile is considered to be the same for all strengths and pharmaceutical forms.
Na podlagi izpostavljenosti in indiciranih odmerkov menimo, da je profil medsebojnega delovanja enak za vse jakosti in farmacevtske oblike.
No dose adjustments are necessary based on gender.
Prilagoditve odmerkov na podlagi spola niso potrebne.
These serious side effects are uncommon (may affect up to 1 in 100 people).
Ti resni neželeni učinki so občasni (lahko se pojavijo pri največ 1 od 100 bolnikov).
BT63 5UA
BT63 5UA Velika Britanija
Side effects seen in children are similar to those seen in adults and adolescents.
Neželeni učinki pri otrocih so podobni tistim pri odraslih in mladostnikih.
This extension trial was designed to evaluate the safety and efficacy of long-term treatment of lumacaftor/ivacaftor.
To podaljšano preskušanje je bilo zasnovano za oceno varnosti in učinkovitosti dolgoročnega zdravljenja z lumakaftorjem/ivakaftorjem.
Patients should be monitored closely for breakthrough fungal infections if such drugs are necessary.
Bolnike je treba skrbno spremljati glede izbruha glivičnih okužb, če so taka zdravila potrebna.
Like all medicines, this medicine can cause side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
6 to 11 years
6 do 11 let
Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded (see section 5.3).
Čeprav so bili v nekaterih primerih prisotni drugi dejavniki tveganja (na primer uporaba kortikosteroidov in izpostavljenost sevanju), ni mogoče izključiti možnega tveganja, ki bi ga lahko pripisali ivakaftorju (glejte poglavje 5.3).
• Loss of appetite
• izguba apetita,
Serious respiratory events were seen more frequently in patients with percent predicted FEV1 (ppFEV1) < 40, and may lead to discontinuation of the medicinal product.
Resne respiratorne dogodke so pogosteje opazili pri bolnikih z napovedanim FEV1 v odstotkih (ppFEV1) < 40 in lahko povzročijo prenehanje jemanja zdravila.
The European Medicines Agency has deferred the obligation to submit the results of studies with Orkambi in one or more subsets of the paediatric population in cystic fibrosis.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Orkambi za eno ali več podskupin pediatrične populacije pri cistični fibrozi.
Your child must keep using all other medicines, unless your child's doctor tells you to stop using any.
Vaš otrok mora še naprej jemati vsa druga zdravila, razen če vam otrokov zdravnik naroči, naj otrok preneha jemati katero od zdravil.
Orkambi should only be prescribed by physicians with experience in the treatment of CF.
Zdravilo Orkambi naj predpisujejo le zdravniki, ki imajo izkušnje z zdravljenjem CF.
Food or liquid should be at room temperature or below.
Hrana ali tekočina naj bo pri sobni ali nižji temperaturi.
Following this period, the recommended daily dose should be continued (see section 4.5).
Po tem obdobju se mora nadaljevati priporočeni dnevni odmerek (glejte poglavje 4.5).
However, increased liver enzymes in the blood have been seen more frequently in younger children than in adults.
Vendar pa so zvišane jetrne encime v krvi pogosteje ugotavljali pri mlajših otrocih kot pri odraslih.
The safety profile in these paediatric patients is generally consistent with that in adult patients.
Varnostni profil pri teh pediatričnih bolnikih se je na splošno ujemal z varnostnim profilom pri odraslih bolnikih.
The recommendations provided under “Clinical comment” in Table 3 are based on drug interaction studies, clinical relevance, or predicted interactions due to elimination pathways.
Priporočila, navedena pod podnaslovom “Klinični komentar” v preglednici 3, temeljijo na študijah interakcij med zdravili, klinični pomembnosti ali napovedanih interakcijah zaradi poti izločanja.
These results were not considered statistically significant within the framework of the testing hierarchy for the individual studies.
Ti rezultati v okviru hierarhije testiranja za posamezne študije niso veljali za statistično signifikantne.
The information reported in Table 3 mostly derives from in vitro studies.
