natgillin/translations-raw huggingface dataset:
The majority of discontinuations in the netarsudil group were associated with ocular adverse reactions, whereas the majority of discontinuations in the timolol group were associated with non-ocular adverse reactions.
Večina prekinitev zdravljenja v skupini, zdravljeni z netarsudilom, je bila povezana z neželenimi učinki na očeh, večina prekinitev zdravljenja v skupini, zdravljeni s timololom, pa je bila povezana z neočesnimi neželenimi učinki.
If you forget to use Rhokiinsa
Če ste pozabili uporabiti zdravilo Rhokiinsa
With the exception of cornea verticillata (see above), no difference in the safety profile for Rhokiinsa has been observed between subjects aged <65 or ≥65 years.
Z izjemo cornee verticillate (glejte zgoraj) med preskušanci, starimi < 65 let, in preskušanci, starimi ≥ 65 let, niso opazili razlik v varnostnem profilu zdravila Rhokiinsa.
Do not use more than one drop in the affected eye(s) once a day.
Ne uporabite več kot ene kapljice na obolelo oko na dan.
• Effects in the eye: Eye redness; fine deposits on the front of the eye and pain where the drops have been put in
• Učinki v očesu: pordelost očesa; drobni depoziti na sprednjem delu očesa in bolečina na mestu vnosa kapljic
• Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper.
• S kapalno konico se ne smete dotakniti očesa, veke, okoliških predelov ali drugih površin.
Contact lenses should be removed prior to instillation of netarsudil and may be reinserted 15 minutes following its administration (see section 4.4).
Pred vkapanjem netarsudila je treba odstraniti kontaktne leče, ki se jih sme ponovno vstaviti 15 minut po dajanju zdravila (glejte poglavje 4.4).
Each ml of solution contains 150 micrograms benzalkonium chloride.
En ml raztopine vsebuje 150 mikrogramov benzalkonijevega klorida.
It is unknown whether netarsudil/metabolites are excreted in human milk.
Ni znano, ali se netarsudil/presnovki izločajo v materino mleko.
After opening the bottle: Do not store above 25°C.
Po odprtju plastenke: shranjujte pri temperaturi do 25 °C.
The most frequently reported adverse reactions associated with discontinuation in the Rhokiinsa groups were conjunctival hyperemia (5.8%), cornea verticillata (3.7%) and vision blurred (1.4%).
Neželeni učinki, o katerih so najpogosteje poročali in so bili povezani s prekinitvijo zdravljenja v skupini, ki je prejemala zdravilo Rhokiinsa, so bili hiperemija veznice (5,8 %), cornea verticillata (3,7 %) in zamegljen vid
If you stop using Rhokiinsa
Če ste prenehali uporabljati zdravilo Rhokiinsa
The following side effects have been observed with Rhokiinsa:
Pri zdravilu Rhokiinsa so opazili naslednje neželene učinke:
The study was designed to show non-inferiority of netarsudil when dosed once daily in the evening to timolol maleate 0.5% dosed twice daily in patients with a baseline IOP of >20 mmHg and <25 mmHg.
Študija je bila zasnovana za dokaz neinferiornosti netarsudila, ki so ga dajali enkrat na dan zvečer, v primerjavi s timololijevim maleatom 0,5 %, ki so ga dajali dvakrat na dan, pri bolnikih z izhodiščnim IOP > 20 mmHg in < 25 mmHg.
There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/ml) post dose on day 1 and day 8.
Po odmerku na 1. dan in 8. dan ni bilo določljivih koncentracij netarsudila (spodnja meja določljivosti (LLOQ) 0,100 ng/ml) v plazmi.
Netarsudil was not mutagenic in a bacterial mutation assay, in a mouse lymphoma assay, or in a rat micronucleus test.
Netarsudil v bakterijskem testu mutacij, v testu mišjega limfoma in testu mikronukleusov pri podganah ni bil mutagen.
• Put back the bottle cap to close the bottle.
• Pokrovček namestite nazaj na plastenko in jo zaprite.
