natgillin/translations-raw huggingface dataset:
Infusion site discomfort, infusion site burning, infusion site swelling, injection site sterile abscess, chest discomfort, fever, rigors, fatigue
Občutek neugodja na mestu aplikacije, pekoča bolečina na mestu aplikacije, otekanje na mestu aplikacije, sterilni absces na mestu aplikacije, neugodje v prsih, zvišana telesna temperatura, okorelost, utrujenost
In a small number of patients undesirable effects have been reported which are related to the route of administration: discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture.
Poročila navajajo neprijeten občutek, pruritus, pekočo bolečino, oteklino ali sterilni absces na mestu venskega vboda.
Symptoms suggestive of hypersensitivity have been noted in approximately 3% of the patients.
O simptomih, ki kažejo na preobčutljivostno reakcijo, poročajo pri približno 3% bolnikov.
Onset of such symptoms has occurred during or shortly after infusions; these have included pruritus, flushing, urticaria/ angioedema, chest discomfort, tachycardia, cyanosis, respiratory symptoms, and paraesthesia.
Takšni simptomi so se začeli med infundiranjem ali kmalu po njem; med njimi so pruritus, navali vročine, urtikarija/ angioedem, neugodje v prsih, tahikardija, cianoza, respiratorni simptomi in parestezije.
Hypotension associated with hypersensitivity has also been reported rarely.
Redka poročila navajajo v povezavi s preobčutljivostjo tudi hipotenzijo.
These symptoms generally respond to treatment with antihistamines and/ or corticosteroids.
Ti simptomi se v glavnem pojavijo zaradi zdravljenja z antihistaminiki in/ ali kortikosteroidi.
A16AB02.
Encimi – imigluceraza (rekombinantna, na makrofage usmerjena β - glukocerebrozidaza), ATC koda A16AB02.
Imiglucerase (recombinant macrophage targeted β -glucocerebrosidase) catalyses the hydrolysis of the glycolipid, glucocerebroside, to glucose and ceramide following the normal degradation pathway for membrane lipids.
Imigluceraza (rekombinantna, na makrofage usmerjena β- glukocerebrozidaza) katalizira hidrolizo glikolipida, glukocerebrozida, v glukozo in ceramid po normalni poti razgradnje membranskih lipidov.
Glucocerebroside is primarily derived from haematopoietic cell turnover.
Glukocerebrozid nastaja primarno v hematopoetični celični presnovi.
Gaucher disease is characterised by a functional deficiency in β -glucocerebrosidase enzymatic activity and the resultant accumulation of lipid glucocerebroside in tissue macrophages, which become engorged and are termed Gaucher cells.
Za Gaucherjevo bolezen je značilna funkcionalno pomanjkljiva encimska aktivnost β- glukocerebrozidaze in posledično kopičenje lipidnega glukocerebrozida v tkivnih makrofagih, ki se zamašijo in pretvorijo v tako imenovane Gaucherjeve celice.
Gaucher cells are typically found in liver, spleen and bone marrow and occasionally, as well, in lung, kidney and intestine.
Gaucherjeve celice so značilno prisotne v jetrih, vranici in kostnem mozgu ter občasno tudi v pljučih, ledvicah in črevesju.
Secondary haematologic sequelae include severe anaemia and thrombocytopenia
Sekundarni hematološki posledici sta huda anemija in trombocitopenija ob značilni napredujoči hepatosplenomegaliji.
5 in addition to the characteristic progressive hepatosplenomegaly.
5 onesposobljajoča posledica Gaucherjeve bolezni.
The skeletal complications are a common, and frequently the most debilitating and disabling feature of Gaucher disease.
Možni skeletni zapleti so osteonekroza, osteopenija s sekundarnimi patološkimi zlomi, motnje v obnavljanju kostnega tkiva, osteoskleroza in kostne krize.
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ ICGG Gaucher Registry”.
Zdravstvene strokovnjake spodbujamo k temu, da vpišejo vse paciente z Gaucherjevo boleznijo, vključno s tistimi s kroničnimi nevronopatskimi manifestacijami bolezni, v register 'ICGG Gaucher Registry'.
The objectives of the “ ICGG Gaucher Registry” are to enhance the understanding of Gaucher disease and to evaluate the effectiveness of enzyme replacement therapy, ultimately leading to improvement in the safe and efficacious use of Cerezyme.
Cilj registra je izboljšanje razumevanja Gaucherjeve bolezni in ocenitev učinkovitosti encimsko nadomestnega zdravljenja, in posledično izboljšanje varne in učinkovite uporabe zdravila Cerezyme.
