natgillin/translations-raw huggingface dataset:
What is Xeljanz? 
Kaj je zdravilo Xeljanz?
These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis. 
Ti encimi imajo pomembno vlogo pri vnetju in okvari sklepov, ki se pojavi pri revmatoidnem artritisu.
By blocking the enzymes, tofacitinib is expected to reduce the inflammation and other symptoms of the disease. 
Tofacitinib naj bi z zaviranjem teh encimov zmanjšal vnetje in druge simptome bolezni.
Xeljanz was expected to be used in the treatment of moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints). 
Zdravilo Xeljanz naj bi se uporabljalo za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča okvaro in vnetje sklepov).
Therefore, in April 2013 the CHMP was of the opinion that the benefits of Xeljanz did not outweigh its risks and recommended that it be refused marketing authorisation. 
Posledično je CHMP aprila 2013 sprejel mnenje, da koristi zdravila Xeljanz niso večje od z njim povezanih tveganj, in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z njim.
These studies compared Xeljanz (in a dose of 5 or 10 mg twice daily) with placebo (a dummy treatment), either alone or as an addition to other background medicines (DMARDs). 
V študijah so primerjali zdravilo Xeljanz (v odmerku 5 ali 10 mg dvakrat na dan) in placebo (zdravilo brez zdravilne učinkovine), ki so ju dajali samostojno ali kot dodatek k drugim zdravilom za osnovno bolezen (imunomodulirajočim antirevmatičnim zdravilom).
What was Xeljanz expected to be used for? 
Za kaj naj bi se zdravilo Xeljanz uporabljalo?
Biological DMARDs are medicines that target specific proteins in the immune system. 
Biološka imunomodulirajoča antirevmatična zdravila (DMARD) so zdravila, ki učinkujejo na določene beljakovine imunskega sistema.
How is Xeljanz expected to work? 
Kako naj bi zdravilo Xeljanz delovalo?
After first use: 1 month. 
Po prvi uporabi: 1 mesec.
Date of first authorisation: 30 June 2009 Date of last renewal: 11 April 2014 
Datum prve odobritve: 30. junij 2009 Datum zadnjega podaljšanja: 11. april 2014
This reduction was observed within the first two weeks of treatment. 
Do tega znižanja je prišlo v prvih dveh tednih zdravljenja.
The relevance for humans is likely to be low but cannot be completely excluded. 
Pomen tega za človeka je verjetno majhen, vendar ga ni mogoče povsem izključiti.
Then take your next dose as usual the following day. 
Uporabite naslednji odmerek kot ponavadi naslednji dan.
You may need medical treatment. 
Morda boste potrebovali zdravniško pomoč.
All patients recovered without complications. 
Vsi bolniki so si opomogli brez zapletov.
Time from randomisation (months) 
Čas od randomizacije (meseci)
Before opening: 
Pred odprtjem:
Detailed instructions for use are provided on the other side of this leaflet. 
Podrobna navodila za uporabo so opisana na drugi strani teh navodil.
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. 
Zdravnik vam bo povedal, kako zdraviti nizek krvni sladkor in kaj storiti, če opazite te opozorilne znake.
These reactions have usually been mild. 
Te reakcije so bile po navadi blage.
The CHMP agrees with the scientific conclusions made by the PRAC. 
Odbor CHMP se strinja z znanstvenimi zaključki odbora PRAC.
The mean duration of diabetes was 12.8 years. 
Povprečno trajanje sladkorne bolezni je bilo 12,8 let.
It also slows food passage through your stomach and can help prevent heart disease. 
Prav tako upočasni prehajanje hrane skozi želodec in lahko pomaga preprečiti bolezni srca.
30 months. 
20 mesecev.
No interaction study has been performed. 
Študija medsebojnega delovanja ni bila izvedena.
Patients at risk 
Bolniki s tveganjem
Ethnic origin 
Etnično poreklo
Using the wrong medicine could cause severe harm. 
Uporaba napačnega zdravila lahko zelo škoduje.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. 
V primeru prevelikega odmerjanja je treba začeti ustrezno podporno zdravljenje glede na bolnikove klinične znake in simptome.
Liraglutide should therefore be used with caution in these patients. 
Liraglutid je treba pri teh bolnikih uporabljati previdno.
