natgillin/translations-raw huggingface dataset:
After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.
Ko enkrat ugotovite, da bolnik dobro prenaša infuzijo, lahko hitrost infundiranja postopoma povečujete pri naslednjih infuzijah.
If you have missed an infusion of Fabrazyme, please contact your doctor.
Če niste prejeli odmerka zdravila Fabrazyme, se obrnite na zdravnika.
Infections and infestations nasopharyngitis rhinitis
Infekcijske in parazitske bolezni nazofaringitis rinitis
Very common adverse reactions included chills, pyrexia, feeling cold, nausea, vomiting, headache and paraesthesia.
Zelo pogosti neželeni učinki so bili mrzlica, pireksija, občutek mraza, navzea, bruhanje, glavobol in parestezija.
Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose.
Na osnovi individualnega odmerka določite celotni volumen 0,9 % raztopine natrijevega klorida za infuzijo (med 50 in 500 ml).
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET Z ZDRAVILOM
If you experience any serious side effect, you should contact your doctor immediately.
Če opazite kateri koli resen neželeni učinek, o tem nemudoma obvestite zdravnika.
What Fabrazyme looks like and contents of the pack
Izgled zdravila Fabrazyme in vsebina pakiranja
The occurrence of an adverse reaction in a single patient is defined as uncommon in light of the relatively small number of patients treated.
Glede na majhno število zdravljenih bolnikov se pojav neželenega učinka pri enem bolniku upošteva za občasnega.
Studies have not been conducted to assess the potential effects of Fabrazyme on impairment of fertility.
Študije za oceno morebitnega škodljivega vpliva zdravila Fabrazyme na plodnost še niso bile opravljene.
• syncope
• sinkopa
For doses lower than 35 mg use a minimum of 50 ml, for doses 35 to 70 mg use a minimum of 100 ml, for doses 70 to 100 mg use a minimum of 250 ml and for doses greater than 100 mg use only 500 ml.
Za odmerke, manjše od 35 mg, uporabite najmanj 50 ml, za odmerke med 35 in 70 mg uporabite najmanj 100 ml, za odmerke med 70 in 100 mg uporabite najmanj 250 ml in za odmerke, ki presegajo 100 mg, uporabite le 500 ml. Nežno obrnite ali nalahko gnetite infuzijsko vrečko, da zmešate razredčeno raztopino.
Severe life-threatening allergic reactions (“anaphylactoid reactions”) have been reported in some patients.
Pri nekaterih bolnikih so poročali o hudih, življenjsko nevarnih alergijskih reakcijah („anafilaktične reakcije“).
No data are available in children 0 to 4 years No dose adjustment is necessary for children 8-16 years
Za otroke od 8. do 16. leta starosti prilagajanje odmerka ni potrebno.
Immune system disorders anaphylactoid reaction
Bolezni imunskega sistema anafilaktičn a reakcija
Incidence of adverse reactions with Fabrazyme treatment System organ class
Pogostnost neželenih učinkov pri zdravljenju z zdravilom Fabrazyme
• rhinitis
• rinitis
• nasopharyngitis
• nazofaringitis
Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Na podlagi njene presnove je malo verjetno, da bi imela agalzidaza beta kakšno medsebojno delovanje z drugimi zdravili s pomočjo posredovanja citokroma P450.
• pain at the extremities
• bolečine v sklepih
EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion
EU/1/01/188/004 1 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/005 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/006 10 vial praška za koncentrat za raztopino za infundiranje
Slowly, withdraw 1.0 ml (equal to 5 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Počasi izvlecite 1,0 ml (kar ustreza 5 mg) rekonstituirane raztopine iz vsake viale do celotne količine, ki je potrebna za bolnikov odmerek.
• upper respiratory tract congestion
• kongestija zgornjega dela dihal
EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion
EU/1/01/188/0011 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/002 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/003 10 vial praška za koncentrat za raztopino za infundiranje
After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta.