During 1 hour intravenous infusions of 4 doses (7.5, 15, 30, 60 U/ kg) of imiglucerase, steady-state enzymatic activity was achieved by 30 minutes.
Med enournim intravenskim infundiranjem 4 odmerkov (7, 5, 15, 30 in 60 enot/ kg) imigluceraze se je pojavila ravnotežna encimska aktivnost po 30 minutah.
Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes.
Po infundiranju se je encimska aktivnost v plazmi hitro zmanjšala z razpolovno dobo od 3, 6 do 10, 4 minute.
Plasma clearance ranged from 9.8 to 20.3 ml/ min/ kg, (mean ± S. D, 14.5 ± 4.0 ml/ min/ kg).
Plazemski očistek je znašal 9, 8 do 20, 3 ml/ min/ kg (srednja vrednost ± SD 14, 5 ± 4, 0 ml/ min/ kg).
The volume of distribution corrected for weight ranged from 0.09 to 0.15 l/ kg (mean ± S. D 0.12 ± 0.02 l/ kg).
Telesni masi prilagojen volumen porazdelitve je bil v območju 0, 09 do 0, 15 l/ kg (srednja vrednost ± SD 0, 12 ± 0, 02 l/ kg).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, and genotoxicicty.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Mannitol Sodium citrate (to adjust pH) Citric acid monohydrate (to adjust pH) Polysorbate 80
Manitol Natrijev citrat (za uravnavanje pH) Citronska kislina monohidrat (za uravnavanje pH) Polisorbat 80
If not used immediately, in-use storage and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C under protection from light.
V nasprotnem primeru uporabnik sam prevzame odgovornost za hranjenje med uporabo in pogoje pred uporabo – čas hranjenja naj ne bo daljši od 24 ur pri temperaturi 2°C - 8°C zaščiteno pred svetlobo.
6 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
6.5 Nature and contents of container
6 6. 5 Vrsta ovojnine in vsebina
The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Zdravilo Cerezyme je pakirano v steklene (prozorne) viale borosilikata vrste I po 20 ml, ki so zaprte z zamaškom iz silikoniziranega butila in opremljene z varnostnim pokrovčkom za dokaz intaktnosti.
To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.3 ml.
Zaradi zagotovitve zadostnega volumna za natančno odvzemanje imajo viale presežek, ki znaša 0, 3 ml.
1 or 25 vials per carton.
1 ali 25 vial v škatli iz kartona.
Each vial of Cerezyme is for single use only.
Po pripravi raztopine vsebuje vsaka viala zdravila Cerezyme 200 enot imigluceraze v 5, 0 ml (40 enot na ml).
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.
Razredčeno raztopino dajemo z intravenskim infundiranjem.
Use Aseptic Technique Reconstitution Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Narahlo premešajte, da se raztopina ne bi začela peniti.
The reconstituted volume is 5.3 ml.
Volumen pripravljene raztopine je 5, 3 ml.
The pH of the reconstituted solution is approximately 6.1.
Njen pH je približno 6, 1.
Dilution The reconstituted solution contains 40 units imiglucerase per ml.
Redčenje Pripravljena raztopina vsebuje 40 enot imigluceraze/ ml.
The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Volumen pripravljene raztopine v vsaki viali zadošča za natančni odvzem nominalnega volumna, ki je 5, 0 ml (ustreza 200 enotam).
Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
Odvzemite 5, 0 ml pripravljene raztopine iz vsake viale in skupno odvzeto količino razredčite z 0, 9% raztopino natrijevega klorida za intravensko uporabo do volumna 100 do 200 ml.
The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Z 0, 9% raztopino natrijevega klorida za intravensko uporabo razredčeno zdravilo je kemično stabilno 24 ur pri temperaturi od 2 do 8 ºC in zaščiteno pred svetlobo; mikrobiološka neoporečnost zdravila pa zavisi od uporabe aseptične tehnike pri pripravi in redčenju raztopine.
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
7 Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, Nizozemska
17 November 1997 Date of latest renewal:
17. november 1997 Datum zadnjega podaljšanja:
Cerezyme 400 U Powder for concentrate for solution for infusion
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje
Each vial contains 400 units* of imiglucerase**.
Vsaka viala vsebuje 400 enot * imigluceraz **.
After reconstitution, the solution contains 40 units of imiglucerase per ml (400 U/ 10 ml).
Po rekonstituciji vsebuje raztopina 40 enot imigluceraze na ml (400 e/ 10 ml).
* An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β -D-glucopyranoside (pNP-Glc) per minute at 37°C. ** modified form of glucocerebrosidase produced in Chinese Hamster Ovary cells by recombinant DNA technology.
* 1 enota encima (e.) je količina encima, ki v 1 minuti katalizira hidrolizo 1 mikromola sintetičnega substrata para- nitrofenil β- D- glukopiranozida (pNP- Glc) pri temperaturi 37 °C. ** spremenjene oblika glukocerebrozidaze, pridobljene s tehnologijo rekombinantne DNK v celicah jajčnika kitajskega hrčka.
After reconstitution, the solution contains 1.24 mmol sodium (400 U/ 10 mL).
Po rekonstituciji vsebuje raztopina 1, 24 mmol natrija (400 e/ 10 mL).
Administration of doses as low as 2.5 U/ kg of body weight three times a week or 15 U/ kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters.
9 Zdravljenje z zelo majhnimi odmerki, po 2, 5 enot/ kg telesne mase trikrat na teden ali po 15 enot/ kg telesne mase enkrat vsaka 2 tedna, je zboljšalo hematološke parametre in visceromegalijo, ne pa tudi kostnih parametrov.
Hypersensitivity Current data suggest that, during the first year of therapy, IgG antibodies to imigluceraseare formed in approximately 15% of the treated patients.
Preobčutljivost Po sedanjih podatkih se pri približno 15% bolnikov prvo leto zdravljenja razvijejo protitelesa IgG za imiglucerazo.
If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised.
Če se reakcije pojavijo, se priporoča takojšnja ustavitev infuzije zdravila Cerezyme in uvedba ustreznega zdravljenja.
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible.
Pri bolnikih s protitelesi za zdravilo Cerezyme (imiglucerazo) se poveča tveganje za preobčutljivostne reakcije (glejte poglavje 4. 8).
Pulmonary hypertension Pulmonary hypertension is a known complication of Gaucher disease.
10 Pljučna hipertenzija Pljučna hipertenzija je znan zaplet Gaucherjeve bolezni.
10 Excipients This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Pomožne snovi To zdravilo vsebuje natrij in se aplicira v 0, 9% intravenski raztopini natrijevega klorida (glejte poglavje 6. 6).
11 Nervous system disorders Uncommon:
11 Bolezni živčevja Občasno:
Tachycardia, cyanosis Vascular disorders
Tahikardija, cianoza Žilne bolezni
Flushing, hypotension
Navali vročine, hipotenzija
12 in addition to the characteristic progressive hepatosplenomegaly.
Zapleti z okostjem so pogosta in često najbolj 12 onesposobljajoča posledica Gaucherjeve bolezni.
6.5 Nature and contents of container
13 6. 5 Vrsta ovojnine in vsebina
To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.6 ml.
Zaradi zagotovitve zadostnega volumna za natančno odvzemanje imajo viale presežek, ki znaša 0, 6 ml.
1, 5 or 25 vials per carton.
1, 5 ali 25 vial v škatli iz kartona.
Each vial of Cerezyme is for single use only.
Po pripravi raztopine vsebuje vsaka viala zdravila Cerezyme 400 enot imigluceraze v 10, 0 ml (40 enot na ml).
Use Aseptic Technique Reconstitution Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Narahlo premešajte, da se raztopina ne bi začela peniti.
The reconstituted volume is 10.6 ml.
Volumen pripravljene raztopine je 10, 6 ml.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Volumen pripravljene raztopine v vsaki viali zadošča za natančni odvzem nominalnega volumna, ki je 10, 0 ml (ustreza 400 enotam).
Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
Odvzemite 10, 0 ml pripravljene raztopine iz vsake viale in skupno odvzeto količino razredčite z 0, 9% raztopino natrijevega klorida za intravensko uporabo do volumna 100 do 200 ml.
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
14 Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, Nizozemska
Genzyme Corporation 500 Soldiers Field Road – Allston, MA 02134 – USA
500 Soldiers Field Road – Allston, MA 02134 - ZDA
37 Hollands Road – Haverhill, Suffolk CB9 8PU - UK
37 Hollands Road – Haverhill, Suffolk CB9 8PU – Združeno kraljestvo
OUTER CARTON/ VIAL
ZUNANJA ŠKATLA/ VIALA
Cerezyme 200 U Powder for concentrate for solution for infusion imiglucerase
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Imigluceraza
Each vial contains 200 units of imiglucerase.
Vsaka viala vsebuje 200 enot imigluceraze.
Mannitol, Sodium Citrate, Citric acid monohydrate and Polysorbate 80.
Pomožne snovi: manitol, natrijev citrat, citronska kislina monohidrat, polisorbat 80.
For intravenous infusion.
Za intravensko infundiranje.
Gooimeer 10 1411 DD Naarden-NL
Gooimeer 10 1411 DD Naarden - Nizozemska
LABEL/ VIAL
NALEPKA/ VIALA
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
22 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Cerezyme 400 U Powder for concentrate for solution for infusion imiglucerase
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Imigluceraza
Each vial contains 400 units of imiglucerase.
Vsaka viala praška vsebuje 400 enot imigluceraze.
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
24 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Each vial contains 400 units of imiglucerase
Vsaka viala vsebuje 400 enot imigluceraze.
26 PACKAGE LEAFLET:
26 NAVODILO ZA UPORABO
Cerezyme 200 U powder for concentrate for solution for infusion Imiglucerase
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Imigluceraza
2.
Kaj je zdravilo Cerezyme in za kaj ga uporabljamo 2.
3.
Kaj morate vedeti, preden boste uporabili zdravilo Cerezyme 3.
4.
Kako uporabljati zdravilo Cerezyme 4.
6.
Možni neželeni učinki 5 Shranjevanje zdravila Cerezyme 6.
WHAT CEREZYME IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CEREZYME IN ZA KAJ GA UPORABLJAMO
Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, and who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of platelets - a type of blood cell), spleen or liver enlargement or bone disease.
Zdravilo Cerezyme se uporablja za zdravljenje bolnikov, pri katerih so potrdili diagnozo Gaucherjeve bolezni tipa 1 ali tipa 3 in ki kažejo znake bolezni, kot so: anemija (nizko število rdečih krvničk), nagnjenost h krvavitvam (zaradi nizkega števila trombocitov – vrste krvnih celic), povečanja vranice ali jeter ali bolezen kosti.
People with Gaucher disease have low levels of an enzyme called β -glucocerebrosidase.
Ljudje z Gaucherjevo boleznijo imajo nizko raven encima, ki se imenuje β- glukocerebrozidaza.
This enzyme helps the body control levels of glucocerebroside.
S pomočjo tega encima telo nadzira ravni glukocerebrozida.
Glucocerebroside is a natural substance in the body, made of sugar and fat.
Glukocerebrozid je naravna snov v telesu, sestavljena iz sladkorja in maščob.
In Gaucher disease glucocerebroside levels can get too high.
Pri Gaucherjevi bolezni so lahko ravni glukocerebrozida previsoke.
Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme β - glucocerebrosidase which is lacking or not active enough in patients with Gaucher disease.
Cerezyme je umetni encim, ki se imenuje imigluceraza in lahko nadomesti naravni encim β - glukocerebrozidazo, ki pri bolnikih z Gaucherjevo boleznijo manjka ali pa ni dovolj aktiven.
BEFORE YOU USE CEREZYME
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO CEREZYME
Do not use Cerezyme
Ne uporabljajte zdravila Cerezyme:
- If you are allergic (hypersensitive) to imiglucerase, or
- Če ste alergični na (preobčutljvi za) imiglucerazo ali
- if you are allergic to any of the other ingredients of Cerezyme.
- katerokoli sestavino zdravila Cerezyme.
Take special care with Cerezyme
Bodite posebno pozorni pri uporabi zdravila Cerezyme
- If you are treated with Cerezyme, you may experience an allergic reaction while you are being
- Pri prejemanju zdravila Cerezyme se lahko pojavijo alergijske reakcije med ali tik po prejemu
given the medicine or shortly after.
zdravila.
- Some patients with Gaucher disease have high blood pressure in the lungs (pulmonary
Nekateri bolniki z Gaucherjevo boleznijo imajo visok krvni pritisk v pljučih (pljučna
hypertension).
hipertenzija).
27 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
27 Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you may be pregnant.
Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete to zdravilo, če ste noseči ali mislite, da ste noseči.
HOW TO USE CEREZYME
KAKO UPORABLJATI ZDRAVILO CEREZYME
The recommended dose of Cerezyme is 60 units/ kg body weight given once every 2 weeks.
Priporočen odmerek zdravila Cerezyme je 60 enot/ kg telesne mase enkrat vsaka 2 tedna.
Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/ she finds the best dose to control your symptoms.
Zdravnik bo skrbno spremljal vaš odziv na zdravljenje in morda odmerek spreminjal (poviševal ali zmanjševal), dokler ne najde odmerka, ki najbolje obvladuje vaše simptome.
The ICGG Gaucher Registry You can ask your doctor to register your patient information into the “ ICGG Gaucher Registry”.
Register “ ICGG Gaucher Registry ” Zdravnika lahko prosite, da vpiše vaše podatke o bolniku v „ ICGG Gaucher Registry “.
Your patient data will be registered anonymously – nobody will know it is information about you.
Vaši podatki o bolniku bodo vpisani anonimno, zato teh podatkov ne bo možno povezati z vami.
If you use more Cerezyme than you should There are no cases of overdose of Cerezyme reported.
Če ste uporabili večji odmerek zdravila Cerezyme, kot bi smeli Ni poročil o primerih prevelikega odmerjanja.
If you forget to use Cerezyme If you have missed an infusion, please contact your doctor.
Če ste pozabili uporabiti zdravilo Cerezyme Če ste izpustili infuzijo, se posvetujte s svojim zdravnikom.
Like all medicines, Cerezyme can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Cerezyme neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.
Če opazite katerikoli resen neželeni učinek ali neželeni učinek, ki ni omenjen v tem navodilu, nemudoma obvestite svojega zdravnika.
28 Common side effects (occurring in more than 1 in 100 patients) are:
28 Pogosti neželeni učinki (pojavijo se pri več kot 1 od 100 bolnikov)
- breathlessness
- zasoplost
- hives/ localised swelling of the skin or lining of the mouth or throat
- izpuščaji/ lokalizirano otekanje kože ali obloge v ustih ali grlu
- itching
- srbenje
- rash
- izpuščaj
Uncommon side effects (occurring in more than 1 in 1000 patients) are:
Občasni neželeni učinki (pojavijo se pri več kot 1 od 1000 bolnikov)
- a sensation of tingling, pricking, burning or numbness of the skin
- občutek mravljinčenja, zbadanja, skelenja ali odrevenelost kože
- increased heart rate
- povišan srčni utrip
- bluish skin
- modrikavost kože
- flushing
- oblivanje
- fall in blood pressure
- zmanjšanje krvnega pritiska
- vomiting
- bruhanje
- nausea
- navzeja
- abdominal cramping
- krči v trebuhu
- diarrhoea
- diareja
- pain in the joints
- bolečine v sklepih
- infusion site discomfort
- nelagodje na mestu infudiranja
- infusion site burning
- skelenje na mestu infundiranja
- infusion site swelling
- oteklost na mestu infundiranja
- injection site sterile abcess
- sterilni abces na mestu injiciranja
- chest discomfort
- stiskanje v prsih
- fever
- vročina
- rigors
- tresavica
These have included itching, flushing, hives/ localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin and fall in blood pressure.
Zajemajo srbenje, oblivanje, izpuščaj/ lokalno oteklost kože ali obloženost ust ali grla, nelagodje v prsih, povišan srčni utrip, modrikavo kožo, zasoplost, občutek zbadanja, ščemenja, skelenja ali otopelosti kože in padec krvnega pritiska.
You may need to be given additional medicines to prevent an allergic reaction (e. g. antihistamines and/ or corticosteroids).
Morda boste prejeli dodatna zdravila, ki bodo preprečila alergijsko reakcijo (npr. antihistaminike in/ ali kortikosteroide).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE CEREZYME
SHRANJEVANJE ZDRAVILA CEREZYME
Store in a refrigerator (2°C – 8°C) Do not use Cerezyme after the expiry date printed on the labelling after the letters “ EXP”.
"EXP".
What Cerezyme contains
Kaj vsebuje zdravilo Cerezyme
Imiglucerase is a modified form of the human enzyme β -
Imigluceraza je modificirana oblika humanega encima β -
glucocerebrosidase produced by recombinant DNA technology.
glukocerebrozidaze, proizvedena z rekombinantno tehnologijo DNK.
- Other ingredients are:
- Druge sestavine so:
- - - -
- manitol
Mannitol Sodium citrate Citric acid monohydrate Polysorbate 80
- polisorbat 80
Important information about some of the ingredients of Cerezyme This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution.
Pomembne informacije o nekaterih sestavinah zdravila Cerezyme To zdravilo vsebuje natrij in se aplicira v 0, 9% intravenski raztopini natrijevega klorida.