natgillin/translations-raw huggingface dataset:
Very rare: may affect up to 1 in 10,000 people • Burning, pain or redness at the injection site
Manje često: mogu se pojaviti u do 1 na 100 osoba • promjena boje vene i proširenje vena
Eye irritation, amblyopia
• glavobolja, omaglica
• The active substance is palonosetron (as hydrochloride).
• Djelatna tvar je palonozetron (u obliku palonozetronklorida).
Aloxi is used in adults to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
Aloxi se primjenjuje u odraslih osoba kako bi se spriječila pojava mučnine i povraćanja prilikom liječenja raka kemoterapijom.
The safety and efficacy of Palonosetron i.v at single doses of 3µg/kg and 10µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Sigurnost i djelotvornost palonozetrona u jednokratnim i.v. dozama od 3 µg/kg i 10 µg/kg ispitivane su u prvom kliničkom ispitivanju provedenom na 72 bolesnika dobnih skupina >28 dana do 23
The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing i.v.
Drugo pedijatrijsko ispitivanje bilo je multicentrično, dvostruko slijepo, dvostruko maskirano,
No dosage adjustment is necessary in elderly patients.
U bolesnika starije dobi nije potrebno prilagođavanje doze.
Hiccups
Štucanje
What Aloxi looks like and contents of the pack Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap, which contains 5 ml of the solution.
Aloxi otopina za injekciju bistra je bezbojna otopina, a dostupna je u pakiranju od jedne bočice stakla tip
The safety and efficacy of Palonosetron i.v at single doses of 1µg/kg and 3µg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
bolesnika dobnih skupina >28 dana do 23 mjeseca (7 bolesnika), 2 do 11 godina (96 bolesnika) i 12 do 16 godina (47 bolesnika) koji su podvrgnuti elektivnom kirurškom zahvatu.
• motion sickness
• omaglica
METHOD OF ADMINISTRATION Read the package leaflet before use
Prije uporabe pročitajte uputu o lijeku.
The safety and efficacy of Palonosetron i.v at single doses of 3 µg/kg and 10 µg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
mjeseca (12 bolesnika), 2 do 11 godina (31 bolesnik) i 12 do 17 godina (29 bolesnika), koji su primali visoko ili umjereno emetogenu kemoterapiju.
How you are given Aloxi
Kako ćete primati Aloxi
IV use
PRILOG III.
(as hydrochloride).
Hiperkalijemija,
Palonosetron
pruritički osip
In a multicentre, randomised, double-blind active control clinical trial of 635 patients set to receive moderately emetogenic cancer chemotherapy.
635 bolesnika primalo je umjereno emetogenu kemoterapiju protiv karcinoma.
• numbness, burning, prickling or tingling sensations on the skin
• kožni osip koji svrbi ili koprivnjača
ondansetron.
sinusna tahikardija
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Jedan ml otopine sadrži 50 mikrograma palonozetrona (u obliku palonozetronklorida).
MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/306/002
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy.
Doza od 250 mikrograma palonozetrona daje se u obliku jedne intravenske bolus injekcije, približno
Ask your doctor or pharmacist for advice before using this medicine if you are breast-feeding.
Ako dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego što uzmete ovaj lijek.
Nervous system disorders Headache Dizziness
Poremećaji bubrega i mokraćnog sustava
MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/306/003
No safety concerns were raised at either dose level.
Sigurnost primjene lijeka nije bila sporna ni uz jednu primijenjenu dozu.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/306/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/306/001
Ask your doctor or nurse for advice before being given this medicine if you are breast-feeding.
Ako dojite, obratite se svom liječniku ili medicinskoj sestri za savjet prije nego što primite ovaj lijek.
The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation.
Nisu se pokazale klinički značajne promjene na brzinu srčanih otkucaja, atrioventrikularnu (AV) provodljivost i srčanu repolarizaciju.
He/She will advise you what is right for you and your baby.
On/ona će Vas savjetovati o tome što je ispravno za Vas i Vaše dijete.
For how long?
Koliko dugo?
When?
Kada?
The maximum daily dose is one infusion.
Maksimalna dnevna doza je jedna infuzija.
If affected, stop these activities until you feel better.
Ako do toga dođe, prekinite s tim aktivnostima dok se ne budete osjećali bolje.
However, in some cases ITP developed years later.
Međutim, u nekim slučajevima ITP se razvio godinama kasnije.
