natgillin/translations-raw huggingface dataset:
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 
U nastavku se nalazi popis primjera ovih vrsta lijekova: - drugi opioidi koji sadrže lijekove poput metadona, određeni lijekovi protiv boli i lijekovi protiv kašlja - neki antidepresivi (koriste se za liječenje depresije) poput izokarboksazida, fenelzina, selegilina, tranilcipromina, valproata i inhibitora monoaminooksidaze (MAOI) koji mogu povećati učinak ovog lijeka
The first dose of buprenorphine/naloxone should be taken only when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone. 
Prvu dozu buprenorfina/naloksona treba uzeti tek kad se pojave znakovi ustezanja, ali ne prije nego što je proteklo 24 sata nakon što je bolesnik zadnji put uzeo metadon.
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
Orthostatic hypotension 
Ortostatska hipotentzija
• have under-active thyroid gland which can cause tiredness or weight gain 
• ako imate smanjenju aktivnost štitne žlijezde, što može uzrokovati umor ili debljanje
• benzodiazepines: This combination may result in death due to respiratory depression of central origin. 
Zubsolv treba koristiti uz oprez kod istovremene primjene s: • benzodiazepinima: Ova kombinacija može dovesti do smrti zbog depresije disanja središnjeg podrijetla.
• abdominal pain, upset stomach or other stomach discomfort, diarrhoea, flatulence, vomiting 
• bol u trbuhu, nadražen želudac ili druge nelagode želudca, proljev, vjetrovi, povraćanje
Since both buprenorphine and naloxone are extensively metabolized in liver, plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment after single-dose administration. 
S obzirom da se buprenorfin i nalokson opsežno metaboliziraju u jetri, njihova izmjerena razina u plazmi bila je viša u bolesnika s umjerenim i teškom oštećenjem jetre nakon primjene jednokratne doze.
Speech disorder Tremor 
Poremećaj govora
• constipation, nausea 
• zatvor, mučnina
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 
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
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. 
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.
Hepatic encephalopathy Syncope 
Jetrena encefalopatija Sinkopa
Arthritis 
Artritis
In patients with severe hepatic insufficiency the use of buprenorphine/naloxone is contraindicated (see section 4.3). 
U bolesnika s teškim oštećenjem jetre primjena buprenorfina/naloksona je kontraindicirana (vidjeti dio 4.3).
• have problems with the biliary tract (e.g. gall bladder, bile duct) 
• ako imate probleme s bilijarnim traktom (npr. žučnim mjehurom, žučnim kanalom)
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. 
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.
• spinning sensation 
• osjećaj vrtenja
• Drowsiness 
• Omamljenost
Insomnia 
Nesanica
- one tablet of Zubsolv 2.9 mg / 0.71 mg each day 
- jedna tableta lijeka Zubsolv 2,9 mg / 0,71 mg svaki dan.
White, triangular tablets, base 7.2 mm and height 6.9 mm, debossed with “1.4” on one side. 
Bijele trokutaste tablete, osnovice 7,2 mm i visine 6,9 mm, s oznakom „1.4” utisnutom na jednoj strani.
• 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. 
Ako uzimate metadon ili dugodjelujući opioid, idealno dozu metadona treba sniziti na manje od 30 mg/dan, prije uvođenja terapije lijekom Zubsolv.
Hypotension 
Hipotenzija
Conjunctivitis Miosis 
Konjunktivitis Mioza
White, diamond shaped tablets, length 9.5 mm and width 8.2 mm, debossed with “8.6” on one side. 
Bijele tablete u obliku dijamanta, duljine 9,5 mm i širine 8,2 mm, s oznakom „8.6” utisnutom na jednoj strani.
White, capsule shaped tablets, length 10.3 mm and width 8.2 mm, debossed with “11.4” on one side. 
Bijele tablete u obliku kapsule, duljine 10,3 mm i širine 8,2 mm, s oznakom „11.4” utisnutom na jednoj strani.
White, oval tablets, length 6.8 mm and width 4.0 mm, debossed with “.7” on one side. 
Bijele ovalne tablete, duljine 6,8 mm i širine 4,0 mm, s oznakom „.7” utisnutom na jednoj strani.
• increased cough 
• pojačan kašalj
Urinary tract infection Vaginal infection 
Vaginalna infekcija
Angioedema 
Angioedem
White, D-shaped tablets, height 7.3 mm and width 5.65 mm, debossed with “2.9” on one side. 
