natgillin/translations-raw huggingface dataset:
The following adverse events occurred more often in patients receiving losartan than placebo: Blood and lymphatic system disorders: not known: anaemia 
Naslednji neželeni učinki so se pogosteje pojavili pri bolnikih, ki so prejemali losartan, kot pri bolnikih, ki so prejemali placebo:
Each Cozaar 50 mg film-coated mg tablet contains 50 mg losartan potassium. 
Vsaka COZAAR 50 mg filmsko obložena tableta vsebuje 50 mg kalijevega losartanata.
Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate. 
Vsaka Cozaar 12,5 mg tableta vsebuje 25,5 mg laktoze monohidrata.
LORTAAN 100mg 
100mg
Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium. 
Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze, ki vsebujejo 25 mg kalijevega losartanata.
A lower dose should be considered for patients with a history of hepatic impairment. 
Pri bolnikih, ki so kdaj imeli okvaro jeter, je treba razmisliti o manjšem odmerku.
Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt). 
Vsaka Cozaar 50 mg tableta vsebuje 50 mg losartana (v obliki kalijeve soli).
• migraine, 
• migrena
Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate. 
Vsaka Cozaar 50 mg tableta vsebuje 25,5 mg laktoze monohidrata.
Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135 
Luksemburg Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Bruselj, Belgija
Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium. 
Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze, ki vsebujejo 100 mg kalijevega losartanata.
Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting 
Bolezni prebavil občasne: diareja, navzeja, bruhanje
White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other. 
Bele, filmsko obložene tablete v obliki kapljice, z oznako 951 na eni strani in brez oznake na drugi strani.
Investigators were instructed to titrate the study medication to 100 mg daily as appropriate; 72 % of patients were taking the 100 mg daily dose for the majority of the time. 
Raziskovalci so dobili navodila, naj odmerek preiskovanega zdravila titrirajo do 100 mg enkrat na dan, če je potrebno.
• shortness of breath (dyspnoea), 
• kratka sapa (dispneja)
• nausea, 
• bruhanje
Each Cozaar 50 mg tablet contains 50 mg of losartan potassium. 
Vsaka Cozaar 50 mg tableta vsebuje 50 mg kalijevega losartanata.
Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt). 
Vsaka Cozaar 100 mg tableta vsebuje 100 mg losartana (v obliki kalijeve soli).
751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of a blood lowering pressure. 
Namen študije je bil poleg koristi za znižanje krvnega tlaka pokazati še zaščitni učinek kalijevega losartanata na ledvice.
Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium. 
Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet z razdelilno zarezo, ki vsebujejo 50 mg kalijevega losartanata.
happening in less than 1 in 10,000 patients not known 
pojavijo se pri manj kot 1 od 10.000 bolnikov neznana pogostnost: (iz razpoložljivih podatkov se ne da oceniti)
Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate. 
Vsaka Cozaar 25 mg tableta vsebuje 12,75 mg laktoze monohidrata.
What Cozaar looks like and contents of the pack Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium. 
Zdravilo Cozaar je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze, ki vsebujejo 12,5 mg kalijevega losartanata.
In the LIFE-Study black patients treated with Losartan had a higher risk of suffering the primary combined endpoint, i.e. a cardiovascular event (e.g. cardiac infarction, cardiovascular death) and especially stroke, than the black patients treated with atenolol. 
V študiji LIFE so imeli bolniki črne rase, zdravljeni z losartanom, večje tveganje za primarni sestavljeni opazovani dogodek, t.j.
• Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment. 
• Zdravljenje bolezni ledvic pri bolnikih s hipertenzijo in sladkorno boleznijo tipa 2 s proteinurijo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 12.5 mg HDPE bottle 
PODATKI NA ZUNANJI OVOJNINI Škatla s HDPE plastenko za Cozaar 12,5 mg
Film-coated tablets 
Filmsko obložene tablete.
White, oval unscored film-coated tablets marked 951 on one side and plain on the other.. Cozaar 50 mg tablet 
Bele, ovalne filmsko obložene tablete brez razdelilne zareze, z oznako 951 na eni strani in brez oznake na drugi strani.
Cozaar contains lactose monohydrate. 
Pomembne informacije o nekaterih sestavinah zdravila Cozaar Zdravilo Cozaar vsebuje laktozo monohidrat.
The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171). 
Cozaar 100 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171).
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom 
Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 100 mg HDPE Bottle 
PODATKI NA ZUNANJI OVOJNINI Škatla s HDPE plastenko za Cozaar 100 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 50 mg HDPE bottle 
PODATKI NA ZUNANJI OVOJNINI Škatla s HDPE plastenko za Cozaar 50 mg
MARKETING AUTHORISATION HOLDER [To be implemented nationally] 
IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica]
Cozaar 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets. 
Cozaar 50 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 ali 500 tablet.
Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135 
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Bruselj, Belgija
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg losartan potassium. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 12,5 mg kalijevega losartanata.
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see section 4.4) 
Kot posledico zaviranja sistema renin-angiotenzin-aldosteron so pri bolnikih s tveganjem poročali o spremembah ledvične funkcije, vključno z ledvično odpovedjo.
NAME OF THE MEDICINAL PRODUCT Cozaar 25 mg film-coated tablets Losartan 
Cozaar 25 mg filmsko obložene tablete losartan
Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. 
Cozaar 100 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets. 
Cozaar 100 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 ali 280 tablet.
Batch 
Ciper
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg blister 
PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar 12,5 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 25 mg 
PODATKI NA ZUNANJI OVOJNINI Škatla za Cozaar 25 mg
The Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171). 
Cozaar 50 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171).
The Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171). 
Cozaar 25 mg tablete lahko vsebujejo še karnauba vosek (E903), titanov dioksid (E171).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister) 
Zgibanka za Cozaar 12,5 mg in 50 mg (pretisni omoti za titracijsko odmerjanje)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg losartan potassium. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 25 mg kalijevega losartanata.
OTHER 
Presnova
The dose may be increased to 100 mg once daily based on blood pressure response from one month after initiation of therapy onwards. 
V izjemnih primerih se odmerek lahko poveča do največ 50 mg enkrat na dan. Odmerek je treba prilagoditi glede na odziv krvnega tlaka.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 100 mg blister 
PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar 100 mg
Ear and labyrinth disorders: common: vertigo 
Ušesne bolezni, vključno z motnjami labirinta pogoste: vrtoglavica
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 100 mg kalijevega losartanata.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg blister 
PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar 50 mg
NAME OF THE MEDICINAL PRODUCT Cozaar 100 mg film-coated tablets Losartan 
Cozaar 100 mg filmsko obložene tablete losartan
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 50 mg kalijevega losartanata.
NAME OF THE MEDICINAL PRODUCT Cozaar 12.5 mg film-coated tablets Losartan 
Cozaar 12,5 mg filmsko obložene tablete losartan
The following wording has been added to SPC Section 5.1.Pharmacodynamic Properties: 
Naslednje besedilo je bilo dodano v poglavje 5.1.
Cozaar film-coated tablets losartan potassium 
NAVODILO ZA UPORABO Cozaar filmsko obložene tablete kalijev losartanat
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. 
Veže se na receptorje v krvnih žilah in tako povzroči, da se zožijo.
• cough, 
• kašelj
Nervous system disorders: not known: migraine 
Bolezni mišično-skeletnega sistema in vezivnega tkiva pogostnost ni znana: mialgija, artralgija
Severe hepatic impairment 
Bolezni ledvic
Patients who weighted >20kg to < 50 kg received either 2.5, 25 or 50 mg of losartan daily and patients who weighted > 50 kg received either 5, 50 or 100 mg of losartan daily. 
Antihipertenzivni učinek zdravila Cozaar so dokazali v klinični študiji, ki je zajela 177 hipertenzivnih pediatričnih bolnikov, starih 6 do 16 let, s telesno maso > 20 kg in hitrostjo glomerulne filtracije > 30 ml/min/1,73 m2. Bolniki, ki so tehtali > 20 kg do < 50 kg, so prejemali bodisi 2,5, 25 ali 50 mg losartana na dan, bolniki, ki so tehtali > 50 kg, pa so prejemali bodisi 5, 50 ali 100 mg losartana na dan.
NAME OF THE MEDICINAL PRODUCT Cozaar 50 mg film-coated tablets Losartan 
Cozaar 50 mg filmsko obložene tablete losartan
Cosaar 100 mg - Filmtabletten Belgium COZAAR 100 mg Belgium COZAAR 50 MG Belgium COZAAR 12,5 mg Belgium COZAAR CARDIO START Belgium LOORTAN 100 mg Belgium LOORTAN 50 mg Belgium LOORTAN 12,50 mg Belgium LOORTAN CARDIO START Bulgaria 
Portugalska COZAAR Portugalska COZAAR 100 mg Portugalska COZAAR IC Portugalska COZAAR IC - Titulação Portugalska LORTAAN IC Portugalska LORTAAN IC- Titulação Portugalska LORTAAN Portugalska LORTAAN 100mg Romunija
You may need to read it again. 
Morda ga boste ţeleli ponovno prebrati.
Open here 
Odprite tukaj
How much and how often to take? 
Koliko in kako pogosto se uporablja?
You will hear a loud click, which means the injection has started. 
Slišali boste glasen klik, kar pomeni, da se je injiciranje začelo.
Age over 65 years 
Starejši od 65 let
The expiry date refers to the last day of that month. 
Datum izteka roka uporabnosti se nanaša na zadnji dan tega meseca.
An updated RMP should be submitted: 
Posodobljen RMP je treba predloţiti:
1.2 You will also need (Figure A): 
1.2 Potrebovali boste tudi (Slika A):
• You did not inject the full dose or 
• niste injicirali celotnega odmerka ali
1.4 You will also need following supplies that are not included in the kit: 
1.4 Potrebovali boste tudi naslednje pripomočke, ki niso priloţeni v kompletu:
Particular attention regarding the risk for infection should be paid when treating the elderly. 
Posebna pozornost glede tveganja okuţb je potrebna pri zdravljenju starejših.
• Properly labeled to warn of hazardous waste inside the container. 
• je pravilno označen za opozorilo pred nevarnimi odpadki, ki jih vsebuje.
Clinical studies in patients suffering hidradenitis suppurativa in this section are merely included for public health reasons. 
Klinične študije pri bolnikih, ki trpijo za hidradenitis suppurativo, so v tem poglavju vključeni samo zaradi javno zdravstvenih razlogov.
Minimum, median and maximum dose 
Najmanjši, srednji in največji odmerek
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predloţitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 
Z namenom, da bi izboljšali sledljivost bioloških zdravil, morata biti ime in številka serije uporabljenega zdravila jasno zabeleţena.
6.6 The needle is now covered and is safe. 
6.6 Injekcijska igla je sedaj pokrita in varna.
61352 Bad Homburg v.d.Höhe Germany 
61352 Bad Homburg v.d.Höhe Nemčija
Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child. 
Opomba: Z vajo boste ugotovili, kakšen kot (od 45° do 90°) je najudobnejši za vas in otroka.
However, please note that Kromeya is neither intended nor authorized for treatment of hidradenitis suppurativa. 
Vendar upoštevajte, da Kromeya ni namenjena, niti pooblaščena za zdravljenje hidradenitis suppurative.
If you do not have a sharps disposal container, you may use a household container that is: 
Če nimate zbiralnika za ostre predmete, lahko uporabite koš za gospodinjske odpadke, ki:
Not known (frequency cannot be estimated from available data) 
Neznana pogostnost (pogostnosti iz razpoloţljivih podatkov ni mogoče oceniti):
1.1 Prepare a clean flat surface, such as a table or countertop, in a well-lit area. 
1.1 Pripravite čisto površino, na primer mizo ali pult, v dobro razsvetljenem prostoru.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neţelenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neţelenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland 
Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Švica
In all situations described below, the benefit/risk balance of therapy should be very carefully considered. 
V vseh spodaj opisanih okoliščinah je treba korist/tveganje zdravljenja zelo natančno pretehtati.
Approximately half the cases were lymphomas. 
V pribliţno polovici primerov je šlo za limfome.
PROBABILITY OF FAILING TREATMENT 
VERJETNOST ZA NEUSPEH ZDRAVLJENJA
Your child may first be given other medicines. 
Vaš otrok bo morda najprej prejel druga zdravila.
Injecting cold medicine may be painful. 
Injiciranje mrzlega zdravila je lahko boleče.
No effects on the breastfed newborns/infants are anticipated. 
Ni pričakovanega učinka na dojene novorojenčke/dojenčke.
Most side effects are mild to moderate. 
Večina neţelenih učinkov je blagih do zmernih.
The primary endpoint was ‘time to treatment failure'. 
Primarni opazovani dogodek je bil “čas do neuspeha zdravljenja”.
According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab. 
Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala adalimumab med nosečnostjo, v primerjavi z materami z enako boleznijo, ki adalimumaba niso jemale.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
Poročanje o domnevnih neţelenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
The liquid should be clear and colorless. 
Tekočina mora biti bistra in brezbarvna.
Results from the overall UC-II study population are shown in Table 26. 
Rezultate celotne populacije v študiji UC-II prikazuje preglednica 26.
Double-blind response at week 12 
Dvojno slepa Odziv v 12. tednu
See section 4.8 for how to report adverse reactions. 
Glejte poglavje 4.8, kako poročati o neţelenih učinkih.
See the end of section 4 for how to report side effects. 
Glejte na koncu poglavja 4, kako poročati o neţelenih učinkih.
Disease flares at the end of 32 weeks a 
Zagon bolezni na koncu 32-tedenskega obdobja a
There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. 
Potrebna je lahko prekinitev uporabe, npr. pred operacijo ali če se pojavi resna okuţba.
Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis. 
Poročila so vključevala primere pljučne in zunajpljučne (tj. diseminirane) tuberkuloze.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi to zdravilo neţelene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Injecting cold medicine can be painful (Figure E). 
Injiciranje mrzlega zdravila je lahko boleče (Slika E)
The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design. 
Na interpretacijo podatkov lahko vplivajo metodološke omejitve raziskave, vključno z majhno velikostjo vzorca in nerandomizirano zasnovo raziskave.
After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase. 
Po 32 tednih ali v primeru zagona bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo.
Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III). 
Bolniki iz študij UC-I in UC-II so imeli moţnost nadaljevati v odprti, dolgoročni podaljšani študiji (UC III).
• blood in urine; 
• kri v urinu;
Warning: Call your healthcare professional or pharmacist if: 
Opozorilo: Pokličite svojega zdravstvenega delavca ali farmacevta, če:
Concurrent administration of biologic DMARDs or TNF-antagonists 
Sočasna uporaba bioloških DMARDs ali antagonistov TNF
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. 
Nekateri neţeleni učinki, ki so bili opaţeni pri adalimumabu, nimajo simptomov in se jih lahko odkrije le pri krvnih testih.
Monoclonal antibodies are proteins that attach to a specific target in the body. 
Monoklonska protitelesa so beljakovine, ki se veţejo na specifične tarče v telesu.
Talk to your healthcare provider if you have any questions. 
Posvetujte se s svojim zdravstvenim delavcem, če imate še kakšna vprašanja.
Double-blind response at week 68 
Dvojno slepa Odziv v 68. tednu
Slowly release your thumb up. 
Palec počasi odmaknite od bata.
Available data suggest that adalimumab does not worsen or cause strictures. 
Razpoloţljivi podatki kaţejo, da adalimumab ne poslabša in ne povzroči striktur.
Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure: 
Nujno morate poiskati zdravniško pomoč, če opazite katerega od naslednjih znakov alergijske reakcije ali popuščanja srca:
Kromeya may be available in other presentations depending on the individual treatment needs. 
Zdravilo Kromeya je lahko na voljo v drugih oblikah, odvisno od individualnih potreb zdravljenja.
An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8. 
V koloni organski sistem po MedDRA se pojavi znak zvezdica (*), če so v zvezi s tem vključene dodatne informacije v poglavjih 4.3, 4.4 in 4.8.
73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy. 
73 % bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
ASDAS inactive disease hs-CRP 
ASDAS neaktivna bolezen hs-CRP
Among those, 109 subjects (63.7%) were reported to be in remission at 10 years. 
Med temi je bilo 109 oseb (63,7 %) po 10 letih v stanju remisije.
• new onset or worsening of psoriasis; 
• pojav ali poslabšanje psoriaze;
This is to remove any air gaps or bubbles. 
S tem odstranite zrak ali zračne mehurčke.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%. 
Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh študij po enem 40 mg odmerku subkutano, je 64 %.
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 kaţejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0.1 % do 1 % glede na materin serum.
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost voţnje in upravljanja strojev
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloţenem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil doseţen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
1.3 Open the kit and take out all components and put them on a clean, dry, flat surface. 
1.3 Komplet odprite, vzemite ven vse pripomočke ter jih poloţite na čisto, suho, ravno površino.
TIME (MONTHS) 
ČAS (MESECI)
• the lot number (on vial label). 
• serijsko številko (na nalepki na viali).
For the full list of excipients, see section 6.1. 
Za celoten seznam pomoţnih snovi glejte poglavje 6.1.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
V razvrstitvah pogostnosti so neţeleni učinki navedeni po padajoči resnosti.
- if you have moderate or severe heart failure. 
- če imate zmerno ali hudo srčno popuščanje.