natgillin/translations-raw huggingface dataset:
Hizentra is also available in pre-filled syringes of 5 and 10 ml.
Zdravilo Hizentra je na voljo tudi v napolnjenih injekcijskih brizgah po 5 ali 10 ml.
Warnings and precautions Talk to your doctor or healthcare professional before using Hizentra.
Pred začetkom uporabe zdravila Hizentra se posvetujte z zdravnikom ali zdravstvenim delavcem.
In total, 57 subjects received 1514 infusions in the placebo group, 57 subjects received 2007 infusions in the 0.2 g/kg bw Hizentra group, and 58 subjects received 2218 infusions in the 0.4 g/kg bw Hizentra group (in total 5739 infusions).
Hizentra 0,2 g/kg TM, 58 preiskovancev pa 2218 infuzij v skupini z odmerkom zdravila Hizentra 0,4 g/kg TM (skupno 5739 infuzij).
No paediatric-specific dose adjustments were necessary to achieve the desired serum IgG levels.
Za doseganje želenih ravni IgG v serumu ni bilo potrebno posebno prilagajanje odmerkov za pediatrične bolnike.
Start infusion.
Hitrost infundiranja
Subjects in both Hizentra dose groups remained stable in electrophysiology parameters.
Glede na elektrofiziološke parametre je stanje preiskovancev v obeh skupinah, ki sta prejemali odmerka zdravila Hizentra, ostalo stabilno.
Contact your doctor if you experience the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomitingafter receiving Hizentra.
Takoj se posvetujte z zdravnikom, če po uporabi zdravila Hizentra opazite naslednje znake ali simptome: hud glavobol, tog vrat, dremavost, zvišala telesna temperatura, fotofobija, siljenje na bruhanjein bruhanje.
► In isolated cases, you may get a bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light, which could be signs of AMS (aseptic meningitis sydrome), which is a temporary reversible non-infectious inflammation of the membranes surrounding the brain and the spinal cord.
► V posamičnih primerih se lahko pojavi hud glavobol s siljenjem na bruhanje, bruhanje, tog vrat, zvišana telesna temperature in občutljivost na svetlobo, kar so lahko znaki AMS (sindrom aseptičnega meningitisa).
• Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
• Napolnjeno injekcijsko brizgo v pretisnem omotu shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Vials
VIALA
Tell your doctor or healthcare professional if you are pregnant, plan to become pregnant or are breast-feeding.
Če ste noseči, načrtujete nosečnost ali dojite, o tem obvestite zdravnika ali zdravstvenega delavca.
ADRs (MedDRA Preferred Term, PT)
NUZ (specifičen izraz klasifikacije neželenih učinkov po MedDRA)
No overall differences in safety or efficacy were observed between CIDP subjects >65 years and CIDP subjects 18 to 65 years of age.
Med preiskovanci s CIDP, starih >65 let, in preiskovanci s CIDP, starih od 18 do 65 let, niso opazili splošnih razlik v varnosti in učinkovitosti.
Hypogammaglobulinaemia and recurrent infections in multiple myeloma (MM) patients.
- hipogamaglobulinemiji in ponavljajočih se bakterijskih okužbah pri bolnikih z multiplim mielomom.
EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003
EU/1/11/687/016
No paediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Za doseganje želenih ravni protiteles IgG v serumu niso bili potrebni posebni odmerki za pediatrične bolnike.
Home-treatment
Zdravljenje na domu
Hizentra is essentially sodium free.
Zdravilo Hizentra je pravzaprav »brez natrija«.
Device-assisted infusion
Infundiranje s pomočjo naprave za infundiranje
What Hizentra is
Kaj je zdravilo Hizentra
3 Thoroughly wash and dry hands 4 Check blistered pre-filled syringes Visually inspect Hizentra for particles in the solution or discoloration as well as expiry date before administering Hizentra.
