FrancophonIA/ELRC3.0 huggingface dataset:
English: 262.5 mg (26.4 ml) twice daily
Croatian: 262,5 mg (26,4 ml) dva puta na dan
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Croatian: uznapredovalom HIV-infekcijom i u bolesnika na dugotrajnom kombiniranom antiretrovirusnom liječenju (CART).
English: AbbVie s.r.o.
Croatian: AbbVie B.V.
English: - The other ingredients are copovidone; sorbitan laurate; silica, colloidal anhydrous.
Croatian: − Drugi sastojci su kopovidon, sorbitanlaurat, bezvodni, koloidni silicijev dioksid.
English: Calcium hydrogen phosphate, anhydrous Silica, colloidal anhydrous Sodium stearyl fumarate
Croatian: Tableta: kopovidon sorbitanlaurat kalcijev hidrogenfosfat, bezvodni silicijev dioksid, koloidni, bezvodni natrijev stearilfumarat
English: Important information regarding medicinal product interactions when ritonavir is used a pharmacokinetic enhancer is also contained in the Summary of Product Characteristics of the coadministered protease inhibitor.
Croatian: Važne informacije o interakcijama među lijekovima kada se ritonavir daje kao farmakokinetički pojačivač mogu se naći i u Sažetku opisa svojstava lijeka za inhibitor proteaze koji se istodobno primjenjuje.
English: Twice Daily Dose 250 mg/m2
Croatian: Doziranje dva puta na dan 250 mg/m²
English: See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Croatian: (vidjeti dio 4.4 i Sažetak opisa svojstava lijeka za vorapaksar).
English: 500 q12h
Croatian: 500 svakih 12h
English: Reduction in the antiretroviral activity of ritonavir is primarily associated with the protease mutations V82A/F/T/S and I84V.
Croatian: Smanjenje antiretrovirusne aktivnosti ritonavira prvenstveno je povezano s mutacijama proteaze
English: Uncommon Increased glucose, increased magnesium, increased alkaline phosphatase
Croatian: Često Povišena vrijednost amilaze, snižene vrijednosti slobodnog i ukupnog tiroksina Manje često Povišena vrijednost glukoze, povišena vrijednost magnezija, povišena vrijednost alkalne fosfataze
English: 300 mg in the morning and 300 mg in the evening
Croatian: 300 mg ujutro i 300 mg navečer
English: Children and adolescents (2 years of age and above) The recommended dosage of Norvir in children is 350 mg/m² by mouth twice daily and should not exceed 600 mg twice daily.
Croatian: Preporučena doza lijeka Norvir u djece je 350 mg/m2 dva puta na dan kroz usta, a doza ne smije premašiti 600 mg dva puta na dan.
English: − The other tablet ingredients are: copovidone, sorbitan laurate, anhydrous calcium hydrogen phosphate, colloidal anhydrous silica, sodium stearyl fumarate.
Croatian: Drugi sastojci u tableti su: kopovidon, sorbitanlaurat, bezvodni kalcijev hidrogenfosfat,
English: 100, single dose 500 q12h
Croatian: 5, jednokratna doza 400 svakih 12h
English: If the dates for submission of a PSUR and the update of a RMP conincide, they can be submitted at the same time.
Croatian: Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: 400 mg in the morning and 300 mg in the evening
Croatian: 400 mg ujutro i 300 mg navečer
English: 500 mg in the morning and 400 mg in the evening
Croatian: 500 mg ujutro i 400 mg navečer
English: Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking Norvir.
Croatian: U bolesnika koji su uzimali Norvir bilo je prijava poremećenih nalaza jetrene funkcije, hepatitisa (upala jetre) i rijetko žutice.
English: ↑ 4-fold
Croatian: Gospina trava
English: What you need to know before you or your child takes Norvir.
Croatian: Što morate znati prije nego što Vi ili Vaše dijete počnete uzimati Norvir.
English: Ritonavir pharmacokinetic parameters were not statistically significantly associated with body weight or lean body mass. Ritonavir plasma exposures in patients 50 - 70 years of age when dosed 100 mg in combination with lopinavir or at higher doses in the absence of other protease inhibitors is similar to that observed in younger adults.
Croatian: 100 mg ritonavira u kombinaciji s lopinavirom, ili u većim dozama ali bez drugog inhibitora proteaza, slična je onoj u mlađih bolesnika.
English: Ritonavir effects on Non-antiretroviral Co-administered Medicinal Products
Croatian: Učinci ritonavira na istodobno primijenjene lijekove koji nisu antiretrovirotici
English: 1250 q12h
Croatian: 1250 svakih 12h
English: 3 mg/kg q8h 500 q12h ↓ 43% An increased dose of theophylline may be required when co-administered with ritonavir, due to induction of CYP1A2.
Croatian: 500 svakih 12h Zbog indukcije CYP1A2 može biti potrebno povećanje doze teofilina kada ga se daje istodobno s ritonavirom.
English: ↑ 15-fold ↑ 5-fold
Croatian: ↑ 15 puta ↑ 5 puta
English: QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3.
Croatian: U randomiziranom, placebom i aktivno (moksifloksacin 400 mg jedanput na dan) nadziranom ,
English: HMG Co-A Reductase Inhibitors
Croatian: Inhibitori reduktaze HMG Co-A
English: Uncommon Diabetes mellitus Rare
Croatian: Rijetko Anafilaksija
English: 30 sachets of powder for oral suspension Carton also contains 1 mixing cup and 2 oral dosing syringes
Croatian: Kutija također sadrži 1 čašu za miješanje i 2 dozirne štrcaljke za usta.
English: Food slightly decreases the bioavailability of the Norvir tablet.
Croatian: Učinak hrane na apsorpciju nakon oralne primjene Hrana malo smanjuje bioraspoloživost
English: Name and address of the manufacturer responsible for batch release Film-coated tablets and powder for oral suspension AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany Powder for oral suspension only
Croatian: Filmom obložene tablete i prašak za oralnu suspenziju AbbVie Deutschland GmbH & Co.
English: Increased methadone dose may be necessary when concomitantly administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer due to induction of glucuronidation.
Croatian: Zbog indukcije glukuronidacije, može biti potrebno povećati dozu metadona kada se daje istodobno s ritonavirom doziranim kao antiretrovirusnim lijekom ili kao farmakokinetičkim pojačivačem.
English: • low levels of blood platelets
Croatian: • visoke razine šećera u krvi
English: Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with ritonavir.
Croatian: Preporučuje se pažljivo praćenje terapijskih učinaka i mogućih nuspojava kada se fentanil daje istodobno s ritonavirom.
English: Each sachet contains 100 mg of ritonavir.
Croatian: Jedna vrećica sadrži 100 mg ritonavira.
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of calcium channel antagonists.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4, zbog čega se očekuje povećanje koncentracije antagonista kalcijevih kanala u plazmi.
English: Fill the syringe a. Push the plunger all the way into syringe.
Croatian: Korak 2. Pogurnite mjehuriće na vrh štrcaljke a.
English: Ritonavir pharmacokinetic parameters have not been studied in patients with renal impairment.
Croatian: Bolesnici s oštećenom funkcijom bubrega Pokazatelji farmakokinetike ritonavira nisu evaluirani u bolesnika s oslabljenom funkcijom bubrega.
English: Ritonavir increases the serum levels of maraviroc as a result of CYP3A inhibition.
Croatian: Maravirok Ritonavir povisuje serumske razine maraviroka zbog inhibicije CYP3A.
English: Mix thoroughly (see Figure 5).
Croatian: ml na štrcaljki (pogledajte sliku 2).
English: Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200mg once daily could be considered.
Croatian: Povećanje doze ritonavira na 200 mg jedanput na dan može se razmotriti samo ako se uz atazanavir i ritonavir istodobno daje i efavirenz.
English: Saquinavir4 ↑ 15-fold ↑ 5-fold Ritonavir
Croatian: Sakvinavir4 ↑ 15 puta
English: Antiarrthymics
Croatian: Antiaritmici
English: Hepatic transaminase elevations exceeding five times the upper limit or normal, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir alone or in combination with other antiretrovirals.
Croatian: U bolesnika koji su uzimali ritonavir, sam ili u kombinaciji s drugim antiretroviroticima, zabilježena su povišenja vrijednosti jetrenih transaminaza više nego peterostruko od gornje granice normale, hepatitis i žutica.
English: Powder for oral suspension.
Croatian: 30 vrećica praška za oralnu suspenziju.
English: Concomitant use of avanafil with ritonavir is contraindicated (see section 4.3).
Croatian: Istodobna primjena avanafila sa ritonavirom je kontraindicirana (vidjeti dio 4.3)
English: AbbVie B.V. Tel: +31 (0)88 322 2843
Croatian: Tel: + 31 (0)88 322 2843
English: Ritonavir increases the serum levels of amprenavir (from fosamprenavir) as a result of CYP3A4 inhibition.
