natgillin/translations-raw huggingface dataset:
Memantine Merz was also studied in three additional studies including a total of 1,186 patients with mild to severe disease. 
Zdravilo Memantine Merz so proučevali še v treh dodatnih študijah, ki so vključevale skupno 1 186 bolnikov z blago do hudo boleznijo.
Memantine Merz must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients. 
Zdravila Memantine Merz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) memantinijev klorid ali katero koli drugo sestavino zdravila.
The company that makes Axura has agreed that its scientific data can be used for Memantine Merz (‘informed consent'). 
Družba, ki izdeluje zdravilo Axura, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Memantine Merz („uporaba dokumentacije s soglasjem“).
In the two studies of mild to moderate disease, patients on Memantine Merz had less severe symptoms after 24 weeks, as measured on the global and cognitive scores. 
V dveh študijah blage do zmerne bolezni so imeli bolniki, ki so prejemali zdravilo Memantine Merz, po 24 tednih manj hudih simptomov, merjeno z globalnimi in kognitivnimi merili.
Memantine Merz memantine hydrochloride 
Memantine Merz memantinijev klorid
Memantine Merz is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation. 
Zdravilo Memantine Merz je na voljo tudi kot peroralna raztopina z dodano črpalko, ki dovede 5 mg memantinijevega klorida ob vsakem črpanju.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Memantine Merz. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Memantine Merz, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In the study of moderately severe to severe disease, patients taking Memantine Merz had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores. 
V študiji z bolniki z zmerno hudo do hudo boleznijo je bilo po 28 tednih pri bolnikih, ki so jemali zdravilo Memantine Merz, ugotovljenih manj simptomov kot pri bolnikih, ki so jemali placebo, merjeno z globalnimi in funkcionalnimi merili.
Other information about Memantine Merz 
Druge informacije o zdravilu Memantine Merz
What benefit has Memantine Merz shown during the studies? 
Kakšne koristi je zdravilo Memantine Merz izkazalo med študijami?
Memantine Merz is a medicine that contains the active substance memantine hydrochloride. 
Memantine Merz je zdravilo, ki vsebuje zdravilno učinkovino memantinijev klorid.
For the full list of all side effects reported with Memantine Merz, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Memantine Merz, glejte navodilo za uporabo.
The active substance in Memantine Merz, memantine hydrochloride, is an antidementia medicine. 
Zdravilna učinkovina zdravila Memantine Merz, memantinijev klorid, je zdravilo za zdravljenje demence.
What is the risk associated with Memantine Merz? 
Kakšna tveganja so povezana z zdravilom Memantine Merz?
Why has Memantine Merz been approved? 
Zakaj je bilo zdravilo Memantine Merz odobreno?
What is Memantine Merz? 
Kaj je zdravilo Memantine Merz?
What is Memantine Merz used for? 
Za kaj se zdravilo Memantine Merz uporablja?
How has Memantine Merz been studied? 
Kako je bilo zdravilo Memantine Merz raziskano?
How does Memantine Merz work? 
Kako zdravilo Memantine Merz deluje?
How is Memantine Merz used? 
Kako se zdravilo Memantine Merz uporablja?
Most of them occurred during the first months of treatment. 
Večinoma so se pojavili v prvih nekaj mesecih zdravljenja.
Patients with such form of the disease may derive less benefit from treatment. 
Bolniki s tovrstno obliko bolezni imajo od zdravljenja manjšo korist.
Diacerein is not recommended in patients older than 65 years. 
Diacereina ne priporočamo bolnikom, starejšim od 65 let.
The capsules must be swallowed intact, without opening them, together with a glass of water. 
Kapsule je treba pogoltniti cele, ne da bi jih odpirali, skupaj s kozarcem vode.
As some patients may experience loose stools or diarrhoea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily. 
Ker imajo lahko nekateri bolniki mehko blato ali drisko, je priporočeni začetni odmerek prva dva do štiri tedne zdravljenja 50 mg enkrat dnevno z večernim obrokom, nato je priporočeni odmerek 50 mg dvakrat dnevno.
As a rule, these effects abate with continuing treatment. 
Praviloma ti učinki z nadaljevanjem zdravljenja izzvenijo.
How to take [Invented Name] 
Kako jemati zdravilo [izmišljeno ime]
The treatment should be taken with food, one with breakfast and the other with evening meal. 
Zdravilo je treba jemati s hrano, prvi odmerek z zajtrkom in drugega z večernim obrokom.