Therefore, it is important to tell your doctor about all medicines you are taking.
Stoga je važno da obavijestite svog liječnika o svim lijekovima koje uzimate.
Talk to your doctor if you are thinking about trying to become pregnant.
Razgovarajte sa svojim liječnikom ako razmišljate o tome da pokušate zatrudnjeti.
• In case of a severe adverse event
• U slučaju teškog štetnog događaja
These are described in section 4.4.
One su opisane u dijelu 4.4.
Occasionally allergic reactions could occur.
Povremeno je moguća pojava alergijskih reakcija.
It is also possible to develop a herpes infection for the first time.
Ujedno je moguće razviti infekciju herpesom prvi put.
Educational Materials for Healthcare Providers are also available:
Dostupni su i edukacijski materijali za zdravstvene radnike:
It is important you understand these risks and how to monitor for them.
Važno je da razumijete te rizike i kako prepoznati njihovu pojavu.
Each infusion will take approximately 4 hours.
Svaka infuzija trajat će približno 4 sata.
Classical biotransformation studies have not been conducted.
Nisu provedena klasična ispitivanja biotransformacije.
This may be a serious medical condition that can be life threatening.
To može biti ozbiljno medicinsko stanje koje može biti opasno po život.
• Together with your patient you need to plan and manage their periodic monitoring.
• Zajedno s bolesnikom morate isplanirati i provoditi periodične kontrole.
In case of serious reactions, the infusion may be slowed down or even stopped.
U slučaju ozbiljnih reakcija, infuzija se može usporiti ili čak prekinuti.
It has not been determined whether they respond differently than younger patients.
Nije utvrđeno reagiraju li stariji bolesnici drugačije od mlađih bolesnika.
This must be diagnosed and treated early, as otherwise the effects can be serious or even fatal.
Treba je rano dijagnosticirati i liječiti, jer u suprotnom njezini učinci mogu biti ozbiljni ili čak smrtonosni.
Not known (frequency cannot be estimated from the available data):
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
• Procedures for proper handling and disposal should be observed.
• Treba se pridržavati postupaka za pravilno rukovanje i zbrinjavanje.
This includes any possible side-effects not listed in this leaflet.
To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
3 Estimated using a mixed model for repeated measures.
3 Procijenjeno korištenjem mješovitog modela za ponovljena mjerenja
The difference was statistically significant (p=0.0002).
Razlika je bila statistički značajna (p=0,0002).
Do not freeze or shake.
Ne zamrzavati niti tresti.
What LEMTRADA is and what it is used for
Što je LEMTRADA i za što se koristi
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
However, these changes did not affect fertility and were therefore considered to be non-adverse.
Ipak, te promjene nisu utjecale na plodnost i ne smatra ih se štetnima.
Mean Age (years) Mean/Median Disease duration
Prosječna dob (godine) Prosječno/medijan trajanje bolesti
Before treatment starts and every month after treatment
Prije početka liječenja i svakog mjeseca nakon liječenja
Testing is needed even if you are feeling well and your MS symptoms are under control.
Pretrage su potrebne čak i ako se osjećate dobro i ako su Vam simptomi multiple skleroze pod kontrolom.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including any vaccinations or herbal medecines).
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove (uključujući sva cijepljenja ili biljne lijekove).
What is multiple sclerosis?
Što je multipla skleroza?
In 79.5% of cases, ITP onset occurred within 4 years after first exposure.
U 79,5% slučajeva ITP se pojavljivao unutar 4 godine nakon prvog izlaganja.
Patients had not received prior therapy for MS.
Bolesnici prije nisu primali terapiju za MS.
Atrial fibrillation*
fibrilacija atrija*
Your doctor will explain to you what tests you will need.
Liječnik će Vam objasniti koje će Vam pretrage biti potrebne.
The safety and efficacy of LEMTRADA in children with MS aged 0 to 18 years have not yet been established.
Sigurnost i djelotvornost lijeka LEMTRADA u djece s MS-om u dobi od 0 do 18 godina još nisu ustanovljene.
Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne podatke.
If you have been diagnosed with cancer in the past, please inform your doctor about it.
Ako vam je u prošlosti bio dijagnosticiran karcinom, molimo obavijestite svojeg liječnika o tome.
88397 Biberach an der Riss GERMANY
88397 Biberach an der Riss
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
In addition, these conditions may occur beyond 4 years, therefore, you must continue to look for signs and symptoms, even after you no longer need to do monthly blood and urine tests.
