natgillin/translations-raw huggingface dataset:
• EMA has reviewed the risk of pneumonia in COPD patients using corticosteroid inhalers and has concluded that this risk applies to all medicines of this class.
• EMA je provela ocjenjivanje rizika od upale pluća u bolesnika oboljelih od KOPB-a koji uzimaju inhalacijske lijekove koji sadrže kortikosteroide i zaključila da taj rizik postoji u slučaju svih lijekova tog razreda.
The evidence did not confirm any differences in risk between products.
Dokazi nisu potvrdili da postoje razlike među proizvodima u pogledu rizika.
The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Ocjenjivanje je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u području lijekova za humanu uporabu, koji je iznio niz preporuka.
• It has been known for some time that inhaled corticosteroid medicines increase the risk of pneumonia (infections of the lungs) in patients taking these medicines for the long-term lung disease COPD (chronic obstructive pulmonary disease).
• Veće je neko vrijeme poznato da inhalacijski lijekovi koji sadrže kortikosteroide povećavaju rizik od upale pluća (infekcije pluća) u bolesnika koji te lijekove uzimaju za liječenje dugotrajne bolesti pluća KOPB (kronična opstruktivna plućna bolest).
• Following a review of the available data, EMA has confirmed the risk of pneumonia with inhaled corticosteroids (ICS) in patients with COPD.
• Nakon ocjenjivanja dostupnih podataka EMA je potvrdila postojanje rizika od upale pluća pri primjeni inhalacijskih lijekova koji sadrže kortikosteroide (ICS) u bolesnika oboljelih od KOPB-a.
Corticosteroid inhalers are widely used in the European Union (EU) to treat COPD and pneumonia is a common side effect of such treatment.
Inhalacijski lijekovi koji sadrže kortikosteroide u širokoj su primjeni u Europskoj uniji (EU) za liječenje KOPB-a, a upala pluća česta je nuspojava tog liječenja.
• Healthcare professionals should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
• Zdravstveni radnici moraju i dalje pozorno pratiti mogućnost razvoja upale pluća u bolesnika oboljelih od KOPB-a jer se klinički znakovi takvih infekcija podudaraju sa simptomima egzacerbacije KOPB-a.
Review finds no differences between products in risk of pneumonia
U ocjenjivanju nisu utvrđene razlike među proizvodima u pogledu rizika od upale pluća
• Corticosteroid inhalers reduce inflammation and swelling in the lungs and so help breathing in patients with COPD.
• Inhalacijski lijekovi koji sadrže kortikosteroide ublažuju upalu i oteknuća u plućima, što oboljelima od KOPB-a olakšava disanje.
There is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS products.
Ne postoje uvjerljivi klinički dokazi koji bi upućivali na razlike u okviru razreda lijekova u pogledu razmjera rizika među inhalacijskim lijekovima koji sadrže kortikosteroide.
Beclomethasone, budesonide, flunisolide, fluticasone propionate and fluticasone furoate are corticosteroids authorised and marketed as inhalation formulations for use in COPD.
Kortikosteroidi koji su odobreni i stavljeni na tržište kao formulacije za inhalaciju za primjenu u bolesnika oboljelih od KOPB-a jesu beklometazon, budezonid, flunisolid, flutikazon propionat i flutikazon furoat.
Do not take a double dose.
Ne uzimajte dvostruku dozu.
Date of latest renewal: 17 June 2008
Datum posljednje obnove: 17. lipnja 2008.
Xenical with food and drink
Xenical s hranom i pićem
This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.
To je važno jer istovremena upotreba više lijekova može pojačati ili oslabiti njihov učinak.
Xenical has been studied in long-term clinical studies of up to 4 years duration.
Xenical je ispitan u dugotrajnim kliničkim studijama u trajanju do 4 godine.
If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times.
Ako u bilo koje doba zaboravite popiti lijek, uzmite ga čim se sjetite, pod uvjetom da je to najviše sat vremena nakon posljednjeg obroka, a zatim ga nastavite uzimati u uobičajeno vrijeme.
Always take Xenical exactly as your doctor has told you.
Uvijek uzmite Xenical točno onako kako Vam je rekao liječnik.
The side effects were generally similar to those observed in adults.
Nuspojave su općenito bile slične onima uočenima u odraslih.
Some fatal cases or cases requiring liver transplantation have been reported.
Prijavljeni su neki slučajevi sa smrtnim ishodom ili slučajevi koji su zahtijevali transplantaciju jetre.
Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Stoga liječenje orlistatom treba započeti tek nakon pomnog razmatranja mogućeg utjecaja na te bolesnike.
This can lead to a decrease of immunosuppressive efficacy.
To može dovesti do smanjenja imunosupresivne djelotvornosti.
Caution should be exercised when prescribing to pregnant women.
Potreban je oprez ako se propisuje trudnicama.
To gain the maximum benefit from Xenical you should follow the nutrition program recommended to you by your doctor.
Da biste od lijeka Xenical imali najveću korist, potrebno je pratiti program prehrane koji Vam je preporučio liječnik.
What XENICAL is and what it is used for
Što je XENICAL i za što se koristi
Losing weight may mean you need adjustments to the dose of these medicines.
Zbog gubitka težine može biti potrebna prilagodba doze tih lijekova.
• Medicines for depression, psychiatric disorders or anxiousness
• lijekova za depresiju, psihijatrijske poremećaje ili tjeskobu
The following side effects have also been reported but their frequency cannot be estimated from the available data:
Prijavljene su i sljedeće nuspojave, ali njihova učestalost se ne može procijeniti na temelju dostupnih podataka:
Stop Xenical if such symptoms occur and tell your doctor.
Prestanite uzimati Xenical ako se pojave takvi simptomi i obavijestite o tome svog liječnika.
Like all medicines, Xenical can cause side effects, although not everybody gets them.
Kao i svi lijekovi, Xenical može uzrokovati nuspojave iako se one neće javiti kod svakoga.
Contents of the pack and other information What XENICAL contains
Sadržaj pakiranja i druge informacije Što XENICAL sadrži
This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time.
To znači da ćete jednu kapsulu uzeti uz doručak, drugu uz ručak i treću uz večeru.
Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.
U suprotnom liječnik može misliti da lijek nije bio učinkovit ili da ga niste dobro podnijeli te može bespotrebno promijeniti liječenje.
Xenical may modify the activity of
Xenical može promijeniti aktivnost:
The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.
Volumen raspodjele ne može se odrediti jer je apsorpcija lijeka minimalna i nema definiranu sistemsku farmakokinetiku.
Other medicines and Xenical
Drugi lijekovi i Xenical
• Medicines to treat HIV.
• lijekova za liječenje infekcije HIV-om.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Obavijestite liječnika ako iz nekog razloga niste uzeli lijek točno onako kako je propisao.
What XENICAL looks like and contents of the pack
Kako XENICAL izgleda i sadržaj pakiranja
In animal reproductive studies, no teratogenic effect was observed.
U životinjskim reproduktivnim modelima nisu pronađeni teratogeni učinci.
- Chronic malabsorption syndrome.
- Kronični malapsorpcijski sindrom.
You may ask your doctor for advice.
Zatražite savjet liječnika.
As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
Kao i uz svaki program za kontrolu tjelesne težine, pretjerani unos masti i kalorija može smanjiti učinak gubitka težine.
If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
Ako popijete više kapsula nego što Vam je liječnik preporučio ili ako netko drugi slučajno popije Vaš lijek, kontaktirajte svog liječnika, ljekarnika ili bolnicu jer ćete možda trebati medicinsku pomoć.
Effects on clotting with anti-coagulants.
Učinci na zgrušavanje uz antikoagulanse.
To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.
Da biste postigli najbolji učinak, izbjegavajte između obroka uzimanje hrane koja sadrži masnoće, poput kolača, čokolade ili grickalica.
In vitro orlistat is > 99 % bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Orlistat se in vitro > 99 % veže za proteine plazme (lipoproteini i albumin najznačajniji su vezni proteini).
These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat.
