FrancophonIA/ELRC3.0 huggingface dataset:
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets Zubsolv 1.4 mg / 0.36 mg sublingual tablets Zubsolv 2.9 mg / 0.71 mg sublingual tablets Zubsolv 5.7 mg / 1.4 mg sublingual tablets Zubsolv 8.6 mg / 2.1 mg sublingual tablets Zubsolv 11.4 mg / 2.9 mg sublingual tablets
Croatian: Zubsolv 0,7 mg / 0,18 mg sublingvalne tablete Zubsolv 1,4 mg / 0,36 mg sublingvalne tablete Zubsolv 2,9 mg / 0,71 mg sublingvalne tablete Zubsolv 5,7 mg / 1,4 mg sublingvalne tablete Zubsolv 8,6 mg / 2,1 mg sublingvalne tablete Zubsolv 11,4 mg / 2,9 mg sublingvalne tablete
English: Dietary administration of buprenorphine in the rat at dose levels of 500 ppm or greater produced a reduction in fertility demonstrated by reduced female conception rates.
Croatian: Primjenom buprenorfina/naloksona zajedno s hranom u štakora pri dozi od 500 ppm ili višoj smanjila se plodnost, što se pokazalo smanjenjem stopa začeća u ženki štakora.
English: Hepatic encephalopathy Syncope
Croatian: Jetrena encefalopatija Sinkopa
English: Arthritis
Croatian: Artritis
English: In patients with severe hepatic insufficiency the use of buprenorphine/naloxone is contraindicated (see section 4.3).
Croatian: U bolesnika s teškim oštećenjem jetre primjena buprenorfina/naloksona je kontraindicirana (vidjeti dio 4.3).
English: • have problems with the biliary tract (e.g. gall bladder, bile duct)
Croatian: • ako imate probleme s bilijarnim traktom (npr. žučnim mjehurom, žučnim kanalom)
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.
Croatian: Dodatno se može uzeti još jedna tableta lijeka Zubsolv od 1,4 mg / 0,36 mg ili 2,9 mg / 0,71 mg 1. dana, ovisno o Vašim potrebama.
English: • spinning sensation
Croatian: • osjećaj vrtenja
English: • Drowsiness
Croatian: • Omamljenost
English: Insomnia
Croatian: Nesanica
English: - one tablet of Zubsolv 2.9 mg / 0.71 mg each day
Croatian: - jedna tableta lijeka Zubsolv 2,9 mg / 0,71 mg svaki dan.
English: White, triangular tablets, base 7.2 mm and height 6.9 mm, debossed with “1.4” on one side.
Croatian: Bijele trokutaste tablete, osnovice 7,2 mm i visine 6,9 mm, s oznakom „1.4” utisnutom na jednoj strani.
English: • Starting treatment of Zubsolv whilst dependent on methadone: If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Zubsolv therapy.
Croatian: Ako uzimate metadon ili dugodjelujući opioid, idealno dozu metadona treba sniziti na manje od 30 mg/dan, prije uvođenja terapije lijekom Zubsolv.
English: Hypotension
Croatian: Hipotenzija
English: 0.7 mg / 0.18 mg
Croatian: ZUBSOLV 0,7 mg / 0,18 mg
English: Conjunctivitis Miosis
Croatian: Konjunktivitis Mioza
English: White, diamond shaped tablets, length 9.5 mm and width 8.2 mm, debossed with “8.6” on one side.
Croatian: Bijele tablete u obliku dijamanta, duljine 9,5 mm i širine 8,2 mm, s oznakom „8.6” utisnutom na jednoj strani.
English: White, capsule shaped tablets, length 10.3 mm and width 8.2 mm, debossed with “11.4” on one side.
Croatian: Bijele tablete u obliku kapsule, duljine 10,3 mm i širine 8,2 mm, s oznakom „11.4” utisnutom na jednoj strani.
English: White, oval tablets, length 6.8 mm and width 4.0 mm, debossed with “.7” on one side.
Croatian: Bijele ovalne tablete, duljine 6,8 mm i širine 4,0 mm, s oznakom „.7” utisnutom na jednoj strani.
English: • increased cough
Croatian: • pojačan kašalj
English: Urinary tract infection Vaginal infection
Croatian: Vaginalna infekcija
English: Angioedema
Croatian: Angioedem
English: White, D-shaped tablets, height 7.3 mm and width 5.65 mm, debossed with “2.9” on one side.
