natgillin/translations-raw huggingface dataset:
In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either emtricitabine 200 mg and tenofovir alafenamide 10 mg (n = 866) once daily or emtricitabine
Predhodno nezdravljeni bolniki, okuženi s HIV-1 V študijah GS-US-292-0104 in GS-US-292-0111 so bolnike randomizirali v razmerju 1:1 za prejemanje emtricitabina 200 mg in tenofoviralafenamida 10 mg (n = 866) enkrat dnevno ali emtricitabina 200 mg + dizoproksiltenofovirata (v obliki fumarata) 245 mg (n = 867) enkrat dnevno, oboje uporabljeno z elvitegravirjem 150 mg + kobicistatom 150 mg v obliki tablete s fiksno kombinacijo odmerkov.
Ctau
SERIJ
Co-administration of Descovy with St. John's wort is not recommended.
Sočasno dajanje zdravila Descovy s šentjanževko se ne priporoča.
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup Age
V oknu podatki manjkajo, a uporablja študijsko zdravilo Delež (%) bolnikov s
The mean change from baseline in CD4+ cell count at Week 48 was -2 cells/mm3.
Povprečna sprememba števila celic CD4+ od izhodišča v 48. tednu je bila
(ng/mL)
Cmax (ng/ml) Ctau (ng/ml)
In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko emtricitabina in tenofoviralafenamida v odprti študiji, v kateri je 50 predhodno nezdravljenih mladostnikov, okuženih s
Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
voksilaprevir (400 mg/100 mg/100 mg+100 mg enkrat dnevno)7/ emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)3
Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily)4
voksilaprevir (400 mg/100 mg/100 mg+100 mg enkrat dnevno)7/ emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (25 mg enkrat dnevno)4
Co-administration of carbamazepine, a P-gp inducer, decreases tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Sočasno dajanje šentjanževke, ki je induktor P-gp, lahko zmanjša koncentracije tenofoviralafenamida v plazmi, kar ima lahko za posledico izgubo terapevtskega učinka in razvoj rezistence.
AUC: ↑ 75%
Cmin: ↑ 58 %
Tenofovir alafenamide: AUC: ↓ 14% Cmax: ↓ 22%
AUC: ↓ 14 % Cmax: ↓ 22 %
AUC: ↑ 48% Cmax: ↔ Cmin: ↑ 66%
AUC: ↔ Cmin: ↑ 46 % Cmax: ↔
Ninety-two percent (66/72 patients) had HBV DNA < 29 IU/mL using missing = failure analysis at Week 48.
HBV DNA < 29 i.e./ml, izmerjeno z analizo manjkajoče = odpoved.
Patients should be informed that dizziness has been reported during treatment with Descovy.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Bolnike je potrebno opozoriti, da se lahko v času zdravljenja z zdravilom Descovy pojavi omotičnost.
ANTIRETROVIRALS HIV protease inhibitors Atazanavir/cobicistat (300 mg/150 mg once daily), tenofovir alafenamide (10 mg)
atazanavir/kobicistat (300 mg/150 mg enkrat dnevno), tenofoviralafenamid (10 mg)
Contents of the pack and other information What Descovy contains
Kaj vsebuje zdravilo Descovy
Emtricitabine: AUC: ↔
AUC: ↔
• anticonvulsants, used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital and phenytoin
- karbamazepin, okskarbazepin, fenobarbital in fenitoin
Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/m
Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrtid Prekinitev uporabe študijskega zdravila zaradi drugih razlogov in nazadnje razpoložljivi HIV-1 RNA
Co-administration of oxcarbazepine, phenobarbital, or phenytoin, all of which are P-gp inducers, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
fenobarbitala ali fenitoina, ki so induktorji P-gp, lahko zmanjša koncentracije tenofoviralafenamida v plazmi, kar ima lahko za posledico izgubo terapevtskega učinka in razvoj rezistence.
Sofosbuvir (400 mg once daily)/ velpatasvir (100 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Priporočilo glede sočasne uporabe z zdravilom Descovy sofosbuvir (400 mg enkrat dnevno)/ velpatasvir (100 mg enkrat dnevno), emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)3
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an openlabel clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in tenofoviralafenamida so ocenili v 48 tednih v odprti klinični študiji (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od
cholesterol and glucose, or in the fasting total cholesterol to HDL cholesterol ratio in either treatment arm at Week 96.
V obeh krakih zdravljenja so bile v 96. tednu le majhne spremembe od začetne vrednosti pri medianih vrednostih na tešče za HDL holesterol in glukozo ter za razmerje skupnega holesterola in HDL holesterola na tešče.