Podatki, navedeni v preglednici 3, večinoma izvirajo iz študij in vitro.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Extension Week 96
96. teden podaljšanja
* In each study, a hierarchical testing procedure was performed within each active treatment arm for primary and secondary endpoints vs. placebo; at each step, P ≤ 0.0250 and all previous tests also meeting this level of significance was required for statistical significance.
*V vsaki študiji so izvedli hierarhični postopek testiranja znotraj vsake skupine aktivnega zdravljenja za primarna in sekundarna končna stanja proti placebu; na vsaki stopnji je bila potrebna za statistično signifikantnost P ≤ 0,0250 in vsi predhodni testi so morali tudi dosegati to raven signifikantnosti.
• Usual dose: Take one sachet of ORKAMBI granules every 12 hours.
• Običajni odmerek: zaužijte eno vrečico zrnc zdravila Orkambi vsakih 12 ur.
The primary efficacy analysis of this extension study included data up to Week 72 of Trial 3 with a sensitivity analysis that included data up to Week 96 of Trial 3.
Primarna analiza učinkovitosti v tej podaljšani študiji je vključevala podatke do 72. tedna preskušanja 3 z analizo občutljivosti, ki je vključevala podatke do 96. tedna preskušanja 3.
After Day 15, heart rate was not monitored in the period after dosing in these studies.
Po 15. dnevu v teh študijah v času po odmerjanju srčne frekvence niso spremljali.
1 sachet every morning and 1 sachet in the evening every other day.
1 vrečica vsako jutro in 1 vrečica zvečer vsak drugi dan
No dose adjustment for montelukast is recommended.
Prilagajanja odmerka montelukasta ne priporočajo.
Children under 2 years old
Otroci, mlajši od 2 let
See Orkambi tablets SmPC for further details
Glejte SPC za tablete zdravila Orkambi za več podrobnosti
Patients aged 12 to 17 years were included in Trials 1 and 2.
Bolniki, stari 12 do 17 let, so bili vključeni v preskušanji 1 in 2.
The clinical relevance of the magnitude of these changes in children 2 to 5 years with cystic fibrosis has not been clearly ascertained in longer-term treatment.
Klinične pomembnosti velikosti teh sprememb pri otrocih, starih 2 do 5 let, s cistično fibrozo pri dolgoročnejšem zdravljenju niso zanesljivo potrdili.
* Based on clinical drug-drug interaction studies.
* Temelji na kliničnih študijah interakcij med zdravili.
The treatment difference in this subgroup was comparable to that observed in patients with ppFEV1 ≥ 40.
Razlika zaradi zdravljenja v tej podskupini je bila primerljiva s tisto, ki so jo ugotovili pri bolnikih s ppFEV1 ≥ 40.
Investigations very common Bacteria in sputum* common
Preiskave zelo pogosti bakterije v sputumu*
Changes in FEV1
Spremembe FEV1
No patients had total bilirubin levels > 2 x ULN.
Noben bolnik ni imel ravni celotnega bilirubina > 2 x ULN.
Side effects in children
Neželeni učinki pri otrocih
The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs.
Beljakovina CFTR je kloridni kanalček, ki je prisoten na površini epitelijskih celic v številnih organih.
↓ fluconazole Due to induction by LUM; fluconazole is cleared primarily by renal excretion as unchanged drug; however, modest reduction in fluconazole exposure has been observed with strong inducers
↓ flukonazol Zaradi indukcije z LUM; flukonazol se odstranjuje predvsem z izločanjem skozi ledvice kot nespremenjeno zdravilo; vendar so opazili zmerno zmanjšanje izpostavljenosti flukonazolu z močnimi induktorji
Morning Evening
zjutraj zvečer
For standard dosing recommendations see Table 1.
Za standardna priporočila za odmerjanje glejte preglednico 1.
Contact your doctor or pharmacist for advice.
Obrnite se na svojega zdravnika ali farmacevta za nasvet.