Bijele tablete u obliku slova D, visine 7,3 mm i širine 5,65 mm, s oznakom „2.9” utisnutom na jednoj strani.
• 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 
• 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.
Zubsolv contains the active substances buprenorphine and naloxone. 
Zubsolv sadrži djelatne tvari buprenorfin i nalokson.
Hypertension Vasodilatation 
Hipertenzija Vazodilatacija
Zubsolv 8.6 mg / 2.1 mg sublingual tablets 
Zubsolv 8,6 mg / 2,1 mg sublingvalne tablete
Zubsolv 5.7 mg / 1.4 mg sublingual tablets 
Zubsolv 5,7 mg / 1,4 mg sublingvalne tablete
“.7” on one side 
„.7” na jednoj strani
• 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) 
• 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.
• eye inflammation or infection, small pupil size 
• upala ili infekcija oka, suženje zjenica
Alopecia Dermatitis exfoliative Dry skin Skin mass 
Alopecija Eksfolijativni dermatitis
1.6-fold increase 
Povećanje od 1,6 puta Povećanje od 2,8 puta
Do not breast-feed whilst taking this medicine, since Zubsolv passes into breast milk. 
S obzirom da se ovaj lijek izlučuje u majčino mlijeko, nemojte dojiti dok uzimate Zubsolv.
Zubsolv 1.4 mg / 0.36 mg sublingual tablets 
Zubsolv 1,4 mg / 0,36 mg sublingvalne tablete
How to take Zubsolv 
Kako uzimati Zubsolv
Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and non-dependent persons in case of accidental or deliberate ingestion. 
Buprenorfin/nalokson u djece i osoba koje nisu ovisne može, u slučaju nehotičnog ili hotimičnog gutanja, uzrokovati tešku, potencijalno životno opasnu depresiju disanja.
Zubsolv 11.4 mg / 2.9 mg sublingual tablets 
Zubsolv 11,4 mg / 2,9 mg sublingvalne tablete
The intention of the naloxone component is to deter intravenous misuse. 
Svrha naloksona kao sastavnice je odvratiti od intravenske zlouporabe ovog lijeka.
White, round tablets, 7 mm in diameter, debossed with “5.7” on one side. 
Bijele okrugle tablete, promjera 7 mm, s oznakom „5.7” utisnutom na jednoj strani.
White, D-shaped tablet, height 7.3 mm and width 5.65 mm 
2,9 mg / 0,71 mg bijela tableta u obliku slova D, visine 7,3 mm i širine 5,65 mm
White, oval tablet, length 6.8 mm and width 4.0 mm 
0,7 mg / 0,18 mg bijela, ovalna tableta, duljine 6,8 mm i širine 4,0 mm
Severe Hepatic Impairment (Child-Pugh Class C) (n=8) 
Teško oštećenje jetre (Child-Pughov stupanj C)
Changing between buprenorphine containing products 
Prelazak s jednog lijeka koji sadrži buprenorfin na drugi
OTHER SPECIAL WARNING(S), IF NECESSARY 
OD LIJEKA, AKO JE POTREBNO
Zubsolv 2.9 mg / 0.71 mg sublingual tablets 
Zubsolv 2,9 mg / 0,71 mg sublingvalne tablete
• are elderly 
• ako ste starija osoba
White, capsule shaped tablet, length 10.3 mm and width 8.2 mm 
11,4 mg / 2,9 mg bijela tableta u obliku kapsule, duljine 10,3 mm i širine 8,2 mm
Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy. 
Prije početka terapije preporučuje se napraviti i dokumentirati osnovne pretrage funkcije jetre i status virusnog hepatitisa.
Zubsolv 0.7 mg / 0.18 mg sublingual tablets 
Zubsolv 0,7 mg / 0,18 mg sublingvalne tablete
Mild hepatic Impairment (Child-Pugh Class A) (n=9) 
Blago oštećenje jetre (Child-Pughov stupanj A)
Pruritus Rash Urticaria 
Pruritus Osip
- 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 
smeteni ili imate halucinacije uzrokovane alkoholom - ako uzimate naltrekson ili nalmefen za liječenje ovisnosti o alkoholu ili opioidima.
How to store Zubsolv 
Kako čuvati Zubsolv
Each 8.6 mg / 2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate). 
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).
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. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
• heat stroke 
• udar topline
Zubsolv 1.4 mg / 0.36 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 1,4 mg / 0,36 mg sublingvalne tablete buprenorfin/nalokson
Zubsolv 11.4 mg / 2.9 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 11,4 mg / 2,9 mg sublingvalne tablete buprenorfin/nalokson
Anxiety 
Konstipacija
Each 0.7 mg / 0.18 mg sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate). 
