FrancophonIA/ELRC3.0 huggingface dataset:
English: ** M-H test: Discontinuations or virological failure considered as failures.
Slovenian: ** M-H test: prekinitve zdravljenja ali virološki neuspehi smatrani kot neuspehi.
English: Patients with liver disease
Slovenian: Bolniki z jetrno boleznijo
English: Push the needle into the skin at a 45-degree angle.
Slovenian: Potisnite injekcijsko iglo v kožo pod kotom 45 stopinj.
English: % of Event comprising Grade 4 reactions
Slovenian: % dogodkov, ki predstavljajo reakcije 4.
English: Less than 13% of the dose was removed during haemodialysis.
Slovenian: Med hemodializo se je odstranilo manj kot 13 % odmerka.
English: The geometric mean changes ranged from 15.2 fold for V38M to 41.6 fold for V38A.
Slovenian: Geometrična sredina sprememb je bila v razponu od 15,2-krat za V38M do 41,6-krat za V38A.
English: Malta (See Ireland)
Slovenian: (See Ireland)
English: gGrade 3= > 3 cm but ≤ 5 cm; Grade 4= > 5 cm.
Slovenian: gStopnja 3 = > 3 cm, toda ≤ 5 cm; stopnja 4 = > 5 cm.
English: Subgroups
Slovenian: Podskupine
English: If not, store in a refrigerator and use within 24 hours.
Slovenian: Če ga ne, ga shranite v hladilnik in uporabite v 24 urah.
English: % of Event comprising Grade 3 reactions
Slovenian: % dogodkov, ki predstavljajo reakcije 3.
English: Other medicines and Fuzeon
Slovenian: Druga zdravila in zdravilo Fuzeon
English: Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 3).
Slovenian: Reakcije na mestu injiciranja so bile najpogostejši neželeni učinek, o katerem so poročali in so se pojavile pri 98 % bolnikov (preglednica 3).
English: Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)
Slovenian: (Voir/siehe Belgique/Belgien)
English: Step A: Getting Started
Slovenian: Korak A: začetna priprava
English: If there is evidence of particulate matter, the vial must not be used and should be discarded or returned to the pharmacy.
Slovenian: Če so vidni delci, viale ne sme uporabiti in jo mora zavreči ali vrniti v lekarno.
English: • shaking (tremor)
Slovenian: • tresenje (tremor),
English: • Do not inject into areas that could become irritated by your belt or the waistline of your clothes.
Slovenian: • Ne injicirajte v mesta, ki jih lahko draži vaš pas ali rob vaših oblačil.
English: He did not experience an adverse reaction as a result.
Slovenian: Posledično ni občutil nobenih neželenih učinkov.
English: How much to use
Slovenian: Koliko zdravila uporabiti
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Slovenian: V skladu z nacionalnimi smernicami je treba sprejeti previdnostne ukrepe za preprečevanje prenosa.
English: fGrade 3= refractory to topical treatment or requiring oral or parenteral treatment; Grade 4= not defined.
Slovenian: fStopnja 3 = refraktarno za lokalno zdravljenje, ali ki zahteva peroralno ali parenteralno zdravljenje; stopnja 4 = ni definirano.
English: This may feel like lumps under the skin.
Slovenian: To lahko občutite kot podkožne grudice.
English: As with other antiretrovirals, enfuvirtide should optimally be combined with other antiretrovirals to which the patient's virus is sensitive (see section 5.1).
Slovenian: Kot velja za druga protiretrovirusna zdravila, enfuvirtid optimalno kombiniramo z drugimi protiretrovirusnimi zdravili, za katere je bolnikov virus občutljiv (glejte poglavje 5.1).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: This metabolite is detected in human plasma following administration of enfuvirtide, with an AUC ranging from 2.4 to 15% of the enfuvirtide AUC.
Slovenian: Presnovek zaznamo v človeški plazmi po dajanju enfuvirtida, z AUC v obsegu od 2,4 do 15 % AUC enfuvirtida.
English: If you forget to use Fuzeon
Slovenian: Če ste pozabili uporabiti zdravilo Fuzeon
English: ● Never use or share used needles.
Slovenian: ● Nikoli ne uporabite ali delite že uporabljenih igel.
English: No case of overdose has been reported.
Slovenian: Ni poročil o primerih prevelikega odmerjanja.
English: The resistance to influenza and streptococcal infection in rats was only weakly compromised.
Slovenian: Odpornost proti gripi in okužbi s streptokoki je bila pri podganah le malo zmanjšana.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Slovenian: Če opazite kakršne koli simptome okužbe ali druge simptome, na primer mišično oslabelost, oslabelost, ki se najprej pojavi v dlaneh in stopalih in nato širi proti trupu, palpitacije, tremor ali hiperaktivnost zaradi potrebnega zdravljenja, nemudoma obvestite zdravnika.
English: This side effect is rare (affects less than 1 in 1,000 people).
Slovenian: Ta neželeni učinek je redek (pojavi se pri manj kot 1 od 1.000 bolnikov).
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost in dojenje • Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: In an Early Access Program study, one patient was administered 180 mg of Fuzeon as a single dose on one occasion.
Slovenian: V študijah programa predhodne dostopnosti (Early Access Program study) je en bolnik enkrat prejel 180 mg zdravila Fuzeon v enkratnem odmerku.
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
English: 1 copies/ml
Slovenian: kopij/ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/252/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/252/001
English: This is attached to the needle and covers it after use to lower the risk of the needle accidently pricking another person.
Slovenian: Pripomoček je pritrjen na iglo in jo po uporabi pokrije ter s tem zmanjša tveganje, da bi se kdo drug po nesreči zbodel.
English: There you will find instructions on how to prepare Fuzeon and how to give yourself an injection.
Slovenian: Tam boste našli navodila, kako pripraviti zdravilo Fuzeon in kako si dati injekcijo.
English: Discontinued due to other reasons†φ§
Slovenian: 4 % ni na voljo prekinitev zaradi drugih vzrokov †φ§
English: • you have chronic hepatitis B or C or another liver disease - you are more likely to get serious liver problems while using this medicine
Slovenian: • imate kronični hepatitis B ali C ali drugo jetrno bolezen - obstaja večja verjetnost, da se ob jemanju tega zdravila pojavijo resne težave z jetri.
English: If it is not used straight away it must be stored in a refrigerator (2°C - 8°C) and used within 24 hours.
Slovenian: Če je ne uporabite takoj, jo shranite v hladilniku (2 °C - 8 °C) in uporabite v 24 urah.
English: After pulling out the needle
Slovenian: Ko ste izvlekli iglo
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Študije o vplivu na sposobnost vožnje in upravljanja strojev niso bile izvedene.
English: If you are preparing both of your daily doses at one time, make sure to use new syringes, Water for Injections, and Fuzeon for each dose.
Slovenian: Če sočasno pripravljate oba dnevna odmerka, poskrbite, da za vsak odmerek uporabite novo injekcijsko brizgo, novo vodo za injekcije in novo zdravilo Fuzeon.
English: This injects the air.
Slovenian: Tako iztisnete zrak.
English: These substitutions were correlated with varying levels of reduced enfuvirtide susceptibility in HIV sitedirected mutants.
Slovenian: Te substitucije so bile korelirane z različnimi stopnjami zmanjšane dovzetnosti za enfuvirtid v lokacijsko usmerjenih mutantah HIV.
English: • Do not breast-feed if you have HIV because HIV may be passed on to the baby.
Slovenian: • Če ste okuženi z virusom HIV, ne smete dojiti, saj se lahko virus HIV prenese na otroka.
English: Gender and Weight: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is 20% lower in females than males irrespective of weight and is increased with increased body weight irrespective of gender (20% higher in a 100 kg and 20% lower in a 40 kg body weight patient relative to a 70 kg reference patient).
Slovenian: Spol in telesna masa: analiza podatkov o plazemskih koncentracijah pri bolnikih v kliničnih preskušanjih je pokazala, da je očistek enfuvirtida ne glede na telesno maso 20 % nižji pri ženskah v primerjavi z moškimi in poraste s povečanjem telesne mase ne glede na spol (20 % višji pri bolniku s telesno maso 100 kg in 20 % nižji pri bolniku s telesno maso 40 kg v primerjavi z referenčnim bolnikom s telesno maso 70 kg).
English: Risk factors that may predict the occurrence or severity of hypersensitivity to enfuvirtide have not been identified.
Slovenian: Dejavniki tveganja, na osnovi katerih bi lahko predvideli pojav ali resnost preobčutljivosti za enfuvirtid, niso bili določeni.
English:  Risk factors for developing this disease include: how long you have been taking anti-HIV medicines, whether you take corticosteroids, how much alcohol you drink, how well your immune system works and being overweight.