Po rekonstituciji s 7,2 ml vode za injekcije vsebuje vsaka viala zdravila Fabrazyme 5 mg/ml (35 mg/7 ml) agalzidaze beta.
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, single dose toxicity, repeated dose toxicity and embryonal/foetal toxicity.
Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti enkratnih odmerkov, toksičnosti pri ponavljajočih se odmerkih in toksičnosti za zarodek oz. plod ne kažejo posebnega tveganja za ljudi.
One vial of powder contains 5 mg of agalsidase beta.
Ena viala vsebuje 5 mg agalzidaze beta.
Adverse reactions reported from clinical trials with a total of 168 patients (154 males and 14 females) treated with Fabrazyme administered at a dose of 1 mg/kg every 2 weeks for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10 and uncommon ≥ 1/1000 to < 1/100) in the table below.
14 žensk), zdravljenih z najmanj eno infuzijo zdravila Fabrazyme v odmerku 1 mg/kg vsaka 2 tedna do največ 5 let, so navedeni v spodnji preglednici po organskih sistemih in po pogostnosti (zelo pogosti: > 1/10, pogosti: ≥ 1/100 do < 1/10 in občasni: ≥ 1/1.000 do < 1/100).
The frequency of IARs decreased over time.
Pogostnost reakcij, povezanih z infuzijo, je s časom upadla.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
(UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
One vial of powder contains 35 mg of agalsidase beta.
Ena viala vsebuje 35 mg agalzidaze beta.
Use of Fabrazyme during pregnancy is not recommended.
Uporaba zdravila Fabrazyme v času nosečnosti ni priporočljiva.
Any unused solution should be discarded.
Vso neuporabljeno raztopino zavrzite.
- Regular review of the administration by the patient and/or caregiver needs to be performed to ensure maintenance of optimal practice.
- Da se zagotovi ohranjanje optimalne prakse, so potrebni redni pregledi dajanja zdravila s strani bolnika in/ali negovalca.
The reconstituted solution cannot be stored and should be promptly diluted.
Rekonstituirana in razredčena raztopina Rekonstituirane raztopine ne shranjujte, ampak jo takoj razredčite.
The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to clear the accumulating substrate in the organ tissues; thereby, preventing, stabilizing or reversing the progressive decline in function of these organs before irreversible damage has occurred.
Mehanizem delovanja Temeljno vodilo encimske nadomestne terapije je ponovna vzpostavitev takšne encimske aktivnosti, ki bo zadoščala za očiščenje nakopičenega substrata v tkivih organov in na ta način preprečevala,
lacrimation increased eye pruritus, ocular hyperaemia
Očesne bolezni povečano solzenje očesni pruritus, očesna hiperemija
Slowly, withdraw 7.0 ml (equal to 35 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Počasi izvlecite 7,0 ml (kar ustreza 35 mg) rekonstituirane raztopine iz vsake viale do celotne količine, ki je potrebna za bolnikov odmerek.
Use of Fabrazyme during breastfeeding is not recommended.
Uporaba zdravila Fabrazyme v času dojenja ni priporočljiva.
However, the effect of Fabrazyme treatment on the kidney function was limited in some patients with advanced renal disease.
Fabrazyme na delovanje ledvic pri nekaterih bolnikih z napredovalo boleznijo ledvic omejen.
Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Osnovni CL je bil 77 ml/min z Vss 2,6 l; razpolovni čas je bil 55 min.
• lethargy
• urtikarija
- The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit
- navodilo za iskanje nujne zdravniške pomoči v primeru vsakega neželenega učinka med infundiranjem, - potrebo po nujnem zdravljenju v primeru neuspešne uporabe venskega dostopa ali neučinkovanja zdravila,
The 2 female patients had little or no GL-3 accumulation in the superficial skin vascular endothelium at baseline, making this conclusion applicable in male patients only.
Obe bolnici ženskega spola sta kopičili GL-3 v žilnem endoteliju vrhnje plasti kože v osnovi le v majhni meri ali sploh ne, kar pomeni, da so bili zaključki uporabni le za bolnike moškega spola.
Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/min; 10 mg/hr) and/or pre-treatment with antihistamines, paracetamol, ibuprofen and/or corticosteroids.
(~0,15 mg/min; 10 mg/uro) in/ali predhodnem zdravljenju z antihistaminiki, paracetamolom, ibuprofenom in/ali kortikosteroidi.
No dose adjustment is necessary for patients with renal insufficiency.
Pri bolnikih z ledvično insuficienco ni potrebna prilagoditev odmerka.
• musculoskeletal stiffness
• zategnjenost mišic
• throat pain
• trebušne bolečine
• lower blood oxygen levels • serious inflammation of the vessels
• nižje ravni kisika v krvi
After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta.
Po rekonstituciji s 1,1 ml vode za injekcije vsebuje vsaka viala zdravila Fabrazyme 5 mg/ml agalzidaze beta.
Do not use the solution if foreign particles are observed or if the solution is discoloured.
Raztopine ne uporabljajte, če v njej opazite tujke ali če je spremenila barvo.
The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2ºC -8ºC.
Rekonstituirane raztopine ne shranjujte, ampak jo takoj razredčite; le razredčeno raztopino lahko shranjujete do 24 ur pri
• decreased blood pressure • hot flush
• znižan krvni tlak
Agalsidase beta is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Agalzidaza beta je beljakovina in pričakujemo, da se presnovno razgradi s hidrolizo peptidov, zato ni pričakovati, da bi okvarjeno jetrno delovanje klinično pomembno vplivalo na farmakokinetiko agalzidaze beta.
- That it is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Fabrazyme.
- Da je odgovornost zdravnika, ki predpiše zdravilo Fabrazyme, da presodi, kateri bolniki so primerni za dajanje zdravila na domu ali za samo dajanje.
• feeling hot
• pekoč občutek
Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Bolezni prebavil navzea, bruhanje trebušne bolečine, bolečine v zgornjem trebušnem predelu, neugodje v trebuhu, neugodje v želodcu, oralna hipestezija, diareja disepsija, disfagija
Fabrazyme 35 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta.
Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Vsaka viala zdravila Fabrazyme vsebuje nominalno vrednost 35 mg agalzidaze beta.
Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Vsako vialo zdravila Fabrazyme 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
Uncommon (may affect up to 1 in 100 people): • tremor
Občasni (se lahko pojavijo pri največ 1 bolniku od 100 bolnikov):
ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Vsako vialo zdravila Fabrazyme 35 mg rekonstituirajte s 7,2 ml vode za injekcije.
Vascular disorders flushing, hypertension, pallor, hypotension, hot flush peripheral coldness --
hipotenzija, vročično zardevanje periferna hladnost
• increased blood pressure • joint pain
• zvišan krvni tlak
Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion
Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje
Fabrazyme 5 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta.
Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje Vsaka viala zdravila Fabrazyme vsebuje nominalno vrednost 5 mg agalzidaze beta.
• tinnitus
• tinitus
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom
Fabrazyme 35 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Vsako vialo zdravila Fabrazyme 35 mg rekonstituirajte s 7,2 ml vode za injekcije.
• itching eyes
• pekoče oči
Renal elimination of agalsidase beta is considered to be a minor pathway for clearance.
Ledvično izločanje velja za manj pomembno pot izločanja agalzidaze beta.
Contents of the pack and other information
Shranjevanje zdravila Fabrazyme Vsebina pakiranja in dodatne informacije
Fabrazyme 5 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje Vsako vialo zdravila Fabrazyme 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
Bolezni mišično skeletnega sistema in vezivnega tkiva bolečine v udih, mialgija, bolečine v hrbtu, mišični krči,
• ear pain
• obrazni edem
• abnormal tear secretion • rash
• nenormalno izločanje solz • izpuščaj
• increased heart beat
• pospešen srčni utrip
• low heart rate
• počasno bitje srca
The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2°C-8°C.
ampak jo takoj razredčite; le razredčeno raztopino lahko shranjujete do 24 ur pri temperaturi
How to store Fabrazyme
Shranjevanje zdravila Fabrazyme
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate.
Pomožne snovi: manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat.
Agalsidase beta clearance was not influenced by weight in this population.
V tej populaciji telesna masa ni imela vpliva na očistek agalzidaze beta.
Talk to your doctor or pharmacist before using Fabrazyme.
Pred začetkom uporabe zdravila Fabrazyme se posvetujte z zdravnikom.
Following treatment with 1 mg/kg every other week for 24 weeks, a dose regimen of 0.3 mg/kg every 2 weeks for 18 months was able to maintain the clearance of cellular GL-3 in the capillary endothelium of the kidney, other kidney cell types and skin (superficial skin capillary endothelium) in the majority of patients.
18 mesecev, vzdrževati očistek celičnega GL-3 v kapilarnem endoteliju ledvic, drugih vrstah ledvičnih celic in koži (površinski kapilarni endotelij kože) pri večini bolnikov.
Another double-blind, placebo-controlled study of 82 patients was performed to determine whether Fabrazyme would reduce the rate of occurrence of renal, cardiac, or cerebrovascular disease or death.
Da bi ugotovili, ali Fabrazyme zmanjšuje stopnjo pogostnosti ledvičnih, srčnih ali cerebrovaskularnih bolezni ali smrti, so opravili še eno dvojno slepo s placebom nadzorovano študijo na 82 bolnikih.
In an additional 5-year open-label paediatric study, 31 male patients aged 5 to 18 years were randomized prior to the onset of clinical symptoms involving major organs and treated with two lower dose regimens of agalsidase beta, 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks.
randomizirali pred pojavom kliničnih simptomov, ki so zajeli pomembne organe, in so jih zdravili z dvema manjšima odmerkoma agalzidaze beta: 0,5 mg/kg vsaka 2 tedna ali 1,0 mg/kg vsake 4 tedne.
Subsequent infusions may need to occur in a clinical setting.
Bolnik mora nadaljnje infuzije prejeti v bolnišnici.
• burning sensation
• oteženo požiranje
• musculoskeletal pain
• mišični krči
• urticaria
• bolehnost
The effect of Fabrazyme treatment on the kidneys may be limited in patients with advanced renal disease.
Bolniki z napredovalo ledvično boleznijo Pri bolnikih z napredovalo ledvično boleznijo bo morda učinek zdravljenja z zdravilom Fabrazyme na ledvicah omejen.
Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well.
Pri bolnikih, ki dobro prenašajo infuzije zdravila Fabrazyme, je mogoče infundiranje na domu.
5 vials of powder for concentrate for solution for infusion.
5 vial praška za koncentrat za raztopino za infundiranje.
Anaphylactoid reactions have been reported in the postmarketing setting.
V času trženja zdravila so poročali o anafilaktičnih reakcijah.
10 vials of powder for concentrate for solution for infusion.
10 vial praška za koncentrat za raztopino za infundiranje.
Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje agalzidaza beta
1 vial of powder for concentrate for solution for infusion.
1 viala praška za koncentrat za raztopino za infundiranje.
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat
• muscle tightness
• mišično-skeletna togost
• runny nose
• zamašenost nosu
Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje agalzidaza beta
Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Fabrazyme 35 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Fabrazyme 35 mg se dobavlja v prozornih 20 ml vialah iz stekla tipa I. Zaporka sestoji iz zamaška iz silikonizirane butilne gume in aluminijastega pokrovčka s plastično odmično kapico.
In one open-label paediatric study, sixteen patients with Fabry disease (8-16 years old; 14 males, 2 females) had been treated for one year at 1.0 mg/kg every 2 weeks.
let; 14 moških, 2 ženski) s Fabryjevo boleznijo z odmerkom 1,0 mg/kg vsaka 2 tedna.
