FrancophonIA/ELRC3.0 huggingface dataset:
English: Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka o rezultatima ispitivanja lijeka(ova) koji sadrži(e) djelatnu tvar ciproteron/etinilestradiol i na koje se odnosi završno izvješće PASS ispitivanja, CMDh smatra da je omjer koristi i rizika lijeka(ova) spomenutog(ih) gore nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Further information on Renvela can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/renvela.
Croatian: Više informacija o lijeku Renvela dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/renvela.
English: This overview was last updated in 07-2019.
Croatian: Sažetak je posljednji put ažuriran u 7.2019.
English: • adult patients on dialysis (a technique to remove unwanted substances from the blood);
Croatian: • odraslih bolesnika na dijalizi (postupak kojim se uklanjaju neželjene tvari iz krvi);
English: • adults and children from 6 years of age with chronic (long-term) kidney disease.
Croatian: • odraslih i djece starije od šest godina koji boluju od kronične (dugotrajne) bolesti bubrega.
English: Renvela (sevelamer carbonate) EMA/357790/2019
Croatian: Renvela (sevelamer karbonat) EMA/357790/2019
English: Renvela received a marketing authorisation valid throughout the EU on 10 June 2009.
Croatian: Lijek Renvela dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 10. lipnja 2009.
English: Renvela (sevelamer carbonate)
Croatian: Renvela (sevelamer karbonat)
English: What is Renvela and what is it used for?
Croatian: Što je Renvela i za što se koristi?
English: Other information about Renvela
Croatian: Ostale informacije o lijeku Renvela
English: What measures are being taken to ensure the safe and effective use of Renvela?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Renvela?
English: The dose to take depends on the patient's level of blood phosphate and, in case of children, their height and weight.
Croatian: Doza ovisi o razini fosfata u krvi bolesnika te, u slučaju djece, o njihovoj visini i težini.
English: The European Medicines Agency therefore concluded that Renvela's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Renvela nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Renvela is available as tablets (800 mg) and as powder (0.8 g, 1.6 g and 2.4 g) in a sachet to be taken 3 times a day with meals.
Croatian: Lijek Renvela dostupan je u obliku tableta (800 mg) i praška (0,8 g, 1,6 g i 2,4 g) u vrećici, a uzima se tri puta dnevno uz obroke.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Renvela 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 Renvela nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Renvela must not be taken on an empty stomach and patients should keep to their prescribed diets.
Croatian: Renvela se ne smije uzimati na prazan želudac, a bolesnici se trebaju pridržavati propisane dijete.
English: When taken with meals, it attaches in the gut to phosphate from food, thereby preventing the phosphate from being absorbed into the body and helping reduce phosphate levels in the blood.
Croatian: Kada se uzima s obrocima, u crijevima se veže na fosfat iz hrane, čime sprječava apsorpciju fosfata u tijelo i pomaže pri snižavanju razine fosfata u krvi.
English: Side effects reported with Renvela are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Renvela pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Renvela are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Renvela kontinuirano se prate.
English: The most common side effects with Renvela (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Croatian: Najčešće nuspojave lijeka Renvela (koje se mogu javiti u više od 1 na 10 osoba) jesu mučnina (slabost), povraćanje, bol u gornjem dijelu abdomena (trbuha) i zatvor.
English: An overview of Renvela and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Renvela i zašto je odobren u EU-u
English: For more information about using Renvela, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Renvela pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Finally, a main study also showed that Renvela was effective at lowering phosphate levels in 100 children: children who took Renvela had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
Croatian: Osim toga, u glavnom ispitivanju kojim je bilo obuhvaćeno 100 djece dokazana je učinkovitost lijeka Renvela u snižavanju razine fosfata: u djece koja su primala lijek Renvela zabilježeno je veće smanjenje fosfora (0,87 mg/dl) nego u one koja su primala placebo (prividno liječenje), u koje je zabilježen porast fosfora od 0,04 mg/dl.
English: What are the risks associated with Renvela?
Croatian: Koji su rizici povezani s lijekom Renvela?
English: In two main studies in 110 adults with kidney disease who were on dialysis, Renvela brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another authorised medicine Renagel.
