natgillin/translations-raw huggingface dataset:
The third study was conducted to evaluate the pharmacodynamics and safety of different dose regimens of Aldurazyme.
Treće ispitivanje provedeno je u svrhu ocjenjivanja farmakodinamike i sigurnosti različitih režima doziranja lijeka Aldurazyme.
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease (see section 5.1).
Aldurazyme je indiciran kao dugotrajna enzimska nadomjesna terapija kod bolesnika s potvrđenom dijagnozom mukopolisaharidoze I (MPS I; nedostatak α-L-iduronidaze) za liječenje manifestacija bolesti koje nisu neurološke naravi (vidjeti dio 5.1).
The safety and efficacy of Aldurazyme was assessed in a randomised, double-blind, placebo controlled, Phase 3 Study of 45 patients, ranging in age from 6 to 43 years.
Sigurnost i djelotvornost lijeka Aldurazyme procijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III u kojemu je sudjelovalo 45 bolesnika u dobi od 6 do
Although patients representing the full range of the disease spectrum were enrolled, the majority of the patients were of the intermediate phenotype, with only one patient exhibiting the severe phenotype.
Iako su u ispitivanje uključeni bolesnici koji su predstavljali cjelokupan raspon spektra ove bolesti, većina je bolesnika imala intermedijarni fenotip, a samo je jedan bolesnik imao težak fenotip.
After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26.
Nakon primjene laronidaze intravenskom infuzijom u trajanju od 240 minuta te u dozi od 100 U/kg tjelesne težine, farmakokinetička svojstva mjerena su u 1., 12. i 26. tjednu.
Four patients (three in the Phase 3 study and one in the Phase 2 study) showed marginal to low level in vitro inhibition of laronidase enzymatic activity, which did not appear to impact clinical efficacy and/or urinary GAG reduction.
Kod četiri bolesnika (tri u ispitivanju faze III i jednog u ispitivanju faze II) uočena je zanemariva do niska razina inhibicije enzimske aktivnosti laronidaze in vitro, što nije imalo utjecaja na kliničku djelotvornost i/ili smanjenje koncentracije GAG-a u mokraći.
Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8).
Teška preosjetljivost (npr. anafilaktička reakcija) na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dijelove 4.4 i 4.8).
Upon study completion, all patients showed reductions in liver size and 50% (9/18) had normal liver size.
Do završetka ispitivanja, kod svih se bolesnika veličina jetre smanjila, a kod 50% (9/18) bila je normalne veličine.
It is recommended to stop breast-feeding during treatment with Aldurazyme.
Preporučuje se prekinuti dojenje tijekom liječenja lijekom Aldurazyme.
No case of overdose has been reported.
Nije prijavljen niti jedan slučaj predoziranja.
Side effects were mainly seen while patients were being given the medicine or shortly after (infusionassociated reactions).
Nuspojave su se uglavnom javljale dok su bolesnici primali lijek ili neposredno nakon toga (reakcije povezane s infuzijom).
Almost all patients developed IgG antibodies to laronidase.
Gotovo su svi bolesnici stvorili IgG protutijela na laronidazu.
The primary efficacy endpoints were changes in percent of predicted normal FVC and absolute distance travelled in the six-minute walk test (6MWT).
Primarne mjere ishoda djelotvornosti bile su promjene postotka predviđenog normalnog FVC-a i apsolutne udaljenosti koju su mogli prijeći u šestominutnom ispitivanju hoda (engl. six-minute walk test, 6MWT).
The frequency of severe allergic reaction (anaphylactic reaction) and swelling of the face is considered common and may affect up to 1 in 10 people.
Teška alergijska reakcija (anafilaktička reakcija) i oticanje lica smatraju se čestim nuspojavama i mogu se javiti u manje od 1 na 10 osoba.
For information on pre-treatment, see section 4.4.
Za podatke o premedikaciji vidjeti dio 4.4.
Pack sizes: 1, 10 and 25 vials.
Veličine pakiranja: 1, 10 i 25 bočica.
When you experience such a reaction, you should immediately contact your doctor.
Kad osjetite takvu reakciju, morate se odmah obratiti svom liječniku.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Ovaj lijek sadrži natrij i primjenjuje se u intravenskoj 0,9%-tnoj otopini natrijeva klorida (vidjeti dio 6.6).
Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Poremećaji odlaganja mukopolisaharida prouzročeni su nedostatkom određenih lizosomskih enzima potrebnih za katabolizam glikozaminoglikana (GAG).
Aldurazyme/Aldurazyme Placebo/Aldurazyme At 208 weeks
Aldurazyme/Aldurazyme Placebo/Aldurazyme
In addition 60 patients in the Phase 2 and 3 studies were tested for in-vitro neutralising effects.
Osim toga, u ispitivanjima faze II i faze III 60 je bolesnika ispitano na in vitro neutralizirajuće učinke.
Patients treated with Aldurazyme may develop infusion-associated reactions (IARs), defined as any related adverse event occurring during the infusion or until the end of the infusion day (see section 4.8).
Kod bolesnika liječenih lijekom Aldurazyme mogu se razviti reakcije povezane s infuzijom, definirane kao bilo koji povezani štetni događaj koji se javi za vrijeme infuzije ili do kraja dana u kojem bolesnik primi infuziju (vidjeti dio 4.8).
Marketing Authorisation Holder: Genzyme Europe B.V.
Nositelj odobrenja za stavljanje lijeka u promet: Genzyme Europe B.V.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 U (approximately 0.58 mg) of laronidase.
1 ml sadrži 100 U (približno 0,58 mg) laronidaze.
You should not be given Aldurazyme during pregnancy unless clearly necessary.
Aldurazyme tijekom trudnoće, osim ako je to izričito neophodno.
The molecule contains 6 N-linked oligosaccharide modifications sites.
Molekula ima 6 mjesta za reakciju s oligosaharidima vezanima s dušikom.
Due to the small patient population, an ADR reported in a single patient is classified as common.
Zbog male populacije bolesnika, nuspojava koja se pojavila u samo jednog bolesnika kategorizira se kao česta.
Most patients seroconverted within 3 months of initiation of treatment; although seroconversion in patients under 5 years old with a more severe phenotype occurred mostly within 1 month (mean 26 days versus 45 days in patients 5 years and older).
Kod većine bolesnika do serokonverzije je došlo unutar 3 mjeseca nakon početka liječenja, iako je kod bolesnika mlađih od 5 godina s težim fenotipom serokonverzija nastupila uglavnom u roku od mjesec dana (srednja vrijednost 26 dana u odnosu na 45 dana kod bolesnika u dobi od 5 ili više godina).
If you miss an infusion of Aldurazyme If you have missed an Aldurazyme infusion, please contact your doctor.
Ako ste propustili infuziju lijeka Aldurazyme, molimo obratite se svom liječniku.
MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α-L-iduronic residues of dermatan sulfate and heparan sulfate.
MPS I je heterogeni i multisustavni poremećaj obilježen nedostatkom α-L-iduronidaze, lizosomske hidrolaze koja katalizira hidrolizu terminalnih α-L-iduronskih ostataka dermatan sulfata i heparan sulfata.
5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
5 ml koncentrata za otopinu u bočici (staklo tipa I) s čepom (silikonizirana klorbutilna guma) i zaštitnim zatvaračem (aluminij) s „flip-off“ zatvaračem (polipropilen).
Reduced or absent α-L-iduronidase activity results in the accumulation of the GAGs, dermatan sulfate and heparan sulfate in many cell types and tissues.
Smanjenje ili izostanak aktivnosti α-L-iduronidaze uzrokuje nakupljanje glikozaminoglikana, dermatan sulfata i heparan sulfata u različitim vrstama stanica i tkivima.
Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes.
Izvucite željeni volumen lijeka Aldurazyme iz bočica pa pomiješajte volumene koje ste izvukli.
How to store Aldurazyme
Kako čuvati Aldurazyme
An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”).
Reakcija povezana s infuzijom je svaka nuspojava koja se javlja tijekom primjene infuzije ili do kraja dana u kojem ste primili infuziju (pogledajte dio 4. "Moguće nuspojave").
Each vial of 5 ml contains 1.29 mmol sodium.
Jedna bočica od 5 ml sadrži 1,29 mmol natrija.
Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases.
Liječenje lijekom Aldurazyme mora nadzirati liječnik s iskustvom u liječenju bolesnika oboljelih od MSP I ili drugih nasljednih metaboličkih bolesti.
