natgillin/translations-raw huggingface dataset:
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including tacrolimus.
U bolesnika liječenih imunosupresivima, uključujući takrolimus, prijavljeni su slučajevi nefropatije povezane s BK virusom kao i slučajevi progresivne multifokalne leukoencefalopatije
The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Envarsus is similar to that of immediate-release tacrolimus.
(AUC0-24) za Envarsus sličan je onome za takrolimus s trenutnim oslobađanjem.
Blood and lymphatic system disorders anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses, abnormal thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy pure red cell aplasia, agranulocytosis, haemolytic anaemia
poremećaj testova koagulacije i krvarenja trombotska trombocito penična purpura, hipoprotrombinemija, trombotska mikroangiopatija izolirana aplazija crvene krvne loze, agranulocitoza,
Each prolonged-release tablet contains 0.75 mg tacrolimus (as monohydrate).
Jedna tableta s produljenim oslobađanjem sadrži 0,75 mg takrolimusa (tacrolimus) (u obliku hidrata).
fever, nausea or vomiting - an infection, leading to problems with your kidney or neurological symptoms - headache, altered mental status, seizures and visual disturbances - weakness, change in skin or eye colour, easy bruising, infection, cough, anaemia
- glavobolju, promijenjeno mentalno stanje, napadaje i poremećaje vida - slabost, promjenjenu boju kože ili bjeloočnica, sklonost nastanku modrica, infekciju,
Envarsus 4 mg prolonged-release tablets tacrolimus
Envarsus 4 mg tablete s produljenim oslobađanjem tacrolimus
CYP3A4 inducers potentially leading to decreased tacrolimus blood levels Clinically, the following substances have been shown to decrease tacrolimus blood levels: Interactions have been observed with rifampicin, phenytoin, and St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
Primijećene su interakcije s rifampicinom, fenitoinom i gospinom travom (Hypericum perforatum), koje mogu zahtijevati povećanje doze takrolimusa u gotovo svih bolesnika.
Respiratory, thoracic and mediastinal disorders parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations respiratory failures, respiratory tract disorders, asthma acute respiratory distress syndrome
dispneja, pleuralni izljev, kašalj, faringitis, nazalna kongestija i upale respiratorno zatajenje,
Envarsus 1 mg prolonged-release tablets tacrolimus
Envarsus 1 mg tablete s produljenim oslobađanjem tacrolimus
Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Druge interakcije koje mogu povećati koncentraciju takrolimusa u krvi
Hepatic impairment
hipertenziju i nesanicu.
Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Prijavljena je povezanost između liječenja takrolimusom te dobroćudnih i zloćudnih neoplazmi, uključujući limfoproliferativne poremećaje povezane s EBV-om i zloćudne promjene na koži.
Package leaflet: Information for the patient Envarsus 0.75 mg prolonged-release tablets Envarsus 1 mg prolonged-release tablets Envarsus 4 mg prolonged-release tablets tacrolimus
Envarsus 0,75 mg tablete s produljenim oslobađanjem Envarsus 1 mg tablete s produljenim oslobađanjem Envarsus 4 mg tablete s produljenim oslobađanjem takrolimus (tacrolimus)
Dosing should be delayed in the presence of elevated ciclosporin blood levels.
U slučaju povišenih razina ciklosporina u krvi, doziranje treba odgoditi.
Envarsus 4 mg prolonged-release tablets
Envarsus 4 mg tablete s produljenim oslobađanjem
This effect may be enhanced if Envarsus is administered in association with alcohol.
Envarsus uzima zajedno s alkoholom.
