FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevention of infections after colorectal surgery
Croatian: Sprečavanje infekcije nakon kolorektalnog kirurškog zahvata
English: Before using Invanz, doctors should consider official guidance on the appropriate use of antibiotics.
Croatian: Prije primjene lijeka Invanz liječnici trebaju proučiti službene smjernice o odgovarajućoj primjeni antibiotika.
English: It must also not be used in patients who are severely allergic to other types of antibiotics, such as penicillins and cephalosporins.
Croatian: Također se ne smije primjenjivati u bolesnika koji su izrazito alergični na druge vrste antibiotika, poput penicilina i cefalosporina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Invanz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Invanz nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: In children, Invanz was as effective as the comparator antibiotics and had similar effectiveness to that in adults.
Croatian: U djece, lijek Invanz bio je jednako djelotvoran kao usporedni antibiotici te slične djelotvornosti kao u odraslih osoba.
English: What are the risks associated with Invanz?
Croatian: Koji su rizici povezani s lijekom Invanz?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invanz 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 Invanz nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Invanz.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Invanz.
English: This upsets the essential functions that keep the cells alive, and so kills the bacteria.
Croatian: To ometa glavne funkcije živih bakterija i ubija bakterije.
English: Infection was absent in about 60% patients given Invanz compared with 49% of patients given cefotetan.
Croatian: U otprilike 60 % bolesnika koji su primali lijek Invanz nije došlo do infekcije, u odnosu na 49 % u bolesnika koji su primali cefotetan.
English: Invanz must not be used in people who are hypersensitive (allergic) to ertapenem or to other antibiotics of the same group (carbapenems).
Croatian: Lijek Invanz ne smiju koristiti osobe koje su preosjetljive (alergične) na ertapenem ili druge antibiotike iz iste skupine (karbapenemi).
English: The active substance in Invanz, ertapenem, belongs to the group of antibiotics known as ‘carbapenems'.
Croatian: Djelatna tvar u lijeku Invanz, ertapenem, ubraja se u skupinu antibiotika poznatih pod nazivom „karbapenemi”.
English: The Committee concluded that it was also effective for treatment of infection in children and for preventing infection after colorectal surgery in adults.
Croatian: Odbor je zaključio da je lijek također djelotvoran za liječenje infekcije u djece i za sprečavanje infekcije nakon kolorektalnog zahvata u odraslih osoba.
English: Other information about Invanz
Croatian: Ostale informacije o lijeku Invanz
English: However, the data were not sufficient to support the use of Invanz in the treatment of urinary tract infections and skin and soft tissue infections, except foot ulcers in diabetes patients.
Croatian: Međutim, podaci nisu bili dostatni da bi poduprli primjenu lijeka Invanz u liječenju infekcija mokraćnih putova i infekcija kože i mekog tkiva, osim u slučaju ulkusa stopala u bolesnika s dijabetesom.
English: The most common side effects with Invanz (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea (feeling sick), vomiting, rash (including nappy rash in children), itching, and problems around the area where the medicine is infused (including pain and inflammation of the vein).
Croatian: Najčešće nuspojave lijeka Invanz (koje se mogu javiti u manje od 1 na 10 osoba) su glavobolja, proljev, mučnina (osjećaj slabosti), povraćanje, osip (uključujući pelenski osip u djece), svrbež i tegobe u blizini mjesta injiciranja (uključujući bol i upalu vene).
English: What benefits of Invanz have been shown in studies?
Croatian: Koje su koristi lijeka Invanz dokazane u ispitivanjima?
English: Invanz was as effective as ceftriaxone or piperacillin/tazobactam for the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and foot infections in diabetes patients: Invanz was effective for 87 to 94% of patients compared with 83 to 92% for the comparator antibiotics.
Croatian: Lijek Invanz bio je jednako djelotvoran kao i ceftriakson ili piperacilin/tazobaktam u liječenju abdominalnih infekcija, izvanbolničke upale pluća, ginekoloških infekcija i infekcija stopala u bolesnika s dijabetesom: Invanz je bio djelotvoran u 87 do 94 % bolesnika u odnosu na 83 do 92 % kod usporednih antibiotika.
English: Invanz was compared with ceftriaxone (another antibiotic) for the treatment of adults with communityacquired pneumonia (866 patients) and urinary tract infections (592 patients), and with a combination of piperacillin and tazobactam for the treatment of abdominal infections (655 patients), gynaecological infections (412 patients), skin and soft tissue infections (infections of the skin and the tissues just beneath the skin, 540 patients); and foot infections in diabetes patients (576 patients).