3 Temeljito si umijte in osušite roke 4 Preglejte napolnjeno injekcijsko brizgo v pretisnem omotu Pred dajanjem zdravila Hizentra s prostim očesom preglejte, da raztopina ne vsebuje vidnih delcev in da ni spremenila barve.
Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.
Imunomodulacija pri odraslih, otrocih in mladostnikih (0-18 let): - Zdravilo Hizentra je indicirano za zdravljenje bolnikov s kronično vnetno demielinizacijsko polinevropatijo (CIDP - Chronic inflammatory demyelinating polyneuropathy) kot vzdrževalno zdravljenje po stabilizaciji z i.v.Ig.
3 Thoroughly wash and dry hands 4 Check Vials Visually inspect Hizentra for particles in the solution or discoloration as well as expiry date before administering Hizentra.
3 Temeljito si umijte in osušite roke 4 Preglejte viale Pred dajanjem zdravila Hizentra s prostim očesom preglejte, da raztopina ne vsebuje vidnih delcev in da ni spremenila barve.
Tremor (including Psychomotor hyperactivity)
•nehotni tresoči gibi v enemali več delih telesa(tremor, vključno s psihomotorično hiperaktivnostjo)
AMS has been reported with use of IVIg or SCIg.
Sindrom aseptičnega meningitisa (AMS - Aseptic Meningitis Syndrome) Pri uporabi i.v.Ig ali s.c.Ig so poročali o AMS.
What Hizentra is used for
Za kaj uporabljamo zdravilo Hizentra
Each pre-filled syringe of 5 ml solution contains: 1 g human normal immunoglobulin Each pre-filled syringe of 10 ml solution contains: 2 g human normal immunoglobulin
Ena napolnjena injekcijska brizga s 5 ml raztopine vsebuje: 1 g humanega polispecifičnega imunoglobulina.
A 24 or larger (i.e. lower gauge number) needle gauge may be required to allow patients to infuse at higher flow rates.
Bolniki bodo za infundiranje z večjo hitrostjo morda potrebovali iglo velikosti G 24 ali večjo (t.j.
Muscle spasm, Muscular weakness
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišično-skeletna bolečina, artralgija pogosti občasni mišični krči, mišična šibkost občasni redki
Keep the blistered pre-filled syringe in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
How to store Hizentra
Shranjevanje zdravila Hizentra
25 ml/site
25 ml/mesto 40 ml/mesto
The solution is clear and pale-yellow or light-brown.
raztopina za subkutano injiciranje Raztopina je prozorna in je bledo rumene ali svetlo rjave barve.
No overall differences in safety or efficacy were observed between PID subjects >65 years and PID subjects 18 to 65 years of age.
Med preiskovanci s PID, starih >65 let, in preiskovanci s PID, starih od 18 do 65 let, niso opazili splošnih razlik v varnosti in učinkovitosti.
PRE-FILLED SYRINGE
Napolnjene injekcijske brizge
No differences were seen in the pharmacodynamic properties between adult and paediatric study patients with PID.
Med odraslimi in pediatričnimi bolniki s PID, zajetimi v študijo, niso opazili razlik v farmakodinamičnih lastnostih.
Pre-filled syringes EU/1/11/687/015 EU/1/11/687/016 EU/1/11/687/017 EU/1/11/687/018
Napolnjene injekcijske brizge EU/1/11/687/015
6 Prepare the tubing
6 Pripravite infuzijski komplet cevke
Hizentra 200 mg/ml solution for subcutaneous injection human normal immunoglobulin (SCIg) For subcutaneous use only.
Hizentra 200 mg/ml raztopina za subkutano injiciranje humani polispecifični imunoglobulin (s.c.Ig) samo za subkutano uporabo
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe human normal immunoglobulin (SCIg) For subcutaneous use only.
Hizentra 200 mg/ml raztopina za subkutano injiciranje v napolnjeni injekcijski brizgi humani polispecifični imunoglobulin (s.c.Ig) samo za subkutano uporabo
Therefore patients receiving measles vaccine should have their antibody status checked.
Pri ošpicah lahko to poslabšanje traja do 1 leta, zato je treba pri bolnikih, ki se cepijo proti ošpicam, preveriti status protiteles.
Replacement therapy
Nadomestno zdravljenje
Each vial of 5 ml solution contains: 1 g of human normal immunoglobulin Each vial of 10 ml solution contains: 2 g of human normal immunoglobulin Each vial of 20 ml solution contains: 4 g of human normal immunoglobulin Each vial of 50 ml solution contains: 10 g of human normal immunoglobulin
Ena viala z 50 ml raztopine vsebuje: 10 g humanega polispecifičnega imunoglobulina.
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe human normal immunoglobulin (SCIg)
Hizentra 200 mg/ml raztopina za subkutano injiciranje v napolnjeni injekcijski brizgi humani polispecifični imunoglobulin (s.c.Ig)
Hizentra 200 mg/ml solution for subcutaneous injection human normal immunoglobulin (SCIg)
Hizentra 200 mg/ml raztopina za subkutano injiciranje humani polispecifični imunoglobulin (s.c.Ig)
Manual push infusion
Hitrost infundiranja pri apliciranju z infuzijsko črpalko
No overall differences in the pharmacokinetic parameters were observed between CIDP subjects >65 years and subjects 18 to 65 years of age.
Med preiskovanci s CIDP, starih >65 let, in preiskovanci, starih od 18 do 65 let, niso opazili splošnih razlik v farmakokinetičnih parametrih.
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe Human normal immunoglobulin (SCIg = Subcutaneous Immunoglobulin)
Hizentra 200 mg/ml raztopina za subkutano injiciranje v napolnjeni injekcijski brizgi humani polispecifični imunoglobulin (s.c.Ig = subkutani imunoglobulin)
Cardiac disorders Tachycardia
Srčne bolezni tahikardija občasni zelo redki
Infusion rate
Imunomodulacija
• Flushing
• omotica
Hizentra 200 mg/ml solution for subcutaneous injection Human normal immunoglobulin (SCIg = Subcutaneous Immunoglobulin)
Hizentra 200 mg/ml raztopina za subkutano injiciranje humani polispecifični imunoglobulin (s.c.Ig = subkutani imunoglobulin)
No overall differences in the pharmacokinetic parameters were observed between PID subjects >65 years and subjects 18 to 65 years of age.
Med preiskovanci s PID, starih >65 let, in preiskovanci, starih od 18 do 65 let, niso opazili splošnih razlik v farmakokinetičnih parametrih.
The entire amount of the mixture should be eaten.
Pojesti je treba celotno količino mešanice.
Do not increase or decrease the amount of medicine without your doctor's approval.
Ne povečujte ali zmanjšujte količine zdravila brez odobritve zdravnika.
It is important to take these supplements exactly as instructed.
Pomembno je, da te dodatke jemljete točno po navodilih.
Your doctor will monitor you for this.
Zdravnik vas bo spremljal v zvezi s tem.
This will help lessen the chance of loss of eyesight.
Na ta način se bo zmanjšala možnost za izgubo vida.
Report any changes to your doctor.
O kakršni koli spremembi obvestite zdravnika.
The recommended dose for you or your child will depend on your or your child's age and weight.
Priporočeni odmerek za vas ali vašega otroka bo odvisen od starosti in telesne mase.
Open Date:
Datum odprtja:
The consequence of this for the clinical use of the drug is unknown.
Posledice tega za klinično uporabo zdravila niso znane.
Discard the open bottle and use a new bottle.
Zavrzite odprto plastenko in uporabite novo.
Take this medicine two times a day, every 12 hours.
Zdravilo jemljite dvakrat na dan, vsakih 12 ur.
You may become drowsy.
Postanete lahko zaspani.
The terminal half-life of cysteamine bitartrate is approximately 4 hours.
Končni razpolovni čas cisteaminijevega bitartrata je približno 4 ure.
Do not take this medicine if the foil seal has been open for more than 30 days.
Zdravila ne smete uporabljati, če je zaščitna folija odprta že več kot 30 dni.