Osim toga, te bolesti mogu se pojaviti i nakon 4 godine pa je stoga potrebno nastaviti paziti na znakove i simptome, čak i nakon što više ne budete trebali provoditi mjesečne kontrole krvi i mokraće.
Your doctor will monitor vital signs, including blood pressure, before and during the infusion.
Liječnik će pratiti vaše vitalne znakove uključujući krvni tlak, prije i tijekom infuzije.
Clinical studies did not include any patients aged over 61 years old.
Klinička ispitivanja nisu obuhvatila bolesnike starije od 61 godina.
It was often self-limiting and relatively mild, although severity and outcome was unknown in many cases.
Često je bila samoograničavajuća i relativno blaga, iako su u mnogo slučajeva težina i ishod bili nepoznati.
(additional test to diagnose kidney disorders)
(dodatne pretrage za dijagnosticiranje poremećaja rada bubrega)
Recommendations on how to mitigate these risks through appropriate patient counselling, monitoring and management.
Preporuke o načinima smanjivanja tih opasnosti putem odgovarajućeg savjetovanja, praćenja i liječenja bolesnika.
LEMTRADA adjusts your immune system to limit its attacks on your nervous system.
LEMTRADA prilagođava Vaš imunološki sustav na način da se ograniče njegovi napadi na Vaš živčani sustav.
Additional follow-up provided data through a median of 4.8 years (maximum 6.7).
Dodatno praćenje pružilo je podatke kroz medijan od 4,8 godina (maksimalno 6,7).
Both cases were serious, were identified early through clinical and laboratory monitoring, and had a positive outcome after treatment.
Oba su slučaja bila ozbiljna, prepoznata rano kroz kliničko i laboratorijsko praćenje, a ishod im je nakon liječenja bio pozitivan.
These results were obtained from a post hoc analysis and should be interpreted cautiously.
Rezultati su dobiveni naknadnom analizom te ih je potrebno interpretirati s oprezom.
The number of normal sperm was significantly reduced (<10%) relative to controls and the percent abnormal sperm (detached heads or no heads) were significantly increased (up to 3%).
Broj normalnih spermija bio je značajno smanjen (< 10%) u odnosu na kontrolnu skupinu i postotak abnormalnih spermija (s odvojenim glavama ili bez glava) bio značajno povećan (do 3%).
Carcinogenesis and mutagenesis
Kancerogeneza i mutageneza
If you develop one of these conditions your doctor will tell you, and take appropriate measures to treat it.
Ako se razvije neka od tih bolesti, liječnik će Vam to reći i poduzeti odgovarajuće mjere za liječenje.
CDI is a measure for sustained disability improvement.
CDI je mjera za trajno poboljšanje onesposobljenosti.
Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C.
Dokazana je kemijska i fizikalna stabilnost lijeka u uporabi tijekom 8 sati na temperaturi od 2°C - 8°C.
• double vision
• dvostruki vid
(to diagnose all important serious side effects listed above)
(za dijagnosticiranje svih prethodno navedenih važnih ozbiljnih nuspojava)
In most cases these are mild but some serious reactions are possible.
U većini su slučajeva one blage, no moguće su i neke ozbiljne reakcije.
• athlete's foot
• atletsko stopalo
Two treatment courses may reduce MS activity for up to 6 years.
Dva ciklusa liječenja mogu smanjiti aktivnost multiple skleroze (MS) do 6 godina.
The antibody has an approximate molecular weight of 150 kD.
Približna molekularna težina protutijela iznosi 150 kD.
The benefits and risks of 5 or more treatment courses have not been established.
Koristi i rizici 5 ili više ciklusa liječenja nisu ustanovljeni.
It is unlikely that your dose would be missed since it is administered by a health care professional.
Nije vjerojatno da ćete propustiti dozu budući da vam ju primjenjuje zdravstveni radnik.
2 Patient Guide:
2 Vodič za bolesnika:
However, there may be benefits of breast milk (which can help protect a baby from infections), so talk to your doctor if you are planning to breast-feed your baby.
Međutim, majčino mlijeko može biti korisno (može zaštititi dijete od infekcija), stoga razgovarajte sa svojim liječnikom ako planirate dojiti dijete.
Safety profile in long-term follow-up
Sigurnosni profil u dugoročnom praćenju
Date of first authorisation: 12 September 2013 Date of latest renewal: 2 July 2018
Datum posljednje obnove odobrenja: 02. srpnja 2018.
Human Immunodeficiency Virus (HIV) infection.
Infekcija virusom humane imunodeficijencije (HIV).
Before initiation of therapy, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection, according to local guidelines.
Prije početka liječenja, svi se bolesnici moraju procijeniti na postojanje aktivne ili neaktivne („latentne“) infekcije tuberkulozom, u skladu s lokalnim smjernicama.
• If non-compliant, patients may need further counseling to highlight the risks of missing scheduled monitoring tests.
• Ako se toga ne pridržavaju, bolesnicima je možda potrebno dodatno savjetovanje, kako bi se naglasili rizici propuštanja zakazanih kontrolnih pretraga.
Administer within 8 hours after dilution.
Primijeniti unutar 8 sati nakon razrjeđivanja.
There have been no studies to assess the carcinogenic or mutagenic potential of alemtuzumab.
Nisu provedena ispitivanja kojima bi se ocijenio kancerogeni ili mutageni potencijal alemtuzumaba.
Summary of the safety profile in clinical studies
Sažetak sigurnosnog profila u kliničkim ispitivanjima
It is unknown if LEMTRADA can be transferred to a baby through breast milk, but there is a possibility that it could be.
Nije poznato može li se LEMTRADA prenijeti na dijete putem majčina mlijeka, no takva mogućnost postoji.
There are certain signs and symptoms that you should look out for yourself.
Postoje određeni znakovi i simptomi na čiju biste pojavu i sami trebali obratiti pozornost.
In general, the infections can be treated with standard medicines.
Infekcije se u načelu mogu liječiti standardnim lijekovima.
Up to two additional treatment courses, as needed, may be considered (see section 5.1):
Mogu se razmotriti najviše dva dodatna ciklusa liječenja ako je potrebno (vidjeti dio 5.1):
Initial treatment of 2 courses:
Početno liječenje od 2 ciklusa:
These are conditions in which your immune system mistakenly attacks your body.
To su bolesti kod kojih imunološki sustav greškom napada vlastito tijelo.
Contents of the pack and other information What LEMTRADA contains
Sadržaj pakiranja i druge informacije Što LEMTRADA sadrži
4.5/3.8 years
4,5/3,8 godina
Human IgG is known to cross the placental barrier; alemtuzumab may cross the placental barrier as well and thus potentially pose a risk to the foetus.
Poznato je da humani IgG prelazi placentarnu barijeru; alemtuzumab također može prijeći placentarnu barijeru i tako potencijalno predstavljati rizik za plod.
Patients with uncontrolled hypertension.
Bolesnici s nekontroliranom hipertenzijom.
LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.
LEMTRADA se smije primjenjivati tijekom trudnoće samo ako potencijalna korist opravdava mogući rizik za plod.
When the inflammation causes symptoms this is often called an “attack” or a “relapse”.
Kada upala uzrokuje simptome, to se često naziva "napadajem"
The incidence of antibodies is highly dependent on the sensitivity and specificity of the assay.
Incidencija protutijela izrazito je ovisna o osjetljivosti i specifičnosti testa.
No characteristics at study entry identified patients who would later receive one or more additional courses.
Nikakve karakteristike na početku ispitivanja nisu identificirale bolesnike koji će kasnije primiti jedan ili više dodatnih ciklusa.
If you cannot reach your doctor, you must seek immediate medical attention.
Ako Vaš liječnik nije dostupan, morate odmah zatražiti liječničku pomoć.
Listeria infection can cause serious illness, including meningitis, but can be treated with appropriate medicines.
Infekcija uzrokovana listerijom može uzrokovati ozbiljnu bolest, uključujući meningitis, ali može se liječiti odgovarajućim lijekovima.
LEMTRADA is not recommended for patients with inactive disease or those stable on current therapy.
LEMTRADA se ne preporučuje za bolesnike kod kojih bolest nije aktivna ili za one koji su stabilni na trenutnoj terapiji.
Fertility and reproduction
Plodnost i reprodukcija
Care should be taken to ensure the sterility of the prepared solution.
Oprez je neophodan kako bi se osigurala sterilnost pripremljene otopine.
Nevertheless, please note that in case of missed dose, this should not be given on the same day as a scheduled dose.
Usprkos tome, molimo imajte na umu da u slučaju propuštene doze, ne smijete ju primijeniti isti dan kao i planiranu dozu.
In order to reduce the chance of getting an infection, your doctor will check if other medicines you are taking might be affecting your immune system.
Kako bi smanjio mogućnost razvoja infekcije, liječnik će provjeriti utječu li možda drugi lijekovi koje uzimate na Vaš imunološki sustav.
The study provides efficacy and safety through a median of 6 years from entry into Studies 1 and 2.
Ispitivanje osigurava podatke o djelotvornosti i sigurnosti kroz medijan od 6 godina od početka Ispitivanja 1 i 2.
A risk to the suckling newborn/infant cannot be excluded.
Ne može se isključiti rizik za dojenu novorođenčad/dojenčad.
• polysorbate 80 (E433)
• polisorbat 80 (E433)
Median % Change in Brain Parenchymal Fraction
Medijan % promjene frakcije moždanog parenhima
Hypotension*, hypertension*
hipotenzija*, hipertenzija*
If you are given more LEMTRADA than you should receive
Ako primite više lijeka LEMTRADA nego što ste trebali
What LEMTRADA looks like and contents of the pack
Kako LEMTRADA izgleda i sadržaj pakiranja
To assist in the education of patients regarding potential side-effects and instructions on what to do in case of certain side-effects, the following risk minimisation materials are available:
Kao pomoć u edukaciji bolesnika o mogućim nuspojavama i uputama o tome što treba napraviti u slučaju pojave određenih nuspojava, dostupni su sljedeći materijali za minimizaciju rizika:
LEMTRADA must be diluted before infusion.
LEMTRADA se prije infuzije mora razrijediti.
• infection due to a virus known as Epstein-Barr virus
• infekcije uzrokovane virusom poznatim kao Epstein-Barr virus
Conclusions cannot be made with available data on the effect of race and gender on the pharmacokinetics of alemtuzumab.
Na temelju dostupnih podataka nije moguće donijeti zaključak o učinku rase i spola na farmakokinetiku alemtuzumaba.
In addition, you will be monitored during the infusion and for 2 hours after the infusion has been completed.
Osim toga, bit ćete pod nadzorom tijekom infuzije i 2 sata po njezinu završetku.
Disability1 (Confirmed Disability Worsening [CDW] 2
Confirmed Disability Worsening, CDW]2)
These additional treatment courses may be adminisitered twelve months or more after the prior treatments.
Ovi dodatni ciklusi liječenja mogu se primijeniti dvanaest ili više mjeseci nakon prethodnog liječenja.
For further information on autoimmune reactions, infections and other information.
Za dodatne informacije o autoimunim reakcijama i infekcijama te ostale informacije
Resources for the management of anaphylaxis or serious reactions (see below) should be available.
Sredstva za zbrinjavanje anafilaksije ili ozbiljnih reakcija (vidjeti ispod) moraju biti dostupna.
CD52 is known to be present in human and rodent reproductive tissues.
Poznato je da je CD52 prisutan u reprodukcijskim tkivima ljudi i glodavaca.
• exaggerated immune response
• pretjeran imunološki odgovor
This analysis includes data from Phase 3 studies only (CAMMS324 and CAMMS323) due to differences in the MRI acquisition algorithms between the Phase 2 and Phase 3 studies.
Ova analiza uključuje samo podatke iz kliničkih ispitivanja faze 3 (CAMMS324 i CAMMS323) zbog razlike u algoritmu prikupljanja MRI između ispitivanja faze 2 i faze 3.
Tell your doctor right away if you have any of these signs of infection
Odmah obavijestite svog liječnika ako primijetite neki od sljedećih znakova infekcije
It can also lead to damage of your lungs, which can result in coughing up blood.
Moguće je, također, oštećenje pluća, što će rezultirati iskašljavanjem krvi.
LEMTRADA is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.
LEMTRADA nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina, jer nije ispitivana u bolesnika s multiplom sklerozom mlađih od 18 godina.
However, research suggests immunomodulatory effects through the depletion and repopulation of lymphocytes, including:
No istraživanja ukazuju na imunomodulatorne učinke putem deplecije i repopulacije limfocita, uključujući:
E339, disodium edetate, E508, E340, E433, sodium chloride, water for injections
E339, dinatrijev edetat, E508, E340, E433, natrijev klorid, voda za injekcije
Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgium
Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgija