natgillin/translations-raw huggingface dataset:
Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 4 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year. 
Nasprotno pa se je izkazalo, da je od bolnikov, ki jim po 12 tednih zdravljenja ni uspelo izgubiti 5 % izhodiščne telesne mase, po enem letu zdravljenja uspelo izgubiti 10 % ali več izhodiščne telesne mase le 5 % bolnikom, ki so jemali orlistat in 4 % bolnikom, ki so jemali placebo.
NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules Orlistat 
IME ZDRAVILA Xenical 120 mg trde kapsule Orlistat
Of these, 49 % of orlistat treated patients and 40 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year. 
Od tega je 49 % bolnikov, ki so jemali orlistat in 40 % bolnikov, ki so jemali placebo, po enem letu zdravljenja izgubilo 10 % ali več izhodiščne telesne mase.
If a meal is missed or contains no fat, the dose of orlistat should be omitted. 
Če obrok ne vsebuje maščob, ali ga bolnik izpusti,
Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat. 
Med zdravljenjem z zdravilom Xenical morate uživati uravnovešeno hrano z veliko sadja in zelenjave ter nadzorovati vnos kalorij.
• If you get any of the side effects, talk to your doctor or pharmacist. 
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four oneyear clinical trials showed that the percentage of responders (≥ 10 % of body weight loss) was 11.3 % with orlistat as compared to 4.5 % with placebo. 
V štirih enoletnih študijah bolnikov s preveliko telesno maso, ki so imeli z antiadiabetiki neustrezno zdravljeno sladkorno bolezen tipa II, je v skupini, zdravljeni z orlistatom, znašala odzivnost 11,3 % (opredeljena kot zmanjšanje telesne mase za 10 % ali več) v primerjavi s 4,5 % pri placebu.
The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell. 
Poročali so tudi o naslednjih neželenih učinkih, vendar iz razpoložljivih podatkov ni mogoče določiti njihove pogostnosti: Alergijske reakcije, katerih glavni simptomi so srbenje, izpuščaj, mehurji (rahlo privzdignjeni srbeči kožni predeli, ki so bolj bledi ali bolj rdeči kot preostala koža), hude težave pri dihanju, slabost, bruhanje in slabo počutje.
Xenical is a medicine used to treat obesity. 
Kaj je zdravilo Xenical in za kaj ga uporabljamo Zdravilo Xenical je namenjeno zdravljenju debelosti.
Marketing Authorisation Holder CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24 
IMETNIK DOVOLJENJA ZA PROMET CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24
- Cholestasis. 
- holestaza, - dojenje.
Glass bottles 
Stekleničke
When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4). 
Pri sočasnem jemanju varfarina ali drugih antikoagulantov in orlistata moramo nadzorovati vrednosti
Fat soluble vitamins 
Vitamini, topni v maščobi
Common: Urinary tract infection 
Pogosti: okužba sečil
- Hypersensitivity to the active substance or to any of the excipients. 
- Znana preobčutljivost na zdravilno učinkovino ali katero koli sestavino zdravila, - kronični malabsorpcijski sindrom,
Contents of the pack and other information 
5 Shranjevanje zdravila Xenical Vsebina pakiranja in dodatne informacije
Blisters: Do not store above 25 °C. 
Pretisni omoti: shranjujte pri temperaturi do 25 °C.
Xenical 120mg hard capsules Orlistat 
IME ZDRAVILA Xenical 120 mg trde kapsule orlistat
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 
NAVODILO ZA UPORABO Xenical 120 mg trde kapsule orlistat Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
How to store XENICAL 
Shranjevanje zdravila Xenical
Pregnancy and breast-feeding 
Presnovne in prehranske motnje
Your doctor may suggest you take a multivitamin supplement. 
Včasih zdravnik med zdravljenjem predpiše multivitaminski pripravek.
Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy. 
Če se telesna masa bolnika po 12 tednih ne zmanjša vsaj za 5 % izhodiščne telesne mase, je treba zdravljenje z orlistatom ukiniti.
Effects on clotting with anti-coagulants. 