These results are presented in Table 7 below:
Te rezultate kaže preglednica 7 v nadaljevanju:
Mean improvement in ppFEV1 was rapid in onset (Day 15) and sustained throughout the 24-week treatment period.
Povprečno izboljšanje ppFEV1 je nastopilo hitro (15. dne) in se vzdrževalo vse 24-tedensko obdobje zdravljenja.
*** The event rate per patient-year was annualised to 48 weeks.
*** Pogostnost dogodkov na bolnika-leto je bila preračunana na leto na 48 tednov.
The majority of events were mild or moderate in severity, non-serious and did not result in treatment discontinuation (see section 4.4).
Večina dogodkov je bila po izraženosti blagih ali zmernih, niso bili resni in niso povzročili prekinitve zdravljenja (glejte poglavje 4.4).
If you experience dizziness, you should not drive or use machines until these symptoms disappear.
Če opazite omotico, ne vozite in ne uporabljajte strojev, dokler ti simptomi ne izginejo.
Therefore, use in transplanted patients is not recommended.
Zato uporaba pri bolnikih s presajenimi organi ni priporočljiva.
Results from Trial 3 are presented in Figure 1 and Table 6.
Rezultati iz preskušanja 3 so predstavljeni na sliki 1 in v preglednici 6.
The worsening of liver function can be fatal.
Poslabšanje delovanja jeter lahko povzroči smrt.
Once mixed, the product has been shown to be stable for one hour, and therefore should be ingested during this period.
Dokazali so, da je mešanica stabilna eno uro po pripravi, zato jo je treba pojesti v tem času.
For patients aged 6 to 11 years
Za bolnike, stare 6 do 11 let
In both trials, treatment with lumacaftor/ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 5).
V obeh preskušanjih je zdravljenje z lumakaftorjem/ivakaftorjem povzročilo statistično signifikantno izboljšanje ppFEV1 (preglednica 5).
Specific studies to evaluate the phototoxic potential of lumacaftor were not conducted; however, evaluation of the available non-clinical and clinical data suggests no phototoxic liability.
Specifičnih študij za ocenjevanje fototoksičnega potenciala niso izvedli; vendar ocena razpoložljivih predkliničnih in kliničnih podatkov ne kaže nagnjenosti k fototoksičnosti.
Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Zdravnik bo pretehtal prednosti dojenja za otroka in prednosti zdravljenja za vas.
Pooled (Trial 1 and Trial 2)
Združeno (preskušanje 1 in preskušanje 2)
If a child experiences dizziness while taking Orkambi, it is advised that the child does not ride a bike or do anything else that needs their full attention, until their symptoms disappear.
Če otrok med jemanjem zdravila Orkambi postane omotičen, je priporočljivo, da se ne vozi s kolesom ali počne česa drugega, kar zahteva njegovo popolno pozornost, dokler simptomi ne izginejo.
Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs.
Primeri obrokov ali prigrizkov, ki vsebujejo maščobe, so tisti, ki so pripravljeni z maslom ali olji, in tisti, ki vsebujejo jajca.
Children under 6 years old
Otroci, mlajši od 6 let
** All patients had pancreatic insufficiency at baseline.
** Vsi bolniki so v izhodišču imeli insuficienco trebušne slinavke.
Table 6: Long-term effect of Lumacaftor/Ivacaftor in Trial 3*
Preglednica 6: Dolgoročni učinek lumakaftorja/ivakaftorja v preskušanju 3*
These menstrual events occurred more frequently in the subset of female patients who were taking hormonal contraceptives (25.0%) versus patients who were not taking hormonal contraceptives (3.5%) (see section 4.5).
Ti menstrualni dogodki so se pojavljali pogosteje v podskupini bolnic, ki so jemale hormonske kontraceptive (25,0 %), kot pri bolnicah, ki jih niso jemale (3,5 %) (glejte poglavje 4.5).
Blood pressure should be monitored periodically in all patients during treatment (see section 4.8).
Pri vseh bolnikih je treba med zdravljenjem občasno spremljati krvni tlak (glejte poglavje 4.8).
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.
