natgillin/translations-raw huggingface dataset:
If you think a medicine has caused a side effect, please check the package leaflet that comes with the medicine for information on how to report it.
Če menite, da je zdravilo povzročilo neželeni učinek, v navodilu za uporabo, ki je priloženo zdravilu, poiščite informacije o tem, kako o njem poročati.
herbal remedies and contraceptives);
ki so na voljo brez recepta, zdravili rastlinskega izvora in kontraceptivi);
How do I know I've experienced a side effect?
Kako vem, da se je pri meni pojavil neželeni učinek?
If you are worried about any suspected side effects from your medicine, please speak to your doctor or pharmacist for advice.
Če ste zaskrbljeni zaradi katerih koli domnevnih neželenih učinkov, se pogovorite z zdravnikom ali farmacevtom.
How do I report a side effect?
Kako lahko poročam o neželenem učinku?
You can check the package leaflet that comes with the medicine.
Poiščete jih lahko v navodilu za uporabo, ki je priloženo zdravilu.
The capsules should be taken with food, preferably at the same time every day.
Kapsule je treba jemati s hrano vsak dan, po možnosti ob približno isti uri.
Further information on Silodosin Recordati can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
Nadaljnje informacije o zdravilu Silodosin Recordati so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
The recommended dose is one 8 mg capsule once a day.
Priporočeni odmerek je ena 8-miligramska kapsula enkrat na dan.
For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Pri moških z zmernimi težavami z ledvicami je začetni odmerek 4 mg enkrat na dan.
In two of the studies the IPSS was around 21 points at the start of the study.
Na začetku dveh študij je bil rezultat vprašalnika IPSS okoli 21 točk.
When enlarged, it can cause problems with the flow of urine.
Če je povečana, lahko povzroči težave pri uriniranju.
The most common side effect with Silodosin Recordati (which may affect more than 1 in 10 people) is a reduction in the amount of semen released during ejaculation.
Najpogostejši neželeni učinek zdravila Silodosin Recordati (ki se lahko pojavi pri več kot 1 osebi od 10) je zmanjšanje količine semena, ki se sprosti med ejakulacijo.
The European Medicines Agency therefore decided that Silodosin Recordati's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Silodosin Recordati večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Three main studies in over 1,800 men showed that Silodosin Recordati was effective at reducing symptoms of BPH, such as problems with urinating.
Tri glavne študije pri več kot 1 800 moških so pokazale, da je bilo zdravilo Silodosin Recordati učinkovito pri zmanjševanju simptomov BPH, kot so težave pri uriniranju.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silodosin Recordati have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Silodosin Recordati upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What measures are being taken to ensure the safe and effective use of Silodosin Recordati?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silodosin Recordati?
Side effects reported with Silodosin Recordati are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Silodosin Recordati, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
For more information about using Silodosin Recordati, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Silodosin Recordati glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The prostate gland is an organ found at the base of the bladder in men.
Prostata je organ, ki leži na dnu mehurja pri moških.
The symptoms were measured using the international prostate symptom score (IPSS).
Simptomi so bili izmerjeni z uporabo mednarodnega vprašalnika o simptomih prostate (IPSS).
In the third study, the IPSS was around 19 points before treatment and fell by 7 points with Silodosin Recordati compared with 6.7 points in men who took tamsulosin (another medicine used for BPH) and 4.7 points with placebo.
V tretji študiji je bil rezultat IPSS pred zdravljenjem približno 19 točk in se je po jemanju zdravila Silodosin Recordati zmanjšal za 7 točk v primerjavi s 6,7 točke pri moških, ki so jemali tamsulozin (drugo zdravilo za zdravljenje BPH), ter 4,7 točke pri tistih, ki so jemali placebo.
Silodosin Recordati can only be obtained with a prescription and is available as capsules (4 and 8 mg).
Predpisovanje in izdaja zdravila Silodosin Recordati je le na recept, na voljo pa je v obliki kapsul (4 mg in 8 mg).
When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Ko se ti receptorji aktivirajo, povzročijo, da se mišice, ki nadzorujejo pretok urina, skrčijo.
The active substance in Silodosin Recordati, silodosin, is an alpha-adrenoreceptor antagonist.
Učinkovina v zdravilu Silodosin Recordati, silodozin, je antagonist alfa-adrenoreceptorjev.
As for all medicines, data on the use of Silodosin Recordati are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Silodosin Recordati stalno spremljajo.
Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Silodosin Recordati je zdravilo, ki se uporablja za zdravljenje simptomov benigne hiperplazije prostate (BHP, razširjene prostate) pri odraslih.
Silodosin Recordati is effective at reducing problems with urinating in men with BPH and its side effects are comparable to those seen with other medicines of the same class.
Zdravilo Silodosin Recordati je učinkovito pri zmanjševanju težav pri uriniranju moških z BPH, njegovi neželeni učinki pa so primerljivi s tistimi, ki veljajo za druga zdravila iz istega razreda.
It works by blocking receptors (targets) called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Deluje tako, da zavira receptorje (prijemališča), ki se imenujejo alfa1A adrenoreceptorji v prostati, mehurju in sečnici (cev, ki vodi iz mehurja in odvaja seč iz telesa).
Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Sindrom intraoperativne ohlapne šarenice (IFIS) se pojavi pri nekaterih bolnikih, ki jemljejo antagoniste alfa-adrenoreceptorjev, in lahko povzroči zaplete med kirurškim posegom sive mrene.
After 12 weeks, the IPSS fell by 6.4 points in the men who took Silodosin Recordati compared with 3.5 points in the men who took placebo (a dummy treatment).
Po 12 tednih se je rezultat IPSS zmanjšal za 6,4 točke pri moških, ki so vzeli zdravilo Silodosin Recordati, v primerjavi s 3,5 točke pri moških, ki so jemali placebo (zdravilo brez učinkovine).
By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Silodozin z zaviranjem teh receptorjev pomaga mišicam, da se sprostijo, kar olajša pretok urina in ublaži simptome BPH.
An overview of Silodosin Recordati and why it is authorised in the EU
Pregled zdravila Silodosin Recordati in zakaj je odobreno v EU
This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.
Zdravilo Silodosin Recordati je enako zdravilu Urorec, za katerega je bilo dovoljenje za promet v EU izdano 29. januarja 2010.
Why is Silodosin Recordati authorised in the EU?
Zakaj je bilo zdravilo Silodosin Recordati odobreno v EU?
Other information about Silodosin Recordati
Druge informacije o zdravilu Silodosin Recordati
What benefits of Silodosin Recordati have been shown in studies?
Kakšne koristi zdravila Silodosin Recordati so se pokazale v študijah?
IFIS is a condition that makes the iris floppy.
IFIS je stanje, ko postane šarenica ohlapna.
What is Silodosin Recordati and what is it used for?
Kaj je zdravilo Silodosin Recordati in za kaj se uporablja?
For the full list of side effects and restrictions of Silodosin Recordati, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Silodosin Recordati glejte navodilo za uporabo.
What are the risks associated with Silodosin Recordati?
Kakšna tveganja so povezana z zdravilom Silodosin Recordati?
How is Silodosin Recordati used?
Kako se zdravilo Silodosin Recordati uporablja?
How does Silodosin Recordati work?
Kako zdravilo Silodosin Recordati deluje?
Member State (EU/EEA)
Država članica EU/EGP
HU - Hungary PannonPharma Kft. Pannonpharma út 1.
HU - Madžarska PannonPharma Kft. Pannonpharma út 1.
Aminocaproic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo aminokaprojsko kislino, z dovoljenjem za promet v Evropski uniji
Bial - Aristegui, Produtos Farmacêuticos,S.A.
PT - Portugalska Bial - Aristegui, Produtos Farmacêuticos,S.A.
solution for injection
Raztopina za injiciranje
List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
ROTTAPHARM, S.L.
ES - Španija ROTTAPHARM, S.L.
ES - Spain
España
• At request of the European Medicines Agency;
• na zahtevo Evropske agencije za zdravila;
Two different pack types are available:
Na voljo sta dve različni vrsti pakiranja:
Date of first authorisation: 22 January 2007 Date of latest renewal: 11 November 2016
Datum prve odobritve: 22. januar 2007 Datum zadnjega podaljšanja: 11. november 2016
Re-use may lead to infection or other illness/injury.
Ponovna uporaba lahko povzroči okužbo ali druge bolezni/poškodbe.
This effect was maintained up to Month 24.
Ta učinek je ostal ohranjen do konca 24. meseca.
Make sure that the pack contains:
Prepričajte se, da pakiranje vsebuje:
• performed or planned intraocular surgery within the previous or next 28 days.
• izvedena ali načrtovana intraokularna operacija v predhodnih ali sledečih 28 dneh.
Systemic clearance was slightly lower, but this was not clinically significant.
Sistemski očistek je bil nekoliko nižji, vendar to ni imelo kliničnega pomena.
However, no special considerations are needed in this population.
Vendar za to skupino niso potrebna posebna opozorila.
The apparent systemic half-life was approximately 6 days.
Navidezni sistemski razpolovni čas je bil približno 6 dni.
Group III vPDT
skupina III vPDT
• Aggressive posterior (AP)-ROP
• agresivna posteriorna (AP)-ROP.
(maintenance of vision, primary endpoint)
(ohranitev vida, primarni cilj opazovanja)
30-Jun-2020
30. junij 2020
If this happens, do not drive or use machines until this resolves.
Če se to zgodi, ne vozite in ne upravljajte strojev, dokler te težave ne minejo.
Final study report:
Zaključno poročilo o študiji:
p<0.0001for both studies
p<0,0001 za obe študiji
• an intraocular pressure of ≥30 mmHg;
• intraokularni tlak ≥30 mmHg;
No carcinogenicity or mutagenicity data are available.
Podatki o kancerogenosti ali mutagenosti niso na voljo.
Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection.
Nekateri bolniki bodo morda potrebovali samo eno injekcijo v prvih 12 mesecih, drugi pa bodo morda potrebovali pogostejše zdravljenje, lahko tudi injiciranje enkrat na mesec.
Treatment of PDR
Zdravljenje PDR
However, evidence of reversibility was observed after recovery.
Vendar so se po okrevanju pokazali znaki reverzibilnosti.
• the syringe is not damaged.
• da brizga ni poškodovana,
The administration of more than three injections per eye has not been studied.
Odmerjanja več kot treh injekcij na oko niso proučili.
• When to seek urgent attention from the health care provider
• v katerih primerih je treba poiskati urgentno zdravstveno pomoč
b p-value for pairwise comparison is one-sided.
Vrednost p za parne primerjave je enostranska.
Check that:
Prepričajte se:
It binds with high affinity to the VEGF-A isoforms (e.g. VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Z visoko afiniteto se veže na izooblike VEGF-A (npr.VEGF110, VEGF121 in VEGF165) in tako preprečuje vezavo VEGF-A na njegove receptorje VEGFR-1 in VEGFR-2.
If any of the above is not true, discard the pre-filled syringe and use a new one.
Če karkoli od zgoraj navedenega ne drži, zavrzite napolnjeno injekcijsko brizgo in vzemite novo.
30-Jun-2023
30. junij 2023
The severity of the inflammatory response generally diminished with subsequent injections or during recovery.
Intenzivnost vnetnega odgovora se je večinoma zmanjšala z naslednjimi injiciranji ali med okrevanjem.
Microscopic ocular changes were related to inflammation and did not indicate degenerative processes.
Mikroskopske spremembe v očesu so bile povezane z vnetjem in niso nakazovale degenerativnih procesov.
The treatment is started with one injection of Lucentis per month.
Zdravljenje se začne z eno injekcijo zdravila Lucentis na mesec.
Following intravitreal administration, no signs of systemic toxicity were detected.
Po intravitrealnem apliciranju niso odkrili nobenih znakov sistemske toksičnosti.
Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
Tako intraokularni tlak kot tudi perfuzijo glave očesnega živca je treba spremljati in ustrezno obravnavati.
Women of childbearing potential should use effective contraception during treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem.
These side effects may also occur in babies born prematurely.
Ti neželeni učinki se lahko pojavijo tudi pri prezgodaj rojenih otrocih.
In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.
Pri bolnikih s SDM, DME, PDR in RVO so na začetku lahko potrebne tri ali več zaporedne mesečne aplikacije.
Detailed instructions for use are given at the end of the leaflet under “How to prepare and administer Lucentis”.
Podrobna navodila za uporabo so opisana na koncu teh navodil pod naslovom “Kako pripraviti in aplicirati zdravilo Lucentis”.
9.5 letters
9,5 črke
Pregnancy and breast-feeding - Women who could become pregnant must use effective contraception during treatment and for at least three further months after the last injection of Lucentis.
Nosečnost in dojenje - Ženske, ki lahko zanosijo, morajo uporabljati učinkovito kontracepcijo v času zdravljenja in še najmanj tri mesece po zadnji injekciji zdravila Lucentis.
If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Lucentis.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se o tem pogovorite z zdravnikom pred zdravljenjem z zdravilom Lucentis.
In the 26-week study, the severity of the vitreous inflammation increased with the number of injections.
V 26-tedenski študiji je intenzivnost vnetja v steklovini naraščala s številom injekcij.
These posterior segment changes diminished, and in some instances resolved, during the recovery period.
Te spremembe v zadajšnjem segmentu so se v obdobju okrevanja zmanjšale, v nekaterih primerih pa so povsem izginile.
The treatment is started with one injection of Lucentis in each eye (some babies may only need treatment in one eye).
Zdravljenje se začne z eno injekcijo zdravila Lucentis v posamezno oko (nekateri otroci potrebujejo zdravljenje samo v enem očesu).
62.9% of Group II patients did not require injections in the second 6 months of the study.
62,9 % bolnikov iz skupine II v drugem 6-mesečnem obdobju v študiji ni več potrebovalo injekcij.
Post-authorisation efficacy study (PAES): CRFB002H2301E1
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): CRFB002H2301E1
In these diseases, Lucentis can help to stabilise and in many cases improve your vision.
Pri navedenih boleznih lahko zdravilo Lucentis prispeva k stabilizaciji in v veliko primerih k izboljšanju vida.
In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Razen tega je potrebno bolnike spremljati v tednu po injekciji, da bi lahko v primeru okužbe omogočili čimprejšnje zdravljenje.
The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity.
Zdravljenje okvare vida zaradi CNV je treba določiti individualno za vsakega posameznega bolnika glede na aktivnost bolezni.
Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
Bolniki, pri katerih pride do teh znakov, ne smejo voziti ali upravljati s stroji, dokler se te začasne motnje vida ne umirijo.
If disease activity recurs, the treatment interval should be shortened accordingly.
Če bolezen spet postane aktivna, je treba interval med odmerki temu primerno skrajšati.
Month 12 -10.5 (16.6) +7.2 (14.4) -9.5 (16.4) +11.3 (14.6) Month 24 -14.9 (18.7) +6.6 (16.5) -9.8 (17.6) +10.7 (16.5)
a po 12 mesecih -10,5 (16,6) +7,2 (14,4) -9,5 (16,4) +11,3 (14,6) po 24 mesecih -14,9 (18,7) +6,6 (16,5) -9,8 (17,6) +10,7 (16,5)
A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Skupno so v te študije vključili 1.323 bolnikov (879 aktivnih in 444 kontrol).
For information on preparation of Lucentis, see section 6.6.
Za pripravo zdravila Lucentis glejte poglavje 6.6.
The warnings and precautions for adults also apply to preterm infants with ROP.
Opozorila in previdnostni ukrepi za odrasle veljajo tudi za nedonošenčke z ROP.
- In some patients the eye pressure may increase for a short period directly after the injection.
- Pri nekaterih bolnikih lahko pride do povišanja očesnega tlaka za kratek čas takoj po injiciranju.
Patients with active severe intraocular inflammation.
Bolniki z aktivnim hudim intraokularnim vnetjem.
No dose adjustment is required in the elderly.
Pri starejših prilagajanje odmerkov ni potrebno.
Caution should be exercised when treating such patients (see section 4.8).
Pri zdravljenju takih bolnikov je potrebna previdnost (glejte poglavje 4.8).
In addition the European Medicines Agency has waived the obligation to submit the results of studies with Lucentis in the following subsets of the paediatric population for ROP: term newborn infants, infants, children and adolescents.
Poleg tega je Evropska agencija za zdravila odstopila od zahteve za predložitev rezultatov študij z zdravilom Lucentis za naslednje podskupine pediatrične populacije za ROP: pri donošenih novorojenčkih, dojenčkih, otrocih in mladostnikih.
The doctor will also give your baby a local anaesthetic to reduce or prevent any pain.
Zdravnik bo vašemu otroku dal tudi lokalni anestetik, da bi zmanjšal oziroma preprečil bolečine.
Tell your baby's doctor if your baby is receiving, has recently received or might receive any other medicines.
Obvestite otrokovega zdravnika, če vaš otrok prejema, je pred kratkim prejel ali pa bo morda začel prejemati katero koli drugo zdravilo.
Patients should also be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
Bolnikom je treba tudi naročiti, da sporočijo, če se intenzivnost intraokularnega vnetja stopnjuje, kar bi bil lahko klinični znak, ki ga je mogoče pripisati tvorbi intraokularnih protiteles.
Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development (see section 5.3).
Študije na opicah javanski makak ne kažejo neposrednih ali posrednih škodljivih učinkov v nosečnosti ali na razvoj zarodka/plodu (glejte poglavje 5.3).
The long-term safety profile in preterm infants has not been established.
Dolgoročnega varnostnega profila pri nedonošenčkih niso ugotavljali.
Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.
Uporabljeno brizgo skupaj z iglo zavrzite v zabojnik za ostre predmete oziroma v skladu z lokalnimi predpisi.
The effect of ranibizumab treatment was similar irrespective of the presence of retinal ischaemia.
Učinek zdravljenja z ranibizumabom je bil približno enak ne glede na prisotnost ishemije mrežnice.
All components are sterile.
Vse komponente so sterilne.
There are no data available on fertility.
O vplivu na plodnost ni na voljo nobenih podatkov.
Populations with limited data
Skupine bolnikov z omejeno količino podatkov
The opening of the sealed tray and all subsequent steps should be done under aseptic conditions.
Odpiranje pretisnega omota in vse nadaljnje korake je treba izvajati v aseptičnih pogojih.
The adverse reactions are listed by system organ class and frequency using the following convention: 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).
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: 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 following information is intended for healthcare professionals only:
NASLEDNJE INFORMACIJE SO NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU:
Do not pull back on the plunger.
Bata ne vlecite nazaj.
Before the injection, your doctor will wash your eye carefully to prevent infection.
Pred injiciranjem bo zdravnik vaše oko pazljivo izpral, da bi preprečil okužbo.
The safety and efficacy of ranibizumab have not yet been established in paediatric patients.
Varnosti in učinkovitosti ranibizumaba pri pediatričnih bolnikih še nista bili dokazani.
DRSS = diabetic retinopathy severity score, n = number of patients who satisfied the condition at the visit, N = total number of study eyes.
DRSS = ocena izraženosti diabetične retinopatije (DRSS - diabetic retinopathy severity score), n = število bolnikov, ki so na obisku ustrezali danemu pogoju, N = skupno število študijskih oči
The excess volume should be expelled prior to injection.
Presežni volumen je treba iztisniti pred injiciranjem.
The nature and timing of the posterior segment inflammation is suggestive of an immune-mediated antibody response, which may be clinically irrelevant.
Narava in časovno pojavljanje vnetja zadajšnjega segmenta kažeta na imunsko posredovan odgovor protiteles, ki je morda klinično nepomemben.
This information will be taken into account to evaluate if Lucentis is the appropriate treatment for you.
Te podatke mora zdravnik upoštevati pri presoji, ali je zdravilo Lucentis primerno za vas.
• a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity;
• poslabšanje najboljše ostrine vida s korekcijo (BCVA - best-corrected visual acuity) za ≥30 črk v primerjavi z zadnjim določanjem ostrine vida;
Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Zdravila Lucentis se pri nosečnicah ne sme uporabljati, razen če možne koristi presegajo možna tveganja za nerojenega otroka.
With both TE regimens, more than 70% of patients maintained their BCVA with an average visit frequency of ≥2 months.
Pri obeh shemah odmerjanja “Zdravi in podaljšaj” je več kot 70 % bolnikov ohranilo svojo BCVA pri povprečni pogostnosti obiskov enkrat na ≥2 meseca.