natgillin/translations-raw huggingface dataset:
At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 25.
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1 : 1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 25.
Consequently, adalimumab can be used during breastfeeding.
Posledično se zdravilo Hulio lahko uporablja med dojenjem.
TIME (WEEKS) Treatment
ČAS (TEDNI)
- Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Hulio and during treatment with Hulio.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden vaš otrok prejme zdravilo Hulio in med zdravljenjem z njim.
Table 27: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Preglednica 27: Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
• 1 gauze pad or cotton ball (not included in Hulio pack)
• 1 blazinico gaze ali kosem vate (ni priložen pakiranju zdravila Hulio).
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 22).
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 22).
1 box of Hulio vial for paediatric use
• 1 škatlo vial zdravila Hulio za pediatrično uporabo;
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Hulio.
Priporočljivo je, da med zdravljenjem z zdravilom Hulio bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
V 4. tednu so bili bolniki randomizirani 1 : 1 bodisi v skupino s standardnim vzdrževalnim odmerkom (40/20 mg vsak drugi teden) ali v skupino z majhnim vzdrževalnim odmerkom (20/10 mg vsak drugi teden), odvisno od njihove telesne mase.
Your doctor, nurse or other healthcare professional will first show you how to inject Hulio pre-filled syringe.
Zdravnik, medicinska sestra ali drug zdravstveni delavec vam bo pokazal, kako si zdravilo Hulio v injekcijski brizgi injicirate sami.
If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash do not inject them more Hulio and contact their doctor immediately since, in rare cases, these reactions can be life-threatening.
Če ima vaš otrok alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Hulio ne injicirajte več in se takoj posvetujte z otrokovim zdravnikom, saj so v redkih primerih te reakcije lahko življenjsko ogrožujoče.
The syringe is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Injekcijska brizga je narejena iz cikličnih olefinskih polimerov z zaporko (klorobutilni kavčuk) in z iglo (nerjavno jeklo) z varovalnim pokrovčkom (mešanica butil/dienskih polimerov ter polipropilen).
Step 7 - Inject Hulio
7. korak - Injicirajte zdravilo Hulio.
A 40 mg pen and a 40 mg prefilled syringe are also available for patients to administer a full 40 mg dose.
Bolnikom sta na voljo tudi 40 mg injekcijski peresnik in 40 mg napolnjena injekcijska brizga za odmerjanje celotnega odmerka 40 mg.
Hulio is used to treat rheumatoid arthritis in adults.
Zdravilo Hulio se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Študija psoriaze IV je primerjala učinkovitost in varnost adalimumaba v primerjavi s placebom pri 217 odraslih bolnikih z zmerno do hudo psoriazo nohtov.
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Psoriatični artritis je vnetje sklepov, povezano s kožno luskavico.
Hulio is used to treat: - adults with non-infectious uveitis with inflammation affecting the back of the eye. - children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.
Zdravilo Hulio se uporablja za zdravljenje: - odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa, - otrok in mladostnikov, starih od 2 do 17 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
pogosti astma, dispneja, kašelj občasni pljučna embolija1), intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralni izliv1)
The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Varnost in učinkovitost adalimumaba sta bili ocenjeni v randomizirani, dvojno slepi, kontrolirani študiji pri 90 pediatričnih bolnikih, starih od 2 do < 18 let, z aktivnim neinfekcijskim anteriornim uveitisom, povezanim z juvenilnim idiopatskim artritisom, ki se niso odzvali na zdravljenje z metotreksatom, ki je trajalo vsaj 12 tednov.
You should not take Hulio with medicines containing the active substances anakinra or abatacept.
Zdravila Hulio ne smete jemati z zdravili, ki vsebujejo učinkovini anakinra ali abatacept.
These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
Solution for injection 1 pre-filled syringe, 2 alcohol pads 2 pre-filled syringes, 2 alcohol pads 6 pre-filled syringes, 6 alcohol pads
1 napolnjena injekcijska brizga, 2 alkoholna zloženca 2 napolnjeni injekcijski brizgi, 2 alkoholna zloženca 6 napolnjenih injekcijskih brizg, 6 alkoholnih zložencev
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04
Sustained Response
Ohranjen odziv
The recommended dose of Hulio for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Hulio za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
The recommended dose of Hulio for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Priporočeni odmerek zdravila Hulio pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
If your child develops a fever that does not go away, or bruises or bleeds very easily or look very pale, call your child's doctor right away.
Če vaš otrok dobi zvišano telesno temperaturo, ki ne mine, če se mu pojavljajo podplutbe, zlahka zakrvavi ali je zelo bled, se takoj posvetujte z njegovim zdravnikom.
• nausea and vomiting;
• siljenje na bruhanje in bruhanje;
The syringe inside the pen is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Injekcijska brizga v injekcijskem peresniku je narejena iz cikličnih olefinskih polimerov z zaporko (klorobutilni kavčuk) in z iglo (nerjavno jeklo) z varovalnim pokrovčkom (mešanica butil/dienskih polimerov ter polipropilen).
- Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Hulio and during treatment with Hulio.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Hulio in med zdravljenjem z njim.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - VIAL SINGLE UNIT PACK
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - ENOJNO PAKIRANJE VIAL
Needle Safety Feature
Varnostni sistem igle
Table 15: Ps Study II (CHAMPION) Efficacy Results at 16 weeks Placebo N=53 n (%)
Preglednica 15: Študija psoriaze II (CHAMPION) - rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
pogosti karcinom kože, ki ne vključuje melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom), benigni tumor občasni limfom**,
If these medicines do not work well enough, you will be given Hulio to reduce the signs and symptoms of your disease.
Če ta zdravila ne delujejo dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili zdravilo Hulio.
The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control - treated patients.
Incidenca resnih okužb je bila 0,04 na bolnikov-let med bolniki, ki so prejemali adalimumab, in 0,03 na bolnikov-let med bolniki, ki so dobivali placebo oziroma primerjalno zdravilo.
a a a p<0.001, adalimumab vs. placebo
b p < 0,001, adalimumab v primerjavi s placebom
Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Poročali so tudi o smrtnih in življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL).
If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Če dobite zvišano telesno temperaturo, ki ne mine, če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Delež (95-% interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1000 bolnikov-let med bolniki, ki so prejemali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
Your doctor, nurse or other healthcare professional will first show you how to inject Hulio pre-filled pen.
Zdravnik, medicinska sestra ali drug zdravstveni delavec vam bo pokazal, kako si zdravilo Hulio v injekcijskem peresniku injicirate sami.
In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let, in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 × ULN pojavila pri 6,1 % bolnikov, zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
With the vial adapter still in the clear package, attach it to the vial stopper by pushing the adapter over the vial until it snaps in place.
Medtem ko je adapter za vialo še v prozorni ovojnini, ga namestite na zaporko viale tako, da ga potiskate navzdol, dokler se ne zaskoči na mestu.
If you do not respond well enough to these medicines, you will be given Hulio to reduce the signs and symptoms of your Crohn's disease.
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Hulio.
In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih, zdravljenih z adalimumabom, in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 × ULN pojavilo pri 2,4 % bolnikov, zdravljenih z adalimumabom, in pri 2,4 % bolnikov v kontrolni skupini.
• 1 alcohol swab
• 1 alkoholni zloženec;
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hulio.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Hulio ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje mase, nekoliko zvišano telesno temperaturo, apatijo).
At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 19.
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1 : 1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 19.
• There have been cases of cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
• Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNFα, so poročali o primerih rakov, ki niso bili limfomi.
Hulio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Hulio je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki se ne odzovejo ustrezno na konvencionalno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
• If you received Hulio during your pregnancy, your baby may have a higher risk for getting an infection.
Če ste prejeli zdravilo Hulio med nosečnostjo, ima lahko vaš dojenček povečano tveganje za okužbo.
• Always keep your sharps container out of the sight and reach of children.
• Vsebnik za ostre predmete vedno shranjujte nedosegljiv otrokom.
o DO NOT put the vial back in the fridge after it has reached room temperature.
◦ Viale NE dajte nazaj v hladilnik, ko se segreje na sobno temperaturo.
For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg/ml (40/20 mg, weekly) and 6.7 ± 3.5 μg/ml (20/10 mg, weekly).
Pri bolnikih, ki so prešli z režima vsak drugi teden na režim vsak teden, so bile povprečne (± SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 µg/ml (40/20 mg tedensko) in 6,7 ± 3,5 µg/ml (20/10 mg tedensko).
For patients who are prescribed a full 40 mg dose of Hulio, a 40 mg pre-filled pen and a 40 mg prefilled syringe are also available from your pharmacist.
Bolnikom, ki jim je predpisan polni 40 mg odmerek zdravila Hulio, sta v lekarni na voljo tudi 40 mg napolnjen injekcijski peresnik in 40 mg napolnjena injekcijska brizga.
***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
***, ** Statistično značilno pri p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med adalimumabom in placebom.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Med temi kožnimi raki je bil delež (95-% interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so prejemali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
o DO NOT use the vial if the solution is cloudy, discoloured, or has particles in it.
◦ Viale NE uporabljajte, če je raztopina motna, obarvana ali vsebuje delce.
ALT elevations ≥ 3 x ULN occurred in 0.9% of adalimumab-treated patients and 0.9% of controlled-treated patients.
≥ 3 × ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
Table 21: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Preglednica 21: Študija Crohnove bolezni pri pediatričnih bolnikih - prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
Gently set the connected vial and adapter down on a flat work surface.
Vialo z nameščenim adapterjem previdno odložite na ravno delovno površino.
Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice), melanom**
Keep this Patient Reminder Card with you at all times and for 4 months after your last injection of Hulio.
To opozorilno kartico za bolnika imejte vedno pri sebi, kar velja še 4 mesece po zadnji injekciji zdravila Hulio, ki jo prejmete.
Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Pri bolnikih, ki so prejemali adalimumab, so poročali o resnih okužbah, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioze, legioneloze in pnevmocistične okužbe.
Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Slika 1: Kaplan-Meierjeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr axSpA II
RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
V študiji revmatoidnega artritisa I je bilo ocenjenih 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata od 10 do 25 mg ostal stalen vsak teden.
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Pri teh bolnikih je pri postavitvi diagnoze in izbiri empiričnega antimikotičnega zdravljenja potreben posvet z zdravnikom specialistom za zdravljenje bolnikov z invazivnimi glivičnimi okužbami.
On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA) (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in Ped ACR 50 (Ped ACR - American College of Rheumatology pediatric) odzivom.
• DO NOT re-use the syringe.
• Injekcijske brizge NE uporabite ponovno.
It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hulio.
Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Hulio opravijo vsa predvidena cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
P Value b
vrednost p
Step 10 - Flip down pink needle cover and remove needle cap Hold the syringe with the needle pointing up.
10. korak - Obrnite rožnati pokrovček igle navzdol in odstranite pokrovček igle.
Carriers of HBV who require treatment with Hulio should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Hulio, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
Step 15 - End of injection, remove syringe, engage needle cover When the syringe is empty, remove syringe and needle from the skin.
15. korak - Injiciranje je končano, odstranite brizgo, namestite pokrovček igle.
Pull the needle cover straight off the syringe.
Pokrovček igle povlecite naravnost z injekcijske brizge.
Step 5 - Attach vial adapter to vial
5. korak - Namestite adapter za vialo na vialo.
For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 μg/ml for the Standard Dose group and 3.5±2.2 μg/ml for the Low Dose group.
Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile povprečne (±SD) najmanjše koncentracije adalimumaba v 52. tednu 9,5 ± 5,6 µg/ml v skupini s standardnim odmerkom in 3,5 ± 2,2 µg/ml v skupini z majhnim odmerkom.
Talk to your doctor or pharmacist before using Hulio.
Pred začetkom uporabe zdravila Hulio se posvetujte z zdravnikom ali farmacevtom.
• DO NOT put the clear needle cap back on the needle.
• NE NAMEŠČAJTE prozornega pokrovčka igle nazaj na iglo.
Step 9 - Detach syringe from vial adapter and attach needle Remove the vial adapter by twisting it off the syringe.
9. korak - Odstranite brizgo z adapterja za vialo in namestite iglo.