FrancophonIA/ELRC3.0 huggingface dataset:
English: STRENSIQ 40 mg/ml 12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
Slovenian: STRENSIQ 40 mg/ml 12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml
English: Each vial contains 12 mg of asfotase alfa (12 mg/0.3 ml).
Slovenian: Ena viala vsebuje 12 mg asfotaze alfa (12 mg/0,3 ml).
English: 7/11 patients in the full analysis set achieved Radiographic Global Impression of Change scores of +2 at Week 24 compared to baseline radiographs.
Slovenian: 7 od 11 bolnikov v celotni skupini za analizo je v 24. tednu v primerjavi z rentgenogrami ob izhodišču doseglo rezultat +2 po lestvici RGI-C.
English: • Localized lipodystrophy (fatty lumps or deceased fatty tissue on the surface of the skin) have been reported at injection sites after several months in patients using Strensiq.
Slovenian: • Pri bolnikih, ki so uporabljali zdravilo Strensiq, so po več mesecih poročali o lokalizirani lipodistrofiji (maščobnih zatrdlinah ali pomanjkanju maščobnega tkiva na površini kože).
English: Each vial contains 18 mg of asfotase alfa (18 mg/0.45 ml).
Slovenian: Ena viala vsebuje 18 mg asfotaze alfa (18 mg/0,45 ml).
English: If injecting 3x per week
Slovenian: Pri injiciranju 3x na teden
English: Each vial contains 28 mg of asfotase alfa (28 mg/0.7 ml).
Slovenian: Ena viala vsebuje 28 mg asfotaze alfa (28 mg/0,7 ml).
English: It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa.
Slovenian: Pri bolnikih, zdravljenih z asfotazo alfa, se priporoča spremljanje koncentracije obščitničnega hormona in kalcija v serum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 mg/ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 40 mg/ml
English: - 10 patients were weaned off any ventilation support (time on ventilation from 3 to 216 weeks).
Slovenian: - 7 bolnikov je bilo odvajenih od invazivne ventilacije (čas na ventilaciji od 12 do
English: • Warning and precautions on the potential risk of medication errors and injection site reactions associated with the use of Strensiq
Slovenian: Izobraževalna gradiva za bolnike in skrbnike morajo vsebovati naslednja ključna sporočila: • opozorila in previdnostne ukrepe glede možnega tveganja napak pri uporabi zdravila in o reakcijah na mestu injiciranja, povezanih z uporabo zdravila Strensiq,
English: Hypoaesthesia oral Nausea
Slovenian: Bolezni prebavil pogosti oralna hipestezija navzea
English: Hypophosphatasia is associated with multiple bone manifestations including rickets / osteomalacia, altered calcium and phosphate metabolism, impaired growth and mobility, respiratory compromise that may require ventilation, and vitamin B6-responsive seizures.
Slovenian: Hipofosfatazija je povezana z več kostnimi manifestacijami, vključno z rahitisom/osteomalacijo, spremenjeno presnovo kalcija in fosfata,
English: Alternative assays (i.e. not utilizing an ALP-conjugated reporter system) may be considered in patients treated with Strensiq.
Slovenian: (tj. takih, kjer se ne uporablja sistem poročevalskih molekul, konjugiranih z AF).
English: 40/69 patients and 32/69 patients did not show apparent catch-up gain in height and in weight, respectively.
Slovenian: 40 od 69 bolnikov ni pokazalo navideznega dohitevanja pridobivanja telesne višine, 32 od 69 bolnikov pa ni pokazalo navideznega dohitevanja pridobivanja telesne mase.
English: Each vial of 0.8 ml solution (100 mg/ml) contains 80 mg of asfotase alfa.
Slovenian: Ena viala z 0,8 ml raztopine (100 mg/ml) vsebuje 80 mg asfotaze alfa.
English: After the 2 mg/kg weekly subcutaneous administration in Cohort 2 the mean (SD) AUCτ was 138595 (6958) and 136109 (41875) following the first and the third dose, respectively.
Slovenian: 138.595 (6.958) po prvem oz. 136.109 (41.875) po tretjem odmerku.
English: In nonclinical safety testing in rats, no body system-specific adverse effects were noted at any dose or route of administration.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinično testiranje varnosti pri podganah ni pokazalo neželenih učinkov, specifičnih za telesni sistem,
English: Gently pinch the skin of the chosen injection area between your thumb and index finger.
Slovenian: S palcem in kazalcem nežno primite izbrano mesto injiciranja.
English: Remove the protective cap from the Strensiq vial.
Slovenian: Z viale zdravila Strensiq odstranite zaščitni pokrovček.