Common side effects (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) - reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
- smanjen broj krvnih stanica (krvnih pločica, crvenih ili bijelih krvnih stanica), povišen broj bijelih krvnih stanica, promjene u broju crvenih krvnih stanica (vidljivo u nalazu pretraga krvi ) - snižena razina magnezija, fosfata, kalija, kalcija ili natrija u krvi, opterećenje tekućinom, povišena razina mokraćne kiseline ili lipida u krvi, smanjen tek, gubitak teka, povišena kiselost krvi, druge promjene u elektrolitima u krvi (vidljivo u nalazu pretraga krvi ) - simptomi tjeskobe, smetenost i gubitak orijentacije, depresija, promjene raspoloženja,
- medicines known as “statins”, used to treat elevated cholesterol and triglycerides - phenytoin or phenobarbital, used to treat epilepsy - prednisolone and methylprednisolone, belonging to the class of corticosteroids and used to treat inflammations or suppress the immune system (e.g. in transplant rejection) - carbamazepine, used to prevent and control seizures - metamizole, used to treat pain and high fever - nefazodone, used to treat depression - herbal preparations containing St. John's Wort (Hypericum perforatum)
- nilotinib i imatinib (koji se koriste za liječenje određenih vrsta raka) - mikofenolatnu kiselinu, koja se koristi za potiskivanje imunološkog sustava radi sprječavanja odbacivanja presađenog organa - lijekove protiv čira na želucu i povrata želučane kiseline (npr. omeprazol, lanzoprazol ili cimetidin)
Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate).
Jedna tableta s produljenim oslobađanjem sadrži 4 mg takrolimusa (tacrolimus) (u obliku hidrata).
Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate).
Jedna tableta s produljenim oslobađanjem sadrži 1 mg takrolimusa (tacrolimus) (u obliku hidrata).
Missed dose
PRIMJENU LIJEKA
Envarsus is a once-a-day oral formulation of tacrolimus.
Envarsus je peroralni farmaceutski oblik takrolimusa koji se primjenjuje jedanput na dan.
Envarsus 1 mg prolonged-release tablets
Envarsus 1 mg tablete s produljenim oslobađanjem
Envarsus contains lactose.
Pomoćne tvari Envarsus sadrži laktozu.
Each prolonged-release tablet contains 4.0 mg tacrolimus (as monohydrate).
Jedna tableta s produljenim oslobađanjem sadrži 4,0 mg takrolimusa (u obliku hidrata).
Prophylaxis of kidney transplant rejection
Sprječavanje odbacivanja presatka bubrega
Each prolonged-release tablet contains 1.0 mg tacrolimus (as monohydrate).
Jedna tableta s produljenim oslobađanjem sadrži 1,0 mg takrolimusa (u obliku hidrata).
hallucination, mental disorders - fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - blurred vision, increased sensitivity to light, eye disorders - ringing sound in your ears - reduced blood flow in the heart vessels, faster heartbeat - bleeding, partial or complete blocking of blood vessels, reduced blood pressure - shortness in breath, disorders of the respiratory tissues in the lung, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms - stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
- krvarenje, djelomično ili potpuno začepljenje krvnih žila, snižen krvni tlak, - nedostatak zraka, promjene u plućnom tkivu, nakupljanje tekućine oko pluća, upala ždrijela, kašalj, simptomi nalik gripi - problemi sa želucem poput upale ili ulkusa koji izazivaju bol u trbuhu ili proljev,
Very rare side effects (may affect up to 1 in 10,000 people): - Muscular weakness - Impaired hearing - Abnormal heart scan - Liver failure - Painful urination with blood in the urine - Increase of fat tissue
- žeđ, pad, osjećaj stezanja u prsištu, smanjena pokretljivost, ulkus Vrlo rijetke nuspojave (mogu se pojaviti u do 1 na 10 000 osoba): - slabost mišića - oštećenje sluha
When converting from tacrolimus immediate-release products (e.g. Prograf capsules) or from Advagraf prolonged-release capsules to Envarsus, trough levels should be measured prior to conversion and within two weeks after conversion.
Advagrafa s produljenim oslobađanjem na Envarsus, moraju se odrediti najniže koncentracije takrolimusa prije prelaska te unutar 2 tjedna nakon prelaska.
Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Tijekom razdoblja nakon presađivanja organa potrebno je pratiti najniže razine takrolimusa u krvi.
abdominal pain, indigestion, constipation, passing wind, bloating, loose stools - bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver - itching, rash, hair loss, acne, increased sweating - pain in joints, limbs or back, muscle cramps - insufficient function of the kidneys, reduced production of urine, impaired or painful urination - general weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed - insufficient function of your transplanted organ
- poteškoće s disanjem, poremećaji dišnog sustava, astma - akutna ili kronična upala gušterače, upala sluznice koja oblaže unutarnju stijenku trbušne šupljine, začepljenje crijeva, povišena razina enzima amilaze u krvi, vraćanje sadržaja želuca u grlo, usporeno pražnjenje želuca
Gastrointestinal disorders diarrhoea, nausea gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools acute and chronic pancreatitis, peritonitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying pancreatic pseudocyst, subileus
gastrointestinalni i abdominalni bolovi, upalna stanja probavnog sustava, krvarenje u probavnom sustavu, ulceracije i perforacije probavnog sustava, ascites, stomatitis i ulceracije, konstipacija,
Vascular disorders hypertension thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders venous thrombosis deep limb, shock, infarction
poremećaji perifernih krvnih žila duboka venska tromboza udova, šok, infarkt
Therapeutic drug monitoring of mycophenolic acid may be appropriate when switching from ciclosporin to tacrolimus or vice versa.
Pri prelasku s ciklosporina na takrolimus i obrnuto možda će biti potrebno terapijsko praćenje koncentracija mikofenolatne kiseline.
While you take Envarsus your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease (e.g. amiloride, triamterene, or spironolactone), nonsteroidal anti-inflammatory substances (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes.
nesteroidne protuupalne lijekove (NSAIL, npr. ibuprofen) koji se koriste protiv vrućice, upale i bolova; antikoagulanse (za razrjeđivanje krvi), ili oralne lijekove za liječenje šećerne bolesti.
Very common side effects (may affect more than 1 in 10 people): - increased blood sugar, diabetes mellitus, increased potassium in the blood - difficulty in sleeping - trembling, headache - increased blood pressure - liver function tests abnormal - diarrhoea, nausea - kidney problems
- povišen šećer u krvi, šećerna bolest, povišena razina kalija u krvi - poteškoće sa spavanjem
Therapeutic drug monitoring
FARMACEUTSKI PODACI
Hypromellose
hemolitička anemija
The educational material for Healthcare Professionals should include information on the following key elements: - The authorised indications - The need for prescribing and dispensing with attention to pharmaceutical form (prolonged-release) and posology (once daily administration).
- Odobrene indikacije - Potrebu da se prilikom propisivanja i izdavanja lijeka obrati pažnja na farmaceutski oblik
In particular, you should tell your doctor if you are taking or have recently taken medicines like: - antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections (e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, and isavuconazole, erythromycin, clarithromycin, josamycin, isoniazid and rifampicin) - HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat,
- lijekove protiv gljivica i antibiotike, osobito takozvane makrolidne antibiotike, koji se koriste za liječenje infekcija (npr. ketokonazol, flukonazol, itrakonazol, vorikonazol,
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus.
U bolesnika liječenih takrolimusom prijavljeni su slučajevi izolirane aplazije crvene loze (engl. pure red cell aplasia, PRCA).
These also included infections caused by MRSA.
Također su bile obuhvaćene infekcije uzrokovane MRSA-om.
In all the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
U svim ispitivanjima glavna mjera djelotvornosti bio je broj bolesnika čija je infekcija izliječena nakon terapije.
Xydalba is given once a week by an infusion lasting 30 minutes.
Xydalba se primjenjuje jednom na tjedan infuzijom koja traje 30 minuta.
