FrancophonIA/ELRC3.0 huggingface dataset:
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Tienam and associated names (see Annex I).
Slovenian: • povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v Odboru;
English: Advice to physicians was provided regarding infections suspected or proven to be due to less susceptible bacterial species (e.g. Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever), recommending treatment with 25 mg/kg every 6 hours.
Slovenian: Zdravniki so dobili nasvete v zvezi z okužbami, ki bi lahko bile ali so dokazano posledica manj občutljivih bakterijskih vrst (na primer bakterije Pseudomonas aeruginosa) in zelo hudih okužb (na primer pri nevtropeničnih bolnikih s povišano telesno temperaturo), pri čemer je bilo priporočeno zdravljenje s 25 mg/kg vsakih 6 ur.
English: 4.1.6 Bone and joint infections
Slovenian: 4.1.6 Okužbe kosti in sklepov
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 25 mg/kg administered every 6 hours.
Slovenian: Priporočljivo je, da se okužbe, ki bi lahko bile ali so dokazano posledica manj občutljivih bakterijskih vrst (na primer bakterije Pseudomonas aeruginosa) in zelo hudih okužb (na primer pri nevtropeničnih bolnikih s povišano telesno temperaturo), zdravijo z odmerkom 25 mg/kg vsakih 6 ur.
English: It is recommended that infections suspected or proven to be due to less susceptible bacterial species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic patients with a fever) should be treated with 1000 mg administered every 6 hours.
Slovenian: Priporočljivo je, da se okužbe, ki bi lahko bile ali so dokazano posledica manj občutljivih bakterijskih vrst (na primer bakterije Pseudomonas aeruginosa) in zelo hudih okužb (na primer pri nevtropeničnih bolnikih s povišano telesno temperaturo), zdravijo z odmerkom 1 000 mg vsakih 6 ur.
English: The CHMP observed that no new safety issues or increased ADRs were observed with the use of imipenem/cilastatin doses of ≥ 4 gm/day as compared to doses of <4 gm/day, based on the review of clinical trial data in the original WMA, PMS data and the literature.
Slovenian: CHMP je izpostavil, da ob pregledu podatkov kliničnih preskušanj v izvirnih dokumentih Svetovne zdravniške organizacije (WMA), študij po pridobitvi dovoljenja za promet (PMS) in literature niso bila opažena nobena nova varnostna vprašanja ali povečani neželeni učinki pri uporabi imipenema/cilastatina v odmerkih ≥ 4 g/dan v primerjavi z odmerki <4 g/dan.
English: “intra- and post-partum infections
Slovenian: „okužbe med porodom in po njem“.
English: “complicated urinary tract infections”
Slovenian: „zapletene okužbe sečil“.
English: 4.1.13 Paediatric use
Slovenian: 4.1.13 Uporaba pri otrocih
English: Then, leave the door open.
Slovenian: Nato pustite vratca odprta.
English: Swing the door to the left.
Slovenian: Zasučite vratca v levo.
English: Injection is complete when:
Slovenian: Injiciranje je končano, ko:
English: Additional environmental conditions
Slovenian: Dodatni okoljski pogoji
English: c Nominal significance.
Slovenian: c Nominalna značilnost.
English: Cumulative Incidence (%)
Slovenian: Kumulativna incidenca (%)
English: It contains electronics that should not get wet.
Slovenian: Vsebuje namreč elektroniko, ki se ne sme zmočiti.
English: Be very careful not to push out any medicine.
Slovenian: Bodite zelo previdni, da ne boste iztisnili nič zdravila.
English: The green light should now be off.
Slovenian: Zelena lučka mora biti zdaj ugasnjena.
English: Then LIFT thumb.
Slovenian: Potem DVIGNITE palec.
English: N Injection takes about 9 minutes.
Slovenian: N Injiciranje traja približno 9 minut.
English: • You can only press the start button once.
Slovenian: • Sprožilni gumb lahko pritisnete le enkrat.
English: Patient Population (N)
Slovenian: Populacija bolnikov (N)
English: A risk to breastfed newborns/infants cannot be excluded.
Slovenian: Tveganja za dojene novorojenčke/dojenčke ne moremo izključiti.
English: The recommended dose depends on the underlying condition:
Slovenian: Priporočeni odmerek je odvisen od osnovne bolezni:
English: This can dry out the medicine.
Slovenian: To lahko izsuši zdravilo.
English: Inject the entire contents.
Slovenian: Injicirajte celotno vsebino.
English: Relative humidity range is 15% to 85%.
Slovenian: Območje relativne vlažnosti je od 15 % do 85 %.
English: Sodium hydroxide (for pH adjustment)
Slovenian: Natrijev hidroksid (za prilagoditev pH)
English: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, U.S.A.
Slovenian: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, ZDA
English: If an error occurs, the automated mini-doser cannot be used.
Slovenian: Če pride do napake, avtomatskega odmernika ni mogoče uporabiti.
English: In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika zdraviti simptomatsko in uvesti podporne ukrepe, kot je potrebno.
English: You will hear a click.
Slovenian: Slišali boste klik.
English: Therefore, close monitoring may be warranted in these patients.
Slovenian: Zato je lahko pri takšnih bolnikih potreben natančen nadzor.
English: e Assessment of time to hospitalisation for unstable angina was ad-hoc.
Slovenian: e Ocena časa do hospitalizacije za nestabilno angino je bila izvedena ad-hoc.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 July 2015
Slovenian: Datum prve odobritve: 17. julij 2015
English: • Make sure you see a green, flashing status light.
Slovenian: • Poskrbite, da boste videli zeleno utripajočo lučko stanja.
English: Tell your healthcare provider if you are allergic to latex.
Slovenian: Zdravniku morate povedati, če ste alergični na lateks.
English: Type BF Applied Part
Slovenian: Aplicirani del tipa BF
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti se zdravila ne smemo mešati z drugimi zdravili.
English: D Keep PUSHING down on the skin.
Slovenian: D Še naprej PRITISKAJTE ob kožo.
English: Do not use if packaging is damaged
Slovenian: Ne uporabite, če je pakiranje poškodovano.
English: To remove:
Slovenian: Za odstranitev:
English: • You may hear beeps indicating your injection has started.
Slovenian: • Morda boste slišali piske, ki označujejo, da se je injiciranje začelo.
English: Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.
Slovenian: Potem se posvetujte z zdravnikom, ki vam bo povedal, kdaj naj uporabite naslednji odmerek; novi razpored uporabe upoštevajte natančno tako, kot vam je naročil zdravnik.
English: The exposure to evolocumab was found to be approximately 40-50% lower compared to healthy subjects.
Slovenian: Izpostavljenost evolokumabu je bila približno 40-50 % manjša kot pri zdravih osebah.
English: DO NOT use any medicine that is left in the used syringe.
Slovenian: NE UPORABITE zdravila, ki je ostalo v uporabljeni brizgi.
English: This resulted in similar time course and extent of absolute LDL-C lowering.
Slovenian: To je povzročilo podoben časovni potek in obseg absolutnega znižanja LDL-H.
English: This will make the injection more comfortable.
Slovenian: Tako bo injiciranje manj neprijetno.
English: Name and address of the manufacturer of the biological active substance Immunex Rhode Island Corporation 40 Technology Way
Slovenian: Ime in naslov izdelovalca biološke učinkovine Immunex Rhode Island Corporation 40 Technology Way
English: Rare: may affect up to 1 in 1,000 people • Swelling of the face, mouth, tongue, or throat (angioedema)
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 oseb • Otekanje obraza, ust, jezika ali grla (angioedem)
English: The mutagenic potential of evolocumab has not been evaluated.
Slovenian: Mutagenega potenciala evolokumaba niso ocenili.
English: Coronary revascularisation
Slovenian: Koronarna revaskularizacija
English: Patients at Risk
Slovenian: Bolniki, izpostavljeni tveganju
English: • The automated mini-doser contains batteries, electronics, and a needle.
Slovenian: • Avtomatski odmernik vsebuje baterije, elektroniko in iglo.
English: GRH0465 v1
Slovenian: GRH0531SL v1
English: Check that:
Slovenian: Preverite:
English: After removal, check the medicine window.
Slovenian: Po odstranitvi preverite okence zdravila.
English: For instructions on administration, see section 6.6 and the ‘Instructions for Use' provided in the carton.
Slovenian: Za navodila za dajanje zdravila glejte poglavje 6.6 in "Navodilo za uporabo", priloženo v škatli.
English: Needle inside (under cover)
Slovenian: Igla je znotraj (pod pokrovčkom)
English: C Gather all materials needed for your injection and then wash your hands thoroughly with soap and water.
Slovenian: C Pripravite vse, kar potrebujete za injiciranje, in si nato roke dobro umijte z milom in vodo.
English: At the end of the first year (week 52 in OSLER and week 48 in OSLER-2), patients entered the all Repatha period in which all patients received open-label Repatha for either another 4 years (OSLER) or 2 years (OSLER-2).
