natgillin/translations-raw huggingface dataset:
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva niso opazili drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
In vitro and in vivo data in non-target species suggest that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Podatki in vitro in in vivo pri neciljnih živalskih vrstah kažejo, da cepivo lahko zagotovi določeno navzkrižno zaščito proti serološki skupini L. interrogans Icterohaemorrhagiae serovar
For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154, and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Za sočasno dajanje s cepivi Canigen, kjer so registrirana: 1 odmerek cepiva Canigen istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebuje virus pasje kuge seva Onderstepoort, pasji adenovirus tipa 2 seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva
Infections may be more likely in younger children.
Okužbe so bolj verjetne pri mlajših otrocih.
Further information on Benlysta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/benlysta.
Nadaljnje informacije za zdravilo Benlysta so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/benlysta.
Patients should therefore be observed for several hours after at least the first two infusions.
Zato je treba vsaj po prvih dveh infuzijah bolnike opazovati nekaj ur.
The first three doses are given at two-week intervals.
Prvi trije odmerki se dajejo z dvotedenskimi presledki.
The Agency also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
Agencija je tudi ugotovila, da učinkovita nadomestna zdravljenja za bolnike, ki so že preizkusili standardno zdravljenje, niso na voljo.
What measures are being taken to ensure the safe and effective use of Benlysta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Benlysta?
Benlysta received a marketing authorisation valid throughout the European Union on 13 July 2011.
Za zdravilo Benlysta je bilo 13. julija 2011 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Benlysta's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Benlysta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Benlysta is given to patients whose disease is still highly active despite standard treatment.
Zdravilo Benlysta se daje bolnikom, pri katerih je bolezen kljub standardnemu zdravljenju še vedno zelo dejavna.
Other information about Benlysta
Druge informacije o zdravilu Benlysta
As for all medicines, data on the use of Benlysta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Benlysta stalno spremljajo.
After this, Benlysta is given once every four weeks.
Pozneje se zdravilo Benlysta daje enkrat na štiri tedne.
The company that markets Benlysta will provide further information on the safety of the medicine from a study and from a register of patients being followed up long-term.
Podjetje, ki trži zdravilo Benlysta, bo zagotovilo dodatne podatke o varnosti zdravila iz študije in registra bolnikov, ki se jih dolgoročno spremlja.
Why is Benlysta authorised in the EU?
Zakaj je bilo zdravilo Benlysta odobreno v EU?
What benefits of Benlysta have been shown in studies?
Kakšne koristi zdravila Benlysta so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benlysta have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Benlysta upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated.
Zdravilo lahko povzroča infuzijske in preobčutljivostne reakcije ter okužbe, vendar ga bolniki na splošno dobro prenašajo.
An overview of Benlysta and why it is authorised in the EU
Pregled zdravila Benlysta in zakaj je odobreno v EU
Side effects reported with Benlysta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Benlysta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Benlysta?
Kakšna tveganja so povezana z zdravilom Benlysta?
Results from a main study involving 93 children aged 5 to 17 years with active SLE showed that Benlysta was distributed in the body in a similar way as in adults and could be expected to have similar benefits.
Rezultati glavne študije, v katero je bilo vključenih 93 otrok, starih od pet do 17 let, z aktivnim sistemskim eritematoznim lupusom, so pokazali, da je bilo zdravilo Benlysta v telesu razporejeno podobno kot pri odraslih, zato je pričakovati, da bo imelo podobne koristi.
The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions which may be severe and life-threatening and can develop several hours after Benlysta is given.
Zdravnik lahko prekine ali zaustavi zdravljenje, če se pri bolniku pojavijo reakcije, povezane z infuzijo (npr. izpuščaji, srbenje in težave z dihanjem), ali preobčutljivostne (alergijske) reakcije, ki so lahko resne in življenjsko nevarne ter se lahko pojavijo nekaj ur po prejemu zdravila Benlysta.
When Benlysta is given as an infusion into a vein, the recommended dose is 10 mg per kilogram body weight given over one hour.
Kadar se zdravilo Benlysta daje v obliki infuzije v veno, je priporočeni odmerek 10 mg na kilogram telesne mase v obdobju ene ure.
Benlysta is available as a powder (120 mg and 400 mg) that is made up into a solution for infusion (drip) into a vein; it is also available as a pre-filled pen and pre-filled syringe (200 mg) for injection under the skin.
Zdravilo Benlysta je na voljo v obliki praška (120 mg in 400 mg) za pripravo raztopine za infundiranje (kapalne infuzije) v veno; na voljo je tudi v napolnjenih peresnikih in napolnjenih injekcijskih brizgah (200 mg) za injiciranje pod kožo.
Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the body's natural defences) attacks normal cells and tissues, causing inflammation and organ damage.
Benlysta je zdravilo, ki se uporablja kot dodatno zdravilo pri bolnikih, starejših od pet let, s sistemskim eritematoznim lupusom (SLE), tj. boleznijo, pri kateri imunski sistem (naravna obramba telesa) napada normalne celice in tkiva ter povzroča vnetje in okvaro organov.
Patients may inject Benlysta themselves once they have been properly trained, if the doctor considers this appropriate.
Bolniki si lahko po ustreznem usposabljanju zdravilo Benlysta injicirajo sami, če zdravnik meni, da je to primerno.
What is Benlysta and what is it used for?
Kaj je zdravilo Benlysta in za kaj se uporablja?
For more information about using Benlysta, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Benlysta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
All infusions with Benlysta, and the first injection under the skin, should be given in a place where these reactions can be managed immediately if they occur.
Vse infuzije zdravila Benlysta in prvi dve podkožni injekciji je treba dajati v ustanovah, v katerih je nemudoma na voljo vse potrebno za obvladovanje takšnih reakcij.
Benlysta can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.
Predpisovanje in izdaja zdravila Benlysta je le na recept, zdravljenje z njim pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem sistemskega eritematoznega lupusa.
Another study involved 836 adult patients with active SLE, who received add-on Benlysta as an injection under the skin once a week for a year.
Dodatna študija je vključevala 836 odraslih bolnikov z aktivnim sistemskim eritematoznim lupusom, ki so eno leto prejemali zdravilo Benlysta kot dodatno zdravilo v obliki podkožne injekcije enkrat na teden.
The most common side effects with Benlysta (which may affect more than 1 in 10 people) are bacterial infections, such as bronchitis (infection in the lungs) and infection of the urinary tract (structures that produce or carry urine), diarrhoea and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Benlysta (ki se lahko pojavijo pri več kot 1 od 10 oseb) so bakterijske okužbe, kot sta bronhitis (okužba pljuč) in okužba sečil (struktur, ki proizvajajo ali prenašajo urin), driska in navzeja (siljenje na bruhanje).
For the full list of side effects and restrictions of Benlysta, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Benlysta glejte navodilo za uporabo.
In adults, Benlysta can also be given as a 200-mg injection under the skin, once a week.
Pri odraslih se lahko zdravilo Benlysta daje tudi v obliki 200-miligramske podkožne injekcije enkrat na teden.
In SLE, some of these antibodies attack the body's own cells and organs instead (autoantibodies).
Pri sistemskem eritematoznem lupusu pa ta protitelesa napadajo lastne celice in organe telesa (avtoprotitelesa).
By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.
Belimumab z zaviranjem delovanja beljakovine BLyS skrajšuje življenjsko dobo limfocitov B ter tako zmanjšuje vnetje in okvaro organov, ki se pojavljajo pri sistemskem eritematoznem lupusu.
The Agency considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE.
Evropska agencija za zdravila je menila, da zdravilo Benlysta, kadar se uporablja kot dodatno zdravilo, zmanjšuje bolezensko dejavnost pri sistemskem eritematoznem lupusu.
The active substance in Benlysta, belimumab, is a monoclonal antibody, a protein that has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer.
Učinkovina v zdravilu Benlysta, belimumab, je monoklonsko protitelo, tj. beljakovina, ki je bila zasnovana tako, da se veže na beljakovino BLyS, ki limfocitom B podaljšuje preživetje, in jo zavira.
SLE can affect almost any organ in the body, and is thought to involve a type of white blood cell called B lymphocytes.
Sistemski eritematozni lupus lahko prizadene skoraj vsak organ v telesu, domneva pa se, da je v njegov nastanek vpletena vrsta belih krvnih celic, imenovanih limfociti B. Te običajno tvorijo protitelesa, ki pomagajo v boju proti okužbam.
How is Benlysta used?
Kako se zdravilo Benlysta uporablja?
The study showed that disease activity decreased in 61% of patients treated with Benlysta, compared with 48% of patients given placebo.
Študija je pokazala, da se je bolezenska dejavnost zmanjšala pri 61 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 48 % bolnikov, ki so prejemali placebo.
In the second study, disease activity decreased in 58% of patients treated with Benlysta, compared with 44% of patients who were given placebo.
V drugi študiji se je bolezenska dejavnost zmanjšala pri 58 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 44 % bolnikov, ki so prejemali placebo.
In the first study, disease activity decreased in 43% of patients treated with Benlysta, compared with 34% of patients who were given placebo.
V prvi študiji se je bolezenska dejavnost zmanjšala pri 43 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 34 % bolnikov, ki so prejemali placebo.
Benlysta contains the active substance belimumab.
Zdravilo Benlysta vsebuje učinkovino belimumab.
Benlysta given by infusion was shown to be more effective than placebo (a dummy treatment) in reducing disease activity when used as an add-on treatment for SLE in two main studies involving 1,693 adult patients with active SLE.
