natgillin/translations-raw huggingface dataset:
What ZINPLAVA looks like and contents of the pack The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid.
Kako ZINPLAVA izgleda i sadržaj pakiranja Koncentrat za otopinu za infuziju je bistra do umjereno opalescentna, bezbojna do blijedožuta tekućina.
Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II.
Imunogenost lijeka ZINPLAVA ocjenjivala se uz pomoć elektrokemiluminiscencije (engl. electrochemiluminescence, ECL) u ispitivanjima MODIFY
Serious adverse reactions
Ozbiljne nuspojave
Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
Lijek ZINPLAVA treba primijeniti tijekom ciklusa antibiotske terapije za liječenje CDI-a (vidjeti dijelove 4.4 i 5.1).
Your dose will be calculated using your body weight.
Doza će se izračunati na temelju
No clinical data are available on the possible effects of bezlotoxumab on fertility.
Nisu dostupni klinički podaci o mogućim učincima bezlotoksumaba na plodnost.
Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable.
Bezlotoksumab se primjenjuje intravenskim putem te je stoga njegova bioraspoloživost trenutačna i potpuna.
All patients received concomitant standard of care antibacterial therapy for CDI.
Svi su bolesnici istodobno primali standardnu antibiotsku terapiju za liječenje CDI-a.
Table 2: CDI Recurrence Rate Through 12 Weeks After Infusion (MODIFY I and MODIFY II, Full Analysis Set
Tablica 2: Stopa recidiva CDI-a tijekom 12 tjedana nakon infuzije (MODIFY
The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤ 3.1 g/dL; [2] ALT ≥ 2X ULN; [3] total bilirubin ≥ 1.3X ULN; or [4] mild, moderate or severe liver disease as reported by the Charlson Co-morbidity Index), as compared to patients with normal hepatic function.
Učinak oštećenja funkcije jetre na farmakokinetiku bezlotoksumaba ocjenjivao se u bolesnika s oštećenjem funkcije jetre (koje se definiralo kao prisutnost dvaju ili više sljedećih elemenata: [1] albumin ≤ 3,1 g/dl; [2] ALT ≥ 2X GGN; [3] ukupni bilirubin ≥ 1,3X GGN; ili [4] blaga, umjerena ili teška bolest jetre prema Charlsonovu indeksu komorbiditeta) u odnosu na bolesnike s normalnom funkcijom jetre.
Bezlotoxumab-mediated drug-drug interactions are unlikely as the target of bezlotoxumab is an exogenous toxin.
Interakcije između lijekova posredovane bezlotoksumabom nisu vjerojatne jer je cilj djelovanja bezlotoksumaba egzogeni toksin.
There was no binding of bezlotoxumab to reproductive tissue in tissue cross reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3).
Bezlotoksumab se nije vezivao za tkivo reproduktivnih organa u ispitivanjima tkivne križne reaktivnosti, a u ispitivanjima toksičnosti ponovljenih doza u miševa nije bilo zamjetnih učinaka na reproduktivne organe mužjaka i ženki (vidjeti dio 5.3).
Table 3: CDI Recurrence Rate by Risk Factor Subgroup (MODIFY I and MODIFY II, Full Analysis Set
Tablica 3: Stopa recidiva CDI-a prema podskupinama faktora rizika (MODIFY
Intravenous use after dilution Single dose vial
Primjena u venu nakon razrjeđivanja Jednodozna bočica
• Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
• Razrijeđenu otopinu za infuziju treba primijeniti intravenski tijekom 60 minuta koristeći sterilan, nepirogen, ugrađeni (in-line) ili pričvrsni (add-on) filtar od 0,2 do 5 µm, s malom sposobnošću vezanja proteina.
ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back.
ZINPLAVA je lijek koji se daje zajedno s antibiotikom za sprječavanje povratka infekcije uzrokovane bakterijom Clostridium difficile u bolesnika u dobi od 18 godina ili starijih u kojih postoji visok rizik od povratka infekcije uzrokovane tom bakterijom (engl.
Name and address of the manufacturer of the biological active substance
Naziv i adresa proizvođača biološke djelatne tvari Lonza Biologics Inc.
Animal reproduction or developmental toxicity studies have not been conducted with bezlotoxumab.
Nisu provedena ispitivanja reproduktivne ili razvojne toksičnosti bezlotoksumaba u životinja.
