natgillin/translations-raw huggingface dataset:
Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes MellitusThrombolysis in Myocardial Infarction (SAVOR) Study SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥6.5% and <12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
SAVOR je bilo ispitivanje kardiovaskularnih ishoda provedeno u 16 492 bolesnika s vrijednostima HbA1c od ≥ 6,5% i < 12% (12 959 bolesnika s potvrđenom kardiovaskularnom bolešću;
Improvements in HbA1c, PPG, and FPG following treatment with saxagliptin 5 mg plus metformin were sustained up to Week 102.
Poboljšane vrijednosti HbA1c, PPG-a i FPG-a nakon liječenja saksagliptinom od 5 mg i metforminom održale su se do 102. tjedna.
Some patients have had the following side effects while taking Onglyza and metformin:
Neki bolesnici imali su sljedeće nuspojave za vrijeme uzimanja lijeka Onglyza i metformina:
Saxagliptin add-on to thiazolidinedione therapy
Saksagliptin kao dodatak terapiji tiazolidindionom
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Veličine pakiranja od 14, 28, 56 i 98 filmom obloženih tableta u neperforiranim blisterima.
Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Veličine pakiranja od 14, 28 i 98 filmom obloženih tableta u neperforiranim kalendarskim blisterima.
The HbA1c change for saxagliptin 5 mg (n=82) compared to TZD plus placebo (n=53) was -0.9% at Week 76.
Promjena vrijednosti HbA1c pri uzimanju saksagliptina od 5 mg (n=82) u odnosu na placebo s TZD (n=53) iznosila je -0,9% u 76. tjednu.
BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 5 mg tablets
BLISTERI (PERFORIRANI / NEPERFORIRANI) za Onglyza 5 mg tablete
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Veličine pakiranja od 14, 28, 56 i 98 filmom obloženih tableta u neperforiranim kalendarskim blisterima.
Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4/5 inducer.
Kad se saksagliptin primjenjuje istodobno sa potentnim induktorom CYP3A4/5, treba pažljivo procijeniti regulaciju glikemije.
CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 5 mg tablets
KALENDARSKI OZNAČEN BLISTER (NEPERFORIRANI) za Onglyza 5 mg tablete
The HbA1c change for saxagliptin 5 mg plus metformin (n=177) compared to metformin plus placebo (n=147) was -0.5% at Week 76.
Promjena HbA1c pri uzimanju saksagliptina od 5 mg s metforminom (n=177) u usporedbi s uzimanjem placeba s metforminom (n=147) iznosila je -0,5% u 76. tjednu.
BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 2.5 mg tablets
BLISTERI (PERFORIRANI / NEPERFORIRANI) za Onglyza 2,5 mg tablete
A placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with a thiazolidinedione (TZD) in patients with inadequate glycaemic control (HbA1c 7-10.5%) on TZD alone.
Placebom kontrolirano ispitivanje u trajanju od 24 tjedna provedeno je da bi se procijenila djelotvornost i sigurnost primjene saksagliptina u kombinaciji s tiazolidindionom (TZD) u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 7%-10,5%) koji su uzimali samo tiazolidindionom.
Metabolism and nutrition disorders Hypoglycaemia
Poremećaji metabolizma i prehrane hipoglikemija vrlo često dislipidemija manje često hipertrigliceri demija manje često
printed on one side and “4214” printed on the other side, in blue ink.
Na jednoj strani imaju plavom tintom otisnutu oznaku „2.5“, a na drugoj „4214“.
CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 2.5 mg tablets
KALENDARSKI OZNAČEN BLISTER (NEPERFORIRANI) za Onglyza 2,5 mg tablete
Reductions in HbA1c were seen across subgroups including gender, age, race, and baseline body mass index (BMI) and higher baseline HbA1c was associated with a greater adjusted mean change from baseline with saxagliptin.
Smanjenje vrijednosti HbA1c opaženo je u svim podskupinama po spolu, dobi, rasi i početnom indeksu tjelesne mase (BMI).
An add-on placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with glibenclamide in patients with inadequate glycaemic control at enrollment (HbA1c 7.5-10%) on a sub-maximal dose of glibenclamide alone.