Croatian: Ritonavir povisuje serumske razine amprenavira (iz fosamprenavira) zbog inhibicije CYP3A4.
English: Some patients taking Norvir can develop serious problems with their pancreas.
Croatian: Norvir mogu javiti ozbiljne poteškoće s gušteračom.
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of erythromycin and itraconazole.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4, zbog čega se očekuje povećanje koncentracije eritromicina i itrakonazola u plazmi.
English: 400 q12h
Croatian: 400 svakih 12h
English: ↑ 4.7-fold
Croatian: ↑ 3-7 puta
English: Ritonavir co-administration is likely to result in increased plasma concentrations of astemizole and terfenadine and is therefore contraindicated (see section 4.3).
Croatian: Istodobno primijenjeni ritonavir vjerojatno bi povećao koncentracije astemizola i terfenadina u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
English: • if your doctor prescribes a full dose, adults may be started on a dose of 3 tablets in the morning and 3 tablets 12 hours later, gradually increasing over a period of up to 14 days to the full dose of 6 tablets twice daily (totaling 1,200mg per day).
Croatian: tablete 12 sati kasnije, postupno povećavajući dozu tijekom razdoblja od najviše 14 dana, do pune doze od 6 tableta dva puta na dan (ukupno 1200 mg dnevno).
English: Ritonavir co-administration is likely to result in increased plasma concentrations of pethidine, piroxicam, and propoxyphene and is therefore contraindicated (see section 4.3).
Croatian: Istodobno primijenjeni ritonavir vjerojatno bi povećao plazmatske koncentracije petidina, piroksikama i propoksifena te je stoga kontraindiciran (vidjeti dio 4.3).
English: Anti-gout treatments
Croatian: Lijekovi za giht
English: − sildenafil if you suffer from a lung disease called pulmonary arterial hypertension that makes breathing difficult.
Croatian: − sildenafil, ako imate plućnu bolest koja se naziva plućna arterijska hipertenzija, koja otežava disanje; bolesnici koji nemaju tu bolest mogu, pod liječničkim nadzorom, uzimati sildenafil za liječenje impotencije (erektilna disfunkcija) (pogledajte i dio Drugi lijekovi i
English: Antiasthmatic
Croatian: Antiastmatici
English: • joint pain and back pain
Croatian: Vrlo često Artralgija i bol u leđima
English: Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition.
Croatian: Darunavir puta Ritonavir povisuje serumske razine darunavira zbog inhibicije CYP3A.
English: Ritonavir medicinal product level decreased
Croatian: Snižava se razina lijeka koji sadržava ritonavir
English: 200 q12h/1h before 200 q12h/ coadministered 200 q12h/6h after Serum concentrations may be increased due to Breast Cancer Resistance Protein (BCRP) and acute P-gp inhibition by ritonavir.
Croatian: 200 svakih 12h 400 svakih 12h ↓ 82% 200 svakih 12h 100 svakih 12h ↓ 39% Primjena ritonavira kao antiretrovirusnog lijeka istodobno s vorikonazolom je kontraindicirana zbog smanjenja koncentracija vorikonazola (vidjeti dio 4.3).
English: 50, single dose 200 q12h ↑ 2.4-fold An increase in the incidence in trazodone-related adverse reactions was noted when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Croatian: 5, jednokratna doza 500 svakih 12h, Zbog indukcije glukuronidacije, može biti potrebno povećati dozu metadona kada se daje istodobno s ritonavirom doziranim kao antiretrovirusnim lijekom ili kao farmakokinetičkim pojačivačem.
English: ↑ 2.4-fold
Croatian: ↑ 2.4 puta
English: Medicinal Product Class
Croatian: FARMACEUTSKI PODACI
English: In intent to treat analyses, 50% and 57% of patients in the 350 and 450 mg/m2 dose groups, respectively, achieved reduction in plasma HIV-1 RNA to ≤ 400 copies/ml at Week 48.
Croatian: ITT analiza je pokazala da se broj kopija HIV-1 RNK nakon 48 tjedana smanjio na ≤ 400/ml u, redom, 50% i 57% bolesnika koji su primali 350 odnosno 450 mg/m ritonavira.
English: ↑ 7.2-fold
Croatian: ↑ 20 do
English: 600 q12h
Croatian: 600 svakih 12h
English: Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when dosed as an antriretroviral agent or as a pharmacokinetic enhancer resulting in increased concentrations of fexofenadine.
