natgillin/translations-raw huggingface dataset:
Clinical response * p value for Standard Dose versus Low Dose comparison.
Klinični odziv *p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku
• the date
• datumu,
Note : images for illustration purposes only
Opomba: slike so namenjene zgolj slikovni ponazoritvi
• Do not give Kromeya to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
• Zdravila Kromeya ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Kromeya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Kromeya razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
Kromeya should only be used during a pregnancy if needed.
Zdravilo Kromeya se med nosečnostjo lahko uporablja samo, če je potrebno.
These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Te okuţbe so lahko bolj resne in vključujejo tuberkulozo, okuţbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali druge nenavadne okuţbe organizma in sepso (zastrupitev krvi).
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Če imate zmeren do hud aktiven revmatoidni artritis, boste morda najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
Following the administration of 24 mg/m
Po uporabi 24 mg/m
Figure 2: Kaplan-Meier curves summarizing time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Slika 2: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
The active ingredient in Kromeya, adalimumab, is a monoclonal antibody.
Učinkovina v zdravilu Kromeya, adalimumab, je monoklonsko protitelo.
In patients who develop HBV reactivation, Kromeya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Kromeya prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
Similar trends (not all statistically significant) were seen in the smaller randomised, double−blind, placebo−controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
Consequently, these infants may be at increased risk for infection.
Posledično je lahko tveganje za okuţbe pri teh dojenčkih večje.
Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Psoriaza v plakih lahko vpliva tudi na nohte, zaradi česar se le-ti lomijo, postanejo debelejši in se dvignejo od svojega leţišča, kar je lahko boleče.
- if your child has moderate or severe heart failure.
• če ima vaš otrok zmerno ali hudo srčno popuščanje.
Population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Populacijsko farmakokinetično in farmakokinetično/farmakodinamično modeliranje in simulacija so za adalimumab napovedali primerljivo izpostavljenost in učinkovitost pri bolnikih, zdravljenih z 80 mg vsak drugi teden v primerjavi s 40 mg vsak teden (vključno z odraslimi bolniki z RA, HS, UC, CD ali Ps, mladostniki s HS in pediatričnimi bolniki ≥ 40 kg s CD).
Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Adalimumab se specifično veţe na TNF in nevtralizira njegovo biološko delovanje, ker zavre njegovo interakcijo z receptorji p55 in p75 za TNF na površini celic.
Adalimumab n=274 (95% confidence interval)
Adalimumab n = 274 (95 % interval zaupanja)
You can help by reporting any side effects you may get.
Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neţelenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Kromeya should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Kromeya nemudoma prekiniti in uvesti ustrezno zdravljenje.
Read the package leaflet before use.
Pred uporabo preberite priloţeno navodilo!
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Adalimumab modulira tudi biološke odzive, ki jih sproţi ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in
p value*
P vrednost*
Vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Učinki povezani z vidom niso bili v korist adalimumaba v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Med vzdrţevalnim zdravljenjem je mogoče kortikosteroide postopoma zmanjšati v skladu s smernicami za klinično prakso.
• increased lipids in the blood;
• povečani lipidi v krvi;
The efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled studies.
Učinkovitost in varnost adalimumaba so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
Do not use Kromeya
Ne uporabljajte zdravila Kromeya
What Kromeya is and what it is used for
Kaj je zdravilo Kromeya in za kaj ga uporabljamo
Following 3 years of adalimumab therapy, 75% (301/402) continued to be in clinical remission per partial Mayo score.
Po 3 letih zdravljenja z adalimumabom jih je 75 % (301/402) ostalo v klinični remisiji po delni oceni Mayo.
After Use
Po uporabi
• facial oedema (swelling) associated with allergic reactions;
• edem obraza (otekanje) povezan z alergijskimi reakcijami;
Your symptoms may return upon stopping treatment.
Vaši simptomi se lahko po prekinitvi zdravljenja povrnejo.