Croatian: U dvama glavnim ispitivanjima na 110 odraslih osoba s bolešću bubrega na dijalizi, primjenom lijeka Renvela snižene su razine fosfata na otprilike 1,5 - 1,6 mmol/l (što je unutar ili blizu normalnog raspona) te je dokazano da je jednako djelotvoran kao i drugi odobreni lijek, tj.
English: How does Renvela work?
Croatian: Kako djeluje Renvela?
English: Renvela is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
Croatian: Renvela je lijek koji se primjenjuje za kontrolu hiperfosfatemije (visoke razine fosfata u krvi) u:
English: In a third main study in 49 adults who were not on dialysis, Renvela reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Croatian: U trećem glavnom ispitivanju na 49 odraslih osoba koje nisu bile na dijalizi, primjenom lijeka Renvela razine fosfata snižene su s 2,0 mmol/l na 1,6 mmol/l.
English: The active substance in Renvela, sevelamer carbonate, is a phosphate binder.
Croatian: Djelatna tvar lijeka Renvela, sevelamer karbonat, vezač je fosfata.
English: What benefits of Renvela have been shown in studies?
Croatian: Koje su koristi od lijeka Renvela utvrđene u ispitivanjima?
English: Studies show that Renvela is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
Croatian: Ispitivanja pokazuju da je lijek Renvela učinkovit u snižavanju razine fosfata u krvi u bolesnika s hiperfosfatemijom, a smatra se da je nuspojave lijeka moguće kontrolirati.
English: Why is Renvela authorised in the EU?
Croatian: Zašto je lijek Renvela odobren u EU-u?
English: Renvela must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut).
Croatian: Renvela se ne smije primjenjivati u osoba s niskom razinom fosfata u krvi ili opstrukcijom (začepljenjem) crijeva.
English: Renvela has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
Croatian: Ispitivanjima je dokazano da je lijek Renvela djelotvoran u snižavanju razine fosfata u krvi u bolesnika s hiperfosfatemijom.
English: For the full list of side effects with Renvela, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Renvela potražite u uputi o lijeku.
English: Renvela should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Croatian: Renvela se treba primjenjivati u kombinaciji s drugim terapijama kao što su nadomjesci kalcija i vitamina
English: Have you recently become ill?
Croatian: - Jeste li se nedavno razboljeli?
English: • you exercise or work too hard just before or after a meal;
Croatian: • vježbate ili teško radite neposredno prije ili poslije obroka,
English: • Humalog is already dissolved in water, so you do not need to mix it.
Croatian: • Humalog je već otopljen u vodi, tako da ga ne morate miješati.
English: Paediatric population Humalog can be used in adolescents and children (see section 5.1).
Croatian: Pedijatrijska populacija Humalog se može primjenjivati u adolescenata i djece (vidjeti dio 5.1).
English: Check the appearance of the insulin.
Croatian: Provjerite izgled inzulina.
English: Humalog is suitable for use in adults and children.
Croatian: Humalog mogu koristiti odrasli i djeca.
English: General information about the safe and effective use of your Pen
Croatian: Opće informacije o sigurnoj i učinkovitoj uporabi brizgalice
English: • Your doctor will tell you if you have to mix Humalog with one of the human insulins.
Croatian: • Liječnik će Vam reći morate li miješati Humalog s jednim od ljudskih inzulina.
English: • Humalog is now available in 2 strengths
Croatian: • činjenicu da je Humalog sada dostupan u 2 jačine
English: It is recommended that the system is primed before starting the infusion to the patient.
Croatian: Preporučuje se provjeriti protok u sustavu prije započinjanja davanja infuzije bolesniku.
English: Invert the Pen 10 times.
Croatian: Preokrenite brizgalicu 10 puta.
English: Humalog KwikPen is available in two strengths.
Croatian: Humalog KwikPen dostupan je u dvije jačine.
English: In one clinical study there was a small (0.38 mmol/l) increase in blood glucose levels at night (3a.m.
Croatian: U jednom je kliničkom ispitivanju zabilježen malen porast (0,38 mmol/l) razine glukoze u krvi tijekom noći (u 3 sata ujutro).
