FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose in adults and adolescents over 15 years of age is Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg a day.
Slovenian: Priporočeni začetni odmerek pri odraslih in mladostnikih, starejših od 15 let, je ena tableta zdravila Zubsolv 1,4 mg/0,36 mg ali 2,9 mg/0,71 mg na dan. Prvi dan se lahko da dodatna tableta zdravila Zubsolv 1,4 mg/0,36 mg ali 2,9 mg/0,71 mg, kar je odvisno od zahtev posameznega bolnika.
English: Both active substances of Zubsolv, buprenorphine and naloxone, are extensively metabolized in the liver, and the plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment.
Slovenian: Ugotovili so, da je plazemska koncentracija obeh, buprenorfina in naloksona, višja pri bolnikih z zmerno in hudo okvaro jeter.
English: • are elderly
Slovenian: • če ste starejši,
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets buprenorphine / naloxone
Slovenian: Zubsolv 8,6 mg/2,1 mg podjezične tablete buprenorfin/nalokson
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent patients.
Slovenian: Med kliničnimi farmakološkimi študijami pri bolnikih, odvisnih od opioidov, so opazili, da agonistični učinki na opioidne receptorje dosežejo najvišjo možno raven (opioid agonist ceiling effect).
English: Zubsolv is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Slovenian: Zdravilo Zubsolv se uporablja za zdravljenje odvisnikov od mamil, ki so privolili v zdravljenje svoje odvisnosti od opioidnih
English: Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy.
Slovenian: Pred začetkom zdravljenja se priporoča izvesti izhodiščne teste delovanja jeter in dokumentirati stanje morebitne okuženosti z virusnim hepatitisom.
English: Each 5.7 mg / 1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta 5,7 mg/1,4 mg vsebuje 5,7 mg buprenorfina (v obliki klorida) in 1,4 mg naloksona (v obliki klorida dihidrata).
English: Serious cases of infections with potential fatal outcome may occur if Zubsolv is misused, by taking it intravenously.
Slovenian: Napačna uporaba zdravila Zubsolv po intravenski poti lahko privede do resnih primerov okužb s potencialno smrtnim izidom.
English: Each 1.4 mg / 0.36 mg sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta 1,4 mg/0,36 mg vsebuje 1,4 mg buprenorfina (v obliki klorida) in 0,36 mg naloksona (v obliki klorida dihidrata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH
Slovenian: PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 8,6 mg / 2,1 mg
English: • Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain and other mental disorders.
Slovenian: Napačen odmerek benzodiazepinov lahko povzroči smrt zaradi dihalne odpovedi (nezmožnosti dihanja); • druga zdravila, po katerih se lahko počutite zaspani in se uporabljajo za zdravljenje anksioznosti, nespečnosti, krčev/epileptičnih napadov, bolečin in drugih duševnih motenj.
English: Each 11.4 mg / 2.9 mg sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta 11,4 mg/2,9 mg vsebuje 11,4 mg buprenorfina (v obliki klorida) in 2,9 mg naloksona (v obliki klorida dihidrata).
English: Zubsolv 2.9 mg / 0.71 mg sublingual tablets buprenorphine / naloxone
Slovenian: Zubsolv 2,9 mg/0,71 mg podjezične tablete buprenorfin/nalokson
English: Zubsolv tablet strength
Slovenian: Jakosti tablet zdravila Zubsolv
English: Abdominal Pain Diarrhoea Dyspepsia Flatulence Vomiting
Slovenian: Bolezni prebavil zaprtost navzea bolečine v trebuhu diareja dispepsija flatulenca bruhanje razjede v ustih obarvanje jezika
English: Hypersensitivity Anaphylactic shock
Slovenian: Bolezni imunskega sistema preobčutljivost anafilaktični šok
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Slovenian: PODATKI NA ZUNANJI OVOJNINI PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 11,4 mg / 2,9 mg
English: 1.6-fold increase
Slovenian: Podobno kot kontrola 1,6-kratno povečanje 2,8-kratno povečanje
English: Below is a list of examples of these types of medicines: - other opioid containing medicines such as methadone, certain pain killers and cough suppressants - some anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors (MAOIs) may increase the effects of this medicine - sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine - barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital - tranquilisers (used to cause sleep or sedation) such as chloral hydrate - clonidine (used to treat high blood pressure) and related medicines may extend the effects of this medicine
Slovenian: - barbiturati (ki se uporabljajo za lažje spanje ali pomiritev), kot sta fenobarbital in sekobarbital; - pomirjevala (ki se uporabljajo za lažje spanje ali pomiritev), kot je kloralhidrat; - klonidin (za zdravljenje visokega krvnega tlaka) in podobna zdravila lahko podaljšajo čas učinkovanja tega zdravila;
English: Decreased appetite Hyperglycaemia Hyperlipidaemia Hypoglycaemia
Slovenian: Presnovne in prehranske motnje zmanjšan tek hiperglikemija hiperlipidemija hipoglikemija
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets buprenorphine / naloxone
Slovenian: Zubsolv 5,7 mg/1,4 mg podjezične tablete buprenorfin/nalokson
English: Clear signs of withdrawal should be evident before taking your first dose of Zubsolv.
