natgillin/translations-raw huggingface dataset:
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).
If Ifirmacombi is used during breast feeding, doses should be kept as low as possible. 
Ako se Ifirmacombi primjenjuje tijekom dojenja, njegove doze trebaju biti što je moguće niže.
What Ifirmacombi is and what it is used for What you need to know before you take Ifirmacombi How to take Ifirmacombi 
Što je Ifirmacombi i za što se koristi Što morate znati prije nego počnete uzimati Ifirmacombi Kako uzimati Ifirmacombi
Not known: tinnitus 
Nije poznato: tinitus
Your doctor will instruct you how to switch from the previous treatment to Ifirmacombi. 
Liječnik će Vas uputiti kako prijeći s prethodnog liječenja na Ifirmacombi.
Uncommon: sexual dysfunction, libido changes 
Manje često: seksualna disfunkcija, promjene libida
Children and adolescents Ifirmacombi should not be given to children and adolescents (under 18 years). 
Djeca i adolescenti Ifirmacombi ne smiju uzimati djeca i adolescenti (mlađi od 18 godina).
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing. 
Ograničeno nakupljanje irbesartana (< 20%) zabilježeno je u plazmi nakon primjene ponovljenih doza jedanput na dan.
However, there was no difference in the half-life and accumulation of irbesartan. 
Nije, međutim, bilo razlika u poluvijeku i nakupljanju irbesartana.
See section 2 "Ifirmacombi contains sodium". 
Vidjeti dio 2. „Ifirmacombi sadrži natrij“.
The frequency of adverse reactions listed below is defined using the following convention: - Very common (1/10) - Common (1/100 to <1/10) - Uncommon (1/1,000 to <1/100) - Rare (1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data) 
Učestalost dolje navedenih nuspojava definirana je na sljedeći način: vrlo često (≥1/10) često (≥1/100 do <1/10) manje često (≥1/1000 do <1/100) rijetko (≥1/10 000 do <1/1000) vrlo rijetko (<1/10 000). nije poznato (ne može se procijeniti iz dostupnih podataka)
Alcohol: potentiation of orthostatic hypotension may occur; 
Alkohol: može se pojaviti ortostatska hipotenzija;
During the 8-week treatment period, there were no reported cases of syncope in either treatment group. 
Tijekom osmotjednog liječenja nije bilo prijavljenih slučajeva sinkope ni u jednoj skupini.
Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity. 
Epidemiološka ispitivanja su pokazala da dugoročno liječenje hidroklorotiazidom smanjuje rizik od kardiovaskularnog morbiditeta i mortaliteta.
The primary treatment is to discontinue drug intake as rapidly as possible. 
Primarno liječenje je što brži prekid primjene lijeka.
jaundice hepatitis, abnormal liver function 
žutica hepatitis, abnormalna funkcija jetre
If any of these side effects causes you problems, talk to your doctor. 
Ako Vam bilo koja od ovih nuspojava uzrokuje probleme, obratite se svom liječniku.
When necessary, Ifirmacombi may be administered with another antihypertensive medicinal product (see section 4.3, 4.4, 4.5 and 5.1). 
Kada je potrebno, Ifirmacombi se može primjenjivati s drugim antihipertenzivnim lijekom (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year. 
U dugoročnim ispitivanjima praćenja učinak kombinacije irbesartan/hidroklorotiazid održao se kroz više od godinu dana.
Side effects associated with irbesartan alone 
Nuspojave povezane sa samim irbesartanom
C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan. 
C irbesartana 80-85% cirkulirajuće radiokativnosti u plazmi odnosi se na nepromijenjeni irbesartan.
What you need to know before you take Ifirmacombi 
Što morate znati prije nego počnete uzimati Ifirmacombi
Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use; 
Presorni amini (primjerice noradrenalin): učinak presornih amina može biti smanjen, ali ne dovoljno da se isključi njihova primjena;
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. 
Simptomi uključuju akutni nastup smanjene oštrine vida ili bol u očima te se obično pojavljuju unutar nekoliko sati do tjedana od početka primjene lijeka.
No significant effects on the number of corpora lutea, implants, or live foetuses were observed. 
Nisu uočeni značajni učinci na broj žutih tijela, implantacija ili živih fetusa.
Pharmacotherapeutic group: angiotensin II antagonists and diuretics, ATC code: C09DA04. 
Farmakoterapijska skupina: antagonisti angiotenzina II i diuretici, ATK oznaka: C09DA04.
Side effects reported in clinical studies for patients treated with Ifirmacombi were: 
Nuspojave prijavljene u kliničkim ispitivanjima u bolesnika liječenih lijekom Ifirmacombi bile su:
Additional information on hydrochlorothiazide interactions: When administered concurrently, the following medicinal products may interact with thiazide diuretics: 
Dodatne informacije o interakcijama hidroklorotiazida: Pri istodobnom liječenju, sljedeći lijekovi mogu ući u interakciju s tiazidskim diureticima:
If you forget to take Ifirmacombi 
Ako ste zaboravili uzeti Ifirmacombi
Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3). 
Irbesartan nije utjecao na fertilitet tretiranih štakora ili njihovog potomstva sve do onih doza koje izazivaju prve znakove toksičnosti u roditelja (vidjeti dio 5.3).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. 
Epidemiološki podaci koji se odnose na rizik od teratogenog učinka nakon primjene ACE inhibitora tijekom prvog tromjesečja nisu bili dostatni za donošenje zaključaka, međutim, manji porast rizika ne može se isključiti.
Not known: respiratory distress (including pneumonitis and pulmonary oedema) 
Nije poznato: respiratorni distres (uključujući pneumonitis i plućni edem)
Such conditions should be corrected before initiating therapy with Ifirmacombi. 
Takva stanja treba korigirati prije započinjanja terapije lijekom Ifirmacombi.
Ifirmacombi is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
Ifirmacombi se ne preporučuje majkama koje doje, a liječnik može izabrati drugu terapiju ako želite dojiti, osobito ako se radi o dojenju novorođenčeta ili nedonoščeta.
If you get any of the above symptoms or get short of breath, stop taking Ifirmacombi and contact your doctor immediately. 
Ako primijetite neki od tih simptoma ili ako osjetite nedostatak zraka, prestanite uzimati Ifirmacombi i odmah se javite svom liječniku.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8). 
Čimbenici rizika razvoja akutnog glaukoma zatvorenog kuta mogu uključivati anamnezu alergije na sulfonamid ili penicilin (vidjeti dio 4.8).
Renal artery stenosis - Renovascular hypertension: 
Stenoza renalne arterije - Renovaskularna hipertenzija: