natgillin/translations-raw huggingface dataset:
Once absorbed, exogenous cholic acid will enter into the body's bile acid pool and will undergo multiple cycles of enterohepatic circulation.
Nakon što se apsorbira, egzogena kolatna kiselina ulazi u tjelesni rezervoar žučne kiseline i podvrgava se višestrukim ciklusima enterohepatičke cirkulacije.
Conjugated cholic acid is secreted into bile and will pass into the small intestine where, in association with other components of bile, it will perform its principal digestive function.
Konjugirana kolatna kiselina se izlučuje u žuč te prelazi u tanko crijevo, gdje, s drugim komponentama žuči, obavlja svoju primarnu probavnu funkciju.
METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Ne žvakati.
Therapeutic efficacy and safety of cholic acid treatment in patients with inborn errors of bile acid metabolism were evaluated.
Ocijenjene su terapijska djelotvornost i sigurnost liječenja kolatnom kiselinom kod bolesnika s prirođenim greškama metabolizma žučne kiseline.
Aluminium-based antacids have been shown to adsorb bile acids in vitro and may be expected to reduce the levels of cholic acid in the same manner as the bile acid sequestering agents.
Utvrđeno je da antacidi bazirani na aluminiju adsorbiraju žučne kiseline in vitro te se može očekivati smanjenje razina žučne kiseline na isti način kao i kod tvari koje vežu žučne kiseline.
Treatment with exogenous cholic acid is intended to replace physiological bile acid in cases of inborn errors of bile acid synthesis.
Liječenje egzogenom kolatnom kiselinom namijenjeno je kao zamjena fiziološke žučne kiseline u slučaju prirođenih grešaka sinteze žučne kiseline.
In patients with CTX (N=3), urinary bile acids at baseline were normal for 1 patient and elevated for 2 patients, elevated for all patients in the worst post-treatment analysis, and normal in the best postbaseline assessment for all 3 patients.
U bolesnika s CTX-om (n=3), žučne kiseline u urinu su u početnim vrijednostima bile normalne u 1 bolesnika i povišene u 2 bolesnika, povišene za sve bolesnike u analizi najlošije vrijednosti nakon liječenja i normalne u procjeni najbolje vrijednosti nakon početne vrijednosti za sva 3 bolesnika.
Patients with hepatic impairment who are treated with cholic acid should be monitored closely (see section 4.4).
Bolesnike s oštećenjem jetrene funkcije koji primaju terapiju kolatnom kiselinom potrebno je pažljivo kontrolirati (vidjeti dio 4.4).
Inborn errors of primary bile acid synthesis involve congenital defects in the primary enzymes responsible for catalysing key reactions in the synthesis of cholic and chenodeoxycholic acids.
Farmakodinamički učinci Prirođene greške sinteze primarne žučne kiseline uključuju prirođene defekte u primarnim enzimima odgovornima za kataliziranje ključnih reakcija u sintezi kolatne i kenodeoksikolatne kiseline.
After administration of cholic acid a down-regulation of bile acid synthesis occurs and there is a strong decrease or almost complete disappearance of abnormal bile acids.
Nakon primjene kolatne kiseline nastupa prilagodba naniže sinteze žučne kiseline te nastupa značajno snižavanje ili gotovo potpuno nestajanje abnormalnih žučnih kiselina.
The rationale for cholic acid therapy is improvement of bile flow and fat absorption and restoration of a physiologic feedback inhibition on bile acid synthesis, lowering the production of toxic bile acid precursors.
Razlog za terapiju kolatnom kiselinom je poboljšanje protoka žuči i apsorpcije masti te ponovna uspostava fiziološke povratne inhibicije sinteze žučne kiseline, smanjujući proizvodnju toksičnih prekursora žučne kiseline.
• feeling out of sorts (malaise)
• osjećaj iscrpljenosti (opće slabosti)
Statistically significant improvements were also observed in the baseline to best postbaseline analyses of serum transaminases.
Statistički značajna poboljšanja također su bila uočena u analizi usporedbe početne vrijednosti i najbolje vrijednosti nakon početne vrijednosti za transaminaze u serumu.
Of the 41 patients described above that were treated in Study CAC-002-01, 13 patients discontinued: 8 due to AEs, 1 for lack/loss of efficacy, 1 was lost to follow-up, and 3 withdrew consent.
Od 41 prethodno opisanog bolesnika koji su liječeni u sklopu ispitivanja CAC-002-01, 13 bolesnika je prekinulo ispitivanje: 8 njih zbog nuspojava, 1 zbog nedostatka/gubitka djelotvornosti, 1 je izgubljen iz praćenja i 3 ih je povuklo pristanak.
No data are available for patients with renal impairment.
Nema dostupnih podataka za bolesnike s oštećenjem funkcije bubrega.
The effect of food on the bioavailability of cholic acid has not been studied.
Nije ispitan učinak hrane na bioraspoloživost kolatne kiseline.
Conjugated cholic acid is absorbed in the ileum via transporters , passed back to the liver and enters another cycle of enterohepatic circulation.
Konjugirana kolatna kiselina apsorbira se u ileumu putem transportera, vraća se natrag u jetru i ulazi u drugi ciklus enterohepatičke cirkulacije.
Cases of severe hepatotoxicity, including cases with fatal outcome, have been reported with the use of cholic acid.
Uz primjenu kolatne kiseline prijavljeni su slučajevi teške hepatotoksičnosti, uključujući slučajeve sa smrtnim ishodom.
Therefore use of phenobarbital in patients treated with cholic acid is contraindicated (see section 4.3).
Stoga je primjena fenobarbitala kontraindicirana kod bolesnika liječenih kolatnom kiselinom (vidjeti dio 4.3).
Of the 52 patients described above that were included in Study CAC-91-10-10 during the 17-year study period, 6 died, 3 had no evidence of treatment, 4 terminated the study, 10 were lost to follow-up, and for 1, data retrieval was unsuccessful.
Od 52 prethodno opisana bolesnika koji su uključeni u ispitivanje CAC-91-10-10 tijekom 17godišnjeg razdoblja ispitivanja, 6 ih je preminulo, 3 nije imalo dokaza o liječenju, 4 je završilo ispitivanje, 10 je izgubljeno iz praćenja, a za 1 bolesnika nisu uspješno prikupljeni podaci.
Marketing Authorisation Holder Retrophin Europe Limited Palmerston House Fenian Street
Nositelj odobrenja za stavljanje lijeka u promet Retrophin Europe Limited Palmerston House
Treatment with oral cholic acid stimulates bile flow and secretion, inhibits production and accumulation of hepatotoxic and cholestatic bile acid precursors and facilitates fat absorption without toxic side effects at therapeutic doses.
Liječenje oralnom kolatnom kiselinom stimulira protok i sekreciju žuči, inhibira stvaranje i nakupljanje hepatotoksičnih i kolestatskih prekursora žučne kiseline, te olakšava apsorpciju masti bez toksičnih nuspojava u terapijskim dozama.
• feeling of pins and needles (mild peripheral neuropathy)
• osjećaj mučnine (blaga mučnina) • osjećaj bockanja i iglica (blaga periferna neuropatija)
Elderly Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.
Starije osobe Sigurnost i učinkovitost kolatne kiseline nisu ispitani kod osoba starijih od 65 godina.
The use of cholic acid may be considered during pregnancy if your doctor considers that the benefits to you outweigh any possible risk.
Primjena kolatne kiseline može se razmotriti tijekom trudnoće, ako Vaš liječnik smatra da koristi za Vas nadmašuju moguće rizike.
This medicinal product has been authorised under ‘exceptional circumstances,' which means that, due to the rarity of the disease and for ethical reasons, it has not been possible to obtain complete information on this medicinal product.
To znači da s obzirom na malu učestalost bolesti i zbog etičkih razloga nije bilo moguće doći do potpunih informacija o ovom lijeku.