• Place your thumb above (not touching) the yellow injection button (Figure M).
• Palec drţite nad (brez dotikanja) rumenim gumbom za injiciranje (Slika M).
Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Poročali so tudi o melanomu in karcinomu Merklovih celic pri bolnikih, zdravljenih z TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Aktivna tuberkuloza ali druge hude okuţbe, npr. sepsa, in oportunistične okuţbe (glejte poglavje 4.4).
• intestinal perforation (hole in the wall of the gut);
• intestinalna perforacija (luknja v steni črevesja);
• After the needle is inserted, release the pinched skin.
• Ko je injekcijska igla vstavljena, izpustite koţno gubo.
The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.
Merila, s katerimi so določali neuspeh zdravljenja so bili poslabšanje ali vztrajno ne-izboljšanje očesnega vnetja, delno izboljšanje z razvojem trajnih sočasnih očesnih bolezni ali poslabšanjem sočasnih očesnih bolezni, nedovoljena uporaba sočasnih zdravil ter prekinitev zdravljenja za daljše časovno obdobje.
117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
117/276 bolnikov iz študije Crohnove bolezni I in 272/777 bolnikov iz študij Crohnove bolezni II in so spremljali vsaj 3 leta odprtega zdravljenja z adalimumabom.
- This medicine has been prescribed for your child only.
- Zdravilo je bilo predpisano samo vašemu otroku in ga ne smete dajati drugim.
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Kromeya cannot be excluded (see section 4.8).
Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Kromeya, ni mogoče izključiti (glejte poglavje 4.8).
Then release the pinched skin.
Nato spustite koţno gubo.
Not all presentations may be marketed.
Na trgu morda ni vseh navedenih pakiranj.
Table 13 Efficacy responses in placebo-controlled AS Study - Study I reduction of signs and symptoms
Preglednica 13 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
3.5 Slowly push the plunger rod all the way in to push the medicine back into the vial.
3.5 Bat počasi potisnite do konca, da potisnete zdravilo nazaj v vialo.
Uncommon (may affect up to 1 in 100 people) • raised bilirubin measurement (liver blood test).
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • povečane vrednosti bilirubina (krvni test jetrne funkcije).
The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Tarča adalimumaba je druga beljakovina, ki se imenuje tumor nekrotizirajoči faktor (TNFα), ki je prisoten v povečanih koncentracijah pri zgoraj navedenih vnetnih boleznih.
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom sta vnetni bolezni, ki se običajno prvič pojavijo v otroštvu.
Warning: Do not lift the pre-filled pen from the skin until the plunger has moved all the way down and all the liquid has been injected.
Opozorilo: Napolnjenega injekcijskega peresnika ne odmikajte od koţe, dokler se ni bat premaknil do konca navzdol in je bila vsa tekočina injicirana.
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
V obdobju pomarketinške uporabe od januarja 2003 do decembra 2010, preteţno pri bolnikih z revmatoidnim artritisom, je bil zabeleţeni deleţ malignomov pribliţno 2,7 na 1000 bolnikov-let zdravljenja.
PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za pribliţno 4,5 μg/ml (95% IZ 0,4-47,6 in 1,9-10,5).
Results from the Short Form Health Survey (SF 36) for all doses/schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/sheme adalimumaba v vseh štirih študijah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
• shortness of breath with exertion or upon lying down or swelling of the feet.
• teţko dihanje ob naporu ali med leţanjem ali otekanje nog.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Kromeya and is positive for antibodies against double-stranded DNA, further treatment with Kromeya should not be given (see section 4.8).
Če se bolniku po zdravljenju z zdravilom Kromeya pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoveriţni DNA, zdravljenja z zdravilom Kromeya ne sme nadaljevati (glejte poglavje 4.8).
This includes any possible side effects not listed in this leaflet (see section 4).
