natgillin/translations-raw huggingface dataset:
If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor. 
Če se vam med zdravljenjem ali po njem pojavijo nova poškodovana območja na koţi, ali če se vam spremeni videz obstoječih oznak ali območij poškodb, morate to povedati zdravniku.
Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at week 56. 
Z boleznijo povezane hospitalizacije in kirurški posegi so bili statistično pomembno zmanjšani pri adalimumabu v primerjavi s placebom v 56. tednu.
Table 23 Maintenance regimen 
Preglednica 23 Vzdrţevalni reţim
Kromeya is available in other presentations. 
Zdravilo Kromeya je na voljo v drugih oblikah.
• double vision; 
• dvojni vid
It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Kromeya. 
Če je mogoče, je za otroke priporočljivo, da pred začetkom zdravljenja z zdravilom Kromeya opravijo vsa načrtovana cepljenja za njihovo starost.
A single pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. 
Posamezna napolnjena injekcijska brizga ali napolnjen injekcijski peresnik se lahko shranjuje pri temperaturi največ do 25 ºC za obdobje do 14 dni.
Again slowly pull the plunger out to the prescribed dose and stop. 
Bat ponovno počasi izvlecite, dokler ne dobite pravega odmerka, ter nato prenehajte.
Table 15 Efficacy response in placebo-controlled period for study nr-axSpA II 
Preglednica 15 Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II
Clear, colourless solution. 
Bistra, brezbarvna raztopina.
• Crohn's disease, 
• Crohnova bolezen,
• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check your child for signs and symptoms of tuberculosis before starting Kromeya. 
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, bo zdravnik vašega otroka pred začetkom zdravljenja z zdravilom Kromeya preiskal glede znakov in simptomov tuberkuloze.
Kromeya 40 mg/0.8 mL solution for injection for paediatric use may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. 
Kromeya 40 mg/0,8 ml raztopine za injiciranje za pediatrično uporabo lahko shranjujete pri temperaturi do največ 25 ºC za obdobje 14 dni.
There is a known association between intermediate uveitis and central demyelinating disorders. 
Znana je zveza med intermediarnim uveitisom in demielinizirajočimi boleznimi osrednjega ţivčevja.
In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B,- NK-cells, monocyte/macrophages, and neutrophils. 
V študiji 64 bolnikov z revmatoidnim artritisom, zdravljenih z adalimumabom, niso odkrili znakov zavrtja odloţene preobčutljivosti, zniţanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/makrofagov ali nevtrofilcev.
Treatment with Kromeya may result in the formation of autoimmune antibodies. 
Zdravljenje z zdravilom Kromeya lahko povzroči nastanek avtoimunskih protiteles.
Table 22 Time to treatment failure in studies UV I and UV II 
Preglednica 22 Čas do neuspeha zdravljenja v študijah UV I in UV II
Corticosteroid taper was permitted after week 
Postopno zmanjšanje odmerka kortikosteroidov je bilo dovoljeno po 8. tednu.
• It is important to tell your doctor if your child has had or has a serious heart condition. 
• Pomembno je, da zdravniku poveste, če je vaš otrok imel ali ima resno bolezen srca.
Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). 
Zdravilo Kromeya je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
What Kromeya looks like and contents of the pack 
Izgled zdravila Kromeya in vsebina pakiranja
• place two fingers on the label area 
• z dvema prstoma primite del z nalepko
• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Kromeya. 
• Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Kromeya preiskal glede znakov in simptomov tuberkuloze.
Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). 
Zdravilo Kromeya je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil (DMARDs - disease-modifying anti-rheumatic drugs).
Single use components and medicine vial (adalimumab) for subcutaneous injection 
Pripomočki za enkratno uporabo in viala (adalimumab) za subkutano injiciranje
Table 27 Time to treatment failure in studies UV I and UV II 
Preglednica 27 Čas do neuspeha zdravljenja v študijah UV I in UV II
6.2 With a quick, short motion, push the needle into the skin at an angle of 45°. 
6.2 S kratkim, hitrim gibom potisnite injekcijsko iglo v koţo pod kotom 45°.
Amongst those who responded (Pediatric ACR 30) at week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period. 
Med tistimi, ki so se odzvali (Pediatric ACR 30) 24. teden (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased 
Preiskave pogosti koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA), zvišanje laktat dehidrogenaze v krvi
If you forget to use Kromeya 
Če ste pozabili uporabiti zdravilo Kromeya
• place two fingers on middle of the clear needle guard 
• injekcijsko brizgo primite z dvema prstoma na sredini prozornega varovala za iglo
Do not recycle your used sharps disposal container. 
Uporabljenega vsebnika za ostre predmete ne smete reciklirati.
Kromeya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system. 
Zdravilo Kromeya vsebuje učinkovino adalimumab, ki deluje na vaš imunski (obrambni) sistem.
Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156. 
Izboljšanje z zdravjem povezane kakovosti ţivljenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
4.2 Choose a different site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems. 
4.2 Vsakič izberite drugo mesto (ki je vsaj 2,5 centimetra oddaljeno od prejšnjega), da bi zmanjšali pordelost, draţenje in druge teţave s koţo.
Aortic aneurysm, vascular arterial occlusion, thrombophlebitis 
občasni aortna anevrizma, zapora arterijskega ţilja, tromboflebitis
Do not try to recap needle as it could lead to needle stick injury. 
Ne poskušajte dati pokrovčka nazaj na injekcijsko iglo, saj se lahko pri tem z iglo poškodujete.
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni „„brez natrija‟‟.
• mood swings (including depression); 
• spremenljivo razpoloţenje (vključno z depresijo);
8.1 To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Figure V). 
8.1 Da si boste laţje zapomnili, kdaj in kje injicirati naslednji odmerek zdravila, si beleţite datume in uporabljena mesta injiciranja (Slika V).
Clinical remission is Mayo score ≤ 2 with no subscore > 1; 
Klinična remisija pomeni oceno Mayo ≤ 2 in nobene podocene > 1.
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. 
Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects). 
Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opaţene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
The inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). 
Vnetje lahko povzroči poslabšanje vida in/ali prisotnost delcev v očesu (črnih pik ali koprenastih črt, ki se premikajo po vidnem polju).
Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions **p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a 
Klinični odgovor pomeni zniţanje ocene Mayo od začetka za ≥ 3 in ≥ 30 % ter zniţanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1; *p < 0,05 za parno primerjavo deleţev med adalimumabom in placebom **p < 0,001 za parno primerjavo deleţev med adalimumabom in placebom a
2.1 Wash your hands well with soap and water (Figure F) and dry them. 
2.1 Roke si dobro umijte z milom in vodo (Slika F) in jih osušite.
Kromeya 40 mg solution for injection in pre-filled syringe EU/1/19/1357/002 
Kromeya 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/19/1357/002
▪ the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. 
• Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča antirevmatična zdravila, vključno z metotreksatom, ni zadosten.
Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more. 
Adalimumab so raziskovali pri 9506 bolnikih v kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
Before Injection 
Pred injiciranjem
Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy. 
Uporaba ţivih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni adalimumabu in utero, ni priporočljiva še 5 mesecev po materini zadnji injekciji adalimumaba med nosečnostjo.
Week 4 
4. teden
• reactivation of hepatitis B infection; 
• reaktivacija okuţbe s hepatitisom B;
• cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer); 
• rak; vključno z rakom, ki zajame limfni sistem (limfom), in melanom (vrsta koţnega raka);
Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo. 
Adalimumab je pokazal statistično večje izboljšanje skupnega števila točk v HAQ-S vprašalniku in točk v telesni komponenti (Physical Component Score (PCS)) v SF-36 vprašalniku od začetka do 12. tedna v primerjavi s placebom.
Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 25. 
Stopnja prenehanja zdravljenja s kortikosteroidi ali imunomodulatorji je predstavljena v preglednici 25.
If your doctor considers that methotrexate is inappropriate, Kromeya can be given alone. 
Če vaš zdravnik meni, da metotreksat ni primeren, lahko zdravilo Kromeya dobivate samo.
In the open-label extension of RA study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients. 
V odprtem podaljšanju študije revmatoidnega artritisa III se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseskozi 8 in 10 let v tej podskupini bolnikov.
• Always inject using the technique your healthcare professional taught you. 
• Zdravilo vedno injicirajte tako, kot vam je pokazal vaš zdravstveni delavec.
Patients should be tested for HBV infection before initiating treatment with Kromeya. 
Bolnike je treba pred začetkom zdravljenja z zdravilom Kromeya testirati na okuţbo s HBV.
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration. 
Po uporabi adalimumaba se je zmanjšala tudi serumska raven matriks metaloproteinaz (MMP-1 in MMP-3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
Kromeya is used in adults to treat these conditions. 
Zdravilo Kromeya se uporablja pri odraslih za zdravljenje teh bolezni.
If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for your child. 
Če ima vaš otrok KOPB ali če veliko kadi, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za vašega otroka primerno.
Warning: Do not use if expiration date has passed. 
Opozorilo: Zdravila ne uporabljajte, če se je rok uporabnosti iztekel.
Kromeya is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye. 
Zdravilo Kromeya se uporablja za zdravljenje otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadane sprednji del očesa.
If you have questions, please ask your doctor. 
Če imate vprašanja, se posvetujte z zdravnikom.
7.2 Throw away the used syringe with the protected needle and the vial with attached vial adapter into a sharps container. 
7.2 Uporabljeno injekcijsko brizgo z zaščiteno injekcijsko iglo in vialo s pritrjenim nastavkom zavrzite v zbiralnik za ostre predete.
Warning: Do not touch the yellow connector. 
Opozorilo: Ne dotikajte se rumenega konektorja.
Among patients who were not in response at week 4, 43% of adalimumab maintenance patients responded by week 12 compared to 30% of placebo maintenance patients. 
Med bolniki, ki se v 4. tednu niso odzvali, se je 43 % bolnikov na vzdrţevalnem odmerku adalimumaba odzvalo do 12. tedna, v primerjavi s 30 % bolnikov na placebu.
Alternatively, if a patient has stopped Kromeya and signs and symptoms of disease recur, Kromeya may be re-administered. 
Če bolnik neha uporabljati zdravilo Kromeya, pa se znaki in simptomi bolezni ponovijo, je alternativno mogoče zdravilo Kromeya znova uvesti.
• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV. 
• Zdravniku morate povedati, če je vaš otrok nosilec virusa hepatitisa B (HBV), če ima aktivno HBV okuţbo ali če mislite, da bi se lahko nalezel HBV.
8.1 To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Figure T). 
8.1 Da si boste laţje zapomnili, kdaj in kje injicirati naslednji odmerek zdravila, si beleţite datume in uporabljena mesta injiciranja (Slika T).
• The liquid is clear, colorless, and free of particles (Figure J). 
• je tekočina bistra, brezbarvna in brez delcev (Slika J).
Warning: Do not detach the pink needle safety cover from the yellow connector. 
Opozorilo: Roza varovala za injekcijsko iglo ne odstranite z rumenega konektorja.
A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1). 
Pri večjem deleţu bolnikov, ki so prejemali adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
The conduct and results of these tests should be recorded on your child's patient reminder card. 
Izvedbo in rezultate teh preiskav je treba zabeleţiti na otrokovi opozorilni kartici.
There is limited experience in the initiation of treatment with adalimumab alone. 
O začetku zdravljenja samo z zdravilom adalimumab so izkušnje omejene.
If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week. 
Če je z 40 mg vsak teden ali 80 mg vsak drugi teden doseţen zadosten odziv na zdravljenje, se lahko odmerek pozneje zmanjša na 40 mg vsak drugi teden.
3.3 Check the label to make sure that: 
3.3 Preglejte nalepko in preverite, ali:
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week. 
Najmanjše koncentracije adalimumaba v serumu v stanju dinamičnega ravnovesja so naraščale pribliţno sorazmerno odmerku po 20, 40 in 80 mg subkutano vsak drugi teden in vsak teden.
Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2). 
V obeh študijah je bil dokazan zgodnji in vzdrţevan učinek adalimumaba na odstotek neuspeha zdravljenja proti placebu (glejte sliko 2).
3.4 Keep the vial and syringe vertical and slowly pull the prescribed dose. 
3.4 Vialo in injekcijsko brizgo drţite navpično in počasi potegnite bat ter brizgo napolnite s predpisanim odmerkom.
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)). 
Adalimumab je pokazal terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti koţe (telesna površina ≥ 10 % (60 % bolnikov) in telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
• oedema (a build-up of fluid in the body which causes the affected tissue to swell); 
• edem (kopičenje tekočine v telesu, ki povzroča nabrekanje prizadetih tkiv);
In rare cases, these infections may be lifethreatening. 
Te okuţbe so lahko v redkih primerih smrtno nevarne.
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e., not identical to the TSS used for rheumatoid arthritis), was used. 
Za oceno so uporabili modificirani celotni seštevek po Sharpu (modified Total Sharp Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
• A clean cotton ball or gauze, and 
• Čist kos vate ali gazo ter
In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001). 
V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in klasičnim zdravljenjem, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in klasičnim zdravljenjem (p < 0,001).
- if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). 
- če imate hudo okuţbo, vključno s tuberkulozo, sepso (zastrupitev krvi) ali drugo oportunistično okuţbo (ponavadi okuţba povezana z oslabljenim imunskim sistemom).
If you forget to give your child a Kromeya injection, you should inject the Kromeya dose as soon as you remember. 
Če pozabite dati vašemu otroku injekcijo zdravila Kromeya, mu morate odmerek zdravila Kromeya injicirati, čim se spomnite.
6.4 Inject 
6.4 Injicirajte
Reporting of suspected adverse reactions 
Poročanje o domnevnih neţelenih učinkih
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12. 
Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrţevalno zdravljenje do 12. tedna.
You should not take Kromeya with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. 
Zdravila Kromeya ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okuţbe.
Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. 
Podatki, ki so na voljo, kaţejo, da je klinični odziv po navadi doseţen v 2-8 tednih zdravljenja.
However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab. 
Poleg tega so iz obdobja trţenja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
You should continue to inject Kromeya for as long as your doctor has told you. 
Nadaljevati morate z injiciranjem zdravila Kromeya tako dolgo, kot vam je naročil zdravnik.
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years. 
Zvišanja ALT ≥ 3 x ULN se niso pojavila v preskušanju faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 leta.
- The active substance is adalimumab. 
- Učinkovina je adalimumab.
Kromeya is a biosimilar medicinal product. 
Zdravilo Kromeya je biološko podobno zdravilo.
1.4 Check the expiration date on the side of the box (Figure B). 
1.4 Preverite rok uporabnosti, ki je odtisnjen na stranici škatle (Slika B).
Step 5 Clean the Injection Site 
5. korak Očistite mesto injiciranja
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially 'sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 0,8 ml odmerek, kar v bistvu pomeni „„brez natrija‟‟.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le na recept s posebnim reţimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
6.3 Gently push the white plunger rod all the way down until the syringe is empty. 
6.3 Neţno potisnite bel bat do konca navzdol, dokler se injekcijska brizga ne izprazni.
2.1 Wash your hands with soap, water and dry them well. 
2.1 Roke si dobro umijte z milom in vodo in jih dobro osušite.
If you receive Kromeya while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy. 
Če prejemate zdravilo Kromeya med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okuţbo do okoli pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.