Patients with familial hypertriglyceridaemia
Bolesnici s obiteljskom hipertrigliceridemijom
Jaundice Increased serum transaminases Gallstones
Povišene transaminaze u serumu
How to use Kolbam
Kako primjenjivati Kolbam
• yellowing of the skin (jaundice)
• žutilo kože (žutica) • lezije kože
Efficacy was demonstrated in two ways: (a) treatment with cholic acid leads to an improvement in liver function as demonstrated by improved liver function test values, (b) Fast Atom Bombardment-Mass Spectrometry (FAB-MS) data demonstrated efficacy by showing that cholic acid treatment led to a suppression of the abnormal urine bile acids that initially led to the diagnosis.
(a) liječenje kolatnom kiselinom rezultiralo je poboljšanjem jetrene funkcije što je vidljivo iz poboljšanja vrijednosti nalaza jetrenih funkcija, (b) podaci masene spektrometrije korištenjem metode bombardiranja brzim atomima (FAB-MS) dokazali su djelotvornost pokazujući da je liječenje kolatnom kiselinom rezultiralo supresijom abnormalnih žučnih kiselina u urinu koje su prvotno i dovele do dijagnoze.
It is recommended that the capsules are taken with food, as this may help to make the cholic acid more effective, and also reduces the likelyhood of diarrhoea.
Preporučuje se uzimanje kapsula s hranom jer ovaj način primjene čini kolatnu kiselinu učinkovitijom te također smanjuje vjerojatnost proljeva.
Serum transaminases were below the ULN for 1 patient and elevated (≥2 times the ULN) for 2 patients at baseline, were elevated for 2 patients in the worst post baseline analysis but were below the ULN for all 3 patients in the best post-treatment analysis.
Transaminaze u serumu bile su ispod gornje granice normale (GGN) za 1 bolesnika i povišene (≥ 2 puta od GGN) za 2 bolesnika pri početnoj vrijednosti, povišene za 2 bolesnika u analizi najlošije vrijednosti nakon početne vrijednosti, ali su bile ispod GGN za sva 3 bolesnika u analizi najbolje vrijednosti nakon liječenja.
Efficacy was demonstrated in two ways: (c) treatment with cholic acid leads to an improvement in liver function as demonstrated by improved liver function test values, (d) Fast Atom Bombardment-Mass Spectrometry (FAB-MS) data demonstrated efficacy by showing that cholic acid treatment led to a suppression of the abnormal urine bile acids that initially led to the diagnosis.
(c) liječenje kolatnom kiselinom rezultiralo je poboljšanjem jetrene funkcije što je vidljivo iz poboljšanja vrijednosti nalaza jetrenih funkcija, (d) podaci masene spektrometrije korištenjem metode bombardiranja brzim atomima (FAB-MS) dokazali su djelotvornost pokazujući da je liječenje kolatnom kiselinom rezultiralo supresijom abnormalnih žučnih kiselina u urinu koje su prvotno i dovele do dijagnoze.
Gallstones have been reported after long-term therapy.
Nakon dugotrajne terapije prijavljeni su žučni kamenci.
The cholic acid dose for patients with familial triglyceridaemia will have to be established and adjusted as necessary (see section 4.2).
Dozu kolatne kiseline kod bolesnika s obiteljskom trigliceridemijom treba utvrditi i prilagoditi prema potrebi (vidjeti dio
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg of cholic acid.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tvrda kapsula sadrži 250 mg kolatne kiseline.
Cholic acid down-regulates bile acid biosynthesis via activation of farnesoid X receptor, which represses transcription of the CYP7A1 gene encoding cholesterol 7α-hydroxylase, the rate-limiting enzyme of bile acid synthesis.
X receptora, koji suzbija transkripciju CYP7A1 gena koji kodira kolesterol 7α-hidroksilazu, enzim koji ograničava brzinu sinteze žučne kiseline.
Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Black Iron Oxide (E172)
Tinta šelak glazura (E904) Propilenglikol (E1520) Jaka otopina amonijaka (E527) Kalijev hidroksid (E525) željezov oksid, crni (E172)
Regarding primary diagnoses, shifts towards improvements in ALT and AST values were shown in individual defect groups.
Vezano uz primarnu dijagnozu, pomak prema poboljšanju vrijednosti ALT-a i AST-a uočen je u grupama s pojedinačnim defektom.
Children Cholic acid has not been studied for safety and effectiveness in babies under one month of age.
Sigurnost i učinkovitost kolatne kiseline nisu ispitani kod dojenčadi mlađe od mjesec dana starosti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of cholic acid.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tvrda kapsula sadrži 50 mg kolatne kiseline.
Kolbam 250 mg: Each capsule contains 250 mg of cholic acid.
Kolbam 250 mg: svaka kapsula sadrži 250 mg kolatne kiseline.
CTX), 2- (or α-) methylacyl-CoA racemase (AMACR) and Cholesterol 7α hydroxylase (CYP7A1) deficiencies.
(AMACR) i kolesterol 7α-hidroksilaze (CYP7A1).
Silicified microcrystalline cellulose
Sadržaj kapsule celuloza, mikrokristalična silicirana magnezijev stearat
Pharmacotherapeutic group: Bile and liver therapy, bile acid preparations; ATC code: A05AA03
Farmakoterapijska skupina: lijekovi za liječenje žuči i jetre, pripravci žučne kiseline, ATK oznaka:
The use of cholic acid may be considered during pregnancy if the doctor considers that the benefits to the patient outweigh the possible risk.
Primjena kolatne kiseline tijekom trudnoće može se uzeti u razmatranje, ako liječnik smatra da koristi za bolesnika nadmašuju mogući rizik.
The 50 mg capsules are orange (black imprint “ASK001” and “50mg”).
Kapsule od 50 mg su narančaste boje (crnim natpisom „ASK001“ i „50 mg“).
NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules.
NAZIV LIJEKA Kolbam 50 mg tvrde kapsule.
Cholic acid can be used during breastfeeding if the doctor considers that the benefits to the patient outweigh the possible risk.
Kolatna kiselina se može primjenjivati tijekom dojenja, ako liječnik smatra da koristi za bolesnika nadmašuju mogući rizik.
Adverse reactions reported in the literature are pruritus and increased serum transaminases in one or two children treated with high doses of cholic acid; however, these adverse reactions disappeared with a reduced dosage.
Opis odabranih nuspojava Nuspojave prijavljene u literaturi su svrbež i povišene transaminaze u serumu kod jedno ili dvoje djece liječenih visokim dozama kolatne kiseline.
Kolbam 50 mg: Each capsule contains 50 mg of cholic acid.
Kolbam 50 mg: svaka kapsula sadrži 50 mg kolatne kiseline.
The 250 mg capsules are white (black imprint “ASK002” and “250mg”).
Kapsule od 250 mg su bijele boje (crnim natpisom „ASK002“ i „250 mg“).
In these cases, serum/bile levels of cholic acid should be closely monitored and the dose adjusted accordingly.
U ovim se slučajevima razine žučne kiseline u serumu/žuči moraju pozorno kontrolirati te se doza kolatne kiseline treba prilagoditi prema potrebi.
Patients with newly diagnosed, or a family history of, familial hypertriglyceridaemia may have poor absorption of cholic acid from the intestine.
Kod bolesnika s novodijagnosticiranom ili s pozitivnom obiteljskom anamnezom obiteljske hipertrigliceridemije moguća je slaba apsorpcija kolatne kiseline u crijevima.
CONTENTS OF THE PACK AND OTHER INFORMATION What Kolbam contains - The active substance is cholic acid.
Što Kolbam sadrži - Djelatna tvar je kolatna kiselina.
• heartburn (gastric reflux)
• žgaravica (vraćanje želučane kiseline)
Patients with newly diagnosed or a family history of familial hypertriglyceridaemia are expected to poorly absorb cholic acid from the intestine.
Kod bolesnika s novodijagnosticiranom ili s pozitivnom obiteljskom anamnezom obiteljske hipertrigliceridemije očekuje se slaba apsorpcija kolatne kiseline u crijevima.
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar
Mean total bilirubin values remained stable in the baseline to worst post-baseline value analysis and decreased in the baseline to best post-baseline analysis.
Srednje vrijednosti ukupnog bilirubina ostale su stabilne u analizi usporedbe početne vrijednosti i najlošije vrijednosti nakon početne i smanjene u analizi usporedbe početne vrijednosti i najbolje nakon početne.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja o interakciji kolatne kiseline i istovremene primjene drugih lijekova ili hrane.
50 mg capsule: Size number 2 capsule with a Swedish orange cap (black imprint “ASK001”) and body (black imprint “50mg”).
50 mg kapsula: kapsula veličine broj 2 s tamnonarančastom kapicom (s crnim natpisom „ASK001“) i tijelom (s crnim natipsom „50 mg“).
NAME OF THE MEDICINAL PRODUCT Kolbam 250 mg hard capsules.
NAZIV LIJEKA Kolbam 250 mg tvrde kapsule.
250 mg capsule: Size number 0 capsule with a white cap (black imprint “ASK002”) and white body (black imprint “250mg”).
250 mg kapsula: kapsula veličine broj 0 s tamnonarančastom kapicom (s crnim natpisom „ASK002“) i tijelom (s crnim natipsom „250 mg“).
Mild nausea Mild reflux Moderate diarrhoea
Blagi refluks Umjeren proljev
No studies on the effects on the ability to drive and use machines have been performed.
Ne očekuje se utjecaj lijeka na sposobnost upravljanja vozilima i strojevima.
MARKETING AUTHORISATION NUMBER EU/1/13/895/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/895/001
Titanium dioxide (E171) Red iron oxide (E172)
Ovojnica kapsule od 50 mg želatina titanijev dioksid (E171) željezov oksid, crveni (E172)
The majority of patients with inborn errors of bile acid metabolism presented with some degree of hepatic impairment at the time of diagnosis; in most patients, the hepatic impairment improved or resolved with treatment.
Većina bolesnika s prirođenim greškama metabolizma žučne kiseline ima određeni stupanj oštećenja funkcije jetre prilikom postavljanja dijagnoze.
Adverse reactions in patients (both adults and children) receiving cholic acid are generally mild to moderate in severity; the main reactions observed are given in the table below.
Nuspojave kod bolesnika (odraslih i djece) koji primaju kolatnu kiselinu su načelno blage do umjerene u svojoj težini.
Kolbam 50 mg hard capsules Kolbam 250 mg hard capsules cholic acid
Kolbam 250 mg tvrde kapsule kolatna kiselina
MARKETING AUTHORISATION NUMBER EU/1/13/895/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/895/002
The registry will monitor accumulating data on efficacy and safety in the treatment of inborn errors in primary bile acid synthesis in infants, children, adolescents and adults due to Sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis,
Registar će pratiti prispjele podatke o djelotvornosti i sigurnosti u liječenju prirođenih grešaka u sintezi primarne žučne kiseline u dojenčadi, djece,
ANNEX II
Dublin 2, Irska
- The other ingredients are: Capsule content: Silicified microcrystalline cellulose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Kolbam 50 mg also contains Red iron oxide (E172).
silicirana mikrokristalična celuloza magnezijev stearat Ovojnica kapsule: želatina titanijev dioksid (E171)
Magnesium stearate
Žučni kamenci
If administration of ciclosporin is considered necessary, serum and urinary bile acid levels should be closely monitored and the cholic acid dose adjusted accordingly.
razine žučne kiseline u serumu i urinu trebaju se pozorno kontrolirati te se doza kolatne kiseline treba prilagoditi prema potrebi.
Titanium dioxide (E171)
Ovojnica kapsule od 250 mg želatina titanijev dioksid (E171)
Kolbam contains a substance called cholic acid.
Što je kolbam i za što se koristi Kolbam sadrži tvar koja se naziva kolatna kiselina.
• Gallstones
• proljev
EXP
Proljev
Shellac (E904)
A05AA03
• Summary of product characteristics
• Sažetak opisa svojstava lijeka
How to store Kolbam 6.
Moguće nuspojave 5. Kako čuvati Kolbam
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule content
PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
• skin lesions
• žučni kamenici
NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules cholic acid
Kolbam 50 mg tvrde kapsule kolatna kiselina
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg cholic acid
Svaka kapsula sadrži 250 mg kolatne kiseline
Preferred Term Frequency
Preporučeni pojam Učestalost
Hepatic impairment
Blaga mučnina
Oestrogens, oral contraceptives and clofibrate (and perhaps other lipid-lowering substances) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of cholic acid.
povećavaju sekreciju kolesterola u jetri i potiču formiranje kolesterolnih žučnih kamenaca, te stoga mogu djelovati protivno djelovanju kolatne kiseline.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 50 mg cholic acid
Svaka kapsula sadrži 50 mg kolatne kiseline
• sickness (mild nausea)
• blago peckanje (svrbež) Prijavljivanje nuspojava
MARKETING AUTHORISATION NUMBER EU/1/13/895/001 DATE OF FIRST AUTHORISATION 20 November 2015
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/895/002
Diarrhoea is also known to occur in cases of excessive dosing with cholic acid.
U slučaju prekomjerne doze kolatne kiseline može nastupiti i proljev.
This dose should not be increased.
Ovu dozu ne treba povećavati.
Ifirmacombi should be taken at least one hour before or four hours after these medications;
Ifirmacombi se mora uzeti najmanje jedan sat prije ili 4 sata poslije tih lijekova;
What Ifirmacombi is and what it is used for
Što je Ifirmacombi i za što se koristi
It is important that you continue to take Ifirmacombi until your doctor tells you otherwise.
Važno je da kontinuirano uzimate Ifirmacombi sve dok Vam liječnik ne odredi drugačije.
While this is not documented with Ifirmacombi, a similar effect should be anticipated.
Iako to nije dokumentirano za Ifirmacombi, može se očekivati sličan učinak.
Additional information on irbesartan interactions:
Dodatne informacije o interakcijama irbesartana:
You should discontinue Ifirmacombi treatment and seek medical attention.
Morate prekinuti liječenje lijekom Ifirmacombi i zatražiti liječničku pomoć.
Primary aldosteronism:
Primarni aldosteronizam:
Irbesartan did not affect survival, development, or reproduction of offspring.
Irbesartan nije utjecao na preživljavanje, razvoj ili reprodukciju mladunčadi.
See also information under the heading “Do not take Ifirmacombi”.
Vidjeti također informacije pod naslovom “Nemojte uzimati Ifirmacombi”.
Always take this medicine exactly as your doctor has told you.
Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao liječnik.
Date of first authorisation: 04 March 2011 Date of latest renewal: 19 November 2015
Datum posljednje obnove odobrenja: 19. studenog 2015.
Ifirmacombi should not be given to children under 18 years of age.
Ifirmacombi ne smiju uzimati djeca mlađa od 18 godina.
Your doctor will normally advise you to stop taking Ifirmacombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ifirmacombi.
Liječnik će Vam obično preporučiti da prestanete koristiti Ifirmacombi prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto lijeka Ifirmacombi.
Ifirmacombi with food, drink and alcohol Ifirmacombi can be taken with or without food.
Ifirmacombi s hranom, pićem i alkoholom Ifirmacombi se može uzeti s hranom ili bez nje.
Metabolic and endocrine effects:
Metabolički i endokrini učinci:
Ifirmacombi is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Ne preporučuje se primjena lijeka Ifirmacombi u djece i adolescenata jer sigurnost i djelotvornost nisu ustanovljene.
Hydrochlorothiazide is excreted in human milk in small amounts.
Hidroklorotiazid se izlučuje u ljudskom mlijeku u manjim količinama.
Since Ifirmacombi contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Budući da Ifirmacombi sadrži hidroklorotiazid, ne preporučuje se tijekom prvog tromjesečja trudnoće.
This could be a sign that you are developing glaucoma, increased pressure in your eye(s).
Ovo može biti znak nastanka glaukoma, povišenog tlaka u oku (očima).
Ifirmacombi can be taken once daily, with or without food.
Ifirmacombi se može uzimati jedanput na dan, s hranom ili bez nje.
Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih (≥ 65 godina) nego u mlađih ispitanika (18 do 40 godina).