English: Each vial contains 80 mg of asfotase alfa (80 mg/0.8 ml)
Slovenian: Ena viala vsebuje 80 mg asfotaze alfa (80 mg/0,8 ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg/ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA 100 mg/ml
English: Lonza Biologics 101 International Drive Pease International Tradeport 03801 Portsmouth United States
Slovenian: 03801 Portsmouth
English: Irritability
Slovenian: Preobčutljivost
English: Skin discolouration Skin disorder (stretched skin)
Slovenian: Bolezni kože in podkožja zelo pogosti eritem pogosti obarvanje kože bolezen kože (raztegnjena koža)
English: Injection site reactions (including injection site atrophy, abscess, erythema, discolouration, pain, pruritus, macule, swelling, contusion, bruising, lipodystrophy (lipoatrophy or lipohypertrophy), induration, reaction, nodule, rash, papule, haematoma, inflammation, urticarial, calcification, warmth, haemorrhage,
Slovenian: makulo, oteklino, kontuzijo, modrico, lipodistrofijo (lipoatrofijo ali lipohipertrofijo), zatrdlino, reakcijo,
English: Each vial contains 0.8 ml solution and 80 mg of asfotase alfa (100 mg/ml).
Slovenian: Ena viala vsebuje 0,8 ml raztopine in 80 mg asfotaze alfa (100 mg/ml).
English: 12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
Slovenian: DRUGI PODATKI 12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml
English: Each vial of 0.7 ml solution (40 mg/ml) contains 28 mg of asfotase alfa.
Slovenian: Ena viala z 0,7 ml raztopine (40 mg/ml) vsebuje 28 mg asfotaze alfa.
English: Sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, water for injections.
Slovenian: natrijev klorid, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat monohidrat, voda za injekcije Za nadaljnje podatke glejte navodilo za uporabo.
English: Each vial contains 0.45 ml solution and 18 mg of asfotase alfa (40 mg/ml).
Slovenian: Ena viala vsebuje 0,45 ml raztopine in 18 mg asfotaze alfa (40 mg/ml).
English: Each vial of 0.3 ml solution (40 mg/ml) contains 12 mg of asfotase alfa.
Slovenian: Ena viala z 0,3 ml raztopine (40 mg/ml) vsebuje 12 mg asfotaze alfa.
English: Each vial of 0.45 ml solution (40 mg/ml) contains 18 mg of asfotase alfa.
Slovenian: Ena viala z 0,45 ml raztopine (40 mg/ml) vsebuje 18 mg asfotaze alfa.
English: Each vial contains 0.3 ml solution and 12 mg of asfotase alfa (40 mg/ml).
Slovenian: Ena viala vsebuje 0,3 ml raztopine in 12 mg asfotaze alfa (40 mg/ml).
English: Each ml of solution contains 100 mg of asfotase alfa.
Slovenian: En ml raztopine vsebuje 100 mg asfotaze alfa.
English: Each vial of 1 ml solution (40 mg/ml) contains 40 mg of asfotase alfa.
Slovenian: Ena viala z 1 ml raztopine (40 mg/ml) vsebuje 40 mg asfotaze alfa.
English: Each ml of solution contains 40 mg of asfotase alfa.
Slovenian: En ml raztopine vsebuje 40 mg asfotaze alfa.
English: Each vial contains 0.7 ml solution and 28 mg of asfotase alfa (40 mg/ml).
Slovenian: Ena viala vsebuje 0,7 ml raztopine in 28 mg asfotaze alfa (40 mg/ml).
English: Each vial contains 1.0 ml solution and 40 mg of asfotase alfa (40 mg/ml).
Slovenian: Ena viala vsebuje 1,0 ml raztopine in 40 mg asfotaze alfa (40 mg/ml).
English: Hypersensitivity reactions include erythema/redness, pyrexia/fever, rash, pruritis, irritability, nausea, vomiting, pain, rigor/chills, hypaesthesia oral, headache, flushing, tachycardia, cough, and signs and symptoms consistent with anaphylaxis (see section 4.4).
Slovenian: Preobčutljivostne reakcije vključujejo eritem/rdečino, pireksijo/zvišano telesno temperaturo, izpuščaj, pruritus, razdražljivost, navzeo, bruhanje, bolečino, rigor/mrzlico, oralno hipestezijo, glavobol,
English: What is Strensiq used for
Slovenian: Za kaj uporabljamo zdravilo Strensiq
English: OTHER
Slovenian: Eden od
English: INFORMATION IN BRAILLE STRENSIQ 100 mg/ml 80 mg/0.8 ml
Slovenian: STRENSIQ 100 mg/ml
English: - Mean (SD) osteoid volume / bone volume was 11.8 (5.9)% at baseline and 8.6 (7.2)% at week 24
Slovenian: 24. tednu; - srednja vrednost (SD) osteoidnegai volumna/kostnega volumna je bila 11,8 (5,9) % ob izhodišču in
English: The active substance is asfotase alfa.
