natgillin/translations-raw huggingface dataset:
The MAH was asked to provide data on safety and efficacy for these subgroups of patients (Losartan, Atenolol, Losartan + HCTZ, Atenolol + HCTZ) in order to gain more insight into the contribution of HCTZ to the overall benefit risk ratio. 
Od imetnika dovoljenja za promet z zdravilom so zahtevali podatke o varnosti in učinkovitosti pri omenjenih podskupinah bolnikov (losartan, atenolol, losartan + HCTZ, atenolol + HCTZ), da bi z njimi dobili boljši vpogled v prispevek, ki ga ima HCTZ na skupno razmerje med koristnimi učinki in tveganjem.
Angiotensin II, a potent vasoconstrictor, is the primary active hormon of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension. 
Angiotenzin II, močan vazokonstriktor, je primarni aktivni hormon sistema renin/angiotenzin in pomemben faktor v patofiziologiji hipertenzije.
Furthermore, losartan does not inhibit ACE (kininase II), the enzyme that degrades bradykinin. 
Nadalje, losartan ne zavira ACE (kininaze II), encima, ki razgrajuje bradikinin.
More than 50% of those patients reaching the target BP on the FDC within 4 weeks did not require a combination. 
Več kot 50 % bolnikov, ki so bili deležni zdravljenja s fiksno kombinacijo odmerkov in so v štirih tednih dosegli ciljni krvni tlak, ni potrebovalo kombinacije zdravil.
During the referral procedure, the MAH proposed amending the indication to substitute “cardiovascular morbidity and mortality” with “stroke”. 
Med napotitvenim postopkom je imetnik dovoljenja za promet z zdravilom predlagal spremembo indikacije, v kateri bi „kardiovaskularno obolevnost in umrljivost“ zamenjal z izrazom „možganska kap“.
Use in the elderly Dosage adjustment is not usually necessary for the elderly. 
Uporaba pri starejših bolnikih Pri starejših bolnikih odmerka običajno ni treba prilagoditi.
When compared to only 8.2% of patients that can reach target BP somewhat faster compared to a stepwise approach, the risk benefit ratio is negative both for patients with severe and for patients with mild to moderate hypertension. 
Če ta odstotek primerjamo s samo 8,2 % bolnika, ki so ciljni krvni tlak dosegli malce hitreje kot tisti, ki so bili deležni zdravljenja po korakih, je razmerje med koristnimi učinki in tveganjem negativno tako za bolnike s hudo kot za bolnike z blago do zmerno hipertenzijo.
The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. 
Najverjetnejši simptomi bi bili hipotenzija in takihardija; bradikardija se lahko pojavi zaradi parasimpatične (vagalne) stimulacije.
Do not use Cozaar Comp after the expiry date which is stated on the container. 
Zdravila Cozaar Comp ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
As with all antihypertensive therapy, symptomatic hypotension may occur in some patients. 
Kot pri vsakem antihipertenzivnem zdravljenju se tudi pri tem lahko pri nekaterih bolnikih pojavi simptomatska hipotenzija.
• if you are on a salt-restricted diet 
• če ste na dieti s hrano z zmanjšano količino soli.
If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage should be adjusted accordingly. 
Če morate predpisati dodatke kalcija, morate spremljati količino kalcija v serumu ter ustrezno prilagoditi odmerek kalcija.
In addition to the active metabolite, inactive metabolites are formed, including two major metabolites formed by hydroxylation of the butyl side chain and a minor metabolite, an N-2 tetrazole glucuronide. 
Poleg aktivnega metabolita se tvorijo tudi neaktivni presnovki, vključno z dvema večjima, ki nastaneta s hidroksilacijo butilne stranske verige, in enim manjšim, N-2 tetrazol glukuronidom.
This composite endpoint can be considered as representative for CV morbidity and mortality, and has translated into this indication in many medicinal products that have been discussed in the CHMP (e.g. statins). 
Ta sestavljeni pokazatelj pomeni kardiovaskularno obolevnost in umrljivost in je bila kot taka indikacija prevedena pri mnogih zdravilih, o katerih so razpravljali v CHMP (npr. statini).
Investigations Rare: Hyperkalaemia, elevation of ALT 
Preiskave Redke: hiperkaliemija, zvišanje ALT
Lindenplatz 1 85540, Haar Germany 
Lindenplatz 1 85540, Haar Nemčija
Hydrochlorothiazide may reduce both plasma volume and uteroplacental blood flow. 
