natgillin/translations-raw huggingface dataset:
The following additional adverse reactions have been observed with Exelon transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Pri uporabi transdermalnih obližev Exelon so dodatno opažali še naslednje neželene učinke: delirij, zvišano telesno temperaturo, zmanjšan apetit, urinska inkontinenca (pogosto), psihomotorična hiperaktivnost (občasno), eritem, urtikarija, mehurčki, alergijski dermatitis (pogostnost neznana).
Exelon transdermal patches 9.5 mg/24 h N = 251
Exelon transdermalni obliži 9,5 mg/24 h N = 251
In pregnant animals, rivastigmine and /or metabolites crossed the placenta.
Pri brejih živalih so rivastigmin in/ali njegovi presnovki prehajali skozi posteljico.
What Exelon is and what it is used for What you need to know before you take Exelon How to take Exelon
Kaj je zdravilo Exelon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Exelon Kako jemati zdravilo Exelon Možni neželeni učinki
Patients with severe hepatic impairment have not been studied, however, Exelon oral solution may be used in this patient population provided close monitoring is exercised (see sections 4.4 and 5.2).
Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili, bolniki iz te populacije lahko kljub temu uporabljajo zdravilo Exelon peroralno raztopino, vendar jih je treba skrbno spremljati (glejte poglavji 4.4 in 5.2).
What you need to know before you take Exelon
Kaj morate vedeti, preden boste vzeli zdravilo Exelon
What Exelon looks like and contents of the pack Exelon oral solution is supplied as 50 ml or 120 ml of a clear, yellow solution (2.0 mg/ml base) in an amber glass bottle with a child-resistant cap, foam liner, dip tube and self aligning plug.
Peroralna raztopina Exelon je na voljo v obliki 50 ml ali 120 ml bistre rumene raztopine (2,0 mg/ml baze), v jantarno obarvani steklenici z za otroke varno zaporko, oblogo iz penaste gume, s kapalnim vložkom in s prilegajočim se zamaškom.
What Exelon contains - The active substance is rivastigmine.
Kaj vsebuje zdravilo Exelon - Učinkovina je rivastigmin.
There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer's disease.
Zdravila Exelon ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Each Exelon 6.0 mg capsule contains 6.0 mg of rivastigmine.
Vsaka kapsula Exelon 6,0 mg vsebuje 6,0 mg rivastigmina.
Each Exelon 1.5 mg capsule contains 1.5 mg of rivastigmine.
Vsaka kapsula Exelon 1,5 mg vsebuje 1,5 mg rivastigmina.
You should not breast-feed during treatment with Exelon transdermal patches.
Med zdravljenjem s transdermalnimi obliži Exelon ne smete dojiti.
What Exelon contains - The active substance is rivastigmine hydrogen tartrate.
Kaj vsebuje zdravilo Exelon - Učinkovina je rivastigminijev hidrogentartrat.
Other side effects seen with Exelon capsules or oral solution and which may occur with the patch:
Drugi neželeni učinki, ki so jih opažali pri uporabi kapsul ali peroralne raztopine Exelon in bi se lahko pojavili tudi pri uporabi obližev:
Transdermal patches Rivastigmine in vivo release rates per 24 h
Odmerjanje transdermalni obliži hitrost sproščanja rivastigmina na 24 ur in vivo
The outside of the backing layer is beige and labelled with “Exelon”, “4.6 mg/24 h” and “AMCX”.
Zunanji del krovne plasti je rjavkasto bele (beige) barve z oznakami “Exelon”, “4.6 mg/24 h” in “AMCX”.
What Exelon looks like and contents of the pack - Exelon 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on the body.
Izgled zdravila Exelon in vsebina pakiranja - Exelon 1,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rumen pokrovček in rumeno telo kapsule z rdečim napisom “EXELON 1,5 mg”.
- Exelon 4.6 mg/24 h transdermal patches: Each patch releasing 4.6 mg of rivastigmine per 24 hours is 5 cm and contains 9 mg of rivastigmine.
