FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor, and the patient closely watched for 30 minutes.
Slovenian: Zaradi tveganj za nastanek hudih alergijskih reakcij mora prvo injiciranje nadzorovati zdravnik, bolnica pa mora ostati pod skrbnim nadzorom še 30 minut po injiciranju.
English: As for all medicines, data on the use of Cetrotide are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cetrotide stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cetrotide have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Cetrotide, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Cetrotide
Slovenian: Druge informacije o zdravilu Cetrotide
English: What benefits of Cetrotide have been shown in studies?
Slovenian: Kakšne koristi zdravila Cetrotide so se pokazale v študijah?
English: Side effects reported with Cetrotide are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Cetrotide, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Results showed that between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for buserelin and 97% for triptorelin.
Slovenian: Rezultati so pokazali, da se pri 95 do 97 % bolnic, ki so prejemale zdravilo Cetrotide, ravni LH niso povečale, v primerjavi z 98 % bolnic, ki so se zdravile z buserelinom, ali 97 % tistih, ki so se zdravile s triptorelinom.
English: In three main studies, Cetrotide was as effective as the comparator treatments in preventing a surge in the production of LH.
Slovenian: V treh glavnih študijah je bilo zdravilo Cetrotide enako učinkovito kot primerjalno zdravljenje pri preprečevanju povečanja proizvodnje LH.
English: Sudden, severe allergic reactions have been reported with Cetrotide and may affect between 1 and 10 patients in 1,000.
Slovenian: Pri zdravilu Cetrotide so poročali o nenadnih in hudih alergijskih reakcijah, ki lahko prizadenejo med 1 in 10 bolnic od 1 000.
English: Why is Cetrotide authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Cetrotide odobreno v EU?
English: What is Cetrotide and what is it used for?
Slovenian: Kaj je zdravilo Cetrotide in za kaj se uporablja?
English: Cetrotide can only be obtained with a prescription and treatment should be carried out by a doctor who has experience in this type of fertility treatment.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora izvajati zdravnik, ki ima izkušnje s to vrsto zdravljenja težav s plodnostjo.
English: An overview of Cetrotide and why it is authorised in the EU
Slovenian: Pregled zdravila Cetrotide in zakaj je odobreno v EU
English: For more information about using Cetrotide, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Cetrotide glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Cetrotide?
Slovenian: Kakšna tveganja so povezana z zdravilom Cetrotide?
English: Once the assisted-reproduction procedure was completed, 23% of patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.
Slovenian: Po zaključku postopka oploditve z biomedicinsko pomočjo je zanosilo 23 % bolnic, ki so prejemale zdravilo Cetrotide, v primerjavi z 32 % v primerjalnih skupinah.
English: Cetrotide must not be used in people who are hypersensitive (allergic) to any hormones that are chemically similar to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone medicines similar to Cetrotide).
Slovenian: Zdravila Cetrotide ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) katere koli hormone, ki so kemično podobni gonadotropin sproščajočemu hormonu, ali eksogene peptidne hormone (hormonska zdravila, ki so podobna zdravilu Cetrotide).
English: It must not be used in women who are pregnant or breastfeeding, or in patients with severe kidney disease.
Slovenian: Ne smejo ga uporabljati nosečnice ali doječe matere ali bolnice, ki imajo huda obolenja ledvic.
English: Treatment starts usually on day 5 or 6 of ovarian stimulation, continued throughout the ovarian stimulation period, until the evening before or the morning of the day when the induction of ovulation (the release of eggs) is planned.
Slovenian: Zdravljenje se začne na peti ali šesti dan ovarijske stimulacije ter se nadaljuje med ovarijsko stimulacijo do večera pred ali jutra na dan načrtovane sprožitve ovulacije (sprostitve jajčec).
English: Cetrotide is a medicine used to prevent premature ovulation (early release of eggs from the ovary).