Hidroklorotiazid lahka zmanjša tako volumen plazme kot tudi uteroplacentarni krvni obtok.
Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide. 
Metformin je treba uporabljati previdno zaradi tveganja za laktacidozo, ki jo povzroči možna ledvična odpoved, povezana s hidroklorotiazidom.
Diuretic agents such as the hydrochlorothiazide contained in Cozaar Comp may interact with other medicines. 
Diuretiki, kot je hidroklorotiazid v zdravilu Cozaar Comp, lahko medsebojno deluje z drugimi zdravili.
Dosage adjustment of antidiabetic agents, including insulin, may be required (see section 4.5). 
V tem primeru je lahko treba prilagoditi odmerjanje antidiabetičnega zdravila, vključno z insulinom (glejte poglavje 4.5).
What Cozaar Comp is and what it is used for Before you take Cozaar Comp How to take Cozaar Comp Possible side effects 
Kaj je zdravilo Cozaar Comp in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cozaar Comp Kako jemati zdravilo Cozaar Comp Možni neželeni učinki
Cozaar Comp is effective in reducing blood pressure in males and females, blacks and non-blacks and in younger (<65 years) and older (≥65 years) patients and is effective in all degrees of hypertension. 
Zdravilo Cozaar Comp je učinkovito za znižanje krvnega tlaka pri moških in ženskah, pri črncih in ostalih rasah, pri mlajših (< 65 let) in starejših (≥ 65 let) bolnikih ter za vse stopnje hipertenzije.
The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. 
Količine hidrokloritizida, ki se odstrani s hemodializo, niso ugotovili.
Studies in rats indicate that losartan crosses the bloodbrain barrier poorly, if at all. 
Raziskave na podganah kažejo, da losartan v zelo majhnem deležu, če sploh, prehaja skozi krvno-možgansko bariero.
The plasma concentrations of losartan and its active metabolite and the absorption of hydrochlorothiazide in elderly hypertensives are not significantly different from those in young hypertensives. 
Plazemske koncentracije losartana in njegovega aktivnega presnovka ter absorbcija hidroklorotiazida pri starejših hipertonikih niso bile pomembno drugačne od tistih pri mladih moških hipertonikih.
Taking Cozaar Comp with food and drink 
Jemanje zdravila Cozaar Comp skupaj s hrano in pijačo
Despite these increases, antihypertensive activity and suppression of the plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade. 
Kljub tem povečanjem pa se ohranjata antihipertenzivna aktivnost in zmanjševanje koncentracije aldosterona v plazmi, kar kaže na učinkovito blokado receptorjev za angiotenzin II.
Thiazides pass the placental barrier and are found in cord blood. 
Tiazidi prehajajo skozi posteljico in jih najdemo v popkovnični krvi.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. 
Tiazidi vplivajo na renalni tubularni mehanizem reabsorpcije elektrolitov in tako neposredno povečujejo izločanje natrija in klorida v približno enakih količinah.
• if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function) 
• če imate zožane arterije (aterosklerozo), angino pektoris (bolečino v prsnem košu zaradi šibkega delovanja srca).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
In case of high dosages of salicylates hydrochlorothiazide may enhance the toxic effect of the salicylates on the central nervous system. 
V primeru velikih odmerkov salicilatov lahko hidroklorotiazid poveča toksični učinek salicilatov na centralno živčevje.
Since then the beneficial effect of atenolol regarding CV morbidity and mortality has been questioned. 
Od takrat dalje obstaja dvom o koristnem učinku atenolola na kardiovaskularno obolevnost in umrljivost.
The reason for this broader indication is that the LIFE study was not a placebo-controlled study, studying the effect on stroke only compared to placebo, but an actively controlled study, comparing a losartan based with an atenolol based antihypertensive treatment using a primary composite endpoint of CV death, stroke and MI. 
Razlog za to razširjeno indikacijo je dejstvo, da študija LIFE ni bila s placebom nadzorovana študija, v kateri bi raziskovali učinek na možgansko kap samo v primerjavi s placebom, temveč je bila aktivno nadzorovana študija, v kateri so primerjali zdravljenje proti hipertenziji na podlagi losartana v primerjavi s tistim na podlagi atenolola, pri tem pa so uporabili sestavljeni primarni pokazatelj za kardiovaskularno smrt, možgansko kap in miokardni infarkt.
Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. 
Bolniki s primarnim hiperaldosteronizmom se na zdravljenje z antihipertenzivi, ki zavirajo sistem renin-angiotenzin, večinoma ne odzovejo.
