natgillin/translations-raw huggingface dataset:
dAdverse events grouping, including urine output increased, polydipsia, micturition urgency, nocturia, pollakiuria and polyuria eMean percent changes from baseline for sotagliflozin 200 mg and 400 mg versus placebo, respectively, were HDL-C 3.3% and 4.2% versus 0.5%; LDL-C 5.0% and 6.1% versus 3.3%; triglycerides 5.7% and 5.4% versus 2.7%.
e Povprečne odstotne spremembe od izhodišča za 200 mg oz. 400 mg sotagliflozina v primerjavi s placebom so bile: holesterol HDL 3,3 % oz. 4,2 % v primerjavi z 0,5 %, holesterol LDL 5,0 % oz. 6,1 % v primerjavi z 3,3 %, trigliceridi 5,7 % oz. 5,4 % v primerjavi z 2,7 %.
LS mean [95%CI]
povprečna vrednost po mNK [95 % IZ]
The mean BMI was 28 kg/m2 and 29% had SBP ≥ 130 mmHg.
Povprečni ITM je bil 28 kg/m2 in 29 % bolnikov je imelo SKT ≥ 130 mmHg.
Foot care
Skrb za stopala
7.0% at week 24, n (%) Body Weight (kg) Baseline, mean
HbA1c < 7,0 % po 24 tednih, n (%) Telesna masa (kg)
Diabetes Treatment Satisfaction Questionnaire Baseline, mean
Vprašalnik zadovoljstva z zdravljenjem sladkorne bolezni (DTSQ)
Your doctor may ask you to stop taking Zynquista until you have recovered
Zdravnik vam bo morda naročil, da prenehate jemati zdravilo
Diabetes Distress Screening Scale Baseline score, mean
DDSS (Diabetes Distress Screening Scale)
The mean eGFR was 92 mL/min/1.73 m2 and 3.3% had eGFR between 45 and 60 mL/min/1.73 m2.
Povprečna eGFR je bila 92 ml/min/1,73 m2 in 3,3 % je imelo eGFR med 45 in 60 ml/min/1,73 m2.
Difference from insulin alone, LS mean [95%CI]
Razlika od insulina samega, povprečna vrednost [95 % IZ]
The mean eGFR was 87 mL/min/1.73 m2 and 5.7% of patients had eGFR between 45 and 60 mL/min/1.73 m2.
87 ml/min/1,73 m2 in 5,7 % bolnikov je imelo eGFR med 45 in 60 ml/min/1,73 m2.
Iron oxide black (E172) Propylene glycol
Črni železov oksid (E172)
If Fournier's gangrene is suspected, sotagliflozin should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Fournierjevo gangreno je treba zdravljenje s sotagliflozinom ukiniti in nemudoma uvesti zdravljenje
In the rat, TSH was considered the primary carcinogen with sotagliflozin functioning as a secondary carcinogen.
sotagliflozin pa deluje kot sekundarni karcinogen.
Sotagliflozin should only be given to patients: - with access to ketone testing materials and immediate access to a clinician if blood or urine ketones are elevated.
- ki imajo dostop do pripomočkov za testiranje ketonov ter takojšen dostop do zdravnika, v primeru, da je koncentracija ketonov v krvi ali urinu povišana.
A.
DKA.
This patient is using ZYNQUISTA for the treatment of Type 1 Diabetes Mellitus (T1DM).
Bolnik za zdravljenje sladkorne bolezni tipa 1 uporablja zdravilo Zynquista.
Blood ketone body increased, serum lipids increasede, haematocrit increasedf
Preiskave zvišanje ketonskih teles, zvišanje lipidov v serumue, zvišanje hematokritaf
fThe proportion of subjects that met the criteria haematocrit >50% was higher in the sotagliflozin 200 mg and 400 mg groups (6.7% and 8.2%) compared to the placebo group (2.7%)
mg sotagliflozina večji (6,7 % in 8,2 %) kot v skupini s placebom (2,7 %).
Patients with a history of chronic or recurrent genital mycotic infections are more likely to develop genital mycotic infections.
Verjetnost za nastanek glivičnih okužb spolovil je večja pri bolnikih, ki imajo v anamnezi kronične ali ponavljajoče se glivične okužbe spolovil.
Extra carbohydrates should be taken if the glucose levels are normal or low.