Croatian: Lijek Invanz uspoređen je s ceftriaksonom (drugim antibiotikom) u liječenju odraslih osoba s izvanbolničkom upalom pluća (866 bolesnika) i infekcijom mokraćnih putova (592 bolesnika), te s kombinacijom piperacilina i tazobaktama za liječenje abdominalnih infekcija (655 bolesnika), ginekoloških infekcija (412 bolesnika), infekcija kože i mekog tkiva (infekcije kože i tkiva neposredno ispod kože, 540 bolesnika), te infekcija stopala u bolesnika s dijabetesom (576 bolesnika).
English: For more information about treatment with Invanz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Invanz pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Invanz is available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein.
Croatian: Lijek Invanz dostupan je u bočici koja sadrži prah koji se otapanjem prije upotrebe pretvara u otopinu za ubrizgavanje (drip) u venu.
English: Invanz is used when the bacteria that cause the infection are likely to be killed by the antibiotic.
Croatian: Lijek Invanz primjenjuje se kada je vjerojatno da će antibiotik ubiti bakterije koje izazivaju infekciju.
English: In studies in children, Invanz was compared with ceftriaxone (for community-acquired pneumonia, 389 children) and with ticarcillin/clavulanate (for intra-abdominal infections, 105 children).
Croatian: U ispitivanjima u djece, lijek Invanz uspoređen je s ceftriaksonom (u liječenju izvanbolničke upale pluća, 389 djece) i s tikarcilinom/klavulanatom (u liječenju intraabdominalnih infekcija, 105 djece).
English: Once the infection has improved, treatment can be switched to an antibiotic that can be given by mouth.
Croatian: Nakon što je došlo do poboljšanja infekcije, liječenje se može nastaviti s antibiotikom koji se primjenjuje peroralno.
English: How is Invanz used?
Croatian: Kako se Invanz koristi?
English: • infections within the abdomen;
Croatian: • intraabdominalnih infekcija;
English: The CHMP noted that Invanz was shown to be effective, albeit with a limited number of severe cases treated during the studies for abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections.
Croatian: CHMP je uočio da se lijek Invanz pokazao djelotvornim, iako je broj teških slučajeva liječenih tijekom ispitivanja liječenja abdominalnih infekcija, izvanbolničke upale pluća, ginekoloških infekcija i infekcija stopala u bolesnika s dijabetesom bio ograničen.
English: For practical information about using Invanz, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Invanz bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Invanz was compared with cefotetan for preventing infection after colorectal surgery.
Croatian: Lijek Invanz uspoređen je s cefotetanom u sprečavanju infekcije nakon kolorektalnog zahvata.
English: Effectiveness was measured as absence of infection 4 weeks after treatment, which involved 952 adults.
Croatian: Mjerilo djelotvornosti u ispitivanju koje je uključivalo 952 odrasle osobe bilo je odsustvo infekcije nakon četiri tjedna liječenja.
English: Invanz is also used in adults to prevent infection after colorectal surgery (surgery in the lower part of the bowel, including the rectum).
Croatian: Lijek Invanz također se primjenjuje u odraslih osoba za sprečavanje infekcije nakon kolorektalnog kirurškog zahvata (operacija debelog crijeva, uključujući rektum).
English: • foot infections in diabetes patients.
Croatian: • infekcija stopala u dijabetičara.
English: Invanz can work on a range of different bacteria, which are listed in the summary of product characteristics (also part of the EPAR).
Croatian: Lijek Invanz može se primjenjivati za različite bakterije, koje su navedene u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: Invanz contains the active substance ertapenem.
Croatian: Lijek Invanz sadrži djelatnu tvar ertapenem.
English: How does Invanz work?
Croatian: Kako djeluje lijek Invanz?
English: For the full list of all side effects reported with Invanz, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Invanz potražite u uputi o lijeku.
English: The dose for smaller children depends on the child's body surface area and the other medicines that the child is taking.
Croatian: Doza za manju djecu ovisi o tjelesnoj površini djeteta i drugim lijekovima koje dijete uzima.
English: It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Croatian: Ne liječi infekcije HIV-om, no može odgoditi oštećenje imunosnog sustava i spriječiti razvijanje infekcija i bolesti povezanih s AIDS-om.
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU), called Kaletra.
Croatian: To znači da je sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Kaletra.
English: This dose is also suitable for children (aged between two and 12 years) provided that they weigh more than 40 kg or have a body surface area (calculated using the child's height and weight) over 1.4 m2.
Croatian: Ta je doza prikladna i za djecu (u dobi između dvije i 12 godina), uz uvjet da imaju više od 40 kg ili da im tjelesna površina (izračunata temeljem visine i težine djeteta) premašuje 1,4 m2.
English: When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection.
Croatian: Kad je enzim blokiran, virus se ne umnožava na uobičajen način, što usporava širenje infekcije.
English: When deciding to use once-daily dosing, the doctor should consider the fact that it might not be as effective as twice-daily dosing at keeping HIV levels low in the long term and may increase the risk of diarrhoea.
Croatian: Pri odlučivanju o primjeni doze jedanput dnevno liječnik treba uzeti u obzir činjenicu da ona dugoročno možda neće biti jednako učinkovita pri održavanju niskih razina HIV-a kao doziranje dvaput dnevno, a može povećati rizik od proljeva.
English: It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).
Croatian: Dostupan je u obliku tableta (100 mg lopinavira i 25 mg ritonavira; 200 mg lopinavira i 50 mg ritonavira).
English: The full EPAR and risk management plan summary for Lopinavir/Ritonavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Lopinavir/Ritonavir Mylan nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.
Croatian: Time se povećavaju razine lopinavira u krvi, što omogućuje primjenu manjih doza lopinavira za jednak antivirusni učinak.
English: For adults (aged 18 years or over) who are infected with HIV that is likely to respond to medicines in the same class as Lopinavir/Ritonavir Mylan (protease inhibitors) the doctor may prescribe the full daily dose of four 200/50-mg tablets as a single dose.
Croatian: Odraslima (u dobi od 18 godina i više) koji su zaraženi HIV-om, a za koje postoji vjerojatnost da će reagirati na lijekove u istom razredu kao što je Lopinavir/Ritonavir Mylan (inhibitori proteaze), liječnik može propisati punu dnevnu dozu od četiri tablete od 200/50 mg kao jednokratnu dozu.
English: In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day.
Croatian: U odraslih i adolescenata (u dobi od 12 godina i više) preporučena doza lijeka Lopinavir/Ritonavir Mylan je dvije tablete od 200/50 mg dvaput dnevno.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Lopinavir/Ritonavir Mylan posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Kaletra.
English: Lopinavir/Ritonavir Mylan is a ‘generic medicine'.
Croatian: Lopinavir/Ritonavir Mylan je „generički lijek”.
English: Lopinavir/Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lopinavir/Ritonavir Mylan koristi se u kombinaciji s ostalim lijekovima protiv HIV-a za liječenje bolesnika u dobi od dvije godine i više zaraženih virusom humane imunodeficijencije tipa 1 (HIV 1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: This is a summary of the European public assessment report (EPAR) for Lopinavir/Ritonavir Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Lopinavir/Ritonavir Mylan.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lopinavir/Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Lopinavir/Ritonavir Mylan nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Because Lopinavir/Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Lopinavir/Ritonavir Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV.
Croatian: Djelatne tvari u ovom lijeku, lopinavir i ritonavir, inhibitori su proteaze, tj. oni blokiraju enzim proteazu koji je povezan s umnožavanjem HIV-a.
English: In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster' that slows down the rate at which lopinavir is broken down by the liver.
Croatian: U lijeku Lopinavir/Ritonavir Mylan lopinavir omogućuje aktivnost, a ritonavir se upotrebljava kao „pojačivač” za usporavanje brzine kojom jetra razgrađuje lopinavir.
English: For more information about treatment with Lopinavir/Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Lopinavir/Ritonavir Mylan pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Other information about Lopinavir/Ritonavir Mylan
Croatian: Ostale informacije o lijeku Lopinavir/Ritonavir Mylan
English: The Committee recommended that Lopinavir/Ritonavir Mylan be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Lopinavir/Ritonavir Mylan u EU-u.
English: Because Lopinavir/Ritonavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Kaletra.
Croatian: Budući da je Lopinavir/Ritonavir Mylan generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje je li lijek bioekvivalentan referentnom lijeku Kaletra.
English: What measures are being taken to ensure the safe and effective use of Lopinavir/Ritonavir Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lopinavir/Ritonavir Mylan?
English: It is not intended to provide practical advice on how to use Lopinavir/Ritonavir Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Lopinavir/Ritonavir Mylan.
English: What is Lopinavir/Ritonavir Mylan and what is it used for?
Croatian: Što je Lopinavir/Ritonavir Mylan i za što se koristi?
English: A risk management plan has been developed to ensure that Lopinavir/Ritonavir Mylan is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Lopinavir/Ritonavir Mylan.
English: Therefore, the CHMP's view was that, as for Kaletra, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Kaletra.
English: Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level.
Croatian: Lopinavir/Ritonavir Mylan u kombinaciji s drugim lijekovima protiv HIV-a smanjuje količinu HIV-a u krvi i održava nisku razinu koncentracije virusa.
English: Lopinavir/Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Croatian: Lopinavir/Ritonavir Mylan izdaje se samo na liječnički recept, a liječenje treba nadzirati liječnik s iskustvom u liječenju infekcije HIV-om.
English: What are the benefits and risks of Lopinavir/Ritonavir Mylan?
Croatian: Koje su koristi i rizici lijeka Lopinavir/Ritonavir Mylan?
English: For practical information about using Lopinavir/Ritonavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjenu lijeka Lopinavir/Ritonavir Mylan pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.
Croatian: Lopinavir/Ritonavir Mylan sadržava djelatne tvari lopinavir i ritonavir.
English: Why is Lopinavir/Ritonavir Mylan approved?
Croatian: Zašto je lijek Lopinavir/Ritonavir Mylan odobren?
English: How is Lopinavir/Ritonavir Mylan used?
Croatian: Kako se Lopinavir/Ritonavir Mylan koristi?
English: How does Lopinavir/Ritonavir Mylan work?
Croatian: Kako djeluje Lopinavir/Ritonavir Mylan?
English: How has Lopinavir/Ritonavir Mylan been studied?
Croatian: Kako je Lopinavir/Ritonavir Mylan ispitivan?
English: Take your next dose at the usual time.
Croatian: Svoju sljedeću dozu uzmite u uobičajeno vrijeme.
English: 69800, France
Croatian: 69800, Francuska
English: Take your capsules as soon as you remember.
Croatian: Uzmite kapsule čim se sjetite.
English: The amount of anagrelide that people take can be different, and this depends on your condition.
Croatian: Količina anagrelida koju ljudi uzimaju može biti različita, a to ovisi o Vašem stanju.
English: You can take the capsules with food or after a meal or on an empty stomach.
Croatian: Kapsule možete uzimati s hranom ili nakon obroka ili na prazan želudac.
English: Do not take more capsules than your doctor has recommended.
Croatian: Ne uzimajte više kapsula nego što Vam je liječnik preporučio.
English: • If you have or think you might have a problem with your heart;
Croatian: • ako imate ili mislite da biste mogli imati teškoća sa srcem;
English: It is best to take the capsule(s) at the same time every day.
Croatian: Najbolje je kapsulu (ili kapsule) uzimati svaki dan u isto vrijeme.
English: The following side effects have been reported but it is not known exactly how often they occur:
Croatian: Slijede nuspojave koje su bile prijavljene, ali nije točno poznato koliko se često javljaju:
English: • > 60 years of age or
Croatian: • dob iznad 60 godina ili
English: Currently available data are described in sections 4.4, 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.4, 4.8, 5.1 i 5.2, ali nije moguće dati preporuku o doziranju.
English: Speak to your doctor if you need advice with contraception.
Croatian: Obratite se liječniku ako Vam je potreban savjet u vezi s kontracepcijom.
English: Mutagenic and carcinogenic potential
Croatian: Mutageni i karcinogeni potencijal
English: 6545 CM Nijmegen NETHERLANDS
Croatian: 6545 CM Nijmegen Nizozemska
English: The starting dose should be maintained for at least one week.
Croatian: Početnu dozu treba uzimati najmanje tjedan dana.
English: The average daily dose tended to be higher in adolescents.
Croatian: Prosječna dnevna doza bila je obično viša u adolescenata.
English: Tell your doctor if you are pregnant or are planning to become pregnant.
Croatian: Obavijestite liječnika ako ste trudni ili planirate zatrudnjeti.
English: Carton only: PC:
Croatian: Samo na kutiji: PC:
English: If you are worried, speak to your doctor.
Croatian: Ako ste zabrinuti, razgovarajte sa svojim liječnikom.
English: After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.
Croatian: Nakon toga liječnik može povećati ili smanjiti broj kapsula koje uzimate kako bi ustanovio dozu koja je za Vas najprikladnija te koja najdjelotvornije liječi Vaše stanje.
English: The capsules must be swallowed whole.
Croatian: Kapsule se moraju progutati cijele.
English: Your doctor will prescribe the best dose for you.
Croatian: Liječnik će propisati dozu koja je za Vas najbolja.
English: Very common side effects: may affect more than 1 in 10 people Headache.
Croatian: Vrlo česte nuspojave: mogu se javiti u više od 1 na 10 osoba Glavobolja.
English: Your doctor may do a blood test which may show an increase in your liver enzymes.
Croatian: Liječnik Vam može napraviti krvnu pretragu koja može pokazati porast jetrenih enzima.
English: Anagrelide or these medicines may not work properly if taken together.
Croatian: Anagrelid ili ti lijekovi možda neće pravilno djelovati ako se uzmu zajedno.
English: Gradual dose titration may help diminish these effects (see section 4.2).
Croatian: Postupna titracija doze može pridonijeti smanjenju tih učinaka (vidjeti dio 4.2).
English: There was also a trend to higher dose-normalised exposure to the active metabolite.
Croatian: Također je postojala tendencija prema većoj izloženosti aktivnom metabolitu normaliziranoj za dozu.