Učinki na strjevanje krvi med zdravljenjem z zdravili, ki zavirajo strjevanje krvi.
Always take Xenical exactly as your doctor has told you. 
Pri jemanju zdravila Xenical natančno upoštevajte zdravnikova navodila.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 120 mg orlistat. 
Ena trda kapsula vsebuje 120 mg orlistata.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5). 
Ker je med hudo drisko lahko peroralna kontracepcija neučinkovita, je v tem primeru priporočljiva uporaba dodatne metode kontracepcije (glejte poglavje 4.5).
- Chronic malabsorption syndrome. 
uporabimo multivitaminske pripravke.
Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37 % of orlistat patients and 19 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment. 
Združeni rezultati petih 2 leti trajajočih študij orlistata in hipokalorične diete so pokazali, da je 37 %
Do not take XENICAL 
naj orlistata ne vzame.
In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption. 
njegove koncentracije pa skrajno nizke (< 10 ng/ml ali 0,02 µmol).
Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 2 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year. 
5 % izhodiščne telesne mase, po enem letu zdravljenja uspelo izgubiti 10 % ali več izhodiščne telesne mase le 5 % bolnikom, ki so jemali orlistat in 2 % bolnikom, ki so jemali placebo.
OUTER CARTON AND BOTTLE LABEL 
PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI ZUNANJA OVOJNINA IN NALEPKA NA STEKLENIČKI
Prescribers should investigate further in case of severe and/or persistent symptoms. 
Če so simptomi hudi ali dolgotrajni ali oboje, naj zdravniki raziščejo njihov vzrok.
8 August 2012 
8. avgust 2012
The European Commission issued a decision on 8 August 2012. 
Evropska komisija je odločbo izdala dne 8. avgusta 2012.
Flolan is marketed in the following EU Member States: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, the Netherlands, Spain, United Kingdom, as well as Norway. 
Zdravilo Flolan se trži v naslednjih državah članicah EU: v Avstriji, Belgiji, na Češkem, Danskem, v Estoniji, Franciji, na Irskem, v Italiji, Luksemburgu, na Malti, Nizozemskem, v Španiji, Združenem kraljestvu in na Norveškem.
Why was Flolan reviewed? 
Zakaj je bilo zdravilo Flolan pregledano?
Flolan is authorised in the EU via national procedures. 
Zdravilo Flolan je bilo odobreno v EU z nacionalnimi postopki.
It is also available under the trade name Epoprostenol. 
Na voljo je tudi pod tržnim imenom Epoprostenol.
• haemodialysis in emergency situations when the use of heparin carries a high risk of causing or exacerbating bleeding, or when heparin is otherwise contraindicated. 
• hemodializo v nujnih primerih, kadar uporaba heparina pomeni veliko tveganje za povzročitev ali poslabšanje krvavitve ali kadar je heparin kako drugače kontraindiciran.
What is Flolan? 
Kaj je zdravilo Flolan?
On 24 May 2012, the European Medicines Agency completed a review of Flolan. 
Evropska agencija za zdravila je 24. maja 2012 končala pregled zdravila Flolan.
The company that markets these medicines is GlaxoSmithKline. 
Ti zdravili trži družba GlaxoSmithKline.
Flolan is a medicine that contains the active substance epoprostenol. 
Flolan je zdravilo, ki vsebuje zdravilno učinkovino epoprostenol.
On 15 June 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Flolan in the EU. 
Evropska komisija je 15. junija 2011 zadevo napotila na odbor CHMP, ki naj bi uskladil dovoljenja za promet z zdravilom Flolan v EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Flolan in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti informacije o predpisovanju zdravila Flolan v Evropski uniji (EU).
The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation), 4.5 (Interaction with Other Medicinal Products and Other Forms of Interaction) and 4.8 (side effects). 
Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), 4.6 (Nosečnost in dojenje) in 4.8 (Neželeni učinki).
The CHMP was of the view that patients with pulmonary veno-occlusive disease could benefit from treatment with Flolan and that for hypotension and angina it was more appropriate to include relevant warnings in section 4.4. 
Menil je, da bi lahko bolniki s pljučno venookluzivno boleznijo imeli koristi od zdravljenja z zdravilom Flolan ter da je v zvezi s hipotenzijo in angino pektoris ustrezneje vključiti zadevna opozorila v poglavje 4.4.
Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Flolan in the elderly and patients with reduced kidney and liver function. 
Odbor CHMP je po uskladitvi indikacij uskladil tudi priporočila v zvezi z uporabo zdravila Flolan pri starejših in bolnikih z zmanjšanim delovanjem ledvic in jeter.
After reviewing the available data supporting the use of the medicine, the CHMP agreed that Flolan should be used for the following: 
Odbor CHMP se je po proučitvi razpoložljivih podatkov, ki podpirajo uporabo zdravila, strinjal, da se zdravilo Flolan uporablja za:
Epoprostenol also widens the blood vessels which helps to lower the blood pressure in the lungs. 
Poleg tega razširi krvne žile, kar pripomore k znižanju krvnega tlaka v pljučih.
In harmonising the contraindications, the CHMP decided to remove three contraindications that were in the SmPCs of some EU countries: pulmonary veno-occlusive disease, hypotension and angina. 
Odbor CHMP se je med usklajevanjem kontraindikacij odločil, da izloči tri kontraindikacije, ki so bile navedene v povzetkih glavnih značilnosti zdravila v nekaterih državah EU: pljučno venookluzivno bolezen, hipotenzijo in angino pektoris.
It is used to prevent blood clotting during haemodialysis (technique for removing waste products from the blood used in patients with kidney disease). 
Uporablja se za preprečevanje strjevanja krvi med hemodializo (tehniko odstranjevanja presnovkov in strupov iz krvi pri bolnikih z ledvičnim obolenjem).
The active substance in Flolan, epoprostenol, is a natural occurring prostaglandin that works by stopping the blood from clotting. 
Zdravilna učinkovina v zdravilu Flolan, epoprostenol, je naravno prisoten prostaglandin, ki preprečuje strjevanje krvi.
Flolan is also used to treat a lung condition called ‘pulmonary arterial hypertension' (high blood pressure in the lungs). 
Uporablja se tudi za zdravljenje pljučne bolezni, imenovane pljučna arterijska hipertenzija (visok krvni tlak v pljučih).
It stops the activation of the blood clotting mechanism by preventing platelets (components that help the blood to clot) from sticking together. 
Ustavi aktivacijo mehanizma za strjevanje krvi s preprečevanjem lepljenja krvnih ploščic (sestavin, ki pripomorejo k strjevanju krvi).
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU. 
Odbor CHMP je ob upoštevanju predloženih podatkov in interne znanstvene razprave menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v vsej EU.
• treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH 
• zdravljenje pljučne arterijske hipertenzije (idiopatske ali podedovane pljučne arterijske hipertenzije in pljučne arterijske hipertenzije, povezane z boleznimi vezivnega tkiva) pri bolnikih z bolezenskimi znaki iz funkcionalnih razredov SZO III in IV za izboljšanje vadbene sposobnosti;
Flolan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)). 
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Flolan potrebna uskladitev.
This might be every 6 to 12 months. 
To je lahko vsake 6 do 12 mesecev.
Date of first authorisation: 17 November 1997 Date of latest renewal: 17 September 2007 
Datum pridobitve dovoljenja za promet: 17. november 1997 Datum zadnjega podaljšanja: 17/09/2007
Therefore no special dosage regimen can be recommended. 
Zato ne moremo priporočiti posebnega režima odmerjanja.
Your doctor will work out your dose based on how severe your symptoms are, and other factors. 
Zdravnik bo odmerek določil na podlagi resnosti vaših simptomov in drugih dejavnikov.
The current medical standards for emergency treatment are to be observed. 
Upoštevati je treba najnovejše zdravstvene standarde za urgentno zdravljenje.
The usual frequency of infusion is once every 2 weeks (see section 4.2). 
Običajna pogostost infundiranja je enkrat na vsaka 2 tedna (glejte poglavje 4.2).
Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose. 
Ko najde ustrezen odmerek, bo zdravnik še vedno preverjal vaš odziv, da se prepriča, da uporabljate pravilen odmerek.
Patient data will be anonymously collected in this Registry. 
V registru bodo podatke o pacientih zbirali anonimno.
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease. 
Vrsta odmernih režimov se je izkazala za učinkovito zoper nekatere ali vse izmed ne-nevroloških manifestacij bolezni.
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 you are allergic to imiglucerase or any of the other ingredients of this medicine (listed in section 6). 
- Če ste alergični na imiglucerazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The cause can be unknown, or it can be due to heart, lung or liver problems. 
Vzrok je lahko neznan ali pa nastane zaradi težav s srcem, pljuči ali jetri.
Subsequent infusions may need to occur in a clinical setting. 
Nadaljnje infuzije bodo morda morali prejemati v kliničnem okolju.
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.
This will not lead to any loss of imiglucerase activity. 
To ne povzroči zmanjšanja aktivnosti imigluceraze.
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.
It is recommended that the diluted solution be administered within 3 hours. 
Razredčeno raztopino je priporočljivo uporabiti v 3 urah.
These variables do not appear to be influenced by dose or duration of infusion, however, only 1 or 2 patients were studied at each dose level and infusion rate. 
Kaže, da na te spremenljivke velikost odmerka ali trajanje infundiranja ne vplivata, vendar pa sta doslej v študiji o posameznih odmerkih in hitrosti infundiranja sodelovala samo 1 ali 2 bolnika.
Cerezyme has no or negligible influence on the ability to drive and use machines. 
Zdravilo Cerezyme nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly. 
Kot z vsemi intravenskimi proteinskimi proizvodi so možne resne preobčutljivostne reakcije alergijske vrste, vendar se pojavijo samo občasno.
The reconstituted solution must be further diluted. 
Rekonstituirano raztopino je treba razredčiti.
Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip). 
Zdravila Cerezyme se ne sme dajati kot mešanico z drugimi zdravili v isti infuziji (kapalna infuzija).
• bone disease after exclusion of other causes such as Vitamin D deficiency 
• bolezen kosti, ko smo izključili druge vzroke zanjo, kot npr. pomanjkanje vitamina D,
Occasionally, small dosage adjustments may be made to avoid discarding partially used vials. 
Občasno lahko odmerek nekoliko spremenite, da ne bi bilo potrebno zavreči delno izpraznjenih vial.
These symptoms generally respond to treatment with antihistamines and/or corticosteroids. 
Ti simptomi se običajno odzovejo na zdravljenje z antihistaminiki in/ali kortikosteroidi.
If you forget to use Cerezyme 
Če ste pozabili uporabiti zdravilo Cerezyme
Paediatric population No dose adjustment is necessary for the paediatric population. 
Pediatrična populacija Za pediatrično populacijo ni potrebno prilagajanje odmerka
Once individual patient response for all relevant clinical manifestations is wellestablished, dosages and frequency of administration may be adjusted with the goal to either maintain already reached optimal parameters for all clinical manifestations or further improve those clinical parameters which have not yet been normalised. 
Ko se odziv posameznega bolnika na vse poglavitne bolezenske znake ustali, se lahko odmerke in pogostost dajanja zdravila prilagodi z namenom, da se vzdržujejo že doseženi optimalni parametri za vse bolezenske znake ali pa da se izboljšajo klinični parametri, ki se še niso normalizirali.
Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health. 
Nezdravljenim ženskam je treba svetovati, da razmislijo o pričetku zdravljenja pred zanositvijo, da bi dosegle optimalno zdravje.
Intravenous use Read the package leaflet before use. 
intravenska uporaba Pred uporabo preberite priloženo navodilo.
Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying Gaucher disease in pregnancy. 
Na voljo so omejene izkušnje, pridobljene na podlagi izidov 150 nosečnosti (osnovane prvenstveno na spontanih poročanjih in pregledu literature), ki nakazujejo, da je uporaba zdravila Cerezyme med nosečnostjo koristna za nadzorovanje osnovne Gaucherjeve bolezni.
If these reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated. 
Če se reakcije pojavijo, se priporoča takojšnja ustavitev infuzije zdravila Cerezyme in uvedba ustreznega zdravljenja.
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland 
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
- some patients with Gaucher disease have high blood pressure in the lungs (pulmonary hypertension). 
- Nekateri bolniki z Gaucherjevo boleznijo imajo visok krvni pritisk v pljučih (pljučna hipertenzija).
From a microbiological safety point of view, the product should be used immediately. 
Razredčena raztopina: Z vidika mikrobiološke varnosti je priporočeno, da zdravilo uporabite takoj.
Symptoms suggestive of hypersensitivity (* marked in the table above) have been noted, overall in approximately 3% of the patients. 
O simptomih, ki kažejo na preobčutljivostno reakcijo (v zgornji preglednici so označeni z znakom *), poročajo pri vsega skupaj približno 3 % bolnikov.
The clinical manifestations of Gaucher disease can adversely affect quality of life. 
Bolezenski znaki Gaucherjeve bolezni lahko negativno vplivajo na kakovost življenja.
Each vial of Cerezyme is for single use only. 
Ena viala zdravila Cerezyme je namenjena samo enkratni uporabi.
Generally, improvements in organ systems with a faster turnover rate, such as the haematological, can be noted far more rapidly than in those with a slower turnover, such as the bone. 
Na splošno se izboljšave opazijo veliko hitreje v organskih sistemih s hitrim obnavljanjem, kot je hematološki, kot pri organskih sistemih s počasnim obnavljanjem, kot je skelet.
The natural history of Gaucher disease usually shows progression, with the risk of irreversible complications arising in various organs over time. 
Anamneza Gaucherjeve bolezni navadno kaže napredovanje, tekom časa pa se lahko v različnih organih pojavi tveganje nepopravljivih zapletov.
Your doctor may test if you have an allergic reaction to imiglucerase. 
Vaš zdravnik lahko testira, ali se na imiglucerazo alergijsko odzovete.
Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake: "EXP".
The usual frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available. 
Običajna pogostost infundiranja je enkrat na vsaka 2 tedna; večina podatkov, ki so na voljo, se nanašajo na navedeno pogostost odmerjanja.
It is recommended that Cerezyme is used immediately after it has been mixed with sterile water. 
Priporoča se, da zdravilo Cerezyme uporabite takoj po tem, ko ga zmešate s sterilno vodo.
A Q4 infusion regimen may be a therapeutic option for some adult patients with stable residual Gaucher disease type 1, but clinical data are limited. 
Q4 režim infundiranja lahko predstavlja možnost zdravljenja za nekatere odrasle bolnike s stabilno rezidualno Gaucherjevo boleznijo tipa 1, vendar so klinični podatki omejeni.
Signs and symptoms presenting in childhood typically represent more severe Gaucher disease. 
Znaki in simptomi, ki se pojavijo v otroštvu, navadno kažejo na bolj resno obliko Gaucherjeve bolezni.
Educational materials for the use of Cerezyme in home infusion, consisting of: 
Izobraževalno gradivo za infundiranje zdravila Cerezyme na domu, sestavljeno iz:
Clinically, Gaucher disease is a heterogeneous phenotypic spectrum. 
Klinično je Gaucherjeva bolezen heterogeni fenotipski spekter.
No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/foetal development, parturition and postnatal development. 
Študije na živalih, za oceno učinkov zdravila Cerezyme na nosečnost, razvoj zarodka/plodu, porod in postnatalni razvoj, niso bile izvedene.
The rate and extent of response to Cerezyme treatment is dose-dependent. 
Stopnja in obseg odziva na zdravilo Cerezyme sta odvisna od velikosti odmerka.
Other medicines and Cerezyme 
Druga zdravila in zdravilo Cerezyme
Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see section 4.8). 
Pri bolnikih s protitelesi za imiglucerazo se poveča tveganje za preobčutljivostne reakcije (glejte poglavje 4.8).