natgillin/translations-raw huggingface dataset:
If you forget to take your medicine at any time, take it as soon as you remember.
Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite.
The proportion of patients with CMV viraemia/syndrome was 13.5 %.
Delež bolnikov s sindromom CMV/viremijo je znašal 13,5 %.
Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
Zdravnik se bo z vami pogovoril o tveganjih v primeru nosečnosti in drugih zdravilih, ki jih lahko jemljete za preprečitev zavrnitve vašega presadka, če:
This medicine does not require any special storage conditions.
Zdravilo ne zahteva posebnih pogojev shranjevanja.
• rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis)
• rifampicin (antibiotik, ki se uporablja za preprečevanje in zdravljenje okužb, kot je tuberkuloza),
300 hard capsules
300 trdih kapsul
If neutropenia develops (absolute neutrophil count < 1.3 x 10
Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1,3 x 10
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy.
Priporočljivi sta dve obliki kontracepcije, ker to zmanjša tveganje nenamerne nosečnosti.
Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
Teste nosečnosti je treba ponavljati, kot je klinično primerno (npr. po kakršni koli vrzeli v kontracepciji).
Paediatric population Interaction studies have only been performed in adults.
Pediatrični bolniki Študije medsebojnega delovanja so izvedli le pri odraslih.
For contraception advice for men see section 4.6.
Za nasvete o kontracepciji za moške glejte poglavje 4.6.
• The dose given will vary depending on the size of the child.
• Dani odmerek bo odvisen od velikosti otroka.
Then continue to take it at the usual times.
Nato nadaljujte z jemanjem kot običajno.
• If this happens, wash the area thoroughly with soap and water.
• Če se to zgodi, površino temeljito sperite z milom in vodo.
Live vaccines should not be given to patients with an impaired immune response.
Živih cepiv ne smemo dajati bolnikom z oslabelim imunskim odzivom.
This effect tended to diminish with continued antibiotic use and to cease within a few days of antibiotic discontinuation.
Ta učinek je pojemal z nadaljnjo uporabo antibiotikov in prenehal v nekaj dneh po ukinitvi antibiotikov.
The following malformations were most frequently reported:
O naslednjih so poročali najpogosteje:
SPECIAL STORAGE CONDITIONS Store below 30 °C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
Myclausen should be used together with other medicines:
Zdravilo Myclausen je treba uporabljati skupaj z drugimi zdravili, kot so:
Calculations based on animal data show that the maximum amount of MPA that could potentially be transferred to woman is so low that it would be unlikely to have an effect.
Izračuni, ki temeljijo na podatkih na živalih, kažejo, da je največja količina mofetilmikofenolata, ki bi se lahko prenesla na žensko, tako nizka, da ni verjetno, da bi imela učinek.
Live vaccines
Živa cepiva
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies.
Zdravnik se bo z vami pogovoril in vam dal pisna navodila, zlasti o učinkih mofetilmikofenolata na nerojene otroke.
Store below 30 °C.
Shranjujte pri temperaturi do 30 °C.
• cholestyramine (used to treat high cholesterol)
• holestiramin (uporablja se za zdravljenje visokega holesterola),
The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung.
Tveganje za bronhiektazijo je lahko povezano s hipogamaglobulinemijo ali z neposrednim učinkom na pljuča.
Also other medicines can affect the way Myclausen works.
Prav tako lahko druga zdravila vplivajo na delovanje zdravila Myclausen.
Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Takoj obvestite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkovmorda boste potrebovali nujno medicinsko pomoč:
You may get general side effects affecting your body as a whole.
Pojavijo se lahko splošni neželeni učinki, ki prizadenejo celo telo.
There have also been reports of bronchiectasis in children and adults (frequency not known).
Poročali so o primerih bronhiektazije pri otrocih in odraslih (pogostnost ni poznana).
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
• vam je ali menite, da bi vam lahko izostala menstruacija, imate neobičajno menstrualno krvavitev ali sumite, da ste noseči;
Two complementary forms of contraception simultaneously are preferred.
Priporočljivo je hkrati uporabljati dve zanesljivi obliki kontracepcije.
• Do not take any capsules that have broken open or split.
• Ne zaužijte kapsul, ki so odprte ali poškodovane.
In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
Pri tistih primerih prevelikega odmerjanja, kjer so poročali o neželenih dogodkih, pa so ti sovpadali z znanim varnostnim profilom zdravila.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila prek nacionalnega centra za poročanje, ki je naveden v Prilogi V.
These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide synthesis in sensitive cells.
Te učinke lahko povežemo s farmakodinamičnim načinom delovanja, to je zaviranje sinteze nukleotidov v občutljivih celicah.
Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Triletni podatki o varnosti pri bolnikih z ledvičnim in srčnim presadkom ne kažejo nobenih nepričakovanih sprememb v incidenci malignosti v primerjavi z enoletnimi podatki.
• feeling anxious or depressed, changes in your mood or thoughts.
• občutek strahu ali depresija, spremembe v razpoloženju ali načinu mišljenja.
If you stop your treatment you may increase the chance of rejection of your transplanted organ.
Če prenehate z zdravljenjem, lahko povečate možnost zavrnitve vašega presadka.
What Myclausen is and what it is used for
Kaj je zdravilo Myclausen in za kaj ga uporabljamo
The antibody response to other vaccines may be diminished (see also section 4.4).
Tudi odziv protiteles na druga cepiva je lahko zmanjšan (glejte tudi poglavje 4.4).
Additional precautions
Dodatni previdnostni ukrepi
Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Resne življenjsko nevarne okužbe vključno z meningitisom, endokarditisom, tuberkulozo in atipičnimi mikobakterijskimi okužbami.
The need to plan a pregnancy will be highlighted.
Poudarjeno bo, da je nosečnost nujno načrtovati.
Urinary problems such as: • kidney problems or the urgent need to pass water (urine).
Težave s sečili, kot so: • težave z ledvicami, nujna potreba po odvajanju vode (urina).
• the amount in your blood of things like sugar, fat or cholesterol.
• količinah drugih snovi v krvi, kot so krvni sladkor, maščobe ali holesterol.
Treatment with Myclausen should be initiated and maintained by appropriately qualified transplant specialists.
Zdravljenje z zdravilom Myclausen mora vpeljati in voditi ustrezen specialist za presaditve.
• phosphate binders (used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood).
• fosfatne vezalce (jemljejo jih ljudje s kronično ledvično odpovedjo, da zmanjšajo količino fosfatov, ki se absorbirajo v kri).
The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Farmakodinamični profil in neželeni učinki, o katerih so poročali, kažejo na to, da vpliv ni verjeten.
• Ciclosporin and corticosteroids.
• ciklosporin in kortikosteroidi.
In this leaflet the shorter name Myclausen is used.
V tem navodilu se uporablja skrajšano ime Myclausen.
The information provided in this section will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy prevention measures.
Informacije v tem poglavju bodo olajšale pravilno razumevanje tveganja in utemeljile vzroke za upoštevanje ukrepov za preprečitev zanositve.
The need for subsequent pregnancy tests during treatment will also be explained.
Pojasnjena bo tudi potreba po nadaljnjih testiranjih nosečnosti med zdravljenjem.
However, at high MPAG plasma concentrations (> 100 µg/mL), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 μg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Splošen nasvet za zmanjšanje tveganja nastanka kožnega raka je, da se bolniki ne izpostavljajo soncu in UV-svetlobi brez uporabe zaščitne obleke in sončne kreme z visokim zaščitnim faktorjem.
As a result, your body will not be as good as normal at fighting infections.
Posledično se vaš organizem ne bo sposoben ubraniti okužb, kot bi se sicer.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate.
Če teh navodil ne boste popolnoma razumeli, se posvetujte s svojim zdravnikom, da vam jih bo ponovno razložil, preden boste vzeli mofetilmikofenolat.
• pneumonia, bronchitis
• pljučnica, bronhitis,
The PRAC therefore recommended to amend the product information, to update information on teratogenic effects and pregnancy as well as the contraception recommendations for male patients.
PRAC je zato priporočil spremembo informacij o zdravilu s posodobitvijo podatkov o teratogenih učinkih in nosečnosti ter priporočil o kontracepciji pri moških bolnikih.
The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals
Izobraževalno gradivo za zdravstvene delavce mora vsebovati: povzetek glavnih značilnosti zdravila, vodnik za zdravstvene delavce.
Precautions to be taken before handling or administering the medicinal product.
Previdnostni ukrepi, ki jih je treba upoštevati pred rokovanjem z zdravilom ali pred njegovim jemanjem
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).
• imate izpuščaje, otekel obraz, ustnice, jezik ali vrat ter težave z dihanjem - lahko imate resno alergijsko reakcijo na zdravilo (kot je anafilaksa, angioedem).
• gut problems including bleeding, liver problems
• težave s prebavili, vključno s krvavitvami, težave z jetri,
Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: 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).
