natgillin/translations-raw huggingface dataset:
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax Disperzi.
Pri bolnikih, ki so jemali zdravilo Olazax Disperzi, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
BN
Pri
Excipient with known effect: Each orodispersible tablet contains 0.46 mg aspartame For the full list of excipients see section 6.1
Pomožne snov z znanim učinkom : Ena orodisperzibilna tableta vsebuje 0,46 mg aspartama.
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 20 mg orodispersible tablets
IME ZDRAVILA Olazax Disperzi 20 mg orodisperzibilne tablete
Yellow coloured circular flat bevelled edge orodispersible tablets with ‘B' debossed on one side.
Rumene, okrogle, ploščate tablete z zaobljenim robom in oznako 'B' na eni strani.
NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glenmark Pharmaceuticals s.r.o.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg olanzapine.
Ena orodisperzibilna tableta vsebuje 10 mg olanzapina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg olanzapine.
Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.
Excipient with known effect: Each orodispersible tablet contains 0.35 mg aspartame For the full list of excipients see section 6.1
Pomožne snov z znanim učinkom : Ena orodisperzibilna tableta vsebuje 0,35 mg aspartama.
Transient, asymptomatic elevations of hepatic aminotransferases , alanine transferase (ALT), aspartatetransferase (AST) have been seen commonly, especially in early treatment.
Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, ALT in AST, posebno na začetku zdravljenja.
Yellow coloured circular flat bevelled edge orodispersible tablets with ‘C' debossed on one side.
Rumene, okrogle, ploščate tablete z zaobljenim robom in oznako 'C' na eni strani.
Olazax Disperzi 5 mg orodispersible tablets
Olazax Disperzi 5 mg orodisperzibilne tablete olanzapin
Very common symptoms in overdose (> 10 % incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca > 10 %) vključujejo tahikardijo,
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 5 mg orodispersible tablets
IME ZDRAVILA Olazax Disperzi 5 mg orodisperzibilne tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine.
Ena orodisperzibilna tableta vsebuje 5 mg olanzapina.
The recommended starting dose is 10 mg/day.
Preprečevanje ponovnega pojava bolezni pri bipolarni motnji: Priporočeni začetni odmerek je 10 mg na dan.
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 10 mg orodispersible tablets
IME ZDRAVILA Olazax Disperzi 10 mg orodisperzibilne tablete
15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 4,39 mmol/l
Talk to your doctor or pharmacist before you take Olazax Disperzi.
Pred začetkom jemanja zdravila Olazax Disperzi se posvetujte s svojim zdravnikom ali s farmacevtom.
INFORMATION IN BRAILLE Olazax Disperzi 10 mg orodispersible tablets 17.
PODATKI V BRAILLOVI PISAVI Olazax Disperzi 10 mg orodisperzibilne tablete
Excipient with known effect: Each orodispersible tablet contains 0.23 mg aspartame For the full list of excipients see section 6.1
Pomožne snov z znanim delovanjem: Ena orodisperzibilna tableta vsebuje 0,23 mg aspartama.
INFORMATION IN BRAILLE Olazax Disperzi 5 mg orodispersible tablets 17.
PODATKI V BRAILLOVI PISAVI Olazax Disperzi 5 mg orodisperzibilne tablete
Olazax Disperzi 15 mg orodispersible tablets
Olazax Disperzi 15 mg orodisperzibilne tablete olanzapin
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine Excipient with known effect: Each orodispersible tablet contains 0.92 mg aspartame For the full list of excipients see section 6.1
Pomožne snov z znanim učinkom : Ena orodisperzibilna tableta vsebuje 0,92 mg aspartama.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥0.01% and < 0.1%) when olanzapine is stopped abruptly.
Prekinitev zdravljenja Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
• Stroke or “mini” stroke (temporary symptoms of stroke)
možgansko kap ali »majhno« možgansko kap (prehodni znaki kapi) Parkinsonovo bolezen težave s prostato zaporo črevesa (paralitični ileus)
Eosinophili a and
Ginekomastija/p
Olazax Disperzi contains the active substance olanzapine.
Zdravilo Olazax Disperzi vsebuje vir fenilalanina.