Placebom kontrolirano ispitivanje saksagliptina u trajanju od 24 tjedna provedeno je zbog procjene djelotvornosti i sigurnosti saksagliptina u kombinaciji s glibenklamidom u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 7,5%-10%) pri uključenju u ispitivanje uz uzimanje submaksimalne doze samo glibenklamida.
Improvements in HbA1c, PPG and FPG following initial therapy with saxagliptin 5 mg plus metformin were sustained up to Week 76.
Poboljšane vrijednosti HbA1c, PPG-a i FPG-a nakon početnog liječenja saksagliptinom od 5 mg i metforminom održale su se do 76. tjedna.
The HbA1c change for saxagliptin 5 mg (n=56) compared to uptitrated glibenclamide plus placebo (n=27) was -0.7% at Week 76.
Promjena HbA1c pri uzimanju saksagliptina od 5 mg (n=56) u usporedbi s placebom s glibenklamidom titriranim na višu dozu (n=27) iznosila je -0,7% u 76. tjednu.
Onglyza 5 mg film-coated tablets
Onglyza 5 mg filmom obložene tablete
Onglyza 2.5 mg film-coated tablets
Onglyza 2,5 mg filmom obložene tablete
• Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, stomach ache and swelling of the hands, ankles or feet (peripheral oedema).
• Često: infekcija u gornjem dijelu prsnog koša ili plućima, infekcija mokraćnih puteva, upala želuca ili crijeva obično uzrokovana infekcijom (gastroenteritis), infekcija sinusa uz bol i začepljenost iza obraza i očiju (upala sinusa), glavobolja, povraćanje, bol u želucu i oticanje šaka, nožnih zglobova ili stopala (periferni edem).
Onglyza 2.5 mg tablets saxagliptin
Onglyza 2,5 mg tablete saksagliptin
Improvements in HbA1c and PPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Poboljšane vrijednosti HbA1c i PPG-a nakon liječenja saksagliptinom od 5 mg održale su se do 76. tjedna.
Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:
Neki bolesnici imali su sljedeće nuspojave za vrijeme uzimanja lijeka Onglyza i tiazolidindiona:
Improvements in HbA1c, PPG and FPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Poboljšane vrijednosti HbA1c, PPG-a i FPG-a nakon terapije saksagliptinom od 5 mg održale su se do 76. tjedna.
Nervous system disorders Dizziness
Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija manje često
• Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, stomach ache and vomiting.
• Često: infekcija u gornjem dijelu prsnog koša ili plućima, infekcija mokraćnih puteva, upala želuca ili crijeva obično uzrokovana infekcijom (gastroenteritis), infekcija gornjih sinusa uz bol i začepljenost iza obraza i očiju (upala sinusa), glavobolja, bol u želucu i povraćanje.
An add-on to metformin placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Saksagliptin se pridodao metforminu u placebo kontroliranom ispitivanju u trajanju od 24-tjedna koje se provodilo zbog procjene djelotvornost i sigurnost primjene saksagliptina u kombinaciji s metforminom u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 7%-10%) koji su se liječili samo metforminom.
Some patients have had the following side effects while taking Onglyza and a sulphonylurea:
Neki bolesnici imali su sljedeće nuspojave za vrijeme uzimanja lijeka Onglyza i sulfonilureje:
OUTER CARTON Onglyza 2.5 mg film-coated tablets
KUTIJA Onglyza 2,5 mg filmom obložene tablete
p-value <0.001 for noninferiority (based on HR <1.3) compared to placebo.
Omjer hazarda prilagođen za kategoriju bubrežne funkcije na početku ispitivanja i kategoriju rizika od kardiovaskularne bolesti na početku ispitivanja. p-vrijednost <0,001 za neinferiornost (na temelju HR <1,3) u usporedbi s placebom. p- vrijednost = 0,99 za superiornost (na temelju HR <1,0) u usporedbi s placebom.
OUTER CARTON Onglyza 5 mg film-coated tablets
KUTIJA Onglyza 5 mg filmom obložene tablete
Onglyza 5 mg film-coated tablets Polyvinyl alcohol Macrogol 3350
Onglyza 5 mg filmom obložene tablete poli(vinilni alkohol)
Common Common Common
Ujedinjeno Kraljevstvo
Anaphylactic reactions including anaphylactic shock
Primjena s lijekovima koji izazivaju hipoglikemiju
Onglyza 5 mg film-coated tablets Saxagliptin
Onglyza 5 mg filmom obložene tablete saksagliptin
Saxagliptin is eliminated by both renal and hepatic pathways.