• redness
• sopenje
Fabry disease
Ušesne bolezni,
Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Fabrazyme 5 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Fabrazyme 5 mg se dobavlja v prozornih 5 ml vialah iz stekla tipa I. Zaporka sestoji iz zamaška iz silikonizirane butilne gume in aluminijastega pokrovčka s plastično odmično kapico.
• red rash
• rdeč izpuščaj
Respiratory, thoracic and mediastinal disorders dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated bronchospasm, pharyngolaryngeal pain, rhinnorhoea, tachypnoea, upper respiratory tract congestion hypoxia
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, zamašenost nosu, stiskanje v grlu, sopenje, kašljanje, poslabšana dispneja bronhospazem,
Manufacturer
Uporaba
- The treating physician will be responsible for determining which patients may be suitable for home or self-administration of Fabrazyme and for arranging for treatment at home and training the patient and/or caregiver in the appropriate skills necessary for this.
- Lečeči zdravnik je odgovoren, da presodi, ali je bolnik primeren za zdravljenje z uporabo zdravila Fabrazyme na domu ali samodajanje.
The net effect of these changes after seroconversion was an increase in exposure of 2- to 3-fold based on AUC and Cmax.
Po serokonverziji IgG je CL padel na 35 ml/min, Vss je zrastel na 5,4 l, razpolovni čas se je povečal na 240 min. Neto učinek teh sprememb po serokonverziji je bil 2 do 3 krat večji po izpostavljenosti glede na AUC in Cmax.
Posology
Redčenje
Patients with advanced renal disease
Bolniki s protitelesi proti r-hαGAL
- Necessary skills have to be acquired by non-healthcare professionals before Fabrazyme may be safely and effectively administered at home. - Their prescribing physician will provide training on the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion
- postopek priprave in dajanja zdravila Fabrazyme, - navodilo za obravnavo možnih neželenih dogodkov,
Nervous system disorders headache, paraesthesia dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope hyperaesthesia, tremor
hipestezija, pekoč občutek, letargija,
• stomach discomfort
• neugodje v trebuhu
The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Navodila za uporabo - rekonstitucija, redčenje in uporaba Prašek za koncentrat za raztopino za injiciranje rekonstituirajte z vodo za injekcije, razredčite z 0,9 %
The level of support required for home infusion will be discussed and agreed by the patient and/or caregiver with the prescribing physician.
Bolnik oz. negovalec se z zdravnikom pogovorita in dogovorita o zahtevah za infundiranje na domu.
• malaise
• utrujenost
In another study with 30 paediatric patients with available pharmacokinetics data, aged 5 to 18 years, treated with two lower dose regimens of 0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks, mean CL was 4.6 and 2.3 ml/min/kg, respectively, mean Vss was 0.27 and 0.22 l/kg, respectively, and mean elimination half-life was 88 and 107 minutes, respectively.
Povprečni CL je bil pri prvih 4,6 in pri drugih 2,3 ml/min/kg, povprečni Vss pri prvih 0,27 in pri drugih 0,22 l/kg, povprečni eliminacijski razpolovni čas pa pri prvih 88 in pri drugih 107 minut.
The educational material for patients should include information on the following key elements: - The prescribing physician may decide that Fabrazyme may be administered at home.
Izobraževalno gradivo mora obsegati naslednje: • priročnik o infundiranju na domu za zdravstveno osebje,
• pain
• bledica
Skin and subcutaneous tissue disorders pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo-papular livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort leukocytoclastic vasculitis
zatekanje obraza, makulopapulozni izpuščaj livedo reticularis, eritematozni izpuščaj, pruritični izpuščaj,
• influenza-like illness
• gripi podobna bolezen • edem
• nasal congestion
• vročično zardevanje
• infusion site pain
• bolečina na mestu infundiranja
The educational programme contains the following:
Izobraževalni program vsebuje naslednje: