natgillin/translations-raw huggingface dataset:
The use of this medicine will be supervised by a doctor experienced in the treatment of patients with homocystinuria.
Primjenu ovog lijeka će nadzirati liječnik iskusan u liječenju bolesnika s homocistinurijom.
180 g of oral powder and three measuring spoons.
180 g oralnog praška i tri mjerne žličice.
However, the dose should be individually titrated according to plasma levels of homocysteine and methionine.
Međutim, dozu treba posebno titrirati u pojedinog bolesnika u skladu s razinama homocisteina i metionina u plazmi.
What Cystadane contains - The active substance is betaine anhydrous.
Što Cystadane sadrži - Djelatna tvar je bezvodni betain.
Based on in vitro data, betaine anhydrous might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Na temelju in vitro podataka, bezvodni betain može ući u interakciju s mješavinama aminokiselina i lijekovima koji sadrže vigabatrin i analoge GABA-e.
This will give the following doses: small measure 100 mg, middle size measure 150 mg and large measure 1 g of betaine anhydrous.
Tako će se odrediti sljedeće doze: mala mjerica 100 mg, srednja mjerica 150 mg i velika mjerica 1 g bezvodnog betaina.
Gastrointestinal disorders like diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue may occur uncommonly (may affect up to 1 in 100 people).
Gastrointestinalni poremećaji poput proljeva, mučnine, povraćanja, nelagode u želucu i upale jezika mogu se javiti manje često (mogu se javiti u do 1 na 100 ljudi).
Homocystinuria is a disease caused by the accumulation of homocysteine which is not converted to cysteine and is characterised by formation of clots in the veins, bone weakness, and skeletal and crystalline lens abnormalities.
Homocistinurija je bolest uzrokovana nakupljanjem homocisteina koji se ne pretvara u cistein te je karakterizirana stvaranjem krvnih ugrušaka u venama, slabljenjem kostiju i poremećajima kostiju i očne leće.
This demonstrates that differences in betaine anhydrous kinetics are most probably due to betaine anhydrous depletion in untreated homocystinuria and are only meaningful for the initial treatment.
To ukazuje da je razlika u kinetici bezvodnog betaina najvjerojatnije uzrokovana deplecijom bezvodnog betaina u neliječenih bolesnika s homocistinurijom pa je značajna samo tijekom započinjanja liječenja.
Most of these patients were also receiving other treatments such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folate with variable biochemical responses.
Većina tih bolesnika je također uzimala i druge pripravke kao što su vitamin B6 (piridoksin), vitamin B12 (kobalamin) i folatna kiselina, s različitim biokemijskim odgovorima.
The recommended dose in children and adults is 100mg/kg/day divided in 2 dosesper day.
Preporučena doza za djecu i odrasle je 100 mg/kg na dan, podijeljeno u dvije doze na dan.
Betaine anhydrous acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Bezvodni betain djeluje kao donor metilne skupine u procesu remetilacije homocisteina u metionin u bolesnika s homocistinurijom.
Each pack contains 1 bottle with 180 g of powder and three measuring spoons.
Svako pakiranje sadrži 1 bocu sa 180 g praška i tri mjerne žličice.
Elevated homocysteine plasma levels are associated with cardiovascular events (such as thrombosis), osteoporosis, skeletal abnormalities, and optic lens dislocation.
Povišene razine homocisteina u plazmi povezane su kardiovaskularnim događajima (poput tromboze), s osteoporozom, poremećajima skeleta i dislokacijom očne leće.
Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine anhydrous.
Dugotrajna ispitivanja kancerogenosti i reproduktivne toksičnosti s bezvodnim betainom nisu provedena.
Mix the measured dose of powder with water, juice, milk, formula or food until completely dissolved and ingest immediately after mixing.
Izmjerenu količinu praška promiješajte s vodom, sokom, mlijekom, adaptiranim mlijekom ili hranom dok se potpuno ne rastopi i odmah progutajte.
- If you have any further questions, ask your doctor or your pharmacist.
- Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
If you take more Cystadane than you should If you accidentally take too much Cystadane, talk to a doctor or pharmacist immediately.
Ako slučajno uzmete previše Cystadanea, odmah obavijestite svog liječnika ili ljekarnika.
- If symptoms of cerebral oedema recur after re-introduction of treatment then betaine anhydrous therapy should be discontinued indefinitely.
- Ako se, nakon ponovne primjene lijeka, simptomi moždanog edema ponovno jave, terapiju bezvodnim betainom treba trajno prekinuti.
Cystadane treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria.