• Current and/or history of liver disease 
• Trenutna jetrna bolezen in/ali jetrna bolezen v anamnezi
Your doctor may ask you to undergo blood tests to check your liver function. 
Zdravnik vas bo morda napotil na krvne preiskave, s katerimi bo preveril delovanje jeter.
From post-marketing surveillance 
Podatki iz obdobja spremljanja po pridobitvi dovoljenja za promet
[The dose recommendation for adults should be as follows] 
Odmerjanje [Priporočeno odmerjanje za odrasle mora biti, kot sledi]
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets 
Priloga III Spremembe relevantnih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo
Intake of diacerein frequently leads to diarrhoea (see section 4.8) that can consequently lead to dehydration and hypokalaemia. 
Jemanje diacereina pogosto povzroči drisko (glejte poglavje 4.8), kar lahko privede do dehidracije in hipokaliemije.
What you need to know before you take [Invented Name] Do not take [Invented Name]: [The following contraindication should be added here and replace any existing wording on hepatic insufficiency] 
Kaj morate vedeti, preden boste vzeli zdravilo [izmišljeno ime] Ne jemljite zdravila [izmišljeno ime]: [Tu je treba dodati naslednje kontraindikacije, ki morajo nadomestiti obstoječe besedilo o jetrni insuficienci]
4.1 Therapeutic indications [This section should be read as follows] 
4.1 Terapevtske indikacije [To poglavje se mora glasiti, kot sledi]
Treatment of symptoms in patients with osteoarthritis of the hip or knee, with delayed effect. 
Zdravljenje simptomov pri bolnikih z osteoartritisom kolka ali kolena z zapoznelim učinkom.
In some cases, diarrhoea was severe with complications such as dehydration and disorders of fluid and electrolyte balance. 
V nekaterih primerih je bila driska huda, z zapleti, kot so dehidracija in motnje ravnovesja tekočin in elektrolitov.
Treatment with [Invented Name] is therefore not recommended for a specific form of hip osteoarthritis called rapidly progressive (worsening) hip osteoarthritis. 
Zdravljenja z zdravilom [izmišljeno ime] zato ne priporočamo pri posebni obliki osteoartritisa kolka, ki se imenuje hitro napredujoči osteoartritis kolka.
Before treatment with diacerein is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease. 
Pred uvedbo zdravljenja z diacereinom je treba bolnika izprašati o morebitnih soobolevnostih in preteklih ali trenutnih jetrnih boleznih ter preveriti prisotnost večjih vzrokov za aktivno jetrno bolezen.
If you have diarrhoea while taking this medicine, stop taking [Invented Name] and contact your doctor to discuss which other treatments you can take. 
Če imate po jemanju zdravila [izmišljeno ime] drisko, ga prenehajte jemati in se posvetujte z zdravnikom glede drugih zdravil, ki jih lahko jemljete.
4.4 Special warnings and precautions for use [The wording on diarrhoea and hepatotoxicity in this section should be presented and read as follows] 
4.4 Posebna opozorila in previdnostni ukrepi [Besedilo o driski in hepatotoksičnosti v tem poglavju se mora glasiti, kot sledi]
It takes some time for [Invented Name] to have its effect. 
Da zdravilo [izmišljeno ime] začne učinkovati, traja nekaj časa.
Intake of diacerein can lead to diarrhoea and hypokalaemia. 
Jemanje diacereina lahko povzroči drisko in hipokaliemijo.
Tell your doctor immediately if you have abdominal pain, jaundice (yellow discolouration of the eyes or skin), impaired consciousness or itching of the skin, as these may indicate serious conditions such as liver disease. 
Če imate trebušne bolečine, zlatenico (rumeno obarvanje oči ali kože), motnje zavesti ali vas srbi koža, se takoj posvetujte z zdravnikom, saj ti znaki lahko kažejo na resno stanje, kot je jetrna bolezen.
[The following wording should also be reflected in this section] Diacerein is not recommended in patients older than 65 years. 
[Tudi spodnje besedilo je treba vnesti v to poglavje] Diacerein se ne priporoča pri bolnikih, starejših od 65 let.
Treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein. 
Zdravljenje z diacereinom ni priporočljivo pri bolnikih s hitro napredujočim osteoartritisom kolka, saj je njihov odziv na diacerein lahko slabši.
Patients should be monitored for signs and symptoms of hepatic injury (see section 4.4). 
Pri bolnikih je treba spremljati pojav znakov in simptomov jetrne poškodbe (glejte poglavje 4.4.)
