natgillin/translations-raw huggingface dataset:
You can also report side effects directly via national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.
O neželenih učinkih lahko poročate tudi neposredno na 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.
Wash your hands before use.
Pred uporabo si umijte roke.
Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated.
Nekatere od teh sprememb so lahko trajne in lahko vodijo do razlik v videzu oči, če je zdravljeno le eno oko.
This medicine works by increasing the amount of liquid that is drained.
To zdravilo deluje tako, da povečuje količino tekočine, ki odteka.
Do not use more than once a day as the effectiveness of treatment may be reduced.
Ne uporabljajte več kot enkrat dnevno, saj se lahko zmanjša učinkovitost zdravljenja.
It is a synthetic prostamide, structurally related to prostaglandin F2 (PGF2), that does not act through any known prostaglandin receptors.
Je sintetični prostamid, strukturno podoben prostaglandinu F2 (PGF2), ki ne deluje preko kateregakoli znanega prostagladinskega receptorja.
LUMIGAN has negligible influence on the ability to drive and use machines.
Zdravilo LUMIGAN ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The table also includes those adverse reactions which occurred with both formulations but at a different frequency.
V preglednici so tudi neželeni učinki, ki so se pojavili pri obeh sestavah, vendar različno pogosto.
There are no adequate data from the use of bimatoprost in pregnant women.
Ni zadostnih podatkov o uporabi bimatoprosta pri nosečnicah.
Your eye contains a clear, watery liquid that feeds the inside of the eye.
Vaše oko vsebuje bistro, vodeno tekočino, ki hrani notranjost očesa.
• Worsening of asthma
• poslabšanje astme,
• Sensitivity to light
• občutljivost na svetlobo.
Warnings and precautions:
Opozorila in previdnostni ukrepi
This medicine is for single use only and does not contain preservatives.
To zdravilo je samo za enkratno uporabo, saj ne vsebuje konzervansov.
These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent ocular disease.
Te vsebnike so nenamerno okužili bolniki, ki so v večini primerov imeli sočasne očesne bolezni.
• Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
• poslabšanje pljučne bolezni, imenovane kronična obstruktivna pljučna bolezen (KOPB),
This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.
To zdravilo se lahko uporablja samostojno ali z drugimi kapljicami, imenovanimi antagonisti adrenenergičnih receptorjev beta, ki prav tako znižujejo tlak.
• An allergic reaction in the eye
• alergijska reakcija v očesu,
You should not drive or use machines until your sight is clear again.
Ne vozite in ne uporabljajte strojev, dokler se vam vid ne zbistri.
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.
Kontaktne leče je potrebno pred vkapanjem odstraniti, 15 minut po vkapanju se jih lahko ponovno vstavi.
Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Študije na živalih so pri visokih maternotoksičnih odmerkih pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
To help you remember, write down the date you opened it in the space on the box.
Da bi se spomnili, si v prostor na škatli zapišite datum, ko ste plastenko odprli.
Opened:
Odprto:
Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03.
Farmakoterapevtska skupina: zdravila za očesne bolezni, analogi prostaglandina, Oznaka ATC: S01EE03.
The plasma protein binding of bimatoprost is approximately 88 %.
Plazemski proteini vežejo približno 88 % bimatoprosta.
For single use only
samo za enkratno uporabo
If you wear contact lenses, take your lenses out before using this medicine.
Če nosite kontaktne leče, jih pred uporabo zdravila odstranite.
Periorbital tissue pigmentation has been reported to be reversible in some patients.
Poročali so, da je pigmentacija periorbitalnega tkiva pri nekaterih bolnikih reverzibilna.
For any information about this medicine, please contact the local representative of the marketing authorisation holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
The prostamide receptor, however, has not yet been structurally identified.
Struktura prostamidnega receptorja še ni odkrita.
Gently pull down the lower eyelid until there is a small pocket.
Nežno povlecite spodnjo veko navzdol, dokler ne nastane majhen žepek.
• Small breaks in the surface of the eye, with or without inflammation
• majhne razpoke na površini očesa z vnetjem ali brez njega.
Animal studies have shown excretion of bimatoprost in breast milk.
Študije na živalih so pokazale, da se bimatoprost izloča v mleko.
The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution.
Na voljo so naslednje velikosti pakiranja: škatla, ki vsebuje 1 ali 3 plastenke po 3 ml raztopine.
This leaflet is available in all EU/EEA languages on the European Medicines Agency we
To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides.
Bimatoprost selektivno posnema učinke pred kratkim odkritih biosintetiziranih učinkovin, imenovanih prostamidi.
- if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.
- če ste v preteklosti morali prenehati uporabljati kapljice za oči zaradi neželenega učinka konzervansa benzalkonijevega klorida.