Slovenian: Ob koncu prvega leta (52. teden v študiji OSLER in 48. teden v študiji OSLER-2) so bolniki vstopili v obdobje z zdravilom Repatha za vse, med katerim so vsi bolniki odprto prejemali zdravilo Repatha ali dodatna 4 leta (OSLER) ali dodatni 2 leti (OSLER-2).
English: It is normal to see a drop of medicine at the end of the needle.
Slovenian: Normalno je, da se na koncu igle pokaže kapljica zdravila.
English: Do not put fingers into the yellow safety guard.
Slovenian: Ne segajte s prsti v rumeni varnostni ščitnik.
English: • Allergic reactions including rash
Slovenian: • Alergijske reakcije, vključno z izpuščaji
English: Important: After you load the automated mini-doser, proceed to the next step without delay.
Slovenian: Pomembno: Ko avtomatski odmernik napolnite, brez odlašanja nadaljujte z naslednjim korakom.
English: The study did not investigate the correlation between atherosclerotic disease regression and cardiovascular events.
Slovenian: Študija ni ocenjevala korelacije med regresijo aterosklerotične bolezni in srčno-žilnimi dogodki.
English: LDL-C reduction of approximately 55% to 75% was achieved with Repatha as early as week 1 and maintained during long-term therapy.
Slovenian: Znižanje LDL-H za približno 55 do 75 % je bilo z zdravilom Repatha doseženo že 1. teden in se je med dolgotrajnim zdravljenjem ohranilo.
English: The long-term safety of sustained very low levels of LDL-C (i.e. < 0.65 mmol/L [< 25 mg/dL]) has not yet been established.
Slovenian: Dolgoročna varnost trajno zelo nizkih vrednosti LDL-H (tj. < 0,65 mmol/l [< 25 mg/dl]) še ni ugotovljena.
English: Insert the needle into the skin using a 45 to 90 degree angle.
Slovenian: Zabodite iglo v kožo pod kotom 45 do 90 stopinj.
English: If the plunger did not fill the window, contact your doctor.
Slovenian: Če bat ni napolnil okenca, se posvetujte z zdravnikom.
English: A flashing green light and a click signals the injection has started.
Slovenian: Utripajoča zelena lučka in klik označujeta, da se je injiciranje začelo.
English: If the automated mini-doser is attached to your body, carefully remove it.
Slovenian: Če imate avtomatski odmernik nameščen na telo, ga previdno odstranite.
English: F Inspect medicine and syringe.
Slovenian: F Preglejte zdravilo in brizgo.
English: • Do not insert the cartridge more than 5 minutes before injection.
Slovenian: • Vložka ne vstavite več kot 5 minut pred injiciranjem.
English: Yellow safety guard
Slovenian: Rumen varnostni ščitnik
English: • Do not place the loaded automated mini-doser on your body if the red status light flashes for more than 5 seconds.
Slovenian: • Ne položite napolnjenega avtomatskega odmernika na telo, če rdeča lučka stanja utripa več kot 5
English: Use a firm and flat skin surface.
Slovenian: Uporabite trdno in ravno površino kože.
English: Elderly patients (age ≥ 65 years) No dose adjustment is necessary in elderly patients.
Slovenian: Starejši bolniki (stari ≥ 65 let) Starejšim bolnikom odmerka ni treba prilagoditi.
English: If you notice an air bubble/gap:
Slovenian: Če opazite zračni mehurček/prazen prostor:
English: Contact your doctor or pharmacist immediately.
Slovenian: Takoj se posvetujte z zdravnikom ali farmacevtom.
English: Automated mini-doser operating temperature range is 15ºC to 40ºC.
Slovenian: Temperaturno območje delovanja avtomatskega odmernika je od 15°C do 40°C.
English: Check the expiration date.
Slovenian: Preverite datum izteka roka uporabnosti.
English: Evolocumab was estimated to have an effective half-life of 11 to 17 days.
Slovenian: Ocenjeni efektivni razpolovni čas evolokumaba je od 11 do 17 dni.
English: (HMD) (combined atorvastatin groups)
Slovenian: (HMD) (združeni podatki skupin z atorvastatinom)
English: There is no specific treatment for Repatha overdose.
Slovenian: Specifičnega zdravljenja za preveliko odmerjanje zdravila Repatha ni.
English: 4.7 Effects on ability to drive and use machines Repatha has no known influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Repatha nima znanega vpliva na sposobnost vožnje in upravljanja strojev.
English: Repatha has not been tested in pregnant women.
Slovenian: Zdravilo Repatha ni preizkušeno pri nosečnicah.
English: • Flu-like symptoms
Slovenian: • Gripi podobni simptomi
English: L When the blue light flashes, the automated mini-doser is ready.
