natgillin/translations-raw huggingface dataset:
The CHMP noted the proposed indication “skin and soft tissue infections” (SSTI). 
CHMP je upošteval predlagano indikacijo „okužbe kože in mehkih tkiv“.
Although data supporting this indication is limited, the CHMP considered the following harmonised indication to be acceptable: 
Čeprav so dokazi v podporo tej indikaciji omejeni, je CHMP menil, da je navedena usklajena indikacija sprejemljiva:
The CHMP noted the proposed the indication “septicaemia” but remarked on the limited and old clinical trial data available. 
CHMP je upošteval predlagano indikacijo „septikemija“ ter izpostavil, da so na voljo samo omejeni in stari podatki kliničnih preskušanj.
The issue of seizures in paediatric patients with systemic malignancies during therapy with imipenem/cilastatin was also discussed and the CHMP was reassured by the absence of evidence in support of an increased risk of seizures in this population. 
Razpravljali so tudi o vprašanju napadov pri pediatričnih bolnikih s sistemski malignimi boleznimi med zdravljenjem z imipenemom/cilastatinom, odsotnost dokazov, ki bi potrdili povečano tveganje napadov pri tej populaciji, pa je CHMP dala dodatno zagotovilo.
The CHMP noted the proposed indication “bone and joint infections” but considered the data submitted to be insufficient. 
CHMP je upošteval predlagano indikacijo „okužbe kosti in sklepov“, vendar je menil, da so predloženi podatki nezadostni.
4.1.9 Prophylaxis 
4.1.9 Profilaksa
The CHMP was of the opinion that in light of the present clinical and PK/PD data, a standard dose of 500 mg every 6 hours or 1g every 8 hours can be accepted, provided that a recommendation is inserted in the SPC stating that for infections suspected or proven to be due to less susceptible organisms (e.g. P. aeruginosa) and for very severe infections (e.g. in neutropenic patients with a fever), the 1000 mg q.i.d should be used. 
CHMP je menil, da je glede na zadnje klinične in farmakokinetične/farmakodinamične podatke običajni odmerek 500 mg vsakih 6 ur ali 1 g vsakih 8 ur sprejemljiv, če se v povzetek glavnih značilnosti zdravila vključi priporočilo, da se za okužbe, ki bi lahko bile ali so dokazano posledica manj občutljivih organizmov (na primer bakterije P. aeruginosa), in za zelo hude okužbe (na primer nevtropenični bolniki s povišano telesno temperaturo) uporablja odmerek 1 000 mg štirikrat na dan.
“Tienam may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.” 
„Zdravilo Tienam se lahko uporablja za zdravljenje nevtropeničnih bolnikov s povišano telesno temperaturo, ki je morda posledica bakterijske okužbe.
“complicated skin and soft-tissue infections” 
„zapletene okužbe kože in mehkih tkiv“.
The presented data were very scarce and imipenem/cilastatin is not considered one of the most effective agents against staphylococci and methicillin-resistant staphylococci are known to be resistant to imipenem/cilastatin. 
Predstavljeni podatki so bili zelo omejeni, imipenem/cilastatin pa se ne šteje kot eno najučinkovitejših zdravil proti stafilokokom, prav tako pa je znano, da so stafilokoki, odporni na meticilin, odporni tudi na imipenem/cilastatin.
4.1.3 Gynaecological infections 
4.1.3 Ginekološke okužbe
The CHMP also assessed the limited data from literature sources and concluded that the claimed broad indication in the treatment of bone and joint infections could not be supported. 
Ovrednotil je tudi omejene podatke iz literature in zaključil, da obširna indikacija pri zdravljenju okužb kosti in sklepov ni utemeljena.
Concomitant use of an appropriate anti-MRSA agent may be indicated when MRSA infections are suspected or proven to be involved in the approved indications. 
Sočasna uporaba ustreznega zdravila proti bakteriji MRSA je lahko indicirana, kadar obstaja sum, da je okuženost z bakterijo MRSA vključena v odobrene indikacije ali pa je to dokazano.