You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left.
Plastenko morate zavreči najpozneje štiri tedne po prvem odprtju, četudi je v njej ostalo še nekaj kapljic.
A decision must be made whether to discontinue breastfeeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Treba se je odločiti, ali naj se prekine dojenje ali naj se prekine zdravljenje z zdravilom LUMIGAN, pri tem pa je treba upoštevati koristi dojenja za otroka in koristi zdravljenja z zdravilom LUMIGAN za mater.
It is unknown whether bimatoprost is excreted in human breast milk.
Ni znano, ali se bimatoprost izloča v materino mleko pri človeku.
Patients with a disruption of the ocular epithelial surface are at greater risk of developing bacterial keratitis.
Pri bolnikih s poškodbo očesne epitelijske površine je nevarnost za pojav bakterijskega keratitisa večja.
Patients with hepatic and renal impairment:
Bolniki z okvaro jeter in ledvic:
LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients.
Zdravila LUMIGAN niso preučevali pri bolnikih z ledvično okvaro ali zmerno do hudo okvaro jeter in ga je zato pri takšnih bolnikih potrebno uporabljati previdno.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution.
Bolnike je treba opozoriti, da vrh kapalke ne sme priti v stik z očesom ali območjem okoli očesa, zato da se prepreči poškodba očesa in okužba raztopine.
• Dry skin
• suha koža,
Side effects where the frequency is not known
Neželeni učinki, pri katerih pogostnost ni znana
No interaction studies have been performed.
Študij medsebojnega delovanja z drugimi zdravili niso izvedli.
You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Plastenke ne smete uporabljati, če je pečat zaščitne zaporke na vratu plastenke pred prvo uporabo poškodovan.
Thus, it is important to apply LUMIGAN as instructed and avoid it running onto the cheek or other skin areas.
Zato je treba zdravilo LUMIGAN uporabljati v skladu z navodili in preprečiti, da steče na lica ali druge predele kože.
This medicine does not contain a preservative.
To zdravilo ne vsebuje konzervansov.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Za benzalkonijev klorid, ki se običajno uporablja v očesnih zdravilih kot konzervans, obstajajo poročila, da povzroča točkasto keratopatijo in/ali toksično ulcerozno keratopatijo.
On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml eye drops, solution usage, the most frequently reported treatment-related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a noninflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years.
S kombinacijo podatkov iz III. faze monoterapije in adjuvantne terapije z zdravilom LUMIGAN 0,3 mg/ml kapljice za oko, raztopina, so bila najpogostejša poročila o neželenih učinkih, kot posledica zdravljenja: rast trepalnic pri do 45 % bolnikov v prvem letu, z upadom števila novih poročil na 7 % pri 2 letih in 2 % pri 3 letih, hiperemija veznice (najpogosteje komaj opazna do blaga in domnevno nevnetnega izvora) pri do 44 % bolnikov v prvem letu, z upadom števila novih poročil na 13 % pri 2 letih in na 12 % pri 3 letih in okularni puritus pri do 14 % bolnikov v prvem letu, z upadom števila novih poročil na 3 % pri 2 letih in 0 % pri 3 letih.
EXP Once the pouch is opened, the single dose containers should be used within 30 days.
EXP Ko je vrečka odprta, enoodmerne vsebnike porabite v 30 dneh.
Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches, respectively.
Škatla, ki vsebuje 30 ali 90 enoodmernih vsebnikov v treh ali devetih vrečkah iz aluminijaste folije.
4 weeks after first opening.
4 tedne po prvem odprtju.
Fertility There are no data on the effects of bimatoprost on human fertility.
Plodnost Ni podatkov o učinkih bimatoprosta na plodnost pri ljudeh.
Take one single-dose container from the pouch and hold it upright (with the cap pointing upwards) and twist off the cap.
Vzemite en enoodmerni vsebnik iz vrečke ter ga držite pokončno (da je pokrovček obrnjen navzgor) in pokrovček odstranite tako, da ga zasukate.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
V nekliničnih študijah so zabeležili učinke le pri izpostavljenosti, ki naj bi znatno presegala maksimalno izpostavljenost pri človeku, kar kaže, da je to za klinično uporabo manj pomembno.
Wait 15 minutes after using the drops, and before you put your lenses back in.
Po uporabi kapljic počakajte 15 minut, preden si ponovno vstavite leče.
These doses resulted in systemic exposures of at least 33- or 97-times higher, respectively, than the intended human exposure.
Pri teh odmerkih je prišlo do najmanj 33- oz. 97-krat večje sistemske izpostavljenosti kot pri priporočeni uporabi pri človeku.
Affecting the body
Učinki na telo:
The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.
Mehanizem delovanja, s katerim bimatoprost znižuje zvišan očesni tlak pri ljudeh, je s povečanjem iztekanja prekatne vodice skozi trabekularno omrežje in povečanje uveoskleralnega iztekanja.
As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.
Tako kot pri ostalih zdravljenjih oči morajo bolniki, če se jim po vkapanju pojavi začasno zamegljen vid, počakati z vožnjo ali upravljanjem s stroji, dokler se vid ne zbistri.
Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years.
Spremembe barve irisa ob uporabi bimatoprosta lahko ne zaznamo nekaj mesecev ali let.
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.
Zdravila LUMIGAN niso preučevali pri bolnikih z obliko srčne blokade težjo kot prve stopnje ali pri nekontroliranem kongestivnem srčnem popuščanju.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else.
Da bi preprečili okužbe in poškodbe očesa pazite, da se z vrhom kapalke ne dotaknete očesa ali česarkoli drugega.
• Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
• simptomi alergijske reakcije (oteklina, rdečina očesa in kožni izpuščaj)
- You have or have had low blood pressure or low heart rate - You have had a viral infection or inflammation of the eye
- če imate ali ste imeli nizek krvni tlak ali počasen srčni utrip, - če ste imeli virusno okužbo ali vnetje očesa.
The increased iris pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and not by an increase in melanocyte number.
Povečanje pigmentacije irisa je kot kaže povzročeno s povečano stimulacijo tvorbe melanina v melanocitih in ne zaradi povečanega števila melanocitov.
However, once the pouch is opened use within 30 days.
Vendar ga morate po odprtju vrečke porabiti v 30 dneh.
Bimatoprost is eliminated primarily by renal excretion, up to 67 % of an intravenous dose administered to healthy adult volunteers was excreted in the urine, 25 % of the dose was excreted via the faeces.
Do 67 % vnesenega intravenskega odmerka zdravim odraslim prostovoljcem je bilo izločeno z urinom, 25 % odmerka je bilo izločeno z blatom.
• An increase in blood-test results that show how your liver is working
• zvišane vrednosti kazalcev v krvi, ki kažejo delovanje jeter.
Since LUMIGAN contains benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised.
Ker zdravilo LUMIGAN vsebuje benzalkonijev klorid, je pri pogosti ali podaljšani uporabi potreben nadzor pri bolnikih s suhimi očmi ali kjer je okvarjena roženica.
No functional or microscopic changes related to the periocular effects were observed, and the mechanism of action for the periocular changes is unknown.
Funkcionalnih ali mikroskopskih sprememb, povezanih s periokularnimi učinki, ni bilo opaziti.
Pack contains 3 or 9 aluminium foil pouches, each containing 10 single-dose containers, for a total of 30 or 90 single-dose containers in a carton, respectively.
Pakiranje vsebuje 3 ali 9 vrečk iz aluminijaste folije, od katerih vsaka vsebuje 10 enoodmernih vsebnikov, tako da je v posamezni škatli 30 ali 90 enoodmernih vsebnikov.
Other side effects reported with eye drops containing phosphates.
Drugi neželeni učinki kapljic za oko, ki vsebujejo fosfate.
• Asthma
• astma,
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Other medicines and LUMIGAN 0.3 mg/mL single-dose Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Druga zdravila in zdravilo LUMIGAN 0,3 mg/ml (enoodmerna oblika) Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• Worsening of vision
• poslabšanje vida,
Patients using LUMIGAN with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
Pri bolnikih, ki zdravilo LUMIGAN uporabljajo z drugimi analogi prostaglandina, je treba spremljati spremembe očesnega tlaka.
• Skin discoloration (periocular)
• sprememba barve kože (periokularno).
Remove contact lenses before use.
Pred uporabo odstranite kontaktne leče.
Co. Mayo Ireland
Westport Co. Mayo Irska
This medicinal product does not require any special storage conditions.
Za to zdravilo niso potrebni posebni pogoji shranjevanja.
- The active substance is bimatoprost.
- Učinkovina je bimatoprost.
To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.
Da bi preprečili okužbo, pazite, da se z vrhom enoodmernega vsebnika ne dotaknete očesa ali česarkoli drugega.
If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
Always use this medicine exactly as your doctor or pharmacist has told you.
Zdravilo uporabljajte vedno natančno po navodilih zdravnika ali farmacevta.
If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.
Če visokega tlaka ne zmanjšamo, lahko pride do bolezni, ki ji pravimo glavkom, ter posledično do poškodbe vida.
If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine.
Če poleg zdravila LUMIGAN uporabljate še druga zdravila za oko, med uporabo zdravila LUMIGAN in drugega zdravila za oko počakajte vsaj 5 minut.
Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution.
Bolnike s kronično obstruktivno pljučno boleznijo, astmo ali oslabelim delovanjem respiratornega sistema zaradi drugih bolezenskih stanj je treba zdraviti previdno.
Make sure that the single-dose container is intact before use.
Prepričajte se, da je enoodmerni vsebnik nepoškodovan.
Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish.
Rjava pigmentacija okoli zenice se v prizadetem očesu običajno koncentrično razširi proti periferiji irisa, ki postane v celoti ali delno bolj rjav.
LUMIGAN should not be used during pregnancy unless clearly necessary.
Če ni nujno potrebno, zdravila LUMIGAN med nosečnostjo ni dovoljeno uporabljati.
Do not use this medicine: - If you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte tega zdravila: - Če ste alergični na bimatoprost ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Since LUMIGAN 0.1 mg/ml contains 200 ppm benzalkonium chloride (four times the concentration in bimatoprost 0.3 mg/ml eye drops), it should be used with caution in dry eye patients, in patients where the cornea may be compromised and in patients taking multiple BAK-containing eye drops.
Ker zdravilo LUMIGAN 0,1 mg/ml vsebuje 200 ppm benzalkonijevega klorida (štirikrat večja koncentracija kot v bimatoprostu 0,3 mg/ml, kapljicah za oko), ga je treba pri bolnikih s suhimi očmi, pri bolnikih pri katerih je morda roženica poškodovana, in pri bolnikih, ki jemljejo več različnih kapljic, ki vsebujejo benzalkonijev klorid, uporabljati previdno.
The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
Pigmentacija se spremeni zaradi povečane vsebnosti melanina v melanocitih in ne zaradi povečanega števila melanocitov.
The dose should not exceed once daily, as more frequent administration may lessen the intraocular pressure lowering effect.
Odmerjanje naj ne presega dajanja enkrat dnevno, kajti pogostejše vkapanje lahko zmanjša učinek zniževanja očesnega tlaka.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1.
Zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neželeni učinki z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov) neželeni učinki so razvrščeni po organskih sistemih v preglednici 1.
Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Po oksidaciji, N-deetiletaciji in glukuronidaciji se tvorijo različne oblike presnovkov.
The solution should be used immediately after opening.
Raztopino morate porabiti takoj po odprtju.
Throw away the single-dose container after you have used it, even if there is some solution left.
Po uporabi enoodmerni vsebnik zavrzite, četudi niste porabili vse raztopine.
In embryo/foetal developmental studies abortion, but no developmental effects were seen in mice and rats at doses that were at least 860-times or 1700-times higher than the dose in humans, respectively.
V razvojnih raziskavah na mišjih in podganjih embrijih/fetusih so zabeležili abortuse, vplivov na embrio-fetalni razvoj pri odmerkih, ki so bili 860oz 1700-krat večji od odmerka pri ljudeh, niso opazili.
Investigations common liver function test abnormal
Preiskave pogosti nenormalni testi jetrne funkcije
Marketing Authorisation Holder and Manufacturer Allergan Pharmaceuticals Ireland Castlebar Road
Imetnik dovoljenja za promet z zdravilom in izdelovalec Allergan Pharmaceuticals Ireland Castlebar Road
After ocular administration in adults, the systemic exposure of bimatoprost is very low with no accumulation over time.
Po lokalni uporabi v očesu pri odraslih je sistemska absorpcija bimatoprosta zelo nizka in bimatoprost se v daljšem časovnem obdobju ne kopiči.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation, since these have been observed during treatment with LUMIGAN.
Pred začetkom zdravljenjenja je potrebno bolnika obvestiti o možni rasti trepalnic, temnenju kože veke in povečani pigmentaciji irisa, saj so to spremembe, ki so jih opazili med zdravljenjem z zdravilom LUMIGAN.
The change may be more noticeable if you are only treating one eye.
Omenjene spremembe lahko ostanejo trajne in so opaznejše,če zdravite le eno oko.
LUMIGAN is used to reduce high pressure in the eye.
LUMIGAN se uporablja za zmanjševanje previsokega očesnega tlaka.
LUMIGAN has not been studied in patients with compromised respiratory function.
Zdravila LUMIGAN niso preizkušali pri bolnikih z oslabelim delovanjem respiratornega sistema.
The most frequently reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 29 % of patients.
Neželeni učinek, o katerem so poročali najpogosteje, je bila hiperemija veznice (večinoma komaj opazna do blaga in brez vnetja), ki se je pojavila pri 29 % bolnikov.
• Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)
• makularni edem (otekanje mrežnice v očesnem ozadju, kar lahko vodi do poslabšanja vida),