All patients subsequently enrolled in an open label extension study where they all received 100 U/kg of Aldurazyme every week for an additional 3.5 years (182 weeks).
Svi su bolesnici nakon toga uključeni u otvoreni produžetak ispitivanja u kojemu su tijekom dodatnih 3,5 godina (182 tjedana) svaki tjedan primali 100 U/kg lijeka Aldurazyme.
There was a rapid reduction in the excretion of urinary GAG (µg/mg creatinine) within the first 4 weeks, which was maintained through the remainder of the study.
U prva 4 tjedna došlo je do naglog smanjenja izlučivanja glikozaminoglikana mokraćom (µg/mg kreatinina), što se održalo tijekom cijelog trajanja ispitivanja.
The presence of antibodies did not appear to be related to the incidence of IARs, although the onset of IARs typically coincided with the formation of IgG antibodies.
Čini se da prisutnost protutijela nije povezana s incidencijom reakcija povezanih s infuzijom iako se nastup reakcija povezanih s infuzijom obično podudarao sa stvaranjem IgG protutijela.
The open label extension study showed improvement and/or maintenance of these effects up to 208 weeks in the Aldurazyme/Aldurazyme group and 182 weeks in the Placebo/Aldurazyme group as indicated in the table below.
208. tjedna u skupini Aldurazyme/Aldurazyme odnosno do 182. tjedna u placebo/Aldurazyme skupini, kao što je prikazano u tablici koja slijedi.
In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol/ibuprofen should be considered.
Ako dođe i do jedne teške reakcije povezane s infuzijom, infuzija se mora prekinuti dok se simptomi ne povuku te treba razmotriti liječenje antihistaminicima i paracetamolom/ibuprofenom.
Based on its metabolism, laronidase is an unlikely candidate for Cytochrome P450 mediated interactions.
S obzirom na njezin metabolizam, nije vjerojatno da će laronidaza sudjelovati u interakcijama posredovanima citokromom P450.
However, severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to 3 hours after Aldurazyme infusions.
Međutim, kod nekih je bolesnika primijećena teška sistemska alergijska reakcija (anafilaktička reakcija) tijekom infuzije lijeka Aldurazyme ili do 3 sata nakon nje.
Very common symptoms (may affect more than 1 in 10 people) which were not serious include headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site.
Vrlo česti simptomi (mogu se javiti u više od 1 na 10 osoba) koji nisu ozbiljni uključuju glavobolju, mučninu, bol u trbuhu, osip, bolest zglobova, bol u zglobovima, bol u leđima, bol u rukama ili nogama, crvenilo praćeno osjećajem užarenosti, vrućicu, zimicu, ubrzane otkucaje srca, povišen krvni tlak i reakcije na mjestu primjene infuzije.
One clinical study focussed mainly on assessing the effect of Aldurazyme on the systemic manifestations of MPS I such as poor endurance, restrictive lung disease, upper airway obstruction, reduced joint range of motion, hepatomegaly and visual impairment.
Jedno kliničko ispitivanje bilo je uglavnom usmjereno na utvrđivanje djelovanja lijeka Aldurazyme na sistemske manifestacije MPS I, kao što su slaba izdržljivost, restriktivna bolest pluća, opstrukcija gornjih dišnih puteva, smanjen raspon pokretljivosti zgloba, hepatomegalija i oštećenje vida.
Each vial of Aldurazyme is intended for single use only.
Jedna bočica lijeka Aldurazyme namijenjena je isključivo za jednokratnu uporabu.
Three clinical trials were performed with Aldurazyme to assess its efficacy and safety.
Provedena su tri klinička ispitivanja kako bi se ocijenila djelotvornost i sigurnost lijeka Aldurazyme.
There is not enough experience of the use of Aldurazyme in pregnant women.
Nema dovoljno iskustava s primjenom lijeka Aldurazyme kod trudnica.
Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and facial oedema (see section 4.4).
Nadalje, kod nekoliko bolesnika koji su u povijesti bolesti imali težak poremećaj gornjih dišnih putova i pluća povezan s MPS I javile su se teške reakcije, uključujući bronhospazam, respiratorni arest i edem lica (vidjeti dio 4.4).
In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment.