Slovenian: Preden vzamete prvi odmerek zdravila Zubsolv, morajo biti jasno vidni odtegnitveni simptomi.
English: Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta vsebuje 8,6 mg buprenorfina (v obliki klorida) in 2,1 mg naloksona (v obliki klorida dihidrata).
English: Heat stroke
Slovenian: • vročinska kap.
English: Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta vsebuje 11,4 mg buprenorfina (v obliki klorida) in 2,9 mg naloksona (v obliki klorida dihidrata).
English: In comparative bioavailability studies Zubsolv 11.4/2.9 mg displayed equivalent buprenorphine exposure to 16/4mg (2 x 8/2mg) buprenorphine/naloxone administered as conventional sublingual tablets however Zubsolv 2 x 1.4/0.36 mg displayed 20% lower buprenorphine exposure to 2 x 2/0.5 mg buprenorphine/naloxone administered as conventional sublingual tablets.
Slovenian: 2 x 1,4 mg/36 mg je bila izpostavljenost buprenorfinu za 20 % nižja kot pri buprenorfinu/naloksonu 2 x 2 mg/0,5 mg v obliki konvencionalne podjezične tablete.
English: • abnormal blood tests swollen, glands (lymph nodes)
Slovenian: • nenormalni izvidi krvnih testov, otekle bezgavke,
English: Each 2.9 mg / 0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta 2,9 mg/0,71 vsebuje 2,9 mg buprenorfina (v obliki klorida) in 0,71 mg naloksona (v obliki klorida dihidrata).
English: Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta vsebuje 1,4 mg buprenorfina (v obliki klorida) in 0,36 mg naloksona (v obliki klorida dihidrata).
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets buprenorphine / naloxone
Slovenian: Zubsolv 0,7 mg/0,18 mg podjezične tablete buprenorfin/nalokson
English: • weakness, chest pain, chills, fever, feeling of general discomfort, pain, swelling (hands and feet)
Slovenian: • šibkost, bolečine v prsih, mrzlica, povišana telesna temperatura, občutek splošnega nelagodja,
English: There are other strengths that are available to be used by your doctor who will decide what is the best treatment for you.
Slovenian: Zdravnik, ki se odloči o najprimernejšem zdravljenju za vas, vam lahko predpiše druge jakosti zdravila.
English: Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta vsebuje 5,7 mg buprenorfina (v obliki klorida) in 1,4 mg naloksona (v obliki klorida dihidrata).
English: Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta vsebuje 0,7 mg buprenorfina (v obliki klorida) in 0,18 mg naloksona (v obliki klorida dihidrata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Slovenian: PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 5,7 mg / 1,4 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
Slovenian: PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 1,4 mg / 0,36 mg
English: Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Slovenian: Ena podjezična tableta vsebuje 2,9 mg buprenorfina (v obliki klorida) in 0,71 mg naloksona (v obliki klorida dihidrata).