Slovenian: Cetrotide je zdravilo, ki se uporablja za preprečevanje prezgodnje ovulacije (zgodnje sprostitve jajčec iz jajčnikov).
English: The most common side effects with Cetrotide (which may affect between 1 and 10 patients in 100) are mild to moderate overstimulation of the ovaries (which can occur as a side effect of the ovarian stimulation procedure itself) and reactions at the injection site, such as redness, swelling and itching.
Slovenian: Najpogostejši neželeni učinki zdravila Cetrotide (ki lahko prizadenejo 1 do 10 bolnic od 100) so blaga do zmerna hiperstimulacija jajčnikov (ki se lahko pojavi kot neželeni učinek samega postopka ovarijske stimulacije) ter reakcije na mestu injiciranja, kot so pordelost, otekanje in srbenje.
English: Cetrotide is an effective alternative to existing treatments for the prevention of premature ovulation and its side effects are manageable.
Slovenian: Zdravilo Cetrotide je učinkovita alternativa obstoječim zdravljenjem za preprečevanje prezgodnje ovulacije, njegovi neželeni učinki pa so obvladljivi.
English: The active substance in Cetrotide, cetrorelix, blocks the effects of luteinising-hormone-releasing hormone (LHRH) in the body.
Slovenian: Učinkovina zdravila Cetrotide, cetroreliks, zavira učinke luteinizirajočega hormona sproščajočega hormona (LHRH) v telesu.
English: During fertility treatment, ovarian stimulation is used to make the ovaries produce more eggs.
Slovenian: Med zdravljenjem težav s plodnostjo se uporablja ovarijska stimulacija z namenom, da jajčniki tvorijo več jajčec.
English: The studies involved 814 women and compared Cetrotide with buserelin nasal spray and triptorelin depot injection.
Slovenian: V študiji je sodelovalo 814 žensk, v njej pa so zdravilo Cetrotide primerjali z nosnim pršilom, ki vsebuje buserelin, in injekcijo triptorelina.
English: How does Cetrotide work?
Slovenian: Kako zdravilo Cetrotide deluje?
English: By blocking the effect of LHRH, Cetrotide stops the production of LH, and therefore prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF).
Slovenian: LHRH ustavi tvorjenje LH in tako prepreči prezgodnjo ovulacijo, ki ima lahko za posledico sprostitev jajčec, ki niso dozorela ali pa so neprimerna za uporabo pri tehnikah, kot je oploditev in-vitro (IVF).
English: LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation.
Slovenian: LHRH uravnava tvorjenje in izločanje drugega hormona, imenovanega luteinizirajoči hormon (LH), ki povzroči ovulacijo.
English: Further injections may be given by the patient herself, as long as she is made aware of the signs of allergic reaction and what to do if they appear.
Slovenian: Zatem si lahko bolnica zdravilo injicira sama, vendar mora biti seznanjena s simptomi alergijske reakcije in ukrepi ob njihovem pojavu.
English: These medicines also act on the secretion of LH, but work by overstimulating the production of LHRH, so that the body in response reduces and stops making LH.
Slovenian: Ta zdravila vplivajo na sproščanje LH, vendar delujejo s prekomernim spodbujanjem tvorjenja LHRH, zato telo zmanjša tvorbo LH ali ga preneha tvoriti.
English: For the full list of side effects and restrictions with Cetrotide, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cetrotide glejte navodilo za uporabo.
English: Cetrotide contains the active substance cetrorelix.
Slovenian: Zdravilo Cetrotide vsebuje učinkovino cetroreliks.
English: It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs).
Slovenian: Zdravilo Cetrotide se daje ženskam v postopku ovarijske stimulacije (zdravljenja zaradi težav s plodnostjo, pri čemer jajčnike spodbujajo, da tvorijo več jajčec).
English: Cetrotide is given by injection under the skin of the lower abdomen (belly).
Slovenian: Zdravilo Cetrotide se daje z injiciranjem v podkožje spodnjega dela trebuha.
English: How is Cetrotide used?
Slovenian: Kako se zdravilo Cetrotide uporablja?
English: Avoid taking alcohol until you have talked to your doctor.
Slovenian: Izogibajte se pitju alkohola, dokler se o tem ne pogovorite s svojim zdravnikom.
English: This applies especially to the medicines listed below taken at the same time with PritorPlus:
Slovenian: To velja zlasti za spodaj našteta zdravila, ki jih jemljete hkrati z zdravilom PritorPlus:
English: NN: {number} {national reimbursement number or other national number identifying the medicinal product}
Slovenian: NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]
English: About 60 % of the oral dose is eliminated within 48 hours.
Slovenian: Približno 60 % peroralnega odmerka se izloči v 48 urah.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2002
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 22. april 2002 Datum zadnjega podaljšanja: 14. maj 2007
English: Therefore the combination should be administered with caution, especially in the elderly.
Slovenian: Zato je treba kombinacijo previdno dajati zlasti starejšim bolnikom.
English: PC: {number} {product code}
Slovenian: PC: {številka} [koda zdravila]
English: Sepsis including fatal outcome
Slovenian: sepsa, tudi z usodnim izidom
English: Terminal elimination half-life was >20 hours.
Slovenian: Končna razpolovna doba izločanja je bila > 20 ur.
English: The tablets should be swallowed with some water or other nonalcoholic drink.
Slovenian: Tablete morate pogoltniti z nekaj vode ali brezalkoholne pijače.
English: Contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Slovenian: Nemudoma morate poklicati svojega zdravnika, farmacevta ali oddelek za nujno pomoč v najbližji bolnišnici.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: Bolnika je treba skrbno spremljati, zdravimo pa simptomatsko in podporno.
English: If a photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Slovenian: Če se med zdravljenjem pojavi fotosenzibilna reakcija, ga je priporočljivo prekiniti.
English: 1: Based on post-marketing experience
Slovenian: 1: Na podlagi izkušenj v obdobju trženja zdravila.
English: SN: {number} {serial number}
Slovenian: SN: {številka} [serijska številka]
English: Renal clearance is about 250 - 300 ml/min.
Slovenian: Ledvični očistek je približno 250 do 300 ml/min.
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Slovenian: Torej je potrebno krvni tlak meriti redno, da bi preverili, ali je v normalnem območju.
English: The most common signs and symptoms of overdose are nausea and somnolence.
Slovenian: Najpogostejša znaka in simptoma prevelikega odmerka sta navzea in zaspanost.
English: Not all pack sizes may be available in your country.
Slovenian: Vsa navedena pakiranja v vaši državi morda niso na voljo.
English: PritorPlus with food and alcohol
Slovenian: Zdravilo PritorPlus skupaj s hrano in alkoholom
English: Your doctor will normally advise you to stop taking PritorPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of PritorPlus.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravilo PritorPlus prenehate jemati, preden boste zanosili ali takoj, ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila PritorPlus jemljete drugo zdravilo.
English: - see pregnancy section.)
Slovenian: - glejte poglavje o nosečnosti),
English: See also information under the heading “Do not take PritorPlus”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila PritorPlus”.
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Slovenian: Primarno zdravljenje je čim hitrejša prekinitev uporabe hidroklorotiazida.
English: This is not considered to be of clinical relevance.
Slovenian: Ta pojav ne velja za klinično pomembnega.
English: Plasma concentrations of telmisartan are generally 2 - 3 times higher in females than in males.
Slovenian: Koncentracije telmisartana v plazmi so pri ženskah večinoma 2- do 3-krat večje kot pri moških.
English: What PritorPlus is and what it is used for
Slovenian: Kaj je zdravilo PritorPlus in za kaj ga uporabljamo
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Slovenian: Nekoliko zmanjšano območje pod krivuljo (AUC) predvidoma ne zmanjša terapevtske učinkovitosti.