Predklinični podatki ne kažejo posebnega tveganja za človeka na osnovi običajnih študij genotoksičnosti in kancerogenega potenciala.
Contents of the pack and other information What Orkambi contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Orkambi
If you stop taking Orkambi You should keep taking the medicine as your doctor directs even if you feel well.
Če ste prenehali jemati zdravilo Orkambi Zdravilo morate še naprej jemati po zdravnikovih navodilih, tudi če se dobro počutite.
Other medicines and Orkambi
Druga zdravila in zdravilo Orkambi
Once mixed, the mixture has been shown to be stable for one hour.
Dokazali so, da je mešanica, potem ko je zmešana, stabilna eno uro.
Anti-inflammatories: ibuprofen
Protivnetna zdravila: ibuprofen
Otherwise, wait until your next scheduled dose as you normally would.
Drugače počakajte in vzemite naslednji načrtovani odmerek, kot bi ga normalno.
• Ringing in the ears*
• zvonjenje v ušesih*,
Because an association with liver injury cannot be excluded, assessments of liver function tests (ALT, AST and bilirubin) are recommended before initiating lumacaftor/ivacaftor, every 3 months during the first year of treatment, and annually thereafter.
Ker povezave s poškodbo jeter ne moremo izključiti, priporočajo izvedbo testov funkcije jeter (ALT, AST in bilirubin) pred uvedbo lumakaftorja/ivakaftorja, vsake 3 mesece med prvim letom zdravljenja, nato pa enkrat na leto.
As a precautionary measure, it is preferable to avoid the use of lumacaftor/ivacaftor during pregnancy unless the clinical condition of the mother requires treatment with lumacaftor/ivacaftor.
Kot previdnostni ukrep je zaželeno, da se izognete uporabi lumakaftorja/ivakaftorja med nosečnostjo, če klinično stanje matere ne zahteva zdravljenja z lumakaftorjem/ivakaftorjem.
Clinical comment
Klinični komentar
At Week 24, 16% of children had a reduction in sweat chloride below 60 mmol/L, and none below 30 mmol/L.
V 24. tednu se je natrijev klorid pri 16 % otrok znižal pod 60 mmol/l, pri nobenem otroku pa pod 30 mmol/l.
Usual dose: Take 2 tablets whole every 12 hours (morning and evening) with fat-containing food.
Običajni odmerek: vzemite 2 celi tableti vsakih 12 ur (zjutraj in zvečer) z mastno hrano.
Results indicate no clinically relevant difference in pharmacokinetic parameters for lumacaftor or ivacaftor between males and females.
Rezultati kažejo, da ni klinično pomembne razlike v farmakokinetičnih parametrih za lumakaftor ali ivakaftor med moškimi in ženskami.
Effect on blood pressure
Vpliv na krvni tlak
• Pain or discomfort in the upper right stomach (abdominal) area
• bolečina ali neugodje v zgornjem desnem predelu trebuha (abdomna),
Pharmacotherapeutic group: Other respiratory system products; ATC code: R07AX30
Farmakoterapevtska skupina: Druga zdravila za zdravljenje bolezni dihal; oznaka ATC: R07AX30.
Lumacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Lumakaftor je v približno 99 % vezan na plazemske beljakovine, predvsem na albumin.
Of the patients who were initiated lumacaftor/ivacaftor at the full dose, one patient had a serious respiratory event, three patients subsequently had their dose reduced, and three patients discontinued treatment.
Od bolnikov, ki so jim uvedli lumakaftor/ivakaftor v polnem odmerku, je imel en bolnik resen respiracijski dogodek, trem bolnikom so pozneje odmerek zmanjšali, trije bolniki pa so prekinili zdravljenje.
Ivacaftor produced a dose-related but transient increase in the blood pressure parameters in dogs at single oral doses up to 60 mg/kg.
Ivakaftor je povzročil z odmerkom povezan, a prehoden porast parametrov krvnega tlaka psov pri enkratnih peroralnih odmerkih do 60 mg/kg.
Mean (SD)
povprečje (SD)