A diagnosis of liver disease is a contraindication to diacerein use (see section 4.3). 
Diagnoza jetrne bolezni je kontraindikacija za uporabo diacereina (glejte poglavje 4.3).
[The following contraindication should be added in this section and replace any existing wording on hepatic insufficiency] 
[V to poglavje je treba dodati naslednje kontraindikacije, ki morajo nadomestiti obstoječe besedilo o jetrni insuficienci]
• if you have any liver problems or a history of liver problems 
• če imate ali ste v preteklosti imeli težave z jetri
Patients should be advised about the signs and symptoms of hepatotoxicity and must be advised to immediately contact their physician in case of appearance of symptoms suggestive of liver damage. 
Bolnike je treba poučiti o znakih in simptomih hepatotoksičnosti ter jim naročiti, naj se ob pojavu simptomov, ki kažejo na jetrno bolezen, takoj obrnejo na zdravnika.
Uncommon (≥ 1/1000 and < 1/100): Cases of elevated hepatic enzymes in serum. 
BOLEZNI JETER, ŽOLČNIKA IN ŽOLČEVODOV Občasni (≥ 1/1000 do < 1/100): primeri zvišanih vrednosti jetrnih encimov v serumu.
Very common (> 1/10): diarrhoea, abdominal pain. 
Zelo pogosti (> 1/10): driska, trebušna bolečina.
Patients should be advised to limit their alcohol intake while on treatment with diacerein. 
Bolnikom je treba svetovati, da med zdravljenjem z diacereinom omejijo uživanje alkohola.
Particular caution should also be exercised in case of hypokalaemia in patients treated with cardiac glycosides (digitoxin, digoxin) (see section 4.5). 
Previdnost je še zlasti potrebna v primeru hipokaliemije pri bolnikih, ki se zdravijo s srčnimi glikozidi (digitoksinom, digoksinom) - glejte poglavje 4.5.
Caution must be exercised in the concomitant administration of diuretics (high-ceiling loop and thiazides) and/or cardiac glycosides (digitoxin, digoxin), as the risk of arrhythmia is increased (see section 4.4). 
Pri sočasnem jemanju diuretikov (diuretikov vhodnega kraka Henlejeve zanke in tiazidov) in/ali srčnih glikozidov (digitoksina, digoksina) je potrebna previdnost, saj se poveča tveganje za aritmijo (glejte poglavje 4.4).
[The following wording should also be reflected in this section] 
[Spodnje besedilo je treba prav tako vnesti v to poglavje]
[The following wording should be reflected in this section] It is recommended that you start treatment with one capsule in the evening for the first 2-4 weeks, after which the dose can be increased to two capsules per day. 
Priporočamo, da zdravljenje pričnete z eno kapsulo zvečer, kar naj traja prva dva do štiri tedne.
Some patients may experience loose stools or diarrhoea after the intake of [Invented Name]. 
Nekateri bolniki imajo po jemanju zdravila [izmišljeno ime] mehko blato ali drisko.
Common (> 1/100 and < 1/10): frequent bowel movements, flatulence. 
Pogosti (> 1/100 do < 1/10): pogosto odvajanje blata, flatulenca.
[The following side effects should be inserted in this paragraph] Common side effects (may affect up to 1 in 10 people treated): - frequent bowel movements, - flatulence - pruritus (itching), rash, eczema (itchy, red rash). 
[V ta odstavek je treba vnesti naslednje neželene učinke] Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 zdravljenih bolnikov): - pogosto odvajanje blata, - napihnjenost, - pruritus (srbečica), izpuščaj, ekcem (srbeč, rdeč izpuščaj).
Caution should be exercised in patients receiving diuretics, because dehydration and hypokalaemia may occur. 
Pri bolnikih, ki jemljejo diuretike, je zaradi morebitnega pojava dehidracije in hipokaliemije potrebna previdnost.
[The following side effects should be inserted in this paragraph] Very common side effects (may affect more than 1 in 10 people treated): - diarrhoea, - abdominal pain 
[V ta odstavek je treba vnesti naslednje neželene učinke] Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 zdravljenih bolnikov): - driska, - trebušna bolečina.
Patients should be advised to stop diacerein treatment in case of diarrhoea and contact their physician to discuss treatment alternatives. 
Bolnikom je treba svetovati, naj v primeru driske zdravljenje z diacereinom prekinejo in se obrnejo na zdravnika ter se z njim pogovorijo o drugih možnostih zdravljenja.