Orodispersible tablet
FARMACEVTSKA OBLIKA orodisperzibilna tableta
Yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'F' na drugi strani.
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
• Weight gain has been seen in patients taking Olazax Disperzi.
Pri bolnikih, ki so jemali zdravilo Olazax Disperzi, so opazili porast telesne teže.
sleepiness, agitation, breathing problems, and difficulty in feeding.
nespečnost, tresenje, tesnoba, slabost in bruhanje.
(≥ 5.17 mmol/l) were observed commonly.
(≥ 5,56 mmol/l - < 7 mmol/l) na visoke (≥ 7 mmol/l).
If you forget to take Olazax Disperzi Take your tablets as soon as you remember.
Če ste vzeli večji odmerek zdravila Olazax Disperzi, kot bi smeli
Yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 15 mg orodispersible tablets Olanzapine
IME ZDRAVILA Olazax Disperzi 15 mg orodisperzibilne tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 15 mg orodispersible tablets Olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
PODATKI V BRAILLOVI PISAVI Olazax Disperzi 15 mg orodisperzibilne tablete EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
MARKETING AUTHORISATION NUMBER(S) EU/1/09/592/005
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/592/005
MARKETING AUTHORISATION NUMBER(S) EU/1/09/592/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/592/004
MARKETING AUTHORISATION NUMBER(S) EU/1/09/592/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/592/002
• Liver or kidney disease
Bolezni jeter, žolčnika in žolčevodov
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 20 mg orodispersible tablets Olanzapine
Olazax Disperzi 20 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 7.5 mg orodispersible tablets Olanzapine
Olazax Disperzi 7,5 mg orodisperzibilne tablete olanzapin
MARKETING AUTHORISATION NUMBER(S) EU/1/09/592/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/592/001
MARKETING AUTHORISATION NUMBER(S) EU/1/09/592/003
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/592/003
Intravenous use, subcutaneous use Vial (glass) 20 ml
10 mg/ml raztopina za injiciranje psi in mačke intravenska uporaba, subkutana uporaba viala (steklo) 20 ml
1 vial
1 viala ni smiselno
Date of first authorisation: 19 March 2015
Datum prve odobritve: 19. Marec 2015
• Tilt your head back and look up at the ceiling.
• Glavo nagnite nazaj in poglejte v strop.
However, no special considerations are needed in these populations.
Vendar pa pri teh populacijah ni potrebna posebna previdnost.
Effects on the immune system
Učinki na imunski sistem
The difference was not statistically significant (p=0.326).
Razlika ni bila statistično značilna (p = 0,326).
Response to treatment should be reassessed at least every 6 months.
Odziv na zdravljenje je treba ponovno oceniti vsaj vsakih 6 mesecev.
Do not put in any more drops until it is time for your next regular dose.
Ne uporabite več kapljic, dokler ni čas za naslednji redni odmerek.
Each single-dose container is sufficient to treat both eyes.
En enoodmerni vsebnik zadošča za zdravljenje obeh očes.
Any unused emulsion should be discarded immediately.
Neporabljeno emulzijo je treba takoj zavreči.
• If you use drops in both eyes, repeat the steps for your other eye.
• Če kapljice uporabljate za obe očesi, korake ponovite še za drugo oko.
- if you are taking any medicines containing steroids.
- če jemljete katera koli zdravila, ki vsebujejo steroide.
EU/1/15/990/001 EU/1/15/990/002
EU/1/15/990/001
• Blink a few times so that the medicine covers your eye.
• Nekajkrat zamežiknite, da zdravilo prekrije vaše oko.
To reduce the systemic absorption, see section 4.2.
Za zmanjšanje sistemske absorpcije glejte poglavje 4.2.
Patients should be advised not to drive or use machines until their vision has cleared.
Bolnikom je treba svetovati, naj ne vozijo in ne uporabljajo strojev, dokler se jim vid ne zbistri.
If you forget to use IKERVIS, continue with the next dose as planned.
Če ste pozabili uporabiti zdravilo IKERVIS, nadaljujte z naslednjim odmerkom, kot je načrtovano.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicine.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
After the 24-month period, 61.3% of 62 patients included in the primary efficacy population did not experience a relapse based on CFS scores.
