natgillin/translations-raw huggingface dataset:
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.
* 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 podaljšanih študijah brez placeba Vključno s podatki iz spontanega poročanja
Concomitant stable doses of one non-biologic immunosuppressant were permitted.
Sočasni stalni odmerki enega nebiološkega imunosupresiva so bili dovoljeni.
• A sharps container (see section 7.2).
• zbiralnik za ostre predmete (glejte poglavje 7.2).
Kromeya can also be given alone.
Zdravilo Kromeya se lahko daje tudi samo.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomoţno snov, navedeno v poglavju 6.1.
Week 8 and 52
8. in 52. teden
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Dovoljeni so bili sočasni stabilni odmerki aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev in 80 % bolnikov je nadaljevalo z dobivanjem vsaj enega od teh zdravil.
If you still see air gaps or bubbles at the tip of the syringe, repeat this step until air gaps or bubbles are gone.
Če v konici injekcijske brizge še vedno vidite zrak ali zračne mehurčke, ta korak ponovite, dokler jih ne odstranite.
TREATMENT FAILURE RATE (%)
ODSTOTEK NEUSPEHA ZDRAVLJENJA (%)
Label area (Kromeya, dose, expiration date)
Nalepka (Kromeya, odmerek, rok uporabnosti)
Doing so could damage the syringe or activate the clear needle guard.
S tem bi lahko poškodovali injekcijsko brizgo ali aktivirali prozorno varovalo za iglo.
Psoriasis study I (REVEAL) evaluated 1212 patients within three treatment periods.
Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
Side effects may occur up to 4 months or more after the last Kromeya injection.
Neţeleni učinki se lahko pojavijo še 4 mesece ali več po zadnji injekciji zdravila Kromeya.
Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Od teh s kliničnim odzivom v 4. tednu jih je bilo 48 % prej izpostavljenih drugim TNF-antagonistom.
• When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
• Ko se je bat premaknil do konca in se je prenehal premikati, drţite injekcijski peresnik na mestu še 5 sekund.
Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski koţni test in rentgensko slikanje prsnih organov) (veljajo lahko lokalna priporočila).
Check components to make sure that the packaging and the content are not damaged.
Pripomočke preglejte in preverite, ali sta ovojnina in vsebina nepoškodovani.
Impaired lung function may increase the risk for developing infections.
Okvarjena pljučna funkcija lahko zveča tveganje za razvoj okuţbe.
One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Razpoloţljivi podatki kaţejo, da je adalimumab po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, dosegel enako velik klinični odziv in je imel podobne varnostne značilnosti kot pred prekinitvijo.
• If you are over 65 years you may be more susceptible to infections while taking Kromeya.
• Če ste starejši od 65 let, ste morda dovzetnejši za okuţbe, če jemljete zdravilo Kromeya.
A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Veliko število (pribliţno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo ţivorojenih otrok z znanim izidom, vključno s 1500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
Tuberculosis can develop during therapy even if your child has had preventative treatment for tuberculosis.
Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok imel preventivno zdravljenje za tuberkulozo.
Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Pri peroralnem dajanju so imunoglobulini G podvrţeni intestinalni proteolizi in imajo nizko biološko razpoloţljivost.
Preclinical data on fertility effects of adalimumab are not available.
Predkliničnih podatkov o učinkih adalimumaba na plodnost ni na voljo.
• serious infections (including blood poisoning and influenza);
• resne okuţbe (vključno z zastrupitvijo krvi in gripo);
Significant response was first observed at week 2 and maintained through 24 weeks (Table
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 13).
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Za kombinirano uporabo z drugimi imunomodulirajočimi antirevmatičnimi zdravili razen metotreksata glejte poglavji 4.4 in 5.1.