natgillin/translations-raw huggingface dataset:
Other less common side effects may include: • shortness of breath and swollen ankles because of heart failure, irregular heart beat, low potassium level in the blood (which may be noticed as weakness and cramps), • breathing difficulties, cough, chest pains and fainting, coughing blood, • swelling and reddening and blistering of the skin around the injection site, • stomach pains from an open sore on the lining of the stomach, also called gastric ulcer and pain and swelling of the food pipe, • fever and chills (covers pneumonitis, plus breathing difficulties and cough), muscle weakness and aches, • yellowing of the skin and/ or eyes, also called jaundice, • change in frequency of urination, painful urination and blood in the urine, • constipation, feeling thirsty and loss of appetite, • skin problems including itchiness of the skin, tender, swollen areas around hair roots and nail disorders, • abnormal manner of walking, • speech difficulties, • back pain, • nose bleeds, • agitation, • sleepiness or drowsiness but sometimes insomnia.
Drugi manj pogosti neželeni učinki so: • kratka sapa in otekli gležnji zaradi popuščanja srca, nereden srčni utrip, nizka vrednost kalija v krvi (kar se lahko opazi ot slabost in pojavi krčev), • težave z dihanjem, kašelj, bolečine v prsih in omedlevico, izkašljevanje krvi, • otekanje, pordečitev in mehurjavost kože okrog mesta injiciranja, • bolečine v želodcu zaradi odprte razjede na oblogi želodca, rane na želodcu, bolečine in otekanje požiralnika, • povišana telesna temperatura in mrzlica (pri pljučnici, težave z dihanjem in kašelj), šibkost in bolečine v mišicah, • porumenitev kože in/ ali oči, čemur rečemo tudi zlatenica • sprememba v pogostosti uriniranja, boleče uriniranje in kri v urinu, • obstipacija, občutek žeje in izguba apetita, • težave s kožo vključno z srbenjem kože, napetostjo, vnetje lasnih mešičkov in težave z nohti, • neobičajen način hoje, • težave pri govorjenju, • bolečine v hrbtu, • krvavenje iz nosu, • agitatacija, • zaspanost ali omotičnost in včasih nespečnost.
During the infusion at the hospital, you may have an allergic reaction and notice any of the following:
Med prejemanjem infuzije v bolnici boste morda dobili alergično reakcijo in opazili naslednje:
light-headedness, tiredness, headache, back pain, flushing.
občutek lahke glave, utrujenost, glavobol, bolečine v hrbtu, rdečica.
HOW TO STORE MYOCET
SHRANJEVANJE ZDRAVILA MYOCET
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2οC – 8οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Ne shranjujte ga dlje kot 24 ur pri temperaturi med 2 ° in 8 °C, razen če rekonstitucija in redčenje nista bila opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
Do not use after the expiry date stated on the label and carton.
Datum izteka roka uporabnosti je natisnjen na ovojnini.
Do not use Myocet if you notice that it shows evidence of discoloration, precipitation or any other particulate matter.
Zdravila Myocet ne uporabljajte, če opazite znake razbarvanja, usedlino ali druge delce.
What Myocet contains:
Kaj vsebuje zdravilo Myocet:
Myocet 50 mg powder and pre -admixtures for concentrate for liposomal dispersion for infusion Liposomal doxorubicin
Myocet 50 mg prašek in dodatki za koncentrat za liposomsko disperzijo za infundiranje
- The active substance is doxorubicin HCl, 50 mg.
- Zdravilna učinkovina je doksorubicinijev klorid, 50 mg.
- The other ingredients are lactose (Myocet doxorubicin HCl vial), egg phosphatidylcholine,
- Pomožne snovi so laktoza (viala z Myocet doksorubicinijevim kloridom), jajčni
cholesterol, citric acid and sodium hydroxide and water for injections (Myocet liposomes vial), and sodium carbonate and water for injections (Myocet buffer vial).
fosfatidilholin, holesterol, citronska kislina, natrijev hidroksid in voda za injiciranje (viala z liposomi Myocet) ter natrijev karbonat in voda za injiciranje (viala s pufrom Myocet).
The marketing authorisation holder is:
Imetnik dovoljenja za promet z zdravilom:
St Mary’s Pharmaceutical Unit Quadrant Centre Cardiff Business Park Llanishan Cardiff Wales CF14 5RA United Kingdom.
St Mary’ s Pharmaceutical Unit Quadrant Centre Cardiff Business Park Llanishan Cardiff Wales CF14 5RA Velika Britanija
This leaflet was last approved on:...
Navodilo je bilo odobreno
28 The following information is intended for healthcare professionals only:
29 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Myocet is supplied as a three-vial system:
Myocet je na voljo v obliki sistema treh vial:
(1) Myocet doxorubicin HCl, (2) Myocet liposomes, and (3) Myocet buffer.
(1) Myocet doksorubicinijev klorid, (2) liposomi Myocet in (3) pufer Myocet.
In addition to these three components, 0.9% (w/v) sodium chloride for injection will also be required for the reconstitution of the doxorubicin HCl.
Poleg teh treh sestavin bo za rekonstitucijo doksorubicinijevega klorida potreben tudi natrijev klorid 9 mg/ ml (0, 9%) raztopina za injiciranje.
Personnel handling this medicinal product during reconstitution should wear protective clothing including masks, goggles and gloves.
• Osebje mora biti usposobljeno za rekonstituiranje zdravila. • Nosečnice med osebjem morajo biti izključene iz rokovanja s tem zdravilom. • Osebje, ki dela s tem zdravilom, mora med rekonstitucijo nositi zaščitna oblačila, vključno z masko, očali in rokavicami. • Vse predmete, ki jih uporabite med dajanjem zdravila ali čiščenjem, vključno z rokavicami, morate dati v vreče za odlaganje visoko rizičnih snovi za nadaljnji sežig pri visoki temperaturi.
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Tekoče odpadke lahko odplaknete z velikimi količinami vode. • Ob morebitnem nenamernem stiku s kožo ali očmi nemudoma izperite z veliko vode.
Aseptic technique must be strictly observed throughout handling of Myocet since no preservative is present.
Med rokovanjem z Myocetom se morate strogo držati aseptičnih tehnik, ker zdravilo ne vsebuje konzervansov.
3.1 Preparation of Myocet
3. 1 Priprava Myoceta
Set up Two alternative heating methods can be used: a Techne DB-3 Dri Block heater or a water bath: • Turn on the Techne DB-3 Dri Block heater and set the controller to 75-76°C.
Priprava Lahko uporabite enega od dveh načinov ogrevanja: grelec Techne DB- 3 Dri Block ali vodno kopel: • vključite grelec Techne DB- 3 Dri Block in nastavite temperaturo na 75- 76°C.
Verify the temperature set point by checking the thermometer(s) on each heat block insert. • If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55-60°C).
Na termometrih na vsakem od grelnih blokov preverite nastavitev temperature. • Če uporabljate vodno kopel, jo vključite in pustite, da se temperatura ustali na 58 °C (55- 60 °C).
Remove the carton of Myocet constituents from the refrigerator.
• Vzemite škatli s sestavinami Myoceta iz hladilnika.
29 Step 2.
2. korak:
Reconstitute doxorubicin HCl • Withdraw 20 ml sodium chloride for injection (0.9%), preservative free, (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation. • Shake well in the inverted position to ensure doxorubicin is fully dissolved.
30 • Vzemite 20 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje brez konzervansov (ni na voljo v kompletu) in jo injicirajte v vsako od vial Myocet doksorubicinijevega klorida, namenjeno pripravi. • Dobro pretresite v obrnjenem položaju, da se doksorubicin povsem raztopi.
Heat in water bath or dry heat block • Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75-76°C) for 10 minutes (not to exceed 15 minutes). • If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55-60°C for 10 minutes (not to exceed 15 minutes). • While heating proceed to step 4
Temperatura na termometru naj bo 55- 60 °C. • Med ogrevanjem nadaljujte s 4. korakom.