- Exelon 4,6 mg/24 h transdermalni obliži: vsak obliž, ki sprosti 4,6 mg rivastigmina na 24 ur, je velik 5 cm in vsebuje 9 mg rivastigmina.
The active substance of Exelon is rivastigmine.
Zdravilna učinkovina v zdravilu Exelon je rivastigmin.
- Exelon 9.5 mg/24 h transdermal patches: Each patch releasing 9.5 mg of rivastigmine per 24 hours is 10 cm and contains 18 mg of rivastigmine.
- Exelon 9,5 mg/24 h transdermalni obliži: vsak obliž, ki sprosti 9,5 mg rivastigmina na 24 ur, je velik 10 cm in vsebuje 18 mg rivastigmina.
Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules rivastigmine
Exelon 1,5 mg trde kapsule Exelon 3,0 mg trde kapsule Exelon 4,5 mg trde kapsule Exelon 6,0 mg trde kapsule rivastigmin
One of the excipients in Exelon oral solution is sodium benzoate.
Ena od pomožnih snovi peroralne raztopine Exelon je natrijev benzoat.
Although less pronounced than with the oral formulation, exposure to rivastigmine (Cmax and AUC) increased over-proportionally by a factor of 2.6 and 4.9 when escalating from 4.6 mg/24 h to 9.5 mg/24 h and to 13.3 mg/24 h, respectively.
Čeprav manj izrazito kot pri peroralnem odmerjanju, se je pri stopnjevanju z odmerka 4,6 mg/24 h na 9,5 mg/24 h oziroma na 13,3 mg/24 h izpostavljenost rivastigminu (Cmax in
ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Exelon 15 cm as compared to Exelon 10 cm
DLSM - razlika po metodi najmanjših kvadratov (angl. difference in least square means) LOCF - metoda prenosa zadnje ocene naprej (angl. Last Observation Carried Forward) ocene pri lestvici ADAS-cog: negativna vrednost razlike po metodi najmanjših kvadratov pomeni večje izboljšanje pri uporabi obliža Exelon 15 cm kot pri uporabi obliža Exelon 10 cm ocene pri lestvici ADCS-IADL: pozitivna vrednost razlike po metodi najmanjših kvadratov pomeni večje izboljšanje pri uporabi obliža Exelon 15 cm kot pri uporabi obliža Exelon 10 cm
Each Exelon 4.5 mg capsule contains 4.5 mg of rivastigmine.
Vsaka kapsula Exelon 4,5 mg vsebuje 4,5 mg rivastigmina.
Exelon 13.3 mg/24 h transdermal patches: Each patch releasing 13.3 mg of rivastigmine per 24 hours is 15 cm and contains 27 mg of rivastigmine.
- Exelon 13,3 mg/24 h transdermalni obliži: vsak obliž, ki sprosti 13,3 mg rivastigmina na 24 ur, je velik 15 cm in vsebuje 27 mg rivastigmina.
No specific interaction studies have been performed with Exelon transdermal patches.
S transdermalnimi obliži Exelon niso izvedli specifičnih študij medsebojnega delovanja.
Each Exelon 3.0 mg capsule contains 3.0 mg of rivastigmine.
Vsaka kapsula Exelon 3,0 mg vsebuje 3,0 mg rivastigmina.
Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of Exelon transdermal patch.
Med neželenimi učinki, ki so jih opažali pri uporabi transdermalnega obliža Exelon, so najbolj pogoste kožne reakcije na mestu apliciranja (običajno blaga do zmerna rdečina kože na mestu apliciranja).
How to remove your Exelon transdermal patch
Kako odstraniti transdermalni obliž Exelon
When and for how long to apply your Exelon transdermal patch
Kdaj namestiti transdermalni obliž Exelon in za koliko časa
Always use Exelon transdermal patches exactly as your doctor has told you.
Pri uporabi transdermalnih obližev Exelon natančno upoštevajte navodila zdravnika.
Exelon should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Zdravila Exelon ne smete jemati sočasno z metoklopramidom (zdravilom, ki ga uporabljamo za ublažitev ali preprečevanje navzee (slabosti s siljenjem na bruhanje) in bruhanja).