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).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 0,7 mg / 0,18 mg
Each 1.4 mg / 0.36 mg sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate). 
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).
Zubsolv 8.6 mg / 2.1 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 8,6 mg / 2,1 mg sublingvalne tablete buprenorfin/nalokson
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 8,6 mg / 2,1 mg
White, diamond shaped tablet, length 9.5 mm and width 8.2 mm 
8,6 mg / 2,1 mg bijela tableta u obliku dijamanta, duljine 9,5 mm i širine 8,2 mm
Haematuria 
Kašalj
Each 2.9 mg / 0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate). 
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).
Zubsolv 2.9 mg / 0.71 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 2.9 mg / 0,71 mg sublingvalne tablete buprenorfin/nalokson
Each 5.7 mg / 1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate). 
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).
Each 11.4 mg / 2.9 mg sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate). 
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).
It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered. 
Kod istovremene primjene induktora (npr. fenobarbitala, karbamazepina, fenitoina, rifampicina) preporučuje se pažljivo praćenje bolesnika koji primaju buprenorfin/nalokson.
14.0-fold increase 
Povećanje od 0,2 puta Povećanje od 3,2 puta Povećanje od 14,0 puta
11.3-fold increase 
Povećanje od 2,7 puta Povećanje od 11,3 puta
Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities. 
Bolesnike treba upozoriti da buprenorfin/nalokson može utjecati na njihovu sposobnost upravljanja vozilima i rada sa teškim strojevima.
Taking Zubsolv 
Uzimanje lijeka Zubsolv
White, triangular tablet, base 7.2 mm and height 6.9 mm 
7,2 mm i visine 6,9 mm
Depersonalisation Drug dependence Euphoric mood Hostility 
Depersonalizacija Ovisnost o lijeku
Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate). 
Jedna sublingvalna tableta sadrži 8,6 mg buprenorfina (u obliku hidroklorida) i 2,1 mg naloksona (u obliku hidroklorid dihidrata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 5,7 mg / 1,4 mg
Zubsolv 5.7 mg / 1.4 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 5,7 mg / 1,4 mg sublingvalne tablete buprenorfin/nalokson
Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate). 
Jedna sublingvalna tableta sadrži 1,4 mg buprenorfina (u obliku hidroklorida) i 0,36 mg naloksona (u obliku hidroklorid dihidrata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 11,4 mg / 2,9 mg
• For patients receiving methadone, the dose of methadone should be reduced to a maximum of 
• Za bolesnike koji primaju metadon, doza metadona treba se sniziti na najviše 30 mg/dnevno prije početka terapije buprenorfinom/naloksonom.
Asthma Dyspnoea Yawning 
Albuminurija Dizurija Hematurija Nefrolitijaza
Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate). 
Jedna sublingvalna tableta sadrži 11,4 mg buprenorfina (u obliku hidroklorida) i 2,9 mg naloksona (u obliku hidroklorid dihidrata).
Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate). 
Jedna sublingvalna tableta sadrži 5,7 mg buprenorfina (u obliku hidroklorida) i 1,4 mg naloksona (u obliku hidroklorid dihidrata).
Migraine Dizziness Hypertonia Paraesthesia Somnolence 
Migrena Omaglica Hipertonija
Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate). 
Jedna sublingvalna tableta sadrži 2,9 mg buprenorfina (u obliku hidroklorida) i 0,71 mg naloksona (u obliku hidroklorid dihidrata).
Citric acid anhydrous Sodium citrate Microcrystalline cellulose Croscarmellose sodium Sucralose 
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
• the concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine 
• na temelju iskustva s morfijem, istovremena primjena inhibitora monoaminooksidaze (MAOI)
Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate). 
Jedna sublingvalna tableta sadrži 0,7 mg buprenorfina (u obliku hidroklorida) i 0,18 mg naloksona (u obliku hidroklorid dihidrata).
Posology 
Buprenorfin
Amenorrhoea Ejaculation disorder Menorrhagia Metrorrhagia 
Poremećaj ejakulacije Menoragija Metroragija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 2,9 mg / 0, 71 mg
• back pain, joint pain, muscle pain, leg cramps (muscle spasm) 
• bol u leđima, bol u zglobovima, bol u mišićima, grčevi u nogama (grč mišića)
Name and address of the manufacturer responsible for batch release 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH 
PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 0,7 mg / 0,18 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 1,4 mg / 0, 36 mg
Initiation therapy 
Uvođenje terapije
Fertility 
Pireksija
Urine abnormality Albuminuria Dysuria 
Bol u abdomenu Proljev
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH 
PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 8,6 mg / 2,1 mg
Zubsolv 0.7 mg / 0.18 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 0,7 mg / 0,18 mg sublingvalne tablete buprenorfin/nalokson
1.7-fold increase 
Povećanje od 1,2 puta Povećanje od 1,1 puta Povećanje od 1,7 puta
Urinary retention 
Zadržavanje mokraće
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH 
PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 2,9 mg / 0,71 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH 
PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 1,4 mg / 0,36 mg
Nephrolithiasis 
Nalokson
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH 
PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 5,7 mg / 1,4 mg
Gastrointestinal disorders 
Dispepsija Flatulencija
Metabolites of buprenorphine accumulate in patients with renal failure. 
U bolesnika sa zatajenjem bubrega nakupljaju se metaboliti buprenorfina.
Hepatic impairment 
Anafilaktički šok
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH 
PAKIRANJE OD 7, 28 i 30 TABLETA JAČINE 11,4 mg / 2,9 mg
The active substances are buprenorphine and naloxone. 
Djelatne tvari su buprenorfin i nalokson.
The product should be used with care in patients with pre-existing breathing problems 
Bolesnici s postojećim problemima s disanjem trebaju uzimati ovaj lijek s oprezom
• drug withdrawal syndrome 
• sindrom ustezanja od lijeka
White, round tablet, 7 mm in diameter 
5,7 mg / 1,4 mg bijela, okrugla tableta, promjera 7 mm
• inflammation of joints 
• upala zglobova
• urine abnormality 
• neuobičajena mokraća
Mannitol 
Amenoreja
Pregnancy 
Mučnina
Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
Ponedjeljak Utorak Srijeda Četvrtak Petak Subota Nedjelja
Within 2 years after Commission Decision. 
U roku od 2 godine od Odluke Komisije
You may need to have blood checks if you take: 
Možda ćete trebati provesti pretrage krvi ako uzimate:
Animal studies are insufficient. 
Ispitivanja na životinjama nisu dostatna.
if you have difficulty in producing urine. 
ako imate poteškoća sa stvaranjem urina.
Based on all available data, the CHMP requires the following: 
Na temelju svih dostupnih podataka, CHMP zahtijeva sljedeće:
Other interactions 
Druge interakcije
You should also tell your doctor: 
Svog liječnika također trebate obavijestiti:
However the terminal half-life was not significantly altered. 
Međutim, terminalni poluvijek nije bio značajno promijenjen.
Compared to the lifetime cancer risk in the European population of approximately 50%, this additional risk is considered to be very low. 
U usporedbi s doživotnim rizikom od razvoja raka u europskoj populaciji od približno 50 %, smatra se da je taj dodatni rizik vrlo nizak.
Measures to mitigate the risk 
Mjere za ublažavanje rizika
The combination should be administered with caution, especially in the elderly. 
Kombinaciju treba primjenjivati s oprezom, posebice u starijih.
This results in an increase in blood pressure. 
To dovodi do povišenja krvnog tlaka.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRVOG ODOBRENJA/ DATUM OBNOVE ODOBRENJA
Try to take your daily dose at about the same time each day. 
Nastojte uzimati svoju dnevnu dozu svaki dan u isto vrijeme.
Some of these effects may be serious and may require medical attention. 
Neke od tih nuspojava mogu biti teške i mogu zahtijevati medicinsku skrb.
If possible, another class of diuretics should be used; 
Ako je moguće, treba primjenjivati diuretike neke druge klase;
No data are available.. 
Nema dostupnih podataka.
However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes. 
Međutim, potrebno je navesti da nitrozamini mogu nastati i u brojnim drugim situacijama, uključujući u biološkim procesima.
The volume of distribution for irbesartan is 53-93 litres. 
Volumen distribucije irbesartana je 53-93 litre.
It may harm them, even if their signs of illness are the same as yours. 
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).
This is the background to the current referral procedure. 
To je kontekst ovog postupka upućivanja.
The study recruited 58 % males. 
Ispitivanje je uključivalo 58% muškaraca.
• Risk Management plan 
• Plan upravljanja rizikom (RMP)
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: 
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:
Chloride deficit is generally mild and usually does not require treatment. 
Deficit klorida je općenito blag i ne zahtijeva liječenje.