The recommended dose is 1,500 mg, given either as a single infusion or as 1,000 mg in the first week followed by 500 mg one week later.
Preporučena doza lijeka iznosi 1500 mg, a može se davati kao jedna infuzija ili u dozi od 1000 mg u prvom tjednu, a nakon toga u dozi od 500 mg tjedan dana poslije.
These side effects were generally of mild or moderate severity.
Te su nuspojave općenito blage ili umjerene težine.
In the 3 studies, between 87% and 94% of patients treated with Xydalba were cured, compared with between 91% and 93% of patients treated with any of the two comparators.
U ta tri ispitivanja 87 % do 94 % bolesnika liječenih lijekom Xydalba bilo je izliječeno, u usporedbi s 91 % do 93 % bolesnika liječenih jednim od dvaju komaparatora.
The full EPAR and risk management plan summary for Xydalba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Xydalba nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patients who received vancomycin and responded to treatment had the option to switch to linezolid after 3 days.
Bolesnici koji su primili vankomicin i reagirali na terapiju imali su mogućnost prelaska na linezolid nakon 3 dana.
In light of the need for new antibiotics targeting multi-resistant bacteria, the CHMP concluded that Xydalba, which showed activity against certain bacteria resistant to other antibiotics, could be a valuable alternative treatment option.
U svjetlu potrebe za novim antibioticima čije je djelovanje usmjereno na multirezistentne bakterije, CHMP je zaključio da bi Xydalba, koji se pokazao djelotvornim protiv određenih bakterija otpornih na druge antibiotike, mogao biti vrijedna alternativna terapijska opcija.
The European Commission granted a marketing authorisation valid throughout the European Union for Xydalba on 19 February 2015.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Xydalba na snazi u Europskoj uniji od 19. veljače 2015.
This is a summary of the European public assessment report (EPAR) for Xydalba.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Xydalba.
What is Xydalba and what is it used for?
Što je Xydalba i za što se koristi?
What measures are being taken to ensure the safe and effective use of Xydalba?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xydalba?
Why is Xydalba approved?
Zašto je Xydalba odobren?
Before using Xydalba, doctors should consider official guidance on the appropriate use of antibiotics.
Prije primjene Xydalba liječnici trebaju proučiti službene smjernice o odgovarajućoj primjeni antibiotika.
It is not intended to provide practical advice on how to use Xydalba.
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Xydalba.
It contains the active substance dalbavancin.
Sadrži djelatnu tvar dalbavancin.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xydalba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Xydalba nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
Xydalba was at least as effective as vancomycin or linezolid at curing the infection.
Lijek Xydalba bio je barem jednako djelotvoran kao vankomicin ili linezolid u liječenju infekcije.
It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria.
Djeluje sprječavajući određene bakterije u stvaranju vlastitih staničnih stijenki te ih na taj način ubija.
What are the risks associated with Xydalba?
Koji su rizici povezani s lijekom Xydalba?
The dose of Xydalba needs to be reduced in patients with severely impaired kidney function.
Dozu će možda trebati smanjiti u bolesnika s teško oštećenom funkcijom bubrega.
A risk management plan has been developed to ensure that Xydalba is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Xydalba.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xydalba, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Xydalba nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Xydalba is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Xydalba je antibiotik koji se koristi u odraslih osoba za liječenje akutnih (kratkotrajnih) bakterijskih infekcija kože i struktura kože (tkiva ispod kože) poput celulitisa (upale dubokog kožnog tkiva), kožnih apscesa i infekcija rana.
Other information about Xydalba
Ostale informacije o lijeku Xydalba
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom for which standard antibiotics do not work.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dalbavancin djeluje protiv bakterija (poput bakterije Staphylococcus aureus otporne na metilicin (MRSA)) na koje standardni antibiotici ne djeluju.
The most common side effects with Xydalba (which may affect between 1 and 3 people in 100) are nausea (feeling sick), diarrhoea and headache.
Najčešće nuspojave lijeka Xydalba (mogu se javiti u 1 do 3 na 100 bolesnika) su mučnina (osjećaj slabosti), proljev i glavobolja.
The active substance in Xydalba, dalbavancin, is a type of antibiotic called glycopeptide.
Djelatna tvar lijeka Xydalba, dalbavancin, tip je antibiotika naziva glikopeptid.
Xydalba was compared with vancomycin (another glycopeptide) or with linezolid (an antibiotic that can be taken by mouth) in three main studies involving a total of around 2,000 patients with serious infections of the skin and soft tissue under the skin, such as cellulitis, skin abscesses and wound infections.
Xydalba je uspoređen s vankomicinom (drugim glikopeptidom) ili linezolidom (antibiotikom koji se uzima na usta) u tri glavna ispitivanja koja su obuhvatila ukupno 2000 bolesnika s ozbiljnim infekcijama kože i mekanog potkožnog tkiva, poput celulitisa, kožnih apscesa i infekcija rana.
For more information about treatment with Xydalba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Xydalba pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Xydalba is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription.
Xydalba je dostupan kao prašak za pripravak otopine za infuziju (drip) u venu i izdaje se samo na liječnički recept.
A list of bacteria against which Xydalba is active can be found in the summary of product characteristics (also part of the EPAR).
Popis bakterija protiv kojih Xydalba djeluje dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
For practical information about using Xydalba, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o korištenju lijeka Xydalba pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
How is Xydalba used?
Kako se Xydalba koristi?
What benefits of Xydalba have been shown in studies?
Koje su koristi lijeka Xydalba utvrđene u ispitivanjima?
How does Xydalba work?
Kako djeluje Xydalba?
Xydalba's safety profile is comparable to that of other antibiotics of the glycopeptide class; side effects affecting hearing and kidney function, which are typical for glycopeptides, have not been shown with the proposed regimens of Xydalba in the clinical trials.
Nuspojave koje utječu na sluh i funkciju bubrega, a koje su tipične za glikopeptide, nisu utvrđene s predloženim režimom lijeka Xydalba u kliničkim ispitivanjima.
For the full list of all side effects and restrictions with Xydalba, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Xydalba potražite u uputi o lijeku.
The main measure of effectiveness was the rate of implantation and pregnancy.
Glavna mjera djelotvornosti bila je stopa implantacije i trudnoće.
Why is Rekovelle approved?
Zašto je Rekovelle odobren?
Rekovelle follitropin delta
Rekovelle folitropin delta
The full EPAR for Rekovelle can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Rekovelle nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Rekovelle and what is it used for?
Što je Rekovelle i za što se koristi?
What measures are being taken to ensure the safe and effective use of Rekovelle?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rekovelle?
Other information about Rekovelle
Ostale informacije o lijeku Rekovelle
The dose can then be modified in subsequent cycles according to the woman's response.
Doza se potom može prilagoditi u narednim ciklusima, ovisno o odgovoru tijela žene.
After the first injection, the woman or their partner may be able to give the injections themselves, if they have been trained and have access to expert advice.
Nakon prve injekcije žena ili njezin partner mogu samostalno ubrizgavati lijek ako su za to obučeni te su im dostupni stručni savjeti.
In severe cases OHSS may lead to difficulty breathing and problems with blood clotting.
U teškim slučajevima OHSS može uzrokovati teškoće pri disanju i probleme sa zgrušnjavanjem krvi.
This is a summary of the European public assessment report (EPAR) for Rekovelle.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Rekovelle.
The safety profile of Rekovelle was considered acceptable and similar to that of GONAL-f.
Sigurnosni profil lijeka Rekovelle smatra se prihvatljivim i sličan je sigurnosnom profilu lijeka GONAL-f.
What are the risks associated with Rekovelle?
Koji su rizici povezani s lijekom Rekovelle?