natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) Repatha 140 mg solution for injection in pre-filled syringe EU/1/15/1016/001 - 1 pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen EU/1/15/1016/002 - 1 pre-filled pen EU/1/15/1016/003 - 2 pre-filled pens EU/1/15/1016/004 - 3 pre-filled pens EU/1/15/1016/005 - 6 (3x2) pre-filled pens (multipack)
Repatha 140 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/15/1016/001 - 1 napolnjena injekcijska brizga Repatha 140 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/15/1016/002 - 1 napolnjen injekcijski peresnik EU/1/15/1016/003 - 2 napolnjena injekcijska peresnika EU/1/15/1016/004 - 3 napolnjeni injekcijski peresniki EU/1/15/1016/005 - 6 (3 x 2) napolnjenih injekcijskih peresnikov (skupno pakiranje) Repatha 420 mg raztopina za injiciranje v vložku
Available data demonstrate that there are no clinically meaningful differences between the safety profiles of patients with LDL-C levels < 0.65 mmol/L and those with higher LDL-C, see section 4.8.
Podatki, ki so na voljo, kažejo, da ni klinično pomembnih razlik v varnostnih značilnostih pri bolnikih s koncentracijo LDL-H < 0,65 mmol/l in bolnikih z višjim LDL-H (glejte poglavje 4.8).
The most commonly reported adverse reactions during pivotal trials, at the recommended doses, were nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and injection site reactions (2.2%).
V ključnih preskušanjih so med uporabo priporočenih odmerkov najpogosteje poročali o neželenih učinkih nazofaringitis (7,4 %), okužba zgornjih dihal (4,6 %), bolečina v hrbtu (4,4 %), artralgija (3,9 %), gripa (3,2 %) in reakcije na mestu injiciranja (2,2 %).
The treatment effect was consistent across all subgroups (including age, type of disease, baseline LDL-C, baseline statin intensity, ezetimibe use, and diabetes) and was driven by a reduction in the risk of myocardial infarction, stroke and coronary revascularisation; no significant difference was seen on cardiovascular or all-cause mortality however the study was not designed to detect such a difference.
Učinek zdravljenja je bil konsistenten med vsemi podskupinami (vključno s starostjo, tipom bolezni, izhodiščnim LDL-H, izhodiščno intenzivnostjo zdravljenja s statini, uporabo ezetimiba in sladkorno boleznijo) in je bil usmerjen z znižanjem tveganja za miokardni infarkt, možgansko kap in koronarno revaskularizacijo; za srčno-žilno umrljivost ali umrljivost zaradi vseh vzrokov niso opazili značilnih razlik, vendar študija ni bila načrtovana za zaznavanje te razlike.
Check that the name Repatha appears on the carton label.
Preverite ime zdravila Repatha na nalepki škatle.
Repatha is used in addition to your cholesterol lowering diet if you are:
Zdravilo Repatha uporabljamo poleg diete za zniževanje holesterola, če ste:
Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C).
Zvišana raven jetrnih LDLR povzroči znižanje holesterola LDL (LDL-H) v serumu.
Reductions in LDL-C and changes in other lipid parameters in 14 adolescent patients (aged ≥ 12 to < 18 years) with homozygous familial hypercholesterolaemia are comparable to those in the overall population of patients with homozygous familial hypercholesterolaemia.
Znižanja LDL-H in spremembe drugih lipidnih parametrov so bile pri 14 mladostnikih (starih od ≥ 12 do < 18 let) s homozigotno družinsko hiperholesterolemijo primerljive tistimi pri celotni populaciji bolnikov s homozigotno družinsko hiperholesterolemijo.
Following a single subcutaneous dose of 140 mg or 420 mg Repatha administered to healthy adults, median peak serum concentrations were attained in 3 to 4 days.
Po enkratnem subkutanem odmerku 140 mg ali 420 mg zdravila Repatha pri zdravih odraslih je bila mediana najvišja koncentracija v serumu dosežena v 3 do 4 dneh.
Over 99% of patients were on moderate to high intensity statin and at least one other cardiovascular medicine such as anti-platelet agents, beta blockers, ACE inhibitors, or angiotensin receptor blockers; median (Q1, Q3) baseline LDL-C was 2.4 mmol/L (2.1, 2.8).
Preko 99 % bolnikov je prejemalo zmerno do visoko intenzivno zdravljenje s statini in vsaj eno dodatno zdravilo za srčno-žilni sistem, kot so antiagregacijska zdravila, zaviralci beta receptorjev, ACE inhibitorji ali zaviralci angiotenzinskih receptorjev; mediana (Q1, Q3) začetnega LDL-H je bila 2,4 mmol/l (2,1, 2,8).
Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Zdravilna učinkovina v zdravilu Repatha je evolokumab, ki je monoklonsko protitelo (vrsta specializirane beljakovine, zasnovana tako, da se veže na ciljno snov v telesu).
Following repeat subcutaneous administration of 140 mg every 2 weeks, the 12-week trough concentrations were 147% higher and 70% lower in patients of 69 kg and 93 kg respectively, than that of the typical 81 kg subject.
Po ponavljajoči se podkožni uporabi 140 mg na 2 tedna je bila najnižja koncentracija 12. teden pri bolnikih z 69 kg 147 % višja in pri bolnikih s 93 kg 70 % nižja kot najnižja koncentracija pri tipičnem preiskovancu s telesno maso 81 kg.
It is okay to hear a pumping sound start and stop during injection.
V redu je, če med injiciranjem slišite začetek in konec zvoka črpanja.
• an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia).
• odrasla oseba z visokim holesterolom v krvi (imate primarno hiperholesterolemijo [heterozigotno družinsko in nedružinsko] ali mešano dislipidemijo).
The review of all reported hypersensitivity reactions revealed a clear evidence of different clinical presentations of hypersensitivity associated with evolocumab.
Pregled vseh poročanih preobčutljivostnih reakcij je pokazal, da so z evolokumabom očitno povezani različni klinični znaki preobčutljivosti.
After reaching room temperature, all injections should be given within a 30 minute period.
Potem, ko zdravilo doseže sobno temperaturo, je treba vse injekcije dati v roku 30 minut.
G Clean the cartridge bottom.
G Očistite dno vložka.
1 See section Description of selected adverse reactions
1 Glejte poglavje Opis izbranih neželenih učinkov
An approximately 20% increase in the clearance is in part mediated by statins increasing the concentration of PCSK9 which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Približno 20 % povečanje očistka je deloma posledica tega, da statini povečajo koncentracijo PCSK9, kar pa ni neugodno vplivalo na farmakodinamično delovanje evolokumaba na lipide.
Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
Zdravilo Repatha je indicirano pri odraslih s primarno hiperholesterolemijo (heterozigotno družinsko in nedružinsko) ali mešano dislipidemijo, kot dodatek dieti:
B Firmly PUSH down the pre-filled pen onto the skin until it stops moving.
B Trdno PRITISNITE napolnjeni injekcijski peresnik ob kožo, dokler se ne neha premikati.
Dose frequency in non-apheresis patients could be titrated up to 420 mg once every 2 weeks based on LDL-C response and PCSK9 levels.
Pogostnost odmerjanja pri bolnikih, ki niso na aferezi, je bilo mogoče titrirati do 420 mg na vsaka 2 tedna glede na odziv LDL-H in koncentracijo PCSK9.
On a clean, well-lit work surface, place the:
Na čisto, dobro osvetljeno, ravno delovno površino položite:
A substantial reduction of LDL-C was observed throughout the study, with achieved median LDL-C ranges of 0.8 to 0.9 mmol/L at each assessment; 25% of patients achieved a LDL-C concentration less than 0.5 mmol/L.
Tekom celotne študije so opažali znatno znižanje LDL-H, mediana doseženega LDL-H je bila v razponu od 0,8 do 0,9 mmol/l ob vsakem merjenju; 25 % bolnikov je doseglo koncentracijo LDL-H nižjo od 0,5 mmol/l.
• Hives, red itchy bumps on your skin (urticaria)
• Koprivke, rdeče, srbeče bulice na koži (koprivnica)
Placebo 13780 Repatha 13784
Placebo 13780 Zdravilo
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
• in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
• v kombinaciji z največjim toleriranim odmerkom statina z drugimi zdravili za zniževanje lipidov ali brez njih, ali
Do not try to inject Repatha until you have been shown how to do it by your doctor or nurse.
Ne poskušajte si injicirati zdravila Repatha, dokler vam zdravnik ali medicinska sestra ne pokažeta, kako to naredite.
This can damage the needle.
S tem lahko poškodujete iglo.
It is important to tell your doctor if you are breast-feeding or plan to do so.
Pomembno je, da zdravniku poveste, če dojite ali če nameravate dojiti.
The Repatha Outcomes Study (FOURIER) was a randomised, event-driven, double-blind study of 27,564 subjects, aged between 40 and 86 years (mean age 62.5 years), with established atherosclerotic CV disease; 81% had a prior MI event, 19% had a prior stroke event and 13% had peripheral arterial disease.
Študija izidov z zdravilom Repatha (FOURIER) je bila randomizirana, pogojena s številom dogodkov, dvojno slepa študija pri 27.564 bolnikih, starih med 40 in 86 let (povprečna starost 62,5 let) s potrjeno aterosklerotično srčno-žilno boleznijo; 81 % bolnikov je imelo predhodni miokardni infarkt, 19 % bolnikov je imelo predhodno možgansko kap in 13 % bolnikov je imelo periferno arterijsko bolezen.
OLE Week 48
Odprto podaljšanje 48. teden
The fluid path within the administration device is made from stainless steel and non-DEHP polyvinyl chloride, with a stainless steel 29 gauge needle.
Tekočinska pot v pripomočku za injiciranje je iz nerjavnega jekla in ne-DEHP polivinilklorida z nerjavno jekleno iglo številka 29.
Important: Wait at least 45 minutes for the automated mini-doser and cartridge to naturally reach room temperature in the carton.
Pomembno: Počakajte vsaj 45 minut, da se avtomatski odmernik in vložek v škatli po naravni poti ogrejeta na sobno temperaturo.
Do not leave the orange cap off for more than 5 minutes.
Peresnika s snetim oranžnim pokrovčkom ne puščajte več kot 5 minut.
N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific schedule visit (n) in the HoFH final analysis set.
Legenda: N (n) = število ocenljivih bolnikov (N) in bolnikov z opaženimi vrednostmi LDL na posameznem načrtovanem obisku (n) v naboru podatkov za končno analizo pri bolnikih s HoDH.
Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
Zdravilo Repatha je indicirano pri odraslih in mladostnikih, starih 12 let ali več, s homozigotno družinsko hiperholesterolemijo v kombinaciji z drugimi zdravili za zniževanje lipidov.
Important: It is important to keep skin stretched or pinched while injecting.
Pomembno: Pomembno je, da kožo med injiciranjem držite raztegnjeno ali stisnjeno.
However, baseline PCSK9 levels and the degree and time course of PCSK9 neutralisation were found to be similar between patients with mild or moderate hepatic impairment and healthy volunteers.
Vendar se je izkazalo, da so bili izhodiščna koncentracija PCSK9 ter stopnja in časovni potek nevtralizacije PCSK9 pri bolnikih z blago ali zmerno okvaro jeter podobni kot pri zdravih osebah.
It is not known whether Repatha is found in breast milk.
Ni znano, ali se zdravilo Repatha pojavi v materinem mleku.
• You may feel a needle pinch.
• Morda boste začutili vbod igle.
avoid storing in your vehicle's glove box or boot.
Izogibajte se shranjevanju na primer v predalu avta ali njegovem prtljažniku.
It is given: together with other cholesterol lowering treatments.
Zdravilo uporabljamo: skupaj z drugimi zdravili za zniževanje holesterola.
Treatment with Repatha resulted in a similar reduction of LDL-C when used alone or in combination with other lipid-lowering therapy.
Znižanje LDL-H je bilo podobno, če je bilo zdravilo Repatha uporabljeno samo, ali če je bilo uporabljeno v kombinaciji z drugimi zdravili za zniževanje lipidov.
• Do not fold the skin adhesive over onto itself.
• Ne prepognite lepila za kožo samega nase.
Start button (Do not press until ready to inject)
Sprožilni gumb (ne pritisnite, dokler niste pripravljeni za injiciranje)
Needle is inside.
Znotraj je igla.
Step 2: Get ready E Open the automated mini-doser by swinging the cartridge door to the right.
2. korak: Pripravite se E Odprite avtomatski odmernik tako, da vratca vložka zasukate v desno.
This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Večji očistek je deloma posledica tega, da statini povečajo koncentracijo proproteinske konvertaze subtilizin/keksin tipa 9 (PCSK9); to ni neugodno vplivalo na farmakodinamični učinek evolokumaba na lipide.
What Repatha contains - The active substance is evolocumab.
Kaj vsebuje zdravilo Repatha - Zdravilna učinkovina je evolokumab.
OLE Week 216
Odprto podaljšanje 216. teden
If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Če želite uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot prejšnjič.
With one hand, hold the cartridge barrel and clean the cartridge bottom with an alcohol wipe.
Z eno roko držite telo vložka in dno vložka očistite z alkoholnim zložencem.
• The status light changes to solid green.
• Se lučka stanja spremeni v stalno prižgano zeleno.
Known hypersensitivity to evolocumab is contraindicated in the EU SmPC, however clinicians and patients should be informed about the possible onset of hypersensitivity reactions during the evolocumab treatment.
Znana preobčutljivost na evolokumab v povzetku glavnih značilnosti zdravila za EU predstavlja kontraindikacijo, zdravnike in bolnike pa je treba obvestiti o možnosti pojava preobčutljivostnih reakcij med zdravljenjem z evolokumabom.
Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother.
Zdravnik vam bo pomagal pri odločitvi, ali naj nehate dojiti ali naj nehate uporabljati zdravilo Repatha, upoštevaje koristi dojenja za otroka in koristi zdravljenja z zdravilom Repatha za vas.
Placebo Repatha
Placebo Zdravilo Repatha
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
• v kombinaciji s statinom ali statinom z drugimi zdravili za zniževanje lipidov pri bolnikih, ki ne morejo doseči ciljnega holesterola LDL z največjim toleriranim odmerkom statina, ali
It is unknown whether evolocumab is excreted in human milk.
Ni znano, ali se evolokumab izloča v materino mleko.
If using the pre-filled pen, place the correct (yellow) end of the pen on the skin before injecting.
Ob uporabi napolnjenega injekcijskega peresnika pred injiciranjem položite pravilen (rumen) konec peresnika na kožo.
The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population.
Varnostne značilnosti v populaciji s homozigotno družinsko hiperholesterolemijo so se ujemale s tistimi, ki so bile ugotovljene v populacijah s primarno hiperholesterolemijo in mešano dislipidemijo.
Each pack contains one, two, three or six single use SureClick pre-filled pens.
Eno pakiranje vsebuje en, dva, tri ali šest napolnjenih injekcijskih peresnikov SureClick za enkratno uporabo.
• 12 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
• stari 12 let ali več in imate visok holesterol v krvi zaradi motnje, ki se pojavlja družinsko (homozigotna družinska hiperholesterolemija, HoDH).
Repatha reduced both percent atheroma volume (PAV; 1.01% [95% CI 0.64, 1.38], p < 0.0001) and total atheroma volume (TAV; 4.89 mm3 [95% CI 2.53, 7.25], p < 0.0001) compared with placebo.
Zdravilo Repatha je v primerjavi s placebom znižalo odstotek volumna ateroma ((PAV - Percent Atheroma Volume); 1,01 % [95 % IZ 0,64, 1,38], p < 0,0001) in celoten volumen ateroma ((TAV - Total Atheroma Volume); 4,89 mm3 [95 % IZ 2,53, 7,25], p < 0,0001).
• Slowly and gently push the plunger rod up to get the air out of the pre-filled syringe.
• Počasi in previdno potisnite bat brizge navzgor, da boste iztisnili zrak iz napolnjene injekcijske brizge.
Treatment effects were sustained over 1 year as demonstrated by reduction in LDL-C from week 12 to week 52.
Učinki zdravljenja so se ohranili v obdobju 1 leta, kot je pokazalo znižanje LDL-H od 12. do 52. tedna.
Following a single 420 mg intravenous dose, the mean (SD) systemic clearance was estimated to be 12 (2) mL/hr.
Po enkratnem 420 mg intravenskem odmerku je bil ocenjeni povprečni (standardni odklon) sistemski očistek 12 (2) ml/uro.
the grey needle cap is missing or not securely attached.
če sivi pokrovček igle manjka ali ni trdno nameščen.
Do not press the start button until you are ready to inject.
Ne pritisnite sprožilnega gumba, dokler niste pripravljeni na injiciranje.
Population pharmacokinetic analysis of integrated data from the Repatha clinical trials did not reveal a difference in pharmacokinetics of evolocumab in patients with mild or moderate renal impairment relative to non-renally impaired patients.
Populacijska farmakokinetična analiza združenih podatkov iz kliničnih preskušanj zdravila Repatha ni pokazala razlik v farmakokinetiki evolokumaba med bolniki z blago ali zmerno okvaro ledvic in bolniki brez okvare ledvic.
Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard.
Mesta injiciranja je treba krožno menjati, zdravila pa se ne sme injicirati v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
TC/ HDLC ratio
Razmerje TC/ HDLH
Step 4: Finish O When the injection is done, grab the skin adhesive to carefully peel the automated minidoser off your skin.
4. korak: Zaključek O Ko je injiciranje končano, primite lepljivo prekritje in avtomatski odmernik previdno odlepite s kože.
Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation.
Evolokumab se selektivno veže na PCSK9 in prepreči, da bi se PCSK9 v obtoku vezal na receptor za lipoproteine majhne gostote (LDLR) na površini jetrnih celic.
There are limited data available on the use of Repatha in the paediatric population.
Podatki o uporabi zdravila Repatha pri pediatrični populaciji so omejeni.
Taking into account the PRAC Assessment Report on the PSUR(s) for evolocumab, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za evolokumab je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
The administration device contains silver oxide-zinc batteries and includes an adhesive patch made from polyester tape with an acrylate adhesive.
Pripomoček za injiciranje vsebuje baterije s srebrovim oksidom-cinkom in ima nameščeno lepljivo površino iz poliestrskega traku z akrilatnim lepilom.
OLE Week 192
Odprto podaljšanje 192. teden
Do not try to use the automated mini-doser until you have been shown how to do it by your doctor or nurse.
Ne uporabljajte avtomatskega odmernika, dokler vam zdravnik ali medicinska sestra ne pokažeta, kako ga uporabljati.
In TAUSSIG, long-term use of Repatha demonstrated a sustained treatment effect as evidenced by reduction of LDL-C of approximately 20% to 30% in patients with homozygous familial hypercholesterolaemia not on apheresis and approximately 10% to 30% in patients with homozygous familial hypercholesterolaemia on apheresis (table 7).
V študiji TAUSSIG je dolgotrajna uporaba zdravila Repatha pokazala trajen terapevtski učinek, kot je pokazalo znižanje LDL-H za približno 20 do 30 % pri bolnikih s homozigotno družinsko hiperholesterolemijo, ki niso bili na aferezi, in približno 10 do 30 % pri bolnikih s homozigotno družinsko hiperholesterolemijo, ki so bili na aferezi (preglednica 7).
A total of 194 severe familial hypercholesterolaemia (non-HoFH) patients and 106 homozygous familial hypercholesterolaemia patients enrolled in TAUSSIG.
Študija TAUSSIG je zajela 194 bolnikov s hudo družinsko hiperholesterolemijo (ne-HoDH) in 106 bolnikov s homozigotno družinsko hiperholesterolemijo.
Subcutaneous regimens of 140 mg every 2 weeks and 420 mg once monthly were equivalent in average LDL-C lowering (mean of weeks 10 and 12) resulting in -72 to -57% from baseline compared with placebo.
Shemi podkožne uporabe 140 mg vsaka 2 tedna in 420 mg enkrat na mesec sta bili enakovredni, kar zadeva povprečno znižanje LDL-H (povprečje 10. in 12. tedna), in sta dosegli znižanje od -72 do57 % v primerjavi s placebom.
Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured particles.
Ne uporabite tega zdravila, če opazite, da je spremenjene barve, ali vsebuje velike grude, kosme ali obarvane delce.
Only use the outer arm if someone else is giving the injection.
Zunanji del nadlakti uporabite le v primeru, če vam injekcijo daje kdo drug.
• The used automated mini-doser will beep when removed from your skin.
• Uporabljeni avtomatski odmernik bo ob odstranitvi s kože zapiskal.
Medicine
ZDRAVILOM
All patients in the study were initially treated with Repatha 420 mg once monthly, except for those receiving lipid apheresis at enrolment who began with Repatha 420 mg once every 2 weeks.
Vsi bolniki v študiji so bili uvodoma zdravljeni z zdravilom Repatha 420 mg enkrat na mesec, razen bolnikov, ki so bili ob vključitvi zdravljeni z lipidno aferezo: ti so zdravljenje z zdravilom Repatha začeli s 420 mg enkrat na 2 tedna.
Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Bolniki, zdravljeni z aferezo, lahko začnejo zdravljenje s 420 mg na vsaka 2 tedna, da se ujema z njihovim razporedom afereze.
ApoA1
Apo A1
• Turn the tray over and gently press the middle of the tray's back to release the syringe into your palm.
• Pretisni omot obrnite in ga na sredini z zadnje strani previdno pritisnite, da se vam bo brizga sprostila v dlan.
Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in table 1 below using the following convention: 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) and very rare (< 1/10,000).
Pogostnosti so razvrščene takole: 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) in zelo redki (< 1/10.000).
There is limited experience with Repatha in paediatric patients.
Izkušenje z zdravilom Repatha pri pediatričnih bolnikih so omejene.
What Repatha looks like and contents of the pack
Izgled zdravila Repatha in vsebina pakiranja
With the cap off, place the yellow end of the pre-filled pen on the skin at 90 degrees.
Pokrovček mora biti odstranjen; prislonite rumeni konec napolnjenega injekcijskega peresnika na kožo pod kotom 90 stopinj.
Each pack contains one single use cartridge co-packed with a single use automated mini-doser.
Eno pakiranje vsebuje en vložek za enkratno uporabo, ki je pakiran skupaj z avtomatskim odmernikom za enkratno uporabo.