V dveh glavnih študijah, ki sta vključevali 1 693 odraslih bolnikov z aktivnim sistemskim eritematoznim lupusom, je bilo dokazano, da je zdravilo Benlysta, dano z infundiranjem, pri zmanjševanju bolezenske dejavnosti učinkovitejše od placeba (zdravila brez učinkovine), kadar se uporablja kot dodatno zdravilo proti sistemskemu eritematoznemu lupusu.
How does Benlysta work?
Kako zdravilo Benlysta deluje?
Ref. EMEA/CHMP/744722/2009 rev. EMEA/H/A-29/1170
: EMEA/CHMP/744722/2009 rev. EMEA/H/A-29/1170
Company responses provided on: 27 August 2009, 26 October 2009 Opinion date:
Odgovori družbe predloženi dne: 27. avgusta 2009, 26. oktobra 2009 Datum izdaje mnenja:
Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Pantoprazole Olinka pantoprazol 20 in 40 mg tablete
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Evropska agencija za zdravila (EMEA) je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Pantoprazole Olinka.
The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
20-miligramske tablete se lahko uporabljajo za lajšanje simptomov refluksa, kot sta zgaga in regurgitacija kisline (vračanje kisline v usta), za dolgoročno zdravljenje in preprečevanje ponovne pojavitve refluksnega ezofagitisa (vnetje požiralnika zaradi kisline), za preprečevanje razjed na želodcu, ki jih lahko povzročajo nekatera zdravila za lajšanje bolečin in vnetij, imenovana neselektivna nesteroidna protivnetna zdravila (NSAID), kadar potrebuje bolnik stalno zdravljenje z NSAID.
Why was Pantoprazole Olinka reviewed?
Zakaj je bilo zdravilo Pantoprazole Olinka pregledano?
The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
40-miligramske tablete se lahko uporabljajo za zdravljenje hujših obolenj zaradi kisline, kot so razjede na želodcu in dvanajstniku, Zollinger-Ellisonovega sindroma (stanja, ki nastane zaradi čezmernega izločanja kisline v želodcu) in za pomoč pri odstranitvi bakterije Helicobacter pylori iz želodca, za katero je znano, da povzroča razjedo na želodcu
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, Germany and Poland.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je zaključil, da koristi zdravila Pantoprazole Olinka odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Združenem kraljestvu ter tudi v naslednjih državah članicah Evropske unije: v Nemčiji in na Poljskem.
This is a procedure when one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Germany and Poland).
za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah (v „zadevnih državah članicah“, v tem primeru v Nemčiji in na Poljskem).
The review was carried out under an ‘Article 29' referral1.
1po členu 29.
Pharmaceutical form Route of administration Packaging Content
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja EU/1/97/040/001 Teslascan 0,01 mmol/ml Raztopina za infundiranje Intravenska uporaba Viala (iz stekla) 50 ml
This risk appears to be higher in children.
Videti je, da je to tveganje večje pri otrocih.
Children aged less than 18 years should not take this medicine.
Otroci, mlajši od 18 let, ne smejo jemati tega zdravila.
Therefore this information is of limited value.
Zato ima ta informacija majhno vrednost.
Elderly patients (over 65 years of age)
Starejši bolniki (nad 65 let)
Modafinil was first authorized in the EU in France, in June 1992.
Modafinil je bil v EU najprej odobren v Franciji junija leta 1992.
The expiry date refers to the last day of the month.
Rok uporabnosti se nanaša na zadnji dan meseca.
It is currently licensed in 21 countries in Europe, and the approved indications vary between Member States.
Trenutno je odobreno v 21 državah v Evropi, vendar se odobrene indikacije med državami članicami razlikujejo.
The efficacy in the long term has also not been demonstrated.
Dolgoročna učinkovitost prav tako ni bila dokazana.
Common: decreased appetite
Pogosti: zmanjšan apetit
Data should be submitted once it is available from the investigators.
Podatke je treba predložiti, ko jih bodo raziskovalci dali na voljo.
Misuse and illicit use accounted for less than 3% of posted messages online.
Napačna in nedovoljena uporaba sta predstavljali manj kot 3 % na spletu objavljenih sporočil.
• The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing modafinil.
• Odbor je upošteval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo modafinil.
Aggressive or hostile behaviour
Agresivno ali sovražno vedenje
• This medicine has the potential for you to become reliant (dependent) on it after long-term use.
• To zdravilo ima potencial, da se nanj navadite (postanete odvisni) po dolgotrajni uporabi.
Take this leaflet and any remaining tablets with you.
S seboj prinesite to navodilo in vse preostale tablete.
As the Committee's assessment of the safety information did not change following re-examination, the Product Information remained unchanged.
Ker se ocena varnostnih informacij Odbora po ponovnem pregledu ni spremenila, informacije o zdravilu ostajajo nespremenjene.