English: Amblyopia Lacrimal disorder
Slovenian: Očesne bolezni ambliopija motnje solznih žlez konjunktivitis mioza
English: Migraine Dizziness Hypertonia Paraesthesia Somnolence
Slovenian: Bolezni živčevja glavobol migrena omotica hipertonija parestezija somnolenca amnezija hiperkinezija epileptični napadi motnje govora tremor hepatična encefalopatija sinkopa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Slovenian: PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 2,9 mg / 0,71 mg
English: Orthostatic hypotension
Slovenian: Žilne bolezni hipertenzija vazodilatacija hipotenzija ortostatska hipotenzija
English: 11.3-fold increase
Slovenian: Podobno kot kontrola 2,7-kratno povečanje 11,3-kratno povečanje
English: • back pain, joint pain, muscle pain, leg cramps (muscle spasm)
Slovenian: • bolečine v hrbtu, bolečine v sklepih, bolečine v mišicah, krči v nogah (mišični krči),
English: The long half-life of methadone should be considered when starting buprenorphine/naloxone.
Slovenian: Ob uvedbi zdravljenja z buprenorfinom/naloksonom je treba upoštevati dolgo razpolovno dobo metadona.
English: Talk to your doctor before taking Zubsolv if you:
Slovenian: Pred začetkom jemanja zdravila Zubsolv se posvetujte z zdravnikom:
English: White, diamond shaped tablet, length 9.5 mm and width 8.2 mm
Slovenian: 8,6 mg/2,1 mg bela tableta v obliki romba z dolžino 9,5 mm in širino
English: Tell your doctor as soon as possible if you miss a dose.
Slovenian: Če pozabite vzeti odmerek, se čim prej posvetujte z zdravnikom.
English: Do not swallow or consume food or any drink until the tablet is completely dissolved.
Slovenian: Dokler se tableta popolnoma ne raztopi, je ne smete pogoltniti ali zaužiti hrane oziroma pijače.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Slovenian: PAKEIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 2,9 mg / 0,71 mg
English: Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is misused.
Slovenian: Po jemanju buprenorfina/naloksona, še posebej ob njegovi napačni uporabi, so poročali o poškodbah jeter.
English: Alopecia Dermatitis exfoliative Dry skin Skin mass
Slovenian: Bolezni kože in podkožja hiperhidroza pruritus izpuščaj urtikarija akne alopecija eksfoliativni dermatitis suha koža kožni vozliči angioedem
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Slovenian: PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 11,4 mg / 2,9 mg
English: White, D-shaped tablet, height 7.3 mm and width 5.65 mm
Slovenian: 2,9 mg/0,71 mg bela tableta v obliki črke D z višino 7,3 mm in širino 5,65 mm z oznako »2.9« na eni strani
English: How to store Zubsolv
Slovenian: Kako jemati zdravilo Zubsolv
English: White, oval tablet, length 6.8 mm and width 4.0 mm
Slovenian: 0,7 mg 0,18 mg bela ovalna tableta dolžine 6,8 mm in širine 4,0 mm z oznako ».7« na eni strani
English: Description of selected adverse reactions
Slovenian: Poročanje o neželenih učinkih
English: An additional tablet of the Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg may be administered on Day 1 depending on your needs.
Slovenian: Na 1. dan vam lahko glede na vaše potrebe dajo dodatno tableto zdravila Zubsolv 1,4 mg/0,36 mg ali 2,9 mg/0,71 mg.
English: Medical withdrawal
Slovenian: Uvajanje zdravljenja
English: An additional Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg may be administered on day one depending on the individual patient's requirement.
Slovenian: ena tableta zdravila Zubsolv 1,4 mg/0,36 mg na dan ali - ena tableta zdravila Zubsolv 2,9 mg/0,71 mg na dan.
English: AUClast
Slovenian: AUCkončni
English: Metabolites of buprenorphine accumulate in patients with renal failure.
Slovenian: Pri bolnikih z odpovedjo ledvic se presnovki buprenorfina kopičijo.
English: White, triangular tablet, base 7.2 mm and height 6.9 mm
Slovenian: 1,4 mg/0,36 mg bela trikotna tableta z dolžino stranice 7,2 mm in višino 6,9 mm z oznako »1.4« na eni strani
English: - Keep this leaflet.
Slovenian: Prepogni tukaj
English: • constipation, nausea
Slovenian: • glavobol, • zaprtost, slabost,
English: • have poor adrenal gland function (e.g. Addison's disease)
Slovenian: • če imate okvare v delovanju nadledvične žleze (npr. Addisonova bolezen), • če imate težave z biliarnim traktom (npr. žolčnik, žolčevod),
English: Severe hepatic impairment.
Slovenian: Huda okvara jeter.
English: LIST OF EXCIPIENTS
Slovenian: • vnetje sklepov,
English: • pain and sores in mouth, tongue discolouration
Slovenian: • astma, zasoplost, zehanje, • bolečine in razjede v ustih, obarvanje jezika,
English: Ear and labyrinth disorders
Slovenian: vključno z motnjami labirinta vrtoglavica
English: Hypertension Vasodilatation
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: How Zubsolv works
Slovenian: Kako zdravilo Zubsolv deluje
English: Within 2 years after Commission Decision.
Slovenian: V dveh letih po sprejetju sklepa Komisije
English: Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014
Slovenian: Datum prve odobritve: 26. november 2009 Datum zadnjega podaljšanja: 11. november 2014
English: Animal studies are insufficient.
Slovenian: Študije na živalih so nezadostne.
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Slovenian: DRUGI PODATKI Ponedeljek Torek Sreda Četrtek Petek Sobota Nedelja
English: This is the background to the current referral procedure.
Slovenian: To je ozadje trenutnega napotitvenega postopka.
English: Your doctor may need to change your dose and/or to take other precautions:
Slovenian: Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe:
English: You may need to have blood checks if you take:
Slovenian: Morda bodo potrebne krvne preiskave, če jemljete:
English: Other interactions
Slovenian: Druge interakcije
English: Assessment of the excess risk of cancer
Slovenian: Ocena čezmernega tveganja za raka
English: Try to take your daily dose at about the same time each day.
Slovenian: Dnevni odmerek poskušajte vzeti vsak dan ob približno istem času.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
English: However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes.
Slovenian: Treba pa je opozoriti, da lahko nitrozamini nastajajo tudi v številnih drugih razmerah, vključno z biološkimi procesi.
English: Compared to the lifetime cancer risk in the European population of approximately 50%, this additional risk is considered to be very low.
Slovenian: V primerjavi z doživljenjskim tveganjem za raka v evropski populaciji, ki je približno 50-odstotno, je to dodatno tveganje zelo majhno.
English: Teva Gyógyszergyár Zrt.
Slovenian: Magyarország Teva Gyógyszergyár Zrt.
English: Some of these effects may be serious and may require medical attention.
Slovenian: Nekateri neželeni učinki so lahko resni in lahko zahtevajo zdravniško pomoč.
English: No data are available..
Slovenian: Podatkov ni na voljo.
English: If possible, another class of diuretics should be used;
Slovenian: Če je mogoče, je treba uporabiti drugo skupino diuretikov.
English: Based on all available data, the CHMP requires the following:
Slovenian: Na podlagi razpoložljivih podatkov odbor CHMP zahteva naslednje:
English: This limit is considered a sufficiently robust threshold for APIs that can technically be reached.
Slovenian: Ta meja velja za dovolj trden prag za učinkovine, ki ga je tehnično mogoče doseči.
English: These interim limits are based on the maximum daily dose authorised in the EU for each of the sartans and therefore vary between them, as outlined in the table below:
Slovenian: Te začasne meje temeljijo na največjem dnevnem odmerku, odobrenem v EU za vsakega od sartanov, zato se med seboj razlikujejo, kot je prikazano v spodnji preglednici:
English: Considerations on monitoring of exposed patients
Slovenian: Razmisleki o spremljanju izpostavljenih bolnikov
English: Manufacturers:
Slovenian: Izdelovalci:
English: PC: SN: NN:
Slovenian: SN: NN:
English: Similar effects have been very rarely reported with irbesartan so far.
Slovenian: O podobnih učinkih so do sedaj pri irbesartanu poročali zelo redko.
English: This results in an increase in blood pressure.
Slovenian: Posledica je zvišan krvni tlak.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/YYYY}.
English: NDMA and NDEA are two of the most potent mutagenic carcinogens known.
Slovenian: NDMA in NDEA sta dve od najmočnejših znanih mutagenih karcinogenih snovi.
English: • Risk Management plan
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: Initially, this was only necessary for valsartan containing APIs from few manufacturers but later also for some other sartans with a tetrazole ring.
Slovenian: Na začetku je bilo to potrebno samo za valsartan, ki je vseboval učinkovine nekaterih proizvajalcev, pozneje pa tudi za nekatere druge sartane s tetrazolnim obročem.
English: Treatment of essential hypertension.
Slovenian: Zdravljenje esencialne hipertenzije.
English: The volume of distribution for irbesartan is 53-93 litres.
Slovenian: Porazdelitveni volumen irbesartana je 53-93 litrov.
English: The impact of NDMA and NDEA on human health is currently only extrapolated from animal studies.
Slovenian: Vpliv NDMA in NDEA na zdravje človeka je trenutno samo ekstrapolirano iz študij pri živalih.
English: Measures to mitigate the risk
Slovenian: Ukrepi za zmanjševanje tveganja
English: Primary aldosteronism
Slovenian: Primarni aldosteronizem
English: Efficacy and safety of sartancontaining medicines in these indications are per se well-established and are not questioned in this referral.
Slovenian: Učinkovitost in varnost zdravil, ki vsebujejo sartan, pri teh indikacijah sta sami po sebi dobro dokazani in v tej napotitvi nista sporni.
English: Additional measures are needed to minimise prospectively the reoccurrence of such contamination.
Slovenian: Potrebni so dodatni ukrepi za zmanjšanje ponovnega pojava tovrstnega onesnaženja v prihodnje.
English: The primary treatment is to discontinue drug intake as rapidly as possible.
Slovenian: Osnovni ukrep je ukinitev uporabe zdravila v najkrajšem možnem času.
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Slovenian: Tablete morate pogoltniti z zadostno količino tekočine (npr. z enim kozarcem vode).
English: Specifically, CHMP considered that NDMA and NDEA limits should be as low as technically possible.
Slovenian: Odbor CHMP je menil, da morajo biti meje za NDMA in NDEA tako nizke, kot je to tehnično mogoče.
English: For an individual risk assessment, data on the exact drug products and batches used by each individual patient would be necessary.
Slovenian: Pri oceni tveganja pri posamezniku bi bili potrebni podatki o točnih zdravilih in serijah, ki jih je uporabljal posamezni bolnik.
English: For these reasons, CHMP could not identify cancer screening methods that patients would benefit from.
Slovenian: Zato odbor CHMP ni mogel določiti metod za presejanje raka, ki bi bolnikom koristile.
English: The ICH M7(R1) guideline sets out principles for determining limits for mutagenic / DNA-reactive impurities.
Slovenian: V smernicah ICH M7(R1) so podana načela za določanje mej za mutagene/DNK-reaktivne nečistote.
English: However, as the DNA damage mechanisms documented in these studies are also relevant in humans and in vitro data in human cells are not significantly different from those in animal cells, it is prudent to assume that effects seen in animals may also occur in humans after exposure to sufficiently large amounts of these nitrosamines.
Slovenian: Ker pa so dokumentirani mehanizmi poškodb DNK pomembni tudi za človeka in ker se podatki in vitro za človeške celice ne razlikujejo bistveno od podatkov za živalske celice, je razumno domnevati, da se učinki, opaženi pri živalih, po izpostavljenosti dovolj veliki količini teh nitrozaminov lahko pojavijo tudi pri človeku.
English: Overall, taking into account the available data assessed in this procedure, the benefit risk balance of medicines containing a sartan with a tetrazole ring remains positive subject to the conditions imposed.
Slovenian: Na splošno je z upoštevanjem razpoložljivih podatkov, ocenjenih v tem postopku, razmerje med tveganji in koristmi zdravil, ki vsebujejo sartan s tetrazolnim obročem, še naprej pozitivno ob upoštevanju zahtevanih pogojev.
English: The underlying concept of the proposed approach is to keep the amount of N-nitrosamine impurities as low as possible, irrespective of the type of sartan or dose.
Slovenian: Osnovno bistvo predlaganega pristopa je čim bolj zmanjšati količino N-nitrozaminskih nečistot, ne glede na vrsto sartana ali odmerek.
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Slovenian: Irbesartan ni vplival na preživetje, razvoj ali sposobnost razmnoževanja potomcev.
English: The most common signs and symptoms of overdose are nausea and somnolence.
Slovenian: Najpogostejši znaki in simptomi prevelikega odmerjanja so navzea in somnolenca.
English: The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Slovenian: Največji učinek na znižanje krvnega tlaka se običajno pojavi v 6-8 tednih po začetku zdravljenja.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Slovenian: Dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: - aliskiren if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Slovenian: - aliskiren če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.