FrancophonIA/ELRC3.0 huggingface dataset:
English: For the preparation of the harmonised product information, the MAH considered the current registered SmPCs of all EU Member States with an active registration, the published literature and the cumulative safety experience with Rocephin as reported in the company's drug safety database and reflected in the appropriate sections of the company's Core Data Sheet (CDS).
Slovenian: Imetnik dovoljenja za promet z zdravilom je pri pripravi usklajenih informacij o zdravilu upošteval vse povzetke glavnih značilnosti zdravila, ki so trenutno registrirani v državah članicah EU, v katerih je to zdravilo odobreno, objavljeno literaturo in kumulativne izkušnje z varnostjo zdravila Rocephin, ki jih je družba zabeležila v zbirki podatkov o varnosti zdravila in ki so obravnavane v ustreznih poglavjih krovnega dokumenta farmacevtske družbe (Core Data Sheet - CDS).
English: There is some evidence from clinical studies supporting the indication bone and joint infections.
Slovenian: Nekaj dokazov iz kliničnih študij, ki podpirajo indikacijo „okužbe kosti in sklepov“, je na voljo.
English: Considering the submitted data, the CHMP was of the view that ceftriaxone is useful in the treatment of syphilis.
Slovenian: Na podlagi predloženih podatkov je odbor CHMP menil, da je ceftriakson koristen pri zdravljenju sifilisa.
English: Amendments were made to the wording for the period of lactation, mentioning the fact that the risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded and that breastfeeding might have to be discontinued due to these effects.
Slovenian: Besedilo v zvezi z dojenjem je bilo spremenjeno, tako da je bila vključena navedba, da ni mogoče izključiti tveganja za drisko ter glivično okužbo sluznic in da je zaradi teh neželenih učinkov včasih treba prenehati dojenje.
English: • Hospital-acquired pneumonia (HAP)
Slovenian: • Bolnišnična pljučnica (BP)
English: The MAH's proposed text was accepted with minor re-wording.
Slovenian: Besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je bilo odobreno z manjšimi spremembami.
English: Skin and soft tissue infections (SSTIs)
Slovenian: Okužbe kože in mehkih tkiv
English: The most frequently reported adverse reactions for Rocephin are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and increased hepatic enzymes.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali pri uporabi zdravila Rocephin, so eozinofilija, levkopenija, trombocitopenija, driska, izpuščaj in povišani jetrni encimi.
English: • The committee considered the identified divergences for the Rocephin and associated names regarding with respect to the therapeutic indications, posology and method of administration sections, as well as the remaining sections of the SmPC.
Slovenian: • Odbor je proučil ugotovljena neskladja med poglavji o terapevtskih indikacijah, odmerjanju in načinu uporabe za zdravilo Rocephin in povezana imena ter tudi preostala poglavja povzetka glavnih značilnosti zdravila;
English: Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.
Slovenian: Ceftriakson se ne presnavlja sistemsko, temveč se zaradi delovanja mikroorganizmov v debelem črevesu pretvori v neaktivne presnovke.
English: The CHMP noted that most of the clinical data stem from studies labeled complicated IAI (cIAI), although these studies included a wide variety of conditions.
Slovenian: Odbor CHMP je ugotovil, da večina kliničnih podatkov izhaja iz študij, ki so bile opredeljene kot študije pri zapletenih intraabdominalnih okužbah, čeprav so vključevale zelo različna stanja.
English: The MAH has provided studies indicating that the pharmacokinetics of ceftriaxoneare not significantly altered in patients with renal and hepatic impairment, both of which may complicate acute infections.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil študije, ki kažejo, da farmakokinetika ceftriaksona ni bistveno drugačna pri bolnikih z okvarami ledvic ali jeter, ki lahko sicer povzročijo zaplete pri akutnih okužbah.
English: Ceftriaxone was demonstrated to have good clinical efficacy in the treatment of gonorrhoea when used as a single dose treatment.
Slovenian: Dokazi kažejo na precejšnjo klinično učinkovitost ceftriaksona pri zdravljenju gonoreje, kadar se uporablja za zdravljenje z enkratnimi odmerki.
English: The MAH has proposed wording for section 5.3 of the SmPC, which reflects the relevant non clinical data with Rocephin that may be informative for safe clinical use.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal besedilo za poglavje 5.3 povzetka glavnih značilnosti zdravila, v katerem so povzeti zadevni predklinični podatki o zdravilu Rocephin, ki bi lahko prispevali k varni klinični uporabi.
English: Limited clinical data are available in support of the efficacy of ceftriaxone in the treatment of syphilis.
Slovenian: Razpoložljivi klinični podatki, ki podpirajo učinkovitost ceftriaksona pri zdravljenju sifilisa, so omejeni.
English: Overall, there is evidence from controlled clinical trials that ceftriaxone is effective in the treatment of AOM.
Slovenian: Na splošno dokazi iz kontroliranih kliničnih preskušanj kažejo, da je ceftriakson učinkovit pri zdravljenju akutnega vnetja srednjega ušesa.
English: The studies report similarly high success rates for both ceftriaxone and the comparator regimens.
Slovenian: Študije kažejo, da so stopnje uspešnosti zdravljenja s ceftriaksonom in primerjalnimi zdravili podobno visoke.
English: Intra-abdominal infections (IAI)
Slovenian: Intraabdominalne okužbe
English: Ceftriaxone is eliminated unchanged renally (by glomerular filtration) and biliary secretion.
Slovenian: V nespremenjeni obliki se izloča skozi ledvica (z glomerulno filtracijo) in z žolčem.
English: Urinary tract infections (UTI), including pyelonephritis
Slovenian: Okužbe sečil, vključno s pielonefritisom
English: The medicinal product is available in vials as powder for solution for injection or infusion.
Slovenian: Na voljo je v obliki praška za raztopino za injiciranje ali infundiranje v vialah.
English: There is sufficient data to harmonise the indication for ceftriaxone in complicated SSTI (cSSTI), since the clinical data presented stem mostly from what was labelled as cSSTI.
Slovenian: Obstajajo pa zadostni podatki, da se lahko za ceftriakson uskladi indikacija pri zapletenih okužbah kože in mehkih tkiv, saj predloženi klinični podatki večinoma izhajajo iz študij, opredeljenih kot študije pri zapletenih okužbah kože in mehkih tkiv.
English: Therefore, the CHMP considered that the wording of the indication IAI acceptable.
Slovenian: Posledično je odbor CHMP menil, da je besedilo indikacije „intraabdominalne okužbe“ sprejemljivo.
English: The MAH's proposal to delete the indication for sinusitis, pharyngitis and prostatitis due to the scarcity of robust clinical trials in these conditions was agreed by the CHMP.
Slovenian: Odbor CHMP se je strinjal s predlogom imetnika dovoljenja za promet z zdravilom, da se izbriše indikacija za sinusitis, faringitis in prostatitis zaradi pomanjkanja zanesljivih kliničnih preskušanj pri teh boleznih.
English: The term convulsions has been added to the tabulated summary of adverse events in section 4.8 of the proposed SmPC following a cumulative review of the events related to convulsions during a Rocephin Periodic Safety Update Report (PSUR) work sharing procedure.
Slovenian: Na podlagi kumulativnega pregleda dogodkov, povezanih s konvulzijami, ki so ga opravili med postopkom delitve dela pri oceni redno posodobljenega poročila o varnosti zdravila (PSUR) za zdravilo Rocephin, je bil v preglednico s povzetkom neželenih učinkov v poglavju 4.8 predlaganega povzetka glavnih značilnosti zdravila vključen pojem „konvulzije“.
English: In view of the available data, the antimicrobial activity of ceftriaxone in the indication of uncomplicated SSTI (uSSTI) is not considered to be appropriate for this agent.
Slovenian: Razpoložljivi podatki kažejo, da ceftriakson s svojim protimikrobnim delovanjem ni primerna učinkovina za indikacijo pri nezapletenih okužbah kože in mehkih tkiv.
English: As agreed with the MAH, the CHMP was of the view that there is insufficient data to support the recommendation for subcutaneous administration of ceftriaxone.
Slovenian: Odbor CHMP je menil, da ni dovolj podatkov, ki bi podprli priporočilo za subkutano dajanje ceftriaksona, s čimer se je strinjal tudi imetnik dovoljenja za promet z zdravilom.
English: Therefore the MAH's proposal to add Stage II and Stage III nomenclature to this indication was considered to be acceptable by the CHMP.
Slovenian: Odbor CHMP je zato menil, da je predlog imetnika dovoljenja za promet z zdravilom, da se v indikacijo dodata pojma II.
English: However IAI was accepted as the indication for ceftriaxone as there are increasing discrepancies in the definition of cIAI and a lack of acceptance of the term amongst many clinicians.
Slovenian: Ker pa obstajajo vse večja razhajanja v opredelitvi zapletenih intraabdominalnih okužb in ker veliko kliničnih zdravnikov ta pojem zavrača, so bile kot indikacija za ceftriakson odobrene intraabdominalne okužbe.
English: Lower Respiratory Tract Infections (LRTI)
Slovenian: Okužbe spodnjih dihal
English: There are no data available.
Slovenian: Podatki niso na voljo.
English: The maximum dose is once daily.
Slovenian: Največji odmerek je enkrat na dan.
English: Very rare: allergic reactions.
Slovenian: Zelo redki: alergijske reakcije.
English: The applicator should be cleaned with warm water each time after use.
Slovenian: Aplikator je treba po vsaki uporabi očistiti s toplo vodo.
English: Results of the WHI studies are presented:
Slovenian: Predstavljeni so izsledki študij WHI:
English: Treatment should not be restarted until the woman is completely mobilised.
Slovenian: Zdravljenje se ne sme ponovno začeti, dokler ženska ni povsem mobilna.
English: He or she will also discuss other possibilities for treatment with you.
Slovenian: Prav tako se bo z vami pogovoril o drugih možnostih zdravljenja.
English: This happens naturally after the menopause.
Slovenian: To se naravno zgodi po menopavzi.
English: HRT does not improve cognitive function.
Slovenian: HNZ ne izboljša kognitivne funkcije.
English: This part of section 3 has not been modified during this procedure]
Slovenian: Ta del poglavja 3 med tem postopkom ni bil spremenjen.]
English: The additional risk becomes clear within a few years.
Slovenian: Dodatno tveganje se pokaže v nekaj letih.
English: This may include an examination of your breasts and/or internal examination, if necessary.
Slovenian: Te lahko vključujejo pregled vaših dojk in/ali preiskave notranjih organov, če so potrebne.
English: The experience treating women older than 65 years is limited.
Slovenian: Izkušenj z zdravljenjem žensk, starejših od 65 let, je malo.
English: Reasons for immediate withdrawal of therapy
Slovenian: Razlogi za takojšnjo ukinitev zdravljenja
English: See your doctor if you notice any changes such as:
Slovenian: Obiščite zdravnika, če opazite spremembe, kot so:
English: It could be a sign that your endometrium has become thicker.
Slovenian: To je lahko znak, da je vaš endometrij postal debelejši.
English: The geometric mean half-life of E2 was 5.05 hours, with high interindividual variability.
Slovenian: Geometrijska sredina razpolovnih časov E2 je bila 5,05 ure ob veliki interindividualni variabilnosti.
English: The extra risk depends on how long you take HRT.
Slovenian: Dodatno tveganje je odvisno od tega, kako dolgo uporabljate HNZ.
English: Free T4 and free T3 concentrations are unaltered.