Croatian: Bijele tablete u obliku slova D, visine 7,3 mm i širine 5,65 mm, s oznakom „2.9” utisnutom na jednoj strani.
English: • For patients dependent upon heroin or short-acting opioids, the first dose of buprenorphine/naloxone should be taken when signs of withdrawal appear, but not less than
Croatian: • Bolesnici ovisni o heroinu ili kratkodjelujućim opioidima, prvu dozu buprenorfina/naloksona trebaju uzeti kad se pojave znakovi ustezanja, ali ne prije nego što je proteklo 6 sati nakon zadnjeg uzimanja opioida.
English: Zubsolv contains the active substances buprenorphine and naloxone.
Croatian: Zubsolv sadrži djelatne tvari buprenorfin i nalokson.
English: Hypertension Vasodilatation
Croatian: Hipertenzija Vazodilatacija
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets
Croatian: Zubsolv 8,6 mg / 2,1 mg sublingvalne tablete
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets
Croatian: Zubsolv 5,7 mg / 1,4 mg sublingvalne tablete
English: “.7” on one side
Croatian: „.7” na jednoj strani
English: • CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of norbuprenorphine Patients receiving Zubsolv should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, azole antifungals such as ketoconazole, itraconazole or macrolide antibiotics)
Croatian: • inhibitorima CYP3A4: ispitivanje interakcija buprenorfina s ketokonazolom (jaki inhibitor CYP3A4) rezultiralo je povećanjem Cmax (za oko 50%) i AUC (područje ispod krivulje) (za oko 70%) buprenorfina, i u manjoj mjeri, norbuprenorfina.
English: • eye inflammation or infection, small pupil size
Croatian: • upala ili infekcija oka, suženje zjenica
English: Alopecia Dermatitis exfoliative Dry skin Skin mass
Croatian: Alopecija Eksfolijativni dermatitis
English: 1.6-fold increase
Croatian: Povećanje od 1,6 puta Povećanje od 2,8 puta
English: Do not breast-feed whilst taking this medicine, since Zubsolv passes into breast milk.
Croatian: S obzirom da se ovaj lijek izlučuje u majčino mlijeko, nemojte dojiti dok uzimate Zubsolv.
English: Zubsolv 1.4 mg / 0.36 mg sublingual tablets
Croatian: Zubsolv 1,4 mg / 0,36 mg sublingvalne tablete
English: How to take Zubsolv
Croatian: Kako uzimati Zubsolv
English: Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and non-dependent persons in case of accidental or deliberate ingestion.
Croatian: Buprenorfin/nalokson u djece i osoba koje nisu ovisne može, u slučaju nehotičnog ili hotimičnog gutanja, uzrokovati tešku, potencijalno životno opasnu depresiju disanja.
English: Zubsolv 11.4 mg / 2.9 mg sublingual tablets
Croatian: Zubsolv 11,4 mg / 2,9 mg sublingvalne tablete
English: The intention of the naloxone component is to deter intravenous misuse.
Croatian: Svrha naloksona kao sastavnice je odvratiti od intravenske zlouporabe ovog lijeka.
English: White, round tablets, 7 mm in diameter, debossed with “5.7” on one side.
Croatian: Bijele okrugle tablete, promjera 7 mm, s oznakom „5.7” utisnutom na jednoj strani.
English: White, D-shaped tablet, height 7.3 mm and width 5.65 mm
Croatian: 2,9 mg / 0,71 mg bijela tableta u obliku slova D, visine 7,3 mm i širine 5,65 mm
English: White, oval tablet, length 6.8 mm and width 4.0 mm
Croatian: 0,7 mg / 0,18 mg bijela, ovalna tableta, duljine 6,8 mm i širine 4,0 mm
English: Severe Hepatic Impairment (Child-Pugh Class C) (n=8)
Croatian: Teško oštećenje jetre (Child-Pughov stupanj C)
English: Changing between buprenorphine containing products
Croatian: Prelazak s jednog lijeka koji sadrži buprenorfin na drugi
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: OD LIJEKA, AKO JE POTREBNO
English: Zubsolv 2.9 mg / 0.71 mg sublingual tablets
Croatian: Zubsolv 2,9 mg / 0,71 mg sublingvalne tablete
English: • are elderly
Croatian: • ako ste starija osoba
English: White, capsule shaped tablet, length 10.3 mm and width 8.2 mm
Croatian: 11,4 mg / 2,9 mg bijela tableta u obliku kapsule, duljine 10,3 mm i širine 8,2 mm
English: Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy.
Croatian: Prije početka terapije preporučuje se napraviti i dokumentirati osnovne pretrage funkcije jetre i status virusnog hepatitisa.
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets
Croatian: Zubsolv 0,7 mg / 0,18 mg sublingvalne tablete
English: Mild hepatic Impairment (Child-Pugh Class A) (n=9)
Croatian: Blago oštećenje jetre (Child-Pughov stupanj A)
English: Pruritus Rash Urticaria
Croatian: Pruritus Osip
English: - are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion, or hallucinations caused by alcohol - are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence
Croatian: smeteni ili imate halucinacije uzrokovane alkoholom - ako uzimate naltrekson ili nalmefen za liječenje ovisnosti o alkoholu ili opioidima.
English: How to store Zubsolv
Croatian: Kako čuvati Zubsolv
English: Each 8.6 mg / 2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta od 8,6 mg / 2,1 mg sadrži 8,6 mg buprenorfina (u obliku hidroklorida) i 2,1 mg naloksona (u obliku hidroklorid dihidrata).
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.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: • heat stroke
Croatian: • udar topline
English: Zubsolv 1.4 mg / 0.36 mg sublingual tablets buprenorphine / naloxone
Croatian: Zubsolv 1,4 mg / 0,36 mg sublingvalne tablete buprenorfin/nalokson
English: Zubsolv 11.4 mg / 2.9 mg sublingual tablets buprenorphine / naloxone
Croatian: Zubsolv 11,4 mg / 2,9 mg sublingvalne tablete buprenorfin/nalokson
English: Anxiety
Croatian: Konstipacija
English: Each 0.7 mg / 0.18 mg sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta od 0,7 mg / 0,18 mg sadrži 0,7 mg buprenorfina (u obliku hidroklorida) i 0,18 mg naloksona (u obliku hidroklorid dihidrata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 0,7 mg / 0,18 mg
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).
Croatian: Jedna sublingvalna tableta od 1,4 mg / 0,36 mg sadrži 1,4 mg buprenorfina (u obliku hidroklorida) i 0,36 mg naloksona (u obliku hidroklorid dihidrata).
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets buprenorphine / naloxone
Croatian: Zubsolv 8,6 mg / 2,1 mg sublingvalne tablete buprenorfin/nalokson
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 8,6 mg / 2,1 mg
English: White, diamond shaped tablet, length 9.5 mm and width 8.2 mm
Croatian: 8,6 mg / 2,1 mg bijela tableta u obliku dijamanta, duljine 9,5 mm i širine 8,2 mm
English: Haematuria
Croatian: Kašalj
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).
Croatian: Jedna sublingvalna tableta od 2,9 mg / 0,71 mg sadrži 2,9 mg buprenorfina (u obliku hidroklorida) i 0,71 mg naloksona (u obliku hidroklorid dihidrata).
English: Zubsolv 2.9 mg / 0.71 mg sublingual tablets buprenorphine / naloxone
Croatian: Zubsolv 2.9 mg / 0,71 mg sublingvalne tablete buprenorfin/nalokson
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).
Croatian: Jedna sublingvalna tableta od 5,7 mg / 1,4 mg sadrži 5,7 mg buprenorfina (u obliku hidroklorida) i 1,4 mg naloksona (u obliku hidroklorid dihidrata).
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).
Croatian: Jedna sublingvalna tableta od 11,4 mg / 2,9 mg sadrži 11,4 mg buprenorfina (u obliku hidroklorida) i 2,9 mg naloksona (u obliku hidroklorid dihidrata).
English: It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered.
Croatian: Kod istovremene primjene induktora (npr. fenobarbitala, karbamazepina, fenitoina, rifampicina) preporučuje se pažljivo praćenje bolesnika koji primaju buprenorfin/nalokson.
English: 14.0-fold increase
Croatian: Povećanje od 0,2 puta Povećanje od 3,2 puta Povećanje od 14,0 puta
English: 11.3-fold increase
Croatian: Povećanje od 2,7 puta Povećanje od 11,3 puta
English: Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities.
Croatian: Bolesnike treba upozoriti da buprenorfin/nalokson može utjecati na njihovu sposobnost upravljanja vozilima i rada sa teškim strojevima.
English: Taking Zubsolv
Croatian: Uzimanje lijeka Zubsolv
English: White, triangular tablet, base 7.2 mm and height 6.9 mm
Croatian: 7,2 mm i visine 6,9 mm
English: Depersonalisation Drug dependence Euphoric mood Hostility
Croatian: Depersonalizacija Ovisnost o lijeku
English: Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta sadrži 8,6 mg buprenorfina (u obliku hidroklorida) i 2,1 mg naloksona (u obliku hidroklorid dihidrata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 5,7 mg / 1,4 mg
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets buprenorphine / naloxone
Croatian: Zubsolv 5,7 mg / 1,4 mg sublingvalne tablete buprenorfin/nalokson
English: Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta sadrži 1,4 mg buprenorfina (u obliku hidroklorida) i 0,36 mg naloksona (u obliku hidroklorid dihidrata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 11,4 mg / 2,9 mg
English: • For patients receiving methadone, the dose of methadone should be reduced to a maximum of
Croatian: • Za bolesnike koji primaju metadon, doza metadona treba se sniziti na najviše 30 mg/dnevno prije početka terapije buprenorfinom/naloksonom.
English: Asthma Dyspnoea Yawning
Croatian: Albuminurija Dizurija Hematurija Nefrolitijaza
English: Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta sadrži 11,4 mg buprenorfina (u obliku hidroklorida) i 2,9 mg naloksona (u obliku hidroklorid dihidrata).
English: Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta sadrži 5,7 mg buprenorfina (u obliku hidroklorida) i 1,4 mg naloksona (u obliku hidroklorid dihidrata).
English: Migraine Dizziness Hypertonia Paraesthesia Somnolence
Croatian: Migrena Omaglica Hipertonija
English: Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta sadrži 2,9 mg buprenorfina (u obliku hidroklorida) i 0,71 mg naloksona (u obliku hidroklorid dihidrata).
English: Citric acid anhydrous Sodium citrate Microcrystalline cellulose Croscarmellose sodium Sucralose
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari manitol citratna kiselina, bezvodna natrijev citrat mikrokristalična celuloza karmelozanatrij, umrežena sukraloza levomentol silicijev dioksid, koloidni, bezvodni natrijev stearilfumarat
English: • the concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine
Croatian: • na temelju iskustva s morfijem, istovremena primjena inhibitora monoaminooksidaze (MAOI)
English: Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Croatian: Jedna sublingvalna tableta sadrži 0,7 mg buprenorfina (u obliku hidroklorida) i 0,18 mg naloksona (u obliku hidroklorid dihidrata).
English: Posology
Croatian: Buprenorfin
English: Amenorrhoea Ejaculation disorder Menorrhagia Metrorrhagia
Croatian: Poremećaj ejakulacije Menoragija Metroragija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 2,9 mg / 0, 71 mg
English: • back pain, joint pain, muscle pain, leg cramps (muscle spasm)
Croatian: • bol u leđima, bol u zglobovima, bol u mišićima, grčevi u nogama (grč mišića)
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH
Croatian: PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 0,7 mg / 0,18 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 1,4 mg / 0, 36 mg
English: Initiation therapy
Croatian: Uvođenje terapije
English: Fertility
Croatian: Pireksija
English: Urine abnormality Albuminuria Dysuria
Croatian: Bol u abdomenu Proljev
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH
Croatian: PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 8,6 mg / 2,1 mg
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets buprenorphine / naloxone
Croatian: Zubsolv 0,7 mg / 0,18 mg sublingvalne tablete buprenorfin/nalokson
English: 1.7-fold increase
Croatian: Povećanje od 1,2 puta Povećanje od 1,1 puta Povećanje od 1,7 puta
English: Urinary retention
Croatian: Zadržavanje mokraće
English: Acne
Croatian: Akne
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Croatian: PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 2,9 mg / 0,71 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
Croatian: PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 1,4 mg / 0,36 mg
English: Nephrolithiasis
Croatian: Nalokson
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Croatian: PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 5,7 mg / 1,4 mg
English: Gastrointestinal disorders
Croatian: Dispepsija Flatulencija
English: Metabolites of buprenorphine accumulate in patients with renal failure.
Croatian: U bolesnika sa zatajenjem bubrega nakupljaju se metaboliti buprenorfina.
English: Hepatic impairment
Croatian: Anafilaktički šok
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Croatian: PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 11,4 mg / 2,9 mg
English: The active substances are buprenorphine and naloxone.
Croatian: Djelatne tvari su buprenorfin i nalokson.
English: The product should be used with care in patients with pre-existing breathing problems
Croatian: Bolesnici s postojećim problemima s disanjem trebaju uzimati ovaj lijek s oprezom
English: • drug withdrawal syndrome
Croatian: • sindrom ustezanja od lijeka
English: White, round tablet, 7 mm in diameter
Croatian: 5,7 mg / 1,4 mg bijela, okrugla tableta, promjera 7 mm
English: • inflammation of joints
Croatian: • upala zglobova
English: • urine abnormality
Croatian: • neuobičajena mokraća
English: Mannitol
Croatian: Amenoreja
English: Pregnancy
Croatian: Mučnina
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Croatian: Ponedjeljak Utorak Srijeda Četvrtak Petak Subota Nedjelja
English: Within 2 years after Commission Decision.
Croatian: U roku od 2 godine od Odluke Komisije
English: You may need to have blood checks if you take:
Croatian: Možda ćete trebati provesti pretrage krvi ako uzimate:
English: Animal studies are insufficient.
Croatian: Ispitivanja na životinjama nisu dostatna.
English: if you have difficulty in producing urine.
Croatian: ako imate poteškoća sa stvaranjem urina.
English: Based on all available data, the CHMP requires the following:
Croatian: Na temelju svih dostupnih podataka, CHMP zahtijeva sljedeće:
English: Other interactions
Croatian: Druge interakcije
English: You should also tell your doctor:
Croatian: Svog liječnika također trebate obavijestiti:
English: However the terminal half-life was not significantly altered.
Croatian: Međutim, terminalni poluvijek nije bio značajno promijenjen.
English: Compared to the lifetime cancer risk in the European population of approximately 50%, this additional risk is considered to be very low.
Croatian: U usporedbi s doživotnim rizikom od razvoja raka u europskoj populaciji od približno 50 %, smatra se da je taj dodatni rizik vrlo nizak.
English: Measures to mitigate the risk
Croatian: Mjere za ublažavanje rizika
English: The combination should be administered with caution, especially in the elderly.
Croatian: Kombinaciju treba primjenjivati s oprezom, posebice u starijih.
English: This results in an increase in blood pressure.
Croatian: To dovodi do povišenja krvnog tlaka.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/ DATUM OBNOVE ODOBRENJA
English: Teva Gyógyszergyár Zrt.
Croatian: Magyarország Teva Gyógyszergyár Zrt.
English: Try to take your daily dose at about the same time each day.
Croatian: Nastojte uzimati svoju dnevnu dozu svaki dan u isto vrijeme.
English: Some of these effects may be serious and may require medical attention.
Croatian: Neke od tih nuspojava mogu biti teške i mogu zahtijevati medicinsku skrb.
English: PC: SN: NN:
Croatian: SN: NN:
English: If possible, another class of diuretics should be used;
Croatian: Ako je moguće, treba primjenjivati diuretike neke druge klase;
English: No data are available..
Croatian: Nema dostupnih podataka.
English: However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes.
Croatian: Međutim, potrebno je navesti da nitrozamini mogu nastati i u brojnim drugim situacijama, uključujući u biološkim procesima.
English: The volume of distribution for irbesartan is 53-93 litres.
Croatian: Volumen distribucije irbesartana je 53-93 litre.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Teva ne preporučuje se uzimati u ranoj trudnoći, a ne smije se uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu primjenjujete li ga u tom razdoblju (vidjeti dio o trudnoći).
English: This is the background to the current referral procedure.
Croatian: To je kontekst ovog postupka upućivanja.
English: The study recruited 58 % males.
Croatian: Ispitivanje je uključivalo 58% muškaraca.
English: • Risk Management plan
Croatian: • Plan upravljanja rizikom (RMP)
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:
Croatian: Te privremene granične vrijednosti temelje se na maksimalnoj dnevnoj dozi odobrenoj u EU-u za svaki od sartana te se stoga međusobno razlikuju, kako je navedeno u tablici navedenoj u nastavku:
English: Chloride deficit is generally mild and usually does not require treatment.
Croatian: Deficit klorida je općenito blag i ne zahtijeva liječenje.