No effects during pregnancy are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Med nosečnostjo ni pričakovati nobenih učinkov, saj je sistemska izpostavljenost netarsudilu zanemarljiva (glejte poglavje 5.2).
How to use Rhokiinsa
Kako uporabljati zdravilo Rhokiinsa
• General side effects: Increased allergic symptoms; dizziness; blurred vision; nasal discomfort and pain; redness or itching of the skin; rash on skin; inflammation of the cartilage; picking of the skin
• Splošni neželeni učinki: povečani alergijski simptomi; omotica; zamegljen vid; nelagodje in bolečina v nosu; pordelost ali srbenje kože; izpuščaj na koži; vnetje hrustanca; praskanje kože
The European Medicines Agency has waived the obligation to submit the results of studies with Rhokiinsa in all subsets of the paediatric population for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Rhokiinsa za vse podskupine pediatrične populacije pri zniževanju zvišanega intraokularnega tlaka pri bolnikih z glavkomom odprtega zakotja ali očesno hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.)
In pregnant rabbits, 3 mg/kg/day (10000 times the recommended ophthalmic dose) and higher showed an increase in post-implantation loss and a decrease in foetal weight.
Pri brejih kuncih je odmerek 3 mg/kg/dan (10000-kratnik priporočenega oftalmičnega odmerka) in več povečal poimplantacijsko izgubo in zmanjšal telesno maso plodov.
Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, ATC code: S01EX05
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za očesne bolezni, zdravila za zdravljenje glavkoma in zdravila za zožitev zenice, koda ATC: S01EX05 Mehanizem delovanja
Due to netarsudil's vasodilating properties, other eye drops should be administered before.
Zaradi vazodilatacijskih lastnosti netarsudila je treba najprej uporabiti druge kapljice za oko.
However, while no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding women to netarsudil is expected to be negligible, no relevant clinical data are available (see section 5.2).
Učinkov na dojenega novorojenčka/dojenčka sicer ni pričakovati, saj je sistemska izpostavljenost doječih mater netarsudilu zanemarljiva, vendar ustrezni klinični podatki niso na voljo (glejte poglavje 5.2).
Rhokiinsa contains an active substance called netarsudil.
Zdravilo Rhokiinsa vsebuje učinkovino, imenovano netarsudil.
Table 1: Mean IOP by visit: PP population with baseline IOP <25 mmHg Study Visit and Time Point
Preglednica 1: Povprečni IOP po obiskih: populacija PP z izhodiščnim IOP < 25 mmHg
Eye ointments should be administered last.
Mazila za oko se dajejo nazadnje.
• Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Če vam pomaga, to počnite pred ogledalom.
Netarsudil, a Rho kinase inhibitor, is believed to reduce IOP by increasing outflow of aqueous humor.
Domneva se, da netarsudil, zaviralec Rho-kinaze, znižuje IOP s povečevanjem odtoka prekatne vodke.
Rhokiinsa is used to lower pressure in the eyes in adults who have an eye condition known as glaucoma or who have raised pressure in their eyes.
Zdravilo Rhokiinsa se uporablja za zniževanje tlaka v očeh pri odraslih z očesno boleznijo, imenovano glavkom, ali tistih s povišanim tlakom v očeh.
The tip of the dispensing container should avoid contacting the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution.
S konico kapalnega dela vsebnika se ne dotikajte očesa, okoliških struktur, prstov ali drugih površin,
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razvoja ne kažejo posebnega tveganja za človeka.
The incidences of hyperemia and vision blurred were sporadic in nature.
Hiperemija in zamegljen vid sta se pojavljala sporadično.
• Effects in the eye: Infection or inflammation of the eye; dryness of the eye or small breaks in the film of liquid on the surface of the eye; eye discharge; itchy eyelids; clouding of the eye and vision may decrease somewhat; eye pain; feeling of grittiness or having something in the eye; general eye redness shortly after drops are put in; spots or patches of eye redness; eye inflammation caused by an allergic reaction or prominent blood vessels; eyes can become watery, sensitive to light; swelling around the eye; blurred vision
• Učinki v očesu: okužba ali vnetje očesa; izsušenost očesa ali majhne razpoke v tekočinskem filmu na površini očesa; izcedek iz očesa; srbeče veke; zameglitev očesa z nekoliko poslabšanim vidom; bolečina v očesu; občutek zrnatosti ali tujka v očesu; splošna pordelost očesa kmalu po vnosu kapljic; točkovna ali lisasta pordelost očesa; vnetje očesa zaradi alergijske reakcije ali izrazite žile; oči lahko postanejo solzne, občutljive na svetlobo; oteklina okoli očesa; zamegljen vid
However, no effects are anticipated, since systemic exposure to netarsudil is negligible (see section 5.2).
Učinkov ni pričakovati, saj je sistemska izpostavljenost netarsudilu zanemarljiva (glejte poglavje 5.2).
If topical overdose of netarsudil should occur, the eye(s) may be flushed with tap water.
Če pride do prevelikega topičnega odmerjanja netarsudila, lahko oko (oči) sperete z vodo iz pipe.
Completion rates in Phase 3 studies were lower in the netarsudil treatment group when compared with the timolol maleate group.
Delež bolnikov, ki so v študijah 3. faze zaključili zdravljenje, je bil nižji v skupini, zdravljeni z netarsudilom, kot v skupini, zdravljeni s timololijevim maleatom.
Conjunctival Hyperaemia
Hiperemija veznice
The non-inferiority margin applied was a difference in mean IOP ≤1.5 mmHg for all time points over all visits through 3 months and ≤1.0 mmHg at a majority of these time points.
9 časovnih točk, izmerjen ob 8:00, 10:00 in 15:00 na 15., 43. in 90. dan. Uporabljena meja neinferiornosti je bila razlika v povprečnem IOP za ≤ 1,5 mmHg pri vseh časovnih točkah pri vseh obiskih v trimesečnem obdobju, in ≤ 1,0 mmHg pri večini od teh časovnih točk.
Once opened, do not store above 25°C.
Po odprtju shranjujte pri temperaturi do 25 °C.
Rhokiinsa is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.
4.1 Terapevtske indikacije Zdravilo Rhokiinsa je indicirano za zniževanje povišanega intraokularnega tlaka (IOP - intraocular pressure) pri odraslih bolnikih s primarnim glavkomom odprtega zakotja ali očesno hipertenzijo.
The cornea verticillata seen in netarsudil-treated patients were first noted at 4 weeks of daily dosing.
Corneo verticillato, ki so jo opazili pri bolnikih, zdravljenih z netarsudilom, so prvič zaznali po
Each ml of solution contains 200 micrograms netarsudil (as mesylate).
En ml raztopine vsebuje 200 mikrogramov netarsudila (v obliki mesilata).
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
V primeru uporabe kontaminirane raztopine lahko pride do resnih poškodb očesa in posledične izgube vida.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
• Twist off the bottle cap, and lie the cap on a clean surface on its side.
• Odvijte pokrovček plastenke in ga odložite na čisto površino.
The IOP reduction with netarsudil dosed once daily was non-inferior to the effect of timolol 0.5% dosed twice daily in patients with baseline IOP of <25 mmHg (Table 1).
Znižanje IOP pri bolnikih z izhodiščnim IOP < 25 mmHg je bilo pri netarsudilu, ki so ga dajali enkrat na dan, neinferiorno v primerjavi z učinkom timolola 0,5 %, ki so ga dajali dvakrat na dan (preglednica 1).
visual field defect
Občasni omotica, izpad vidnega polja
Only one plasma concentration at 0.11 ng/ml for the active metabolite was observed for one subject on day 8 at 8 hours post-dose.
8. dan 8 ur po odmerku opazili koncentracijo aktivnega presnovka v plazmi 0,11 ng/ml.