Liječenje Cystadaneom treba nadzirati liječnik s iskustvom u liječenju bolesnika s homocistinurijom.
- If any symptoms of cerebral oedema like morning headaches with vomiting and/or visual changes appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
- Pri pojavi bilo kojeg simptoma moždanog edema kao što su jutarnje glavobolje s povraćanjem i/ili promjene vida, treba provjeriti koncentraciju metionina u plazmi i pridržavanje režima prehrane, a primjenu Cystadanea prekinuti.
Monitoring plasma homocysteine levels has demonstrated that the onset of action of betaine anhydrous occurred within several days and that a steady-state response was achieved within one month.
Praćenjem razine homocisteina u plazmi utvrđeno je da se početak učinka bezvodnog betaina može očekivati tijekom nekoliko dana, a stanje dinamičke ravnoteže se postiže unutar jednog mjeseca.
Therapeutic monitoring
Praćenje terapijskog učinka
Description of selected adverse reactions *Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine anhydrous therapy in patients with CBS deficiency, with complete recovery after treatment discontinuation.
*Manje česti slučajevi teškog cerebralnog edema i hipermetioninemije prijavljeni su unutar 2 tjedna do 6 mjeseci od početka terapije bezvodnim betainom u bolesnika s nedostatkom CBS-a, uz potpuni oporavaka nakon prekida liječenja.
Lightly shake the bottle before opening.
Lagano protresite bocu prije otvaranja.
White crystalline free flowing powder.
Bijeli kristalinični sipki prašak.
Contact your doctor or pharmacist before stopping.
Prije prestajanja kontaktirajte svog liječnika ili ljekarnika.
How to take Cystadane
Kako uzimati Cystadane
In CBS-deficient patients without dietary restriction of methionine, excessive accumulation of methionine has been observed.
U bolesnika s CBS manjkom bez ograničenja unosa metionina prehranom, zamijećeno je prekomjerno nakupljanje metionina.
As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine anhydrous therapy has been postulated as a possible mechanism of action.
S obzirom na to da je u bolesnika s hipermetioninemijom zabilježen cerebralni edem, sekundarna hipermetioninemija kao posljedica terapije bezvodnim betainom smatra se mogućim mehanizmom djelovanja.
Biotransformation Betaine anhydrous is a methyl group donor
Bezvodni betain je donor metilne skupine.
• shake the bottle lightly before opening
• lagano protresite bocu prije otvaranja
Summary of the safety profile
Sažetak sigurnosti primjene
Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Cystadane je potrebno primijeniti kao dodatak uz druge terapije poput vitamina B6 (piridoksin), vitamina B12 (kobalamin), folatne kiseline i uz pridržavanje propisanog režima prehrane.
If you are taking amino-acid mixture or medicines such as vigabatrin or Gaba analogues (medicine used to treat epilepsy), please tell your doctor as they might interact with your treatment with Cystadane.
Molimo obavijestite svog liječnika ako uzimate mješavinu aminokiselina ili lijekove kao što su vigabatrin ili analozi GABA-e (lijekovi koji se koriste za liječenje epilepsije), jer bi oni mogli utjecati na liječenje Cystadaneom.
Three measuring spoons (green, blue, pink) dispense 100mg, 150mg or 1g of betaine anhydrous.
Tri mjerne žličice (zelena, plava, ružičasta) mjere 100 mg, 150 mg ili 1 g bezvodnog betaina.
• take a heaped spoonful of powder out of the bottle
• uzmite vrhom punu žlicu praška iz boce
During pregnancy, administering betaine anhydrous in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma homocysteine would be compatible with good maternal and foetal outcomes.
Primjena bezvodnog betaina kao dodatka piridoksinu, folatnoj kiselini, antikoagulansima i režimu prehrane tijekom trudnoće uz pomno praćenje razine homocisteina u plazmi sukladna je s dobrim ishodom trudnoće, kako za majku, tako i za dijete.
Data on a limited number of exposed pregnancies indicate no adverse event of betaine anhydrous on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiologic data are available.
Podaci na ograničenom broju trudnica koje su bile izložene betainu ukazuju da nije bilo štetnog učinka bezvodnog betaina na trudnoću i zdravlje ploda/novorođenčeta.
If you notice side effects like headaches, vomiting or a change in your vision and you are of the homocystinuria subtype called CBS (cystathionine beta-synthase deficiency), please contact your doctor immediately, they could be signs of a swelling in the brain (cerebral oedema).
Ako uočite nuspojave poput glavobolje, povraćanja ili promjene u svom vidu i imate podtip homocistinurije zvani CBS (nedostatak cistation beta sintaze), obratite se odmah svom liječniku jer to mogu biti znakovi oticanja mozga (cerebralnog edema).U tom će slučaju liječnik pratiti razinu metionina u Vašem tijelu te će Vas pitati o prehrani.
Betaine anhydrous has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Pokazalo se da bezvodni betain povećava razinu metionina i S-adenozil metionina (SAM) u plazmi u bolesnika s MTHFR nedostatkom i cbl poremećajem.
• the middle size blue spoon measures 150 mg of betaine anhydrous powder ;
• srednja plava žličica mjeri 150 mg bezvodnog praška betaina;
- There is no other ingredient.
- Nema pomoćnih tvari.
Three measuring spoons are provided which dispense either 100 mg, 150 mg or 1 g of betaine anhydrous.
Priložene su tri mjerne žličice koje mjere 100 mg, 150 mg ili 1 g bezvodnog betaina.
Shelf life after the first opening: 3 months.
Rok valjanosti nakon prvog otvaranja: 3 mjeseca.
Cystadane 1 g oral powder Betaine anhydrous
Cystadane 1 g oralni prašak bezvodni betain
How to store Cystadane
Kako čuvati Cystadane
• the powder left in the spoon is one spoonful
• količina praška koji je ostao u žličici odgovara mjeri žličice
Uncommon: diarrhoea, glossitis, nausea, stomach discomfort, vomiting Skin and subcutaneous tissue disorders Uncommon: hair loss, hives, skin odour abnormal Renal and urinary disorders
Manje često: ispadanje kose, koprivnjača, neugodan miris kože Poremećaji bubrega i mokraćnog sustava Manje često: urinarna inkontinencija Pretrage
Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e. CBS deficiency; MTHFR deficiency and cbl defect.
Bezvodni betain snižava razinu homocisteina u plazmi u tri tipa homocistinurije, tj. kod nedostatka cistationin beta-sintaze (CBS), 5,10-metilen tetrahidrofolat reduktaze (MTHFR) i poremećaja metabolizma kofaktora kobalamina (cbl).
Betaine anhydrous supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid of patients with homocystinuria.
Pokazalo se da u bolesnika s homocistinurijom dodatak bezvodnog betaina poboljšava metaboličke abnormalnosti cerebrospinalnog likvora.
• the small green spoon measures 100 mg of betaine anhydrous powder;
• mala zelena žličica mjeri 100 mg bezvodnog praška betaina;
Uncommon: brain oedema*
Manje često: edem mozga*
Symptoms of cerebral oedema include morning headaches with vomiting and/or visual changes High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
U tih bolesnika zabilježene su velika povećanja koncentracije metionina u plazmi u rasponu od 1000 do 3000 µM.
What Cystadane looks like and contents of the pack Cystadane is a white crystalline free flowing powder.
Cystadane je bijeli kristalinični sipki prašak.
1 g of oral powder contains 1 g of betaine anhydrous.
1 g oralnog praška sadrži 1 g bezvodnog betaina.
Gastrointestinal disorders like diarrhoea, glossitis, nausea, stomach discomfort, vomiting and dental disorders may occur uncommonly.
Manje često se mogu javiti poremećaji gastrointestinalnog sustava poput proljeva, glositisa, mučnine, nelagode u želucu, povraćanja i dentalnih poremećaja.
Absorption The absolute bioavailability of betaine anhydrous has not been determined.
Apsolutna bioraspoloživost bezvodnog betaina nije određivana.
Reported adverse reactions are listed below, by system organ class and by frequency.
Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
1 g of powder contains 1 g of betaine anhydrous.
1 g praška sadrži 1 g bezvodnog betaina.
• the large pink spoon measures 1 g of betaine anhydrous powder.
• velika ružičasta žlica mjeri 1 g bezvodnog praška betaina.
EXP Shelf life after the first opening: 3 months.
Rok valjanosti Rok valjanosti nakon prvog otvaranja: 3 mjeseca.
HDPE bottles with a child resistant closure.
6.5 Vrsta i sadržaj spremnika HDPE boce sa zatvaračem sigurnim za djecu.
Hepatic or renal impairment
Bolesnici s oštećenjem jetre ili bubrega
Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du General de Gaulle F-92 800 Puteaux France
Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du General de Gaulle F-92 800 Puteaux Francuska
A. MANUFACTURERs RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
Recordati Rare Diseases Immeuble "Le Wilson" 70, avenue du Général de Gaulle F-92800 Puteaux France
Recordati Rare Diseases Immeuble "Le Wilson" 70 avenue du Général de Gaulle F-92800 Puteaux Francuska
The contents of one tube are given into each infected ear.
Sadržaj jedne tube daje se u svako zaraženo uho.
A single treatment is required however the full effect may only be seen 28 days later.
Potrebna je jedna primjena, ali potpuni učinak može biti vidljiv tek nakon 28 dana.
Avoid swallowing the product or accidentally transferring it from hand to mouth.
Izbjegavajte gutanje proizvoda ili slučajni prijenos s ruke na usta.
The inside of the ear should be cleaned and dry before treatment.
Unutrašnjost uha treba biti očišćena i suha prije primjene.
In case of accidental eye exposure, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
U slučaju nehotičnog izlaganja očiju, oči treba temeljito ispirati vodom 10 do 15 minuta.
Other information about Neptra
Ostale informacije o VMP-u Neptra
This was more effective than the control group of 27 dogs, which received a placebo (dummy treatment) and for which the reduction was 49%.
To je bilo učinkovitije od kontrolne skupine od 27 pasa koja je primala placebo (prividno liječenje) i za koje je smanjenje bilo 49 %.
Further information on Neptra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/neptra.
Više informacija o VMP-u Neptra nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/neptra.
What is Neptra and what is it used for?
Što je Neptra i za što se koristi?
Neptra can cause serious eye irritation if it accidentally gets into the eyes when the dog shakes its head during or just after application.
Neptra može izazvati ozbiljnu iriitaciju oka ako slučajno uđe u oči kada pas trese glavom tijekom ili neposredno nakon primjene.
Two of the active substances in Neptra, florfenicol and terbinafine, act against possible causes of infection.
Dvije djelatne tvari u VMP-u Neptra, florfenikol i terbinafin, djeluju protiv mogućih uzroka infekcije.
It must also not be used if the ear drum is perforated, in dogs with generalised demodectic mange (skin infestation caused by a specific type of mite) or in pregnant or breeding animals.
Također, ne smije se upotrijebiti ako je bubnjić perforiran, u pasa s generaliziranom demodikozom (infestacija kože uzrokovana određenom vrstom grinja) ili u gravidnih ili rasplodnih životinja.
In case of accidental skin contact, exposed skin should be thoroughly washed with water.
U slučaju nehotičnog kontakta s kožom, izloženu kožu treba temeljito isprati vodom.
Neptra (florfenicol / terbinafine / mometasone)
Neptra (florfenikol/terbinafin/mometazon)
Florfenicol is an antibiotic which works by blocking the production of proteins, which are essential components of bacterial cell walls.
Florfenikol je antibiotik koji djeluje tako što blokira proizvodnju proteina koji su kjučne komponente bakterijskih staničnih stijenki.
Neptra may be harmful after swallowing.
VMP Neptra može biti štetan ako se proguta.
What are the risks associated with Neptra?
Koji su rizici povezani s VMP-om Neptra?
Although no potential for skin irritation was indicated by studies, skin contact should be avoided.
Iako ispitivanja nisu pokazala mogućnost iritacije kože, doticaj s kožom treba izbjegavati.
It is therefore recommended that this medicine is applied only by veterinarians or under their close supervision and that measures are taken to reduce the risk (e.g. wearing safety glasses during treatment, massaging the ear canal well after application to ensure even distribution of product, restraining the dog after application).
Stoga se preporučuje da ovaj VMP primjenjuju samo veterinari ili da se primjenjuje pod njihovim pomnim nadzorom i da se poduzmu mjere za smanjenje rizika (npr. nošenje zaštitnih naočala tijekom terapije, dobro masiranje ušnog kanala nakon primjene kako bi se osigurala ujednačena raspodjela proizvoda, obuzdavanje psa nakon primjene).
Neptra must not be used in dogs who are allergic to the active substances, to other corticosteroids or to any of the other ingredients.
Ne smije se upotrebljavati kod pasa koji su alergični na djelatne tvari, druge kortikosteroide ili bilo koji drugi sastojak lijeka.
The European Medicines Agency decided that Neptra's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a Neptra nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
The third active substance, mometasone, is a corticosteroid, a medicine that reduces inflammation and pain associated with the infection.
Treća je djelatna tvar kortikosteroid naziva mometazon, lijek koji smanjuje upalu i bol povezane s infekcijom.
Neptra (florfenicol / terbinafine / mometasone) EMA/560411/2019
Neptra (florfenikol/terbinafin/mometazon) EMA/687937/2019
Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Terbinafin ubija gljivice blokirajući stvaranje ergosterola, važnog sastavnog dijela stanične stijenke gljivica.
Side effects with Neptra occur very rarely, with the most often reported (which may affect up to 1 in 10,000 dogs) being whining, head shaking, nystagmus (uncontrolled eye movements), vomiting, inner ear disorders causing imbalance, loss of appetite, hyperactivity and application site pain and inflammation shortly after applying the medicine.
Nuspojave VMP-a Neptra nastaju vrlo rijetko, a najčešće su zabilježene (mogu se javiti u do 1 na 10 000 pasa) glasanje, otresanje glavom, nistagmus (nekontrolirani pokreti očiju), povraćanje, poremećaj unutarnjeg uha koji uzrokuje gubitak ravnoteže, gubitak apetita, hiperaktivnost te bol na mjestu primjene i upala ubrzo nakon primjene.
In a field study in the US involving dogs again with ear infections due to both organisms, 67 dogs treated with Neptra had a reduction in clinical score of 77% over 30 days.
U ispitivanju na terenu provedenom u SAD-u koje su bili uključeni psi s infekcijama oba uha zbog oba organizma, 67 pasa liječenih VMP-om Neptra imalo je smanjenje kliničkog rezultata od 77 % tijekom 30 dana.
Neptra is a veterinary medicine used to treat dogs with short lived or recurrent ear infections (otitis externa) caused by two organisms: Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Neptra je veterinarski lijek koji se koristi za liječenje pasa s kratkotrajnim ili opetovanim infekcijama uha (otitis externa) koje uzrokuju dva organizma: Staphylococcus pseudintermedius (bakterija) i Malassezia pachydermatitis (gljivica).
Why is Neptra authorised in the EU?
Zašto je VMP Neptra odobren u EU-u?
An overview of Neptra and why it is authorised in the EU
Pregled informacija o VMP-u Neptra i zašto je odobren u EU-u
The medicine is available as ear drops and can only be obtained with a prescription.
VMP je dostupan kao kapi za uši i izdaje se samo na veterinarski recept.
Neptra contains three active substances: florfenicol, terbinafine and mometasone.
Neptra sadrži tri djelatne tvari: florfenikol, terbinafin i mometazon.
For more information about using Neptra, see the package leaflet or contact your veterinarian or pharmacist.
Za dodatne informacije o primjeni VMP-a Neptra pogledajte uputu o VMP-u, odnosno obratite se svom veterinaru ili ljekarniku.
How does Neptra work?
Kako djeluje Neptra?
What benefits of Neptra have been shown in studies?
Koje su koristi od VMP-a Neptra utvrđene u ispitivanjima?
In case of accidental swallowing medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
U slučaju slučajnog nehotičnog gutanja potrebno je odmah potražiti liječnički savjet te mu pokazati uputu o VMP-u ili njegovu etiketu.
In a field study in Europe involving dogs with ear infections with both Staphylococcus pseudintermedius and Malassezia pachydermatitis 43 Neptra treated dogs had their signs of infection reduced by 71% after 28 days which was as effective as the comparator group of 45 dogs, treated with another veterinary medicine authorised for ear infections, for which the reduction was 74%.
Neptra znakovi infekcije smanjili su se za 71 % nakon 28 dana što je bilo jednako učinkovito kao i u usporednoj skupini od 45 pasa liječenih drugim veterinarskim lijekom odobrenim za infekcije uha, za koji je smanjenje iznosilo 74 %.
If symptoms develop, medical advice should be sought and the package leaflet or the label shown to the doctor.
U slučaju pojave simptoma potrebno je odmah potražiti liječnički savjet te mu pokazati uputu o VMP-u ili njegovu etiketu.
Neptra received a marketing authorisation valid throughout the EU on 10 December 2019.
Za VMP Neptra izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od
The medicine must not be given to patients who have a severe infection.
Lijek se ne smije davati bolesnicima koji imaju tešku infekciju.
Polivy has been given a ‘conditional authorisation'.
Za lijek Polivy izdano je „uvjetno odobrenje”.
What measures are being taken to ensure the safe and effective use of Polivy?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Polivy?
If the patient develops an infusion-related reaction, the infusion should be slowed down or interrupted.
Ako se u bolesnika razvije takva reakcija, infuziju je potrebno usporiti ili prekinuti.
What is Polivy and what is it used for?
Što je Polivy i za što se koristi?
Serious side effects can occur; however, these are manageable if appropriate measures are in place.
Moguće su ozbiljne nuspojave, ali one se mogu kontrolirati primjenom odgovarajućih mjera.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Polivy is for infusion (drip) into a vein over 90 minutes.
Polivy se daje intravenskom infuzijom (ukapavanjem) u trajanju od 90 minuta.