Slovenian: Koncentraciji prostega T4 in prostega T3 sta nespremenjeni.
English: After stopping treatment risk remain elevated for at least 10 years.
Slovenian: Po prekinitvi zdravljenja tveganje ostane povečano še vsaj 10 let.
English: Your doctor will explain the effects of stopping treatment and when to stop it.
Slovenian: Zdravnik vam bo pojasnil, kakšne so posledice prekinitve zdravljenja in kdaj ga lahko prekinete.
English: # Overal risk ratio.
Slovenian: # Celotno razmerje tveganja.
English: * Taken from baseline incidence rates in developed countries.
Slovenian: * Vzeto iz izhodiščnih incidenc v razvitih državah.
English: The occurrence of such an event is more likely in the first year of HRT than later.
Slovenian: Pojav teh dogodkov je verjetnejši v prvem letu HNZ kot pozneje.
English: Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
Slovenian: Opomba: ker se izhodiščna incidenca raka dojke med državami EU razlikuje, se sorazmerno temu spreminja tudi število dodatnih primerov raka dojke.
English: The risk ratio is not constant but will increase with increasing duration of use
Slovenian: Razmerje tveganja ni stalno, ampak se povečuje s trajanjem uporabe.
English: HRT will not prevent memory loss.
Slovenian: HNZ ne preprečuje izgube spomina.
English: Free or biologically active hormone concentrations are unchanged.
Slovenian: Koncentracije prostih ali biološko aktivnih hormonov se ne spremenijo.
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse.
Slovenian: Ženskam je treba pojasniti, o katerih spremembah dojk morajo poročati zdravniku ali medicinski sestri.
English: Therapeutic indications (areas of use):
Slovenian: Terapevtske indikacije (področja uporabe):
English: In case the applicator is damaged you should not use it and inform the manufacturer.
Slovenian: Če je aplikator poškodovan, ga ne uporabljajte in obvestite proizvajalca.
English: Section 4.6 Fertility, Pregnancy and lactation
Slovenian: Poglavje 4.6 Plodnost, nosečnost in dojenje
English: Medical history and regular check-ups
Slovenian: Zdravstvena zgodovina in redni pregledi
English: Continue with your treatment as normal.
Slovenian: Nadaljujte z zdravljenjem po običajnem razporedu.
English: In most cases, [invented name] is used for 2-3 weeks.
Slovenian: V večini primerov se zdravilo [izmišljeno ime] uporablja od 2-3 tedne.
English: - Estradiol is a female sex hormone.
Slovenian: - Estradiol je ženski spolni hormon.
English: - The level of risk is dependent on the duration of use (see section 4.4).
Slovenian: - Stopnja tveganja je odvisna od trajanja uporabe (glejte poglavje 4.4).
English: If your vaginal skin is very vulnerable, be careful when inserting the applicator into the vagina.
Slovenian: Če je koža vaše nožnice zelo občutljiva, bodite pri vstavljanju aplikatorja v nožnico previdni.
English: The use of HRT carries risks which need to be considered when deciding whether to start taking [invented name], or whether to carry on taking it.
Slovenian: Uporaba HNZ je povezana s tveganji, ki jih je treba upoštevati pri odločitvi o tem, ali naj se zdravilo [izmišljeno ime] začne uporabljati oziroma ali naj se še naprej uporablja.
English: The following risks apply to HRT medicines which circulate in the blood.
Slovenian: Tveganja, navedena v nadaljevanju, so povezana z zdravili za HNZ, ki krožijo v krvi.
English: It should be taken into account that these conditions may recur or be aggravated during oestrogen treatment, in particular:
Slovenian: Upoštevati je treba, da se lahko ta stanja med estrogenskim zdravljenjem ponovno pojavijo ali poslabšajo, še zlasti:
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Slovenian: V vseh primerih je treba najmanj enkrat na leto skrbno oceniti tveganja in koristi ter hormonsko nadomestno zdravljenje nadaljevati, samo dokler so koristi večje od tveganj.