Slovenian: Učinkovina je asfotaza alfa.
English: Skin redness (erythema)
Slovenian: skeleče mišice (mialgija)
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema pogosti večja nagnjenost k modricam
English: Strensiq 40 mg/ml solution for injection (12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml) asfotase alfa
Slovenian: Navodilo za uporabo Strensiq 40 mg/ml raztopina za injiciranje (12 mg/0,3 ml 18 mg/0,45 ml 28 mg/0,7 ml 40 mg/1 ml)
English: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection
Slovenian: Strensiq 40 mg/ml raztopina za injiciranje Strensiq 100 mg/ml raztopina za injiciranje
English: System Organ Class
Slovenian: let] Organski sistem
English: Cohort 1 (n=3) of the study received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 1 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
Slovenian: 3 mg/kg, nato pa so sledili 3 odmerki po 1 mg/kg subkutano v tedenskih intervalih od 2. do 4. tedna.
English: • Areas with a good amount of fat below the skin (thighs, arms (deltoids), abdomen and buttocks) are the most suitable areas to inject.
Slovenian: • Za injiciranje so najbolj primerni predeli z zadostno količino maščobe pod kožo (stegna, roke
English: Invert the vial and syringe.
Slovenian: Zasukajte vialo in brizgo na glavo.
English: Anaphylactoid reactions Hypersensitivity
Slovenian: Bolezni imunskega sistema pogosti anafilaktoidne reakcije preobčutljivost2
English: NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection asfotase alfa
Slovenian: Strensiq 40 mg/ml raztopina za injiciranje asfotaza alfa
English: Stretched skin, skin discolouration Feeling sick (nausea), numbness of the mouth (hypoaesthesia oral) Aching muscles (myalgia)
Slovenian: zvišana telesna temperatura (pireksija), razdražljivost rdečina kože (eritem) bolečine v dlaneh in stopalih kontuzija (modrica) glavobol
English: Supplements of calcium and oral vitamin D may be required.
Slovenian: Morda bo treba dodajati kalcij in peroralni vitamin D. Glejte poglavje 5.1.
English: NAME OF THE MEDICINAL PRODUCT Strensiq 100 mg/ml solution for injection asfotase alfa
Slovenian: Strensiq 100 mg/ml raztopina za injiciranje asfotaza alfa
English: After being trained by the doctor or specialized nurse, you can inject Strensiq yourself at home.
Slovenian: Zdravilo Strensiq si lahko injicirate sami doma po tem, ko vas bo o pravilni uporabi zdravila poučil zdravnik ali specializirana medicinska sestra.
English: Volume to be injected
Slovenian: ki ga je treba injicirati
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje pogosti hipokalciemija
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 100 mg of asfotase alfa.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En ml raztopine vsebuje 100 mg asfotaze alfa.
English: How to store Strensiq
Slovenian: Shranjevanje zdravila Strensiq
English: Excipients
Slovenian: Imunogenost
English: Dark blue
Slovenian: Alexion Europe SAS
English: • Weight gain may occur during your treatment with Strensiq.
Slovenian: • Pri bolniku se lahko telesna masa med zdravljenjem poveča.
English: Injection site cellulitis
Slovenian: Infekcijske in parazitske bolezni pogosti celulitis na mestu injiciranja
English: At study completion patients had received a median of over 60 months of treatment (24 to 68 months).
Slovenian: Ob zaključku študije so bolniki prejeli mediano prek 60 mesecev
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC {number}
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: Strensiq 100 mg/ml solution for injection Filled volumes of the vials are: 0.8 ml
Slovenian: Napolnjeni volumni vial so: 0,8 ml
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Slovenian: Izgled zdravila Strensiq in vsebina pakiranja
English: Talk to your doctor in case of problems with your vision.
Slovenian: Če imate težave z vidom, se posvetujte z zdravnikom.
English: MARKETING AUTHORISATION HOLDER
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: BATCH NUMBER Lot
Slovenian: PC {številka}
English: Lipodystrophy
Slovenian: Lipodistrofija
English: At study completion, patients had received a median of over 79 months (6.6 years) of treatment (1 to >84 months).
Slovenian: (6,6 let) zdravljenja (od 1 do > 84 mesecev).
English: Date of first authorisation: 10 November 2017
Slovenian: Datum prve odobritve: 10 november 2017
English: This may appear several days after birth.
Slovenian: Ti se lahko pojavijo nekaj dni po rojstvu.
English: Less than daily dosing
Slovenian: Manj kot dnevno odmerjanje
English: 751 05 Uppsala Sweden
Slovenian: 751 05 Uppsala Švedska
English: • Children and adolescents
Slovenian: • Otroci in mladostniki
English: This medicine should not be taken by those under 15 years of age.
Slovenian: Tega zdravila ne smejo jemati osebe, mlajše od 15 let.
English: • sensitivity to heat or cold
Slovenian: • občutljivost na toplo ali mrzlo,
English: • Diagnosis of unrelated medical conditions
Slovenian: • Diagnoze nepovezanih zdravstvenih stanj
English: Do not swallow.
Slovenian: Ne pogoltnite.
English: When a hepatic event is suspected, further biological and etiological evaluation is required.
Slovenian: Če sumite na jetrni dogodek, je treba opraviti nadaljnje biološko in etiološko ovrednotenje.
English: The patient should be transferred to an environment where full resuscitation facilities are available.
Slovenian: Bolnika je treba prenesti v okolje, kjer so na voljo vsi pripomočki za oživljanje.
English: Acute alcoholism or delirium tremens.
Slovenian: Akutni alkoholizem ali delirium tremens.
English: Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Slovenian: Zato je treba odmerke omejiti in se izogniti tej kombinaciji v primerih, ko obstaja tveganje za napačno uporabo.
English: The frequency of possible side effects listed below is defined using the following convention:
Slovenian: Pogostnost spodaj navedenih možnih neželenih učinkov je opredeljena po naslednjem dogovoru:
English: Do not give this medicine to anyone else.
Slovenian: Tega zdravila ne smete dati nikomur drugemu.
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: • some medicines may decrease the effect of Zubsolv.
Slovenian: • nekatera zdravila lahko zmanjšajo učinek zdravila Zubsolv.
English: Hepatitis and hepatic events
Slovenian: Hepatitis in hepatični dogodki
English: No synergistic enhancement of toxicity has been observed.
Slovenian: Sinergistične okrepitve toksičnosti niso opazili.
English: • benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Slovenian: • benzodiazepini: ta kombinacija lahko povzroči smrt zaradi respiratorne depresije centralnega izvora.
English: Precautions to be taken before induction
Slovenian: Previdnostni ukrepi pred indukcijo
English: These may be signs of a life-threatening allergic reaction
Slovenian: To so lahko znaki življenjsko nevarne alergijske reakcije;
English: It can cause death or otherwise harm them.
Slovenian: Povzroči lahko smrt ali druge poškodbe.
English: • Take the dose once a day or as advised by your doctor.
Slovenian: • Odmerek vzemite enkrat dnevno, kot vam je naročil zdravnik.
English: Elderly No pharmacokinetic data in elderly patients are available.
Slovenian: Farmakokinetičnih podatkov za starejše bolnike ni na voljo.
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥/10,000
Slovenian: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do
English: This product can cause dependence.
Slovenian: To zdravilo lahko povzroča odvisnost.
English: They may also cause central nervous system depression, which is very serious.
Slovenian: Povzročajo tudi depresijo centralnega živčnega sistema, ki je zelo nevarna.
English: If the blister is damaged, discard the tablet.
Slovenian: Če je pretisni omot poškodovan, tableto zavrzite.
English: This medicine may mask pain symptoms that could assist in the diagnosis of some diseases.
Slovenian: To zdravilo lahko prikrije simptome bolečine, ki lahko pomagajo pri diagnozi nekaterih bolezni.
English: The syndrome is generally delayed for several hours to several days after birth.
Slovenian: Sindrom se na splošno pojavi z zamikom več ur ali več dni po rojstvu.
English: The recommended starting dose for adults and adolescents over the age of 15 years is:
Slovenian: Priporočeni začetni odmerek pri odraslih in mladostnikih, starejših od 15 let, je:
English: • Remove the tablet as described below.
Slovenian: • Tableto vzemite iz pretisnega omota, kot je opisano spodaj.
English: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Slovenian: Nadomestno zdravljenje odvisnosti od opioidov v okviru medicinskega, socialnega in psihološkega zdravljenja.
English: Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes.
Slovenian: Začetni odmerki naloksona lahko znašajo do 2 mg in jih je treba ponavljati vsake 2-3 minute.
English: Tell your doctor immediately or seek urgent medical attention if you experience serious side effects, such as:
Slovenian: Takoj se posvetujte s svojim zdravnikom ali poiščite nujno medicinsko pomoč, če se pojavijo resni neželeni učinki, kot so:
English: Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Slovenian: Buprenorfin se lahko napačno uporablja ali zlorablja podobno kot druge zakonite ali nezakonite opioide.
English: You can also report side effects directly via the national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Other side effects
Slovenian: Drugi stranski učinki
English: If more than one tablet is required, they may be taken all at the same time or in two divided portions; the second portion is to be taken directly after the first portion has dissolved.
Slovenian: Če bolnik potrebuje več kot eno tableto zdravila, jih lahko vzame naenkrat ali v dveh enakih delih; drugi del je treba vzeti neposredno za tem, ko se prvi del raztopi.
English: Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments.
Slovenian: Preiskovance so na kliniki vsak dan pregledali (od ponedeljka do petka) za namen odmerjanja zdravila in ocenjevanja njegove učinkovitosti.
English: The maximum daily dose is 17.2 mg.
Slovenian: Največji dnevni odmerek je 17,2 mg.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Absorption and distribution
Slovenian: Absorpcija in porazdelitev
English: General supportive measures should be initiated, including close monitoring of respiratory and cardiac status of the patient.
Slovenian: Uvesti je treba splošne podporne ukrepe, ki vključujejo pozorno spremljanje dihanja in srčnega utripa bolnika.
English: Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Slovenian: Neželeni učinki so temeljili na znani farmakološki aktivnosti opioidnih agonistov in/ali antagonistov.
English: Do not push the tablet through the foil.
Slovenian: Tablete ne potiskajte skozi folijo.
English: Respiratory depression as a result of central nervous system depression is the primary symptom requiring intervention in the case of overdose because it may lead to respiratory arrest and death.
Slovenian: Respiratorna depresija kot posledica depresije centralnega živčnega sistema je primarni simptom, ki zahteva ukrepanje v primeru prevelikega odmerjanja, saj lahko povzroči dihalni zastoj in smrt.
English: • Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms
Slovenian: • Tablet ne žvečite ali pogoltnite, ker zdravilo ne bo delovalo in se lahko pri vas pojavijo odtegnitveni simptomi.
English: Zubsolv with food, drink and alcohol
Slovenian: Zdravilo Zubsolv skupaj s hrano, pijačo in alkoholom
English: Respiratory depression
Slovenian: Respiratorna depresija
English: The absorption of buprenorphine is followed by a rapid distribution phase (distribution half-life of 2 to 5 hours).
Slovenian: Absorpciji buprenorfina sledi faza hitre porazdelitve (porazdelitveni razpolovni čas 2 do 5 ur).
English: (buprenorphine/naloxone)
Slovenian: (buprenorfin/nalokson)
English: Never open the blister in advance.
Slovenian: Pretisnega omota ne odpirajte vnaprej.
English: Do not take this medicine in front of children.
Slovenian: Zdravila ne jemljite v prisotnosti otrok.
English: • deterioration of brain function that is a serious complication of liver disease
Slovenian: • poslabšanje delovanja možganov, ki je resen zaplet bolezni jeter,
English: • alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7)
Slovenian: • alkoholnimi pijačami ali zdravili, ki vsebujejo alkohol, saj alkohol okrepi sedativni učinek buprenorfina (glejte poglavje 4.7)
English: The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Slovenian: Učinkovitost buprenorfina v odmerku 8 mg na dan je bila podobna učinku zmernega odmerka aktivne kontrole, vendar enakovrednosti niso dokazali.
English: A patent airway and assisted or controlled ventilation must be assured.
Slovenian: Zagotoviti morate prehodnost dihalnih poti in asistirano ali nadzorovano ventilacijo.
English: The use of this medicinal product by the oral route is therefore inappropriate.
Slovenian: Peroralna uporaba tega zdravila zato ni primerna.
English: This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Zubsolv.
Slovenian: To se lahko pogosteje zgodi v prvih nekaj tednih zdravljenja, ko se vaš odmerek spreminja, lahko pa tudi med uživanjem alkohola ali jemanjem drugih pomirjeval sočasno z zdravilom Zubsolv.
English: The risks of using Zubsolv in pregnant women are not known.
Slovenian: Tveganja uporabe zdravila Zubsolv pri nosečnicah niso znana.
English: Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.
Slovenian: Zdravljenja na noben način ne spreminjajte in ga ne prekinite brez soglasja svojega zdravnika.
English: Severe respiratory insufficiency.
Slovenian: Huda respiratorna insuficienca.