natgillin/translations-raw huggingface dataset:
How to store HBVAXPRO 10 micrograms Contents of the pack and other information 
Shranjevanje cepiva HBVAXPRO 10 mikrogramov Vsebina pakiranja in dodatne informacije
Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms 
Bolezni dihal, prsnega koša in mediastinalnega prostora bronhospazmu podobni simptomi zelo redki (< 1/10.000)
0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps. 
0,5 ml suspenzije v viali (steklo) z zamaškom (siva butilna guma) in aluminijastim obročkom s plastično dvižno zaporko.
The schedule is two injections with an interval of one month followed by a third injection 6 months after the first administration (0, 1, 6 months). 
Shema cepljenja: dve injekciji v enomesečnem presledku, ki jima sledi tretja injekcija 6 mesecev po prvi (0, 1 in 6 mesecev).
Two immunisation schedules can be recommended: - two injections with an interval of one month followed by a third injection 6 months after the first administration (0, 1, 6 months). 
Priporočimo lahko dve shemi primarnega cepljenja: - dve injekciji v enomesečnem presledku, ki jima sledi tretja injekcija 6 mesecev po prvi (0, 1 in
Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa 
Bolezni imunskega sistema serumska bolezen, anafilaksija, nodozni poliarteritis zelo redki (< 1/10.000)
What HBVAXPRO 5 micrograms looks like and contents of the pack 
Izgled cepiva HBVAXPRO 5 mikrogramov in vsebina pakiranja
In two trials conducted in older adolescents and adults, 95.6-97.5 % of vaccinees developed a protective level of antibodies, with geometric mean titres in these trials ranging from 535 - 793 IU/l. 
V kliničnih raziskavah se je zaščitna raven protiteles proti površinskemu antigenu virusa hepatitisa B (≥ 10 i.e./l) pojavila pri 96 % od 1497 zdravih dojenčkov, otrok, mladostnikov in odraslih, ki so dobili ciklus treh odmerkov prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B. V dveh preskušanjih pri starejših mladostnikih in odraslih se je pri 95,6-97,5 % cepljenih osebah razvila zaščitna raven protiteles z geometričnim povprečjem titra 535-793 i.e./l.
Musculoskeletal, connective tissue and bone disorders Arthralgia, Arthritis, Myalgia, Pain in extremity 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, artritis, mialgija, bolečina v okončini zelo redki (< 1/10.000)
HBVAXPRO 40 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free'. 
Cepivo HBVAXPRO 40 mikrogramov vsebuje natrij: To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
HBVAXPRO is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients. 
Cepivo HBVAXPRO je indicirano za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri odraslih bolnikih, ki so pred dializo ali na dializi.
HBVAXPRO 10 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free'. 
Cepivo HBVAXPRO 10 mikrogramov vsebuje natrij: To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
EU/1/01/183/001 - pack of 1 EU/1/01/183/018 - pack of 10 EU/1/01/183/019 - pack of 1 
EU/1/01/183/001 - pakiranje po 1 EU/1/01/183/018 - pakiranje po 10 EU/1/01/183/019 - pakiranje po 1
What HBVAXPRO 40 micrograms looks like and contents of the pack 
Izgled cepiva HBVAXPRO 40 mikrogramov in vsebina pakiranja
EU/1/01/183/029 - pack of 10 EU/1/01/183/032 - pack of 20 
EU/1/01/183/029 - pakiranje po 10 EU/1/01/183/032 - pakiranje po 20
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients. 
Cepivo je indicirano za aktivno imunizacijo proti okužbi z vsemi znanimi podtipi virusa hepatitisa B pri bolnikih, ki so pred dializo in na dializi.
A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen is less than 10 IU/l. 
O obnovitvenem odmerku je treba razmisliti pri tistih ceplenih osebah, pri katerih je raven protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBsAg) pod 10 i.e./l.
EU/1/01/183/013 - pack of 10 EU/1/01/183/026 - pack of 1 
EU/1/01/183/013 - pakiranje po 10 EU/1/01/183/026 - pakiranje po 1
Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy 
Bolezni krvi in limfatičnega sistema trombocitopenija, limfadenopatija zelo redki (< 1/10.000)
What HBVAXPRO 10 micrograms looks like and contents of the pack 
Izgled cepiva HBVAXPRO 10 mikrogramov in vsebina pakiranja
0.5 ml of suspension in pre-filled syringe (glass) without needle with a plunger stopper (gray chlorobutyl). 
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo) brez igle z batnim zamaškom (sivi klorbutil).