English: Application beyond 4 weeks is not recommended, due to potential systemic exposure to estradiol during treatment.
Slovenian: Uporaba, daljša od štirih tednov, ni priporočljiva zaradi morebitne sistemske izpostavljenosti estradiolu med zdravljenjem.
English: The following values were determined after single-dose administration of 2 g [invented name], equivalent to 200 µg E2: AUCδ0-∞ = 887.5 pg/ml*h; AUCδ0-tz = 799.5 pg/ml*h; Cδmax = 86.2 pg/ml.
Slovenian: Po dajanju enkratnega odmerka 2 g zdravila [izmišljeno ime], ki ustreza 200 µg E2, so določili naslednje vrednosti: AUCδ0-∞ = 887,5 pg/ml*h; AUCδ0-tz = 799,5 pg/ml*h; Cδmax = 86,2 pg/ml.
English: - Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Slovenian: - Spodaj so predstavljeni rezultati največjega randomiziranega s placebom kontroliranega preskušanja (študija WHI) in najobsežnejše epidemiološke študije (MWS).
English: Especially prolonged use (>4 weeks) is therefore not recommended.
Slovenian: Zlasti daljša uporaba (> štiri tedne) zato ni priporočljiva.
English: If a dose is forgotten, it should be taken as soon as the patient remembers.
Slovenian: Če bolnica pozabi vzeti odmerek, ga mora vzeti, takoj ko se spomni.
English: It is inserted into your vagina, so the hormone is released where it is needed.
Slovenian: Vstavi se v nožnico, tako da se hormon sprošča tam, kjer je potreben.
English: *Study in women with no uterus
Slovenian: *Študija pri ženskah brez maternice
English: Speak to your doctor for advice.
Slovenian: Za nasvet se obrnite na zdravnika.
English: If so, you should see your doctor more often for check-up's.
Slovenian: V tem primeru boste morali pogosteje hoditi na preglede k zdravniku.
English: [In this section the use of the cream with the applicator is inserted.
Slovenian: [V ta del se vstavi opis uporabe kreme z aplikatorjem.
English: HRT is therefore contraindicated in these patients (see section 4.3).
Slovenian: HNZ je zato pri teh bolnicah kontraindicirano (glejte poglavje 4.3).
English: Treatment may be started on any convenient day.
Slovenian: Bolnice lahko zdravljenje začnejo na kateri koli dan, ki jim ustreza.
English: If prolonged immobilisation is to follow elective surgery, temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Slovenian: Če bo načrtovanemu kirurškemu posegu sledila daljša imobilizacija, je priporočljivo, da se od štiri do šest tednov prej začasno prekine HNZ.
English: Endogenous 17β-estradiol induces and maintains the primary and secondary female sexual characteristics.
Slovenian: Endogeni 17β-estradiol povzroči in ohranja primarne in sekundarne ženske spolne znake.
English: During prolonged use, you should look out for possible systemic effects (affecting the whole body).
Slovenian: Med daljšo uporabo morate biti pozorni na morebitne sistemske učinke (ki vplivajo na celo telo).
English: - It belongs to a group of hormones called oestrogens.
Slovenian: - Spada v skupino hormonov, ki jih imenujemo estrogeni.
English: $ When the analysis was restricte to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than non-users
Slovenian: $ Ko je bila analiza omejena na ženske, ki pred študijo niso uporabljale HNZ, v prvih petih letih zdravljenja ni bilo opaznega povečanega tveganja, po petih letih pa je bilo tveganje večje kot pri ženskah, ki niso uporabljale HNZ.
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
Slovenian: Krvni strdki so lahko resni in če kateri od njih pripotuje do pljuč, lahko povzroči bolečine v prsnem košu, zasoplost, omedlevico ali celo smrt.
English: * WHI study in women with no uterus, which did not show an increase in risk of breast cancer.