You should not use this medicine if you are pregnant, particularly during the first trimester.
Zdravila ne smete jemati, če ste noseči, še zlasti pa ne v prvem trimesečju.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Pogostnost neželenih učinkov je razvrščena po naslednjih kriterijih: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Different organs are affected at different ages.
Prizadetost različnih organov se pokaže pri različnih starostih bolnika.
Regular blood and urine tests to measure the levels of the body's important electrolytes are also necessary to help you or your doctor correctly adjust the doses of these supplements.
Redni krvni in urinski testi za merjenje pomembnih elektrolitov v telesu so potrebni tudi zato, ker pomagajo vam oziroma vašemu zdravniku pravilno prilagoditi odmerke omenjenih dodatkov.
The education pack is aimed at strengthening awareness of important identified and potential risks as well as appropriate patient selection, the need for dose titration and patient monitoring.
Izobraževalni paket bo namenjen povečanju ozaveščenosti o pomembnih ugotovljenih in možnih tveganjih ter tudi o pravilni izbiri bolnikov, potrebi po titraciji odmerka in spremljanju bolnikov.
After opening do not store above 25°C.
Po odprtju shranjujte pri temperaturi do 25 °C.
Should overdosing occur, the respiratory and cardiovascular systems should be supported appropriately.
Če pride do prevelikega odmerjanja, je treba uvesti ustrezno respiratorno in kardiovaskularno podporno zdravljenje.
- Your medical treatment may include, in addition to cysteamine, one or more supplements to replace important electrolytes lost through the kidneys.
- vaše zdravljenje lahko poleg cisteamina vključuje še enega ali več dodatkov za nadomeščanje pomembnih elektrolitov, ki se izgubljajo skozi ledvice.
•Guidance on appropriate patient selection and dose titration.
• smernice za pravilno izbiro bolnikov in titracijo odmerka;
Examine your skin while taking this medicine.
Med uporabo zdravila si pregledujte kožo.
There is no adequate data from the use of cysteamine in pregnant women.
Ni ustreznih podatkov o uporabi cisteamina pri nosečnicah.
Consult your child's doctor for complete directions.
Za podrobna navodila se posvetujte z zdravnikom vašega otroka;
Cysteamine has minor or moderate influence on the ability to drive and use machines.
Cisteamin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Keep the container tightly closed in order to protect from light and moisture.
Vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred svetlobo in vlago.
Do not use this medicine after the expiry date, which is stated on the carton and the bottle label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na plastenki poleg oznake »EXP«.
PROCYSBI is a medicine that reacts with cystine to decrease its level within the cells.
PROCYSBI je zdravilo, ki reagira s cistinom in tako znižuje njegovo raven znotraj celic.
Talk to your doctor if you have any unusual stomach symptoms or changes in stomach symptoms.
Posvetujte se z zdravnikom, če opazite kakršne koli neobičajne simptome želodčnih težav ali spremembe simptomov želodčnih težav.
When these reactions appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
Kadar se ti učinki pojavijo ob uvedbi zdravljenja s cisteaminom, lahko začasna prekinitev in ponovno postopno uvajanje zdravljenja učinkovito izboljšata toleranco.
Do not give gastro-resistant hard capsules to children under 6 years of age because they may not be able to swallow them and they may choke.
Gastrorezistentnih trdih kapsul ne smete dajati otrokom do 6. leta starosti, ker jih morda ne bodo mogli pogoltniti in se lahko zadušijo.
Physicians should routinely monitor the skin and bones of patients receiving cysteamine.
Zdravniki morajo redno spremljati kožo in kosti bolnikov, ki prejemajo cisteamin.
In some cases, these skin lesions were associated with skin striae and bone lesions first seen during an X-ray examination.
V nekaterih primerih so bile te kožne lezije povezane s kožnimi strijami in lezijami kosti, ki so jih najprej opazili pri rentgenskem slikanju.
Since some of these side effects are serious, ask your doctor to explain their warning signs.
Ker so nekateri od teh neželenih učinkov resni, se posvetujte z zdravnikom o njihovih opozorilnih znakih.
In clinical studies with healthy volunteers, the most frequent adverse reactions were very common GI symptoms (16%) and occurred primarily as single episodes that were mild or moderate in severity.
V kliničnih študijah z zdravimi prostovoljci so bili najpogostejši neželeni učinki zelo pogosti prebavni simptomi (16 %), ki so se največkrat pojavili samo enkrat in so bili blagi ali zmerni.
PROCYSBI with food and drink
Zdravilo PROCYSBI skupaj s hrano in pijačo
Method of administration You should take this medicine only by mouth.
Način uporabe Zdravilo lahko jemljete izključno skozi usta.
Your doctor will routinely monitor your skin and bones and reduce or stop your treatment if needed (see section 4).
Vaš zdravnik bo redno spremljal vašo kožo in kosti ter po potrebi zmanjšal odmerek ali prekinil zdravljenje (glejte poglavje 4).
Therefore, cysteamine bitartrate should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.4).
Zato cisteaminijevega bitartrata ne smete uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno (glejte poglavje 4.4).
The effect on pregnancy of untreated cystinosis is also unknown.
Vpliv nezdravljene cistinoze na nosečnost prav tako ni znan.
• Hypersensitivity to the active substance, any form of cysteamine (mercaptamine), or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino, katero koli obliko cisteamina (merkaptamina) ali katero koli pomožno snov, navedeno v poglavju 6.1.
When starting therapy, patients should not engage in potentially hazardous activities until the effects of the medicinal product on each individual are known.
Ob uvedbi terapije se bolniki ne bi smeli ukvarjati s potencialno nevarnimi dejavnostmi, vse dokler ni pojasnjen učinek, ki ga ima zdravilo na posameznega bolnika.
Do not use this medicine if you are breastfeeding (see section 2 under “Do not use PROCYSBI”).
Zdravila ne smete uporabljati, če dojite (glejte poglavje 2 pod »Ne jemljite zdravila PROCYSBI«).
Cysteamine is the simplest stable aminothiol and a degradation product of the amino acid cysteine.
Cisteamin je najpreprostejši stabilni aminotiol ter produkt razgradnje aminokisline cisteina.
• Hypersensitivity to penicillamine.
• Preobčutljivost na penicilamin.
This is a condition where there is high pressure in the fluid around the brain.
To je bolezen, za katero je značilen visok tlak v tekočini, ki obdaja možgane.
Measurement timing: PROCYSBI should be administered every 12 hours.
Čas merjenja: zdravilo PROCYSBI je treba dajati vsakih 12 ur.
Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious GI toxicity and what steps to take if they occur.
Zdravniki morajo biti pozorni na znake razjed in krvavitev ter morajo bolnike in/ali njihove skrbnike poučiti o znakih in simptomih resne gastrointestinalne toksičnosti ter o tem, kaj storiti, če jih opazijo.
In the few cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
V tistih nekaj primerih, pri katerih so opravili histopatološko preiskavo kože, so rezultati kazali na angioendoteliomatozo.
A white plastic bottle contains 60 capsules.
Bela plastenka vsebuje 60 kapsul.
At this dose, weight gain and survival of the offspring during lactation was also reduced.
Pri tem odmerku sta se zmanjšala tudi prirastek telesne mase in preživetje mladičev v obdobju laktacije.
Two cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
Poročali so o dveh primerih nefrotskega sindroma, ki se je pojavil v 6 mesecih po začetku zdravljenja in se je po prekinitvi zdravljenja postopoma izboljšal.
When starting therapy, you should not drive, use machines, or engage in other dangerous activities until you know how the medicine affects you.
Na začetku zdravljenja ne smete upravljati vozil in strojev ali se ukvarjati z nevarnimi dejavnostmi, dokler ne veste, kako zdravilo vpliva na vas.