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels. 
• zvišana količina kalija (ki lahko povzroči nenormalen srčni ritem), znižan hemoglobin
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product. 
V primeru z diuretikom povzročene dehidracije obstaja povečano tveganje za akutno ledvično odpoved, še posebej pri velikih odmerkih jodovega pripravka.
Foetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs in the F1 generation, was observed when females were treated prior to and throughout gestation. 
Pri podganah so škodljive učinke na plod, ki so se pokazali z rahlim povečanjem pojavnosti odvečnih reber v generaciji F1, opazili, če so samice zdravili pred in med brejostjo.
Hertfordshire, EN11 9BU United Kingdom 
Hertfordshire EN11 9BU Velika Britanija
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing). 
Huda alergijska reakcija (izpuščaj, srbenje, otekanje obraza, ustnic, otekanje v ustih ali žrelu, ki lahko oteži požiranje ali dihanje).
• if you have or have had severe vomiting and/or diarrhoea 
• če ste močno bruhali in/ali imeli hudo drisko.
Following an oral dose of 14C-labeled losartan in man, about 35% of radioactivity is recovered in the urine and 58% in the feces. 
Po peroralnem/intravenskem odmerku s 14C označenega losartana pri človeku najdemo približno 35 %radioaktivnosti v urinu, 58 % pa v blatu.
The adverse events were restricted to those which were formerly observed with losartan potassium salt and/or hydrochlorothiazide. 
Neželeni učinki so bili omejeni na tiste, ki so jih že predhodno opazili pri kalijevem losartanatu in/ali hidroklorotiazidu.
Important information about some of the ingredients of Cozaar Comp 
Pomembne informacije o nekaterih sestavinah zdravila Cozaar Comp
About 14% of an intravenously- or orally-administered dose of losartan is converted to its active metabolite. 
Približno 14 % intravensko ali peroralno danega odmerka losartana se pretvori v njegov aktivni presnovek.
• Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations, 
• nizek krvni tlak, ki je lahko povezan s spremembo položaja (občutek omotičnosti ali slabotnosti, ko vstanete, angina pektoris (bolečina v prsnem košu), nenormalen srčni utrip, možganskožilni dogodek (TIA - mini kap), srčni napad, palpitacije
In patients with left ventricular failure, 25 mg and 50 mg doses of losartan produced positive hemodynamic and neurohormonal effects characterized by an increase in cardiac index and decreases in pulmonary capillary wedge pressure, systemic vascular resistance, mean systemic arterial pressure and heart rate and a reduction in circulating levels of aldosterone and norepinephrine, respectively. 
Pri bolnikih s popuščanjem levega ventrikla so 25 mg in 50 mg odmerki losartana povzročili pozitivne hemodinamske in nevrohormonske učinke, za katere so bili značilni povečan srčni indeks in zmanjšanje pljučnega kapilarnega zagozditvenega tlaka, sistemskega vaskularnega upora, povprečnega sistemskega arterijskega tlaka in srčne frekvence ter zmanjšanje ravni cirkulirajočega aldosterona oz. noradrenalina.
• Inflammation of blood vessels, which is often associated with a skin rash or bruising, 
• vneje krvnih žil, ki je pogosto povezano s kožnim izpuščajem ali modricami
There is no experience with the use of Cozaar Comp in children. 
Izkušenj z uporabo zdravila Cozaar Comp pri otrocih nimamo.
The concomitant use of potassium sparing diuretics, potassium supplements and potassium containing salt substitutes with losartan/ hydrochlorothiazide is not recommended (see section 4.5). 
Sočasne uporabe diuretikov, ki varčujejo kalij, kalijevih dodatkov in nadomestkov soli, ki vsebujejo kalij, ter kombinacije losartan/hidroklorotiazid ne priporočamo (glejte poglavje 4.5).
Section 4.3 Contra-indications 
Poglavje 4.3 Kontraindikacije
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldesterone by the adrenal gland, caused by an abnormality within the gland). 
• če imate primarni hiperaldosteronizem (sindrom, povezan s povečanim izločanjem hormona aldosterona iz nadledvične žleze, zaradi okvare znotraj žleze).
• Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels, 
• izguba apetita, povečana količina sečne kisline ali protin, povečana količina sladkorja v krvi, nenormalna vrednost elektrolitov v krvi
When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately and, if appropriate, alternative therapy should be started. 