Slovenian: * Študija WHI pri ženskah brez maternice, ki ni pokazala povečanega tveganja za raka dojke.
English: Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.
Slovenian: Intravaginalni aplikator lahko povzroči manjšo lokalno poškodbo, zlasti pri ženskah z resno atrofijo nožnice.
English: As in all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery.
Slovenian: Tako kot pri vseh bolnikih po kirurškem posegu je treba razmisliti o preventivnih ukrepih za preprečitev VTE po njem.
English: Investigations including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Slovenian: Preiskave z ustreznimi napravami za slikanje, kot je na primer mamografija, je treba opraviti v skladu s trenutno uveljavljenimi praksami za presejalne preglede, prilagojenimi kliničnim potrebam posamezne ženske.
English: This medicine contains inactive ingredients (especially stearates) that may reduce the functionality of these products, thereby making them less reliable.
Slovenian: Zdravilo vsebuje neaktivne sestavine (zlasti stearate), ki lahko zmanjšajo funkcionalnost teh izdelkov in s tem tudi njihovo zanesljivost.
English: The following categories are used to express the frequency of side effects: Very common: more than 1 in 10 patients treated Common:
Slovenian: Pogostnost neželenih učinkov je opredeljena z naslednjimi kategorijami: Zelo pogosti: več kot 1 bolnica od 10, ki uporabljajo zdravilo
English: The relative risk does not change with age or time since menopause.
Slovenian: Relativno tveganje se s starostjo ali trajanjem menopavze ne spreminja.
English: Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar or slightly smaller risk (see Section 4.8).
Slovenian: Nekatere študije, vključno s preskušanjem WHI, kažejo, da bi dolgotrajna uporaba kombiniranih zdravil za HNZ lahko bila povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
English: [The following text should be inserted after the section “Clean the applicator after use”]
Slovenian: [Besedilo v nadaljevanju je treba vstaviti za odstavek „Po uporabi očistite aplikator“.]
English: The biological effect of 17β-estradiol is carried out through a number of specific oestrogen receptors.
Slovenian: Biološko delovanje 17β-estradiola poteka prek številnih specifičnih estrogenskih receptorjev.
English: For more information about these side effects, see Section 2
Slovenian: Za več informacij o teh neželenih učinkih glejte poglavje 2.
English: Usually, it's nothing to worry about, but you should make an appointment to see your doctor.
Slovenian: To običajno ni razlog za skrb, vendar pa se kljub temu naročite na obisk pri zdravniku.
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 kateri koli neželeni učinki postanejo resni ali če opazite neželene učinke, ki niso navedeni v tem navodilu, se posvetujte z zdravnikom ali farmacevtom.
English: Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
Slovenian: Pri ženskah, ki že prejemajo kronično antikoagulantno zdravljenje, je treba skrbno pretehtati koristi in tveganja HNZ.
English: Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.
Slovenian: Estrogeni ohranjajo pH v nožnici okoli normalnega (4,5), s čimer krepijo normalno bakterijsko floro.
English: The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in nonusers, especially during the first year of taking it.
Slovenian: Tveganje za krvne strdke v venah je približno 1,3- do 3-krat večje pri uporabnicah HNZ kot pri ženskah, ki ga ne uporabljajo, zlasti v prvem letu uporabe.
English: The endometrial safety of prolonged treatment and repeated treatment courses is unknown.
Slovenian: Varnost endometrija pri daljšem zdravljenju in ponavljajočem se zdravljenju ni znana.
English: Thus, prednisolone is particularly suitable for the treatment of inflammatory dermatoses in problem areas, as it has weak anti-inflammatory, antiallergic and antipruritic properties.
Slovenian: Prednizolon je zato posebno primeren za zdravljenje vnetnih dermatoz na problematičnih predelih, saj ima šibke protivnetne, protialergijske in antipruritične učinke.
English: However, being a HRT product, the following need to be considered:
Slovenian: Ker je to zdravilo za HNZ, je treba upoštevati naslednje: