FrancophonIA/ELRC3.0 huggingface dataset:
English: 80339 München, Germany
Slovenian: 80339 München, Nemčija
English: Infants and children up to 12 years of age.
Slovenian: Dojenčki in otroci do 12. leta starosti.
English: Most of these patients took medication just prior to going to bed.
Slovenian: Večina teh bolnikov je vzela zdravilo tik pred spanjem.
English: Adults, including the elderly:
Slovenian: Odrasli, vključno starostniki:
English: B. LABELLING
Slovenian: B. OZNAČEVANJE
English: Concomitant administration should therefore be avoided.
Slovenian: Zato se je treba sočasni uporabi izogibati.
English: You should take one capsule ORACEA each day in the morning.
Slovenian: Vsak dan zjutraj morate vzeti eno kapsulo zdravila ORACEA.
English: Opacode Black S-1-8114
Slovenian: Opacode črno S-1-8114
English: In clinical trials patients were treated for 16 weeks.
Slovenian: V kliničnih preskušanjih so bolnike zdravili 16 tednov.
English: • Changes in the number or type of certain blood cells
Slovenian: • Spremembe v številu ali tipu določenih krvnih celic
English: These effects may be symptoms of a severe allergic (hypersensitivity) reaction.
Slovenian: Ti učinki so lahko simptomi resne alergijske (preobčutljivostne) reakcije.
English: Distribution, metabolism and elimination:
Slovenian: Porazdelitev, metabolizem in eliminacija:
English: The data resulting from this study should be provided to the relevant national competent authorities for assessment.
Slovenian: Podatke iz omenjene študije mora posredovati ustreznim nacionalnim pristojnim organom v vrednotenje.
English: • Abnormal reaction of the skin to sunlight
Slovenian: • nenormalna reakcija kože na sončno svetlobo
English: Studies in animals have not demonstrated a teratogenic effect.
Slovenian: Študije na živalih niso pokazale teratogenega učinka.
English: Other interactions:
Slovenian: Druge interakcije:
English: • Allergic reaction causing swelling of the eyes, lips or tongue*
Slovenian: • Alergijska reakcija, ki povzroči otekanje oči, ustnic ali jezika *
English: Pharmacokinetics in special populations:
Slovenian: Farmakokinetika pri posebnih populacijah:
English: • Allergic (hypersensitivity) reaction throughout the body*
Slovenian: • Alergijska (preobčutljivostna) reakcija po vsem telesu*
English: • Changes in some blood tests (amount of glucose in blood or tests of liver function).
Slovenian: • Spremembe pri nekaterih krvnih testih (količina glukoze v krvi ali testi jetrne funkcije).
English: Very rare: Bulging fontanelle in infants
Slovenian: Zelo redki: Izbočena fontanela pri dojenčkih
English: Swallow the capsule whole and do not chew it.
Slovenian: Pogoltnite celo kapsulo in je ne žvečite.
English: The possibility of an increased risk of bleeding events should be borne in mind.
Slovenian: Treba je upoštevati možnost večjega tveganja krvavitev.
English: • Increased pressure in the brain
Slovenian: • Zvišan tlak v možganih
English: The clinical significance of these findings is not known.
Slovenian: Klinični pomen teh ugotovitev ni znan.
English: This reaction is more common during long-term use of the medicinal product but has been observed following repeated short-term courses.
Slovenian: Ta reakcija je bolj običajna med dolgotrajno uporabo zdravila, vendar je bila opažena po večkratnih kratkotrajnih odmerkih.
English: Thyroid function is normal.
Slovenian: Ščitnična funkcija je normalna.
English: • Damage to red blood cells (haemolytic anaemia)
Slovenian: • Poškodbe rdečih krvnih celic (hemolitična anemija)
English: Patients should be evaluated after 6 weeks and, if no effect is seen, consideration should be given to stopping treatment.