Po 24mesečnem obdobju 61,3 % od 62 bolnikov, vključenih v primarno populacijo učinkovitosti, ni imelo recidiva na podlagi rezultatov CFS.
67 patients were enrolled (37.9% of the 177 patients having ended Sansika).
Vključenih je bilo 67 bolnikov (37,9 % od 177 bolnikov, ki so zaključili študijo Sansika).
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
You should visit your doctor at least every 6 months to assess the effect of IKERVIS.
Zdravnika morate obiskati vsaj vsakih 6 mesecev, da oceni učinek zdravila IKERVIS.
The most common side effects are in and around the eyes.
Najpogostejši neželeni učinki so v očesu in okoli njega.
Pre-existing infections may also be aggravated (see section 4.3).
Poslabšajo se lahko tudi že obstoječe okužbe (glejte poglavje 4.3).
Elderly patients The elderly population has been studied in clinical studies.
Starejšo populacijo so preučili v kliničnih študijah.
The beneficial effect on keratitis was maintained in the open phase of the study, from Month 6 and up to Month 12.
Koristni učinki na keratitis so se ohranili v odprti fazi študije, od 6. meseca do 12. meseca.
It is likely to be attributable to ciclosporin.
Verjetno ga je treba pripisati ciklosporinu.
This helps to stop IKERVIS getting into the rest of the body.
To pomaga preprečiti, da bi zdravilo IKERVIS prešlo v preostali del telesa.
At completion of the SANSIKA study (12 month study), patients were asked to enter the Post SANSIKA study.
Ob zaključku študije SANSIKA (12-mesečna študija) so bolnike prosili, da vstopijo v študijo Post SANSIKA.
• Discard the single dose container as soon as you have used it, even if there is still some liquid left in it.
• Enoodmerni vsebnik zavrzite takoj, ko ga uporabite, četudi je v njem še nekaj tekočine.
After 12 months of treatment, values were below the low limit of detection for 56 patients and below the low limit of quantification in 19 patients.
Po 12. mesecih zdravljenja so bile vrednosti pod spodnjo mejo detekcije za 56 bolnikov in pod spodnjo mejo kvantifikacije za 19 bolnikov.
Assessment of DED symptoms by VAS showed a worsening of patient's discomfort from the time treatment was first stopped to the time it was restarted except pain which remained relatively low and stable.
Ocena simptomov DED po VAS je pokazala poslabšanje nelagodja bolnikov od časa prve ustavitve zdravljenja do časa nadaljevanja, razen bolečine, ki je ostala relativno nizka in stabilna.
This may result in a decrease in systemic undesirable effects and an increase in local activity (see section 4.4).
To lahko zmanjša sistemske neželene učinke in poveča lokalno aktivnost (glejte poglavje 4.4).
Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after instillation, to reduce the systemic absorption.
Bolnikom je treba naročiti, naj uporabljajo nazolakrimalno okluzijo ali zaprejo veke za 2 minuti po vkapanju, da se sistemska absorpcija zmanjša.
This study was designed to monitor the long-term efficacy and relapse rates in patients who have previously received IKERVIS.
Ta študija je bila zasnovana za spremljanje dolgotrajne učinkovitosti in stopenj recidiva pri bolnikih, ki so predhodno prejemali zdravilo IKERVIS.
If a dose is missed, treatment should be continued on the next day as normal.
Če bolnik odmerek izpusti, je treba z zdravljenjem nadaljevati naslednji dan kot običajno.
The median global VAS score increased from the time treatment was first stopped (23.3%) to the time treatment was restarted (45.1%).
Mediani globalni rezultat VAS se je od časa prve ustavitve zdravljenja (23,3 %) do časa nadaljevanja zdravljenja (45,1 %) povečal.
If you could become pregnant you must use contraception while using this medicine.
Če lahko zanosite, morate med uporabo tega zdravila uporabljati kontracepcijo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
The proportion of responders in the IKERVIS group was 28.6%, compared to 23.1% in the vehicle group.
Delež odzivnih bolnikov v skupini z zdravilom IKERVIS je bil 28,6 % v primerjavi s 23,1 % v skupini z vehiklom.
Patients wearing contact lenses have not been studied.
Uporabe pri bolnikih, ki nosijo kontaktne leče, niso preučili.
• After using IKERVIS, press a finger into the corner of your eye by the nose and close gently the eyelids for 2 minutes (picture 3).
• Po uporabi zdravila IKERVIS s prstom pritisnite na kot očesa pri nosu in veko 2 minuti nežno masirajte (slika 3).
Pack sizes: 30 and 90 single-dose containers.
Velikosti pakiranja: 30 in 90 enoodmernih vsebnikov.
Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when Ikervis is used for years.
Zato se priporočajo redni pregledi očesa (očes), npr. vsaj vsakih 6 mesecev, če se zdravilo IKERVIS daje več let.
If overdose with IKERVIS occurs, treatment should be symptomatic and supportive.
V primeru prevelikega odmerjanja zdravila IKERVIS naj bo zdravljenje simptomatsko in podporno.
- if you have had or have a cancer in or around your eye. - if you have an eye infection.
- če imate ali ste kdaj imeli raka na očesu ali okoli njega.
Careful monitoring of patients with severe keratitis is recommended.
Priporoča se natančno spremljanje bolnikov s hudim keratitisom.
This medicinal product may induce temporary blurred vision or other visual disturbances which may affect the ability to drive or use machines (see section 4.8).
To zdravilo lahko povzroči začasno zamegljenost vida ali druge motnje vida, ki lahko vplivajo na sposobnost vožnje ali upravljanja strojev (glejte poglavje 4.8).
What IKERVIS is and what it is used for 2.
Kaj je zdravilo IKERVIS in za kaj ga uporabljamo 2.
Ikervis should not be used if you are pregnant.
Zdravila IKERVIS ne smete uporabljati, če ste noseči.
What you need to know before you use IKERVIS 3.
Kaj morate vedeti, preden boste uporabili zdravilo IKERVIS 3.
Other medicines and IKERVIS
Druga zdravila in zdravilo IKERVIS
In both studies one third of the patients in average had Sjögren's syndrome; as for the overall population, a statistically significant improvement in CFS in favour of IKERVIS was observed in this subgroup of patients.
V obeh študijah je imela Sjögrenov sindrom povprečno ena tretjina bolnikov; kot za celotno populacijo so tudi za to podskupino bolnikov opazili statistično značilno izboljšanje po CFS v korist zdravila IKERVIS.
SANTEN Oy
Francija SANTEN Oy
All available evidence suggests that ciclosporin acts specifically and reversibly on lymphocytes and does not depress haematopoiesis or has any effect on the function of phagocytic cells..
Vsi razpoložljivi dokazi kažejo, da deluje ciklosporin specifično in reverzibilno na limfocite in ne zavira hematopoeze in nima vpliva na delovanje fagocitnih celic.
IKERVIS is likely to be present in breast milk in very small amounts.
Verjetno je, da je zdravilo IKERVIS v materinem mleku prisotno v zelo majhnih količinah.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom IKERVIS, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Ciclosporin belongs to a group of medicines known as immunosuppressive agents that are used to reduce inflammation.
Ciklosporin sodi v skupino zdravil, znanih kot imunosupresivi, ki se uporabljajo za zmanjšanje vnetja.
Measurable values not exceeding 0.206 ng/mL were measured in eight patients, values considered to be negligible.
Merljive vrednosti, ki niso presegle 0,206 ng/ml, so izmerili pri osmih bolnikih, vendar veljajo vrednosti za zanemarljive.
Caution should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.
Previdnost je potrebna pri zdravljenju teh bolnikov sočasno z zdravilom IKERVIS, zlasti z zaviralci beta, za katere je znano, da zmanjšujejo izločanje solz.
Patients should be advised not to instil more than one drop in the affected eye(s).
Bolniku je treba naročiti, naj si v prizadeto oko (očesi) ne nakapa več kot ene kapljica.
Do not use a double dose to make up for the forgotten dose.
Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
The following side effects have been reported:
Poročali so o naslednjih neželenih učinkih:
IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients.
Zdravila IKERVIS niso preučili pri bolnikih z očesnim herpesom v anamnezi, zato ga je treba pri takih bolnikih uporabljati previdno.
In Post SANSIKA study patients alternatively received IKERVIS treatment or no treatment depending on CFS score (patients received IKERVIS when there was a worsening of keratitis).
V študiji Post SANSIKA so bolniki alternativno prejemali zdravljenje z zdravilom IKERVIS ali nobenega zdravljenja, odvisno od rezultata CFS (bolniki so prejemali zdravilo IKERVIS ob poslabšanju keratitisa).
The co-primary endpoints were the change in CFS score, and the change in global score of ocular discomfort unrelated to study medication instillation, both measured at Month 6.
Sočasni primarni opazovani dogodki so bili sprememba rezultata CFS in sprememba globalnega rezultata očesnega nelagodja, nepovezanega z vkapavanjem študijskega zdravila, oboje izmerjeno v 6. mesecu.
The most common adverse reactions were eye pain (19.2%), eye irritation (17.8%), lacrimation (6.4%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%) which were usually transitory and occurred during instillation.
Najpogostejši neželeni učinki so bili bolečina v očesu (19,2 %), draženje očesa (17,8 %), solzenje (6,4 %), očesna hiperemija (5,5 %) in eritem veke (1,7 %), ki so bili običajno prehodni in so se pojavili med vkapanjem.
Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections.
Bolniki, ki se zdravijo z imunosupresivi, vključno s ciklosporinom, so bolj izpostavljeni tveganju okužbe.
The European Medicines Agency has waived the obligation to submit the results of studies with IKERVIS in all subsets of the paediatric population for dry eye disease (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom IKERVIS za vse podskupine pediatrične populacije s sindromom suhega očesa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended dose is one drop in each affected eye, once daily at bedtime.
Priporočeni odmerek je ena kapljica v vsako prizadeto oko, enkrat na dan pred spanjem.
Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not understand.
Navodila za uporabo Natančno upoštevajte ta navodila in se posvetujte z zdravnikom ali farmacevtom, če česa ne razumete.
One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).
En mililiter emulzije vsebuje 0,05 mg cetalkonijevega klorida (glejte poglavje 4.4).
Studies in animals suggest that ciclosporin inhibits the development of cell-mediated reactions.
Študije pri živalih kažejo, da ciklosporin zavira razvoj reakcij, pri katerih posredujejo celice.
Seven patients had measurable values (from 0.105 to 1.27 ng/mL), all considered to be negligible values.
Sedem bolnikov je imelo merljive vrednosti (od 0,105 do 1,27 ng/ml), vendar so vrednosti veljale za zanemarljive.
CLINICAL PARTICULARS 4.1 Therapeutic indication
4.1 Terapevtska indikacija
IKERVIS is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Zdravila IKERVIS ne uporabljajte pri nosečnicah, razen če je možna korist za mater večja kot možno tveganje za zarodek.
One case of severe epithelial erosion of the cornea identified as corneal decompensation by the investigator resolved without sequeleae was reported.
En poročan primer hude erozije epitelija roženice, ki ga je raziskovalec opisal kot roženično dekompenzacijo, je izzvenel brez posledic.
It is also known to up-regulate the release of anti-inflammatory cytokines.
Znano je tudi, da zvišuje sproščanje protivnetnih citokinov.
• Pull down your lower eyelid (picture 2).
• Spodnjo veko povlecite navzdol (slika 2).
After 6 months of ocular instillation of IKERVIS once per day, 327 patients had values below the lower limit of detection (0.050 ng/mL) and 35 patients were below the lower limit of quantification (0.100 ng/mL).
IKERVIS v oko enkrat na dan je imelo 327 bolnikov vrednosti pod spodnjo mejo detekcije (0,050 ng/ml) in 35 bolnikov je bilo pod spodnjo mejo kvantifikacije (0,100 ng/ml).
SANTEN Oy Niittyhaankatu 20 33720 Tampere Finland
Niittyhaankatu 20 33720 Tampere
In 374 patients from the two efficacy studies, plasma concentrations of ciclosporin were measured before administration and after 6 months (SICCANOVE study and SANSIKA study) and 12 months of treatment (SANSIKA study).
Pri 374 bolnikih iz dveh študij učinkovitosti so koncentracije ciklosporina v plazmi izmerili pred dajanjem in po 6. mesecih (študija SICCANOVE in študija SANSIKA) in po 12. mesecih zdravljenja (študija SANSIKA).