Therefore, the CHMP did not consider imipenem/cilastatin to be an appropriate antibiotic for the empiric treatment of this life-threatening infection as the risk of selecting for MRSA is especially high. 
CHMP je zato menil, da imipenem/cilastatin ni primeren antibiotik za empirično zdravljenje te smrtno nevarne okužbe, saj je tveganje selekcije bakterije MRSA še posebno visoko.
The CHMP was of the opinion that in light of the present clinical and PK/PD data, for paediatric patients ≥1 year of age, a standard dose of 15 or 25 mg/kg/dose administered every 6 hours is recommended. 
CHMP je menil, da se glede na zadnje klinične in farmakokinetične/farmakodinamične podatke za pediatrične bolnike, stare eno leto ali več, priporoča običajni odmerek 15 ali 25 mg/kg/odmerek, ki se daje vsakih 6 ur.
The MAH discussed a number of specific indications, including community acquired pneumonia (CAP), cystic fibrosis, nosocomial pneumonia or ventilator associated pneumonia. 
Imetnik dovoljenja za promet z zdravilom je obravnaval več specifičnih indikacij, vključno z zunajbolnišnično pridobljeno pljučnico, cistično fibrozo, bolnišnično pridobljeno pljučnico in z ventilatorji povezano pljučnico.
The CHMP noted the proposed indication “lower respiratory tract infections” but considered the indication to be non-specific and therefore no longer appropriate, according to the Guideline on Antibacterial agents. 
CHMP je upošteval predlagano indikacijo „okužbe spodnjih dihal“ in menil, da je indikacija nespecifična in ob upoštevanju Smernice o protibakterijskih zdravilih ni več ustrezna.
“The antibacterial spectrum of imipenem/cilastatin should be taken into account especially in lifethreatening conditions before embarking on any empiric treatment. 
„Pred pričetkom kakršnega koli empiričnega zdravljenja je treba upoštevati protibakterijski spekter imipenema/cilastatina, zlasti pri smrtno nevarnih stanjih.
The CHMP considered that the data provided by the MAH included sufficient evidence that imipenem/cilastatin is efficacious in most studies in treating complicated intra-abdominal infections including e.g., intra-abdominal abscesses, peritonitis, complicated appendicitis, gall bladder empyema. 
CHMP je menil, da so v predloženih podatkih imetnika dovoljenja za promet z zdravilom zadostni dokazi, da je imipenem/cilastatin učinkovit v večini študij pri zdravljenju zapletenih intraabdominalnih okužb, med drugim intraabdominalnih abscesov, peritonitisa, kompliciranega apendicitisa, empiemov žolčnika.
The CHMP noted and assessed the available clinical trial and publication data showing that imipenem/cilastatin is effective and well tolerated in the treatment of “Complicated Skin and soft-tissue infections”. 
CHMP je upošteval in ocenil razpoložljive podatke iz kliničnih preskušanj ter objavljene podatke o učinkovitosti in dobrem prenašanju imipenema/cilastatina pri zdravljenju „zapletenih okužb kože in mehkih tkiv“.
The MAH acknowledged that the spectrum of imipenem/cilatstatin does not cover Chlamydia trachomatis, and that there is insufficient evidence that Neisseria gonorrhoeae is a good target for therapy with this agent. 
Imetnik dovoljenja za promet z zdravilom je potrdil, da spekter imipenema/cilastatina ne vključuje klamidije (Chlamydia trachomatis) ter da ni zadostnih dokazov, ki bi potrdili, da je to zdravilo primerno za zdravljenje gonoreje (Neisseria gonorrhoeae).
4.1.2 Lower respiratory tract infections 
4.1.2 Okužbe spodnjih dihal
In addition, the term “genitourinary tract infections” was considered outdated. 
Poleg tega so menili, da je izraz „okužbe sečil in spolovil“ zastarel.
The CHMP noted the proposed indication “genitourinary infections” but stated that imipenem/cilastatin should be used only in severe bacterial infections suspected or due to pathogens resistant to other beta-lactams and susceptible to imipenem/cilastatin. 