Very rare 
Zelo redki
Important information 
Pomembne informacije
• in addition to other medicinal products for the treatment of diabetes. 
• kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni.
• Risk Management Plan 
• Načrt za obvladovanje tveganj (RMP)
You can give yourself the injection at any time of the day, regardless of meals. 
Zdravilo si lahko injicirate ob kateri koli uri, ne glede na obroke.
It is not known whether liraglutide is excreted in human milk. 
Ni znano, ali se liraglutid izloča v človeško mleko.
Do not change your dose unless your doctor has told you to. 
Ne spreminjajte odmerka, če vam tega ne naroči zdravnik.
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications 
• kot monoterapija, kadar metformin ni primeren zaradi intolerance ali kontraindikacij;
If you split the dose wrong, you may inject too much or too little liraglutide. 
Če odmerek razdelite napačno, lahko injicirate preveč ali premalo liraglutida.
It also ensures that the dosing is accurate. 
Zagotavlja tudi točnost odmerjanja.
If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible. 
Če opazite te simptome, morate nemudoma poiskati medicinsko pomoč in o tem čim prej obvestiti zdravnika.
• The starting dose is 0.6 mg once a day, for at least one week. 
• Začetni odmerek je 0,6 mg enkrat na dan vsaj en teden.
• Decreased appetite 
• zmanjšan apetit
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Primary endpoint - MACE Components of MACE: 
Primarni opazovani dogodek - MACE Komponente MACE:
Patients should be informed of the characteristic symptoms of acute pancreatitis. 
Bolnike je treba seznaniti z značilnimi simptomi akutnega pankreatitisa.
Frequencies for all events have been calculated based on their incidence in phase 3a clinical trials. 
Za vse dogodke so pogostnosti izračunane glede na njihovo pojavnost v kliničnih preskušanjih faze 3a.
Do not take an extra dose or increase the dose on the following day to make up for the missed dose. 
Ne uporabite dodatnega odmerka oziroma ne povečajte odmerka naslednji dan, da bi nadoknadili zamujen odmerek.
• Do not try to wash, soak or lubricate it - this can harm the pen. 
• Ne poskušajte ga oprati, namočiti ali namazati - to je za injekcijski peresnik lahko škodljivo.
Patients with an event (%) 
Bolniki, pri katerih je prišlo do dogodka (%)
The estimated hazard ratio was consistently below 1 for all 3 MACE components. 
Ocenjeno razmerje ogroženosti je bilo dosledno manjše od 1 za vse 3
• Dehydration, sometimes with a decrease in kidney function 
• dehidracija, včasih vključno z zmanjšanjem funkcije ledvic
The duration of observation was a minimum of 3.5 years and up to a maximum of 5 years. 
3,5 leta in do največ 5 let.
These reactions usually diminish within a few days or weeks on continued treatment. 
Ponavadi se med nadaljevanjem zdravljenja po nekaj dneh ali tednih zmanjšajo.
ATC code: A10BJ02 
Oznaka ATC: A10BJ02.
Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. 
Akutni pankreatitis je bil opažen pri uporabi agonistov receptorjev GLP-1.
There are no adequate data from the use of liraglutide in pregnant women. 
Ni zadostnih podatkov o uporabi liraglutida pri nosečnicah.
Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
Avoid driving or using machines if you experience signs of hypoglycaemia. 
Izogibajte se upravljanju vozil ali uporabi strojev, če občutite znake hipoglikemije.
Before you use the pen for the first time, your doctor or nurse will show you how to use it. 
Preden prvič uporabite injekcijski peresnik, vam bo zdravnik ali medicinska sestra pokazal/-a, kako ga uporabljate.
2 IU a According to the individualised recommendation by the investigator at the previous visit, for example depending on whether the patient has experienced hypoglycaemia. 
aGlede na individualizirana raziskovalčeva priporočila na prejšnjem pregledu, npr. odvisno od tega, ali je bolnik imel hipoglikemijo.
This leaflet was last revised in Other sources of information 
Navodilo je bilo nazadnje posodobljeno: Drugi viri informacij
The injection site and timing can be changed without dose adjustment. 
Mesto in čas injiciranja je mogoče spreminjati brez prilagoditve odmerka.
No data are available in children below 10 years of age. 
Za otroke, mlajše od 10 let, podatki niso na voljo.
Victoza should not be used during pregnancy because it is not known if it may harm your unborn child. 
Zdravila Victoza se ne sme uporabljati med nosečnostjo, saj ni znano, če lahko škoduje nerojenemu otroku.
Warfarin and other coumarin derivatives 
Varfarin in drugi kumarinski derivati
This is normal and does not affect your dose. 
To je normalno in ne vpliva na injicirani odmerek.
Interaction studies have only been performed in adults. 
Študije medsebojnega delovanja so izvedli le pri odraslih bolnikih.
Use a calculator to plan the doses. 
Za načrtovanje odmerkov uporabite kalkulator.
Do not inject it into a vein or muscle. 
Zdravila ne injicirajte v veno ali mišico.
Do not use the cartridge scale to measure how much liraglutide to inject - it is not accurate enough. 
Ne uporabljajte merila na vložku za merjenje količine liraglutida za injiciranje - to ni dovolj natančno.
This will make any air bubbles collect at the top of the cartridge. 
Tako se bodo zračni mehurčki zbrali na vrhu vložka.
Needles are not included. 
Igle niso priložene.
Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required. 
Študije medsebojnega delovanja niso pokazale klinično pomembne upočasnitve absorpcije, torej prilagoditev odmerka ni potrebna.
This indicates the pen is defective and you must use a new one. 
To namreč pomeni, da je injekcijski peresnik pokvarjen in morate uporabiti novega.
Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
If you stop using it, your blood sugar levels may increase. 
Če prenehate uporabljati zdravilo, se lahko koncentracija krvnega sladkorja poveča.
• Your doctor will tell you when to increase it to 1.2 mg once a day. 
• Zdravnik vam bo povedal, kdaj morate odmerek povečati na 1,2 mg enkrat na dan.
Animal studies did not indicate direct harmful effects with respect to fertility but slightly increased early embryonic deaths at the highest dose. 
Študije na živalih niso pokazale neposrednih škodljivih vplivov na plodnost, so pa pokazale nekaj več zgodnjih embrionalnih smrti pri največjem odmerku.
• Do not try to repair your pen or pull it apart. 
• Ne poskušajte ga popraviti ali razstaviti.
For further instructions on administration, see section 6.6. 
Za dodatna navodila glede apliciranja zdravila glejte poglavje 6.6.
The mean age was 64 years and the mean BMI was 32.5 kg/m². 
Povprečna starost je bila 64 let in povprečni ITM je bil 32,5 kg/m2.
If no drop appears, repeat steps E to G up to four times. 
Če se kapljica ne pojavi, ponavljajte korake od E do G največ štirikrat.
Victoza has no or negligible influence on the ability to drive and use machines. 
Zdravilo Victoza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
However, if it is more than 12 hours since you should have used Victoza, skip the missed dose. 
Če pa je minilo že več kot 12 ur, odkar bi morali uporabiti zdravilo Victoza, preskočite ta odmerek.
Combination therapy with sulfonylurea is only valid for adult patients. 
Kombinirano zdravljenje s sulfonilsečnino velja le za odrasle bolnike.
If there is still no drop of liraglutide, change the needle and repeat steps E to G once more. 
Če še ne vidite kapljice liraglutida, zamenjajte iglo in ponovite korake E do G še enkrat.
During use: 
Med uporabo:
GLP-1 receptors are also expressed in specific locations in the heart, vasculature, immune system, and kidneys. 
Receptorji GLP-1 so izraženi tudi na določenih mestih v srcu, ožilju, imunskem sistemu in ledvicah.
Never try to put the inner needle cap back on the needle. 
Nikoli ne poskušajte znova namestiti notranjega pokrovčka na iglo.
Other clinical data 
Drugi klinični podatki
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
This prevents contamination, infection and leakage. 
To prepreči kontaminacijo, okužbo in puščanje.
Because of lack of experience, Victoza should not be used during breast-feeding. 
Zaradi pomanjkanja izkušenj se zdravila Victoza ne sme uporabljati med dojenjem.
On average, 8.6% of patients developed antibodies. 
V povprečju so se protitelesa razvila pri 8,6 % bolnikov.
The safety profile of liraglutide was generally similar to that observed in other studies with liraglutide. 