Slovenian: Bolnike je treba po 6 tednih pregledati in če učinek ni viden, je treba razmisliti o prenehanju zdravljenja.
English: Each pack contains 56 capsules.
Slovenian: V vsaki ovojnini je 56 kapsul.
English: The conditions of the Marketing Authorisation are set out in Annex IV.
Slovenian: Pogoji dovoljenja za promet so navedeni v Dodatku IV.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTAVLIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: Between 40% and 60% of an administered dose can be accounted for in the urine by 92 hours, and approximately 30% in the faeces.
Slovenian: Med 40% in 60% vnešenega odmerka lahko pričakujemo v urinu v 92 urah, in približno 30% v blatu.
English: The clinical relevance of these findings remains unknown.
Slovenian: Klinična pomembnost teh ugotovitev je še neznana.
English: However, the studies submitted concerning the absence of risk for selection of antibiotic resistance in the normal microbiota were not considered as fully convincing, due to limitations in the methods used.
Slovenian: Vendar študije, predložene v zvezi z odsotnostjo tveganja selekcije odpornosti proti antibiotikom pri normalnem mikrobiotu, niso bile štete za popolnoma prepričljive zaradi omejitev uporabljenih metod.
English: Interactions affecting other medicinal products:
Slovenian: Interakcije, ki vplivajo na druga zdravila:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORACEA
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ORACEA
English: The indication rosacea as defined by the study inclusion criteria was regarded to fulfil these criteria.
Slovenian: Meni, da indikacija rozacee, kakor je bila opredeljena v vključitvenih kriterijih študije, izpolnjuje te pogoje.
English: • Inflammation of the nose and throat
Slovenian: • Vnetje nosu in grla
English: This probably leading to a higher risk for adverse reactions, such as development of resistance in the commensal microflora.
Slovenian: To verjetno povzroča večje tveganje neželenih učinkov, kot je razvoj odpornosti pri komenzalni mikroflori.
English: Do not take a double dose to make up for a forgotten capsule.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, da bi nadomestili pozabljeno kapsulo.
English: ORACEA and certain other medications may not work properly when taken together.
Slovenian: ORACEA in določena druga zdravila lahko nepravilno delujejo, če jih jemljemo skupaj.
English: • High or increased blood pressure
Slovenian: • Visok ali zvišan krvni tlak
English: Quinapril may reduce the absorption of doxycycline due to the high magnesium content in quinapril tablets.
Slovenian: Kvinapril lahko zmanjša absorpcijo doksiciklina zaradi visoke vsebnosti magnezija v tabletah kvinaprila.
English: • Worsening of the immune system disease known as systemic lupus erythematosus (SLE)
Slovenian: • Poslabšanje bolezni imunskega sistema, ki je poznana kot sistemski eritematozni lupus (SLE)
English: Therefore it is recommended that patients should be assessed 4 weeks after stopping treatment.
Slovenian: Zato priporočamo, da bolnike po 4 tednih po prenehanju zdravljenja ponovno pregledate.
English: Therefore such medicinal products or foodstuffs should be taken after a period of 2 to 3 hours following ingestion of doxycycline.
Slovenian: Zato je treba ta zdravila ali hrano zaužiti 2 do 3 urah po prejemu doksiciklina.
English: The scope, design and end-points should be in line with similar trials published in the literature.
Slovenian: Cilj, zasnova in kazalniki izida morajo biti v skladu s podobnimi preskušanji, objavljenimi v literaturi.
English: The CHMP was also satisfied with the explanation on the exclusion criteria of nodule numbers, as no effect on nodules is claimed in the proposed indication.
Slovenian: Odbor je bil tudi zadovoljen z razlago izključitvenih kriterijev glede števila nodulov, saj v predlagani indikaciji ni naveden učinek na nodule.
English: The scope, design and endpoints of the study should be in line with similar trials published in the literature and the study protocol should be validated by and submitted to the National Competent Authority of the Reference Member State within three months of approval.
Slovenian: Cilj, zasnova in kazalniki izida študije morajo biti v skladu s podobnimi preskušanji, objavljenimi v literaturi, protokol študije pa mora prejeti in potrditi pristojni nacionalni organ referenčne države članice v treh mesecih od odobritve.
English: Overall it is estimated that, since authorization, more than 400,000 prescriptions for Oracea were filled at pharmacies in the USA up to November 2007 and the post-marketing experience identified no new safety concerns.
Slovenian: Ocenjujejo, da so od odobritve do novembra 2007 v lekarnah v ZDA izdali zdravilo Oracea na več kot 400 000 receptov, pri čemer v obdobju trženja zdravila niso odkrili nobenih novih varnostnih zadržkov.
English: Important information about some of the ingredients of ORACEA ORACEA contains sugar (sucrose).
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila ORACEA ORACEA vsebuje sladkor (saharozo).
English: Cardinal Health UK 417 Ltd, Great Oakley, Corby, Northamptonshire NN18 8HS, UK.
Slovenian: Cardinal Health UK 417 Ltd, Great Oakley, Corby, Northamptonshire NN18 8HS, VB.
English: Upon discontinuation, lesions tended to reappear at 4 weeks follow-up.
Slovenian: Po prenehanju zdravljenja so se lezije po 4 tednih ponovno pojavile.
English: ORACEA may make certain antibiotics, including penicillins, less effective.
Slovenian: Zdravilo ORACEA lahko povzroči, da so določeni antibiotiki, vključno penicilini, manj učinkoviti.
English: • Inflammation of the membrane surrounding the heart
Slovenian: • Vnetje membrane, ki obdaja srce
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco na nekatere sladkorje, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: Symptoms:
Slovenian: Simptomi:
English: The capsules are beige in colour and bear the marking “CGPI 40”.
Slovenian: Kapsule so beige barve in imajo oznako “CGPI 40”.
English: Do not take milk or dairy products at the same time as ORACEA since these products contain calcium which may reduce the effectiveness of ORACEA.
Slovenian: Ne uživajte mleka ali mlečnih izdelkov sočasno z zdravilom ORACEA, saj ti pripravki vsebujejo kalcij, ki lahko zmanjša učinkovitost zdravila ORACEA.
English: Since no formal dose-response studies have been conducted, Phase III data were analyzed to investigate the existence of a dose-efficacy relationship.
Slovenian: Ker formalne študije odmerka in odziva niso bile opravljene, so podatke študij III. faze analizirali za dokaz odvisnosti med odmerkom in učinkovitostjo.
English: In humans, the use of tetracyclines during a limited number of pregnancies has not revealed any specific malformation to date.
Slovenian: Uporaba tetraciklinov v omejenem številu nosečnosti pri ljudeh ni pokazala specifičnih malformacij.
English: The Applicant considered that studies against other active treatments were not practical or warranted, in the case of Oracea.
Slovenian: Predlagatelj je menil, da študije s primerjanjem z drugimi aktivnimi zdravljenji v primeru zdravila Oracea niso bile praktične ali utemeljene.
English: This leaflet was last approved in
Slovenian: To navodilo je bilo odobreno
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Prosimo, obvestite svojega zdravnika ali farmacevta, če jemljete, ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Tell your doctor about medications that you are taking or plan to take whilst you are taking ORACEA .
Slovenian: Obvestite svojega zdravnika o zdravilih, ki jih jemljete, ali jih nameravate jemati med jemanjem zdravila ORACEA.
English: A. SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: A. POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: As for other tetracyclines, doxycycline forms a stable calcium complex in any boneforming tissue.
Slovenian: Tako kot drugi tetraciklini tudi doksiciklin tvori stabilen kalcijev kompleks v kateremkoli kostnem tkivu.
English: The CHMP also considered that the survey referred to by the Applicant, showing that papulopustular lesions are readily recognized and rated by dermatologists providing a qualitative as well as quantitative measurement, was relevant; therefore the currently proposed indication was considered clinically applicable and practical.
Slovenian: Odbor je tudi menil, da je pomembna raziskava, na katero se sklicuje predlagatelj in ki kaže, da dermatologi enostavno prepoznavajo in ocenjujejo papulopustularne lezije, kar omogoča kvalitativno in kvantitativno merjenje, zato se trenutno predložena indikacija šteje za klinično uporabno in praktično.
English: ORACEA must not be used to treat infections caused by organisms susceptible (or suspected to be susceptible) to doxycycline.
Slovenian: Zdravilo ORACEA se ne sme uporabljati za zdravljenje okužb, ki jih povzročajo organizmi, ki so občutljivi (ali za katere sumimo, da so občutljivi) na doksiciklin.
English: Post-marketing experience has not identified any new safety concerns.
Slovenian: V obdobju trženja zdravila niso odkrili nobenih novih varnostnih zadržkov.
English: Very rare: Brown-black microscopic discolouration of thyroid tissue has been reported with long term use of tetracyclines.
Slovenian: Zelo redki: O rjavo-črnem mikroskopskem obarvanju tkiva ščitnice so poročali po dolgotrajni uporabi tetraciklinov.
English: If you take more ORACEA capsules than you should, ask your doctor immediately for advice.
Slovenian: Če vzamete več kapsul zdravila ORACEA, kot bi jih morali, nemudoma poiščite nasvet pri svojem zdravniku.
English: Treatment should cease if evidence of raised intracranial pressure develops.
Slovenian: Z zdravljenjem je treba prenehati, če se pojavi povišan intrakranialni tlak.
English: The following adverse reactions have been observed in patients receiving tetracyclines:
Slovenian: Naslednje neželene učinke so zaznali pri bolnikih, ki so prejemali tetracikline:
English: The manufacturer responsible for batch release is:
Slovenian: Izdelovalec, odgovoren za izdajo serije je:
English: The procedure was referred to the CHMP, who raised a number of issues through a List of Questions and a subsequent List of Outstanding Issues, which were addressed by the Applicant.
Slovenian: Postopek je bil napoten na Odbor za zdravila za uporabo v humani medicini (CHMP), ki je sprožil številne zadržke preko seznama vprašanj in naknadnega seznama nerešenih zadržkov, ki jih je naslovil na predlagatelja.
English: A peri/postnatal toxicity study in rats revealed no significant effects at therapeutically relevant doses.
Slovenian: Peri/postnatalna študija toksičnosti pri podganah ni pokazala pomembnejših učinkov pri terapevtsko ustreznih odmerkih.
English: Doxycycline is excreted in the urine and faeces as unchanged active substance.
Slovenian: Doksiciklin se izloča v urin in blato kot nespremenjena aktivna snov.
English: In the pivotal placebo-controlled studies with ORACEA in rosacea, 269 patients were treated with ORACEA 40 mg once daily and 268 patients were treated with placebo for 16 weeks.
Slovenian: V študijah, kontroliranih s placebom, z zdravilom ORACEA pri rozacei, so 269 bolnikov zdravili z zdravilom ORACEA 40 mg enkrat dnevno in 268 bolnikov s placebom 16 tednov.
English: Mechanism of Action: The pathophysiology of the inflammatory lesions of rosacea is, in part, a manifestation of a neutrophil-mediated process.
Slovenian: Mehanizem delovanja: Patofiziologija vnetnih lezij pri rozacei, je delno manifestacija nevtrofilno povzročenega postopka.
English: The Applicant addressed the concern that no comparator study was provided by arguing that a controlled clinical trial using an active comparator such as systemic doxycycline was not required, as the development program was in line with a number of ICH guidelines CPMP/ICH/291/95 and CPMP/ICH/135/95 which do not require an active comparator and with the E10 Guidance for the choice of control group in clinical trials (CPMP/ICH/364/96), which supports the use of a placebo control group as the most appropriate design where ethically and practically feasible.
Slovenian: Predlagatelj je odgovoril na zadržek, da ni predložil študije s komparatorjem, z argumentom, da nadzorovano klinično preskušanje z aktivnim komparatorjem, kot je sistemski doksiciklin, ni potrebno, saj je bil razvojni program v skladu z več priporočili ICH, CPMP/ICH/291/95 in CPMP/ICH/135/95, ki ne zahtevajo uporabe aktivnega komparatorja, ter s priporočilom E10 za izbiro kontrolnih skupin v kliničnih preskušanjih (CPMP/ICH/364/96), ki podpira uporabo kontrolne skupine s placebom, kot najprimernejšo zasnovo v primerih, ko je to etično in praktično izvedljivo.
English: Following the administration of the 40 mg modified release formulation of doxycycline, the maximum excreted concentrations of doxycycline will be between 0.03 - 0.16 mg/L for all excretion mechanisms.
Slovenian: Po uporabi 40 mg oblike doksiciklina z modificiranim sproščanjem so največje izločene koncentracije doksiciklina od 0,03 do 0,16 mg/l za vse mehanizme izločanja.
English: The CHMP agreed with the ICH guidelines, stating that an active comparator is not required if it is considered ethically and practically feasible to use placebo in the control group.
Slovenian: Odbor CHMP se je strinjal s priporočili ICH in navedel, da aktivni komparator ni potreben, če je uporaba placeba v kontrolni skupini etična in praktično dostopna.
English: This reaction was shown to be reversible when the medicinal product was discontinued.
Slovenian: Izkazalo se je, da je ta reakcija reverzibilna, ob prenehanju zdravljenja.
English: Finally, the CHMP also acknowledged the difficulty in breaking down the different subgroups of rosacea since symptoms often overlap between the different subtypes and recognised that Oracea is aimed towards the treatment of papules and pustules rather than treatment of rosacea as a whole or treatment of a specific subtype.
Slovenian: Na koncu je odbor CHMP tudi potrdil težavno razvrščanje rozacee v podskupine, ker se med podtipi bolezni simptomi pogosto prekrivajo, ter ugotovil, da je zdravilo Oracea usmerjeno k zdravljenju papul in pustul in ne zdravljenju rozacee kot celote ali zdravljenju specifičnega podtipa.
English: The clinical studies showed no treatment-related serious AEs and tolerability seems to be unaffected by gender, age or disease severity.
Slovenian: V kliničnih študijah niso odkrili resnih neželenih učinkov, povezanih z zdravljenjem, hkrati pa toleranca ni odvisna od spola, starosti ali resnosti bolezni.
English: Doxycycline has been shown to inhibit neutrophil activity and several pro-inflammatory reactions including those associated with phospholipase A2, endogenous nitric oxide and interleukin-6.
Slovenian: Doksiciklin zavira nevtrofilno aktivnost in številne predvnetne reakcije, vključno tiste, povezane s fosfolipazo A2, endogenim dušikovim oksidom in interlevkinom-6.
English: ORACEA should not be used in patients with ocular manifestations of rosacea (such as ocular rosacea and/or blepharitis/meibomianitis) as there are limited efficacy and safety data in this population.
Slovenian: Zdravila ORACEA se ne sme uporabljati pri bolnikih z očesno manifestacijo rozacee (kot je očesna rozacea in/ali blefaritis/meibomianitis), ker v tej populaciji ni zadostne učinkovitosti in obstaja premalo podatkov o varnostni.
English: Concomitant use not recommended:
Slovenian: Sočasna uporaba se odsvetuje:
English: OTHER SPECIAL WARNING(S), IF NECESSARY Swallow whole, do not crush or chew.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Pogoltnite celo kapsulo, ne trite ali ne žvečite.
English: Doxycycline has no or negligible influence on the ability to drive and use machines.
Slovenian: Doksiciklin nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: If you suspect or learn that you are pregnant whilst taking ORACEA, contact your doctor immediately.
Slovenian: Če med jemanjem zdravila ORACEA sumite, ali izveste, da ste noseči, se nemudoma posvetujte s svojim zdravnikom.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen, ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Mean change from baseline to Week 16 in total inflammatory lesion count:
Slovenian: Povprečna sprememba od izhodišča do 16. tedna v skupnem številu vnetnih lezij:
English: The only treatments currently widely authorized in the EU are topical therapies containing metronidazole or azelaic acid, which require twice daily administration and may give rise to local adverse events such as skin irritation or worsening of rosacea.
Slovenian: Edini terapiji, ki sta trenutno odobreni v EU, sta topični terapiji z metronidazolom ali azelainsko kislino, pri katerih je potrebna uporaba dvakrat dnevno, obstaja pa možnost lokalnih neželenih učinkov, kot sta draženje kože in poslabšanje rozacee.
English: This may include the discontinuation of doxycycline and the institution of specific antibiotic therapy.
Slovenian: To lahko vključuje prenehanje zdravljenja z doksiciklinom in uvedba specifičnega antibiotičnega zdravljenja.
English: At doses greater than 50 mg/kg/day fertility and reproductive performance were adversely affected in rats.
Slovenian: Pri odmerkih, večjih od 50 mg/kg/dan, je bila fertilnost in reproduktivna učinkovitost pri podganah močno prizadeta.
English: In vivo microbiological studies using similar exposure to the active substance for 6 to 18 months could not demonstrate any effect on the dominating bacterial flora sampled from the oral cavity, skin, intestinal tract and vagina.
Slovenian: In vivo mikrobiološke študije z uporabo podobne izpostavljenosti aktivni učinkovini 6 do 18 mesecev niso pokazale učinka na prevladujočo bakterijsko floro, vzeto iz ustne votline, s kože, iz intestinalnega trakta ali vagine.
English: There is a possibility that ORACEA reduces the effectiveness of oral contraceptives, resulting in pregnancy.
Slovenian: Obstaja možnost, da zdravilo ORACEA zmanjša učinkovitost oralnih kontraceptivov, kar ima lahko za rezultat nosečnost.
English: With regard to target site exposure of bacteria to doxycycline, the Applicant referred to several publications stating that the resulting concentrations of antibacterially-active drug will be very low, leading to a very low risk of resistance pressure.
Slovenian: V zvezi z izpostavljenostjo bakterij doksiciklinu na ciljnem mestu se je predlagatelj skliceval na več objav, kjer je navedeno, da so nastale koncentracije protibakterijsko aktivnega zdravila zelo nizke, kar povzroči zelo majhno tveganje pritiska na odpornost.
English: ANNEX I LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Doxycycline showed no mutagenic activity and no convincing evidence of clastogenic activity.
Slovenian: Doksiciklin ni izkazal mutagene aktivnosti in nobene prepričljive prisotnosti klastogene aktivnosti.
English: - The CHMP considers that Oracea is well tolerated and is satisfied with the safety profile when in conjunction with the commitment to carry out a post-marketing study as set out in Annex IV and the revision of the Summary of Product Characteristics as set out in Annex III,
Slovenian: - Odbor CHMP meni, da bolniki zdravilo Oracea dobro prenašajo, in je zadovoljen z varnostnim profilom v povezavi z zavezo k izvedbi študije v obdobju trženja, kakor je določeno v Dodatku IV in popravljenem povzetku glavnih značilnosti zdravila, ki je opredeljen v Dodatki III,
English: • Yeast infection around the anus or genitals
Slovenian: • Infekcija s kvasovkami okoli anusa ali genitalij