Adjust pH of liposomes • Withdraw 1.9 ml of Myocet liposomes.
Uravnavanje vrednosti pH liposomov Vzemite 1, 9 ml liposomov Myocet.
Inject into Myocet buffer vial to adjust the pH of liposomes.
Injicirajte v vialo s pufrom Myocet in tako uravnajte pH • vrednost liposomov.
Add pH-adjusted liposomes to doxorubicin • Using a syringe, withdraw the entire vial contents of pH-adjusted liposomes from the Myocet buffer vial. • Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block.
V doksorubicin dodajte liposome z uravnano vrednostjo pH Z brizgo zajemite celotno vsebino liposomov z uravnano vrednostjo pH iz viale s pufrom Myocet. • Vzemite vialo z rekonstituiranim Myocet doksorubicinijevim kloridom iz vodne kopeli ali suhega • grelca.
Then IMMEDIATELY (within 2 minutes) inject pH-adjusted liposomes into vial of heated reconstituted Myocet doxorubicin HCl.
Nato NEMUDOMA (v največ 2 minutah) injicirajte liposome z uravnano vrednostjo pH v vialo z ogretim, rekonstituiranim Myocet doksorubicinijevim kloridom.
The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet.
Grelec Techne DB- 3 Dri Block je v celoti validiran za uporabo pri konstituciji Myoceta.
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/25 ml of concentrate for liposomal dispersion for infusion (2 mg/ml).
Končni rekonstituirani pripravek Myoceta vsebuje 50 mg doksorubicinijevega klorida/ 25 ml koncentrata za liposomsko disperzijo za infundiranje (2 mg/ ml).
After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride for injection, or 5% (w/v) glucose for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet so that a final concentration of 0.4 to 1.2 mg/ml doxorubicin is obtained.
Po rekonstituciji morate končni izdelek dodatno razredčiti v natrijevem kloridu 9 mg/ ml (0, 9%) raztopini za injiciranje ali v glukozi 50 mg/ ml raztopini za injiciranje na končno prostornino 40 ml do 120 ml na 50 mg rekonstituiranega Myoceta, tako da dobite končno koncentracijo 0, 4 do 1, 2 mg/ ml doksorubicina.
Once constituted, the liposomal dispersion for infusion containing liposome encapsulated doxorubicin should be a red orange opaque homogeneous dispersion.
Liposomska disperzija za infundiranje, ki vsebuje doksorubicin, enkapsuliran v liposomih, mora biti po konstituciji rdeče- oranžna neprosojna homogena disperzija.
It has been demonstrated that once reconstituted Myocet has a chemical and physical in-use stability at room temperature for up to 8 hours or in a refrigerator (2-8οC) for up to 5 days.
Dokazano je, da ima Myocet po rekonstituciji kemično in fizikalno stabilnost med uporabo do 8 ur pri sobni temperaturi in do 5 dni v hladilniku (2– 8 °C).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 -8οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Ne shranjujte ga dlje kot 24 ur pri temperaturi med 2 ° in 8 °C, razen če rekonstitucija in redčenje nista bila opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
Myocet should be administered by intravenous infusion over a period of 1 hour.
Infundiranje traja 1 uro.
Myozyme is a powder to be made up into a solution for infusion (drip into a vein).
Zdravilo Myozyme je prašek za pripravo raztopine za infundiranje (dajanje v veno).
Patients with Pompe disease do not have enough of an enzyme called alpha-glucosidase.
Bolniki s to boleznijo nimajo dovolj encima, imenovanega alfa- glukozidaza.
This enzyme normally converts glycogen (a carbohydrate) into glucose.
Ta encim navadno spreminja glikogen (ogljikov hidrat) v glukozo.
If the enzyme is not present, glycogen builds up in certain tissues, particularly the heart and muscle, including the diaphragm (the main breathing muscle under the lungs).