English: The safety and efficacy of PritorPlus in children and adolescents aged below 18 have not been established.
Slovenian: Varnost in učinkovitost zdravila PritorPlus pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: Activated charcoal may be useful in the treatment of overdose.
Slovenian: Aktivno oglje je lahko koristno pri zdravljenju po prevelikem odmerku.
English: You do not need to take any action if this happens.
Slovenian: Če se to zgodi, ni treba storiti ničesar.
English: The European Medicines Agency has waived the obligation to submit the results of studies with PritorPlus in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom PritorPlus za vse podskupine pediatrične populacije s hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Elderly Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Slovenian: Starejši Farmakokinetika telmisartana se med starejšimi bolniki in bolniki, mlajšimi od 65 let, ne razlikuje.
English: PritorPlus can have influence on the ability to drive and use machines.
Slovenian: Zdravilo PritorPlus lahko vpliva na sposobnost vožnje in upravljanja strojev.
English: There are no adequate data from the use of PritorPlus in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila PritorPlus pri nosečnicah.
English: • if you have severe kidney disease.
Slovenian: • če imate hudo ledvično bolezen,
English: The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Slovenian: Funkcija teh receptorjev ni znana, kakor tudi ne posledice njihovega prevelikega spodbujanja z angiotenzinom II, katerega raven telmisartan poveča.
English: The use of PritorPlus in children and adolescents up to the age of 18 years is not recommended.
Slovenian: Uporabe zdravila PritorPlus pri otrocih in mladostnikih do 18. leta ne priporočamo.
English: Exacerbation or activation of systemic lupus erythematosus
Slovenian: poslabšanje ali aktiviranje sistemskega eritematoznega lupusa
English: The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Slovenian: Povprečen navidezen volumen porazdelitve je približno 500 l, kar kaže na dodatno tkivno vezavo.
English: Chloride deficit is generally mild and usually does not require treatment.
Slovenian: Pomanjkanje klorida je običajno blago in ga ni potrebno zdraviti.
English: Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body.
Slovenian: Zdravljenje s hidroklorotiazidom lahko povzroči neravnovesje elektrolitov v telesu.
English: • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
Slovenian: • če vaš zdravnik odkrije, da imate nizko raven kalija ali visoko raven kalcija v krvi in da tega stanja zdravljenje ne izboljša,
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Slovenian: • drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6)
English: In functionally anephric patients the elimination half-life is about 34 hours.
Slovenian: Pri bolnikih brez ledvične funkcije je razpolovna doba izločanja približno 34 ur.
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, ATC code: C09DA07
Slovenian: Farmakoterapevtska skupina: antagonisti angiotenzina II in diuretiki, oznaka ATC: C09DA07
English: Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Slovenian: Alkohol vam lahko dodatno zniža krvni tlak ali poveča verjetnost, da boste omotični ali se počutili slabotno.
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Slovenian: Hidroklorotiazida ne smemo uporabljati za zdravljenje esencialne hipertenzije pri nosečnicah, razen v redkih primerih, kadar ni možno drugo zdravljenje.
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Slovenian: C označenega telmisartana odpade na glukuronid približno 11 % radioaktivnosti, izmerjene v plazmi.
English: Some people feel dizzy or tired when taking PritorPlus.
Slovenian: Nekateri ljudje so med zdravljenjem z zdravilom PritorPlus omotični ali utrujeni.
English: Serum electrolytes and creatinine should be monitored frequently.
Slovenian: Potrebna je pogosta kontrola serumskih elektrolitov in kreatinina.
English: Both substances help to control high blood pressure.
Slovenian: Obe učinkovini pomagata uravnavati visok krvni tlak.
English: These findings are considered to be due to the pharmacological activity of telmisartan.
Slovenian: Menijo, da so našteti pojavi posledica farmakološkega delovanja telmisartana.
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l- acid glycoprotein.