Varnostni profil liraglutida je bil na splošno podoben kot pri drugih študijah z liraglutidom.
It is not an insulin and should therefore not be used as a substitute for insulin. 
To zdravilo ni insulin in se ga zato ne sme uporabljati kot zamenjavo za insulin.
Liraglutide is not a substitute for insulin. 
Liraglutid ni nadomestilo za insulin.
It is unknown whether the reduced pup growth is caused by reduced pup milk intake due to a direct GLP-1 effect or reduced maternal milk production due to decreased caloric intake. 
Ni znano, ali je upočasnjena rast mladičev posledica zmanjšanja hranjenja mladičev z materinim mlekom zaradi neposrednega vpliva GLP-1 ali posledica manjšega nastajanja mleka pri materi zaradi manjšega kaloričnega vnosa.
If your pen is already in use, go to ‘Select your dose', step H. 
Če je injekcijski peresnik že bil uporabljen, glejte poglavje ‘Izbira odmerka', korak H.
What Victoza is and what it is used for What you need to know before you use Victoza How to use Victoza 
Kaj je zdravilo Victoza in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Victoza Kako uporabljati zdravilo Victoza
Victoza should not be used if it has been frozen. 
Zdravila Victoza ne smete uporabiti, če je bilo zamrznjeno.
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. 
Za rezultate študij v zvezi s kombinacijami, učinki na urejenost glikemije in srčno-žilne dogodke, ter skupinami bolnikov, ki so jih preučili, glejte poglavja 4.4., 4.5 in 5.1.
Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark 
Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd Danska
Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%. 
Absolutna biološka uporabnost liraglutida po subkutani aplikaciji je približno 55 %.
Patients (%) achieving 
Bolniki (%), ki so dosegli vrednost
It is not known if Victoza passes into breast milk, therefore do not use this medicine if you are breastfeeding. 
Ni znano, ali zdravilo Victoza prehaja v materino mleko in zato ne jemljite tega zdravila, če dojite.
• Your doctor may tell you to further increase the dose to 1.8 mg once a day, if your blood glucose is not adequately controlled with a dose of 1.2 mg. 
• Zdravnik vam bo morda naročil, da še povečate odmerek na 1,8 mg enkrat na dan, če glukoze v krvi ni mogoče ustrezno nadzorovati z odmerkom 1,2 mg.
In addition, liraglutide had a beneficial effect on plasma lipids. 
Poleg tega je imel liraglutid tudi ugoden vpliv na lipide v plazmi.
Liraglutide should not be used during pregnancy, and the use of insulin is recommended instead. 
Liraglutida se ne sme uporabljati med nosečnostjo; namesto tega se uporablja insulin.
Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility. 
Razen rahlega zmanjšanja števila živih ugnezdenj študije na živalih niso pokazale škodljivih učinkov na plodnost.
Pull out the needle. 
Izvlecite iglo.
Be careful not to bend or damage the needle. 
Pazite, da igle ne zvijete ali poškodujete.
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation 
Priloga IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
It helps your body reduce your blood sugar level only when blood sugar is too high. 
Zdravilo pomaga telesu zmanjšati koncentracijo krvnega sladkorja, le kadar je krvni sladkor previsok.
If you selected a wrong dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer. 
Če ste pomotoma izbrali napačen odmerek, ga preprosto spremenite tako, da izbirnik odmerka zavrtite naprej ali nazaj, dokler ni s kazalnikom poravnan želeni odmerek.
A stepwise approach to insulin dose reduction is recommended. 
Priporoča se postopen pristop k zmanjševanju odmerka insulina.
Keep the dose button pressed down and leave the needle under the skin for at least 6 seconds. 
Še naprej držite potisni gumb, igla pa naj pod kožo ostane vsaj 6 sekund.
Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure). 
Odkrili so tudi dva manj pomembna presnovka v plazmi (≤9 % in ≤5 % celotne plazemske izpostavljenosti radioaktivnosti).
There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients. 
Izkušenj pri zdravljenju bolnikov s srčnim popuščanjem razreda IV po razvrstitvi New York Heart Association (NYHA) ni in zato uporaba liraglutida pri teh bolnikih ni priporočljiva.
It is important to avoid dehydration by drinking plenty of fluids. 
