natgillin/translations-raw huggingface dataset:
The European Medicines Agency has waived the obligation to submit the results of studies with VPRIV in all subsets of the paediatric population with type 2 Gaucher disease.
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s VPRIV-om u svim podskupinama pedijatrijske populacije s Gaucherovom bolešću tipa 2.
The accumulation of glucocerebroside in the liver and spleen leads to organomegaly.
Nakupljanje glukocerebrozida u jetri i slezeni dovodi do organomegalije.
Information is presented by system organ class and frequency according to MedDRA convention.
Podaci su navedeni prema klasifikaciji organskih sustava i učestalosti u skladu s MedDRA konvencijom.
57 patients were treatment-naïve.
57 bolesnika nije prethodno bilo liječeno.
There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease.
Nije bilo očitih farmakokinetičkih razlika između muških i ženskih bolesnika s Gaucherovom bolešću tipa
It should not be shaken.
Ne smije se tresti.
The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Nositelj odobrenja (MAH) mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala za primjenu infuzije lijeka VPRIV kod kuće, uključujući medije komunikacije, načine distribucije i druge aspekte programa.
Excipient with known effect: One vial contains 12.15 mg sodium.
Pomoćna tvar s poznatim učinkom: Jedna bočica sadržava 12,15 mg natrija.
Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range (4 to 17 years).
Dvadeset od 94 bolesnika (21%) koji su primili velaglucerazu alfa tijekom kliničkih ispitivanja bili su u pedijatrijskom ili adolescentskom rasponu dobi (od 4 do 17 godina).
Uncommon side effects are: - blurry vision (may be associated with an infusion-related reaction) - vomiting
Manje česte nuspojave su: - zamagljen vid (može biti povezano s reakcijom povezanom s infuzijom) - povraćanje
Must be administered through a 0.22 µm filter.
Mora se primijeniti kroz filtar od 0,22 µm.
An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion.
Reakcija povezana s infuzijom definirana je kao bilo koja nuspojava koja nastane unutar 24 sata od početka infuzije velagluceraze alfa.
Velaglucerase alfa is a glycoprotein.
Velagluceraza alfa je glikoprotein.
To further evaluate the relationship, in cases of severe infusion-related reactions and in cases of lack or loss of effect patients should be tested for the presence of antibodies and the results reported to the company.
Kako bi se dodatno procijenila povezanost, u slučajevima teških reakcija povezanih s infuzijom te u slučajevima gubitka ili smanjenja učinka lijeka, bolesnike treba testirati na prisutnost protutijela, a rezultate prijaviti tvrtki.
Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.
Žene s Gaucherovom bolešću koje su trudne ili planiraju trudnoću trebaju porazgovarati sa svojim liječnikom prije primjene ovog lijeka.
The educational materials for the use of VPRIV in home infusion are aimed at providing guidance on how to manage risk of infusion-related reactions including allergic-type hypersensitivity reactions in a home setting.
Edukacijski materijali za primjenu infuzije lijeka VPRIV kod kuće imaju za cilj pružiti upute za upravljanje rizikom od reakcija povezanih s infuzijom uključujući reakcije preosjetljivosti alergijskog tipa koje se pojavljuju kod kućne primjene.
A severe allergic reaction, with difficulty breathing, swelling of the face, lips, tongue or throat occured.
Pojavila se i teška alergijska reakcija s otežanim disanjem, oticanjem lica, usnica, jezika ili grla.
Elderly patients may be treated within the same dose range (15 to 60 units/kg) as other adult patients.
Stariji bolesnici mogu se liječiti u istom rasponu doze (od 15 do 60 jedinica/kg) kao drugi odrasli bolesnici.
Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
Liječenju treba pristupiti s oprezom u bolesnika koji su pokazali simptome preosjetljivosti na velaglucerazu alfa ili drugu enzimsku nadomjesnu terapiju.
VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated.
VPRIV se ne smije davati u infuziji s drugim lijekovima jer kompatibilnost u otopini s drugim lijekovima nije ispitana.
• Manual for patients with Gaucher Disease who receive home infusion;
• priručnik za bolesnike s Gaucherovom bolešću koji primaju infuzije kod kuće;
None of the subjects in the pharmacokinetic studies were positive for anti-velaglucerase alfa antibodies on the days of pharmacokinetic evaluation.
Ni jedan od ispitanika u farmakokinetičkim ispitivanjima nije bio pozitivan na protutijela antivelagluceraza alfa na dane farmakokinetičke evaluacije.
Fertility Animal studies show no evidence of impaired fertility.
Plodnost Ispitivanja na životinjama nisu pružila dokaz o poremećaju plodnosti.
What VPRIV is and what it is used for What you need to know before VPRIV is used How VPRIV is used
Što je VPRIV i za što se koristi Što morate znati prije nego počnete primjenjivati VPRIV Kako primjenjivati VPRIV
Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.
Obavijestite svog liječnika ako Vam se ranije pojavila reakcija povezana s infuzijom na drugu nadomjesnu enzimsku terapiju za Gaucherovu bolest.
Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study.
Samo je 1 od 163 bolesnika koji su bili ocjenjivani razvio anti-velagluceraza alfa protutijela tijekom ispitivanja.
In the clinical trials, one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa.
U kliničkim ispitivanjima, jedan od 94 (1%) bolesnika razvio je protutijela IgG razreda na velaglucerazu alfa.
Prevention and Management of infusion related reactions including hypersensitivity reactions The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Sprječavanje i zbrinjavanje reakcija povezanih s infuzijom, uključujući reakcije preosjetljivosti Zbrinjavanje reakcija povezanih s infuzijom treba se temeljiti na težini reakcije te uključivati usporavanje brzine infuzije, terapiju lijekovima poput antihistaminika, antipiretika i/ili kortikosteroida, i/ili prekid te ponovno uvođenje liječenja s duljim vremenom infuzije.
Velaglucerase alfa serum concentrations rose rapidly for the first 20 minutes of the 60-minute infusion before leveling off, and Cmax was typically attained between 40 and 60 minutes after the start of the infusion.
Koncentracija velagluceraze alfa u serumu naglo je porasla u prvih 20 minuta 60-minutne infuzije prije početka pada, a Cmax se tipično postizao između 40 i 60 minuta nakon početka infuzije.
• About the disease, treatment and home infusion;
• o bolesti, liječenju i primjeni infuzije kod kuće;
** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
**Proizvodena tehnologijom rekombinantne DNK u staničnoj liniji humanih fibroblasta HT-1080.
The build-up of this material causes the signs and symptoms found in Gaucher disease.
Nakupljanje ove tvari dovodi do znakova i simptoma Gaucherove bolesti.
Caution should be exercised when prescribing to pregnant women.
Treba biti oprezan prilikom propisivanja lijeka trudnicama.
There was no indication of significant improvements of the neurological manifestations of type 3 Gaucher disease except for one patient in this study.
U tom ispitivanju nije bilo pokazatelja značajnih poboljšanja neuroloških manifestacija Gaucherove bolesti tipa 3, osim u jednog bolesnika.
• Emergency plan provided by the prescriber including who to call and what to do in the case of a serious hypersensitivity reaction.
• plan postupanja u hitnim situacijama koji će sastaviti liječnik koji je lijek propisao, uz uključene informacije o tome kome se obratiti i što poduzeti u slučaju ozbiljne reakcije preosjetljivosti.
The high clearance of velaglucerase alfa from serum (mean 6.7 to 7.6 ml/min/kg) is consistent with the rapid uptake of velaglucerase alfa into macrophages via mannose receptors.
Visoki klirens velagluceraze alfa iz seruma (srednja vrijednost od 6,7 do 7,6 ml/min/kg) u skladu je s brzim preuzimanjem velagluceraze alfa od makrofaga putem manoznih receptora.
What you need to know before VPRIV is used
Što morate znati prije nego počnete primjenjivati VPRIV
A risk-benefit assessment is required for women with Gaucher disease who are considering pregnancy.
Procjena rizika i koristi nužna je za žene s Gaucherovom bolesti koje planiraju trudnoću.
Talk to your doctor before VPRIV is used - If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects).
Obratite se svom liječniku prije primjene VPRIV-a - Ako se liječite VPRIV-om, mogu Vam se pojaviti nuspojave tijekom ili nakon infuzije (pogledajte dio 4 za moguće nuspojave).
Velaglucerase alfa exhibited an approximately linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased approximately proportional to the dose over the dose range 15 to 60 Units/kg.
Velagluceraza alfa pokazala je otprilike linearan (tj. prvog reda) farmakokinetički profil te su se Cmax i AUC povećavali otprilike proporcionalno dozi unutar raspona doza od 15 do 60 jedinica/kg.
Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
Svaka bočica od 400 jedinica priprema se za primjenu s 4,3 ml sterilne vode za injekcije.
The Guide for Healthcare Professionals Treating Patients with Gaucher Disease should contain the following key elements:
Vodič za zdravstvene radnike koji liječe bolesnike s Gaucherovom bolešću mora sadržavati sljedeće ključne elemente:
Table 2: Results at 24 months - Change from Baseline - Study 044 ITT Population Clinical Parameters
Tablica 2: Rezultati nakon 24 mjeseca - promjena u odnosu na početnu vrijednostispitivanje 044 - ITT populacija
Some solution will remain in the vial:
Dio će otopine ostati u bočici:
Skin and subcutaneous tissue disorders rash, urticaria, pruritus
Poremećaji kože i potkožnog tkiva osip, urtikarija, pruritus
When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body.
Kada ovaj enzim nedostaje ili ne funkcionira pravilno, u stanicama tijela se nakuplja tvar nazvana glukocerebrozid.
VPRIV may be given to children and adolescents (2 to 17 years of age) at the same dose and frequency as in adults.
VPRIV se može davati djeci i adolescentima (u dobi od 2 do 17 godina) u istoj dozi i istom učestalosti kao kod odraslih.
Store in the refrigerator (2ºC - 8ºC).
Čuvati u hladnjaku (2°C - 8°C).
Elderly (≥65 years old)
Stariji bolesnici (u dobi ≥65 godina)
If any of these happen tell your doctor immediately.
Ako se bilo što od ovoga dogodi, odmah obavijestite svog liječnika.
After the end of the infusion, velaglucerase alfa serum concentrations fell rapidly in a monophasic or biphasic fashion with a mean t1/2 ranging from 5 to 12 minutes at doses of 15, 30, 45, and 60 Units/kg.
Nakon završetka infuzije, koncentracija velagluceraze alfa u serumu naglo je pala, monofazično ili bifazično, sa srednjom vrijednošću t1/2 u rasponu od 5 do 12 minuta pri dozama od 15, 30, 45 i 60 jedinica/kg.
Each 400 Units vial of this medicine contains 12.15 mg sodium.
Svaka bočica ovog lijeka od 400 jedinica sadržava 12,15 mg natrija.
Velaglucerase alfa is manufactured to contain predominantly high-mannose-type glycans to facilitate internalisation of the enzyme by the phagocytic target cells via the mannose receptor.
Velagluceraza alfa se proizvodi tako da sadržava prvenstveno glikane visoko manoznog tipa kako bi se olakšala internalizacija enzima od strane ciljanih fagocitnih stanica putem receptora za manozu.
- If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
Ako je reakcija teška, liječnik će odmah prekinuti intravensku infuziju te započeti odgovarajuće liječenje.
There is no experience with overdose of velaglucerase alfa.
Nema iskustva s predoziranjem velaglucerazom alfa.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Bolesnice koje imaju Gaucherovu bolest i ostanu trudne mogu ući u razdoblje pojačane aktivnosti bolesti tijekom trudnoće i babinja.
- The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”).
Drugi sastojci su saharoza, natrijev citrat dihidrat, citratna kiselina hidrat i polisorbat 20 (vidjeti dio 2 „VPRIV sadržava natrij“).
In Study 025EXT, 7 of 10 patients received home therapy at least once during 60 months of treatment.
U ispitivanju 025EXT, 7 od 10 bolesnika primilo je terapiju kod kuće najmanje jednom tijekom 60 mjeseci liječenja.
• Guide for Healthcare Professionals Treating Patients with Gaucher Disease;
• vodič za zdravstvene radnike koji liječe bolesnike s Gaucherovom bolešću;
The range of velaglucerase alfa clearance in paediatric patients (N=7, age range 4 to 17 years) was contained within the range of clearance values in adult patients (N=15, age range 19 to 62 years).
Raspon klirensa velagluceraze alfa kod pedijatrijskih bolesnika (N=7, raspon dobi od 4 do 17 godina) bio je unutar raspona vrijednosti klirensa kod odraslih bolesnika (N=15, raspon dobi od 19 do 62 godine).
By month 57, 8 out of the 8 patients had achieved a reduction of at least 2 points in the lumbar spine Bone Marrow Burden (BMB) score as assessed by MRI scan.
Do 57. mjeseca, 8 od 8 bolesnika postiglo je redukciju od najmanje 2 točke u rezultatu opterećenja koštane srži (BMB, engl.
Patients who switched from long-term imiglucerase treatment to velaglucerase alfa (N=38)
Bolesnici koji su prešli s dugotrajnog liječenja imiglucerazom na velaglucerazu alfa (N=38)
This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Ovaj lijek se smije primjenjivati samo pod odgovarajućim medicinskim nadzorom liječnika koji je educiran za liječenje Gaucherove bolesti.
It requires reconstitution and dilution and is intended for intravenous infusion only.
Zahtijeva pripremu i razrjeđivanje i namijenjen je isključivo intravenskoj infuziji.
The most common adverse reactions were infusion-related reactions.
Najčešće nuspojave bile su reakcije u vezi s infuzijom.
See section 4.4.
Pogledajte dio 4.4.
A total of 95 patients (73 adult and 22 paediatric) who participated in studies 032, 034, and 039 enrolled in the open label extension study and were treated with velaglucerase alfa.
Ukupno 95 bolesnika (73 odraslih i 22 pedijatrijska) koji su sudjelovali u ispitivanjima 032, 034 i 039 bili su uključeni u otvoreni produžetak ispitivanja i liječeni velaglucerazom alfa.
The manual for patients with Gaucher Disease who receive home infusion should contain the following key elements:
Priručnik za bolesnike s Gaucherovom bolešću koji primaju infuzije kod kuće mora sadržavati sljedeće ključne elemente:
For patients developing anaphylaxis in a home setting it should be considered to continue treatment in a clinical setting.
Za bolesnike koji razviju anafilaksiju prilikom primjene kod kuće, treba razmotriti nastavak liječenja u kliničkom okruženju.
63 kDa, has 497 amino acids, and the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase.
Monomer ima oko 63 kDa, 497 aminokiselina, te isti slijed aminokiselina kao i glukocerebrozidaza, ljudski enzim koji se pojavljuje u prirodi.
Sodium citrate dihydrate (E331) Citric acid monohydrate (E330) Polysorbate 20
6.1 Popis pomoćnih tvari saharoza natrijev citrat dihidrat (E331) citratna kiselina hidrat (E330) polisorbat 20
These reactions include; - headache - dizziness - fever/body temperature increased - decreased blood pressure or increased blood pressure - nausea and tiredness - chest discomfort - difficulty in breathing - itching
Te reakcije uključuju: - glavobolju - omaglicu - vrućicu/povišenu tjelesnu temperaturu - sniženi krvni tlak ili povišeni krvni tlak - mučninu i umor - nelagodu u prsnom košu - otežano disanje - svrbež
Phase I/II study HGT-GCB-068 was conducted to explore the efficacy and safety of velaglucerase alfa ERT in treatment naïve children and adolescents with type 3 Gaucher disease.
Ispitivanje faze I/II, HGT-GCB-068, provedeno je da bi se istražile djelotvornost i sigurnost primjene velagluceraze alfa kao enzimskog nadomjesnog liječenja djece i adolescenata s Gaucherovom bolešću tipa 3, koji prethodno nisu bili liječeni.
Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa.
Protutijela mogu igrati ulogu u reakcijama u vezi s liječenjem koje su zabilježene u primjeni velagluceraze alfa.
Study 058 was an open-label clinical safety study in 211 patients including 205 patients previously treated with imiglucerase 6 treatment-naïve patients and 57 patients aged 65 years or older (56/57 had switched from imiglucerase to velaglucerase alfa).
Ispitivanje 058 bilo je otvoreno kliničko ispitivanje sigurnosti na 211 bolesnika uključujući 205 bolesnika koji su ranije primali terapiju imiglucerazom, 6 bolesnika koji prethodno nisu bili liječeni i 57 bolesnika u dobi od 65 godina ili starijih (56/57 je prešlo s imigluceraze na velaglucerazu alfa).
If the dates of submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
Svaka će bočica sadržavati volumen od 4,0 ml (100 jedinica/ml) koji se može izvući.
Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide in the lysosome, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.
Velagluceraza alfa nadomješta ili zamjenjuje beta-glukocerebrozidazu, enzim koji katalizira hidrolizu glukocerebrozida do glukoze i ceramida u lizosomu, smanjujući količinu nakupljenog glukocerebrozida i ispravljajući patofiziologiju Gaucherove bolesti.
There are no or limited amount of data from the use of velaglucerase alfa in pregnant women.
Nema podataka ili su podaci o primjeni velagluceraze alfa u trudnica ograničeni.
Do not use if the solution is discoloured or if foreign particles are present.
Nemojte koristiti ako otopina promijeni boju ili ako su prisutne vidljive čestice.
Treatment with velaglucerase alfa was administered as the same number of units and regimen as their imiglucerase dose.
Liječenje velaglucerazom alfa bilo je primijenjeno u istom broju jedinica te režimu liječenja kao što je bila njihova doza imigluceraze.
Mean change from baseline (95% CI)
Srednja promjena u odnosu na početnu vrijednost (95% CI)
Patients received doses ranging from 30 to 60 Units/kg (median dose 35 Units/kg) every other week for up to 84 months (7 years).
Bolesnici su primili doze u rasponu od 30 do 60 jedinica/kg (medijan doze od 35 jedinica/kg) svaki drugi tjedan kroz najviše 84 mjeseca (7 godina).
Normal spleen is defined as 0.2% of body weight; normal liver as 2.5% of body weight Note: Imputation was applied to intermittent missing data.
Normalna slezena definira se kao 0,2% tjelesne težine; normalna jetra kao 2,5% tjelesne težine
VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.
VPRIV se može davati starijima (u dobi preko 65 godina) u istoj dozi i učestalosti kao kod odraslih.
- The active substance is velaglucerase alfa.
- Djelatna tvar je velagluceraza alfa.
This should be taken into consideration by patients on a controlled sodium diet.
To se treba uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study.
U ispitivanju 034, 25 od 40 bolesnika primilo je terapiju kod kuće barem jednom tijekom 12-mjesečnog ispitivanja.
Patients treated with imiglucerase for 9 months and then velaglucerase alfa for 15 months (N=16)
Bolesnici liječeni imiglucerazom 9 mjeseci i zatim velaglucerazom alfa 15 mjeseci (N=16)
It is not known whether velaglucerase alfa is excreted in human milk.
Nije poznato izlučuje li se velagluceraza alfa u majčino mlijeko.
If you are breast feeding or considering breast-feeding, you should talk to your doctor before this medicine is used.
Ako dojite ili razmatrate mogućnost dojenja, morate razgovarati sa svojim liječenikom prije primjene ovog lijeka.
20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap.
Bočica od 20 ml (staklo tipa I) s čepom (butilnom gumom prevučenom fluoro-rezinom), jednodijelnim zatvaračem i „flip-off“ poklopcem.
This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells".
Taj manjak enzima dovodi do nakupljanja glukocerebrozida prvenstveno u makrofagima, zbog čega nastaju pjenaste stanice ili „Gaucherove stanice“.
Very common side effects are: - bone pain - joint pain - back pain - weakness/loss of strength/tiredness
Vrlo česte nuspojave su: - bol u kostima - bol u zglobovima - bol u leđima - slabost/gubitak snage/umor
Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises.
Zahvaćanje kostiju dovodi do abnormalnosti skeleta te deformiteta kao i do kriza s bolovima u kostima.
Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies.
Reakcije povezane s infuzijom bile su najčešće opažene nuspojave kod bolesnika liječenih u kliničkim ispitivanjima.
Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase.
Gaucherova bolest je autosomno recesivni poremećaj izazvan mutacijama u genu GBA koji dovodi do manjka lizosomalnog enzima beta-glukocerebrozidaze.
Nervous system disorders headache, dizziness
Poremećaji živčanog sustava glavobolja, omaglica
- If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment - Most of the time you can still be given VPRIV even if you experience one of these reactions.
- U slučajevima teških reakcija i/ili gubitka učinka ovog lijeka, liječnik će obaviti pretragu krvi kako bi provjerio protutijela koja mogu utjecati na ishod Vašeg liječenja.
The safety profile of VPRIV in clinical studies involving children and adolescents aged 4 to 17 years was similar to that observed in adult patients.
Profil sigurnosti VPRIV-a u kliničkim ispitivanjima koja su obuhvaćala djecu i adolescente u dobi od 4 do 17 godina bio je sličan onom zabilježenom kod odraslih bolesnika.
See section 5.2.
Pogledajte dio 5.2.
VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only.
VPRIV zahtijeva rekonstituciju i razrjeđivanje i namijenjen je isključivo primjeni putem intravenske infuzije.