natgillin/translations-raw huggingface dataset:
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.
At least 61 % of the oral dose is eliminated unchanged within 24 hours.
Najmanje 61% oralno primijenjene doze eliminira se nepromijenjeno unutar 24 sata.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Bolesnika je potrebno pomno nadzirati, a liječenje treba biti simptomatsko i suportivno.
For these reasons, CHMP could not identify cancer screening methods that patients would benefit from.
Iz tih razloga CHMP nije mogao utvrditi metode probira na rak od kojih bi bolesnici imali koristi.
Manufacturers:
Proizvođači:
Assessment of the excess risk of cancer
Procjena prekomjernog rizika od nastanka raka
Treatment of essential hypertension.
Liječenje esencijalne hipertenzije.
Primary aldosteronism
Primarni aldosteronizam
The most common signs and symptoms of overdose are nausea and somnolence.
Najčešći znakovi i simptomi predoziranja su mučnina i somnolencija.
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Do maksimalnog učinka na sniženje krvnog tlaka trebalo bi doći 6-8 tjedana nakon početka liječenja.
If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Ako se tijekom liječenja pojavi reakcija fotoosjetljivosti, preporučuje se prekid terapije.
Max. daily dose (mg)
Maksimalna dnevna doza (mg)
Metabolic and endocrine effects
Metabolički i endokrini učinci
Considerations on monitoring of exposed patients
Razmatranja u pogledu praćenja izloženih bolesnika
The primary treatment is to discontinue drug intake as rapidly as possible.
Primarno liječenje je prekid primjene lijeka što je prije moguće.
NDMA and NDEA are two of the most potent mutagenic carcinogens known.
NDMA i NDEA dvije su najjače poznate mutagene tvari karcinogenih svojstava.
Irbesartan does not require metabolic activation for its activity.
Irbesartan ne treba metaboličku aktivaciju za svoje djelovanje.
Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014
Datum posljednje obnove: 11. studeni 2014.
The impact of NDMA and NDEA on human health is currently only extrapolated from animal studies.
Učinak koji NDMA i NDEA imaju na ljudsko zdravlje trenutačno se samo ekstrapolira iz ispitivanja na životinjama.