Pomembno je preprečiti dehidracijo, tako da pijete veliko tekočin.
Victoza must not be administered intravenously or intramuscularly. 
Zdravila Victoza se ne sme aplicirati intravensko ali intramuskularno.
Split your dose into two injections: 
V tem primeru lahko: Odmerek razdelite na dve injiciranji:
• Beta-cell function 
• Delovanje celic beta
These findings in rodents are caused by a non-genotoxic, specific GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive. 
Te učinke pri glodalcih povzroča negenotoksičen, specifičen mehanizem prek receptorjev GLP-1, za katerega so glodalci zelo občutljivi.
Combination with oral antidiabetics 
Kombinacija s peroralnimi antidiabetiki
Pharmacokinetic properties were assessed in clinical studies in the paediatric population with type 2 diabetes aged 10 years and above. 
Farmakokinetične lastnosti so ocenili v kliničnih študijah znotraj pediatrične populacije s sladkorno boleznijo tipa 2 v starosti 10 let ali več.
• If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). 
• če uporabljate insulin; zdravnik vam bo povedal, kako zmanjšate odmerek insulina, ter vam priporočil pogostejše spremljanje sladkorja v krvi, da preprečite pojav hiperglikemije (visoka raven sladkorja v krvi) in diabetične ketoacidoze (zaplet pri sladkorni bolezni, ki nastopi, ko telo zaradi pomanjkanja insulina ni sposobno razgraditi glukoze).
MACE: major adverse cardiovascular event %: proportion in percent of subjects with an event N: number of subjects 
MACE: pomembni srčno-žilni neželeni dogodki %: delež preiskovancev, ki so doživeli dogodek, v odstotkih N: število preiskovancev
Keep away from the freezer compartment. 
Ne shranjujte v bližini zamrzovalnega razdelka.
• Blood pressure and heart rate 
• Krvni tlak in srčni utrip
Both treatments resulted in mean body weight loss of approximately 3 kg. 
Pri obeh zdravljenjih se je telesna masa v povprečju zmanjšala za približno 3 kg.
This is because it may block the injection. 
S tem namreč lahko ustavite injiciranje.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
• A severe form of allergic reaction (anaphylactic reaction) with additional symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc. 
• huda oblika alergijske reakcije (anafilaktična reakcija) z dodatnimi simptomi, kot so težave z dihanjem, otekanje grla in obraza, hiter utrip srca, itd.
• Clean the pen with a cloth moistened with a mild detergent. 
• Čistite ga s krpo, navlaženo z blagim detergentom.
From clinical trials and marketed use, overdoses have been reported of up to 40 times (72 mg) the recommended maintenance dose. 
V kliničnih študijah in po prihodu zdravila na trg so poročali o prevelikih odmerjanjih zdravila, vse do 40-kratnega (72 mg) največjega priporočenega vzdrževalnega odmerka.
Primary outcome or vital status at end of trial was available for 99.7% and 99.6% of participants randomised to liraglutide and placebo, respectively. 
Primarni izid oz. vitalni status na koncu preskušanja je bil na voljo za 99,7 % preiskovancev, ki so prejemali liraglutid in 99,6 % preiskovancev, ki so prejemali placebo.
Victoza is given as an injection under the skin (subcutaneous). 
Zdravilo Victoza je namenjeno injiciranju pod kožo (subkutana uporaba).
Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Victoza is used in combination with a sulfonylurea or insulin. 
Bolnikom je treba svetovati, naj upoštevajo previdnostne ukrepe in se tako izognejo hipoglikemiji med vožnjo in upravljanjem strojev, predvsem kadar uporabljajo zdravilo Victoza skupaj s sulfonilsečnino ali insulinom.
Liraglutide is metabolised in a similar manner to large proteins without a specific organ having been identified as major route of elimination. 
Presnova liraglutida je podobna presnovi velikih beljakovin in ni nobenega določenega organa, ki bi veljal kot glavna pot izločanja.
Do not use this medicine if the solution is not clear and colourless or almost colourless. 
Tega zdravila ne uporabljajte, če raztopina ni bistra in brezbarvna ali skoraj brezbarvna.
Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues. 
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, analogi glukagonu podobnega peptida-1 (GLP-1).
Weight loss was sustained. 
Izguba telesne mase se je ohranila.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.