How to use Exelon
Kako uporabljati zdravilo Exelon
The patient's weight should be monitored during therapy with Exelon transdermal patches.
Med zdravljenjem s transdermalnimi obliži Exelon je treba spremljati bolnikovo telesno maso.
The outside of the backing layer is beige and labelled with “Exelon”, “13.3 mg/24 h” and “CNFU”.
Zunanji del krovne plasti je rjavkasto bele (beige) barve z oznakami “Exelon”, “13.3 mg/24 h” in “CNFU”.
Where to apply your Exelon transdermal patch
Kam namestiti transdermalni obliž Exelon
The outside of the backing layer is beige and labelled with “Exelon”, “9.5 mg/24 h” and “BHDI”.
Zunanji del krovne plasti je rjavkasto bele (beige) barve z oznakami “Exelon”, “9.5 mg/24 h” in “BHDI”.
You should not breast-feed during treatment with Exelon.
Med zdravljenjem z zdravilom Exelon ne smete dojiti.
Exelon 4.6 mg/24 h transdermal patch Exelon 9.5 mg/24 h transdermal patch Exelon 13.3 mg/24 h transdermal patch rivastigmine
Exelon 4,6 mg/24 h transdermalni obliž Exelon 9,5 mg/24 h transdermalni obliž Exelon 13,3 mg/24 h transdermalni obliž rivastigmin
Exelon 4.6 mg/24 h transdermal patch Exelon 9.5 mg/24 h transdermal patch Exelon 13.3 mg/24 h transdermal patch
Exelon 4,6 mg/24 h transdermalni obliž Exelon 9,5 mg/24 h transdermalni obliž Exelon 13,3 mg/24 h transdermalni obliž
Exelon transdermal patches 9.5 mg/24 h
Exelon transdermalni obliži 9,5 mg/24 h
Caution when Exelon is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Previdnost je potrebna pri sočasni uporabi zdravila Exelon in katerega od antagonistov adrenergičnih receptorjev beta (učinkovin, kot je atenolol, ki ga uporabljamo za zdravljenje visokega krvnega tlaka, angine pektoris in drugih bolezni srca).
- Exelon 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “EXELON 4,5 mg” on the body.
- Exelon 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo kapsule z belim napisom “EXELON 4,5 mg”.
Exelon 1.5 mg hard capsules
Exelon 1,5 mg trde kapsule
1 transdermal patch per sachet
1 transdermalni obliž na vrečko
Exelon 1.5 mg hard capsules rivastigmine
Exelon 1,5 mg trde kapsule rivastigmin
- Exelon 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “EXELON 3 mg” on the body.
- Exelon 3,0 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo kapsule z rdečim napisom “EXELON 3 mg”.
Exelon 4.5 mg hard capsules
Exelon 4,5 mg trde kapsule
Exelon 2 mg/ml oral solution rivastigmine
Exelon 2 mg/ml peroralna raztopina rivastigmin
Exelon 6.0 mg hard capsules
Exelon 6,0 mg trde kapsule
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “EXELON 4,5 mg” on body.
Belkast do rahlo rumen prašek v kapsuli z rdečim pokrovčkom in rdečim telesom kapsule z belim napisom “EXELON 4,5 mg”.
- Exelon 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “EXELON 6 mg” on the body.
- Exelon 6,0 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo kapsule z rdečim napisom “EXELON 6 mg”.
• Uneven heartbeat and poor control of movements Other side effects seen with Exelon transdermal patches and which may occur with the hard capsules:
Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev Exelon in bi se lahko pojavili tudi pri uporabi trdih kapsul:
Exelon 3.0 mg hard capsules
Exelon 3,0 mg trde kapsule
Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with Exelon transdermal patches.
Pri bolnikih z Alzheimerjevo boleznijo, ki so jih zdravili s transdermalnimi obliži Exelon, starost ni vplivala na izpostavljenost rivastigminu.
Exelon 4.6 mg/24 h transdermal patch rivastigmine
Exelon 4,6 mg/24 h transdermalni obliž rivastigmin
Exelon 4.5 mg hard capsules rivastigmine
Exelon 4,5 mg trde kapsule rivastigmin
Exelon 9.5 mg/24 h transdermal patch rivastigmine
Exelon 9,5 mg/24 h transdermalni obliž rivastigmin
Exelon 6.0 mg hard capsules rivastigmine
Exelon 6,0 mg trde kapsule rivastigmin
Exelon 13.3 mg/24 h transdermal patch rivastigmine
Exelon 13,3 mg/24 h transdermalni obliž rivastigmin
Exelon 3.0 mg hard capsules rivastigmine
Exelon 3,0 mg trde kapsule rivastigmin
How to apply your Exelon transdermal patch
Kako namestiti transdermalni obliž Exelon
Exelon 2 mg/ml oral solution
Exelon 2 mg/ml peroralna raztopina
Exelon 4.6 mg/24 h transdermal patch
Exelon 4,6 mg/24 h transdermalni obliž
42 transdermal patches (sachet: paper/PET/PE/alu/PA)
42 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on body.
Belkast do rahlo rumen prašek v kapsuli z rumenim pokrovčkom in rumenim telesom kapsule z rdečim napisom “EXELON 1,5 mg”.
Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “EXELON 6 mg” on body.
Belkast do rahlo rumen prašek v kapsuli z rdečim pokrovčkom in oranžnim telesom kapsule z rdečim napisom “EXELON 6 mg”.
Exelon might interfere with anticholinergic medicines some of which are medicines used to relieve stomach cramps or spasms (e.g. dicyclomine), to treat Parkinson's disease (e.g. amantadine) or to prevent motion sickness (e.g. diphenhydramine, scopolamine, or meclizine).
ki se uporabljajo za lajšanje želodčnih krčev (npr. diciklomin), za zdravljenje Parkinsonove bolezni (npr. amantadin) ali za preprečevanje potovalne slabosti (npr. difenhidramin, skopolamin ali meklizin) oziroma ta zdravila lahko vplivajo na rivastigmin.
Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “EXELON 3 mg” on body.
Belkast do rahlo rumen prašek v kapsuli z oranžnim pokrovčkom in oranžnim telesom kapsule z rdečim napisom “EXELON 3 mg”.
How to take Exelon
Kako jemati zdravilo Exelon
42 transdermal patches (sachet: paper/PET/alu/PAN)
42 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Izgled zdravila Exelon in vsebina pakiranja
Exelon 13.3 mg/24 h transdermal patch
Exelon 13,3 mg/24 h transdermalni obliž
Exelon 9.5 mg/24 h transdermal patch
Exelon 9,5 mg/24 h transdermalni obliž
No study was conducted with Exelon transdermal patches in subjects with hepatic impairment.
Pri osebah z okvaro jeter niso opravili nobene študije s transdermalnimi obliži Exelon.
7 transdermal patches (sachet: paper/PET/PE/alu/PA)
7 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
84 transdermal patches (sachet: paper/PET/PE/alu/PA)
84 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
60 transdermal patches (sachet: paper/PET/PE/alu/PA)
60 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
- if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
Ne jemljite zdravila Exelon - če ste alergični na rivastigmin (zdravilno učinkovino v zdravilu Exelon) ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če opazite kožno reakcijo, ki se širi preko površine, ki jo pokriva transdermalni obliž, če je reakcija na tem mestu močneje izražena (če se pojavijo mehurčki, če je vnetje oziroma oteklina vse bolj izrazita) in če se ti znaki v 48 urah po odstranitvi transdermalnega obliža ne izboljšajo.
90 transdermal patches (sachet: paper/PET/PE/alu/PA)
90 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
30 transdermal patches (sachet: paper/PET/PE/alu/PA)
30 transdermalnih obližev (vrečka: papir/PET/PE/alu/PA)
No study was conducted with Exelon transdermal patches in subjects with renal impairment.
Pri osebah z okvaro ledvic niso opravili nobene študije s transdermalnimi obliži Exelon.
7 transdermal patches (sachet: paper/PET/alu/PAN)
7 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
• Uneven heartbeat and poor control of movements Other side effects seen with Exelon transdermal patches and which may occur with the oral solution:
Drugi neželeni učinki, ki so jih opažali pri uporabi transdermalnih obližev Exelon in bi se lahko pojavili tudi pri uporabi peroralne raztopine:
84 transdermal patches (sachet: paper/PET/alu/PAN)
84 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
60 transdermal patches (sachet: paper/PET/alu/PAN)
60 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
90 transdermal patches (sachet: paper/PET/alu/PAN)
90 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
30 transdermal patches (sachet: paper/PET/alu/PAN)
30 transdermalnih obližev (vrečka: papir/PET/alu/PAN)
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase
In vitro kaže ta presnovek zelo majhno stopnjo zaviranja holinesteraze (< 10 %).
Baseline 265 27.5 271 25.8 Week 48 Value
Povprečje ob izhodišču  SD 27,0  10,3 Povprečna sprememba po 24 tednih  SD
(picture 8).
(slika 8).
Each box contains:
Vsaka škatla vsebuje:
Monitoring is required.
Potrebno je spremljanje.
Date of first authorisation: 19 January 2017 10.
Datum prve odobritve: 19 januar 2017
You can usually carry on taking the drops, unless the effects are serious.
Običajno lahko nadaljujete z uporabo kapljic, razen če so učinki resni.
OCT-1 study
Študija OCT-1
• Repeat the step 3 for the other eye.
• Ponovite 3. korak za drugo oko.
The treatment should not be stopped.
Zdravljenja ne smemo prekiniti.
If a drop misses your eye Try again.
Če kapljica zgreši oko Poskusite znova.
19 patients were under 6 years old, 21 between 6 and 12 years old and 29 between 12 and 18 years old.
19 bolnikov je bilo mlajših od 6 let, 21 bolnikov je bilo starih od 6 do 12 let, 29 bolnikov pa od 12 do 18 let.
• You must throw away the dropper bottle 7 days after you first opened it even if it is not empty.
• Kapalno steklenico morate zavreči 7 dni po tem, ko ste jo prvič odprli, čeprav ni prazna.
Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Pogostnost je opredeljena kot: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The majority of these adverse reactions are transient and most are mild or moderate.
Večina teh neželenih učinkov je prehodnih in blagih ali zmernih.
It will facilitate the use of the drops.
To bo olajšalo uporabo kapljic.
Do not drive or use machines until your vision is clear.
Ne vozite in ne uporabljajte strojev, dokler vaš vid ni oster.
Frequency, type and severity of adverse reactions in children are the same as in adults.
Pogostost, vrsta in resnost neželenih učinkov pri otrocih so enake kot pri odraslih.
Before first opening: store in a refrigerator.
Pred prvim odprtjem: shranjujte v hladilniku.
Therefore, oral cysteamine should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
Zato peroralnega cisteamina ne smemo uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno.
• Make sure that you do not lose the small white cap (picture 5) that comes on the top of the dropper.
• Pazite, da ne izgubite majhne bele zaporke (slika 5), ki se namesti na vrh kapalke.
The mean IVCM total score was calculated for 11 patients.
Povprečna skupna ocena IVCM je bila izračunana za 11 bolnikov.
Temporary (in average less than 1 minute) blurred vision or other visual disturbances may affect the ability to drive or use machines.
Začasno (v povprečju manj kot 1 minuto), zamegljen vid ali druge motnje vida vplivajo na sposobnost vožnje ali upravljanja s stroji.
Each carton box contains 1 vial and 1 dropper applicator.
Vsaka kartonska škatla vsebuje 1 vialo in 1 kapalni aplikator.
The recommended interval between each instillation is 4 hours.
Priporočeni časovni presledek med vsakim vkapanjem je 4 ure.
Clinical data on safety and efficacy were collected during the 2 clinical trials (OCT-1 and CHOC studies).
Klinični podatki o varnosti in učinkovitosti so bili zbrani v 2 kliničnih preskušanjih (študiji OCT-1 in CHOC).
CHOC study
Študija CHOC
Photophobia tended to improve over time.
S časom se je izboljšala tudi fotofobija.
After first opening: 7 days.
Po prvem odprtju: 7 dni.
If you wear soft contact lenses
Če nosite mehke kontaktne leče
Therefore talk to your doctor before stopping this treatment.
Zato se pred prenehanjem zdravljenja posvetujte z zdravnikom.
• Get the dropper bottle and a mirror.
• Vzemite kapalno steklenico in ogledalo.
Do not use Cystadrops If you are allergic to cysteamine or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Cystadrops, če ste alergični na cisteamin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The efficacy and safety results are similar in both paediatric and adult populations.
Rezultati učinkovitosti in varnosti so podobni pri otrocih in odraslih.
None of the patients discontinued treatment over the 5 year follow-up.
Po več kot 5 letih spremljanja nobeden od bolnikov ni prekinil zdravljenja.
Do not stop using Cystadrops without speaking to your doctor.
Ne prenehajte z uporabo zdravila Cystadrops brez posveta z zdravnikom.
• Keep Cystadrops at room temperature (it will facilitate the use of the dropper).
• Zdravilo Cystadrops hranite pri sobni temperaturi (to bo olajšalo uporabo kapalke).
This study assessed the safety and efficacy of Cystadrops during 5 years.
V tej študiji so ocenili varnost in učinkovitost zdravila Cystadrops v 5 letih.
The patient should be told to discard the dropper bottle after 7 days of use.
Bolniku je treba svetovati, da zavrže kapalno steklenico po 7 dneh uporabe.
Do not remove the dropper from the vial.
Kapalke ne odstranite z viale.
Dose adaptation was performed following ocular examination.
Odmerek je bil prilagojen po očesnem pregledu.
15 patients were exposed to Cystadrops.
Zdravilu Cystadrops je bilo izpostavljenih 15 bolnikov.
• Hold the dropper bottle, pointing down, between your thumb and fingers.
• Kapalno steklenico držite obrnjeno navzdol med palcem in prsti.
• 1 dropper applicator.
• 1 kapalni aplikator.
Only use the drops in your eyes (ocular use).
Kapljice uporabljajte samo za oči (okularna uporaba).
The drop will go in here (picture 6).
Vanj bo padla kapljica (slika 6).
Cystadrops may be used in paediatric patients from 2 years of age at the same dose as in adults (see section 5.1).
Zdravilo Cystadrops se lahko uporablja pri pediatričnih bolnikih, starejših od 2 let, v enakem odmerku kot pri odraslih (glejte poglavje 5.1).
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.The expiry date refers to the last day of that month.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
This is equivalent to 0.6 g/m2/day in the rat, which is less than half the recommended clinical maintenance dose of cysteamine, i.e. 1.30 g/m2/day.
To pri podganah pomeni 0,6 g/m2/dan, kar je malo manj kot polovica priporočenega kliničnega vzdrževalnega odmerka cisteamina, tj. 1,30 g/m2/dan.
There are no adequate data from the use of cysteamine in pregnant women.
Ni zadostnih podatkov o uporabi cisteamina pri nosečnicah.
The following side effects were reported:
Poročali so o naslednjih neželenih učinkih:
After 30 days of treatment and at a median frequency of 4 instillations per day, an average 30% decrease in the IVCM total score was observed.
Po 30 dneh zdravljenja z mediano pogostnosti 4 vkapanj na dan so ugotovili povprečno zmanjšanje skupne ocene IVCM za 30 %.
• Check the opening date that you wrote down on the carton box.
• Preverite datum odprtja, ki ste ga zapisali na škatlo.
If you use Cystadrops with another eye medicine Ensure that there is at least a 10 minute gap between using Cystadrops and the other eye medicine.
Če uporabljate zdravilo Cystadrops z drugim zdravilom za oči Pazite, da med uporabo zdravila Cystadrops in drugega zdravila za oči preteče vsaj 10 minut.