Slovenian: L Ko modra lučka utripa, je avtomatski odmernik pripravljen.
English: Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab.
Slovenian: Zdravila Repatha ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z evolokumabom.
English: Stroke (fatal/non-fatal) d
Slovenian: Možganska kap (smrtna/ne-smrtna)d
English: In clinical studies, 0.3% of patients (48 out of 17,992 patients) treated with at least one dose of Repatha tested positive for binding antibody development.
Slovenian: V kliničnih študijah je imelo 0,3 % bolnikov (48 od 17.992 bolnikov), ki so prejeli vsaj en odmerek zdravila Repatha, pozitiven izvid testiranja za ne-nevtralizacijska protitelesa.
English: If you forget to take Repatha
Slovenian: Če ste pozabili vzeti zdravilo Repatha
English: B Open the carton and peel away the white paper cover.
Slovenian: B Odprite škatlo in odlepite beli prekrivni papir.
English: Repatha is a medicine that lowers levels of 'bad' cholesterol, a type of fat, in the blood.
Slovenian: Zdravilo Repatha je zdravilo, ki znižuje "slabi" holesterol, vrsto maščobe v krvi.
English: Important: To attach the automated mini-doser securely, it is important to use a firm and flat skin surface.
Slovenian: Pomembno: Za varno namestitev avtomatskega odmernika je pomembno, da uporabite trdno in ravno površino kože.
English: It is recommended that 12 and 13 year olds are supervised by an adult when they are using the automated mini-doser.
Slovenian: Priporočljivo je, da 12- in 13-letnike pri uporabi avtomatskega odmernika nadzira odrasla oseba.
English: No time dependent changes were observed in serum concentrations over a period of 124 weeks.
Slovenian: Med obdobjem 124 tednov niso opažali od časa odvisnih sprememb v koncentraciji v serumu.
English: 4.5 Interaction with other medicinal products and other forms of interaction No formal drug-drug interaction studies have been conducted for Repatha.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja zdravil z zdravilom Repatha niso izvedli.
English: Population pharmacokinetic analyses suggest that no dose adjustments are necessary for age, race or gender.
Slovenian: Populacijske farmakokinetična analize kažejo, da odmerka ni treba prilagoditi glede na starost, raso ali spol.
English: If you use more Repatha than you should
Slovenian: Če ste uporabili večji odmerek zdravila Repatha, kot bi smeli
English: Absolute CV risk was balanced between treatment groups, in addition to the index event all patients had at least 1 major or 2 minor CV risk factors; 80% had hypertension, 36% had diabetes mellitus, and 28% were daily smokers.
Slovenian: Absolutno srčno-žilno tveganje je bilo uravnoteženo med zdravljenima skupinama, poleg indeksnega dogodka so imeli vsi bolniki vsaj 1 večji ali 2 manjša srčno-žilna dejavnika tveganja; 80 % bolnikov je imelo hipertenzijo, 36 % jih je imelo sladkorno bolezen in 28 % jih je bilo dnevnih kadilcev.
English: C When you are ready to inject, pressthe grey start button.
Slovenian: C Ko ste pripravljeni na injiciranje, pritisnite sivi sprožilni gumb.
English: It is not known if Repatha will harm your unborn baby.
Slovenian: Ni znano, ali zdravilo Repatha škoduje nerojenemu otroku.
English: B Remove the air bubble / gap.
Slovenian: B Odstranite zračni mehurček/prazen prostor.
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri do 1 od 10 oseb
English: Important: If medication leaks from the loaded automated mini-doser contact your doctor or pharmacist.
Slovenian: Pomembno: Če zdravilo izteka iz napolnjenega avtomatskega odmernika, se posvetujte z zdravnikom ali farmacevtom.
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Slovenian: Pričakovati je, da njegova presnova in odstranjevanje potekata po poteh očistka imunoglobulinov, ki vodijo v razgradnjo do majhnih peptidov in posameznih aminokislin.
English: Cardiovascular risk reduction in adults with established atherosclerotic cardiovascular disease
Slovenian: Znižanje srčno-žilnega tveganja pri odraslih s potrjeno aterosklerotično srčno-žilno boleznijo
English: b 2-sided log-rank test stratified by randomisation stratification factors collected via IVRS.
Slovenian: b 2-stranski log-rank test, stratificiran z randomiziranimi faktorji stratifikacije, pridobljenimi iz IVRS.
English: Repatha is a human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Slovenian: Zdravilo Repatha je človeško monoklonsko protitelo IgG2, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka (CHO - Chinese hamster ovary).
