natgillin/translations-raw huggingface dataset:
Pregnancy and breast-feeding:
Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
25 Ask your doctor or pharmacist for advice before taking any medicine.
25 Svojega zdravnika morate opozoriti, če ste noseči oziroma nameravate zanositi.
Important information about some of the ingredients of Aldara cream:
Pomembne informacije o nekaterih sestavinah kreme Aldara:
Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216) lahko povzročita alergijske reakcije (možno zakasnjene).
Cetyl and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Cetilalkohol in stearilalkohol lahko povzročita lokalne kožne reakcije (npr. kontaktni dermatitis).
HOW TO USE ALDARA CREAM
KAKO UPORABLJATI KREMO ALDARA
Always use Aldara cream exactly as your doctor has told you.
Pri uporabi kreme Aldara natančno upoštevajte zdravnikova navodila.
•
● Če se zdravite zaradi genitalnih bradavic:
If you are being treated for genital warts:
• Če se zdravite zaradi genitalnih bradavic
Application Instructions – (Mon, Wed and Fri) 1.
Navodila za nanos (ponedeljek, sreda in petek) 1.
Dry thoroughly.
Roke in mesto zdravljenja temeljito posušite.
Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
Kremo nežno vtirajte v kožo dokler ne izgine.
3 square inches).
Količina kreme v eni vrečki zadostuje za prekritje 20 cm2 področja z bradavicami.
26 Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 “Take special care with Aldara cream:”)
Moški z bradavicami pod kožico penisa morajo vsak dan kožico potegniti nazaj in kožo pod njo umiti (glejte poglavje 2. “ Bodite posebno pozorni pri uporabi kreme Aldara: ”).
Continue to use Aldara cream as instructed until your warts have completely gone (half the females who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients warts may clear as early as 4 weeks).
Vendar pa lahko bradavice izginejo že po 4 tednih.
• If you are being treated for basal cell carcinoma:
• Če se zdravite zaradi karcinoma bazalnih celic:
Application Instructions – (Mon, Tues, Wed, Thurs and Fri) 1.
Navodila za nanos (ponedeljek, torek, sreda, četrtek in petek) 1.
0.5 inch) around the affected area.
Nanesite tanek sloj kreme Aldara na prizadeto področje in 1 cm okoli prizadetega področja.
Wash hands with soap and water.
Po nanosu kreme zavrzite odprto vrečko in si umijte roke z milom in vodo.
• If you are being treated for actinic keratosis
• Če se zdravite zaradi aktinične keratoze
If you use more Aldara cream than you should:
Če ste uporabili večji odmerek kreme Aldara, kot bi smeli:
If you forget to use Aldara cream:
Če ste pozabili nanesti kremo Aldara:
27 If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
The frequency of side effects is classified as follows:
Kot vsa zdravila ima lahko tudi krema Aldara neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects (likely to occur in more than 1 in 10 patients) Common side effects (likely to occur in fewer than 1 in 10 patients) Uncommon side effects (likely to occur in fewer than 1 in 100 patients) Rare side effects (likely to occur in fewer than 1 in 1,000 patients) Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).
Zelo pogosti neželeni učinki (pojavi se pri več kot 1 na 10 bolnikov) Pogosti neželeni učinki (pojavi se pri manj kot 1 na 10 bolnikov) Občasni neželeni učinki (pojavi se pri manj kot 1 na 100 bolnikov) Redki neželeni učinki (pojavi se pri manj kot 1 na 1000 bolnikov) Zelo redki neželeni učinki (pojavi se pri manj kot 1 na 10000 bolnikov
If any of the side effects gets serious, or if you notice any side effects not mentioned 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.
● If you are being treated for genital warts:
● Če se zdravite zaradi genitalnih bradavic:
Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Pogosto se je pri nekaterih bolnikih (4% ali manj) pojavil glavobol, občasno zvišana telesna temperatura in gripi podobni simptomi in bolečine v mišicah in sklepih; prolaps maternice; bolečine ob spolnem odnosu pri ženskah; motnje erekcije; povečano potenje; slabost; simptomi v želodcu in trebuhu; zvonjenje v ušesih; rdečica; utrujenost; omotica; migrena; mravljinčenje; nespečnost; depresija; pomanjkanje apetita; otekle žleze, bakterijske, virusne in glivične okužbe (npr. herpesna okužba v ustih); okužbe v nožnici vključno s kandidazo; kašelj in prehlad z vnetim žrelom.
28 Many of the undesirable effects of Aldara cream are due to its local action on your skin.
28 Večina neželenih učinkov kreme Aldara izvira iz njenega lokalnega delovanja na kožo.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.
Občasni neželeni učinki so se pri nekaterih bolnikih pojavile spremembe na mestu nanosa (izcedek, vnetje, oteklina, razvoj krast, razpokanje kože, mehurčki, dermatitis) ali draženje, občutek slabosti, izsušena usta, gripi podobni simptomi in utrujenost.
● If you are being treated for actinic keratosis
● Če se zdravite zaradi aktinične keratoze:
Very commonly the treated skin may be slightly itchy.
Zelo pogosto lahko zdravljena koža rahlo srbi.
Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.
Občasni neželeni učinki so se pri nekaterih bolnikih pojavile spremembe na mestu nanosa (krvavitev, vnetje, izcedek, občutljivost, oteklina, majhne otekline v koži, mravljinčenje, tvorba krast, zabrazgotinjenje, razjeda ali občutek toplote ali neugodja) ali vnetje sluznice nosu, zamašen nos, gripa in gripi podobni simptomi, depresija, draženje oči, oteklina očesne veke, bolečine v žrelu, driska, aktinična keratoza, rdečina, otekanje obraza, razjede, bolečine v udih, zvišana telesna temperatura, občutek slabosti in drgetanje.
HOW TO STORE ALDARA CREAM
SHRANJEVANJE KREME ALDARA
Sachets should not be re -used once opened.
Ko je vrečka enkrat odprta, je ne smete ponovno uporabiti.
Ask your pharmacist to dispose of medicines no longer required.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
What Aldara cream contains:
Kaj vsebuje kreme Aldara:
Each sachet contains 250 mg cream (100 mg cream contains
Vsaka vrečka vsebuje 250 mg kreme (100 mg kreme vsebuje 5
5 mg imiquimod).
mg imikvimoda).
- The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft
- Pomožne snovi so izostearinska kislina, benzilalkohol, cetilalkohol, stearilalkohol, beli vazelin,
paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.
polisorbat 60, sorbitan stearat, glicerol, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), ksantanski gumi, prečiščena voda.
What Aldara cream looks like and contents of the pack:
Izgled kreme Aldara in vsebina pakiranja:
- Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.
- Vrečka Aldara 5% kreme vsebuje 250 mg bele do rahlo rumene kreme.
- Each box contains 12 single-use polyester/aluminium foil sachets.
- V škatlici je 12 vrečk za enkratno uporabo iz poliesterske/ aluminijske folije.
MARKETING AUTHORISATION HOLDER:
Imetnik dovoljenja za promet z zdravilom:
Meda AB Box 906 170 09 Solna Sweden
Meda AB Box 906 170 09 Solna Švedska Izdelovalec:
3M Health Care Limited Derby Road Loughborough Leicestershire LE11 5SF, United Kingdom
3M Health Care Limited Derby Road Loughborough Leicestershire LE11 5SF, Velika Britanija
KG Benzstraße 1
KG Benzstraße 1 61352 Bad Homburg Tel: +49 (0) 6172 888 01
Norge Meda A/S Askerveien 61
Norge Meda A/ S Askerveien 61 1384 Asker Tlf: +47 66 75 33 00
30
30 Eesti Österreich MediNet International Ltd.
Rua do Centro Cultural, 13 1749-066 Lisboa Tel: +351 21 842 0300
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100G, sector 6 Bucureşti Tel.: + 40 (0) 21 408 63 34
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United Kingdom Meda Pharmaceuticals Ltd.
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Lietuva MediNet International Ltd.
This leaflet was last approved in (MM/YYYY)
Navodilo je bilo odobreno
Aldurazyme is a solution for infusion (drip into a vein).
Zdravilo Aldurazyme je raztopina za infundiranje (kapalno infuzijo v veno).
It contains the active substance laronidase.
Vsebuje zdravilno učinkovino laronidazo.