Če je koncentracija glukoze normalna ali nizka, mora bolnik zaužiti dodatne ogljikove hidrate.
Stage IV (eGFR ≥15 and <30 mL/min/1.73 m2) sotagliflozin exposures were 1.95 and 2.25 fold higher compared to subjects with normal renal function.
Pri preiskovancih s kronično ledvično boleznijo v stadiju IIIb (eGFR ≥ 30 in < 45 ml/min/1,73 m2) je bila izpostavljenost sotagliflozinu 1,95-krat večja in pri tistih v stadiju IV (eGFR ≥ 15 in < 30 ml/min/1,73 m2) 2,25-krat večja kot pri preiskovancih z normalnim delovanjem ledvic.
Zynquista 200 mg film coated tablets:
Zynquista 200 mg filmsko obložene tablete:
Baseline, mean in units % change from baseline, LS mean % difference from insulin alone, LS mean
Izhodiščno, povprečna vrednost % spremembe od izhodišča, povprečna vrednost po mNK % razlike od insulina samega,
Treatment with sotagliflozin also resulted in reduction in body weight and FPG compared with insulin alone (see Table 4).
Zdravljenje s sotagliflozinom je v primerjavi s skupino s samim insulinom privedlo do zmanjšanja telesne teže in glukoze v plazmi na tešče (glejte preglednico 4).
• Signs and symptoms of DKA include: - nausea, vomiting, or abdominal pain - anorexia - excessive thirst - unusual fatigue or sleepiness - difficulty breathing - confusion
- prekomerno žejo - nenavadno utrujenost ali zaspanost - težko dihanje - zmedenost
An increase in total exposure and Cmax of rosuvastatin of ca 1.2- and 1.4-fold, respectively, was demonstrated when co-administered with sotagliflozin and is not deemed clinically relevant.
Med sočasno uporabo rosuvastatina s sotagliflozinom so ugotovili približno 1,2-kratno večjo izpostavljenost rosuvastatinu in približno 1,4-kratno povečanje njegove Cmax, vendar klinično nepomembno.
Your blood sugar levels may increase when you stop taking Zynquista.
Če prenehate jemati zdravilo Zynquista, se vam koncentracija krvnega sladkorja lahko zviša.
Local intestinal inhibition of SGLT1, the major transporter for glucose absorption, delays and reduces glucose absorption in the proximal intestine, resulting in a blunting and delay of postprandial hyperglycaemia.
upočasni in zmanjša absorpcijo glukoze v proksimalnem delu črevesja; posledica je zakasnjena in upočasnjena postprandialna hiperglikemija.
Zynquista 200 mg film-coated tablets
Zynquista 200 mg filmsko obložene tablete
The mean eGFR was 92 mL/min/1.73 m2 and 5 % had eGFR between 45 and 60 mL/min/1.73 m2.
Povprečna eGFR je bila 92 ml/min/1,73 m2 in 5 % bolnikov je imelo eGFR med 45 in 60 ml/min/1,73 m2.
You can also get the Patient Alert Card by scanning the QR code or by visiting the website below:
QR-kodo, ali če obiščete to spletno mesto:
Insulin Insulin + sotagliflozi n 200 mg
Insulin Insulin + 200 mg sotagliflozi na
Temporary interruption of sotagliflozin should be considered when treating pyelonephritis and urosepsis.
V primeru zdravljenja pielonefritisa ali urosepse je treba razmisliti o začasnem prenehanju uporabe sotagliflozina.
In study 3 at 24 weeks incidences of severe hypoglycaemia were 2.4% and 3.0% on placebo and sotagliflozin 400 mg, respectively and the reduction in the rate of hypoglycaemic events at 24 weeks (blood glucose ≤3.1 mmol/L) for sotagliflozin 400 mg was 22% (p<0.001) compared to insulin alone.
24 tednih pa so se hipoglikemični dogodki (glukoza v krvi ≤ 3,1 mmol/l) s 400 mg sotagliflozina zmanjšali za 22 % v primerjavi s samim insulinom (p < 0,001).
Zynquista 200 mg film-coated tablets sotagliflozin
Zynquista 200 mg filmsko obložene tablete sotagliflozin
There is limited experience in clinical trials in patients with moderate and severe hepatic impairment.
Pri bolnikih z zmerno in hudo okvaro jeter so klinične izkušnje uporabe sotagliflozina omejene.
LS mean % Difference from insulin alone, adjusted mean [95%CI]
Razlika od insulina samega, povprečna vrednost po mNK [95 % IZ]
b Adverse event grouping, including, but not limited to, balanoposthitis, genital infections fungal, balanitis candida, epididymitis.
b Skupina neželenih učinkov, ki med drugim obsega balanopostitis, glivične okužbe spolovil,
At week 24 and 52 the change from baseline in creatinine was equal to or less than 0.02 mg/dL for both sotagliflozin 200 and sotagliflozin 400 mg.
Po 24 in 52 tednih je bila sprememba kreatinina od izhodišča 0,02 mg/dl ali manj tako z
Urinary glucose excretion
Farmakodinamični učinki Izločanje glukoze v urinu
Baseline (after 6-week insulin optimisation), mean Change from baseline, LS mean Difference from insulin alone, LS mean (p-value)
Izhodiščne (po 6-tedenski optimizaciji insulina), povprečna vrednost po mNK
In study 3 there was a significant reduction in FPG of 0.79 mmol/L (p<0.001) with sotagliflozin 400 mg at 24 weeks compared to insulin alone.
V študiji 3 se je glukoza v plazmi na tešče po 24 tednih s 400 mg sotagliflozina statistično značilno znižala za 0,79 mmol/l (p < 0,001) v primerjavi s samim insulinom.
Patients were then maintained on optimised insulin and randomized to sotagliflozin 200 mg, sotagliflozin 400 mg or insulin alone.
Bolnike so vzdrževali na optimalnih odmerkih insulina, nato so jih razdelili v skupine: sotagliflozin
- Consider discontinuing sotagliflozin if adequate insulinisation cannot be achieved on treatment.
- Če med zdravljenjem ni mogoče doseči ustrezne insulinizacije, razmislite o prenehanju uporabe sotagliflozina.
Rate of nocturnal‡ documented hypoglycaemia† (events per patient year) at thresholds of
Delež dokumentiranih hipoglikemij† (dogodki na bolnika in leto) s pragom ≤ 3,1
It is recommended that patients obtain several baseline blood or urine ketone levels over one to two weeks period prior to initiation of sotagliflozin therapy, and patients should become familiar with the behaviours/circumstances associated with elevated ketone levels and how to address them.
Priporočljivo je, da bolniki v obdobju tedna do dveh pred uvedbo zdravljenja s sotagliflozinom večkrat izmerijo izhodiščne vrednosti ketonov v krvi ali urinu.
Temporary interruption of treatment with sotagliflozin should be considered until the fluid loss is corrected.
Dokler izguba tekočine ni odpravljena, pride v poštev začasna prekinitev zdravljenja s sotagliflozinom.
Effects of sotagliflozin on other medicinal products There is an increase in AUC0-inf and Cmax of digoxin (27% and 52% respectively) when coadministered with sotagliflozin 400mg, due to inhibition of P-gp by sotagliflozin.
Med sočasno uporabo digoksina s 400 mg sotagliflozina se zaradi zavrtja P-gp, ki ga povzroči sotagliflozin, povečata AUC0-inf (27 %) in Cmax (52 %) digoksina.
The adverse effects on embryo-fetal development at 350 mg/kg/day were associated with maternal toxicity (body weight loss/decreased body weight gain and decreased food consumption during gestation day (GD) 6 to 8).
Neželeni učinki na embrio-fetalni razvoj ob odmerku 350 mg/kg/dan so bili povezani z maternalno toksičnostjo
Baseline, mean in units/day % change from baseline, LS mean % difference from insulin alone, LS mean
Izhodiščno, povprečna vrednost, % spremembe od izhodišča, povprečna vrednost po mNK % razlike od insulina
In the broader pool, including all type 1 diabetes mellitus patients in phase 2 and 3 studies, the exposure-adjusted incidence rate was 3.07, 5.29 and 0.76 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo (see section 4.4).
5,29 in 0,76 preiskovanca na 100 bolnikov-let za 200 mg sotagliflozina, 400 mg sotagliflozina in placebo (glejte poglavje 4.4).
≤3.1 or ≤3.9 mmol/L
ali ≤ 3,9 mmol/l
Insulin Insulin + sotagliflozin 200 mg
Insulin Insulin + 200 mg sotagliflozina
The apparent volume of distribution of sotagliflozin following administration of a single 400 mg oral dose of [14C]-sotagliflozin was found to be very high with a mean value of 9392 L.