The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate 
Nacionalni pristojni organi bodo morda morali v sodelovanju z zadevno državo članico posodobiti spremembe povzetka glavnih značilnosti zdravila in navodil za uporabo.
[In addition, any existing dose recommendation for patients with hepatic impairment should be deleted from this section as diacerein is now contraindicated in patients with liver disease.] 
[Poleg tega je treba iz tega poglavja izbrisati vsako priporočilo glede odmerka za bolnike z jetrno okvaro, saj je diacerein zdaj kontraindiciran pri bolnikih z jetrno boleznijo.]
What [Invented Name] is and what it is used for [This section should be read as follows] [Invented Name] contains diacerein and is used to relieve symptoms of osteoarthritis of the hip or knee. 
Zdravilo [izmišljeno ime] vsebuje diacerein in se uporablja za lajšanje simptomov osteoartritisa kolka ali kolena.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 
BOLEZNI JETER, ŽOLČNIKA IN ŽOLČEVODOV
You should not take laxatives during your treatment with [Invented Name]. 
Med zdravljenjem z zdravilom [izmišljeno ime] ne jemljite odvajal.
[In addition, any existing dose recommendation in case of hepatic impairment should be deleted from this section as diacerein is now contraindicated in patients with liver disease.] 
[Iz tega poglavja je treba izbrisati tudi vsako priporočilo glede odmerka v primeru jetrne okvare, saj je diacerein zdaj kontraindiciran pri bolnikih z jetrno boleznijo.]
Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase (see section 4.8). 
Pri jemanju diacereina v obdobju po pridobitvi dovoljenja za promet so poročali o povišanih vrednostih jetrnih encimov v serumu in akutnih simptomatskih poškodbah jeter (glejte poglavje 4.8).
Concomitant intake of laxatives should be avoided. 
Izogibati se je treba sočasnemu jemanju odvajal.
[Invented Name] with food, drink and alcohol [The following wording should be reflected in this section] Drinking alcohol while taking [Invented Name] may increase the risk of liver damage. 
Zdravilo [izmišljeno ime] skupaj s hrano, pijačo in alkoholom [Spodnje besedilo je treba vnesti v to poglavje]
Posology 
Driska
Other medicines and [Invented Name] [The following wording should be reflected in this section] Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Common (> 1/100 and < 1/10): pruritus, rash, eczema. 
BOLEZNI KOŽE IN PODKOŽJA Pogosti (> 1/100 do < 1/10): pruritus, izpuščaj, ekcem.
[The following wording should be reflected in this section] In some cases, diarrhoea can be severe with life threatening complications such as fluid loss and electrolyte disturbances. 
V nekaterih primerih je driska lahko huda, pride lahko do življenjsko nevarnih zapletov, kot so izguba tekočine in motnje elektrolitov.
Liver problems including raised liver enzymes in the blood and hepatitis (inflammation in the liver) have been reported in some patients taking diacerein. 
Pri nekaterih bolnikih, ki so jemali diacerein, poročajo o težavah z jetri, vključno s povišanimi vrednostmi jetrnih encimov v krvi in hepatitisu (vnetju jeter).
Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported in the post-marketing phase with diacerein. 
Iz obdobja po pridobitvi dovoljenja za promet z diacereinom poročajo o primerih akutne jetrne poškodbe, vključno s povišanimi vrednostmi jetrnih encimov v serumu, in primerih hepatitisa.
You should limit your alcohol consumption while you are undergoing treatment with [Invented Name]. 
Med zdravljenjem z zdravilom [izmišljeno ime] omejite pitje alkohola.
Talk to your doctor before taking [Invented Name] if you have ever suffered from liver disease. 
Če ste kadar koli imeli jetrno bolezen, se pred začetkom jemanja zdravila [izmišljeno ime] posvetujte z zdravnikom.
Treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected. 
Če se zvišajo vrednosti jetrnih encimov oziroma če odkrijete znake ali simptome jetrne poškodbe, je treba zdravljenje z diacereinom prekiniti.
Warnings and precautions [The following wording should be reflected in this section] 
Druga zdravila in zdravilo [izmišljeno ime] [Spodnje besedilo je treba vnesti v to poglavje]
Diarrhoea 
BOLEZNI PREBAVIL
[The following side effects should be inserted in this paragraph] Uncommon side effects (may affect up to 1 in 100 people): 
[V ta odstavek je treba vnesti naslednje neželene učinke] Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - povišane vrednosti jetrnih encimov v krvnih preiskavah.
Signs of hepatic injury should be monitored and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury. 