Neželeni učinki so znotraj organskih sistemov razvrščeni po pogostnosti v naslednje skupine: 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), z neznano pogostnostjo (iz podatkov, ki so na voljo, določitev ni mogoča).
For patients, the text should be appropriately separated for men and women.
Pri slednjem mora biti besedilo ločeno za bolnike in bolnice.
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
• kratka sapa, kašelj, vzrok katerih je lahko bronhiektaza (stanje v katerem so dihalne poti nenormalno razširjene) ali fibroza pljuč (brazgotinjenje pljuč).
Non-melanoma skin carcinomas occurred in 3.6 % of patients; other types of malignancy occurred in 1.1 % of patients.
Pri 3,6 % bolnikov so opazili nemelanomski kožni rak, druge vrste malignosti pa so se pojavile pri 1,1 % bolnikov.
It is recommended, however, to administer Myclausen at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Vseeno je priporočljivo, da dajemo zdravilo Myclausen vsaj eno uro pred ali tri ure po dajanju sevelamerja, zato da zmanjšamo vpliv na absorpcijo mikofenolne kisline.
Talk to your doctor if you develop a persistent cough or breathlessness
Pogovorite se s svojim zdravnikom, če pri sebi opazite trdovratni kašelj ali zasoplost,
Norfloxacin and metronidazole
Norfloksacin in metronidazol
It is not known whether this substance is excreted in human milk.
Ni znano, ali se ta učinkovina v materino mleko izloča tudi pri ljudeh.
There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8).
Poročali so tudi o posameznih primerih intersticijske pljučne bolezni in pulmonalne fibroze, nekateri od teh so bili smrtni (glejte poglavje 4.8).
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije pri živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Limit the amount of sunlight and UV light you get.
Omejite izpostavljenost sončni svetlobi in UV-žarkom.
Heart and blood vessel problems such as: • change in blood pressure, unusual heartbeat, widening of blood vessels.
Težave s srcem in krvnimi žilami, kot so: • spremembe krvnega tlaka, nenavaden srčni utrip, razširitev krvnih žil.
It is recommended that the second test should be performed 8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two test 8 - 10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8 - 10 days later.
Če pri presaditvah od umrlih darovalcev pred začetkom zdravljenja ni mogoče opraviti dveh testov v razmiku 8-10 dni (zaradi časovnih omejitev organov za presaditev), je treba test nosečnosti opraviti neposredno pred začetkom zdravljenja, naslednji test pa 8-10 dni po prvem.
Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Telmisartan spreminja izločanje mikofenolne kisline tako, da okrepi izražanje receptorja PPAR gama (PPAR - peroxisome proliferator-activated receptor), kar posledično okrepi izražanje in aktivnost encima UGT1A9.
The educational materials should be implemented within four months after completion of this procedure and shall contain the following key elements:
Izobraževalna gradiva morajo biti implementirana v štirih mesecih po zaključku tega postopka.
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy;
Mofetilmikofenolat je močan humani teratogen s povečanim tveganjem za spontani splav in kongenitalne malformacije v primeru izpostavljenosti med nosečnostjo;
A minor acylglucuronide (AcMPAG) is also formed.
Pri tem se tvori tudi nekaj acilglukuronida (AcMPAG).
The recommended dose is 600 mg per taken twice a day.
Priporočeni odmerek je 600 mg/m dvakrat na dan.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Organi hematopoetskega in limfatičnega sistema so bili primarni organi, ki so bili prizadeti v toksikoloških študijah mofetilmikofenolata, ki so jih izvajali na podganah, miših, psih in opicah.
Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants.
O primerih hepatitisa zaradi reaktivacije hepatitisa B ali hepatitisa C so poročali pri bolnikih nosilcih, ki so bili zdravljeni z imunosupresivi.
If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Myclausen.
Če karkoli izmed naštetega velja za vas (ali ste negotovi), se nemudoma pogovorite s svojim zdravnikom, preden vzamete zdravilo Myclausen.
Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.
Zdravniki morajo zagotoviti, da bolnice, ki jemljejo mofetilmikofenolat, razumejo tveganje za škodo otroku, nujnost uporabe učinkovite kontracepcije in nujnost, da se nemudoma posvetujejo s svojim zdravnikom, če obstaja možnost, da je prišlo do zanositve.
Patients taking Myclausen should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year.
Med zdravljenjem z zdravilom Myclausen moramo napraviti preiskave celotne krvne slike enkrat na teden prvi mesec, dvakrat mesečno v drugem in tretjem mesecu in nato enkrat mesečno v prvem letu.
MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Mikofenolna kislina je močan, selektivni, nekompetitivni in reverzibilni zaviralec inozin-monofosfat-dehidrogenaze in tako zavira de novo sintezo gvanozinskih nukleotidov, brez vključevanja v DNA.
Patients will be informed that they should not stop taking mycophenolate mofetil but must contact their doctor immediately.
Bolnice bodo obveščene, da ne smejo prenehati z jemanjem mofetilmikofenolata, ampak da morajo nemudoma obvestiti zdravnika.
These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Ti so nezadostni za navodila o priporočenem odmerjanju, zato uporaba zdravila Myclausen v tej starostni skupini ni priporočljiva.
Other in vitro tests for detection of gene mutation did not demonstrate genotoxic activity.
Drugi in vitro testi za določanje genskih mutacij niso pokazali genotoksičnosti.
In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T and B lymphocytes.
V primerih trajne klinično pomembne hipogamaglobulinemije je treba razmisliti o primernem kliničnem ukrepu, upoštevajoč močan citostatični učinek, ki ga ima mikofenolna kislina na limfocite T in B.
Other medicines and Myclausen
Druga zdravila in zdravilo Myclausen
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete nosečnost, se pred jemanjem tega zdravila posvetujte z zdravnikom ali s farmacevtom.
• If you have any unexpected bruising or bleeding
• če imate kakršnekoli nepričakovane podplutbe ali krvavitve,
• Swallow your capsules whole with a glass of water.
• Pogoltnite cele kapsule s kozarcem vode.
It is recommended to monitor MPA exposure levels and to adjust Myclausen doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Priporočljivo je spremljanje ravni izpostavljenosti mikofenolni kislini in prilagoditev odmerkov zdravila Myclausen za ohranitev klinične učinkovitosti, kadar sočasno dajemo rifampicin.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Mofetilmikofenolat ni vplival na plodnost podganjih samcev pri peroralnih odmerkih do 20 mg/kg/dan.
It will explain that although this guide is very important it does not provide full information on mycophenolate mofetil and that the SmPC (healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read carefully.
Razložil bo, da kljub pomembnosti vodnika ta ne vsebuje vseh podatkov o mofetilmikofenolatu in da je zato treba natančno prebrati tudi povzetek glavnih značilnosti zdravila (za zdravstvene delavce) in navodilo za uporabo (za bolnike), ki sta priložena.
Treatment during rejection episodes
Zdravljenje med zavrnitveno reakcijo
MPA AUC values across age groups were similar in the early and late posttransplant period.
Vrednosti AUC mikofenolne kisline so bile v starostnih skupinah podobne v začetnem in poznejšem obdobju po presaditvi.
Multidrug resistance protein 1 (MDR1) is also able to transport MPA, but its contribution seems to be confined to the absorption process.
Protein za multiplo odpornost na zdravila 1 (MDR1 - Multidrug resistance protein 1) je prav tako lahko prenašalec mikofenolne kisline, vendar se zdi, da prispeva le k absorpciji.
6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
Z zdravljenjem boste nadaljevali toliko časa, kolikor bo potrebno za preprečitev zavrnitve vašega presadka.
Myclausen with food and drink Taking food and drink has no effect on your treatment with Myclausen.
Zdravilo Myclausen skupaj s hrano in pijačo Jemanje skupaj s hrano in pijačo nima učinka na zdravljenje z zdravilom Myclausen.
• tremor, muscle spasms, convulsions
• tremor, mišični krči, konvulzije,
Patients receiving Myclausen should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Bolnikom, ki prejemajo zdravilo Myclausen, je treba naročiti, da morajo takoj poročati o kakršnem koli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
Tablet core
Jedro tablet:
In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
V nekaj od teh primerov je zamenjava zdravila Mofetilmikofenolata za drugi imunosupresiv povzročila izboljšanje respiratornih simptomov.
What you need to know before you take Myclausen
Kaj morate vedeti, preden boste vzeli zdravilo Myclausen
In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12 h) of 18 % to 70 %.
Pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno dajanje mofetilmikofenolata in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0-12 h) za 18 % do 70 %.
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
V splošnem je lahko pri starejših bolnikih (starih 65 let ali več) zaradi imunosupresije nevarnost za neželene učinke povečana.
It will provide details about the nature and magnitude of the risk, in line with the information provided in the SmPC.
Opisane bodo podrobnosti o naravi in velikosti tveganja v skladu s podatki v povzetku glavnih značilnosti zdravila.