• Effects in the eye: Increased fluid pressure inside the eye; inflammation of the coloured part of the eye (the iris); bulging of iris; growth of eyelashes; eyelid dryness; eye disease related to diabetes; excess folds of the conjunctiva; blindness; blurred, double and halo vision; cataracts; abnormal turning outward of the lower eyelid; small colored spots on the eye surface; eye dryness caused by inflammation of the glands of the eyelids; eye allergy; eyelid crusting; glassy eyes; loss of eyelashes; tiredness
• Učinki v očesu: zvišan tlak tekočine v očesu; vnetje obarvanega dela očesa (šarenice); izbočena šarenica; rast trepalnic; suhost vek; očesna bolezen, povezana s sladkorno boleznijo; čezmerno gubanje veznice; slepota; zamegljen in dvojni vid ter videnje sija okrog luči; katarakte; neobičajno obračanje spodnje veke navzven; majhna obarvana mesta na očesni površini; suhost očesa zaradi vnetja žlez v vekah; očesna alergija; kraste na vekah; steklaste oči; izpadanje trepalnic; utrujenost
Table 2: Mean IOP by visit: PP population with baseline IOP ≥25 and <30 mmHg Study Visit and Time Point
Preglednica 2: Povprečni IOP po obiskih: populacija PP z izhodiščnim IOP ≥ 25 in < 30 mmHg
What Rhokiinsa looks like and contents of the pack Rhokiinsa is a clear, liquid eye drop solution in a plastic bottle.
Zdravilo Rhokiinsa je bistra, tekoča raztopina kapljic za oko v plastenki.
Do not swallow or inject.
da ne kontaminirate raztopine.
This medicinal product contains benzalkonium chloride.
Zdravilo Rhokiinsa vsebuje benzalkonijev klorid.
EXPIRY DATE
Občasni ekskoriacija
A randomised, double-blind, multicentre Phase 3 clinical trial compared the efficacy and safety of netarsudil once daily with that of timolol maleate 0.5% twice daily in reducing IOP in a total of 708 patients with open-angle glaucoma or ocular hypertension.
V randomiziranem, dvojno slepem, multicentričnem kliničnem preskušanju 3. faze so primerjali učinkovitost in varnost netarsudila enkrat na dan z učinkovitostjo in varnostjo timololijevega maleata
Systemic exposure to netarsudil following topical ocular administration has been shown to be negligible.
4.9 Preveliko odmerjanje Dokazali so, da je sistemska izpostavljenost netarsudilu po topični očesni uporabi zanemarljiva.
Contents of the pack and other information
Shranjevanje zdravila Rhokiinsa Vsebina pakiranja in dodatne informacije
System Organ Classification
Organski sistem
Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
Rhokiinsa 200 mikrogramov/ml kapljice za oko, raztopina netarsudil
Rhokiinsa contains benzalkonium chloride This medicine contains approximately 150 micrograms benzalkonium chloride in each ml of solution.
To zdravilo vsebuje približno 150 mikrogramov benzalkonijevega klorida v enem ml raztopine.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
NAME OF THE MEDICINAL PRODUCT Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
IME ZDRAVILA Rhokiinsa 200 mikrogramov/ml kapljice za oko, raztopina
Frequency Adverse reactions instillation site erythema, instillation site discomfort, instillation site pruritis, vital dye staining cornea present, intraocular pressure increased
Neželeni učinki prisotno obarvanje roženice z vitalnim barvilom, zvišan intraokularni tlak
Sodium hydroxide (for pH-adjustment) Water for injections
6.1 Seznam pomožnih snovi benzalkonijev klorid manitol borova kislina natrijev hidroksid (za uravnavanje pH) voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rhokiinsa 200 micrograms/ml eye drops netarsudil
IME ZDRAVILA IN POT(I) UPORABE Rhokiinsa 200 mikrogramov/ml kapljice za oko netarsudil okularna uporaba
What you need to know before you use Rhokiinsa Do not use Rhokiinsa: - if you are allergic to netarsudil or any of the other ingredients of this medicine (listed in section
Kaj morate vedeti, preden boste uporabili zdravilo Rhokiinsa Ne uporabljajte zdravila Rhokiinsa:
PHARMACEUTICAL FORM AND CONTENTS Eye drops, solution
FARMACEVTSKA OBLIKA IN VSEBINA kapljice za oko, raztopina 1 x 2,5 ml
Rhokiinsa is supplied sterile in opaque white low density polyethylene bottles (2.5 ml fill in a 4 ml container) and tips with white polypropylene caps and anti-tamper seals.
(polnjenje 2,5 ml v 4-ml vsebniku) s kapalno konico z belim polipropilenskim pokrovčkom in tesnilom za zaščito pred poseganjem v zdravilo.
If you get any side effects, talk to your doctor, or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Netarsudil and its active metabolite AR-13503 was found to have a possible phototoxic potential in a modified 3T3 NRU-PT in vitro assay, where the wavelength was extended to include UVB light.
Z modificiranim testom 3T3 NRU-PT in vitro, pri katerem so valovne dolžine razširili in vanje vključili tudi UVB-svetlobo, so ugotovili, da imata netarsudil in njegov aktivni presnovek AR-13503
How to store Rhokiinsa
Shranjevanje zdravila Rhokiinsa
Common headache Uncommon dizziness,
Pogosti krvavitev v veznico, zamegljen vid,
Boric acid
diabetična retinopatija,
Common conjunctival haemorrhage, vision blurred, lacrimation increased, erythema of eyelid, eye pruritis, eye irritation, visual acuity reduced, eyelid oedema, punctate keratitis, conjunctival oedema, foreign body sensation in eyes, conjunctivitis, conjunctivitis allergic, photophobia, eyelid pruritus, eye pain, corneal opacity, dry eye, eye discharge,
občutek tujka na mestu vkapanja, draženje na mestu vkapanja, steklaste oči, utrujenost, izsušenost na mestu vkapanja, edem na mestu vkapanja, parestezija na mestu vkapanja, obarvanost veznice,
You may find that your vision is blurred or abnormal just after using Rhokiinsa.
Vpliv na sposobnost upravljanja vozil in strojev Morda boste tik po uporabi zdravila Rhokiinsa ugotovili, da imate zamegljen ali nenormalen vid. Ne vozite in ne upravljajte strojev, dokler ti simptomi ne izginejo.
The following adverse reactions have been reported with netarsudil, dosed once daily.
Pri netarsudilu, ki so ga dajali enkrat na dan, so poročali o naslednjih neželenih učinkih.
Uncommon dermatitis allergic, dermatitis contact, lichenification, petechiae Musculoskeletal and connective tissue disorders Uncommon polychondritis Injury, poisoning and procedural complications Uncommon excoriation 1 See Description of selected adverse reactions for further information
Občasni alergijski dermatitis, kontaktni dermatitis, lihenifikacija, petehije
Nervous system disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Rinse your eye with warm water.
Če ste uporabili večji odmerek zdravila Rhokiinsa, kot bi smeli Oko si sperite s toplo vodo.
Respiratory, thoracic and mediastinal disorders Uncommon nasal discomfort, rhinalgia
motnja veke, disfunkcija Meibomovih žlez, pigmentacija roženice, diplopija, ektropij,
Date of first authorisation: 28 February 2002 Date of latest renewal: 20 November 2006
Datum prve odobritve: 28. februar 2002 Datum zadnjega podaljšanja: 20. november 2006
Therefore it should not be used in this age group.
Zato se ga pri tej starostni skupini ne sme uporabljati.
Data from six major trials are presented here.
Tukaj so prikazani podatki iz šestih velikih raziskav.
Your doctor will decide which strength is best for you.
Zdravnik bo odločil, katera jakost je primerna za vas.
Improvement is usually seen within one week.
Izboljšanje je ponavadi vidno v enem tednu.
These may include monitoring of vital signs and observation of clinical status.
To lahko vključuje nadziranje vitalnih znakov in opazovanje kliničnega stanja.
The average total body clearance is approximately 2.25 l/h.
Povprečni celotni telesni očistek je približno 2,25 l/uro.
The results in the control group were similar.
Izsledki v kontrolni skupini so bili primerljivi.
Treatment duration was for up to three weeks.
Zdravljenje je trajalo do tri tedne.
If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before.
Če mazilo pozabite nanesti ob predvidenem času, ga nanesite, čim se spomnite, in nato nadaljujte kot prej.
Specific studies have not been conducted in older people.
Posebne študije pri starejših ljudeh niso bile izvedene.
In addition, ask your doctor for advice on other appropriate sun protection methods.
Poleg tega zdravnika prosite za nasvet o drugih primernih načinih za zaščito pred soncem.
• increased skin sensitivity (especially to hot and cold)
• zvečana občutljivost kože (zlasti za vročino in mraz);
Children, 2-15 years
Otroci, 2-15 let
• feeling of warmth
• občutek toplote;
The primary response to vaccination was not affected.
Ni bilo vpliva na primarni odziv na cepljenje.
Rosacea* Lentigo*
Rozacea* Lentigo*
However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.
Vendar pa klinične izkušnje, ki so na voljo pri tej populaciji bolnikov, ne kažejo potrebe po prilagajanju odmerka.
If ingested, general supportive measures may be appropriate.
Če oseba zdravilo zaužije, utegnejo biti primerni splošni podporni ukrepi.
If you accidentally swallow some ointment
Če pomotoma zaužijete nekaj mazila
Do not try to induce vomiting.
Ne poskušajte izzvati bruhanja.
Other medicines, cosmetics and Protopic
Druga zdravila, kozmetična sredstva in zdravilo Protopic
It is supplied in tubes containing 10, 30 or 60 grams of ointment.
Pripravljeno je v tubah, ki vsebujejo po 10, 30 ali 60 gramov mazila.
Reproduction toxicity
Reprodukcijska toksičnost
Adults, ≥16 years
Odrasli, ≥ 16 let
§ lower values = greater improvement
§ nižje vrednosti = večje izboljšanje
It is unclear whether the effect of tacrolimus is due to systemic immunosuppression or a local effect.
Ni jasno, ali je učinek takrolimusa posledica sistemske imunosupresije ali lokalnega učinka.
• Before applying Protopic after a bath or shower, be sure your skin is completely dry.
• Preden zdravilo Protopic nanesete po kopeli ali prhanju, se prepričajte, da je koža popolnoma suha.
4.6 Fertility, Pregnancy and lactation
4.6 Plodnost, nosečnost in dojenje
Response rate of ≥ 60%
Delež odziva z ≥ 60-%
• Avoid using the ointment inside your nose or mouth or in your eyes.
• Mazila ne uporabljajte v nosu, ustih ali na očeh.
At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated.
Ob prvih znakih recidiva (ponovnega izbruha) simptomov bolezni je treba zdravljenje začeti znova.
The incidence and nature of most adverse events were similar in the two treatment groups.
Incidenca in narava večine neželenih učinkov sta bili v obeh terapevtskih skupinah podobni.
Fertility There are no fertility data available.
Podatki o plodnosti niso na voljo.
Protopic treatment should begin at the first appearance of signs and symptoms.
Zdravljenje z zdravilom Protopic je treba začeti ob prvem pojavu znakov in simptomov.
Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AH01
Farmakoterapevtska skupina: Druga dermatološka zdravila, oznaka ATC: D11AH01
The majority of these cases were related to infections (skin, respiratory tract, tooth) and resolved with appropriate antibiotic therapy.
Večina teh primerov je bila povezana z okužbami (koža, dihala, zobje) in je izginila po ustreznem antibiotičnem zdravljenju.
Do not use this medicine after the expiry date which is stated on the tube and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na tubi in škatli poleg oznake »EXP«.
Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Velikosti pakiranj: 10 g, 30 g in 60 g. Na trgu morda ni vseh navedenih pakiranj.
Systemic carcinogenicity studies in mice (18 months) and rats (24 months) revealed no carcinogenic potential of tacrolimus.
Raziskave sistemske kancerogenosti pri miših (18 mesecev) in podganah (24 mesecev) niso odkrile kancerogenega potenciala takrolimusa.
• The safety of using Protopic for a long time is not known.
• Varnost dolgotrajne uporabe zdravila Protopic ni znana.