Ob potrjeni nosečnosti je treba zdravljenje z zdravilom Cozaar Comp takoj prekiniti, in, če je primerno, začeti alternativno zdravljenje.
As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in nonblacks, possibly because of higher prevalence of low-renin states in the black hypertensive population. 
Tako kot so opazili za zaviralce angiotenzinske konvertaze, so tudi losartan in drugi antagonisti angiotenzina pri zmanjševanju krvnega tlaka pri črncih manj učinkoviti kot pri ostalih rasah, verjetno zaradi velike pojavnosti visokih vrednosti renina v črnski populaciji hipertonikov.
Losartan maintains glomerular filtration rate and reduces filtration fraction. 
Losartan ne spremeni hitrosti glomerularne filtracije, zniža pa frakcijo filtracije.
Thiazides pass into human milk and may inhibit lactation. 
Tiazidi pri človeku prehajajo v materino mleko in lahko zavirajo izločanje mleka.
At the time of the study, beta-blockade alone, or in combination with diuretics had shown to reduce rates of many CV events by 15-45%. 
Med študijo so dokazali, da samostojno zaviralno delovanje na beta receptorje ali v kombinaciji z diuretiki zmanjša odstotek mnogih kardiovaskularnih dogodkov za 15-45 %.
• if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus). 
• če imate ali ste imeli alergijo, astmo ali bolezen, ki povzroča bolečine v sklepih, kožne izpuščaje in zvišano telesno temperaturo (sistemski eritematozni lupus).
In a study specifically designed to assess the incidence of cough in patients treated with losartan as compared to patients treated with ACE inhibitors, the incidence of cough reported by patients receiving losartan or hydrochlorothiazide was similar and was significantly less than in patients treated with an ACE inhibitor. 
V študiji, zasnovani posebej za oceno pojavnosti kašlja pri bolnikih, zdravljenih z losartanom, v primerjavi z bolniki, zdravljenimi z zaviralci ACE, je bila pojavnost kašlja pri bolnikih, ki so prejemali losartan ali hidroklorotiazid podobna in pomembno manjša kot pri bolnikih, zdravljenih z zaviralcem ACE.
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. 
Najpogostejši znaki in simptomi, ki so jih opazili, so tisti, ki jih povzročata zmanjšana količina elektrolitov (hipokaliemija, hipokloremija, hiponatriemija) in dehidracija zaradi močne diureze.
Common (affecting less than one person in 10 but more than one person in 100): 
Pogosti (pojavijo se pri manj kot eni od 10 oseb in več kot eni od 100 oseb):
Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. 
Sočasna uporaba antagonistov angiotenzina II ali diuretikov in NSAR-ov lahko poveča tveganje za poslabšanje ledvične funkcije, vključno z akutno ledvično odpovedjo, ter poveča količino kalija v serumu, še posebej pri bolnikih z že obstoječim slabim delovanjem ledvic.
The active metabolite is 10- to 40-times more active than losartan on a weight for weight basis. 
Aktivni presnovek je 10- do 40-krat bolj aktiven kot losartan (v isti količini).
Preparations containing lithium should not be taken with Cozaar Comp without close supervision by your doctor. 
Pripravki, ki vsebujejo litij, se v kombinaciji z zdravilom Cozaar Comp brez natančnega nadzora zdravnika ne smejo uporabljati.
• if you have high calcium or low potassium levels or you are on a low potassium diet 
• če imate visoko vrednost kalcija ali nizko vrednost kalija ali ste na dieti z zmanjšanim vnosom kalija.
Just resume your usual schedule. 
Nadaljujte z običajnim jemanjem.
Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana 
Merck Sharp & Dohme, inovativna zdravila d.o.o., Smartinska cesta 140, 1000 Ljubljana, Slovenija
Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them. 
Kot vsa zdravila, ima lahko tudi zdravilo Cozaar Comp neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Cozaar Comp is supplied in the following pack sizes: 
Cozaar Comp je na voljo v naslednjih pakiranjih:
Rifampicin and fluconazole have been reported to reduce levels of active metabolite. 
Poročali so, da rifampicin in flukonazol zmanjšata količino aktivnega presnovka.
Hydrochlorothiazide (HCTZ) is a thiazide diuretic which has also been used as an antihypertensive agent. 
Hidroklorotiazid (HCTZ) je tiazidni diuretik, ki so ga uporabljali tudi kot sredstvo proti hipertenziji.