[14C]-sotagliflozina je bil izredno velik; njegova povprečna vrednost je bila 9392 l.
Male genital mycotic infections*,b, † urinary tract infections*' †
glivične okužbe moških spolovil*,b, †
Insulin + sotagliflozin 400 mg
Insulin + 400 mg sotagliflozina
Sotagliflozin should not be used in patients with severe renal impairment, end stage renal disease (ESRD) or in patients on dialysis as it has not been studied in these patients (see section 4.2).
(KOL) in pri bolnikih na dializi, ker pri teh bolnikih ni raziskan (glejte poglavje 4.2).
However, the mechanism behind the limited increase in exposure is not completely elucidated as sotagliflozin and M19 (sotagliflozin 3-O-glucuronide) are characterized as BCRP inhibitors in vitro and M19 also as an inhibitor OATP1B3 and OAT3.
(sotagliflozin-3-O-glukuronid) in vitro zavirata BCRP, M19 pa zavira tudi OATP1B3 in OAT3.
In a 12-week dose ranging study, consistent with SGLT2 inhibition, 24-h placebo corrected change from baseline Urinary Glucose Excretion (UGE) increased by 57.7 grams (p<0.001) and 70.5 grams (p<0.001) in patients with type 1 diabetes taking 200 mg and 400 mg sotagliflozin respectively, which is consistent with SGLT2 inhibition.
57,7 gramov (p <0,001) in 70,5 gramov (p <0,001) pri bolnikih s sladkorno boleznijo tipa 1, ki so prejemali 200 mg in 400 mg sotagliflozina, kar je skladno z zaviranjem SGLT2.
Talk to your doctor, pharmacist or nurse before taking Zynquista, and during treatment: • if you have the following symptoms, which may be a sign of a serious condition, diabetic ketoacidosis (see also section 4):
• če se vam pojavijo naslednji simptomi, ki so lahko znaki redke, toda resne motnje, imenovane diabetična ketoacidoza (glejte tudi poglavje 4):
Insulin + sotagliflozin
Insulin + 200 mg sotagliflozin
> 1.5-3.0 mmol/L Moderate
Grozeča DKA > 1,5-3,0 mmol/l
Hepatic impairment
Pojavnost hudih hipoglikemij
HbA1c (%) Baseline (after 6-week insulin optimisation), mean
Izhodišče (po 6-tedenski optimizaciji insulina), povprečna vrednost
At Week 24, mean
povprečna vrednost Po 24 tednih,
At week 24, treatment with 200 mg or 400 mg sotagliflozin provided statistically significant reductions in HbA1c (p-value <0.001) compared to insulin alone.
Po 24 tednih je zdravljenje z 200 mg ali 400 mg sotagliflozina doseglo statistično značilno znižanje
No overall differences in safety were observed with sotagliflozin treatment as compared to insulin alone in subjects with eGFR between 45 and 60 mL/min/1.73 m2.
Pri preiskovancih z eGFR med 45 in 60 ml/min/1,73 m2 na splošno niso opazili razlik v varnosti med zdravljenjem s sotagliflozinom v primerjavi s samim insulinom.
• if you are using a low dose of insulin
- z nizko potrebo po insulinu.
No dose adjustment is recommended in patients with mild hepatic impairment.
Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
Bolus insulin dose (units/day) Baseline, mean % Change from baseline,
Odmerek bazalnega insulina (enote/dan)
400 mg (N=525)
(N = 525)
200 mg (N=524)
(N = 524)
All UTI events were mild or moderate in intensity except for one severe case (male subject in the sotagliflozin 400 mg group).
Vse okužbe sečil so bile blage ali zmerne, razen enega hudega primera
Printing ink
Črnilo
Breast-feeding
Propilenglikol
For subjects with CKD Stage IIIb (eGFR ≥30 and <45 mL/min/1.73 m2) and CKD
Kreatinin (mg/dl) eGFR (ml/min/1,73 m2
At week 24, treatment with 400 mg sotagliflozin before the first meal of the day resulted in statistically significant more patients achieving the net benefit primary endpoint (proportion of patients with HbA1c <7.0% at week 24 and no episode of severe hypoglycaemia, and no episode of DKA from randomisation to Week 24) compared with insulin alone (28.6% versus 15.2%) (p-value<0.001) and provided statistically significant mean reductions in HbA1c (p-value <0.001).