Ti su simptomi uglavnom blagi, javljaju se na početku liječenja, a osobito su izraženi nakon obroka koji sadrže visoku razinu masti.
It is not known whether these findings translate into long-term clinical benefits.
Nije jasno može li se iz ovih nalaza izvesti zaključak o dugotrajnoj kliničkoj koristi.
The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Vrijeme potrebno za potpuno izlučivanje (stolicom i urinom) iznosilo je od 3 do 5 dana.
In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases.
bolesnika liječenih amiodaronom klinički značaj ovog učinka za sada ostaje nepoznat, ali može postati klinički značajan u nekim slučajevima.
Both populations received multivitamin supplements.
Obje skupine su primale multivitaminske pripravke.
17498 Mesekenhagen Germany or
17498 Mesekenhagen
Ciclosporin blood levels should be monitored until stabilised.
Razine ciklosporina u krvi valja pratiti sve dok se ne stabiliziraju.
Your doctor may suggest you take a multivitamin supplement.
Liječnik vam može preporučiti uzimanje multivitaminskog pripravka.
Approximately 97 % of the administered dose was excreted in faeces and 83 % of that as unchanged orlistat.
Približno 97 % primijenjene doze izlučilo se stolicom, a od toga 83 % kao nepromijenjeni orlistat.
It has not been demonstrated that the effect on HbA1c is independent from weight reduction.
Nije utvrđeno je li učinak na HbA1c neovisan o smanjenju tjelesne težine.
There is no relevant indication for use of Xenical in children.
Nema relevantne indikacije za uporabu lijeka Xenical u djece.
Therefore, these patients should be monitored for possible changes in the frequency and/or severity of convulsions.
Stoga, te bolesnike treba pratiti zbog mogućih promjena u učestalosti i/ili težini konvulzija.
The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
Primarni rezultat bio je promjena indeksa tjelesne mase (BMI) od početka do kraja ispitivanja.
The undigested fat cannot be absorbed and is eliminated by your body.
Neprobavljena masnoća ne može se apsorbirati i izlučuje se iz tijela.
If a meal is missed or contains no fat, the dose of orlistat should be omitted.
Ako se obrok preskače ili ne sadrži masti, dozu orlistata treba izostaviti.
What Xenical is and what it is used for What you need to know before you take Xenical How to take Xenical
Što je Xenical i za što se koristi Što morate znati prije nego počnete uzimati Xenical Kako uzimati Xenical
Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours.
Ukoliko bi došlo do značajnog predoziranja orlistatom, preporučuje se nadzor bolesnika tijekom 24 sata.
Do not change the prescribed dose yourself unless your doctor tells you to.
Nemojte mijenjati propisanu dozu, ako Vam to nije savjetovao liječnik.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, čak i one koji se izdaju bez recepta.
Increase in liver transaminases and in alkaline phosphatase.
Povišenje jetrenih transaminaza i alkalne fosfataze.
Lack of interactions
Odsutnost interakcija
• Amiodarone.
• amiodarona.
For a full list of excipients, see 6.1.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
If you take more XENICAL than you should
Ako uzmete više lijeka XENICAL nego što ste trebali
Orlistat minimally partitions into erythrocytes.
Orlistat minimalno ulazi u eritrocite.
• Ciclosporin.
• ciklosporina.
Pharmaco-therapeutic group: Peripherally acting antiobesity agent, ATC code A08AB01.
Farmakoterapijska skupina: lijekovi protiv pretilosti s perifernim djelovanjem, ATK oznaka A08AB01.
Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Na temelju istraživanja na ljudima i životinjama, bilo koji sistemski učinak koji bi proizlazio iz svojstva orlistata da inhibira lipazu trebao bi biti brzo reverzibilan.
M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively).
M1 i M3 imaju otvoreni beta-laktonski prsten i iznimno slabu aktivnost inhibicije lipaza (1000, odnosno 2500 puta slabiju nego orlistat).
• The active substance is orlistat.
• Djelatna tvar je orlistat.
Glass bottles
Staklene boce
See Chapter 2, take special care with Xenical.
Pogledajte dio 2. Budite posebno oprezni s lijekom Xenical.
The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal.
Preporučena doza orlistata je jedna kapsula od 120 mg uzeta s vodom neposredno prije, za vrijeme ili unutar jednog sata nakon svakog glavnog obroka.
Xenical is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Xenical se ne preporučuje osobama koje uzimaju akarbozu (lijek koji se koristi za liječenje šećerne bolesti tipa 2).
The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/m2 in favour of orlistat).
Rezultati su bili znatno bolji u skupini koja je primala orlistat (razlika u BMI-u od 0,86 kg/m2 u korist orlistata).
Medicines should not be disposed via wastewater or household waste.
Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal.
Xenical se veže za enzime u probavnom sustavu (lipaze) i sprječava ih da razgrade dio masnoća unesenih hranom.
Xenical is a medicine used to treat obesity.
Xenical je lijek koji je namijenjen liječenju pretilosti.
Common: Anxiety
Često: tjeskoba
Inform your doctor whether you suffer from problems with your kidney.
Obavijestite svog liječnika ukoliko imate problema s bubrezima.
Xenical can be taken immediately before, during a meal or up to one hour after a meal.
Xenical se može uzimati neposredno prije, za vrijeme ili do sat vremena nakon obroka.
The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing.
Učinak orlistata rezultira povećanim izlučivanjem masti stolicom već 24 do 48 sati nakon uzimanja lijeka.
The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.
Odsutnost ovih interakcija dokazana je u specifičnim studijama interakcija lijek-lijek.
It is recommended that the diet should be rich in fruit and vegetables.
Preporučuje se prehrana bogata voćem i povrćem.
• if you have cholestasis (liver disorder)
• ako imate kolestazu (poremećaj jetre),
The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose.
Kumulativno bubrežno izlučivanje tvari povezanih s orlistatom bilo je < 2 % primijenjene doze.
The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e.g. in a 2000 kcal/day diet, > 30 % of calories from fat equates to > 67 g of fat).
Mogućnost pojave gastrointestinalnih nuspojava (vidjeti dio 4.8.) može se povećati u slučajevima uzimanja orlistata uz obroke koji sadrže visok udio masti (primjerice, u dnevnoj prehrani od 2000 kcal, >30% kalorija iz masti jednako je > 67 g masti).
In order to ensure adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered.
Kako bi se osigurala pravilna prehrana, bolesnicima koji su na dijeti radi kontrole težine treba savjetovati prehranu bogatu voćem i povrćem, a može se razmotriti i uzimanje multivitaminskih pripravaka.
Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases.
Orlistat je potentan, specifičan inhibitor gastrointestinalne lipaze, dugog djelovanja.
Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Nakon prekida terapije, sadržaj masti u stolici obično se za 48 do 72 sata vraća na razinu prije početka liječenja.
Cases of rectal bleeding have been reported with Xenical.
Zabilježeni su slučajevi rektalnog krvarenja uz Xenical.
If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of orlistat or at bedtime.
Ako se preporuči uzimanje multivitaminskog pripravka, treba ga uzeti barem dva sata nakon uzimanja orlistata ili prije spavanja.
PHARMACEUTICAL FORM AND CONTENTS 21 hard capsules
OBLIK I SADRŽAJ 21 tvrda kapsula
Be sure to discuss these and other medicines you may be taking with your doctor.
Posavjetujte se s liječnikom o tim i ostalim lijekovima koje možda uzimate.
Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.
Nema dokaza da doze orlistata više od 120 mg tri puta dnevno pružaju dodatnu korist.
OUTER CARTON AND BOTTLE LABEL
KUTIJA I NALJEPNICA BOČICE
84 hard capsules
84 tvrde kapsule
Common: Urinary tract infection
Često: infekcija urinarnog trakta
No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed.
Nisu opažene interakcije s amitriptilinom, atorvastatinom, bigvanidima, digoksinom, fibratima, fluoksetinom, losartanom, fenitoinom, fenterminom, pravastatinom, nifedipinom GITS (Gastrointestinal Therapeutic System), nifedipinom sa sporim oslobađanjem, sibutraminom ili alkoholom.
Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall.
Temeljem podataka dobivenih ispitivanjem na životinjama, vjerojatno je da se orlistat metabolizira uglavnom unutar stijenke gastrointestinalnog sustava.
Your doctor may need to monitor your blood coagulation.
Liječnik će možda morati pratiti zgrušavanje krvi.
The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides.
Inaktivirani enzim nije, stoga, raspoloživ za hidrolizu prehrambene masti, u obliku triglicerida, u slobodne masne kiseline i monogliceride koje bi se mogle apsorbirati.
In addition your daily intake of fat should be distributed evenly over three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.
Uz to, dnevni unos masti treba raspodijeliti u tri glavna obroka jer ako se Xenical uzima uz obrok bogat mastima, povećava se mogućnost smetnji u probavnom traktu.
It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases.
Njegovo terapijsko djelovanje odvija se u lumenu želuca i tankom crijevu gdje stvara kovalentne veze s aktivnim serinskim mjestom gastričnih i gušteračnih lipaza.
If you have missed several doses, please inform your doctor and follow the advice given to you.
Ako zaboravite uzeti nekoliko doza obavijestite liječnika i slijedite njegove upute.
PVC/ PVDC blisters containing 21, 42 and 84 hard capsules.
PVC/PVDC blisteri koji sadrže 21, 42 i 84 tvrde kapsule.
Upper respiratory infection Lower respiratory infection
infekcija gornjeg dišnog sustava infekcija donjeg dišnog sustava
The vast majority of patients receiving up to four full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
Velika većina bolesnika koji su u okviru kliničkih ispitivanja primali terapiju orlistatom i do pune četiri godine, imali su vrijednosti vitamina A, D, E i K te beta-karotena unutar normalnog raspona.
Driving and using machines Xenical has no known effect on your ability to drive a car or operate machinery.
Upravljanje vozilima i strojevima Xenical nema poznati učinak na sposobnost upravljanja vozilima ili strojevima.
Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.
Xenical je indiciran u liječenju pretilosti, u kombinaciji s niskokaloričnom dijetom.
In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ml and 108 ng/ml respectively), these metabolites are considered to be pharmacologically inconsequential.
S obzirom na tu nisku inhibicijsku aktivnost i nisku razinu u plazmi u terapijskim dozama (prosječno 26 ng/ml, odnosno 108 ng/ml), ti se metaboliti ne smatraju farmakološki značajnim.
If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.
Ako se orlistat uzima uz visokomasni obrok, može se povećati mogućnost pojave gastrointestinalnih nuspojava.
The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day.
Uobičajena doza lijeka Xenical je jedna kapsula od 120 mg uz svaki od tri glavna obroka dnevno.
When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Kad se varfarin ili drugi antikoagulansi daju u kombinaciji s orlistatom, potrebno je nadzirati vrijednosti internacionalnog normaliziranog omjera (INR, engl. international normalised ratio) (vidjeti dio 4.4) .
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 July 1998
Datum prvog odobrenja: 29. srpnja 1998.
The possibility of this happening may increase if Xenical is taken with a diet high in fat.
Mogućnost da se to dogodi povećava se ako se Xenical uzima istovremeno s hranom bogatom mastima.
Hepatitis (inflammation of the liver).
Hepatitis (upala jetre).
Taking Xenical during pregnancy is not recommended.
Ne preporučuje se uzimanje lijeka Xenical tijekom trudnoće.
Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat.
Koncentracija nepromijenjenog orlistata u plazmi nije se mogla odrediti (< 5 ng/ml) osam sati nakon peroralne primjene orlistata.
This risk is increased in patients with underlying chronic kidney disease and/or volume depletion (see section 4.8).
Taj je rizik povećan u bolesnika s podležećom kroničnom bolešću bubrega i/ili deplecijom volumena (vidjeti dio 4.8).
INFORMATION IN BRAILLE xenical
16. PODACI NA BRAILLEOVOM PISMU xenical