The LIFE study has been assessed in the past and this has led to the registration of the more extensive indication, i.e. the reduction of the cardiovascular morbidity and mortality (as measured by the combined incidence of CV death, stroke and MI) instead of stroke only. 
Študijo LIFE so že ocenili v preteklosti, zaradi česar je prišlo do registracije razširjene indikacije, tj. zmanjšanje kardiovaskularne obolevnosti in umrljivosti (kot je bilo izmerjeno s kombinirano pojavnostjo kardiovaskularnih smrti, možganskih kapi ter miokardnih infarktov), namesto uporabe samo izraza možganska kap.
Amphotericin B (parenteral), corticosteroids, ACTH or stimulant laxatives Hydrochlorothiazide may intensify electrolyte imbalance, particularly hypokalaemia. 
Amfotericin B (parenteralni), kortikosteroidi, ACTH ali kontaktna odvajala Hidroklorotiazid lahko poslabša neravnovesje elektrolitov, še posebej hipokaliemijo.
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported (in particular, in patients whose renal function is dependent on the renin-angiotensin-aldosterone system, such as those with severe cardiac insufficiency or pre-existing renal dysfunction). 
Zaradi zaviranja sistema renin-angiotenzin-aldosteron so poročali o spremembah delovanja ledvic, vključno z ledvično odpovedjo (še posebej pri bolnikih, katerih ledvična funkcija je odvisna od sistema renin-angiotenzin-aldosteron, kot je pri bolnikih s hudo srčno insuficienco ali že obstoječimposlabšanjem delovanja levic).
Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade. 
Losartan je peroralno aktiven antagonist receptorja angiotenzina II (Ang-II), ki deluje na receptor podtipa AT1 in s tem zavira učinke Ang-II v kaskadi renin angiotenzinskega sistema (RAS).
No specific information is available on the treatment of overdosage with Cozaar Comp. 
O zdravljenju prevelikega odmerjanja zdravila Cozaar Comp nimamo specifičnih informacij.
Merck Sharp & Dohme OÜ Peterburi tee 46, Tallinn 11415, Estonia 
Merck Sharp & Dohme OÜ Peterburi tee 46, Talin 11415, Estonija
• Severe renal impairment (i.e. creatinine clearance <30 ml/min) 
• Huda okvara ledvic (tj. kreatininski očistek < 30 ml/min).
The CHMP considered that the following contra-indications should be included in the SPC in all MSs: Severe renal impairment; Electrolyte disturbances such as hyponatremia, hypokalemia, hypercalcemia; Hyperuricaemia; Pregnancy and lactation; LAPP lactose deficiency; Liver insufficiency; Addison's disease. 
CHMP je menil, da je treba v vseh različicah povzetka glavnih značilnosti zdravila vključiti naslednje kontraindikacije: huda okvara ledvic; motnje elektrolitov, kot so hiponatremija, hipokalemija, hiperkalcemija, hiperuricemija; nosečnost in dojenje; Lappovo pomanjkanje laktaze; jetrna insuficienca; Addisonova bolezen.
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. 
Absorpcija hidroklorotiazida je motena v prisotnosti smol, ki so anionski izmenjevalci.
• if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment 
• če imate nizko vrednost kalija, nizko vrednost natrija ali visoko vrednost kalcija, ki se jih ne da pozdraviti.
• if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant 
• če imate zožane arterije, ki vodijo do ledvic (stenoza ledvične arterije) ali vam deluje samo ena ledvica ali pa so vam pred kratkim presadili ledvico.
When pregnancy is diagnosed, treatment with Cozaar Comp should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6). 
Ob potrjeni nosečnosti je treba zdravljenje z zdravilom Cozaar Comp takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4.3 in 4.6).
Losartan/HCTZ tablets must not be used in patients with severe renal impairment (i.e. creatinine clearance <30 ml/min) (see section 4.3). 
Tablet losartan/HCTZ ne smejo jemati bolniki s hudo ledvično okvaro (to je s kreatininskim očistkom < 30 ml/min) (glejte poglavje 4.3).
Anticholinergic agents (e.g. atropine, biperiden) 
Antiholinergiki (npr. atropin, biperiden)
Via G Fabbroni 6, 00191 Rome Italy 
Via G Fabbroni 6, 00191 Rim, Italija
They may cause fetal electrolyte disturbances and possibly other reactions that have been observed in adults. 
Pri plodu lahko porušijo ravnovesje elektrolitov in verjetno povzročijo tudi druge reakcije kot pri odraslih.