Posvetujte se tudi, če opazite katere koli neţelene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
V predvidenem kohortnem registru je bilo vključenih 257 ţensk z revmatoidnim artritisom (RA) ali Crohnovo boleznijo (CB), zdravljenih z adalimumabom vsaj v prvem trimesečju nosečnosti, in 120 ţensk z RA ali CB, ki niso bile zdravljene z adalimumabom.
Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Med drugimi resnimi okuţbami, zabeleţenimi v kliničnih preskušanjih, so bile pljučnica, pielonefritis, septični artritis in septikemija.
• Do not use the 40 mg pre-filled syringe or 40 mg pre-filled pen if doses other than 40 mg are recommended.
• Ne uporabljajte 40 mg napolnjene injekcijske brizge ali 40 mg napolnjenega injekcijskega peresnika, če so priporočene ostale jakosti.
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Indukcija klinične remisije (definirane kot CDAI < 150) je bila ovrednotena v dveh študijah, študija Crohnove bolezni I (CLASSIC I) in študija Crohnove bolezni II (GAIN).
6 months 13.3% 65.1% 19.1% 12 months NA
6 mesecev 13,3 % 65,1 % 19,1 % 46,0 % 29,5 % 63,3 % 12 mesecev
7.1 Now that you have completed your injection, update your record with:
7.1 Po zaključenem injiciranju zabeleţite podatke o:
Discontinuation of immunomodulators
Prenehanje z imunomodulatorji
Median time to disease flare
Srednji čas do zagona bolezni
• ankylosing spondylitis,
• ankilozirajoči spondilitis,
Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Od bolnikov, ki so bili odzivni v 8. tednu, jih je bilo v 52. tednu 47 % odzivnih, 29 % v remisiji, 41 % je imelo celjenje sluznice in 20 % jih je bilo v remisiji brez steroidov za ≥ 90 dni.
The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab should be carefully considered.
Potrebno je upoštevati potencialno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in adalimumaba.
The following side effects have been observed with adalimumab:
Naslednji neţeleni učinki so bili ugotovljeni med uporabo adalimumaba:
Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Glede na naravo neţelenih dogodkov, opaţenih pri kombiniranem zdravljenju z etanerceptom in anakinro, lahko podobne toksičnosti nastanejo tudi pri uporabi anakinre in drugih antagonistov TNF.
Treatment with Kromeya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Zdravljenja z zdravilom Kromeya se ne sme začeti pri bolnikih z aktivnimi okuţbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Psoriasis study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Študija pri psoriazi II (CHAMPION) je primerjala učinkovitost in varnost adalimumaba z metotreksatom in placebom pri 271 bolnikih.
There were no distinct differences between adalimumab-treated and untreated women for the secondary endpoints spontaneous abortions, minor birth defects, preterm delivery, birth size and serious or opportunistic infections and no stillbirths or malignancies were reported.
Ni bilo opaznih razlik med nosečnicami, zdravljenimi z adalimumabom in nezdravljenimi glede sekundarnih opazovanih dogodkov, kot so spontani splavi, manjši defekti ob rojstvu, prezgodnji porodi, porodna velikost in resne ali oportunistične okuţbe, prav tako ni bilo opisanih mrtvorojenosti ali malignosti.
Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Kromeya se lahko uporablja kot monoterapija v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
V klinični študiji z drugim antagonistom TNF so opaţali poslabšanje kongestivnega srčnega popuščanja in večjo umrljivost zaradi kongestivnega srčnega popuščanja.
During treatment with Kromeya, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Med zdravljenjem z zdravilom Kromeya je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
• Made of a heavy-duty plastic;
• je izdelan iz močne plastike;
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil (NSAIDs - Nonsteroidal Anti-inflammatory drugs) in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Adalimumab je značilno zmanjšal tveganje za neuspeh zdravljenja za 75 % glede na placebo, kot prikazuje razmerje ogroţenosti (HR = 0,25 [95 % IZ: 0,12, 0,49]).
Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in RA study III.
Z zdravjem povezano kakovost ţivljenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v študiji revmatoidnega artritisa III vnaprej določena primarna končna točka po 52 tednih.
Warning: If the plunger rod is pulled completely out, throw away the syringe.
Opozorilo: Če je bat popolnoma izvlečen, zavrzite injekcijsko brizgo.
Then administer your child's next dose as you would have on the originally scheduled day, had you not forgotten a dose.
Nato dajte vašemu otroku naslednji odmerek, kot bi ga uporabili po prvotnem urniku, če ne bi pozabili odmerka.
0.8 mL solution in pre-filled Physioject
0,8 ml raztopina v napolnjenem Physioject
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week 12.
Ti rezultati nakazujejo, da nekaterim bolnikom, ki se ne odzovejo do 4. tedna, koristi nadaljevanje vzdrţevalnega zdravljenja do 12 tedna.
Warning: Do not use the pre-filled pen if the name on the label is not Kromeya and/or the expiration date on the label has passed.
Opozorilo: Injekcijske brizge ne uporabljajte, če na injekcijskem peresu ni imena Kromeya in/ali če se je rok uporabnosti iztekel.
The pen is a single use, disposable, handheld, mechanical injection device.
Peresnik je enoodmerna, enkratna, ročna, mehanska injekcijska naprava.
No clinical data are available on the use of an adalimumab loading dose in children < 6 years of age (see section 5.2).
Klinični podatki o uporabi polnilnega odmerka adalimumaba pri otrocih, mlajših od 6 let, niso na voljo (glejte poglavje 5.2).
Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3% on placebo and 10% on adalimumab.
Med bolniki, pri katerih predhodno anti-TNF zdravljenje ni bilo uspešno, jih je 52. teden doseglo remisijo 3 % na placebu in 10 % na adalimumabu.
Patients taking TNF-antagonists are more susceptible to serious infections.
Bolniki, ki uporabljajo antagoniste tumor nekrotizirajočega faktorja (TNF), so bolj dovzetni za resne okuţbe.
In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years.
V odprtem podaljšanju študije revmatoidnega artritisa III se je večina bolnikov, ki so se odzvali po ACR, odzivala še naprej v času sledenja do 10 let.
Description of selected adverse reactions
Opis izbranih neţelenih učinkov
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Zdravljenja so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin in/ali soli zlata.
Standard dose
Standardni odmerek
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci tumor nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04
diverticulitis
divertikulitis
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija HBV okuţbe lahko smrtno nevarna.
MTX = methotrexate **p < 0.01, adalimumab versus placebo
MTX = metotreksat **p < 0,01, adalimumaba v prim.
Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Nekateri od teh bolnikov so bili zdravljeni tudi z zdravilom azatioprinom ali merkaptopurinom.
Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab.
O primerih poslabšanja kongestivnega srčnega popuščanja so poročali tudi pri bolnikih, ki so prejemali adalimumab.
The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Varnost in učinkovitost adalimumaba so ocenili v dveh študijah (pJIA I in II) pri otrocih z aktivnim poliartikularnim ali poliartikularnim juvenilnim idiopatskim artritisom, z različnimi tipi začetka JIA (najpogosteje negativen revmatoidni faktor ali pozitiven poliartritis in razširjen oligoartritis).
• lupus-like syndrome;
• sindrom podoben lupusu;
• Do not use the Kromeya pre-filled syringe if it has been dropped or crushed, as the pre-filled syringe may be broken even if you cannot see the break.
• Zdravila Kromeya napolnjena injekcijska brizga ne uporabljajte, če vam je padlo iz rok ali je bila brizga strta, saj je lahko injekcijska brizga poškodovana, tudi če ne vidite razpok.
Your doctor will decide if your child should receive Kromeya.
On se bo odločil, ali lahko vaš otrok dobiva zdravilo Kromeya.