Bezlotoxumab has no or negligible influence on the ability to drive and use machines.
Bezlotoksumab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours.
Razrijeđena otopina lijeka ZINPLAVA može se čuvati na sobnoj temperaturi do 16 sati ili u hladnjaku (na temperaturi od 2°C do 8°C) do 24 sata.
The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2), moderate (eGFR 30 to < 60 mL/min/1.73 m 2), or severe
Učinak oštećenja funkcije bubrega na farmakokinetiku bezlotoksumaba ocjenjivao se u bolesnika s blagim (eGFR od 60 do < 90 ml/min/1,73 m 2), umjerenim (eGFR od 30 do < 60 ml/min/1,73 m 2) ili teškim (eGFR od 15 do < 30 ml/min/1,73 m 2) oštećenjem funkcije bubrega ili u terminalnoj fazi bolesti bubrega (eGFR < 15 ml/min/1,73 m 2) u odnosu na bolesnike s normalnom funkcijom bubrega
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne komplikacije često reakcije na infuziju†
These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA treated patients.
Te su nuspojave prijavljene sa sličnom učestalošću u bolesnika koji su primali placebo kao i u bolesnika liječenih lijekom ZINPLAVA.
Following treatment with ZINPLAVA in MODIFY I and MODIFY II, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.
I i MODIFY II, nijedan od 710 bolesnika u kojih se mogla provesti ocjena nije imao pozitivan nalaz na protutijela na bezlotoksumab nastala tijekom liječenja.
Bezlotoxumab is catabolized through protein degradation processes; metabolism does not contribute to its clearance.
Bezlotoksumab se katabolizira procesima razgradnje proteina; metabolizam ne pridonosi njegovu klirensu.
There are no data on repeated administration of bezlotoxumab in patients with CDI.
Nema podataka o ponovljenoj primjeni bezlotoksumaba u bolesnika s CDI-om.
In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
U kliničkim ispitivanjima, u bolesnika s CDI-om primijenjena je samo jedna doza lijeka ZINPLAVA (vidjeti dio
The adverse reactions after the second dose were not markedly different from those observed after the first dose, and are consistent with adverse reactions observed in the two Phase 3 trials (MODIFY I and MODIFY II; see section 5.1) in which all patients received a single dose.
Nuspojave nakon primjene druge doze nisu se značajno razlikovale od onih opaženih nakon primjene prve doze te su odgovarale nuspojavama opaženima u dva ispitivanja faze 3 (MODIFY
• You should keep taking your antibiotic for CDI as directed by your doctor.
• Nastavite uzimati antibiotik za liječenje infekcije bakterijom Clostridium difficile prema uputama Vašeg liječnika.
ZINPLAVA should not be administered as an intravenous push or bolus.
ZINPLAVA se ne smije primijeniti intravenskom brzom ili bolusnom injekcijom.
What ZINPLAVA contains - The active substance is bezlotoxumab.
Što ZINPLAVA sadrži - Djelatna tvar je bezlotoksumab.
Characteristic at study entry
Značajka pri uključivanju u ispitivanje
There is no experience with repeat administration of ZINPLAVA in patients with CDI.
Nema iskustva s ponovljenom primjenom lijeka ZINPLAVA u bolesnika s CDI-om.
ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab
ZINPLAVA 25 mg/ml koncentrat za otopinu za infuziju bezlotoksumab
• If you are breast-feeding or are planning to breast-feed, check with your doctor first.
• Ako dojite ili planirate dojiti, najprije o tome razgovarajte sa svojim liječnikom.
ZINPLAVA should be administered during the course of antibacterial therapy for CDI.
Lijek ZINPLAVA treba primijeniti tijekom ciklusa antibiotske terapije CDI-a.
The efficacy of ZINPLAVA (bezlotoxumab) was investigated in two randomised, double-blind, placebo-controlled, multicentre, Phase 3 studies (MODIFY I and MODIFY II) where 810 patients were randomised to bezlotoxumab and 803 to placebo.
Djelotvornost lijeka ZINPLAVA (bezlotoksumab) ispitivala se u dva randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja faze 3 (MODIFY
ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back.
ZINPLAVA djeluje tako da se pričvrsti za taj toksin i blokira njegovo djelovanje te na taj način sprječava povratak simptoma infekcije bakterijom Clostridium difficile.