Saksagliptin se eliminira i putem bubrega i putem jetre.
Onglyza 2.5 mg film-coated tablets saxagliptin
Onglyza 2,5 mg filmom obložene tablete saksagliptin
4 Median follow-up is based on patients treated.
4 Medijan praćenja temelji se na broju liječenih bolesnika.
Date of first authorisation: 26/05/2016
Datum prvog odobrenja: 26. svibnja 2016.
(furunculosis)
(pleuritis)
• You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na infliksimab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
If acute infusion reactions occur, the infusion must be interrupted immediately.
Ako se pojave akutne reakcije na infuziju, infuzija se mora odmah prekinuti.
Write the new expiry date on the carton including day/month/year.
Napišite na kutiju novi rok valjanosti koji uključuje dan/mjesec/godinu.
The patient reminder card shall contain the following key messages:
Kartica s podsjetnikom za bolesnika sadržavat će sljedeće ključne poruke:
In this situation, do not return to refrigerated storage again.
U tom slučaju ne vraćajte lijek ponovno u hladnjak.
• Flixabi will be given to you by your doctor or nurse.
• Flixabi će Vam dati Vaš liječnik ili medicinska sestra.
Flixabi is also used in adults and children 6 years of age or older for:
Flixabi se također koristi u odraslih i djece u dobi od 6 ili više godina za liječenje:
• You will be monitored while you are given Flixabi and also for 1 to 2 hours afterwards.
• Bit ćete pod nadzorom dok primate Flixabi, te 1 do 2 sata nakon toga.
Flixabi belongs to a group of medicines called ‘TNF blockers'.
Flixabi pripada skupini lijekova koji se nazivaju " blokatori TNF-a".
Do not use Flixabi if any of the above applies to you.
Nemojte primijeniti Flixabi ako se nešto od navedenog odnosi na Vas.
EU/1/16/1106/001 EU/1/16/1106/002 EU/1/16/1106/003 EU/1/16/1106/004 EU/1/16/1106/005
EU/1/16/1106/002 EU/1/16/1106/003 EU/1/16/1106/004 EU/1/16/1106/005
• It is recommended that when Flixabi is prepared for infusion, it is used as soon as possible (within 3 hours).
• Preporučuje se pripremljenu otopinu za infuziju lijeka Flixabi upotrijebiti što prije (u roku od 3 sata).
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Akutne reakcije na infuziju, uključujući anafilaktičke reakcije, mogu se razviti tijekom (u roku od nekoliko sekundi) ili unutar nekoliko sati nakon infuzije.
Results from week 54 are shown in Table 4.
Rezultati u 54. tjednu prikazani su u tablici 4.
The interval between the last maintenance dose and the first reinduction dose ranged from 35-231 days.
Interval između zadnje doze održavanja i prve doze ponovljenog uvodnog režima liječenja kretao se od 35 do 231 dana.
Discuss the use of contraception during this time with your doctor.
Razgovarajte sa svojim liječnikom o uporabi kontracepcije tijekom tog razdoblja
It should be noted that suppression of TNFα may mask symptoms of infection such as fever.
Treba napomenuti da supresija TNFα može prikriti simptome infekcije poput vrućice.
• Reduce the signs and symptoms of your disease,
• umanjili znakovi i simptomi bolesti
Median (Interquartile range) Patients with no deterioration/patients evaluated (%)
(interkvartilni raspon) Bolesnici bez pogoršanja/evaluirani bolesnici (%)
For women taking infliximab including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Ženama koje uzimaju infliksimab, uključujući i one starije od 60 godina, liječnik može preporučiti redovite preglede za prevenciju raka grlića maternice.
A low proportion of the infusion reactions was serious allergic reactions.
Mali udio reakcija na infuziju činile su teške alergijske reakcije.
Flixabi will be stored by the health professionals at the hospital or clinic.
Flixabi će čuvati zdravstveni radnici u bolnici ili klinici.
≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab
≥ 5 x GGN placebo infliksimab placebo infliksimab placebo infliksimab placebo infliksimab
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy.
U oko 3% bolesnika liječenje je prekinuto zbog reakcija povezanih s infuzijom i svi su se bolesnici oporavili s ili bez medicinskog liječenja.
• In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
• U nekih bolesnika koji primaju infliksimab tijelo možda neće proizvoditi dovoljno krvnih stanica koje pomažu u borbi protiv infekcije ili pomažu zaustaviti krvarenje.
The potential risk with the combination of AZA or 6-MP and Flixabi should be carefully considered.
Treba pomno razmotriti potencijalni rizik primjene kombinacije AZA ili 6-MP i lijeka Flixabi.
Flixabi should only be used during pregnancy if your doctor feels it is necessary for you.
Flixabi se tijekom trudnoće smije primjenjivati samo ako Vaš liječnik smatra da je to neophodno za Vas.
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Najvažniji rezultati za djelotvornost u ispitivanjima IMPACT i IMPACT 2 prikazani su u tablici 9:
≥ 50% improvement PGA of cleared (0) or minimal (1)
Poboljšanje ≥ 50% PGA čist (0) ili minimalan (1)
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Unutar klasifikacije organskih sustava, nuspojave su navedene prema sljedećim kategorijama učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Ako se ne primijeni odmah, trajanje i uvjeti čuvanja prije uporabe odgovornost su korisnika i ne smiju biti dulji od 24 sata na temperaturi od 2°C do 8°C.
ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Odgovor ACR 20* Odgovor ACR 50* Odgovor ACR 70* PASI odgovor (% bolesnika)
• Blood test result showing ‘antibodies' against your own body.
• nalazi krvnih pretraga koji ukazuju na prisutnost 'protutijela' na vlastito tijelo
The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Relativno pomanjkanje TNFα prouzročeno anti-TNF terapijom može pokrenuti autoimuni proces.
Upon removal from refrigerated storage, Flixabi must not be returned to refrigerated storage.
Nakon što je izvađen iz hladnjaka, Flixabi se ne smije vratiti u hladnjak na čuvanje.
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Flixabi treatment.
Žene reproduktivne dobi moraju razmotriti uporabu odgovarajuće kontracepcije kako bi se spriječila trudnoća i nastaviti je koristiti najmanje 6 mjeseci nakon primjene posljednje doze lijeka Flixabi.
Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Infliksimab je ispitivan samo u kombinaciji s konvencionalnom imunosupresivnom terapijom.
Combined data from ACT 1 & 2
Zbirni podaci iz ispitivanja ACT 1 i ACT 2
Control a
Kontrolna skupina a
The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Djelotvornost infliksimaba do 54. tjedna ispitivala se u ispitivanju ACT 1.
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
intersticijska bolest pluća (uključujući brzu progresivnu bolest, fibrozu pluća i pneumonitis)
What Flixabi is and what it is used for
Što je Flixabi i za što se koristi
Complete fistula response (%)
Potpuni odgovor fistula (%)
• Treatment with TNF blockers such as Flixabi may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
• Liječenje blokatorima TNF-a kao što je Flixabi može izazvati ponovnu aktivaciju virusa hepatitisa B u bolesnika koji nose taj virus, što u nekim slučajevima može ugroziti život.
If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued.
Pojavi li se kod infuzije reakcija povezana sa skraćenom infuzijom, može se razmotriti sporija brzina za buduće infuzije, ako se terapija nastavlja.
Because human immunoglobulins are excreted in milk, women must not breast-feed for at least 6 months after Flixabi treatment.
Budući da se humani imunoglobulini izlučuju u majčino mlijeko, žene ne smiju dojiti najmanje 6 mjeseci nakon liječenja lijekom Flixabi.
Serious infections were reported in 12% (7/60) of all treated patients.
Ozbiljne infekcije prijavljene su u 12% svih liječenih bolesnika (7/60).
Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2
Tablica 9 Učinci na ACR i PASI u ispitivanjima IMPACT i IMPACT 2
Your doctor will advise you what other medicines you must keep using while you are having Flixabi.
Liječnik će Vam savjetovati koje lijekove morate nastaviti uzimati dok primate Flixabi.
What Flixabi is and what it is used for What you need to know before you use Flixabi How Flixabi will be given Possible side effects
Što je Flixabi i za što se koristi Što morate znati prije nego počnete primati Flixabi Kako primjenjivati Flixabi Moguće nuspojave
Patients who did not respond to infliximab at week 8 (n=15) received no further medicinal product and returned for safety followup.
Bolesnici koji nisu odgovorili na infliksimab u 8. tjednu (n = 15) nisu dalje primali lijek i praćeni su radi ocjene sigurnosti primjene.
• If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
• Ako je prekid u liječenju infliksimabom trajao dulje od 16 tjedana, povećan je rizik od pojave alergijskih reakcija kod ponovnog početka liječenja.
Had treatment with any medicine containing infliximab before
Prethodno liječenje bilo kojim lijekom koji sadrži infliksimab
In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
U svim je slučajevima liječenje infliksimabom bilo prekinuto i/ili uvedeno drugo liječenje, uz potpuno povlačenje znakova i simptoma.
Depression, insomnia.
depresija, nesanica
Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse reactions, including infection.
Potreban je oprez i kontinuirani nadzor bolesnika kod prelaska s jednog biološkog lijeka na drugi, jer preklapanje biološkog djelovanja može dodatno povećati rizik od nuspojava, uključujući infekciju.
The concomitant use of Flixabi with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Istodobna primjena lijeka Flixabi s drugim biološkim lijekovima se ne preporučuje zbog mogućeg povećanog rizika od infekcije i drugih mogućih farmakoloških interakcija.
Flixabi may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
Flixabi se može čuvati na temperaturama do najviše 25°C u jednokratnom razdoblju do 6 mjeseci, ali vrijeme čuvanja ne smije biti dulje od originalnog roka valjanosti.
• Melanoma (a type of skin cancer).
• melanom (vrsta raka kože)
Other medicines and Flixabi
Drugi lijekovi i Flixabi
It is important that you tell your baby's doctors and other health care professionals about your Flixabi use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Važno je da djetetovog pedijatra i druge zdravstvene radnike obavijestite o svojem primanju lijeka Flixabi, tako da mogu odlučiti kada bi Vaše dijete trebalo primiti neko cjepivo,uključujući živa cjepiva kao što je BCG (primjenjuje se za sprječavanje tuberkuloze).
Flixabi works by selectively attaching to TNF alpha and blocking its action.
Flixabi djeluje tako što se selektivno vezuje za TNF alfa i onemogućuje njegovo djelovanje.
No dose recommendations can be made (see section 5.2).
Ne mogu se dati preporuke za doziranje (vidjeti dio 5.2).
including bovine tuberculosis (disseminated BCG infection), see section 4.4
*uključujući goveđu tuberkulozu (diseminiranu BCG infekciju), vidjeti dio 4.4.
Myocardial ischaemia/myocardial infarction.
ishemija miokarda/infarkt miokarda
Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Trenutno dostupni farmakokinetički podaci opisani su u dijelu 5.2, međutim, nije moguće dati preporuku o doziranju u djece mlađe od 6 godina.
Experimental data show that TNFα is essential for the clearing of intracellular infections.
Eksperimentalni podaci pokazuju da je TNFα neophodan za uklanjanje unutarstanične infekcije.
Flixabi must be given concomitantly with methotrexate.
Flixabi se mora davati istodobno s metotreksatom.
For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8).
Za više podataka o sigurnosti primjene infliksimaba u starijih bolesnika (vidjeti dijelove 4.4 i 4.8).
If these medicines do not work well enough, you will be given Flixabi which you will take in combination with another medicine called methotrexate to:
Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete Flixabi koji ćete koristiti u kombinaciji s drugim lijekom koji se zove metotreksat kako bi se:
What Flixabi looks like and contents of the pack
Kako Flixabi izgleda i sadržaj pakiranja
• Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
• Obavijestite liječnika ako ste nedavno primili ili trebate primiti liječenje terapijskim infektivnim agensom (poput unosa BCG-a koji se koristi za liječenje raka).
For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Uvjete čuvanja na temperaturi do 25°C prije rekonstitucije lijeka vidjeti u dijelu 6.3.
Elevations of ALT ≥ 5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Opažen je povišen ALT ≥ 5 puta iznad gornje granice normale (GGN) (vidjeti tablicu 2).
• Children and adults taking Flixabi may have an increased risk of developing lymphoma or another cancer.
• Djeca i odrasli koji uzimaju Flixabi mogu imati povećan rizik za razvoj limfoma ili neke druge vrste raka.
Before reconstitution 4 years at 2°C - 8°C.
Prije rekonstitucije: 4 godina na temperaturi 2°C-8°C.