Če encima primanjkuje, se začne glikogen kopičiti v določenih tkivih, zlasti v srcu in mišičnih tkivih ter v trebušni preponi (glavni dihalni mišici pod pljuči).
The progressive build-up of glycogen causes a wide range of signs and symptoms, including an enlarged heart, breathing difficulties and muscle weakness.
Naraščajoče kopičenje glikogena povzroča celo vrsto znakov in simptomov, med drugim povečano srce, težave pri dihanju in oslabelost mišic.
The disease can appear at birth but also later in life.
Bolezen se lahko pojavi že ob rojstvu, pa tudi kasneje v življenju.
For this late-onset form of the disease, the benefits of Myozyme have not been proven.
Pri zakasnjenem pojavu bolezni koristi zdravila Myozyme niso bile dokazane.
Because the number of patients with Pompe disease is low, the disease is considered ‘ rare’, and Myozyme was designated as an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Ker je število bolnikov s Pompejevo boleznijo majhno, velja ta bolezen za redko, zato je bilo zdravilo Myozyme dne 14. februarja 2001 določeno kot zdravilo sirota (zdravilo, ki se uporablja pri redkih boleznih).
Myozyme treatment should be supervised by a doctor who has experience in the management of patients with Pompe disease or other inherited diseases of the same type.
Zdravljenje z zdravilom Myozyme mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s Pompejevo boleznijo ali drugimi dednimi boleznimi istega tipa.
Myozyme is used as an infusion of 20 mg per kilogram body weight given once every two weeks.
Zdravilo Myozyme se daje v obliki infuzije v odmerku 20 mg na kilogram telesne mase enkrat vsaka dva tedna.
The starting infusion rate should be 1 mg/ kg per hour, which should be gradually increased by 2 mg/ kg/ hr every 30 minutes until the maximum rate of 7 mg/ kg/ hr is reached.
Začetna hitrost infundiranja naj bo 1mg/ kg na uro in naj se vsakih 30 minut postopoma zviša za 2 mg/ kg/ uro, dokler ni dosežena najvišja stopnja 7 mg/ kg/ uro.
Myozyme may be given to children, adolescents, adults or elderly patients.
Zdravilo Myozyme se lahko daje otrokom, mladostnikom, odraslim ali starejšim bolnikom.
Enzyme replacement therapy provides patients with the enzyme they are lacking.
Z encimsko nadomestno terapijo zagotavljamo bolnikom encim, ki jim ga primanjkuje.
Myozyme is designed to replace the human enzyme alpha-glucosidase, which is missing in people with Pompe disease.
Zdravilo Myozyme je namenjeno nadomeščanju humanega encima, alfa- glukozidaze, ki ga ljudje s Pompejevo boleznijo nimajo.
The active substance in Myozyme, alglucosidase alfa, is a copy of the human enzyme produced by a method known as ‘ recombinant DNA technology’: the enzyme is made by a cell that has received a gene (DNA) that makes it able to produce the enzyme.
Zdravilna učinkovina zdravila Myozyme, alglukozidaza alfa, je kopija humanega encima, ki jo proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri celica prejme gen (DNK) s katerim lahko tvori gen encim.
The replacement enzyme helps to break down glycogen and stops it building up in the cells.
Nadomestni encim pomaga razgraditi glikogen in tako prepreči njegovo kopičenje v celicah.
Myozyme has been studied in two main studies involving a total of 39 babies and infants with Pompe disease.
Zdravilo Myozyme je bilo raziskano v dveh glavnih študijah, ki sta vključevali skupno 39 dojenčkov in otrok s Pompejevo boleznijo.
These patients were compared with a ‘ historical comparison group ’ of patients with Pompe disease who had not received treatment and did not take part in the studies.
Te bolnike so primerjali s historično primerjalno skupino bolnikov s Pompejevo boleznijo, ki niso bili zdravljeni in niso sodelovali v študijah.
The main measures of effectiveness were the number of patients who survived and the number who did not need a ventilator.