HBVAXPRO 5 micrograms is a suspension for injection in a syringe. 
Cepivo HBVAXPRO 5 mikrogramov je suspenzija za injiciranje v injekcijski brizgi.
1 ml of suspension in pre-filled syringe (glass) without needle with a plunger stopper (gray chlorobutyl). 
1 ml suspenzije v napolnjeni injekcijski brizgi (steklo) brez igle z batnim zamaškom (sivi klorbutil).
In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy adults. 
Poleg tega so pri zdravih odraslih dokazali obstoj s cepivom sproženega imunskega spomina za površinski antigen virusa hepatitisa B (HBsAg) z anamnestičnim odzivom protiteles na obnovitveni odmerek prejšnjega pripravka Merckovega rekombinantnega cepiva proti hepatitisu B. Tako kot pri drugih cepivih proti hepatitisu B trajanje zaščitnega učinka pri zdravih cepljenih osebah trenutno ni znano.
EU/1/01/183/007 - pack of 1 EU/1/01/183/008 - pack of 10 
EU/1/01/183/007 - pakiranje po 1 EU/1/01/183/008 - pakiranje po 10
HBVAXPRO 40 micrograms is a suspension for injection in a vial. 
Cepivo HBVAXPRO 40 mikrogramov je suspenzija za injiciranje v viali.
HBVAXPRO 10 micrograms - single dose pre-filled syringe without needle - Pack of 1, 10 
HBVAXPRO 10 mikrogramov - enoodmerna napolnjena injekcijska brizga brez iglepakiranje po 1, 10
EU/1/01/183/027 - pack of 10 EU/1/01/183/028 - pack of 1 
EU/1/01/183/027 - pakiranje po 10 EU/1/01/183/028 - pakiranje po 1
HBVAXPRO 10 micrograms is a suspension for injection in a syringe. 
Cepivo HBVAXPRO 10 mikrogramov je suspenzija za injiciranje v injekcijski brizgi.
• Low platelet count, Lymph node disease 
• majhno število trombocitov, bolezen limfnih vozlov,
0.5 ml of suspension in pre-filled syringe (glass) with 2 separate needles with a plunger stopper (gray chlorobutyl). 
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z 2 priloženima iglama z batnim zamaškom (sivi klorbutil).
- The first dose of the vaccine should be given within 7 days of exposure and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site. 
- Čim prej po izpostavljenosti (v 24 urah) je treba uporabiti imunoglobulin proti hepatitisu B. - Prvi odmerek cepiva je treba dati v 7 dneh po izpostavljenosti; dati ga je mogoče hkrati z imunoglobulinom proti hepatitisu B, vendar na drugo vbodno mesto.
HBVAXPRO 5 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10 
HBVAXPRO 5 mikrogramov - enoodmerna napolnjena injekcijska brizga z 1 priloženo iglopakiranje po 1, 10
HBVAXPRO 5 micrograms is a suspension for injection in a vial. 
Cepivo HBVAXPRO 5 mikrogramov je suspenzija za injiciranje v viali.
1 ml of suspension in pre-filled syringe (glass) with 2 separate needles with a plunger stopper (gray chlorobutyl). 
1 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z 2 priloženima iglama z gumijastim batnim zamaškom (sivi klorbutil).
The deltoid muscle is the preferred site for injection in adults. 
Pri odraslih je najprimernejše mesto za injiciranje deltoidna mišica.
- The first dose of the vaccine should be given within 7 days of birth and can be administered simultaneously with hepatitis B immunoglobulin at birth, but at a separate injection site. 
- Takoj po rojstvu (v 24 urah) en odmerek imunoglobulina proti hepatitisu B. - Prvi odmerek cepiva je treba dati v 7 dneh po rojstvu; dati ga je mogoče hkrati z imunoglobulinom proti hepatitisu B, vendar na drugo vbodno mesto.
HBVAXPRO 40 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA) 
HBVAXPRO 40 mikrogramov, suspenzija za injiciranje cepivo proti hepatitisu B (rekombinantna DNA)
HBVAXPRO 5 micrograms suspension for injection Hepatitis B vaccine (rDNA) 
HBVAXPRO 5 mikrogramov suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
HBVAXPRO 5 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA) 
HBVAXPRO 5 mikrogramov, suspenzija za injiciranje cepivo proti hepatitisu B (rekombinantna DNA)
HBVAXPRO 40 micrograms suspension for injection Hepatitis B vaccine (rDNA) 
HBVAXPRO 40 mikrogramov suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
Schedule 0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration. 
Ciklus cepljenja mora obsegati tri injekcije: shema 0, 1 in 6 mesecev: dve injekciji v presledku enega meseca, tretja injekcija 6 mesecev po prvi injekciji.
The syringe should be well shaken until a slightly opaque white suspension is obtained. 
Pred uporabo je treba injekcijsko brizgo dobro pretresti, da nastane rahlo motna bela suspenzija.
HBVAXPRO 10 micrograms is a suspension for injection in a vial. 
Cepivo HBVAXPRO 10 mikrogramov je suspenzija za injiciranje v viali.
The upper arm muscle is the preferred site for injection in adults. 
Pri odraslih je najprimernejše mesto za injiciranje mišica na nadlakti.
HBVAXPRO 10 micrograms suspension for injection Hepatitis B vaccine (rDNA) 
HBVAXPRO 10 mikrogramov suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
Others vaccines and HBVAXPRO 40 micrograms 
Shranjevanje cepiva HBVAXPRO 40 mikrogramov
The deltoid muscle is the preferred site for injection in children and adolescents. 
Pri otrocih in mladostnikih je najprimernejše mesto za injiciranje deltoidna mišica.
HBVAXPRO 10 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA) 
HBVAXPRO 10 mikrogramov, suspenzija za injiciranje cepivo proti hepatitisu B (rekombinantna DNA)
0.5 ml of suspension in pre-filled syringe (glass) with 1 separate needle with a plunger stopper (gray chlorobutyl). 
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z 1 priloženo iglo z batnim zamaškom (sivi klorbutil).
How HBVAXPRO 5 micrograms is given 
Kako se uporablja cepivo HBVAXPRO 5 mikrogramov
What HBVAXPRO 5 micrograms contains 
Kaj vsebuje cepivo HBVAXPRO 5 mikrogramov
Others vaccines and HBVAXPRO 10 micrograms 
Shranjevanje cepiva HBVAXPRO 10 mikrogramov
How HBVAXPRO 10 micrograms is given 
Kako se uporablja cepivo HBVAXPRO 10 mikrogramov
How HBVAXPRO 40 micrograms is given 
Kako se uporablja cepivo HBVAXPRO 40 mikrogramov
What HBVAXPRO 40 micrograms contains 
Kaj vsebuje cepivo HBVAXPRO 40 mikrogramov
HBVAXPRO can be administered at the same time as with hepatitis B immunoglobulin, at a separate injection site. 
Druga cepiva in cepivo HBVAXPRO 40 mikrogramov Cepivo HBVAXPRO se lahko uporabi hkrati z imunoglobulinom proti hepatitisu B, a na drugem vbodnem mestu.
The deltoid muscle is the preferred site for injection in adults and adolescents. 
Pri odraslih in mladostnikih je najprimernejše mesto za injiciranje deltoidna mišica.
HBVAXPRO 5 micrograms suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA) 
HBVAXPRO 5 mikrogramov suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rDNA)
1 ml of suspension in pre-filled syringe (glass) with 1 separate needle with a plunger stopper (gray chlorobutyl). 
1 ml suspenzije v napolnjeni injekcijski brizgi (steklo) z 1 priloženo iglo z gumijastim batnim zamaškom (sivi klorbutil).
What HBVAXPRO 10 micrograms contains 
Kaj vsebuje cepivo HBVAXPRO 10 mikrogramov
HBVAXPRO 10 micrograms suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA) 
HBVAXPRO 10 mikrogramov suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rDNA)
The upper arm muscle is the preferred site for injection in children and adolescents. 
Pri otrocih in mladostnikih je najprimernejše mesto za injiciranje mišica na nadlakti.
Others vaccines and HBVAXPRO 5 micrograms 
Shranjevanje cepiva HBVAXPRO 5 mikrogramov
The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. 
Cepivo je treba pred uporabo pregledati zaradi morebitne nastale oborine ali spremembe barve vsebine.
The upper arm muscle is the preferred site for injection in adults and adolescents. 
Pri odraslih in mladostnikih je najprimernejše mesto za injiciranje mišica na nadlakti.
HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA) 
HBVAXPRO 10 mikrogramov, suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rekombinantna DNA)
HBVAXPRO 5 mcg suspension for injection Hepatitis B vaccine (rDNA) 
HBVAXPRO 5 µg suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA) 
HBVAXPRO 5 mikrogramov, suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu B (rekombinantna DNA)
HBVAXPRO 40 mcg suspension for injection Hepatitis B vaccine (rDNA) 
HBVAXPRO 40 µg suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
HBVAXPRO 10 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10 HBVAXPRO 10 micrograms - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10, 
HBVAXPRO 10 mikrogramov - enoodmerna napolnjena injekcijska brizga z 2 priloženima iglama - pakiranje po 1, 10, 20
Hepatitis B virus surface antigen, recombinant (HBsAg) *................... 40 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al 
Rekombinantni površinski antigen virusa hepatitisa B (HBsAg) * .................. 40 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,50 miligrama Al
HBVAXPRO 10 mcg suspension for injection Hepatitis B vaccine (rDNA) 
HBVAXPRO 10 µg suspenzija za injiciranje cepivo proti hepatitisu B (rDNA)
Hepatitis B virus surface antigen, recombinant (HBsAg) * ................... 5 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al 
Rekombinantni površinski antigen virusa hepatitisa B (HBsAg) * .................. 5 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,25 miligrama Al
HBVAXPRO 5 micrograms - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10, 
HBVAXPRO 5 mikrogramov - enoodmerna napolnjena injekcijska brizga z 2 priloženima iglama - pakiranje po 1, 10, 20, 50
Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain 
vnetje možganov, poslabšanje multiple skleroze, multipla skleroza, napadi krčev,
Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema Very rare (<1/10,000) Musculoskeletal, connective tissue and bone disorders Arthralgia, Arthritis, Myalgia, Pain in extremity 
Splošne težave in spremembe na mestu aplikacije lokalne reakcije (na mestu injiciranja): prehodna občutljivost, eritem, zatrdlina pogosti (≥1/100 do utrujenost, zvišana telesna temperatura, splošno slabo počutje, gripi podobni simptomi zelo redki (< 1/10.000)
Hepatitis B virus surface antigen, recombinant (HBsAg) *................... 10 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al 
Rekombinantni površinski antigen virusa hepatitisa B (HBsAg) * .................. 10 mikrogramov adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,50 miligrama Al
Talk to your doctor, pharmacist or nurse before you or your child receive HBVAXPRO 5 micrograms. 
Preden vi ali vaš otrok prejmete cepivo HBVAXPRO 5 mikrogramov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Dizziness and Fainting 
glavobol, omotica in omedlevica,
Talk to your doctor, pharmacist or nurse before you receive HBVAXPRO 40 micrograms. 
Preden prejmete cepivo HBVAXPRO 40 mikrogramov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
How much and how often to take? 
Koliko in kako pogosto vzeti?
These infections may be serious and include: 
Te okužbe so lahko resne in vključujejo:
(See section 4.5). 
(glejte poglavje 4.4).
36400 O Porriño Pontevedra, Spain and 
36400 O Porriño Pontevedra, Španija in
Wash and dry your hands. 
Umijte in posušite si roke.
• Do not inject through clothes 
• Ne injicirajte skozi oblačila
What should I do before I give myself a subcutaneous injection of Humira? 
Kaj moram narediti, preden si dam podkožno injekcijo zdravila Humira?
This represented an 84% median reduction in injection site pain. 
To je predstavljalo 84 % srednjega zmanjšanja bolečine na mestu injiciranja.
If the yellow indicator is not shown in the window, the plunger has not advanced adequately and the injection is not complete. 
Če se rumeni kazalnik ne prikaže v okencu, se bat ni ustrezno premaknil naprej in injiciranje ni dokončano.
Available data suggest that Humira does not worsen or cause strictures. 
Razpoložljivi podatki kažejo, da zdravilo Humira ne poslabša in ne povzroči striktur.
Date of first authorisation: 8 September 2003 Date of latest renewal: 8 September 2008 
Datum prve odobritve: 8 September 2003 Datum zadnjega podaljšanja: 8 September 2008
For example, do not warm it in a microwave or in hot water 
Na primer, ne smete segrevati v mikrovalovni pečici ali v vroči vodi.
DO NOT use the same site that was used for the last injection. 
NE UPORABITE istega mesta kot ste ga uporabili za zadnje injiciranje
2D code 
2D koda
Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment. 
Na splošno med bolniki, ki so prekinili študijo, jih je 18 % prekinilo študijo zaradi neželenih učinkov in 8 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
Check the inspection window. 
Preverite kontrolno okence.
Date of first authorisation: 08 September 2003 Date of latest renewal: 08 September 2008 
Datum prve odobritve: 08 September 2003 Datum zadnjega podaljšanja: 08 September 2008
• A loud “click” will signal the start of the injection 
• Glasen “klik” bo znak, da se je injiciranje začelo.
Slowly take your thumb off the plunger. 
Počasi umaknite palec iz bata.
Store in a refrigerator (2C - 8C). 
Shranjujte v hladilniku (2 °C - 8 °C).
Double-Blind Response at Week 68 
Dvojno slepa Odziv v 68. tednu
Clinical results were assessed for induction of remission at Week 8 and for maintenance of remission at Week 52. 
Klinične rezultate so ocenili glede indukcije remisije 8. teden in glede ohranitve remisije 52. teden.
• Do not touch the needle with your fingers or let the needle touch anything 
• Ne dotikajte se igle s prsti ali dovolite, da se igla dotakne česar koli.
doctor or pharmacist. 
medicinska sestra ali farmacevt.
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 13). 
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 13).
Monoclonal antibodies are proteins that attach to a specific target. 
Monoklonska protitelesa so beljakovine, ki se vežejo na specifične tarče.
Patients were allowed to continue on study medication beyond Week 78 until they had access to Humira. 
Bolnikom je bilo dovoljeno prejemati zdravilo v preskušanju tudi po 78. tednu, dokler niso imeli dostopa do zdravila Humira.
• The automatic needle guard will not activate unless all the liquid is injected 
• Avtomatski ščitnik za iglo se ne bo aktiviral, razen če se vsa tekočina injicira.
The recommended doses for Humira in each of the approved uses are shown in the following table. 
Priporočeni odmerki zdravila Humira za vsako odobreno uporabo so prikazani v naslednji tabeli.
There are two caps - one is grey and labelled ‘1' and the other is plum and labelled ‘2'. 
Nameščena ima dva pokrovčka - eden je siv in označen z '1', drugi pa škrlatne in označen z '2'.
First read all the instructions carefully and then follow them step by step. 
Navodila najprej natančno preberite in jih upoštevajte korak za korakom.
aspergillosis and listeriosis). 
aspergiloza in listerioza).
Double-Blind Response at Week 12 
Dvojno slepa Odziv v 12. tednu
Humira may be available in other strengths and/or presentations depending on the individual treatment needs. 
Zdravilo Humira je lahko na voljo v drugih jakostih in/ali oblikah, odvisno od individualnih potreb zdravljenja.
• infections caused by viruses, fungi, parasites or bacteria 
• okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije
1 Pack of 2 boxes each containing: 
1 pakiranje z dvema škatlama vsebuje:
What Humira is and what it is used for 
Kaj je zdravilo Humira in za kaj ga uporabljamo
Humira is intended for the treatment of the inflammatory diseases described below: 
Zdravilo Humira je namenjeno za zdravljenje vnetnih bolezni, opisanih spodaj:
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data 
* Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri odprtih podaljšanih študijah
Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. 
Omejeni podatki iz objavljene literature kažejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0.1 % do 1 %
DO NOT RECAP as you may damage the needle inside. 
NE POKRIVAJTE S POKROVČKOM, ker lahko poškodujete iglo v notranjosti.
It must be clear and colourless. 
Biti mora bistra in brezbarvna.
1) Setting up 
1) Priprava
You will set the volume to the prescribed dose in step 4, Dose Preparation. 
Količino boste nastavili na predpisani odmerek v 4. koraku, Priprava odmerka.
Place hand on the middle of the pen so that neither the grey cap (1) nor the plum cap (2) is covered. 
Roko položite na sredino peresnika, tako da ne zakrivate ne sivega pokrovčka (1) in ne škrlatnega pokrovčka (2).
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 of0.1-0.2 nM). 
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IK50 0,1-0,2 nM).
The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10. 
Primarni cilj študije je bila klinična remisija v 26. tednu, definirana kot vrednost PCDAI ≤ 10.
Data beyond Week 78 were generally consistent with these results but the number of enrolled subjects declined after this time. 
Podatki, zbrani po 78. tednu, so bili na splošno v skladu s temi rezultati, vendar se je število vključenih bolnikov zmanjšalo po tem času.
Take Humira out of the refrigerator. 
Zdravilo Humira vzemite iz hladilnika.
• A small amount of liquid on the injection site is normal 
• Majhna količina tekočine na mestu injiciranja je normalna.
NA NA 9.5% 41.5% 
NP 9,5 % 41,5 %
≥30% Reduction in Skin Pain 
≥30 % zmanjšanje bolečine na kožib
• Certain vaccines may cause infections and should not be given while receiving Humira. 
• Določena cepiva lahko povzročijo okužbe, zato se jih med zdravljenjem z zdravilom Humira ne sme uporabljati.