Clear to moderately opalescent, colourless to pale yellow liquid.
Bistra do umjereno opalescentna, bezbojna do blijedožuta tekućina.
How to store ZINPLAVA
Kako čuvati lijek ZINPLAVA
• If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
• Ako se razrijeđena otopina čuva u hladnjaku, prije primjene pričekajte da se vrećica za intravensku primjenu ugrije na sobnu temperaturu.
ZINPLAVA has no effect on the CDI you have now.
ZINPLAVA nema učinka na infekciju bakterijom Clostridium difficile koju trenutno imate.
Lonza Biologics Inc. 101 International Drive Portsmouth
101 International Drive
No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with hepatic impairment and patients with normal hepatic function.
Nisu utvrđene klinički važne razlike u izloženosti bezlotoksumabu između bolesnika s oštećenjem funkcije bubrega i onih s normalnom funkcijom bubrega.
Preparation of diluted solution
Priprema razrijeđene otopine
Concomitant oral standard of care (SoC) antibacterial therapy for CDI was given together with ZINPLAVA.
Standardna peroralna antibiotska terapija za liječenje CDI-a primjenjivala se istodobno s lijekom ZINPLAVA.
Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) Based on the Miettinen and Nurminen method without stratification Based on medical conditions or medications received that may result in immunosuppression Zar score ≥ 2
Svi randomizirani ispitanici = podskupina svih randomiziranih bolesnika, isključujući: (i) ispitanike koji nisu primili infuziju ispitivanog lijeka, (ii) ispitanike koji nisu imali pozitivan nalaz pretrage stolice na toksogeni C. difficile; (iii) ispitanike koji nisu primili protokolom definiranu standardnu terapiju unutar 1 dana od infuzije Standardna terapija = standardna antibiotska terapija (metronidazol ili vankomicin ili fidaksomicin)
Sodium citrate dihydrate (E331) Water for injections
80 (E433), natrijev klorid, natrijev citrat dihidrat (E331), voda za injekcije i natrijev hidroksid
If refrigerated, allow the IV bag to come to room temperature prior to use.
Ako se vrećica za intravensku primjenu čuva u hladnjaku, prije primjene pričekajte da se ugrije na sobnu temperaturu.
Age ≥ 65 years
6.3 Rok valjanosti
Bezlotoxumab has limited extravascular distribution.
Ekstravaskularna distribucija bezlotoksumaba je ograničena.
ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid.
ZINPLAVA je bistra do umjereno opalescentna, bezbojna do blijedožuta tekućina.
- The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).
6.1 Popis pomoćnih tvari citratna kiselina hidrat (E330) dietilentriaminpentaacetatna kiselina polisorbat 80 (E433) natrijev klorid natrijev citrat dihidrat (E331) voda za injekcije natrijev hidroksid (E524) (za prilagodbu pH)
Placebo with SoC Percent (n/N)
Placebo sa standardnom terapijom Postotak (n/N)
It is unknown whether bezlotoxumab is secreted in human milk.
Nije poznato izlučuje li se bezlotoksumab u majčino mlijeko.
• Inspect vial contents for discoloration and particulate matter prior to dilution.
• Sadržaj bočice treba prije razrjeđivanje pregledati zbog moguće promjene boje i prisutnosti vidljivih čestica.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Pripremljeni lijek ne smije se čuvati dulje od ukupno 24 sata na temperaturi od 2°C - 8°C ili 16 sati na sobnoj temperaturi (25°C ili nižoj).
Each mL contains 25 mg bezlotoxumab.
Jedan ml sadrži 25 mg bezlotoksumaba.
One 40 mL vial contains 1,000 mg of bezlotoxumab.
Jedna bočica od 40 ml sadrži 1000 mg bezlotoksumaba.
ZINPLAVA is given with the antibiotic therapy you are taking for CDI.
ZINPLAVA se daje uz antibiotsku terapiju koju uzimate za liječenje infekcije bakterijom Clostridium difficile.
Each mL of concentrate contains 25 mg bezlotoxumab.
Jedan ml koncentrata sadrži 25 mg bezlotoksumaba.
ZINPLAVA contains the active substance bezlotoxumab.
ZINPLAVA sadrži djelatnu tvar bezlotoksumab.