Cysteamine bitartrate should not be administered with food rich in fat or proteins, or with frozen food like ice-cream.
Cisteaminijevega bitartrata se ne sme jemati skupaj s hrano, bogato z maščobami ali beljakovinami, ali z zamrznjeno hrano, kot je sladoled.
One patient subsequently died of acute cerebral ischemia with marked vasculopathy.
En bolnik je pozneje umrl zaradi akutne možganske ishemije z izrazito vaskulopatijo.
EXP Discard 30 days after opening the foil seal.
EXP Zavrzite 30 dni po odprtju zaščitne folije.
The physician education pack should contain the Safety Checklist, the Summary of Product Characteristics and Package Leaflet.
Izobraževalni paket za zdravnike mora vsebovati varnostni kontrolni seznam, povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The relative bioavailability is about 125% as compared to immediate-release cysteamine.
Relativna biološka uporabnost je v primerjavi s cisteaminom s takojšnjim sproščanjem približno 125-odstotna.
What PROCYSBI is and what it is used for
Kaj je zdravilo PROCYSBI in za kaj ga uporabljamo
Thirty-nine (39) patients were included in the final primary per protocol efficacy analysis.
V končno primarno analizo učinkovitosti po protokolu so vključili devetintrideset (39) bolnikov.
If a dose is missed, it should be taken as soon as possible.
Če je bil odmerek izpuščen, ga je treba vzeti, kakor hitro je to mogoče.
If your doctor prescribes bicarbonate, do not take it at the same time as PROCYSBI; take bicarbonate at least one hour before or at least one hour after the medicine.
Če vam zdravnik predpiše bikarbonat, ga ne smete jemati sočasno z zdravilom PROCYSBI; bikarbonat vzemite vsaj eno uro pred ali vsaj eno uro po zaužitju zdravila.
If you missed a dose of medicine, you should take it as soon as possible.
Če ste izpustili odmerek zdravila, ga vzemite, kakor hitro je to mogoče.
Co-administration with electrolyte and mineral replacement
Sočasna uporaba s terapijami za nadomeščanje elektrolitov in mineralov
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 September 2013
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 06. september 2013 Datum zadnjega podaljšanja: 26 Julij 2018
It is important to take PROCYSBI in a consistent way over time.
Pomembno je, da zdravilo PROCYSBI jemljete dalj časa na dosleden način.
Since oral cysteamine doesn't prevent deposits of cystine crystals in the eye, you should continue taking cysteamine eye drops as prescribed by your doctor.
Ker peroralna uporaba cisteamina ne preprečuje nalaganja cistinskih kristalov v očesu, morate še naprej uporabljati kapljice za oko s cisteaminom, ki vam jih je predpisal zdravnik.
Your doctor will monitor you with eye examinations to find and treat this problem early.
Zdravnik bo opravljal preglede oči, namenjene odkrivanju in zgodnjemu zdravljenju teh težav.
This is equivalent to 0.6 g/m2/day in the rat, which is slightly less than the recommended clinical maintenance dose of cysteamine, i.e. 1.3 g/m2/day.
To pri podganah pomeni 0,6 g/m2/dan, kar je malo manj kot polovica priporočenega kliničnega vzdrževalnega odmerka cisteamina, tj. 1,3 g/m2/dan.
You will receive regular eye examinations to identify this condition as early treatment can prevent vision loss.
Imeli boste redne preglede oči za odkrivanje te bolezni, saj lahko zgodnje zdravljenje prepreči izgubo vida.
Food intake reduces the absorption of PROCYSBI at 30 minutes pre-dose (approximately 35% decrease in exposure) and at 30 min post-dose (approximately 16 or 45% decrease in exposure for intact and open capsules respectively).
Hrana zmanjša absorpcijo zdravila PROCYSBI, če se jo zaužije 30 minut pred odmerkom (približno 35 % manjša izpostavljenost) ali 30 minut po odmerku zdravila (približno 16 oziroma 45 % manjša izpostavljenost pri celih oziroma odprtih kapsulah).