Glavni merili učinkovitosti sta bili število bolnikov, ki so preživeli in število bolnikov, ki niso potrebovali predihavanja.
Additional studies looked at the effect of Myozyme in 15 patients with late-onset disease.
Dodatne študije so proučevale učinek zdravila Myozyme pri 15 bolnikih z zakasnjenim pojavom bolezni.
In the first main study, which involved babies less than six months old, all 18 patients treated with Myozyme were alive at 18 months of age, and 15 of these did not need ventilation.
V prvi glavni študiji z dojenčki, mlajšimi od šest mesecev, je bilo pri 18 mesecih starosti živih vseh 18 bolnikov, zdravljenih z zdravilom Myozyme, 15 od teh pa ni potrebovalo predihavanja.
In contrast, only one of the 42 patients in the historical comparison group was alive at 18 months of age.
Nasprotno pa je v historični primerjalni skupini pri starosti 18 mesecev ostal živ le eden od 42 bolnikov.
The results were confirmed in the other study, which involved children aged between six months and three and a half years.
Ti rezultati so bili potrjeni še z drugo študijo, ki je vključevala otroke, stare od 6 mesecev do treh let in pol.
In late-onset disease, the effect of Myozyme was variable and more difficult to measure.
Pri bolnikih z zakasnjenim pojavom bolezni je bil učinek zdravila Myozyme raznolik in težje izmerljiv.
The studies could not prove a clear benefit in this type of the disease.
Študije niso mogle jasno dokazati koristi zdravila za to vrsto bolezni.
During the studies, the most common side effects with Myozyme (seen in more than 1 patient in 10) were tachycardia (rapid heart rate), flushing (redness), cough, tachypnoea (rapid breathing rate), vomiting, urticaria (hives), rash, pyrexia (fever) and decreased oxygen saturation (low oxygen levels in the blood).
Najpogostejši neželeni učinki zdravila Myozyme med študijami (opaženi pri več kot 1 bolniku od 10) so bili tahikardija (pospešen srčni utrip), zardevanje, kašelj, tahipneja (pospešeno dihanje), bruhanje, urtikarija (srbeč izpuščaj), izpuščaji, pireksija (povišana telesna temperatura) in zmanjšana nasičenost s kisikom (nizke ravni kisika v krvi).
Almost all of these occurred during or just after the infusion.
Skoraj vsi ti učinki so se pojavili med infundiranjem ali tik po njem.
For the full list of all side effects reported with Myozyme, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri zdravilu Myozyme, glejte navodilo za uporabo.
Patients who receive Myozyme may develop antibodies (proteins that are produced in response to Myozyme).
Bolniki, ki prejemajo zdravilo Myozyme, lahko razvijejo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Myozyme).
The effect of these antibodies on the safety and effectiveness of Myozyme is not yet clear.
Učinek teh protiteles na varnost in učinkovitost zdravila Myozyme še ni jasen.
Myozyme should not be used in people who may be hypersensitive (allergic) to alglucosidase alfa or any of the other ingredients.
Zdravila Myozyme ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) alglukozidazo alfa ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Myozyme’ s benefits are greater than its risks for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Pompe disease (acid alpha-glucosidase deficiency).
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Myozyme pri dolgoročni encimski nadomestni terapiji pri bolnikih s potrjeno diagnozo Pompejeve bolezni (pomanjkanje kisline alfa- glukozidaze) večje od z njim povezanih tveganj.
The Committee recommended that Myozyme be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Myozyme odobri dovoljenje za promet.
What information is still awaited for Myozyme?
Katere informacije o zdravilu Myozyme še pričakujemo?
The company will continue to study the effect of Myozyme in late-onset patients.
Družba bo še nadalje raziskovala učinek zdravila pri bolnikih z zakasnjenim pojavom bolezni.
Which measures are being taken to ensure the safe use of Myozyme?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Myozyme?
The company that makes Myozyme is putting a plan in place to ensure that Myozyme is used safely, mainly by monitoring how patients who receive Myozyme develop antibodies, by setting up a register for all Pompe disease sufferers, and by ensuring that doctors know about the reactions that patients may have to the infusion.
Družba, ki izdeluje zdravilo Myozyme, vzpostavlja načrt za zagotavljanje varne uporabe zdravila Myozyme, ki v glavnem obsega spremljanje, kako se pri bolnikih, ki prejemajo Myozyme, razvijejo protitelesa, vodenje evidence vseh bolnikov, ki trpijo za Pompejevo boleznijo, ter zagotavljanje, da so zdravniki seznanjeni z vsemi reakcijami, ki jih bolniki utegnejo imeti na infundiranje.
Other information about Myozyme:
Druge informacije o zdravilu Myozyme:
The European Commission granted a marketing authorisation valid throughout the European Union for Myozyme to Genzyme Europe B. V. on 29 March 2006.
Evropska komisija je dovoljenje za promet z zdravilom Myozyme, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B. V. dne 29. marca. 2006.
The record of Myozyme’ s designation as an orphan medicine can be found here.
Zapis o določitvi zdravila Myozyme kot zdravila sirote je na voljo tukaj.
The full EPAR for Myozyme can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Myozyme je na voljo tukaj.
Route of EU number
< Izmišljeno ime < Številka postopka EMEA >
Invented name
< vsebina
administration
velikost pakiranja
Packaging
< Številka EU >
Content
< ime >
Package size
(koncentracija) >
Powder for concentrate for solution for infusion
Prašek za koncentrat Intravenska za raztopino za uporaba infundiranje
Myozyme 50 mg, powder for concentrate for solution for infusion.
Myozyme 50 mg prašek za koncentrat za raztopino za infundiranje
After reconstitution, the solution contains 5 mg of alglucosidase alfa/ ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ ml.
Po rekonstituciji raztopina vsebuje 5 mg alglukozidaze alfa/ ml in po redčenju koncentracija niha od 0, 5 mg do 4 mg/ ml.
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α -glucosidase deficiency).
Myozyme je namenjen dolgoročni encimski nadomestni terapiji (enzyme replacement therapy, ERT) pri bolnikih s potrjeno diagnozo Pompejeve bolezni (pomanjkanje α- glukozidaze).
The benefits of Myozyme in patients with late-onset Pompe disease have not been established (see section 5.1).
Koristi Myozyme pri bolnikih s poznim nastopom Pompejeve bolezni niso ugotovljene (glejte poglavje 5. 1).
The recommended dosage regimen of alglucosidase alfa is 20 mg/ kg of body weight administered once every 2 weeks as an intravenous infusion.
Priporočen odmerek zdravila alglukozidaze alfa je 20 mg/ kg telesne mase in ga dajemo enkrat na dva tedna v obliki intravenske infuzije.
It is recommended that the infusion begin at an initial rate of 1 mg/ kg/ hr and be gradually increased by 2 mg/ kg/ hr every 30 minutes if there are no signs of infusion associated reactions (IARs) until a maximum rate of 7 mg/ kg/ hr is reached.
Postopno jo povečujemo za 2 mg/ kg/ uro vsakih 30 minut, če ni prisotnih reakcij, povezanih z infuzijo (infusion associated reactions, IARs), dokler ni dosežena najvišja stopnja 7 mg/ kg/ uro.
IARs are described in section 4.8.
IARs so opisani v poglavju 4. 8.
Posology for children, adolescents, adults and elderly:
Odmerjanje pri otrocih, mladostnikih, odraslih in starejših:
The safety and efficacy of Myozyme have been primarily evaluated in children with ages ranging from infancy to adolescence.
Varnost in učinkovitost zdravila Myozyme sta bila prvotno ovrednotena pri otrocih od dojenčka do mladostnika.
There is no evidence for special considerations when Myozyme is administered to children, adolescents, adults or elderly patients.
Ni dokazov, da bi bila pri uporabi zdravila Myozyme pri mladostnikih, odraslih ali starejših bolnikih potrebna posebna pazljivost.