Infected with a hypervirulent strain
Infekcija hipervirulentnim sojem Infekcija ribotipom 027
Name and address of the manufacturer responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet SP Labo N.V.
Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
How you are given ZINPLAVA 4.
Kako ćete primiti lijek ZINPLAVA
Each vial contains 1,000 mg bezlotoxumab.
Jedna bočica sadrži 1000 mg bezlotoksumaba.
ZINPLAVA with SoC Percent (n/m)
ZINPLAVA sa standardnom terapijom Postotak (n/m)
Citric acid monohydrate (E330) Diethylenetriaminepentaacetic acid Polysorbate 80 (E433)
- Drugi sastojci su citratna kiselina hidrat (E330), dietilentriaminpentaacetatna kiselina, polisorbat
Nausea, diarrhoea
Poremećaji probavnog sustava često mučnina, dijareja
Pyrexia
Portsmouth
Placebo with SoC Percent (n/m) Difference (95% CI)
Placebo sa standardnom terapijom Postotak (n/m)
ZINPLAVA with SoC Percent (n/N)
ZINPLAVA sa standardnom terapijom Postotak (n/N)
7 May 2015
7. svibnja 2015.
This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
To znači da blokira kanale na površini stanica kroz koje kalcij normalno ulazi u stanice.
In addition, there were concerns that the safety of the medicine had not been fully demonstrated and one unresolved quality issue.
Nadalje, postojale su zabrinutosti da sigurnost VMP-a nije bila u potpunosti dokazana, kao i jedno nerazriješeno pitanje kvalitete.
What is Lodipressin?
Što je Lodipressin?
What were the CVMP's main concerns that led to the refusal?
Koji su glavni razlozi za zabrinutost CVMP-a rezultirali odbijanjem?
After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Nakon razmatranja razloga za ovaj zahtjev CVMP je ponovno pregledao prvotno mišljenje i potvrdio je odbijanje izdavanja odobrenja za stavljanje u promet od 7. svibnja 2015.
Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Lodipressin se trebao koristiti za liječenje mačaka sa sistemskom arterijskom hipertenzijom (visok krvni tlak).
As part of its application the company presented the results of a field study involving cats with blood pressure of 160 mmHg or above.
Tvrtka je u sklopu zahtjeva predstavila rezultate terenskog ispitivanja koje je uključivalo mačke s krvnim tlakom 160 mmHg ili višim.
In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
U drugom dijelu ispitivanja 23 su mačke tijekom 16 tjedana primale Lodipressin, a nije bilo skupine koja je primala placebo.
The CVMP therefore maintained its recommendation that the marketing authorisation be refused.
CVMP je stoga zadržao preporuku da se odbije odobrenje za stavljanje u promet.
The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
U početnom dijelu sudjelovalo je 19 mačaka, među kojima je njih 11 liječeno VMP-om Lodipressin, a osam ih je primalo placebo (prividno liječenje) dva tjedna.
This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
To znači da, iako postoje određeni dokazi da je Lodipressin djelotvoran u snižavanju krvnoga tlaka, nije bilo moguće donijeti nepobitne zaključke o njegovoj djelotvornosti za liječenje visokog krvnog tlaka u mačaka.
Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Lodipressin je veterinarsko-medicinski proizvod koji sadrži djelatnu tvar amlodipin besilat.
By reducing the entry of calcium into these cells, amlodipine prevents the blood vessel from contracting, thus lowering the blood pressure.
Smanjivanjem prodiranja kalcija u te stanice amlodipin sprječava kontrakciju stijenki krvnih žila te tako snižava krvni tlak.
On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Odbor za veterinarsko-medicinske proizvode (CVMP) usvojio je negativno mišljenje, preporučujući odbijanje izdavanja odobrenja za stavljanje u promet veterinarskomedicinskog proizvoda (VMP) Lodipressin koji je namijenjen liječenju sistemske arterijske hipertenzije u mačaka.
During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Tijekom ponovnog pregleda CVMP je u obzir uzeo savjet stručne skupine u području liječenja mačaka.
At the time of the initial evaluation, the CVMP considered that there were deficiencies in the way the field study had been designed and conducted and the results had been presented.
U vrijeme donošenja prvotne ocjene CVMP je smatrao da su prisutni nedostaci u odnosu na oblik i provedbu terenskog ispitivanja te predstavljanje rezultata.
What was Lodipressin expected to be used for?
Za što se Lodipressin trebao koristiti?
How is Lodipressin expected to work?
Kako je Lodipressin trebao djelovati?
The company that applied for authorisation is Le Vet Beheer B.V.
Tvrtka CLe Vet Beheer B.V. podnijela je zahtjev za izdavanje odobrenja.
The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Stručna skupina savjetovala je da, unatoč određenim dokazima prikupljenima na temelju terenskog ispitivanja u odnosu na snižavanje krvnoga tlaka, brojni nedostaci u ispitivanju nisu omogućili donošenje zaključka da koristi VMP-a Lodipressin u liječenju visokog krvnog tlaka u mačaka nadilaze rizike.
Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Odbijanje odobrenja za stavljanje u promet veterinarskomedicinskog proizvoda Lodipressin (amlodipin besilat)
When calcium enters the cells in the blood vessel walls this causes contraction.
Ulazak kalcija u stanice uzrokuje kontrakciju u stijenkama krvnih žila.
Refusal of the marketing authorisation for Lodipressin (amlodipine besilate) EMA/55773/2016
Odbijanje odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda Lodipressin (amlodipin besilat)
If you or your child forgets to take the third (last) dose at the right time, take it as soon as you remember.
Ako Vi ili Vaše dijete zaboravite uzeti treću (posljednju) dozu u pravo vrijeme, uzmite je čim se sjetite.
These include (but are not limited to):
Tu pripadaju (ali popis nije ograničen samo na njih):
It is not known whether these toxic effects are reversible.
Nije poznato jesu li ovi toksični učinci reverzibilni.
All patients were clinically cured.
Svi su bili klinički izliječeni.
Never take more than one dose on the same day to make up for a missed dose.
Nikad nemojte uzeti više od jedne doze u istom danu kako biste nadoknadili propuštenu dozu.
The mixture should be used immediately after preparation.
Mješavina se mora primijeniti odmah nakon pripreme.
* see section 5.1
* vidjeti dio 5.1
Take one dose on each day.
Svakog dana uzmite jednu dozu.
If this happens within:
Ako se to dogodi u roku od:
Most of the side effects are not severe and normally disappear within a few days or weeks after treatment.
Nuspojave većinom nisu teške i obično nestanu u roku od nekoliko dana ili tjedana nakon liječenja.
• 31-60 minutes, half the dose must be taken again.
• 31-60 minuta, mora se ponovno uzeti polovica doze.
The daily dose depends on the patient's body weight.
Dnevna doza ovisi o tjelesnoj težini bolesnika.
Then take the third (last) dose approximately 24 hours after the second dose.
Zatim uzmite treću (posljednju) dozu približno 24 sata nakon druge doze.
Your doctor will advise you when these readings will be taken.
Liječnik će Vas obavijestiti kad će se napraviti ova pretraga.
Concomitant treatment with such medicinal products is not recommended.
Ne preporučuje se istovremeno liječenje takvim lijekovima.
If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.
Ako je tablete teško progutati, možete ih zdrobiti i pomiješati s vodom; mješavinu popijte odmah.
Daily dose (mg)
Dnevna doza (mg)
Eurartesim with food and drink
Eurartesim s hranom i pićem
− This medicine has been prescribed for you only.
- Ovaj je lijek propisan Vama.
Do not use this medicine if you notice the blister is open.
Ovaj lijek se ne smije upotrijebiti ako primijetite da je blister otvoren.
The table in this section is for adult patients only.
Tablica u ovom dijelu odnosi se samo na odrasle bolesnike.
• is taking certain other medicines which could cause possible metabolic interactions.
• uzimate određene druge lijekove koji mogu prouzročiti moguće metaboličke interakcije.
You or your child can drink water at any time.
Vi ili Vaše dijete smijete piti vodu cijelo vrijeme.
Always take Eurartesim exactly as your doctor has told you to.
Uvijek uzmite Eurartesim točno onako kako Vam je rekao liječnik.
• knows that any member of your family (parents, grandparents, brothers or sisters) died suddenly due to a heart problem or was born with heart problems;
• znate da je neki član Vaše obitelji (roditelji, bake, djedovi, braća ili sestre) iznenada umro zbog srčanih poremećaja ili je bio rođen sa srčanim poremećajem;