English: - HUMALOG suspensions - cloudy insulins - should look white after mixing.
Croatian: - HUMALOG suspenzije - mutni inzulini - nakon miješanja trebaju izgledati bijele.
English: Inject Humalog as your physician or nurse has taught you.
Croatian: Injicirajte Humalog onako kako su Vas naučili liječnik ili medicinska sestra.
English: ii) Mixing Humalog with longer-acting Human Insulins (see section 6.2) Humalog should be mixed with longer-acting human insulins only on the advice of a doctor.
Croatian: ii) Miješanje lijeka Humalog s humanim inzulinima dugog djelovanja (vidjeti dio 6.2) Humalog se smije miješati s humanim inzulinima dugog djelovanja samo po preporuci liječnika.
English: Warning signs are listed in section 4 of this leaflet.
Croatian: Upozoravajući znakovi popisani su u dijelu 4. ove upute.
English: Humalog BASAL has an activity profile that is very similar to that of a basal insulin (NPH) over a period of approximately 15 hours.
Croatian: Humalog BASAL ima profil djelovanja vrlo sličan profilu bazalnog inzulina (NPH) u razdoblju od približno 15 sati.
English: • Additional risk minimisation measures (Humalog 200 units/ml)
Croatian: • Dodatne mjere minimizacije rizika (Humalog 200 jedinica/ml)
English: If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.
Croatian: Ako često imate hipoglikemiju ili je teško prepoznajete, porazgovarajte o tome sa svojim liječnikom.
English: • Do not freeze Humalog.
Croatian: • Ne zamrzavajte Humalog.
English: Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.
Croatian: Sada na isti način ubrizgajte zrak u bočicu lijeka Humalog, ali nemojte izvući iglu.
English: Reduction of the mean of combined morning / evening two-hour postprandial blood glucose
Croatian: Sniženje srednje kombinirane jutarnje/večernje vrijednosti glukoze u krvi dva sata poslije obroka1
English: The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Humalog should be trained on the correct use of the pre-filled pen before prescribing or dispensing Humalog.
Croatian: Nositelj odobrenja mora se pobrinuti da zdravstveni radnici budu obaviješteni o tome da se svi bolesnici kojima je propisan Humalog moraju obučiti o pravilnoj uporabi napunjene brizgalice prije nego što im se propiše ili izda lijek Humalog.
English: Date of last renewal: 30th April 2006
Croatian: Datum posljednje obnove odobrenja: 30. travnja 2006.
English: Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Čim prije obavijestite liječnika ako osjetite znakove srčanog zatajivanja kao što je neuobičajeni nedostatak daha ili naglo povećanje tjelesne mase ili lokalizirano oticanje (edem).
English: • you have an infection or illness (especially diarrhoea or vomiting);
Croatian: • dobijete infekciju ili se razbolite (osobito ako imate proljev ili povraćate)
English: Humalog with alcohol
Croatian: Humalog s alkoholom
English: You should never mix Humalog with insulins produced by other manufacturers or animal insulins.
Croatian: Nikada ne smijete miješati Humalog s inzulinima drugih proizvođača niti s inzulinima životinjskog podrijetla.
English: Hyperglycaemia can be brought about by:
Croatian: Hiperglikemija može nastupiti ako:
English: 100 units/ml
Croatian: 100 jedinica/ml.
English: If necessary, Humalog may also be administered intravenously, for example: for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Croatian: Ako je potrebno, Humalog se može primijeniti i intravenski, primjerice radi kontrole razine glukoze u krvi kod ketoacidoze, akutne bolesti ili tijekom odnosno nakon operativnog zahvata.
English: Ask your doctor to tell you about glucagon.
Croatian: Vam da informacije o glukagonu.
English: NAME OF THE MEDICINAL
Croatian: NAZIV LIJEKA
English: The DHPC and patient communication are aimed at increasing awareness about the fact that Humalog is now available in two strengths and describing key differences in the design of the packages and the pre-filled pen devices to minimise the risk of medication errors and mix up between the two different strengths of Humalog.
Croatian: Svrha Pisma zdravstvenim radnicima i obavijesti za bolesnika je osvijestiti činjenicu da je Humalog sada dostupan u dvije jačine te opisati najvažnije razlike u dizajnu pakiranja i napunjenih brizgalica kako bi se minimizirao rizik od medikacijskih pogrešaka i slučajne zamjene dviju različitih jačina lijeka Humalog.
English: Do not use the pen to administer Humalog by a different way.
Croatian: Nemojte koristiti ovu brizgalicu za primjenu lijeka Humalog na neki drugi način.
English: If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the two can be mixed in the syringe.
Croatian: Ako režim liječenja zahtijeva istodobnu injekciju bazalnog inzulina i lijeka Humalog, ta se dva inzulina mogu pomiješati u štrcaljki.
English: • some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
Croatian: • neke antidepresive (inhibitore monoaminooksidaze ili selektivne inhibitore ponovne pohrane serotonina),
English: Humalog is also indicated for the initial stabilisation of diabetes mellitus.
Croatian: Humalog je indiciran i za početnu stabilizaciju šećerne bolesti.
English: 2 units.
Croatian: jedinice.
English: • It is normal to see a small amount of insulin left in the Pen that you cannot inject.
Croatian: • Normalno je da u brizgalici vidite malu količinu preostalog inzulina koju ne možete injicirati.
English: • If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before.
Croatian: • Ako promijenite vrstu inzulina koju koristite (primjerice prelazite s ljudskog ili životinjskog inzulina na lijek Humalog), možda ćete trebati uzimati više ili manje lijeka nego ranije.
English: Humalog in cartridges is only suitable for subcutaneous injections from a Lilly reusable pen or compatible pump systems for continuous subcutaneous insulin infusion (CSII).
Croatian: Humalog u ulošcima prikladan je samo za supkutano injiciranje brizgalicom za višekratnu uporabu koju proizvodi Lilly ili kompatibilnim sustavima s pumpom za kontinuiranu supkutanu infuziju inzulina (engl. continuous subcutaneous insulin infusion, CSII).
English: Humalog KwikPen is available in two strengths, 100 units/ml and 200 units/ml.
Croatian: Humalog KwikPen dostupan je u dvije jačine, 100 jedinica/ml i 200 jedinica/ml.
English: Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta (pogledajte dio "Upozorenja i mjere opreza“).
English: If repeated or severe low blood glucose levels occur consider the need to reduce or stop an insulin infusion.
Croatian: slučaju ponovljenih ili teških epizoda niske razine glukoze u krvi treba razmotriti je li potrebno smanjiti ili prekinuti infuziju inzulina.
English: This rapid onset of activity allows a Humalog injection (or, in the case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime.
Croatian: Taj brz nastup djelovanja omogućuje da se injekcija (odnosno, u slučaju primjene kontinuiranom supkutanom infuzijom, bolus) lijeka Humalog primijeni u kratkom vremenskom razmaku u odnosu na obrok.
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE Read the Instructions for Use before you start taking Humalog Junior KwikPen and each time you get another Humalog Junior KwikPen.
Croatian: PRIJE UPORABE PROČITAJTE OVAJ PRIRUČNIK Pročitajte Priručnik za uporabu prije nego što počnete koristiti Humalog Junior KwikPen i svaki put kad dobijete novu brizgalicu Humalog Junior KwikPen.
English: In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin, received 4 months of treatment with Humalog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomised sequence.
Croatian: U dva 8-mjesečna, otvorena, ukrižena ispitivanja bolesnici sa šećernom bolešću tipa 2 koji prethodno nisu primali inzulinsku terapiju ili su već primali jednu ili dvije injekcije inzulina su tijekom 4 mjeseca nasumičnim redoslijedom dobivali Humalog Mix25 (dvaput na dan s metforminom) i inzulin glargin
English: Using Humalog in an infusion pump
Croatian: Primjena lijeka Humalog u infuzijskoj pumpi
English: The MAH shall provide a Dear Healthcare Professional Letter (DHPC) and patient communication prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and, where required, all pharmacists who are expected to dispense Humalog.
Croatian: Nositelj odobrenja će prije stavljanja lijeka u promet dostaviti Pismo zdravstvenim radnicima i obavijest za bolesnika svim liječnicima i medicinskim sestrama za koje se očekuje da će sudjelovati u liječenju i zbrinjavanju bolesnika sa šećernom bolešću te, gdje je to potrebno, svim ljekarnicima za koje se očekuje da će izdavati Humalog.
English: • If the Dose Knob is hard to push:
Croatian: • Ako Vam je teško pritisnuti gumb za doziranje:
English: Humalog KwikPens
Croatian: Humalog KwikPen
English: • Do not freeze Humalog 200 units/ml solution for injection.
Croatian: • Ne zamrzavajte Humalog 200 jedinica/ml otopinu za injekciju.
English: Humalog 200 units/ml KwikPen is also indicated for the initial stabilisation of diabetes mellitus.
Croatian: Humalog 200 jedinica/ml KwikPen indiciran je i za početnu stabilizaciju šećerne bolesti.
English: If you stop using Humalog.
Croatian: Ako prestanete primjenjivati Humalog
English: Pack of 5 and 10
Croatian: Pakiranje od 5 i 10 uložaka
English: The label is white with an orange colour bar and there is an orange to yellow, burgundy colour band.
Croatian: Naljepnica je bijela s narančastom crtom te narančastim do žutim i tamnocrvenim prstenom.
English: • Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of Humalog you want.
Croatian: • Upotrijebite čistu, sterilnu štrcaljku i iglu da probušite gumeni čep i navučete željenu količinu lijeka Humalog.
English: Dose Knob Blue, with raised ridges on end and side
Croatian: Plavi s izbočenjima na vrhu i stranama
English: For example if you do need to inject a mixture, draw the Humalog into the syringe before the long acting insulin.
Croatian: Morate li injicirati mješavinu, Humalog navucite u štrcaljku prije dugodjelujućeg inzulina.
English: Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.
Croatian: Brizgalica Humalog 100 jedinica/ml Junior KwikPen prikladna je za bolesnike kojima bi mogle koristiti preciznije prilagodbe doza inzulina.
English: • DO NOT dial your dose by counting the clicks because you may dial the wrong dose.
Croatian: • NEMOJTE odmjeravati dozu brojanjem 'klikova' jer biste mogli odmjeriti pogrešnu dozu.
English: This rapid onset of activity allows a Humalog injection to be given very close to mealtime.
Croatian: Taj brz nastup djelovanja omogućuje da se injekcija lijeka Humalog primijeni u kratkom vremenskom razmaku u odnosu na obrok.
English: Do NOT use Humalog Junior KwikPen - if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).
Croatian: NEMOJTE primjenjivati Humalog Junior KwikPen - ako ste alergični na inzulin lispro ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Hypoglycemic Activity
Croatian: Hipoglikemijsko djelovanje
English: - If you usually need more than 30 units, ask your healthcare professional if a different
Croatian: - AkoVam obično treba više od 30 jedinica, upitajte zdravstvenog radnika bi li za Vas bila primjerenija neka druga brizgalica Humalog KwikPen.
English: - The whole unit numbers are printed on the dial.
Croatian: Na brojčaniku su otisnute cijele jedinice.
English: • Always keep spare syringes and a spare vial of Humalog Mix25.
Croatian: • Uvijek sa sobom nosite rezervne štrcaljke i rezervnu bočicu lijeka Humalog Mix25.
English: Combination of Humalog with pioglitazone
Croatian: Kombinacija lijeka Humalog s pioglitazonom
English: Administration of Humalog Mix25 to children below 12 years of age should be considered only in case of an expected benefit when compared to soluble insulin.
Croatian: Primjenu lijeka Humalog Mix25 u djece mlađe od 12 godina treba razmotriti samo ako se očekuje dodatna korist u odnosu na primjenu topljivog inzulina.
English: Do not use if it is cloudy, coloured,
Croatian: Nemojte je upotrijebiti ako je mutna,
English: Do NOT use Humalog 200 units/ml KwikPen - if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).
Croatian: NEMOJTE primjenjivati Humalog 200 jedinica/ml KwikPen - ako ste alergični na inzulin lispro ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)