CHMP je upošteval predlagano indikacijo „okužbe sečil in spolovil“, vendar je menil, da se lahko imipenem/cilastatin uporablja le pri hudih bakterijskih okužbah, ki bi lahko bile ali so posledica patogenov, odpornih na druge betalaktame in občutljivih za imipenem/cilastatin.
Furthermore imipenem/cilastatin has no activity against MRSA and is therefore not considered to be an appropriate antibiotic for the empiric treatment of SSTIs caused by staphylococci since the risk of selecting for MRSA is quite high. 
Imipenem/cilastatin prav tako ne deluje proti bakteriji MRSA in se tako ne šteje za ustrezni antibiotik za empirično zdravljenje okužb kože in mehkih tkiv, ki jih povzročajo stafilokoki, saj je tveganje selekcije bakterije MRSA precej visoko.
• 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). 
• 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;
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. 
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.
4.1.6 Bone and joint infections 
4.1.6 Okužbe kosti in sklepov
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. 
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.
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. 
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.
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. 
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.
“intra- and post-partum infections 
„okužbe med porodom in po njem“.
“complicated urinary tract infections” 
„zapletene okužbe sečil“.
4.1.13 Paediatric use 
4.1.13 Uporaba pri otrocih
Then, leave the door open. 
Nato pustite vratca odprta.
Swing the door to the left. 
Zasučite vratca v levo.
Injection is complete when: 
Injiciranje je končano, ko:
Additional environmental conditions 
Dodatni okoljski pogoji
c Nominal significance. 
c Nominalna značilnost.
Cumulative Incidence (%) 
Kumulativna incidenca (%)
It contains electronics that should not get wet. 
Vsebuje namreč elektroniko, ki se ne sme zmočiti.
Be very careful not to push out any medicine. 
Bodite zelo previdni, da ne boste iztisnili nič zdravila.
The green light should now be off. 
Zelena lučka mora biti zdaj ugasnjena.
Then LIFT thumb. 
Potem DVIGNITE palec.
N Injection takes about 9 minutes. 
N Injiciranje traja približno 9 minut.
• You can only press the start button once. 
• Sprožilni gumb lahko pritisnete le enkrat.
Patient Population (N) 
Populacija bolnikov (N)
A risk to breastfed newborns/infants cannot be excluded. 
Tveganja za dojene novorojenčke/dojenčke ne moremo izključiti.
The recommended dose depends on the underlying condition: 
Priporočeni odmerek je odvisen od osnovne bolezni:
This can dry out the medicine. 
To lahko izsuši zdravilo.
Inject the entire contents. 
Injicirajte celotno vsebino.
Relative humidity range is 15% to 85%. 
Območje relativne vlažnosti je od 15 % do 85 %.
Sodium hydroxide (for pH adjustment) 
Natrijev hidroksid (za prilagoditev pH)
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, U.S.A. 
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, ZDA
If an error occurs, the automated mini-doser cannot be used. 
Če pride do napake, avtomatskega odmernika ni mogoče uporabiti.
In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. 
V primeru prevelikega odmerjanja je treba bolnika zdraviti simptomatsko in uvesti podporne ukrepe, kot je potrebno.
You will hear a click. 
Slišali boste klik.
Therefore, close monitoring may be warranted in these patients. 
Zato je lahko pri takšnih bolnikih potreben natančen nadzor.
e Assessment of time to hospitalisation for unstable angina was ad-hoc. 
e Ocena časa do hospitalizacije za nestabilno angino je bila izvedena ad-hoc.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 July 2015 
Datum prve odobritve: 17. julij 2015
• Make sure you see a green, flashing status light. 
• Poskrbite, da boste videli zeleno utripajočo lučko stanja.
Tell your healthcare provider if you are allergic to latex. 
Zdravniku morate povedati, če ste alergični na lateks.
Type BF Applied Part 
Aplicirani del tipa BF
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti se zdravila ne smemo mešati z drugimi zdravili.
D Keep PUSHING down on the skin. 
D Še naprej PRITISKAJTE ob kožo.
Do not use if packaging is damaged 
Ne uporabite, če je pakiranje poškodovano.
To remove: 
Za odstranitev:
• You may hear beeps indicating your injection has started. 
• Morda boste slišali piske, ki označujejo, da se je injiciranje začelo.
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. 
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.
The exposure to evolocumab was found to be approximately 40-50% lower compared to healthy subjects. 
Izpostavljenost evolokumabu je bila približno 40-50 % manjša kot pri zdravih osebah.
DO NOT use any medicine that is left in the used syringe. 
NE UPORABITE zdravila, ki je ostalo v uporabljeni brizgi.
This resulted in similar time course and extent of absolute LDL-C lowering. 
To je povzročilo podoben časovni potek in obseg absolutnega znižanja LDL-H.
This will make the injection more comfortable. 
Tako bo injiciranje manj neprijetno.
Name and address of the manufacturer of the biological active substance Immunex Rhode Island Corporation 40 Technology Way 
Ime in naslov izdelovalca biološke učinkovine Immunex Rhode Island Corporation 40 Technology Way
Rare: may affect up to 1 in 1,000 people • Swelling of the face, mouth, tongue, or throat (angioedema) 
Redki: pojavijo se lahko pri največ 1 od 1.000 oseb • Otekanje obraza, ust, jezika ali grla (angioedem)
The mutagenic potential of evolocumab has not been evaluated. 
Mutagenega potenciala evolokumaba niso ocenili.
Patients at Risk 
Bolniki, izpostavljeni tveganju
• The automated mini-doser contains batteries, electronics, and a needle. 
• Avtomatski odmernik vsebuje baterije, elektroniko in iglo.
GRH0465 v1 
GRH0531SL v1
Check that: 
Preverite:
After removal, check the medicine window. 
Po odstranitvi preverite okence zdravila.
For instructions on administration, see section 6.6 and the ‘Instructions for Use' provided in the carton. 
Za navodila za dajanje zdravila glejte poglavje 6.6 in "Navodilo za uporabo", priloženo v škatli.
Needle inside (under cover) 
Igla je znotraj (pod pokrovčkom)
C Gather all materials needed for your injection and then wash your hands thoroughly with soap and water. 
C Pripravite vse, kar potrebujete za injiciranje, in si nato roke dobro umijte z milom in vodo.
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). 
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).
It is normal to see a drop of medicine at the end of the needle. 
Normalno je, da se na koncu igle pokaže kapljica zdravila.
Do not put fingers into the yellow safety guard. 
Ne segajte s prsti v rumeni varnostni ščitnik.
• Allergic reactions including rash 
• Alergijske reakcije, vključno z izpuščaji
Important: After you load the automated mini-doser, proceed to the next step without delay. 
Pomembno: Ko avtomatski odmernik napolnite, brez odlašanja nadaljujte z naslednjim korakom.
The study did not investigate the correlation between atherosclerotic disease regression and cardiovascular events. 
Študija ni ocenjevala korelacije med regresijo aterosklerotične bolezni in srčno-žilnimi dogodki.
LDL-C reduction of approximately 55% to 75% was achieved with Repatha as early as week 1 and maintained during long-term therapy. 
Znižanje LDL-H za približno 55 do 75 % je bilo z zdravilom Repatha doseženo že 1. teden in se je med dolgotrajnim zdravljenjem ohranilo.
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. 
Dolgoročna varnost trajno zelo nizkih vrednosti LDL-H (tj. < 0,65 mmol/l [< 25 mg/dl]) še ni ugotovljena.
Insert the needle into the skin using a 45 to 90 degree angle. 
Zabodite iglo v kožo pod kotom 45 do 90 stopinj.
If the plunger did not fill the window, contact your doctor. 
Če bat ni napolnil okenca, se posvetujte z zdravnikom.
A flashing green light and a click signals the injection has started. 
Utripajoča zelena lučka in klik označujeta, da se je injiciranje začelo.
If the automated mini-doser is attached to your body, carefully remove it. 
Če imate avtomatski odmernik nameščen na telo, ga previdno odstranite.
F Inspect medicine and syringe. 
F Preglejte zdravilo in brizgo.
• Do not insert the cartridge more than 5 minutes before injection. 
• Vložka ne vstavite več kot 5 minut pred injiciranjem.