Slovenian: Telmisartan se obsežno veže na plazemske beljakovine (> 99,5 %), predvsem albumin in kisli glikoprotein alfa-1.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Slovenian: Hidroklorotiazid sproži diurezo v 2 urah, doseže največji učinek približno po 4 urah, njegovo delovanje pa traja približno 6 do 12 ur.
English: There are usually no symptoms of high blood pressure before damage occurs.
Slovenian: Visok krvni tlak običajno ne povzroča simptomov, dokler se ne pojavijo okvare.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Slovenian: dihalna stiska (tudi pnevmonitis in pljučni edem)
English: Electrolyte imbalance
Slovenian: Motnje elektrolitskega ravnovesja
English: Chest pain Influenza-like illness, pain
Slovenian: gripi podobna bolezen, bolečina
English: Additional information on individual components
Slovenian: Dodatni podatki o posameznih sestavinah zdravila
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking PritorPlus.
Slovenian: Z zdravnikom se morate posvetovati, ali je treba med jemanjem zdravila PritorPlus prilagoditi odmerek vašega drugega zdravila.
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Slovenian: Epidemiološke raziskave so pokazale, da dolgotrajno zdravljenje s hidroklorotiazidom zmanjša tveganje obolevnosti in umrljivost zaradi srčnožilnih bolezni.
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Slovenian: C označenega telmisartana se je večina odmerka (> 97 %) izločila z blatom po biliarni poti.
English: The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in placebo controlled trials.
Slovenian: Skupna pogostnost neželenih učinkov, o kateri so poročali za telmisartan (41,4 %), je bila večinoma primerljiva s podatki za placebo (43,9 %) v kliničnih preskušanjih nadzorovanih s placebom.
English: • Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na katero koli učinkovino ali katero koli pomožno snov navedeno v poglavju 6.1
English: By 3 hours after administration plasma concentrations are similar whether telmisartan is taken fasting or with food.
Slovenian: Tri ure po dajanju so koncentracije v plazmi pri jemanju na tešče in s hrano podobne.
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Slovenian: Kombinacija obeh sestavin ima aditiven antihipertenzivni učinek, zato učinkoviteje znižuje krvni tlak kot posamični sestavini.
English: If you forget to take PritorPlus
Slovenian: Če ste pozabili vzeti zdravilo PritorPlus
English: The mechanism of the antihypertensive effect of thiazide diuretics is not fully known.
Slovenian: Mehanizem antihipertenzivnega delovanja tiazidnih diuretikov še ni povsem jasen.
English: Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Slovenian: Telmisartan lahko poveča hipotenzivni učinek drugih antihipertenzivov.
English: The following adverse reactions listed below have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events.
Slovenian: Našteti neželeni učinki zdravila so zbrani iz vseh kliničnih preskušanj pri bolnikih, ki so se s telmisartanom zdravili zaradi hipertenzije, ali pri bolnikih starih 50 let ali starejših, z velikim tveganjem za srčnožilne dogodke.
English: In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Slovenian: Telmisartan pri hipertenzivnih bolnikih znižuje sistolični in diastolični krvni tlak, ne da bi vplival na hitrost pulza.
English: In clinical trials however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women.
Slovenian: Vendar v kliničnih preskušanjih pri ženskah niso zasledili pomembno večjega odziva krvnega tlaka niti večje pogostnosti ortostatske hipotenzije.
English: • if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
Slovenian: • če ste alergični na hidroklorotiazid ali katerokoli drugo sulfonamidno zdravilo,
English: Adverse reactions reported in all clinical trials and occurring more frequently (p 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Slovenian: Neželeni učinki, o katerih so poročali v vseh kliničnih preskušanjih in so se pojavljali pogosteje (p  0,05) pri telmisartanu in hidroklorotiazidu kot pri placebu, so našteti po organskih sistemih.
English: Elimination Telmisartan: Following either intravenous or oral administration of
Slovenian: Izločanje Telmisartan: Po intravenskem ali peroralnem dajanju s