English: If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor's instructions on how to take these medicines together.
Slovenian: Če vam je zdravnik predpisal zdravilo Repatha skupaj z drugimi zdravili za zniževanje holesterola, upoštevajte zdravnikova navodila za hkratno uporabo teh zdravil.
English: On the basis of the scientific conclusions for evolocumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing evolocumab is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za evolokumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) evolokumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Repatha must not be administered intravenously or intramuscularly.
Slovenian: Zdravila Repatha se ne sme dajati intravensko ali intramuskularno.
English: • The single use automated mini-doser for subcutaneous injection is intended only for use with the cartridge.
Slovenian: • Avtomatski odmernik za subkutano injiciranje za enkratno uporabo je namenjen le za uporabo z vložkom.
English: Changes in unbound PCSK9 and serum lipoproteins were reversible upon discontinuation of Repatha.
Slovenian: Spremembe nevezanega PCSK9 in lipoproteinov v serumu so bile po prenehanju uporabe zdravila Repatha reverzibilne.
English: No overall differences in safety or efficacy were observed between these patients and younger patients.
Slovenian: V celoti med temi bolniki in mlajšimi bolniki niso ugotovili razlik v varnosti in učinkovitosti.
English: d The treatment effect on stroke was driven by a reduction in risk of ischaemic stroke; there was no effect on haemorrhagic or undetermined stroke.
Slovenian: d Učinek zdravljenja na možgansko kap je bil posledica zmanjšanja tveganja za ishemično možgansko kap; vpliva na hemoragično ali nedoločeno možgansko kap ni bilo.
English: The loaded automated mini-doser will lay flat on your body.
Slovenian: Napolnjeni avtomatski odmernik bo ležal plosko na telesu.
English: A total of 1,324 patients enrolled in OSLER.
Slovenian: Študija OSLER je zajela skupno 1.324 bolnikov.
English: 45 minutes.
Slovenian: Počakajte 45 minut.
English: Hazard Ratio, 0.80 (95% CI, 0.73, 0.88) P<0.0001
Slovenian: Razmerje ogroženosti, 0,80 (95 % IZ, 0,73, 0,88) p<0,0001
English: Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Slovenian: Za rezultate študije glede učinka na holesterol LDL, srčno-žilne dogodke in o preiskovanih bolnikih glejte poglavje 5.1.
English: Do not stretch for thigh Important: Adjust your body posture to avoid skin folds and bulges.
Slovenian: Ne raztezajte kože na stegnu Pomembno: Prilagodite telesno držo tako, da ne bo kožnih gub ali izboklin.
English: After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks.
Slovenian: Zdravnik se lahko po 12 tednih odloči za povečanje odmerka na 420 mg na vsaka dva tedna.
English: A total of 3,681 patients enrolled in OSLER-2.
Slovenian: Študija OSLER-2 je zajela skupno 3.681 bolnikov.
English: Important: You must push all the way down but do not touch the grey start button until you are ready to inject.
Slovenian: Pomembno: Potisniti morate do konca dol, vendar se ne dotikajte sivega sprožilnega gumba, dokler niste pripravljeni na injiciranje.
English: The relative risk of the MACE composite (CV death, MI, or stroke) was significantly reduced by 20%.
Slovenian: Relativno tveganje za sestavljen dogodek MACE (srčno-žilna smrt, miokardni infarkt ali možganska kap) je bilo značilno znižano za 20 %.
English: • You hear several beeps.
Slovenian: • Slišite več piskov.
English: During injection, keep the automated mini-doser a minimum of 10 cm (4 inches) away from other electronics such as mobile phones.
Slovenian: Med injiciranjem mora biti avtomatski odmernik vsaj 10 cm odmaknjen od kakršne koli elektronske naprave, na primer od mobilnega telefona.
English: Insert the cartridge bottom first.
Slovenian: Najprej vstavite dno vložka.
English: Do not touch the grey start button
Slovenian: Ne dotikajte se sivega sprožilnega gumba
English: • Alcohol wipes.
Slovenian: • alkoholne zložence.
English: Step 2: Get ready A Carefully pull the grey needle cap straight out and away from your body.
Slovenian: 2. korak: Pripravite se A Previdno potegnite sivi pokrovček igle naravnost z brizge in proč od telesa.
English: Combination with a statin and statin with other lipid-lowering therapies
Slovenian: Kombinacija s statinom in s statinom z drugimi zdravili za zniževanje lipidov
English: No data on the effect of evolocumab on human fertility are available.
Slovenian: Podatkov o vplivu evolokumaba na plodnost pri človeku ni.