Croatian: Ritonavir doziran kao antiretrovirusni lijek ili kao farmakokinetički pojačivač može modificirati istjecanje feksofenadina posredovan Pglikoproteinom, zbog čega će se povećati koncentracije feksofenadina.
English: − A history of liver disease.
Croatian: Preboljelu bolest jetre.
English: Ritonavir co-administration is likely to result in increased plasma concentrations of cisapride and is therefore contraindicated (see section 4.3).
Croatian: Istodobno primijenjeni ritonavir vjerojatno povećava koncentracije cisaprida u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
English: Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition.
Croatian: Ritonavir povisuje serumske razine amprenavira zbog inhibicije CYP3A4.
English: − products containing St John's wort (Hypericum perforatum) as this may stop Norvir from working properly.
Croatian: − pripravke koji sadržavaju gospinu travu (Hypericum perforatum) jer oni mogu prekinuti ispravno djelovanje lijeka Norvir; gospina trava često se koristi u biljnim pripravcima koje možete nabaviti bez recepta.
English: Tear open sachet (see Figure 3).
Croatian: Korak 4. Otvorite vrećicu (pogledajte sliku 3).
English: What Norvir is and what it is used for What you need to know before you or your child takes Norvir How to take Norvir
Croatian: Što morate znate prije nego što Vi ili Vaše dijete počnete uzimati Norvir Kako uzimati Norvir
English: − Sildenafil or tadalafil for impotence (erectile dysfunction).
Croatian: − avanafil ili vardenafil (koristi se za liječenje erektilne disfunkcije)
English: 500 q12h ↑ 3.4-fold
Croatian: 500 svakih 12h ↑ 4 puta
English: Very common Pruritus, rash (including erythematous and maculopapular)
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često Pruritus, osip (uključujući eritematozni i makulopapularni)
English: The Summary of Product Characteristics of the co-administered protease inhibitor should be consulted for specific recommendations.
Croatian: Specifične preporuke treba potražiti u Sažetku opisa svojstava lijeka za određeni inhibitor proteaza.
English: Ritonavir dosed as a pharmacokinetic enhancer The interaction profiles of HIV-protease inhibitors, co-administered with low dose ritonavir, are dependent on the specific co-administered protease inhibitor.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač Važne informacije o interakcijama među lijekovima kada se ritonavir daje kao farmakokinetički pojačivač mogu se naći i u Sažetku opisa svojstava lijeka za inhibitor proteaze koji se istodobno primjenjuje.
English: ↑ 16-fold
Croatian: Ritonavir ↔ ↔
English: (erectile dysfunction) under their doctor's supervision (see the section on Other medicines and Norvir);
Croatian: (pogledajte dio Drugi lijekovi i Norvir);
English: Pharmacokinetic data indicate that no dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).
Croatian: Farmakokinetički podaci upućuju na to da dozu ne treba prilagođavati bolesnicima s blago do umjereno oslabljenom funkcijom jetre
English: Rare: may affect up to 1 in 1,000 people
Croatian: Rijetke: mogu se javiti u do 1 na 1000 osoba • teška ili za život opasna kožna reakcija,
English: c. Slowly pull the plunger back to the 10 ml mark on the syringe (see Figure 2).
Croatian: c. Polako povlačite klip natrag prema oznaci od 10
English: 0.125, single dose 200, 4 doses ↑ > 20 fold Ritonavir co-administration is likely to result in increased plasma concentrations of triazolam and is therefore contraindicated (see section 4.3).
Croatian: Petidin, piroksikam, propoksifen Istodobno primijenjeni ritonavir vjerojatno bi povećao plazmatske koncentracije petidina, piroksikama i propoksifena te je stoga kontraindiciran (vidjeti dio 4.3).
English: ↓ 40% ND Ritonavir increases the serum levels of tipranavir as a result of CYP3A inhibition.
Croatian: Ritonavir povisuje serumske razine tipranavira zbog inhibicije CYP3A.
English: Concomitant medicinal product levels increased or decreased α1-Adrenoreceptor Antagonist
Croatian: Antagonisti α1-adrenoreceptora
English: Haemophilia
Croatian: • omaglica
English: Desipramine
Croatian: Dojenje
English: 400 single
Croatian: 100 svakih
English: Tel.: +48 22 372 78 00
Croatian: AbbVie Polska Sp. z o.o. Tel: +48 22 372 78 00
English: Smoke cessation
Croatian: Sredstva za odvikavanje od pušenja
English: • increase in urination
Croatian: Opseg povećanja
English: 100 q12h Saquinavir4
Croatian: Sakvinavir4
English: The concomitant use of ritonavir is not recommended due to potential increase in vorapaxar exposure (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena ritonavira jer može doći do povećanja izloženosti vorapaksaru
English: Fill the syringe a. Push the plunger completely into the syringe.
Croatian: Potisnite klip skroz u štrcaljku.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: Cl/F (L/h)
English: 200 q12h
Croatian: 200 svakih 12h
English: 300 q6h
Croatian: 200 svakih 8h 300 svakih 6h
English: Further information on Semglee can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Semglee možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Semglee is used once a day at the same time each day.
Croatian: Lijek Semglee primjenjuje se jedanput na dan, svakog dana u isto vrijeme.
English: What measures are being taken to ensure the safe and effective use of Semglee?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Semglee?
English: Semglee (insulin glargine) EMA/57790/2018
Croatian: Semglee (inzulin glargin) EMA/57790/2018
English: The most common side effect with Semglee (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Croatian: Najčešća nuspojava lijeka Semglee (koja se može javiti u više od 1 na 10 osoba) jest hipoglikemija (niska razina glukoze u krvi).
English: Semglee is a ‘biosimilar medicine'.
Croatian: Semglee je „biosličan lijek”.
English: This means that Semglee is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, lijek Semglee vrlo je sličan biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Croatian: Dijabetes je bolest pri kojoj bolesnik ima visoku razinu šećera u krvi zbog toga što tijelo ne može proizvoditi inzulin (dijabetes tipa 1) ili zbog toga što tijelo ne proizvodi dovoljno inzulina ili ga ne može učinkovito koristiti (dijabetes tipa 2).
English: What is Semglee and what is it used for?
Croatian: Što je Semglee i za što se koristi?
English: Because Semglee is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Croatian: Budući da je lijek Semglee biosličan lijek, ispitivanja učinkovitosti i sigurnosti nisu bila potrebna jer su učinkovitost i sigurnost već jasno utvrđene za inzulin glargin.
English: The reference medicine for Semglee is Lantus.
Croatian: Referentni lijek za lijek Semglee je Lantus.
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Croatian: Kontrolom razine glukoze u krvi simptomi dijabetesa se smanjuju te se tako izbjegavaju komplikacije.
English: However, a supportive study in 558 patients with type 1 diabetes showed Semglee and Lantus had similar effects.
Croatian: Međutim, popratno ispitivanje na 558 bolesnika s dijabetesom tipa 1 pokazalo je da lijekovi Semglee i Lantus imaju slične učinke.
English: For more information about using Semglee, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Semglee pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: As for all medicines, data on the use of Semglee is continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Semglee kontinuirano se prate.
English: An overview of Semglee and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Semglee i zašto je odobren u EU-u
English: Patients in the study had previously had their level of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled, brought under control with Lantus; continuing treatment with either Semglee or Lantus for 24 weeks indicated comparable control of HbA1c levels with both, the level changing by an average of 0.14% in patients given Semglee, and 0.11% in those given Lantus.
Croatian: Najprije je razina glikoziliranog hemoglobina (HbA1c), tvari koja upućuje na to koliko se dobro kontrolira glukoza u krvi, u bolesnika u ispitivanju stavljena pod kontrolu lijekom Lantus, a nastavak liječenja lijekom Semglee ili lijekom Lantus tijekom 24 tjedna upućivao je na usporedivu kontrolu razina HbA1c za oba lijeka, pri čemu se razina u bolesnika kojima se davao Semglee u prosjeku mijenjala za 0,14 %, a u bolesnika kojima se davao Lantus za 0,11 %.
English: Patients can inject themselves with Semglee if they have been trained appropriately.
Croatian: Bolesnici si mogu sami ubrizgati lijek Semglee ako su ispravno obučeni.
English: Side effects reported with Semglee are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Semglee pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Semglee
Croatian: Ostale informacije o lijeku Semglee
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Semglee have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Semglee nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Semglee (insulin glargine)
Croatian: Semglee (inzulin glargin)
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Semglee has been shown to have a comparable quality, safety and effectiveness to Lantus.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, za lijek Semglee utvrđena usporediva kakvoća, sigurnost i učinkovitost kao za Lantus.