Slovenian: • Dejavniki tveganja za pojav te bolezni vključujejo: čas jemanja zdravil proti virusu HIV, jemanje kortikosteroidov, količino zaužitega alkohola, kako dobro deluje vaš imunski sistem in če imate preveliko telesno maso.
English: The addition of Fuzeon to background antiretroviral therapy generally did not increase the frequency or severity of most adverse reactions.
Slovenian: Dodatek zdravila Fuzeon temeljnemu protiretrovirusnemu zdravljenju v splošnem ni povečal pogostnosti ali resnosti večine neželenih učinkov.
English: ● Never mix your medicine with tap water.
Slovenian: ● Svojega zdravila nikoli ne mešajte z vodo iz pipe.
English: After reconstitution: Store in a refrigerator (2°C - 8°C).
Slovenian: Po rekonstituciji shranjujte v hladilniku (2-8 °C).
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Slovenian: Med jemanjem tega zdravila okužbo z virusom HIV še vedno lahko prenesete na drugo osebo, čeprav je tveganje zmanjšano z učinkovitim protiretrovirusnim zdravljenjem.
English: Elderly: There is no experience in patients > 65 years old.
Slovenian: Starejši: pri bolnikih, starejših od 65 let, ni izkušenj.
English: Slowly pull back the plunger until the water reaches the 1.1 ml mark.
Slovenian: Počasi izvlecite bat, dokler voda ne doseže oznake 1,1 ml.
English: The relationship of these substitutions to in vivo effectiveness of enfuvirtide has not been established.
Slovenian: Razmerje teh substitucij do in vivo učinkovitosti enfuvirtida ni bilo ugotovljeno.
English: Bone disease (osteonecrosis)
Slovenian: Bolezni kosti (osteonekroza)
English: Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.
Slovenian: Zdravilo Fuzeon naj predpisujejo zdravniki z izkušnjami pri zdravljenju okužbe s HIV.
English: When to have someone to help you
Slovenian: Če potrebujete pomoč,
English: In these the addition of Fuzeon did not increase the incidence of hepatic events.
Slovenian: Pri njih dodatek zdravila Fuzeon ni povečal pojavnosti jetrnih dogodkov.
English: Conversely, mutations in aa 36-45 of gp41 which give resistance to enfuvirtide would not be expected to give cross resistance to other classes of antiretrovirals.
Slovenian: Nasprotno se za mutacije v AK 36-45 glikoproteina 41, ki dajejo odpornost proti enfuvirtidu, ne bi pričakovalo, da bi dale navzkrižno odpornost proti drugim razredom protiretrovirusnih učinkovin.
English: If this happens, your blood levels of virus may begin to rise.
Slovenian: Če se bo to zgodilo, bodo koncentracije virusa v krvi ponovno pričele rasti.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Slovenian: Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se jim pojavijo bolečine v sklepih, togost sklepov ali težave z gibljivostjo.
English: In vitro human microsomal studies and in in vivo studies indicate that enfuvirtide is not an inhibitor of CYP450 enzymes.
Slovenian: In vitro mikrosomalne študije pri ljudeh ter in vivo študije kažejo, da enfuvirtid ni zaviralec encimov CYP450.
English: Paediatric population: The pharmacokinetics of enfuvirtide have been studied in 37 paediatric patients.
Slovenian: Pediatrična populacija: farmakokinetiko enfuvirtida so proučevali pri 37 pediatričnih bolnikih.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: Studies in guinea pigs indicated a potential for enfuvirtide to produce delayed contact hypersensitivity.
Slovenian: Študije na morskih prašičkih so pokazale, da enfuvirtid lahko povzroči pozno kontaktno preobčutljivost.
English: The injection should be given at a site different from the preceding injection site and where there is no current injection site reaction.
Slovenian: Injiciramo drugam, kot je bila dana prejšnja injekcija, in na mesto, kjer trenutno ni reakcije po injiciranju.
English: Other PK studies suggest no difference between Asians and Caucasians after adjusting exposure for body weight.
Slovenian: Druge farmakokinetične študije ne kažejo razlik med Azijci in belci po prilagajanju telesne mase.
English: Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV.
Slovenian: Kdaj naj se uporablja zdravilo Fuzeon Zdravilo Fuzeon uporabljamo za zdravljenje virusa humane imunske pomanjkljivosti (HIV) - v kombinaciji z drugimi protiretrovirusnimi zdravili pri bolnikih, ki so okuženi z virusom HIV.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Slovenian: Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
English: Where available, resistance testing may be appropriate (see sections 4.4 and 5.1).
Slovenian: Če je mogoče, lahko testiramo rezistenco (glejte poglavji 4.4 in 5.1).
English: If you need help, ask your partner, a friend, or a family member.
Slovenian: prosite vašega partnerja, prijatelja ali sorodnika.
English: What Fuzeon is and what it is used for What you need to know before you use Fuzeon How to use Fuzeon
Slovenian: Kaj je zdravilo Fuzeon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Fuzeon Kako jemati zdravilo Fuzeon
English: In addition there have been a small number of hypersensitivity reactions attributed to enfuvirtide and in some cases recurrence has occurred upon re-challenge (see section 4.4).
Slovenian: Prišlo je tudi do manjšega števila preobčutljivostnih reakcij, pripisanih enfuvirtidu, v nekaterih primerih se je ob ponovni uvedbi zdravila reakcija ponovila (glejte poglavje 4.4).
English: The vast majority of ISRs occurred within the first week of Fuzeon administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities.
Slovenian: Velika večina lokalnih reakcij na mestu injiciranja se je pojavila v prvem tednu dajanja zdravila Fuzeon, povezane pa so bile z blago do zmerno bolečino ali neugodjem na mestu injiciranja brez omejevanja vsakodnevnih dejavnosti.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo.
English: • You can inject into your upper arm, upper thigh or stomach area (abdomen).
Slovenian: • Injicirate lahko v zgornji del roke, zgornji del stegna ali področje trebuha (abdomna).
English: • The active substance is enfuvirtide.
Slovenian: • Učinkovina je enfuvirtid.
English: The relationship between the in vitro susceptibility of HIV-1 to enfuvirtide and inhibition of HIV-1 replication in humans has not been established.
Slovenian: Razmerje med in vitro dovzetnostjo HIV-1 za enfuvirtid in zaviranjem replikacije HIV-1 pri ljudeh ni bilo ugotovljeno.
English: A statistically significant increase was seen for pneumonia and lymphadenopathy.
Slovenian: Statistično značilno povečanje je bilo pri pljučnici in limfadenopatiji.
English: Patients should be informed that Fuzeon is not a cure for HIV-1 infection.
Slovenian: Bolnikom moramo povedati, da zdravilo Fuzeon ne ozdravi okužbe z virusom HIV-1.
English: Mothers should be instructed not to breast-feed if they are receiving enfuvirtide because of the potential for HIV transmission and any possible undesirable effects in breast-fed infants.
Slovenian: Materam, ki prejemajo enfuvirtid, moramo dojenje odsvetovati zaradi možnosti prenosa virusa HIV in drugih možnih neželenih učinkov pri dojenih dojenčkih.
English: However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped
Slovenian: Če pa je do naslednjega rednega odmerka manj kot 6 ur, potem naj izpuščenega odmerka ne vzamejo.
English: - Make sure you have 1.0 ml of liquid in the syringe (or whatever amount your doctor prescribed, if it is different).
Slovenian: • Prepričajte se, da imate v injekcijski brizgi 1,0 ml raztopine (ali drugačno prostornino, če vam je tako predpisal zdravnik).
English: Gently turn the vial upside down.
Slovenian: Nežno obrnite vialo z zgornjo stranjo navzdol.
English: 11.0 to 15.5
Slovenian: 11,0 do 15,5
English: Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals'.
Slovenian: Zdravilo Fuzeon vsebuje učinkovino enfuvirtid in spada v skupino zdravil, ki se imenujejo protiretrovirusna zdravila.
English: This is where the bone tissue dies because the blood supply has been lost (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: To je bolezen, pri kateri kostno tkivo odmre zaradi izgube prekrvitve kosti (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
English: All patients received an optimised background (OB) regimen consisting of 3 to 5 antiretroviral agents selected on the basis of the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance measurements.
Slovenian: Vsi bolniki so prejemali optimizirano temeljno zdravljenje, ki je vključevalo 3 do 5 protiretrovirusnih učinkovin, izbranih na podlagi bolnikovega predhodnega poteka zdravljenja, kot tudi izhodiščnih genotipskih in fenotipskih meritev virusne odpornosti.
English: 2 ml vial, colourless glass type 1
Slovenian: 2 ml viala, brezbarvno steklo tipa 1
English: ● When handling the syringe, do not touch the needle.
Slovenian: ● Ko držite injekcijsko brizgo, se ne dotikajte igle.
English: • If foaming happens, it may take longer for the powder to dissolve completely.
Slovenian: • Če se pojavi penjenje, lahko traja dalj časa, da se prašek popolnoma raztopi.
English: • Make sure you have 1.1 ml of Water for Injections in the syringe.
Slovenian: • Prepričajte se, da imate v injekcijski brizgi 1,1 ml vode za injekcije.
English: There were insufficient examples of multiple substitutions to determine any consistent patterns of substitutions or their effect on viral susceptibility to enfuvirtide.
Slovenian: Primeri multiplih substitucij so bili nezadostni za določitev pravilnih substitucij ali njihovih učinkov na virusno dovzetnost za enfuvirtid.
English: • Your doctor has prescribed Fuzeon to help control your HIV infection.
Slovenian: • Vaš zdravnik vam je predpisal zdravilo Fuzeon, da bi vam pomagal nadzirati vašo okužbo s
English: Solvent This medicinal product does not require any special storage conditions.
Slovenian: Vehikel Za shranjevanje zdravila niso potrebna posebna navodila.
English: In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible.
Slovenian: V primeru izpuščenega odmerka zdravila Fuzeon je treba bolnikom naročiti, naj vzamejo izpuščeni odmerek takoj ko je mogoče.
English: • hold the plastic cap under the needle protector
Slovenian: ● držite plastični pokrov pod igelno zaščito,
English: Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
Slovenian: Dogodki so vključevali osip, vročino, slabost in bruhanje, mrzlico, rigor, nizek krvni tlak in povišane serumske koncentracije jetrnih transaminaz v različnih kombinacijah in možno primarno reakcijo imunskih kompleksov,
English: The Manufacturer responsible for batch release is Roche Pharma AG
Slovenian: Izdelovalec, odgovoren za sproščanje zdravila Roche Pharma AG
English: Breast-feeding: It is not known whether enfuvirtide is secreted in human milk.
Slovenian: Dojenje: Ni znano, ali se enfuvirtid izloča v materino mleko.
English: Section 7 tells you how to prepare Fuzeon and how to give yourself an injection.
Slovenian: Poglavje 7 opisuje, kako pripraviti zdravilo Fuzeon in kako si lahko injekcijo date sami.
English: This is when your doctor may decide to no longer keep treating you with Fuzeon.
Slovenian: Takrat se bo zdravnik lahko odločil, da prekinete z zdravljenjem z zdravilom Fuzeon.
English: If the reconstituted solution cannot be injected immediately, it must be kept refrigerated until use and used within 24 hours.
Slovenian: Če pripravljene raztopine ni mogoče injicirati takoj, jo moramo do uporabe hraniti v hladilniku in uporabiti v 24 urah.
English: It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell.
Slovenian: Je zaviralec strukturnega preurejanja HIV-1 glikoproteina 41 in deluje s specifično zunajcelično vezavo na to virusno beljakovino ter tako prepreči zlitje virusne celične membrane in celične membrane tarčne celice ter onemogoči vstop virusne RNA v tarčno celico.
English: Fuzeon should be used with caution in these populations (see sections 4.2 and 5.2).
Slovenian: Zdravilo Fuzeon moramo pri teh skupinah bolnikov uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: Fuzeon helps by preventing this.
Slovenian: Zdravilo Fuzeon pomaga tako, da ta vstop prepreči.
English: 3 ml vial, colourless glass type 1
Slovenian: 3 ml viala, brezbarvno steklo tipa 1
English: When using a higher threshold for eosinophilia (>1.4 x 109/l), the patient exposure adjusted rate of eosinophilia is equal in both groups (1.8 patients with event per 100 patientyears).
Slovenian: Če upoštevamo višji prag za eozinofilijo (> 1,4 x 109/l), je bolnikovi izpostavljenosti prilagojen delež eozinofilije enak v obeh skupinah (1,8 bolnikov z dogodkom na 100 bolnikovih let).
English: Also do not use the Water for Injections if you see any particles in the vial or if the water is cloudy.
Slovenian: Prav tako ne uporabljajte vode za injekcije, če ste v viali opazili trdne delce ali če je voda motna.
English:  Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Slovenian: • Znaki osteonekroze so togost sklepa, bolečine (zlasti v kolku, kolenu in rami) in težave z gibljivostjo.