Po 24 tednih je zdravljenje s 400 mg sotagliflozina pred prvim obrokom dneva povzročilo, da je statistično značilno več bolnikov doseglo primarni opazovani dogodek neto koristi (delež bolnikov s
Discontinuation due to genital mycotic infections occurred in 1.2%, 1.1% and 0.8% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
%, 1,1 % in 0,8 % med prejemniki 200 mg sotagliflozina, 400 mg sotagliflozina in med prejemniki placeba.
Talc Indigo carmine aluminium lake (E132).
Indigotin E132
Date of first authorisation: 13 March 2013 Date of latest renewal: 8 December 2017
Datum prve odobritve: 13. marec 2013 Datum zadnjega podaljšanja: 8. decembra 2017
Also the proportion of patients gaining ≥ 2 or
Tudi delež bolnikov, ki so pridobili ≥ 2 ali
Your doctor will be aware of this and will take it into account when monitoring your eye.
Vaš zdravnik to ve in bo to upošteval pri spremljanju vašega očesa.
This is generally reversible and will usually disappear without treatment.
To je običajno reverzibilno in navadno izgine brez zdravljenja.
In the majority of cases recovery occurred within 6 months.
V večini primerov je okrevanje nastopilo v 6 mesecih.
Currently available data on paediatric use are described in section 5.1.
Trenutno razpoložljivi podatki o pediatrični uporabi so opisani v poglavju 5.1.
• Key signs and symptoms of serious adverse events
• Ključni znaki in simptomi resnih neželenih učinkov
Proper aseptic injection techniques must always be used.
Vedno je treba uporabiti pravilne aseptične tehnike injiciranja.
If this happens, do not drive or use any tools or machines until your vision improves.
Če se to zgodi, ne vozite in ne uporabljajte orodij ali strojev, dokler se vid ne izboljša.
Population with no or limited data
Populacija, pri kateri podatkov ni oziroma so omejeni
No systemic interactions are anticipated.
Sistemske interakcije niso pričakovane.
Bilateral treatment
Bilateralno zdravljenje
The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces.
Makula skrbi za središčni vid, ki je potreben za vsakodnevna opravila, kot so vožnja, branje in prepoznavanje obrazov.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden prejmete to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
Information about storage
Informacije o shranjevanju
Most of these events occurred during or after vitrectomy in both groups.
Večina dogodkov se je v obeh skupinah pojavila med vitrektomijo ali po njej.
Retinogram abnormal
Nenormalen retinogram
Each vial should only be used once and for the treatment of a single eye.
Vsako vialo uporabite le enkrat in za zdravljenje enega očesa.
Most of the adverse reactions occurred within the first week after the injection.
Večina neželenih učinkov se je pojavila v prvem tednu po injiciranju.
The majority of events were non-serious, mild and generally resolved spontaneously.
Večina dogodkov ni bila resnih, pač pa blagih in je običajno izzvenela spontano.
A difference was maintained through the end of the studies (Month 6).
Razlika se je ohranila do konca študije (6. meseca).
You will not be given Jetrea more than once into the same eye.
Zdravila Jetrea ne boste prejeli več kot enkrat v isto oko.
• When to seek urgent attention from the health care provider
• Kdaj poiskati nujno medicinsko pomoč.
Use thawed solution by: ----- / ----- / ----
Odmrznjeno raztopino uporabite do: ----- / ----- / ----
Routine observation is recommended in all above situations.
V vseh zgoraj navedenih situacijah se priporoča rutinsko opazovanje.
This should be taken into consideration when using these tests for the diagnosis or monitoring of other conditions (see section 4.8).
To je treba upoštevati pri izvedbi omenjenih preiskav za diagnostiko ali spremljanje drugih bolezni (glejte poglavje 4.8).
In these cases, patients should not drive or use machines until the visual disturbances have resolved.
V teh primerih naj bolniki ne vozijo ali upravljajo strojev, dokler motnja vida ne izzveni.
Repeated administration in the same eye is not recommended (see section 4.4).
Ponovnega dajanja v isto oko ne priporočamo (glejte poglavje 4.4).
The majority of these reactions were non-serious, mild to moderate in intensity and resolved within 2 to 3 weeks.
Večina neželenih učinkov ni bila resnih, bili so blagi do zmerni ter so izginili v roku 2 do 3 tednov.
The diluted solution should be used immediately as it contains no preservatives.
Razredčeno raztopino je treba uporabiti takoj, saj ne vsebuje konzervansov.
*Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system.
*Okriplazmin je skrajšana oblika humanega plazmina, izdelanega z uporabo tehnologije rekombinantne DNA v ekspresijskem sistemu kvasovke Pichia pastoris.
If an overdose occurs, close monitoring is recommended.
V primeru prevelikega odmerjanja se priporoča skrbno spremljanje.
No carcinogenicity, mutagenicity or reproductive and developmental toxicity data are available.
Podatki o kancerogenosti, mutagenosti ali toksičnosti za razmnoževanje in razvoj niso na voljo.
Your ophthalmologist/doctor or pharmacist is responsible for storing this medicine and disposing of any unused solution correctly.
Vaš oftalmolog/zdravnik ali farmacevt je odgovoren za shranjevanje tega zdravila in pravilno odstranjevanje neuporabljene raztopine.
At Month 24, the proportions were 48/145 (33.3%) and 32/73 (43%), respectively.
V 24. mesecu sta bila deleža 48/145 (33,3 %) oziroma 32/73 (43 %).
Combined JETREA
kombinirano JETREA
Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.
Nekatere učinke (kot so utrinki, lebdeči delci) lahko v nekaterih primerih opazimo tudi na nezdravljenem očesu.
Intraocular inflammation/infection may be assessed using biomicroscopy between 2 and 7 days following the injection.
Intraokularno vnetje/okužbo je mogoče oceniti z biomikroskopijo med 2 in 7 dnem po injiciranju.
The intravitreal injection of JETREA may have a moderate influence on the ability to drive and use machines due to possible temporary visual disturbances (see section 4.8).
Intravitrealno injiciranje zdravila JETREA ima lahko zmeren vpliv na sposobnost vožnje in upravljanja strojev zaradi možnih začasnih motenj vida (glejte poglavje 4.8).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom (MAH) se mora pred prihodom zdravila na trg v vsaki državi članici dogovoriti za izobraževalni program z nacionalnim pristojnim organom.
The safety findings observed in study TG-MV-009 were consistent with the known safety profile for JETREA.
Varnostne ugotovitve, ki so jih opazili v študiji TG-MV-009 so bile skladne z znanim varnostnim profilom zdravila JETREA.
Elderly The elderly population has been studied in clinical studies.
Starejši bolniki Dajanje zdravila starejši populaciji so preučili v kliničnih študijah.
Patients should be monitored appropriately (see section 4.8 and 5.3).
Bolnike je treba primerno spremljati (glejte poglavji 4.8 in 5.3).
The medicinal product should be diluted and used immediately.
Zdravilo je treba razredčiti in takoj uporabiti.
There is no relevant use of Jetrea in children and adolescents below 18 years old.
Zdravilo Jetrea ni primerno za uporabo pri otrocih in mladostnikih, starih do 18 let.
Jetrea should not be used during pregnancy or breast-feeding unless your doctor/ophthalmologist thinks it is clearly necessary.
Zdravila Jetrea ne uporabljajte med nosečnostjo ali dojenjem, razen če vaš zdravnik/oftalmolog meni, da je to nujno potrebno.
% VMA Resolution
% odprav VMA
To prepare Jetrea for intravitreal injection, adhere to the following instructions: 1.
Za pripravo zdravila Jetrea v obliki intravitrealne injekcije upoštevajte naslednja navodila: 1.
Store in a freezer.
Shranjujte v zamrzovalniku.
Administration in close temporal association with other medicinal products in the same eye may affect the activity of both medicinal products and is therefore not recommended.
Dajanje v tesnem časovnem zaporedju z drugimi zdravili v isto oko lahko vpliva na delovanje obeh zdravil, zato se odsvetuje.
When administered intravenously, ocriplasmin enters the endogenous protein catabolism pathway through which it is rapidly inactivated via its interactions with protease inhibitor α2-antiplasmin or α2-macroglobulin.
Pri intravenski uporabi okriplazmin vstopi v katabolično pot endogene beljakovine, prek katere se hitro inaktivira zaradi interakcije z zaviralcem proteaze α2-antiplazminom ali α2-makroglobulinom.