Če se diacerein uporablja sočasno z drugimi zdravili, povezanimi z jetrnimi poškodbami, je potrebno spremljanje znakov jetrne poškodbe ter previdnost.
Content Pack Size 
4 napolnjene brizge + 4 igle
Responses were maintained on average for around 14 months. 
Odzivi so bili v povprečju ohranjeni približno 14 mesecev.
Further information on Alunbrig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Alunbrig. 
Nadaljnje informacije o zdravilu Alunbrig so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Alunbrig.
The medicine is available as tablets (30 mg, 90 mg and 180 mg). 
Zdravilo je na voljo v obliki tablet (30 mg, 90 mg in 180 mg).
Treatment can continue for as long as the patient benefits from it. 
Zdravljenje se nadaljuje tako dolgo, dokler je za bolnika koristno.
The European Medicines Agency decided that Alunbrig'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 Alunbrig večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The most common side effects with Alunbrig (which may affect more than 1 in 4 people) are hyperglycaemia (high blood sugar levels), hyperinsulinaemia (high blood insulin levels), anaemia (low red blood cell counts), nausea (feeling sick), low white blood cell counts including decreased levels of the white blood cells called lymphocytes, diarrhoea, tiredness, cough, headache, hypophosphataemia (low blood levels of phosphates), rash, vomiting, dyspnoea (difficulty breathing), hypertension (high blood pressure), myalgia (muscle pain), peripheral neuropathy (damage to the nerves in the extremities) and blood test results indicating abnormalities of liver (increased levels of ALT and AST and alkaline phosphatase), pancreas (increased lipase and amylase), muscle function (increased CPK) or blood clotting (increased APTT). 
Najpogostejši neželeni učinki zdravila Alunbrig (ki se lahko pojavijo pri več kot 1 od 4 bolnikov) so hiperglikemija (visoka raven sladkorja v krvi), hiperinzulinemija (visoka raven inzulina v krvi), anemija (nizko število rdečih krvničk), navzeja (siljenje na bruhanje), nizko število belih krvničk, vključno z zmanjšanim številom belih krvnih celic, imenovanih limfociti, driska, utrujenost, kašelj, glavobol, hipofosfatemija (nizka reven fosfatov v krvi), izpuščaj, bruhanje, dispneja (oteženo dihanje), hipertenzija (visok krvni tlak), mialgija (bolečine v mišicah), periferna nevropatija (poškodba živcev v okončinah) in rezultati krvnih preiskav, ki nakazujejo na nepravilnosti jeter (povečane vrednosti ALT in AST in alkalne fosfataze), trebušne slinavke (povečanje lipaze in amilaze), delovanja mišic (povišana raven CPK) ali strjevanja krvi (povečane vrednosti APTT).
The recommended starting dose is 90 mg taken once a day for the first 7 days and then increased to 180 mg once a day afterwards. 
Priporočeni začetni odmerek je 90 mg enkrat na dan v prvih sedmih dneh in nato 180 mg na dan.
What measures are being taken to ensure the safe and effective use of Alunbrig? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alunbrig?
Out of patients who received 90 mg Alunbrig a day and increased to 180 mg after 7 days, around 56% showed a complete or partial response to the medicine. 
Med bolniki, ki so prejeli 90-miligramski odmerek zdravila Alunbrig na dan, ki je bil po sedmih dneh povišan na 180 mg na dan, je pri 56 % prišlo do popolnega ali delnega odziva na zdravilo.
As for all medicines, data on the use of Alunbrig are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Alunbrig stalno spremljajo.
Other information about Alunbrig 
Druge informacije o zdravilu Alunbrig
Once appropriate measures are taken to manage the potentially serious side effect of lung disease, the safety profile of Alunbrig is considered manageable. 
Po sprejemu ustreznih ukrepov za obvladovanje potencialno resnega neželenega učinka bolezni pljuč velja varnostni profil zdravila Alunbrig za obvladljivega.
Patients with severely reduced kidney function should be closely monitored especially during the first week of treatment for symptoms of lung disease such as cough or difficulty breathing. 
Bolnike z močno okvarjenim delovanjem jeter je treba skrbno spremljati med prvim tednom zdravljenja glede znakov bolezni pljuč, kot je kašelj in težave z dihanjem.
Why is Alunbrig authorised in the EU? 
Zakaj je zdravilo Alunbrig odobreno v EU?
An overview of Alunbrig and why it is authorised in the EU 
Pregled zdravila Alunbrig in zakaj je odobreno v EU
Side effects reported with Alunbrig are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Alunbrig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.