natgillin/translations-raw huggingface dataset:
p < 0.001 for the comparisons between guselkumab and placebo for the co-primary endpoints.
p < 0,001 za primerjavo med guselkumabom in placebom p < 0,001 za primerjavo med guselkumabom in adalimumabom za glavne sekundarne cilje opazovanja p < 0,001 za primerjavo med guselkumabom in placebom za druge primarne cilje opazovanja primerjave med guselkumabom in adalimumabom niso izvajali p < 0,001 za primerjavo med guselkumabom in adalimumabom
Tremfya 100 mg solution for injection in pre-filled syringe
Tremfya 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Do not touch, fan or blow on the injection site after you have cleaned it.
Ko ste mesto injiciranja očistili, se ga ne dotikajte in ne sušite s fenom ali pihanjem.
Take the pre-filled pen out of the carton.
Napolnjen injekcijski peresnik vzemite iz škatle.
Each pre-filled pen contains 100 mg of guselkumab in 1 mL.
En napolnjen injekcijski peresnik vsebuje 100 mg guselkumaba v 1 ml raztopine.
Very common Upper respiratory infections Common
Bolezni prebavil pogosti diareja
Medication injects as you push.
Medtem ko potiskate držalo, se zdravilo injicira.
Do not use the pre-filled pen if it is dropped after removing the cap.
Če vam napolnjen injekcijski peresnik po odstranitvi pokrovčka pade iz rok, ga ne uporabite.
Week After Randomisation
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Week
PASI
National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je to ustrezno, bodo zagotovili, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Študijo je treba izvesti v več kot eni državi članici, protokol pa je treba predložiti odboru PRAC v treh mesecih od izdaje sklepa Komisije v zvezi s tem postopkom;
The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use.
3. imetniki dovoljenj za promet z zdravilom morajo izvesti študijo o uporabi zdravil, namenjeno oceni učinkovitosti ukrepov za zmanjšanje tveganja ter spremljanju nenamenske uporabe.
A study shall be conducted to generate robust data on the efficacy of domperidone in the relief of symptoms of nausea and vomiting in children at the recommended doses.
1. izvesti je treba študijo za pridobitev zanesljivih podatkov o učinkovitosti priporočenih odmerkov domperidona pri lajšanju simptomov slabosti in bruhanja pri otrocih.
The Marketing Authorisation Holders for the rectal formulations that remain authorised shall conduct a pharmacokinetic study to generate data to allow for a comparison between the rectal and oral formulations.
2. imetniki dovoljenj za promet s farmacevtskimi oblikami za rektalno uporabo, ki so še naprej odobrene, morajo izvesti farmakokinetično študijo za pridobitev podatkov, ki bodo omogočili primerjavo med farmacevtskimi oblikami za rektalno in peroralno uporabo.
The final study report shall be submitted to the National Competent Authorities within 1 year of the commission decision for this procedure.
Končno poročilo o študiji je treba pristojnim nacionalnim organom predložiti v enem letu od izdaje sklepa Komisije v zvezi s tem postopkom;
The Marketing Authorisations Holders of products for which a paediatric indication is approved shall submit the protocols of new or ongoing studies to the National Competent Authorities within 4 months of the commission decision for this procedure.
Imetniki dovoljenj za promet z zdravili, ki so odobrena za pediatrično indikacijo, morajo pristojnim nacionalnim organom predložiti protokole novih študij ali študij, ki že potekajo, v štirih mesecih od izdaje sklepa Komisije v zvezi s tem postopkom.
The final study report shall be submitted to the National Competent Authorities within 36 months of endorsement of the protocol, and updates on progress with recruitment to the study shall be submitted to the National Competent Authorities on a yearly basis.
Končno poročilo o študiji je treba pristojnim nacionalnim organom predložiti v 36 mesecih od potrditve protokola, enkrat na leto pa je treba predložiti tudi poročilo o napredku pri pridobivanju oseb za sodelovanje v študiji;
Within 3 months of the commission decision for this procedure, the MAHs shall submit to the National Competent Authorities a Risk Management Plan containing the key elements described in the PRAC assessment report.
4. imetniki dovoljenj za promet z zdravilom morajo pristojnim nacionalnim organom v treh mesecih od izdaje sklepa Komisije v zvezi s tem postopkom predložiti načrt obvladovanja tveganj, ki bo vseboval ključne elemente, opisane v poročilu o oceni zdravila odbora PRAC.
Ref. EMEA/CHMP/220307/2006
EMEA/CHMP/220307/2006
SURFAXIN was designated as an ‘orphan medicine' on 29 July 2004.
Zdravilo SURFAXIN je bilo določeno kot zdravilo sirota dne 29. julija 2004.
London, 29 June 2006
London, 29. junija 2006 Ref. dok.
The main concern of the CHMP was related to the way the medicine is made, and in particular to the stability of the medicine.
Glavni zadržki CHMP so bili povezani z načinom izdelave zdravila in še posebej z njegovo stabilnostjo.
It contains fat ingredients and a synthetic protein (sinapultide).
Vsebuje maščobne sestavine in sintetično beljakovino (sinapultid).
It is supplied in a vial containing 8 ml of the medicinal product.
Na voljo je v vialah, ki vsebujejo po 8 ml zdravila.
The presence of synthetic ingredient prevents potential risks associated with animal-derived substance such as potential transmission of infectious agents.
Z uporabo sintetične sestavine se izognemo morebitnemu tveganju, povezanemu z uporabo snovi živalskega porekla, kot je na primer morebiten prenos povzročiteljev okužb.
Data to support the indication for the treatment of RDS were not sufficient.
Podatki v podporo indikaciji za zdravljenje sindroma dihalne stiske niso bili zadostni.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for SURFAXIN
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo SURFAXIN
The effects of SURFAXIN were first tested in experimental models before being studied in humans.
Učinki zdravila SURFAXIN so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
Therefore, at the time of the withdrawal, the Committee's provisional view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Zato je bil v času umika Odbor začasnega mnenja, da koristni učinki niso bili zadostno dokazani in niso večji od znanih tveganj.
It mainly occurs in premature babies, where the onset of difficulty in breathing is within minutes to a few hours after birth.
Največkrat se pojavi pri nedonošenčkih, pri katerih težave dihanja nastopijo že v nekaj minutah do nekaj urah po rojstvu.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with SURFAXIN?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila SURFAXIN?
The letter from the Company notifying the EMEA of the withdrawal of SURFAXIN is available here.
Dopis, s katerim je podjetje obvestilo EMEA o umiku zdravila SURFAXIN, je na voljo tukaj.
The CHMP was still questioning whether the design and the results of the studies were sufficient to establish that the product will be at least as effective and safe as other surfactant agents currently used to prevent RDS.
CHMP je še vedno v dvomih, ali so načrt in rezultati raziskave zadostni, da bi bilo mogoče na njihovi podlagi ugotoviti, ali bo zdravilo vsaj tako učinkovito in varno kot druga površinsko aktivna sredstva, ki se trenutno uporabljajo za preprečevanje sindroma dihalne stiske.
The company mainly presented the results of two studies on the prevention of RDS, involving over 1,500 premature neonates in total, where SURFAXIN was compared with other surfactant agents (one which has no protein component and two others which contain animal-derived protein).
Podjetje je v glavnem predstavilo rezultate dveh raziskav o preprečevanju sindroma dihalne stiske, ki sta skupno zajemali 1500 nedonošenčkov in v katerih so zdravilo SURFAXIN primerjali z drugimi površinsko aktivnimi sredstvi (eno je bilo brez beljakovinske sestavine, drugi dve pa sta vsebovali beljakovine živalskega porekla).
SURFAXIN was expected to be used for the prevention of RDS in premature neonates of less than 32 weeks of gestational age (babies born 8 weeks or more too early), and, the treatment of RDS in premature neonates of less than 37 weeks of gestational age (babies born 3 weeks or more too early).
Zdravilo SURFAXIN naj bi se uporabljalo za preprečevanje sindroma dihalne stiske pri nedonošenčkih gestacijske starosti manj kot 32 tednov (novorojenčki, rojeni 8 ali več tednov prezgodaj) in za zdravljenje sindroma dihalne stiske pri nedonošenčkih gestacijske starosti manj kot 37 tednov (novorojenčki, rojeni 3 ali več tednov prezgodaj).
Effectiveness was measured by looking at frequency of RDS, survival with or without related pulmonary disorder (“bronchopulmonary dysplasia”), at different points in time.
Učinkovitost so merili z opazovanjem pogostosti sindroma dihalne stiske in stopnje preživetja z ali brez povezane pljučne motnje (bronhopulmonarna displazija) v različnih časovnih točkah.
Following CHMP opinion, it usually takes around 2 months for the European Commission to grant an authorisation.
Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
What documentation was presented by the Company to support the application to the CHMP?
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
On 7 June 2006, Pharm Research Associates (UK) Limited has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their marketing application for SURFAXIN, for the prevention and treatment of respiratory distress syndrome (RDS) in premature babies.
Podjetje Pharm Research Associates (UK) Limited je 7. junija 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet za zdravilo SURFAXIN, namenjeno preprečevanju in zdravljenju sindroma dihalne stiske (RDS) pri nedonošenčkih.
What is SURFAXIN?
Kaj je zdravilo SURFAXIN?
RDS is a lung disorder that causes increasing difficulty in breathing.
Sindrom dihalne stiske je pljučna motnja, ki povzroča vedno težje dihanje.
The company informed the EMEA that there were no ongoing clinical trials or compassionate use programmes with SURFAXIN at the time of the withdrawal.
EMEA je prejela obvestilo podjetja, da v času umika vloge niso tekla nobena klinična preizkušanja ali programi sočutne uporabe zdravila SURFAXIN.
SURFAXIN is an artificial surfactant expected to compensate for the lack of natural surfactant in babies with RDS.
Zdravilo SURFAXIN je umetni surfaktant, ki lahko domnevno nadomesti pomanjkanje naravnega surfaktanta pri dojenčkih s sindromom dihalne stiske.
Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at around day 180) to the Company.
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
Active substances: sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid.
Zdravilne učinkovine: sinapultid, dipalmitoil-fosfatidilholin, palmitoil-oleoil fosfatidilglicerol in palmitinska kislina.
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that SURFAXIN could not be approved for the prevention and treatment of respiratory distress syndrome in premature babies.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo SURFAXIN ni mogoče odobriti dovoljenja za zdravljenje nedonošenčkov s sindromom dihalne stiske.
In infants, RDS is caused by a lack of lung surfactant; a complex of protein and fat that is normally present in lungs and helps the air sacs of the lung to inflate with air easily.
Sindrom dihalne stiske pri novorojenčkih je posledica pomanjkanja pljučnega surfaktanta, kompleksa beljakovine in maščobe, ki je običajno prisoten v pljučih in lajša polnjenje pljučnih mešičkov z zrakom.
RDS is a life-threatening disease.
Sindrom dihalne stiske je življenjsko nevarna bolezen.
What was SURFAXIN expected to be used for?
Za kaj naj bi se zdravilo SURFAXIN uporabljalo?
The active substances of SURFAXIN are sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid.
Zdravilne učinkovine zdravila SURFAXIN so sinapultid, dipalmitoil-fosfatidilholin, palmitoil-oleoil, fosfatidilglicerol in palmitinska kislina.
How is SURFAXIN expected to work?
Kako naj bi zdravilo SURFAXIN delovalo?
The likelihood of lack of surfactant is higher in premature neonates.
Pri nedonošenčkih je verjetnost pomanjkanja surfaktanta večja.
SURFAXIN is a white suspension (i.e. a solution in which active substance is dissolved) to be administered into the lungs via a tube.
raztopina v kateri je raztopljena zdravilna učinkovina) za dovajanje v pljuča s pomočjo tubusa.
The application was at the stage of review of answers to remaining questions, adopted at around day 180, when the Company withdrew it. After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues.
Ko je podjetje vlogo umaknilo, je bila ta na stopnji pregledovanja odgovorov na preostala vprašanja, ki so bili prejeti okoli 180. dne.
Subcutaneous use pre-filled syringe (glass)
6 mg raztopina za injiciranje subkutana uporaba napolnjena brizga (steklena)
• you are under 18 years.
• če ste mlajši od 18 let.
The test will take about 45 minutes.
Test bo trajal približno 45 minut.
A supply of drinking water will be needed.
Potrebna bo oskrba s pitno vodo.
Your doctor now wants to find out if the treatment has worked.
Vaš zdravnik sedaj hoče ugotoviti, če je to zdravljenje učinkovalo.
Wait 5 minutes
Počakajte 5 minut
This is especially important after eradication therapy.
To je še posebej pomembno po eradikacijskem zdravljenju.
This should be checked routinely.
To se preverja rutinsko.
Test is now complete
Test je sedaj končan
How does the test work?
Kako deluje test?
Do not smoke, eat or drink during this time.
Med tem ne smete kaditi, jesti ali piti.
This is not supplied within the box.
To ni priložen v škatli.
There are no concerns in relation to the clinical use of the product.
Ni pomislekov glede na klinično uporabo izdelka.
If there is a significant increase in the amount of
Če je ta količina znatno povečana.
(v) patient fasted for hours Please note that (i) - (iii) will affect result of test.
(v) Bolniki se je postil zadnjih ur Prosimo upoštevajte, da imajo točke (i) - (iii) vpliv na rezultat testa.
IRMS source parameters and tuning must be optimised daily.
Izvorne parametre IRMS in nastavitve je treba optimirati dnevno.
The specificity estimates were all above 90 % with corresponding lower confidence limits ranging from 85 % to 90 %.
Ocene specifičnosti so vse bile nad 90 % z ustreznimi spodnjimi mejami zaupanja od 85 % do 90 %.
Your doctor will tell you when the results of your test will be available and who to contact for these results.
Zdravnik vas bo obvestil, kdaj bodo rezultati testa na razpolago in na koga se boste morali obrniti za rezultate.
You must not smoke before or during the test.
Neposredno pred ali med testom ne smete kaditi.
This is important for the proper functioning of the test.
To je zelo pomembno za pravilno opravljanje testa.
The endogenous production of urea amounts to 25 - 35 g/day.
Endogena proizvodnja sečnine znaša 25 - 35 g/dan.
This is not included in this kit but may have been supplied separately.
Ta ni vključen v tem setu, lahko pa je dostavljen ločeno.
• fasting (not taking food) may have medical implications for you
• če ima lahko post (neuživanje hrane) za vas medicinske posledice.
Explanation of results:
Pojasnilo rezultatov:
It is important to follow the instructions for use described in Section 6.6 adequately, otherwise the validity of the test result will be questionable.
Pomembno je, da natančno upoštevate vsa navodila za uporabo opisana v poglavju 6.6, saj so v nasprotnem primeru lahko testni rezultati vprašljivi.
Overdose is unlikely to occur in the intended clinical circumstances.
Preveliko odmerjanje je v predvidenih kliničnih okoliščinah malo verjetno.
If a repeat test is required, it should not be carried out until the following day.
Če je potreben ponovni test, se ga ne sme opravljati do naslednjega dne.
The test procedure involves the following steps: (A brief form of these instructions is included on the back of the Analysis Request Form)
Testni postopek obsega sledeče korake: (skrajšana verzija teh navodil se nahaja na zadnji strani obrazca za naročilo analize)
Instruments must be linear over a wide range of CO2 concentrations, typically 1.0 - 6.0%.
Instrumenti morajo meriti linearno na širokem območju koncentracij CO2 (običajno 1,0 - 6,0 %).
Do not take the test if:
Ne jemljite test:
Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Spain.
Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Španija.
The expiry date refers to the last day of that month.
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca..
Suppression of H. pylori might give false negative results.
Supresija H. pylori lahko daje lažne negativne rezultate.
A security label for re-sealing the kit is also provided.
Prav tako je priložena varnostna etiketa za ponovno zapečatenje seta.
The dissolved tablet must be taken immediately.
Raztopljeno tableto morate zaužiti takoj.
Adults: The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure.
Odrasli bolniki: tableto je treba raztopiti v vodi ter raztopino zaužiti 10 minut po začetku postopka dihalnega testa.
You will be asked to drink a "test meal".
Prosili vas bodo, da popijete t.i. "testni obrok".
Driving and using machines This test should not affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ta test ne bo vplival na vašo sposobnost upravljanja vozil in strojev.
Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika,farmacevta ali medicinske sestre, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Transfer of the breath sample through the analytical system must be accomplished without isotope fractionation.
Prenos vzorcev izdihanega zraka skozi analizni sistem mora biti dosežen brez frakcioniranja izotopov.
Dispose of the empty sachet, mixing vial and straws as normal waste, but keep this leaflet for reference.
Prazno vrečko, vialo za mešanje in slamice odstranite kot običajne odpadke, vendar pa to navodilo shranite za referenco.
C in the breath will depend on the type of food that you have eaten.
Dejanska količina 13C je odvisna od vrste hrane, ki ste jo zaužili.
Therefore, the test must not be used until four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Iz tega razloga se testa ne sme uporabljati pred potekom štirih tednov po sistemskem antibakterijskem zdravljenju in dveh tednov po zadnjem odmerku zdravil, ki zavirajo sekrecijo kisline.
In comparison with biopsy based techniques for diagnosing H.pylori infection, using data from two therapeutic trials, Pylobactell achieved during different conditions (prestudy and follow-up visits) sensitivity estimates above 95 % with lower one-sided 95 % confidence limit ranging from 93 % to 98 %.
V primerjavi z metodami za ugotavljanje infekcije s H. pylori, ki temeljijo na biopsiji, ob upoštevanju podatkov dveh terapevtskih preskušanj, je Pylobactell pod različnimi pogoji (pred študijo in ob kontrolnih pregledih bolnikov po zdravljenju) dosegel ocene občutljivosti nad 95 % s spodnjo enostransko 95 % mejo zaupanja z ustreznimi spodnjimi mejami zaupanja od 93 % do 98 %.
Breath samples collected during a test must remain in the original containers before analysis by IRMS.
Vzorci izdihanega zraka, ki se zbirajo med testom, morajo pred analizo z IRMS ostati v originalnih vsebnikih.
Patient Name:
Ime bolnika:
It is excreted unchanged in the urine.
Izloča se nespremenjena s sečem.
• part of your stomach has been removed (partial gastrectomy) as the reliability of the test has not been proven in these patients
• če so vam odstranili del želodca (delna gastrektomija), ker pri teh bolnikih zanesljivost testa še ni bila dokazana.
You should fast for 4 hours before taking the test (See Section 2 Taking Pylobactell with food and drink)
Post: morate se postiti 4 ure pred opravljanjem testa (glejte poglavje 2, Uporaba zdravila Pylobactell skupaj s hrano in pijačo).
A positive urea breath test alone does not clinically confirm that eradication therapy is indicated.
Sam pozitiven rezultat dihalnega testa s sečnino še ni klinična potrditev, da je indicirano eradikacijsko zdravljenje.
(iii) eradication therapy in the last 28 days?
(iii) bil na eradikacijskem zdravljenju v zadnjih 28 dnevih?
(i) antibiotics in the last 28 days?
(i) v zadnjih 28 dnevih jemal antibiotike?
It is therefore unlikely that the dose of 100 mg urea should cause any adverse effect on pregnancy and lactation.
Zatorej je le malo verjetno, da bi odmerek 100 mg sečnine lahko povzročal kakršnekoli neželene učinke med nosečnostjo in dojenjem.
Analytical file reference: Laboratory code:
Sklic na datoteko analize: Laboratorijska koda:
ADDITIONAL KIT ITEM: SECURITY LABEL
DODATNI PREDMET SETA: VARNOSTNA ETIKETA {OZNAKA}
Reference gases must be standardised against an appropriate international standard to allow interlaboratory comparison of results.
Referenčni plin mora biti standardiziran po ustrezni mednarodni normi, tako da je možna primerjava rezultatov med laboratoriji.
Fill out the analysis request form with patient details on the left hand side of the form and the doctor's name and address on the right hand side.
Izpolnite obrazec za naročilo analize z bolnikovimi podatki na levi strani obrazca ter z imenom in naslovom zdravnika na desni strani.
For patients who do not tolerate the recommended test meal, an alternative test meal should be given.
Bolniki, ki ne prenašajo priporočenega testnega obroka, naj prejmejo alternativni testni obrok.
Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.
Alternativno je možno uporabiti katerokoli drugo ustrezno validirano metodo, ki jo mora opraviti ustrezno kvalificiran laboratorij.
Care should be taken in patients where fasting may have medical implications.
Posebna previdnost je potrebna pri bolnikih, pri katerih bi post lahko imel zdravstvene posledice.
It is not necessary to blow hard into the tubes, just breathe normally and cap them quickly.
Ni potrebno, da močno izdihnete v epruvete, temveč dihajte kot običajno ter nemudoma namestite zaporko.
• You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days
• če ste v zadnjih 28 dneh jemali antibiotike ali zdravila za zdravljenje okužbe z bakterijo Helicobacter pylori.