Yellow safety guard 
Rumen varnostni ščitnik
• Do not place the loaded automated mini-doser on your body if the red status light flashes for more than 5 seconds. 
• Ne položite napolnjenega avtomatskega odmernika na telo, če rdeča lučka stanja utripa več kot 5
Use a firm and flat skin surface. 
Uporabite trdno in ravno površino kože.
Elderly patients (age ≥ 65 years) No dose adjustment is necessary in elderly patients. 
Starejši bolniki (stari ≥ 65 let) Starejšim bolnikom odmerka ni treba prilagoditi.
If you notice an air bubble/gap: 
Če opazite zračni mehurček/prazen prostor:
Contact your doctor or pharmacist immediately. 
Takoj se posvetujte z zdravnikom ali farmacevtom.
Automated mini-doser operating temperature range is 15ºC to 40ºC. 
Temperaturno območje delovanja avtomatskega odmernika je od 15°C do 40°C.
Check the expiration date. 
Preverite datum izteka roka uporabnosti.
Evolocumab was estimated to have an effective half-life of 11 to 17 days. 
Ocenjeni efektivni razpolovni čas evolokumaba je od 11 do 17 dni.
(HMD) (combined atorvastatin groups) 
(HMD) (združeni podatki skupin z atorvastatinom)
There is no specific treatment for Repatha overdose. 
Specifičnega zdravljenja za preveliko odmerjanje zdravila Repatha ni.
4.7 Effects on ability to drive and use machines Repatha has no known influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Repatha nima znanega vpliva na sposobnost vožnje in upravljanja strojev.
Repatha has not been tested in pregnant women. 
Zdravilo Repatha ni preizkušeno pri nosečnicah.
• Flu-like symptoms 
• Gripi podobni simptomi
L When the blue light flashes, the automated mini-doser is ready. 
L Ko modra lučka utripa, je avtomatski odmernik pripravljen.
Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. 
Zdravila Repatha ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z evolokumabom.
Stroke (fatal/non-fatal) d 
Možganska kap (smrtna/ne-smrtna)d
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. 
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.
If you forget to take Repatha 
Če ste pozabili vzeti zdravilo Repatha
B Open the carton and peel away the white paper cover. 
B Odprite škatlo in odlepite beli prekrivni papir.
Repatha is a medicine that lowers levels of 'bad' cholesterol, a type of fat, in the blood. 
Zdravilo Repatha je zdravilo, ki znižuje "slabi" holesterol, vrsto maščobe v krvi.
Important: To attach the automated mini-doser securely, it is important to use a firm and flat skin surface. 
Pomembno: Za varno namestitev avtomatskega odmernika je pomembno, da uporabite trdno in ravno površino kože.
It is recommended that 12 and 13 year olds are supervised by an adult when they are using the automated mini-doser. 
Priporočljivo je, da 12- in 13-letnike pri uporabi avtomatskega odmernika nadzira odrasla oseba.
No time dependent changes were observed in serum concentrations over a period of 124 weeks. 
Med obdobjem 124 tednov niso opažali od časa odvisnih sprememb v koncentraciji v serumu.
4.5 Interaction with other medicinal products and other forms of interaction No formal drug-drug interaction studies have been conducted for Repatha. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja zdravil z zdravilom Repatha niso izvedli.
Population pharmacokinetic analyses suggest that no dose adjustments are necessary for age, race or gender. 
Populacijske farmakokinetična analize kažejo, da odmerka ni treba prilagoditi glede na starost, raso ali spol.
If you use more Repatha than you should 
Če ste uporabili večji odmerek zdravila Repatha, kot bi smeli
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. 
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.
C When you are ready to inject, pressthe grey start button. 
C Ko ste pripravljeni na injiciranje, pritisnite sivi sprožilni gumb.
It is not known if Repatha will harm your unborn baby. 
Ni znano, ali zdravilo Repatha škoduje nerojenemu otroku.
B Remove the air bubble / gap. 
B Odstranite zračni mehurček/prazen prostor.
Common: may affect up to 1 in 10 people 
Pogosti: pojavijo se lahko pri do 1 od 10 oseb