Aldurazyme is used for enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; α -L-iduronidase deficiency) to treat the non-neurological symptoms of the disease (not connected with the brain or nerves).
Zdravilo Aldurazyme se uporablja za terapijo z nadomestnimi encimi pri bolnikih s potrjeno diagnozo mukopolisaharidoze tipa I (MPS I; pomanjkanje α- L- iduronidaze), in sicer za zdravljenje nenevroloških znakov bolezni (ki niso povezani z možgani ali živčnim sistemom).
MPS I is a rare, inherited disease, where the level of α -L-iduronidase enzyme activity is much lower than normal.
Mukopolisaharidoza tipa I je redka dedna bolezen, pri kateri je stopnja aktivnosti encima α- L- iduronidaze mnogo nižja od normalne.
This means that certain substances (glycosaminoglycans, GAGs) are not broken down, so they build up in most of the organs in the body and damage them.
To pomeni, da se nekatere snovi (glikozaminoglikani) ne razgradijo, ampak se kopičijo v večini telesnih organov, kjer povzročajo škodo.
The non-neurological symptoms of MPS I can be an enlarged liver, stiff joints which make moving more difficult, less lung volume, heart disease and eye disease.
Nenevrološki znaki mukopolisaharidoze tipa I so lahko povečanje jeter, togost sklepov, kar otežuje gibanje, manjši volumen pljuč, srčne bolezni in očesna obolenja.
Because the number of patients with MPS I is low, the disease is considered ‘ rare’, and Aldurazyme was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Ker je število bolnikov z mukopolisaharidozo tipa I majhno, velja ta bolezen za redko, zato je bilo zdravilo Aldurazyme dne 14. februarja 2001 določeno kot „ zdravilo sirota “ (zdravilo za redke bolezni).
Aldurazyme treatment should be supervised by a doctor experienced in the management of patients with MPS I or other inherited metabolic diseases.
Terapijo z zdravilom Aldurazyme mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z mukopolisaharidozo tipa I ali drugimi dednimi presnovnimi boleznimi.
Administration of Aldurazyme should be carried out in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction.
Pred infuzijo bo morda treba bolnikom dati določena zdravila za preprečevanje alergijske reakcije.
Aldurazyme is given once every week as an intravenous infusion.
Zdravilo Aldurazyme se daje enkrat tedensko v obliki intravenske infuzije.
Aldurazyme is designed for long-term use.
Aldurazyme je namenjen dolgoročni uporabi.
It is produced by a method known as ‘ recombinant DNA technology’: the enzyme is made by a cell which has received a gene (DNA) that makes it able to produce the enzyme.
Zdravilna učinkovina zdravila Aldurazyme, laronidaza, je kopija človeškega encima α- L- iduronidaze, ki jo izdelujejo po metodi, imenovani „ tehnologija rekombinantne DNA “: encim izdela celica, ki je prejela ustrezni gen (DNA) za tvorbo encima.
Laronidase replaces the enzyme missing in patients with MPS I.
Laronidaza nadomesti manjkajoči encim pri bolnikih z mukopolisaharidozo tipa I.
By supplying the missing enzyme, the symptoms of MPS I are controlled and this improves the patient ’ s quality of life.
Z nadomestitvijo manjkajočega encima se vzpostavi nadzor nad mukopolisaharidozo tipa I, kar izboljša kakovost bolnikovega življenja.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Aldurazyme been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Aldurazyme raziskano?
Aldurazyme has been studied in 45 patients aged five years and over with a confirmed diagnosis of MPS I.
Zdravilo Aldurazyme so preučevali pri 45 bolnikih, starih pet let in več, s potrjeno diagnozo mukopolisaharidoze tipa I.
The study compared the effect of Aldurazyme to that of placebo (a dummy treatment).
V študiji so primerjali učinek zdravila Aldurazyme s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness was the lung function (forced vital capacity, FVC) and the distance the patients could walk over six minutes before and after 26 weeks of treatment, but the study continued for up to four years.
Glavni merili učinkovitosti sta bili delovanje pljuč (forsirana vitalna kapaciteta – FVC) ter razdalja, ki so jo bolniki bili zmožni prehoditi v šestih minutah pred in po 26 tednih zdravljenja, pri čemer je študija trajala do štiri leta.
Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year.
Zdravilo Aldurazyme so preučevali tudi pri 20 otrocih, starih manj kot pet let, ki so zdravilo Aldurazyme prejemali leto dni.
The study was looking mainly at the safety of the medicine, but it also measured its effectiveness (looking at its effect on reducing levels of GAGs in the urine and on the size of the liver).
V študiji so v glavnem preučevali varnost zdravila, merili pa so tudi njegovo učinkovitost (njegov učinek na zmanjševanje ravni glikozaminoglikanov v urinu in na velikost jeter).
What benefit has Aldurazyme shown during the studies?
Kakšne koristi je zdravilo Aldurazyme izkazalo med raziskavami?
The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks.
Študija je pokazala, da je zdravilo Aldurazyme po 26 tednih izboljšalo forsirano vitalno kapaciteto pljuč in zmožnost hoje bolnikov.
This effect was maintained for up to four years.
Ta učinek zdravila se je obdržal do štiri leta.
In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60% and half of the children treated had a liver of a normal size at the end of the study.
Pri otrocih, starih manj kot pet let, je zdravilo Aldurazyme znižalo ravni glikozaminoglikanov v urinu za okoli 60% in polovica zdravljenih otrok je na koncu študije imela normalno velikost jeter.
Most of the side effects seen with Aldurazyme are reactions caused by the infusion rather than the medicine itself.
Večina neželenih učinkov, opaženih pri jemanju zdravila Aldurazyme, so reakcije, ki so bolj posledica infuzije kot zdravila samega.
These are generally mild to moderate in intensity and decrease with time.
Neželeni učinki so na splošno blagi do zmerni v intenzivnosti in sčasoma izzvenijo.
The most common side effects with Aldurazyme in patients over the age of five (seen in more than 1 patient in 10) are headache, nausea (feeling sick), abdominal (tummy) pain, rash, arthropathy (damage to the joints), arthralgia (joint pain), back pain, pain in the extremities (hands and feet), flushing, pyrexia (fever) and reactions at the site of the infusion.
Najpogostejši neželeni učinki zdravila Aldurazyme pri bolnikih, starih več kot pet let (opaženi pri več kot 1 bolniku od 10), so glavobol, navzeja (občutek slabosti), bolečina v trebuhu, izpuščaji, artropatija (poškodba sklepov), artralgija (bolečine v sklepih), bolečine v hrbtu, bolečine v okončinah (v rokah in nogah), rdečica, pireksija (povišana telesna temperatura) in reakcije na mestu infundiranja.
In patients under five years of age, the very common side effects are increased blood pressure, decreased oxygen saturation (a measure of lung function), tachycardia (fast heart rate), pyrexia and chills.
Pri bolnikih, starih manj kot pet let, so zelo pogosti neželeni učinki povišan krvni tlak, zmanjšana saturacija kisika (merilo delovanja pljuč), tahikardija (hiter srčni utrip), pireksija in mrzlica.
For the full list of all side effects reported with Aldurazyme, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aldurazyme, glejte Navodilo za uporabo.
Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme).
Skoraj vsi bolniki, ki prejemajo zdravilo Aldurazyme, razvijejo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Aldurazyme.
The effect of these on the safety and effectiveness of the medicine is not fully known.
Učinek teh protiteles na varnost in učinkovitost zdravila še ni v celoti znan.
Aldurazyme should not be used in people who may have a severe allergic reaction (anaphylactic reaction) to laronidase or any of the other ingredients.
Zdravila Aldurazyme se ne sme uporabljati pri osebah, ki utegnejo imeti hudo alergično reakcijo (anafilaktična reakcija) na laronidazo ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aldurazyme gives effective control of the symptoms of MPS I.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da zdravilo Aldurazyme zagotavlja učinkovit nadzor simptomov mukopolisaharidoze tipa I.
The Committee decided that Aldurazyme’ s benefits are greater than its risks for long-term enzyme replacement therapy in patients with a confirmed diagnosis of MPS I.
Odbor je menil, da so koristi zdravila Aldurazyme pri dolgoročni terapiji z nadomestnimi encimi pri bolnikih s potrjeno diagnozo mukopolisaharidoze tipa I večje od z njim povezanih tveganj.
The Committee recommended that Aldurazyme be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Aldurazyme odobri dovoljenje za promet.
Aldurazyme has been authorised under ‘ Exceptional Circumstances’.
Dovoljenje za promet z zdravilom Aldurazyme je bilo podeljeno v „ izjemnih okoliščinah “.
This means that, because the disease is rare, it has not been possible to obtain complete information about Aldurazyme.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu Aldurazyme.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Vsako leto bo Evropska agencija za zdravila (EMEA) pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
What information is still awaited for Aldurazyme?
Katere informacije o zdravilu Aldurazyme še pričakujemo?
The company that makes Aldurazyme will monitor patients receiving Aldurazyme, looking at reactions to the infusion and the development of antibodies.
Podjetje, ki izdeluje zdravilo Aldurazyme, bo spremljalo bolnike, ki prejemajo zdravilo Aldurazyme, in beležilo reakcije na infundiranje ter razvoj protiteles.
Other information about Aldurazyme:
Druge informacije o zdravilu Aldurazyme:
The European Commission granted a marketing authorisation valid throughout the European Union for Aldurazyme to Genzyme Europe B. V. on 10 June 2003.
Evropska komisija je dovoljenje za promet z zdravilom Aldurazyme, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B. V. dne 10. junija 2003.
The record of Aldurazyme’ s designation as an orphan medicine is available here The full EPAR for Aldurazyme can be found here.
Zapis o določitvi zdravila Aldurazyme kot zdravila sirote je na voljo tukaj Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aldurazyme je na voljo tukaj.
This summary was last updated in 12-2007.
Povzetek je bil nazadnje posodobljen 12- 2007.
Route of administration
pot uporabe
Content (concentration)
vsebina (koncentracija)
Concentrate for solution for infusion
koncentrat za pripravo raztopine za infundiranje
Aldurazyme 100 U/ ml concentrate for solution for infusion
Aldurazyme, 100 e/ ml koncentrat za raztopino za infundiranje.
1 ml contains 100 U (approximately 0.58 mg) of laronidase.
1 ml vsebuje 100 e (približno 0, 58 mg) laronidaze.
The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute.
Enota aktivnosti (e) je opredeljena kot hidroliza enega mikromola substrata (4- MUI) na minuto.
Laronidase is a recombinant form of human α -L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Laronidaza je rekombinantna oblika človeške α- L- iduronidaze in se proizvaja s tehnologijo rekombinacije DNA z uporabo ovarijske celične kulture kitajskih hrčkov.
Each vial of 5 ml contains 1.29 mmol sodium.
Vsaka 5 ml viala vsebuje 1, 29 mmol natrija.
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 non- neurological manifestations of the disease (see section 5.1).
Zdravilo Aldurazyme je namenjeno dolgoročni terapiji z nadomestnimi encimi pri bolnikih s potrjeno diagnozo mukopolisaharidoze tipa I (MPS I; pomanjkanje α- L- iduronidaze), in sicer za zdravljenje nenevroloških znakov bolezni (glejte poglavje 5. 1).
Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases.
Terapijo z zdravilom Aldurazyme mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z mukopolisaharidozo tipa I ali drugimi dednimi boleznimi presnove.
The recommended dosage regimen of Aldurazyme is 100 U/ kg body weight administered once every week as an intravenous infusion.
Priporočeni režim odmerjanja je pri zdravilu Aldurazyme enkrat tedensko z odmerkom 100 e/ kg telesne mase v obliki intravenske infuzije.
The initial infusion rate of 2 U/ kg/ h may be incrementally increased every fifteen minutes, if tolerated, to a maximum of 43 U/ kg/ h.
Začetno hitrost infuzije 2 e/ kg/ h lahko postopoma povečujete vsakih petnajst minut, če bolnik to dobro prenaša, do največje hitrosti 43 e/ kg/ h.
The total volume of the administration should be delivered in approximately 3-4 hours.
Bolnik mora prejeti celoten odmerek zdravila v približno 3 do 4 urah.
For information on pre-treatment, see section 4.4 and for further instructions, see section 6.6.
Informacije glede predhodnega zdravljenja so v poglavju 4. 4; za nadaljnja navodila glejte poglavje 6. 6.