U kliničkim su se ispitivanjima reakcije povezane s infuzijom obično mogle zbrinuti smanjenjem brzine infuzije i (prethodnom) primjenom antihistaminika i/ili antipiretika (paracetamola ili ibuprofena), čime je bolesniku omogućen nastavak liječenja.
OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
A single patient with pre-existing airway compromise developed a severe reaction three hours from the start of the infusion (at week 62 of treatment) consisting of urticaria and airway obstruction, requiring tracheostomy.
Samo se kod jednog bolesnika s već postojećim poremećajem dišnih puteva javila teška reakcija tri sata nakon početka primjene infuzije (u 62. tjednu liječenja), a sastojala se od urtikarije i opstrukcije dišnih puteva koja je zahtijevala traheotomiju.
It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with an 0.2 µm in-line filter.
Preporučuje se razrijeđenu otopinu lijeka Aldurazyme primijeniti kroz infuzijski sustav s ugrađenim filtrom od 0,2 µm.
The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients.
Sigurnost i djelotvornost lijeka Aldurazyme kod bolesnika sa zatajivanjem bubrega ili jetre nisu ocijenjene pa se ne može preporučiti režim doziranja za te bolesnike.
If you are treated with Aldurazyme, you may develop infusion-associated reactions.
Ako se liječite lijekom Aldurazyme, mogu se javiti reakcije povezane s infuzijom.
No information is available on the effects of Aldurazyme on fertility.
Nema podataka o učincima lijeka Aldurazyme na plodnost.
The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment).
Većina nuspojava povezanih s primjenom lijeka u kliničkim ispitivanja svrstana je u skupinu reakcija povezanih s infuzijom, koje su se javile kod 53% bolesnika u kliničkom ispitivanju faze III (liječenje u trajanju do 4 godine) te kod 35% bolesnika u ispitivanju u kojemu su sudjelovali bolesnici u dobi do
By the end of the Phase 3 study (or at time of early study withdrawal), 13/45 patients had no detectable antibodies by radioimmunoprecipitation (RIP) assay, including 3 patients that had never seroconverted.
Do završetka ispitivanja faze III (ili u vrijeme ranijeg izlaska iz ispitivanja) u 13/45 bolesnika, među koje se ubrajaju i 3 bolesnika u kojih serokonverzija nikada nije nastupila, testom radioimunoprecipitacije (RIP) nije otkrivena prisutnost protutijela.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH CHILDREN
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
If these reactions occur, immediate discontinuation of Aldurazyme is recommended and appropriate medical treatment should be initiated.
U slučaju takvih reakcija preporučuje se odmah prekinuti infuziju lijeka Aldurazyme i uvesti odgovarajuće liječenje.
MPS I disease
Bolest MPS I
With initial administration of Aldurazyme or upon re-administration following interruption of treatment, it is recommended that patients be administered pre-treatment medicines (antihistamines and/or antipyretics) approximately 60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Kod prve primjene lijeka Aldurazyme ili kod ponovne primjene nakon prekida liječenja preporučuje se približno 60 minuta prije početka infuzije bolesnicima dati premedikaciju (antihistaminike i/ili antipiretike), kako bi se mogućnost reakcija povezanih s infuzijom svela na najmanju moguću mjeru.
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week.
Preporučeni režim doziranja lijeka Aldurazyme je 100 U/kg tjelesne težine jedanput na tjedan.
If clinically indicated, administration of pre-treatment medications with subsequent infusions of Aldurazyme should be considered.
Ako je klinički indicirano, treba razmotriti primjenu premedikacije prije sljedećih infuzija lijeka
• bluish color of the skin (due to lower levels of oxygen in the blood)
Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) • plavičasta boja kože (zbog snižene razine kisika u krvi)
If you experience any reaction like this, you should contact your doctor immediately.
Ako dobijete takvu reakciju, morate se odmah javiti svom liječniku.
MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Nositelj odobrenja Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
Patients received either 100 U/kg of Aldurazyme or placebo every week for a total of 26 weeks.
Bolesnici su svaki tjedan tijekom ukupno 26 tjedana primali 100 U/kg lijeka Aldurazyme ili placebo.
The 200 U/kg IV every 2 weeks regimen may be an acceptable alternative for patients with difficulty receiving weekly infusions; however, there is no evidence that the long term clinical efficacy of these two dose regimens is equivalent.
Režim od 200 U/kg intravenski svaka 2 tjedna može biti prihvatljiva alternativa za bolesnike koji imaju poteškoća s primanjem infuzije svaki tjedan.
Prior to use visually inspect the solution for particulate matter.
Prije uporabe vizualno pregledajte sadrži li otopina čestice.
Infusion 1 Mean ± SD
Infuzija 1
In this 26-week open label study, 33 MPS I patients received 1 of 4 dose regimens of Aldurazyme: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks; or 300 U/kg IV every 2 weeks.
U tom su otvorenom ispitivanju u trajanju od 26 tjedana, 33 bolesnika s MPS I primala jedan od četiri ispitivana režima doziranja lijeka Aldurazyme: 100 U/kg intravenski svaki tjedan (preporučena doza), 200 U/kg i.v. svaki tjedan, 200 U/kg i.v. svaka 2 tjedna ili 300 U/kg i.v. svaka 2 tjedna.
These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction.
Navedene reakcije mogu biti posebno teške ako već imate začepljenje gornjih dišnih puteva kao posljedicu mukopolisaharidoze I.
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion.
Preporučeni režim doziranja lijeka Aldurazyme je 100 U/kg tjelesne težine jedanput tjedno infuzijom u venu.
ADRs to Aldurazyme reported during the Phase 3 study and its extension in a total of 45 patients age 5 years and older and treated up to 4 years are listed below using the following categories of frequency: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
(≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
It is not known whether Aldurazyme appears in breast milk.
Nije poznato izlučuje li se Aldurazyme u majčino mlijeko.
Aldurazyme contains sodium
Aldurazyme sadrži natrij
Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Aldurazyme se mora primijeniti u odgovarajućem kliničkom okruženju s dostupnom opremom za oživljavanje za slučaj hitne medicinske intervencije.
Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Odredite ukupan volumen infuzije na temelju bolesnikove tjelesne težine; 100 ml (ako je tjelesna težina 20 kg ili manje) ili 250 ml (ako je tjelesna težina veća od 20 kg) 0,9% otopine natrijeva klorida za infuziju (9 mg/ml).
For instruction on dilution of the medicinal product before administration, see section 6.6.
Za uputu o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor.
Dođe li do tih reakcija, liječnik mora odmah prekinuti infuziju lijeka Aldurazyme i započeti odgovarajuće liječenje.
The most frequent adverse drug reactions (ADRs) were: headache, nausea, abdominal pain, rash, arthralgia, backpain, pain at extremity, flushing, pyrexia, infusion site reactions, blood pressure increased, oxygen saturation decreased,
Najčešće nuspojave bile su: glavobolja, mučnina, bol u abdomenu, osip, artralgija, bol u leđima, bol u ekstremitetima, crvenilo praćeno osjećajem užarenosti, pireksija, alergijske reakcije na mjestu infuzije, povišen krvni tlak, smanjena zasićenost kisikom, tahikardija i zimica.
The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h.
Početna brzina infuzije od 2 U/kg/h može se, ako bolesnik podnosi, postupno povećavati svakih petnaest minuta, do najviše 43 U/kg/h.
Each vial of 5 ml contains 500 U of laronidase.
Jedna bočica od 5 ml sadrži 500 U laronidaze.
In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol/ibuprofen and/or corticosteroids) and a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the previous reaction occurred.
U slučaju ponovne umjerene reakcije povezane s infuzijom ili ponovnog uvođenja lijeka nakon jedne teške reakcije, treba razmotriti premedikaciju (antihistaminicima i paracetamolom/ibuprofenom i/ili kortikosteroidima) te smanjenje brzine infuzije na 1/2 - 1/4 brzine pri kojoj se reakcija prethodno pojavila.
Pack size: 1, 10 and 25 vials per carton.
Veličina pakiranja: 1, 10 i 25 bočica u kutiji.
Careful consideration should be given to the patient's clinical status prior to administration of Aldurazyme.
Prije primjene lijeka Aldurazyme treba pažljivo razmotriti klinički status bolesnika.
Patients with an acute underlying illness at the time of Aldurazyme infusion appear to be at greater risk for IARs.
Bolesnici koji u vrijeme infuzije lijeka Aldurazyme boluju od neke akutne podležeće bolesti izloženi su većem riziku od reakcija povezanih s infuzijom.