natgillin/translations-raw huggingface dataset:
The Marketing Authorisation provides all physicians who intend to prescribe TYSABRI with a physician pack containing the following elements:
Imetnik dovoljenja za promet z zdravilom oskrbi vse zdravnike, ki nameravajo predpisovati zdravilo TYSABRI, s paketom za zdravnike, ki vsebuje naslednje elemente:
The Member States shall discuss and agree the physician pack with the MAH and ensure that:
Države članice se bodo z imetnikom dovoljenja za promet z zdravilom dogovorile o paketu za zdravnike in zagotovile, da:
The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Obrazec za nadaljevanje zdravljenja mora vsebovati elemente obrazca za začetek zdravljenja, poleg tega pa še navedbo, da tveganje za PML narašča s trajanjem zdravljenja ter da zdravljenje, ki traja dlje kot 24 mesecev, predstavlja še dodatno tveganje.
• Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
• potrditev, da bolnik razume tveganje za PML in da je prejel kopijo obrazca in kartico s posebnimi opozorili
• Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
• potrditev, da se je zdravnik z bolnikom pogovoril o tveganju za PML ter tveganju za IRIS, če se zdravljenje prekine zaradi suma na PML
• Patient alert card
• Kartico s posebnimi opozorili za bolnika
A copy of the treatment initiation form A patient alert card including a core text agreed by the CHMP o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o The need to inform the National Competent Authority about any cases of PML
o Če naj bi zdravljenje trajalo dlje kot 24 mesecev, zahtevo, da se bolnike obvesti o povečanem tveganju za razvoj PML in se jim da kopijo obrazca za nadaljnje zdravljenje o Zahtevo, da se nacionalni pristojni organ obvesti o vseh primerih PML
• Information on PML and IRIS including the risk of developing PML during Tysabri treatment stratified by prior treatment with immunosuppressants and JC virus infection.
TYSABRI, opredeljeno glede na predhodno zdravljenje z imunosupresivi in okužbo z virusom JC
• Information that atypical/opportunistic infections, and in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk o Other factors associated with an increased risk for the development of PML Immunosuppressant treatment prior to the use of Tysabri Presence of anti-JC virus antibodies o A stratification of the risk of developing PML based on the three identified risk factors o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections o The recommendation that patients should have MRI scans at the following times Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRIi At the first sign of any symptoms indicative of the possibility of PML.
• Informacijo, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključno z: o da tveganje za PML narašča s trajanjem zdravljenja in da zdravljenje, ki traja dlje kot 24
o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
enkrat letno med zdravljenjem z zdravilom TYSABRI ob prvih znakih kakršnih koli simptomov, ki kažejo na možnost pojava PML o Zahtevo, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom TYSABRI in se jim da:
1 Article 29(2) of Directive 2001/83/EC, as amended.
1 Člen 29(2) of Direktive 2001/83/ES, kot je bila spremenjena.
The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.
Referenčna država članica je bila Finska, zadevne države članice pa so bile Belgija, Nemčija, Luksemburg in Nizozemska.
The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Zadevne države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je podelila referenčna država članica.
The application was withdrawn in the Netherlands and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Vloga je bila umaknjena na Nizozemskem in Nemčija je 15. decembra 2004 Evropski agenciji za zdravila podala razloge za nesoglasje.
During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Na sestanku v juniju 2005, je CHMP glede na vse predložene podatke ter znanstveno razpravo znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansopon ugodno.
Lansopon (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Lansopon (lansoprazol) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega vnetja požiralnika, ZollingerEllisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo
A Marketing Authorisation for Lansopon (15 mg and 30 mg) was previously granted to Hexal AG in
Dovoljenje za promet z zdravilom Lansopon (15 mg in 30 mg) je bilo prvotno dodeljeno družbi Hexal AG iz Finske 7. novembra 2003.
Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
V primerjavi z referenčnim zdravilom so bile ugotovljene znatne razlike v zvezi z razdelkom o odmerjanju v Povzetku glavnih značilnosti zdravila.
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansopon 15 mg and 30 mg
Lansopon 15 mg in 30 mg
15 September 2005 EMEA/CHMP/230274/2005
EMEA/CHMP/230274/2005 ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA
Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of
Odbor za zdravila za uporabo v humani medicini je izrazil strinjanje s spremembami v razdelku 4.2 (Odmerjanje in način uporabe) Povzetka glavnih značilnosti zdravila, ki navajajo natančna priporočila glede odmerjanja za antibiotike v skladu s “Točkami, ki jih je treba upoštevati pri sestavi besedila za zdravljenje z eradikacijo Helicobacter pylori v izbranih poglavjih Povzetka glavnih značilnosti zdravila”, in 23. junija 2005 sprejel pozitivno mnenje.
Further information on Semintra can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Semintra so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Other information about Semintra:
Druge informacije o zdravilu Semintra:
Semintra received a marketing authorisation valid throughout the EU, on 13 February 2013.
Zdravilo Semintra je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 13. februarja 2013.
If contact with the eyes occurs they should be rinsed with water.
V primeru stika z očmi jih je treba izprati z vodo.
The European Medicines Agency decided that Semintra's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Semintra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Hands should be washed after giving the medicine.
Po dajanju zdravila si je treba umiti roke.
Pregnant women should take special care to avoid contact with the product.
Nosečnice se morajo še posebno izogibati stiku z zdravilom.
Why is Semintra authorised in the EU?
Zakaj je bilo zdravilo Semintra odobreno v EU?
Two different strengths are available: 4 mg/ml to reduce proteinuria and 10 mg/ml to treat high blood pressure.
Na voljo sta dve različni jakosti: 4 mg/ml za zniževanje proteinurije in 10 mg/ml za zdravljenje visokega krvnega tlaka.
An overview of Semintra and why it is authorised in the EU
Pregled zdravila Semintra in zakaj je odobreno v EU
What are the risks associated with Semintra?
Kakšna tveganja so povezana z zdravilom Semintra?
What benefits of Semintra have been shown in studies?
Kakšne koristi je zdravilo Semintra izkazalo v študijah?
What is Semintra and what is it used for?
Kaj je zdravilo Semintra in za kaj se uporablja?
Semintra is a veterinary medicine used in cats to reduce proteinuria (protein in the urine) and to treat high blood pressure.
Semintra je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zniževanje proteinurije (beljakovin v urinu) in za zdravljenje visokega krvnega tlaka pri mačkah.
This allows blood pressure to drop with a resulting decrease in protein in the urine which may slow down progression of kidney disease.
Tako se krvni tlak zniža, posledično pa se zmanjša količina beljakovin v urinu, kar lahko upočasni napredovanje ledvične bolezni.
High blood pressure is also a long term problem of ageing cats which can occur with chronic kidney disease, hyperthyroidism (overactive thyroid gland) and other conditions.
Tudi visok krvni tlak je dolgoročna težava starajočih se mačk, ki se lahko pojavi pri kronični ledvični bolezni, hipertiroidizmu (čezmerno aktivni ščitnici) in drugih stanjih.
The target SBP is between 120 and 140 mmHg.
Ciljna vrednost sistoličnega krvnega tlaka je med 120 in 140 mmHg.
People who are hypersensitive to telmisartan or other angiotensin II receptor antagonists should avoid contact with Semintra.
Osebe, preobčutljive za telmisartan ali druge antagoniste receptorjev angiotenzina II, se morajo izogibati stiku z zdravilom Semintra.
Semintra decreased protein in the urine within the first seven days after the start of treatment.
Zdravilo Semintra je zmanjšalo količino beljakovin v urinu v prvih sedmih dneh zdravljenja.
The medicine is given once a day by mouth using the measuring syringe provided.
Zdravilo se daje enkrat na dan peroralno s priloženo merilno brizgo.
The most common side effects seen with Semintra are mild and short-lived vomiting and diarrhoea (which may affect up to 1 in 10 cats treated with the 10 mg/ml strength solution).
Najpogostejši neželeni učinki, opaženi pri zdravilu Semintra, sta blago in kratkotrajno bruhanje in driska (ki lahko prizadeneta največ 1 mačko od 10, zdravljenih z raztopino jakosti 10 mg/ml).
Angiotensin II is a powerful vasoconstrictor (a substance that constricts blood vessels).
Angiotenzin II je močan vazokonstriktor (snov, ki zožuje krvne žile).
If Semintra is swallowed accidentally, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
V primeru nenamernega zaužitja zdravila Semintra nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
After 4 weeks the dose can be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg.
Po štirih tednih se odmerek pri mačkah s sistoličnim krvnim tlakom pod 140 mmHg lahko zmanjša.
Proteinuria can occur with chronic (long-term) kidney disease in cats, a common disease in elderly cats characterised by a progressive deterioration of kidney function over time.
Proteinurija se lahko pojavi pri kronični (dolgotrajni) bolezni ledvic pri mačkah, ki je pri starejših mačkah pogosta, zanjo pa je značilno postopno slabšanje delovanja ledvic.
The person administering Semintra should avoid getting it in their eyes.
Oseba, ki daje zdravilo Semintra, mora paziti, da ji zdravilo ne pride v oči.
For a full list of all side effects reported with Semintra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Semintra, glejte navodilo za uporabo.
The active substance in Semintra, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Učinkovina v zdravilu Semintra, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
The recommended dose to reduce proteinuria is 1 mg telmisartan per kg bodyweight.
Priporočeni odmerek za zmanjšanje proteinurije je 1 mg telmisartana na kg telesne mase.
To treat high blood pressure an initial dose of 2 mg telmisartan per kg bodyweight is used.
Za zdravljenje visokega krvnega tlaka se uporablja začetni odmerek 2 mg telmisartana na kg telesne mase.
In a second field study involving 294 cats with hypertension with average age 13 years, 194 cats given Semintra once a day for 28 days had a reduction of SBP of 25 mmHg at day 28 compared to 11 mmHg for 100 cats given placebo (a dummy treatment).
V drugi terenski študiji, ki je vključevala 294 mačk s hipertenzijo, starih povprečno 13 let, se je sistolični krvni tlak po 28 dneh pri 194 mačkah, ki so prejemale zdravilo Semintra enkrat na dan 28 dni, znižal za 25 mmHg, pri 100 mačkah, ki so prejemale placebo (zdravilo brez zdravilne učinkovine), pa se je znižal za 11 mmHg.
In a field study involving 224 cats with chronic kidney disease, aged mainly over 11 years, Semintra was as effective as benazepril, another veterinary medicine used to reduce proteinuria, in reducing proteinuria.
V terenski študiji, ki je vključevala 224 mačk s kronično ledvično boleznijo, večinoma starih več kot 11 let, je bilo zdravilo Semintra pri zniževanju proteinurije enako učinkovito kot benazepril, drugo
At the end of the 28 days Semintra treated cats continued to be treated for an additional 92 days and these cats had a reduction of SBP of more than 20 mmHg for the entire 4 month study period.
Po koncu 28-dnevnega obdobja so se mačke, zdravljene z zdravilom Semintra, zdravile še dodatnih 92 dni, sistolični krvni tlak pa se jim je v celotnem štirimesečnem obdobju študije znižal za več kot 20 mmHg.
Semintra must not be given to pregnant or lactating cats.
Zdravilo Semintra se ne sme uporabljati pri brejih mačkah ali mačkah v obdobju laktacije.
By blocking the receptor to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to expand.
Telmisartan z zaviranjem receptorja, na katerega se angiotenzin II običajno veže, prepreči učinek hormona, kar privede do razširitve žil.
Semintra is available as a solution to be given by mouth and can only be obtained with a veterinary prescription.
Zdravilo Semintra je na voljo v obliki raztopine, ki se daje peroralno, njegovo predpisovanje in izdaja pa je le na veterinarski recept.
How is Semintra used?
Kako se zdravilo Semintra uporablja?
How does Semintra work?
Kako zdravilo Semintra deluje?
Date of first authorisation: 19 November 2007 Date of latest renewal: 19 November 2012
Datum prve odobritve: 19. november 2007 Datum zadnjega podaljšanja: 19. november 2012
This study is ongoing.
Študija še poteka.
(Best response rate)
(največji delež odzivov)
**Also includes preferred term anorexia
**vključuje tudi bolj uporabljen izraz anoreksija
These changes are unlikely to be clinically important.
Te spremembe po vsej verjetnosti niso klinično pomembne.
- Risk Management Plan (RMP)
• Načrt za obvladovanje tveganj (RMP)
Unexpected, rapid weight gain should be carefully investigated.
Nepričakovan, hiter porast teže je treba temeljito raziskati.
Interaction studies have only been performed in adults.
Interakcijske študije so izvajali samo pri odraslih.
Sudden death
Nenadna smrt
This is a long-term treatment.
Gre za dolgotrajno zdravljenje.
The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Hipokaliemija in hipomagneziemija lahko še dodatno okrepita ta učinek.
This medicine contains lactose (also known as milk sugar).
To zdravilo vsebuje laktozo (znano tudi kot mlečni sladkor).
Rifampicin and nilotinib should not be used concomitantly.
Rifampicina in nilotiniba se ne sme uporabljati sočasno.
Tasigna blocks this signal, and thus stops the production of these cells.
Zdravilo Tasigna ovira ta signal in tako ustavi izdelovanje teh celic.
- Do not open the hard capsules unless you are unable to swallow them.
- Trdih kapsul ne odpirajte razen, če jih ne morete pogoltniti.
The total daily dose you give to your child must not exceed 800 mg.
Celotni dnevni odmerek, ki ga dajete otroku, ne sme presegati 800 mg.
Some children and adolescents taking Tasigna may have slower than normal growth.
Pri nekaterih otrocih in mladostnikih, ki jemljejo zdravilo Tasigna, je rast lahko počasnejša kot normalno.
Accelerated phase
Pospešena faza
Do not drink grapefruit juice or eat grapefruit.
Ne pijte grenivkinega soka in ne jejte grenivk.
Months since randomisation
meseci po randomizaciji
60-month analysis
60 mesečna analiza
Follow all the doctor's instructions carefully.
Skrbno se ravnajte po vseh navodilih vašega zdravnika.
The doctor will calculate the correct dose to use and tell you which and how many capsules of Tasigna to give to your child.
Zdravnik bo izračunal pravi odmerek za uporabo in vam povedal, katere in koliko kapsul zdravila Tasigna boste dajali otroku.
Use in children and adolescents - The dose given to your child will depend on your child's body weight and height.
Uporaba pri otrocih in mladostnikih - Odmerek, ki ga bo prejemal vaš otrok, bo odvisen od njegove telesne mase in telesne višine.
Time since TFR (weeks)
čas od TFR (tedni)
More than 60% of all patients were Caucasian and 25% of all patients were Asian.
Več kot 60 % vseh bolnikov je bilo belcev, 25 % vseh bolnikov pa je bilo azijcev.
Investigations Very common:
Preiskave zelo pogosti:
They may differ from the general information contained in this leaflet.
Morda se ta razlikujejo od splošnih navodil v tem navodilu za uporabo.
Do not take Tasigna - if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Tasigna - če ste alergični na nilotinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Take the hard capsules: - twice a day (approximately every 12 hours); - at least 2 hours after any food; - then wait 1 hour before eating again.
Trdi kapsuli vzemite: - dvakrat na dan (približno vsakih 12 ur); - vsaj 2 uri po uživanju kakršnekoli hrane; - nato počakajte vsaj 1 uro, preden spet jeste.
More frequent follow-up of these patients should be considered.
Pri teh bolnikih velja razmisliti o pogostejših kontrolnih pregledih.
Approximately 12% of subjects in the clinical study were 65 years of age or over.
Približno12 % oseb v klinični študiji je bilo starih 65 let ali več.
Bioavailability/bioequivalence studies
Študije biološke uporabnosti/bioekvivalentnosti
Molecular relapse can occur during the treatment-free phase, and long-term outcome data are not yet available.
V obdobju brez zdravljenja lahko pride do molekularnega relapsa, podatki o dolgoročnih izidih pa še niso na voljo.
In general the changes in clinical chemistry were fully reversible after a four-week recovery period and the histological alterations showed partial reversibility.
Na splošno so bile spremembe s področja klinične kemije popolnoma reverzibilne v 4-tedenskem obdobju okrevanja, histološke spremembe pa so bile le deloma reverzibilne.
- the level of sugar and fats in the blood.
- vrednosti sladkorja in maščob v krvi.
Taking Tasigna at the same time each day will help you remember when to take your hard capsules.
Če boste jemali zdravilo Tasigna vsak dan ob istem času, si boste najlaže zapomnili, kdaj morate vzeti trdi kapsuli.
Unchanged nilotinib accounted for 69% of the dose.
Nespremenjeni nilotinib je znašal 69 % odmerka.
Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Večina neželenih učinkov je blagih do zmernih in večinoma izzvenijo po nekaj dneh do nekaj tednih zdravljenja.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Vaš zdravnik bo redno spremljal vaše stanje in preverjal, ali zdravljenje dosega želeni učinek.
Tasigna is available in the following pack sizes:
Zdravilo Tasigna je na voljo v naslednjih velikostih pakiranj:
Tasigna has no or negligible influence on the ability to drive and use machines.
Tasigna nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Dose adjustments or modifications
Prilagoditve in modifikacije odmerkov
If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose.
Če bolnik pozabi vzeti odmerek, ne sme vzeti dodatnega odmerka, ampak naj vzame naslednji običajni predpisani odmerek.
Pregnancy and breast-feeding - Tasigna is not recommended during pregnancy unless clearly necessary.
Nosečnost in dojenje - Uporaba zdravila Tasigna med nosečnostjo ni priporočena, če to ni nujno potrebno.
Metabolism and nutrition disorders Decreased appetite **
Presnovne in prehranske motnje zmanjšan apetit**
If you think you may be allergic, tell your doctor before taking Tasigna.
Če mislite, da bi bili lahko alergični, povejte svojemu zdravniku preden vzamete zdravilo Tasigna.
The AUC of imatinib was increased by 18% to 39%, and the AUC of nilotinib was increased by 18% to 40%.
AUC imatiniba se je povečala za 18 % do 39 %, AUC nilotiniba pa za 18 % do 40 %.
Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Zdravljenje je treba nadaljevati, dokler je pri bolniku mogoče opaziti klinične koristi oziroma do pojava nesprejemljive toksičnosti.
Stopping Tasigna without your doctor's recommendation places you at risk for worsening of your disease which could have life-threatening consequences.
Če prenehate jemati zdravilo Tasigna brez zdravnikovega priporočila, tvegate poslabšanje bolezni, kar lahko ima življenjsko ogrožujoče posledice.
These adverse reactions are included based on clinical relevance.
Ti neželeni učinki so vključeni na podlagi kliničnega pomena.
These medicines should be avoided during your treatment with Tasigna.
Tem zdravilom se je treba med zdravljenjem z zdravilom Tasigna izogibati.
Table 12 Response in CML
Preglednica 12 Odzivi pri KML
Similar events were observed in post-marketing reports.
O podobnih dogodkih so poročali tudi v obdobju trženja zdravila.
In addition, the toxicity profile in juvenile rats was comparable to that observed in adult rats.
Poleg tega je bil tudi profil toksičnosti pri mladičih primerljiv s tistim, ki so ga opažali pri odraslih živalih.
Main metabolic pathways identified in healthy subjects are oxidation and hydroxylation.
Poglavitna presnovna procesa, ki so ju ugotovili pri zdravih osebah, sta oksidacija in hidroksilacija.
Prolongation of the QT interval or an irregular heart beat may lead to sudden death.
Podaljšanje intervala QT ali nepravilno bitje srca lahko vodita v nenadno smrt.
Your doctor may prescribe a lower dose depending on how you respond to treatment.
Zdravnik vam bo morda predpisal nižji odmerek glede na vaš odziv na zdravljenje.
Tasigna must not be taken in conjunction with food (see sections 4.2 and 4.5) and should be taken 2 hours after a meal.
Zdravila Tasigna se ne sme jemati skupaj s hrano (glejte poglavji 4.2 in 4.5), ampak ga je treba vzeti 2 uri po obroku.
In the event of overdose, the patient should be observed and appropriate supportive treatment given.
V primeru zaužitja prevelikega odmerka je treba bolnika opazovati in poskrbeti za ustrezno podporno zdravljenje.