Statistically significant differences were seen in the subjective parameters (ESS and CGI-C).
Statistično pomembne razlike so ugotovili pri subjektivnih parametrih (ESS in CGI-C).
Overall benefit/risk assessment
Splošna ocena koristi in tveganj
However the effect size is small and does not necessarily reflect a clinically significant benefit.
Vendar je velikost učinka majhna in ne odraža nujno klinično pomembne koristi.
You may want to consider asking a family member or close friend to help you look out for signs of depression or other changes in your behaviour.
Družinskega člana ali dobrega prijatelja lahko prosite, naj vam pomaga paziti na znake depresije ali druge spremembe vedenja.
The benefit-risk balance in this indication is therefore considered to be positive under the normal conditions of use.
Razmerje med koristmi in tveganji za to indikacijo se zato pri normalnih pogojih uporabe šteje za pozitivno.
This is usually mild or moderate, dose-dependent and disappears within a few days.
Ta je navadno blag ali zmeren, odvisen od odmerka in izgine v nekaj dneh.
Your doctor in some cases may decide to increase your daily dose up to 400 mg.
V nekaterih primerih se vaš zdravnik lahko odloči, da poveča vaš dnevni odmerek na do 400 mg.
Other side effects include the following:
Drugi neželeni učinki vključujejo naslednje:
• You feel any change in your mental health and wellbeing.
• čutite spremembo v duševnem zdravju ali počutju.
The Committee considered that further risk minimisation measures would not adequately address the concern as the magnitude of the risk is not fully determined.
Odbor je menil, da dodatni ukrepi za zmanjševanje tveganje ne bi ustrezno obravnavali težave, saj obseg tveganja ni popolnoma ugotovljen.
Improvements were also noted in the subjective measurements.
Izboljšave so opazili tudi pri subjektivnih meritvah.
• Misinterpretation of the risks associated to modafinil
• Napačna interpretacija tveganj, povezanih z modafinilom.
Idiopathic Hypersomnia
Idiopatska hipersomnija
These differences, although statistically significant, are very small and therefore its clinical significance is questioned.
Čeprav so te razlike statistično pomembne, so po drugi strani zelo majhne, zato je njihov klinični pomen vprašljiv.
The study is intended to be initiated in September 2010 and the final report will be submitted in 4Q2011.
Začetek študije je načrtovan za september 2010, končno poročilo pa bo predloženo v zadnjem četrtletju leta 2011.
Tell your doctor straight away if you notice that you are becoming depressed, feel aggressive or hostile towards other people or have suicidal thoughts or other changes in your behaviour (see section 4).
Takoj povejte zdravniku, če opazite, da postajate depresivni, ste agresivni ali sovražni do drugih ljudi ali imate samomorilne misli ali spremembe v vedenju (glejte poglavje 4).
This is further illustrated by the fact that patients at the end of the trial were sufficiently sleepy to meet the entrance criteria for the study (MSLT<6 minutes).
To potrjuje dejstvo, da so bili bolniki na koncu preskušanja dovolj zaspani, da so izpolnili vstopna merila za študijo (MSLT <6 minut).
Sleepiness associated with narcolepsy is the only indication approved in all Member States where the product is approved.
Zaspanost, povezana z narkolepsijo, je edina indikacija, odobrena v vseh državah članicah, kjer je zdravilo odobreno.
• You notice a skin rash or itching (especially if it affects your whole body).
• opazite izpuščaj na koži ali srbenje (zlasti če prizadene celotno telo).
Three of these had a fatal outcome, and for the majority, causality could not be excluded.
Trije primeri so se končali s smrtnim izidom, za večino pa ni bilo možno izključiti vzročnosti.
Suicide-related behaviour
S samomorom povezano vedenje
Steps to ensure good sleep hygiene may include a review of caffeine intake.
Koraki za vzdrževanje dobre spalne higiene lahko vključujejo pregled vnosa kofeina.
• Have any heart problems or high blood pressure.
• če imate težave s srcem ali visok krvni tlak.
Data presented in support of this indication includes a total of 6 patients, of which at least 2 actually presented with excessive sleepiness due to sleep apnoea.
Podatki, predstavljeni v podporo tej indikaciji, vključujejo skupno 6 bolnikov, od katerih sta vsaj dva dejansko imela čezmerno zaspanost zaradi apneje med spanjem.
Stop taking this medicine and tell your doctor straight away if
Takoj prekinite jemanje tega zdravila in obvestite zdravnika, če:
You may also have a high temperature (fever) and abnormal blood test results.
Prav tako imate lahko visoko temperaturo (vročino) in nenormalne rezultate krvnih preiskav;
• Have kidney or liver problems (because you will need to take a lower dose).
• če imate težave z ledvicami ali jetri (ker boste morali jemati manjši odmerek);