N/A 10.6
(n = 103)
Gastrointestinal disorders Very common:
Znaki osteonekroze so:
Co-administration of Descovy with other medicinal products that inhibit P-gp and BCRP activity (e.g., cobicistat, ritonavir, ciclosporin) is expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Pričakuje se, da sočasno dajanje zdravila Descovy z drugimi zdravili, ki zavirajo aktivnost P-gp in BCRP (npr. kobicistatom,
In open-label Study GS-US-292-1249, the efficacy and safety of emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet (E/C/F/TAF), were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
(E/C/F/TAF), ocenili pri odraslih bolnikih s sočasno okužbo s HIV-1 in kroničnim hepatitisom B. Devetinšestdeset od 72 bolnikov se je pred tem zdravilo s protiretrovirusno terapijo, ki je vsebovala TDF.
Cmax
CART.
Darunavir/ritonavir (800/100 mg once daily), tenofovir alafenamide (10 mg once daily)
darunavir/ritonavir (800/100 mg enkrat dnevno),
In a separate study, emtricitabine and tenofovir alafenamide given with darunavir and cobicistat as a fixed-dose combination tablet was also associated with smaller reductions in BMD (as measured by hip and lumbar spine DXA analysis) through 48 weeks of treatment compared to darunavir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
V ločeni študiji pa je bila tudi kombinacija emtricitabina in tenofoviralafenamida v povezavi z darunavirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov do vključno 48. tedna zdravljenja povezana z manjšim zmanjšanjem
HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of emtricitabine and tenofovir alafenamide were evaluated in an open-label clinical study in which 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min) were switched to emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
(GS-US-292-0112), v kateri je 248 bolnikov, okuženih s HIV-1, ki se bodisi predhodno še niso zdravili (n = 6) ali so imeli virusno supresijo (n = 242), z blago do zmerno ledvično okvaro (ocenjena hitrost glomerularne filtracije po metodi Cockcroft-Gault [eGFRCG]: 30-69 ml/min) prejemalo emtricitabin in tenofoviralafenamid v kombinaciji z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
togost sklepov bolečine v sklepih (zlasti v kolkih, kolenih in ramenih) težave pri gibanju  Če opazite katerega koli od teh simptomov, obvestite svojega zdravnika.
Dose of Descovy
Režim z zdravilom Descovy
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 15 March 2016.
Ker je družba predložila zahtevane dodatne informacije, so izjemne okoliščine prenehale veljati 15. marca 2016.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočila odbora CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls).
V vseh študijah so cepljene ovce in govedo primerjali z necepljenimi živalmi (kontrolami).
The most common side effect with Bluevac BTV8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Najpogostejši neželeni učinek zdravila Bluevac BTV8 (ki lahko prizadene največ 1 žival od 10) je povišanje telesne temperature od 0,5 do 1,0 ˚C, ki ne traja dlje kot dan do dva.
The first injection is given from two and a half months of age and a second injection is given three weeks later.
Prva injekcija se daje od starosti dveh mesecev in pol dalje, druga pa tri tedne pozneje.
The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age.
Učinkovitost cepiva so proučevali v vrsti laboratorijskih preskušanj pri ovcah in govedu najmanjše priporočene starosti.
The full EPAR for Bluevac BTV8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Bluevac BTV8 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
For booster vaccination a single injection is given every year.
Za obnovitveno cepljenje se vsako leto injicira en odmerek.
Protection starts 31 days after the second injection in cattle and 20 days after the second injection in sheep.
Zaščita pri govedu se začne 31 dni po drugi injekciji, pri ovcah pa 20 dni po drugi injekciji.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bluevac BTV8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Bluevac BTV8 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin), ki spodbudita reakcijo imunskega sistema.
For more information about treatment with Bluevac BTV8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Bluevac BTV8 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produces antibodies against it.
Ko govedo in ovce prejmejo cepivo, imunski sistem živali prepozna virus kot „tujek“ in proti njemu tvori protitelesa.
In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi istemu tipu virusa modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The European Commission granted a marketing authorisation valid throughout the EU, for Bluevac BTV8 on 14 April 2011.
Evropska komisija je dovoljenje za promet z zdravilom Bluevac BTV8, veljavno po vsej Evropski uniji, izdala 14. aprila 2011.
Bluevac BTV8 was originally authorised under ‘exceptional circumstances' because, as bluetongue disease falls under national disease control programmes, limited information was available at the time of approval.
Zdravilo Bluevac BTV8 je prvotno pridobilo dovoljenje za promet v izjemnih okoliščinah, saj so bile zaradi dejstva, da bolezen modrikastega jezika spada v okvir nacionalnega programa nadzora bolezni, v času izdaje dovoljenja za promet na voljo le omejene informacije.
The withdrawal period for meat and milk from cattle and sheep treated with Bluevac BTV8 is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za meso in mleko goveda in ovac, zdravljenih z zdravilom Bluevac BTV8, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
The vaccine is given to cattle and sheep as two injections under the skin.
Cepivo se govedu in ovcam injicira pod kožo v dveh odmerkih.
Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep.
Klinični znaki bolezni vključujejo povišano telesno temperaturo, razjede na koži ter otekanje in občasno modrikasto barvo jezika, ki sta prisotna večinoma pri ovcah.
For the full list of restrictions and all side effects reported with Bluevac BTV8, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Bluevac BTV8, glejte navodilo za uporabo.
The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Študije so pokazale, da cepivo preprečuje viremijo pri ovcah in govedu ter zmanjšuje klinične znake pri ovcah, okuženih s serotipom 8 virusa modrikastega jezika.
The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Glavna merila učinkovitosti cepiva so bila viremija (količina virusa BTV8 v krvi) in klinični znaki okužbe z virusom modrikastega jezika.
Bluevac BTV8 contains bluetongue viruses of one type (‘serotype 8').
Zdravilo Bluevac BTV8 vsebuje en tip virusov modrikastega jezika („serotip 8“).
Bluevac BTV8 is a vaccine.
Zdravilo Bluevac BTV8 je cepivo.
Bluevac BTV8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Zdravilo Bluevac BTV8 je cepivo, ki se uporablja pri govedu in ovcah za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrikastega jezika.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle.
Cepivo se uporablja pri ovcah za preprečevanje viremije (prisotnosti virusov v krvi) in zmanjšanje kliničnih znakov, ki jih povzroča virus modrikastega jezika, ter pri govedu za preprečevanje viremije.
bluetongue virus vaccine serotype 8 (inactivated)
cepivo z virusom modrikastega jezika, serotip 8 (inaktivirano)
Bluevac BTV8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Cepivo Bluevac BTV8 vsebuje inaktivirani virus modrikastega jezika, ki ne povzroča bolezni.
What is Bluevac BTV8 and what is it used for?
Kaj je zdravilo Bluevac BTV8 in za kaj se uporablja?
What benefits have Bluevac BTV8 shown in studies?
Kakšne koristi je zdravilo Bluevac BTV8 izkazalo v študijah?
What are the risks associated with Bluevac BTV8?
Kakšna tveganja so povezana z zdravilom Bluevac BTV8?
Why is Bluevac BTV8 approved?
Zakaj je bilo zdravilo Bluevac BTV8 odobreno?
Other information about Bluevac BTV8:
Druge informacije o zdravilu Bluevac BTV8
The vaccine contains inactivated (killed) bluetongue virus serotype 8.
Vsebuje inaktivirane (uničene) viruse modrikastega jezika, serotip 8.
How does Bluevac BTV8 work?
Kako zdravilo Bluevac BTV8 deluje?
How is Bluevac BTV8 used?
Kako se zdravilo Bluevac BTV8 uporablja?
1 pre-filled syringe
4 napolnjene injekcijske brizge
4 (4 x 1) pre-filled syringes (multipack)
4 (4x1) napolnjene injekcijske brizge (skupno pakiranje)
0.5 ml (40000 IU/ml) 6 (6 x 1) pre-filled syringes (multipack)
6 (6x1) napolnjenih injekcijskih brizg (skupno pakiranje)
1.0 ml (40000 IU/ml) 4 (4 x 1) pre-filled syringes (multipack)
40000 Raztopina za injiciranje Subkutana ali napolnjena 1,0 ml
1 g / 1 g Powder for concentrate for solution for infusion
1 g / 1 g prašek za koncentrat za raztopino za infundiranje
Intravenous use vial (glass)
Intravenska uporaba stekleni viali
What measures are being taken to ensure the safe and effective use of Izba?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Izba?
The European Commission granted a marketing authorisation valid throughout the European Union for Izba on 20 February 2014.
Evropska komisija je dovoljenje za promet z zdravilom Izba, veljavno po vsej Evropski uniji, izdala 20. februarja 2014.
The full EPAR for Izba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Izba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What are the risks associated with Izba?
Kakšna tveganja so povezana z zdravilom Izba?
Other information about Izba
Druge informacije o zdravilu Izba
What is Izba and what is it used for?
Kaj je zdravilo Izba in za kaj se uporablja?
It is not intended to provide practical advice on how to use Izba.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In patients taking Izba, the average eye pressure (measured at 8 am in the morning) was 19.4, 19.3 and 19.2 mmHg following 2 weeks, 6 weeks and 3 months of treatment, respectively, which matched the pressure seen at similar time points in patients taking Travatan (19.5, 19.3 and 19.3 mmHg).
Pri bolnikih, ki so prejemali zdravilo Izba, je bil povprečen očesni tlak (merjen ob 8. uri zjutraj) 19,4 mmHg po dveh tednih, 19,3 mmHg po šestih tednih in 19,2 mmHg po treh mesecih zdravljenja, kar je bilo podobno ravnem tlaka, izmerjenim v podobnih časovnih točkah pri bolnikih, zdravljenih z zdravilom Travatan (19,5, 19,3 in 19,3 mmHg).
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Izba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Izba večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Why is Izba approved?
Zakaj je bilo zdravilo Izba odobreno?
This is a summary of the European public assessment report (EPAR) for Izba.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Izba.
This helps to reduce the pressure inside the eye.
To pripomore k znižanju očesnega tlaka.
What benefits of Izba have been shown in studies?
Kakšne koristi je zdravilo Izba izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Izba have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Izba upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Izba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Izba preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
An eye-drop solution containing travoprost at a concentration of 40 microgram/ml has been already authorised in the EU as Travatan since 2001.
Kapljice za oko, ki vsebujejo travoprost v koncentraciji 40 mikrogramov/ml, so že bile odobrene v EU pod imenom Travatan od leta 2001.
The study showed that Izba was as effective as Travatan at reducing pressure in the eye following 2 weeks, 6 weeks and 3 months of treatment.
Študija je pokazala, da je zdravilo Izba enako učinkovito kot zdravilo Travatan pri zniževanju očesnega tlaka po dveh tednih, šestih tednih in treh mesecih zdravljenja.
In the study of children with glaucoma or ocular hypertension given Travatan, the average eye pressure was reduced by around 27% after 12 weeks.
V študiji, ki je zajela otroke z glavkomom ali očesno hipertenzijo, zdravljene z zdravilom Travatan, se je povprečni očesni tlak po 12 tednih zmanjšal za okoli 27 %.
It was calculated that Izba used in children would result in a similar reduction in pressure.
Izračunali so, da lahko zdravilo Izba pri otrocih povzroči podobno znižanje očesnega tlaka.
It can also be used in children from 3 years of age who have ocular hypertension or childhood glaucoma.
Lahko se uporablja tudi pri otrocih, starejših od treh let, ki imajo očesno hipertenzijo ali glavkom, ki se pojavi v otroštvu.
The safety profile of Izba seemed more favourable than that of the higher-strength solution, as side effects were less frequent with Izba.
Varnostni profil zdravila Izba je bil videti ugodnejši od profila raztopine z odmerkom večje jakosti, saj so bili pri uporabi zdravila Izba neželeni učinki manj pogosti.
Both medicines were given as one drop in the affected eye once a day, in the evening.
Obe zdravili sta se uporabljali v odmerku ene kapljice v prizadeto oko enkrat dnevno v večernem času.
The active substance in Izba, travoprost, is a prostaglandin analogue (a man-made version of a prostaglandin, substances naturally found in the body).
Zdravilna učinkovina v zdravilu Izba, travoprost, je analog prostaglandina (umetna različica prostaglandina, ki je naravno prisoten v telesu).
Izba (30 microgram/ml) has been investigated in a main study involving 864 patients with open-angle glaucoma or ocular hypertension, whose average eye pressure was 27 mmHg.
Zdravilo Izba (30 mikrogramov/ml) so proučevali v glavni študiji, ki je zajela 864 bolnikov z glavkomom z odprtim zakotjem ali očesno hipertenzijo, katerih povprečni tlak v očesu je bil 27 mmHg.
When pressure in the eye is raised, it can cause damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Kadar je očesni tlak povišan, lahko pride do poškodb mrežnice (membrane na zadnji strani zrkla, ki je občutljiva za svetlobo) in vidnega živca, ki pošilja signale iz očesa v možgane.
Izba is an eye-drop solution that is used to reduce intraocular pressure (pressure inside the eye) in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal).
Zdravilo Izba je raztopina v obliki kapljic za oko, ki se uporablja za zniževanje intraokularnega tlaka (tlaka v notranjosti očesa) pri odraslih, ki imajo glavkom z odprtim zakotjem (bolezen, pri kateri je tlak v očesu povišan, ker tekočina ne more iztekati iz njega), in odraslih z očesno hipertenzijo (povišanim očesnim tlakom).
For practical information about using Izba, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Izba naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.