FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Dafiro HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Dafiro HCT u svim podskupinama pedijatrijske populacije u liječenju esencijalne hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you take more Dafiro HCT than you should
Croatian: Ako uzmete više Dafiro HCT-a nego što ste trebali
English: Marked and potentially prolonged systemic hypotension, including shock with fatal outcome, have been reported with amlodipine.
Croatian: Prijavljena je izražena i potencijalno produljena sistemska hipotenzija, uključujući šok sa smrtnim ishodom, prilikom primjene amlodipina.
English: if you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na amlodipin ili na bilo koji drugi blokator kalcijevih kanala, valsartan, hidroklorotiazid, lijekove dobivene sulfonamida (lijekovi koji se koriste za liječenje infekcija prsišta ili mokraćnog sustava) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Circulating hydrochlorothiazide is bound to serum proteins (40-70%), mainly serum albumin.
Croatian: Cirkulirajući hidroklorotiazid se veže na proteine u serumu (40-70%), uglavnom na serumski albumin.
English: Vasculitis necrotising and toxic epidermal necrolysis
Croatian: Nekrotizirajući vaskulitis i toksična epidermalna nekroliza
English: Pressor amines (e.g. noradrenaline, adrenaline)
Croatian: Presorni amini (npr. noradrenalin, adrenalin)
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Dafiro HCT.
Croatian: Ti bi mogli biti simptomi povišenog tlaka u Vašem oku, koji se može pojaviti unutar nekoliko sati do tjedan dana nakon uzimanja Dafiro HCT-a.
English: • medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin or penicillin G;
Croatian: • lijekovima koji mogu smanjiti količinu kalija u Vašoj krvi, kao što su diuretici (tablete za izmokravanje), kortikosteroidi, laksativi, amfotericin ili penicilin G;
English: This could result in sub-therapeutic effects of thiazide diuretics.
Croatian: To može rezultirati subterapijskim učincima tiazidnih diuretika.
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Croatian: Povećani rizik od nemelanomskog raka kože (engl. non-melanoma skin cancer, NMSC) [karcinom bazalnih stanica (engl. basal cell carcinoma, BCC) i karcinom skvamoznih stanica (engl. squamous cell carcinoma, SCC)] kod povećane kumulativne izloženosti hidroklorotiazidu zabilježen je u dvjema epidemiološkim studijama na temelju danskog Nacionalnog registra za rak.
English: • neuropathy
Croatian: • neuropatija
English: if you are taking any of the following medicines used to treat high blood pressure: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Croatian: ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću. aliskiren.
English: • sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)
Croatian: • kihanje/curenje iz nosa uzrokovano upalom sluznice nosa (rinitis)
English: Alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Tijekom dojenja je poželjno alternativno liječenje s bolje utvrđenim sigurnosnim profilom, posebno kod dojenja novorođenčeta ili nedonoščeta.
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products.
Croatian: U slučaju dehidracije izazvane diuretikom postoji povećan rizik od akutnog zatajenja bubrega, posebno kod primjene visokih doza proizvoda s jodom.
English: Systemic exposure to valsartan is slightly elevated in the elderly as compared to the young, but this has not been shown to have any clinical significance.
Croatian: Sistemska izloženost valsartanu bila je u starijih nešto veća nego u mladih; to međutim nema nikakav klinički značaj.
English: • decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)
Croatian: • smanjen broj krvnih pločica što može rezultirati stvaranjem neuobičajenih modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica)
English: Amlodipine CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir)
Croatian: Amlodipin CYP3A4 inhibitori (tj. ketokonazol, itrakonazol, ritonavir)
English: • changes in blood tests for kidney function, increase of potassium in your blood, low level of red blood cells
Croatian: • promijene rezultata krvnih pretraga za bubrežnu funkciju; povišenje kalija u krvi; niska razina crvenih krvnih stanica
English: Uncommon (may affect up to 1 in 100 people): • severely decreased urine output (decreased kidney function)
Croatian: Manje često(mogu se javiti u do 1 na 100 osoba): • jako smanjeno mokrenje (smanjena funkcija bubrega)
English: • disorders combining rigidity, tremor and/or movement disorders
Croatian: • poremećaji koji kombiniraju krutost, nevoljno drhtanje i/ili poremećaje kretanja
English: Vitamin D and calcium salts
Croatian: Vitamin D i kalcijeve soli
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Croatian: Značajna hiperkalcijemija može biti dokaz skrivenog hiperparatireoidizma.
English: Therefore, Dafiro HCT is not recommended in this population.
Croatian: Stoga se u ovoj populaciji Dafiro HCT ne preporučuje.
English: Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Croatian: Refrakterna hipokalijemija, hiponatrijemija, hiperkalcijemija i simptomatska hiperuricemija.
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Dafiro HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Croatian: Statistički veći udjeli bolesnika postigli su kontrolu krvnog tlaka (<140/90 mmHg) s Dafiro HCT-om (71%) u usporedbi s primjenom bilo koje od tri dvojne kombinacijske terapije (45-54%) (p<0,0001).
English: Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed.
Croatian: Opažena je hiponatrijemija, praćena neurološkim simptomima (mučnina, progresivna dezorijentacija, apatija).
English: In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
Croatian: U bolesnika s teškim zatajivanjem srca čija funkcija bubrega može ovisiti o aktivnosti sustava renin-angiotenzin-aldosteron, liječenje ACE inhibitorima i antagonistima angiotenzinskih receptora bilo je povezano s oligurijom i/ili progresivnom azotemijom, i (rijetko) s akutnim zatajenjem bubrega i/ili smrću.
English: Severe hypotension.
Croatian: Teška hipotenzija.
English: • decreased number of white blood cells
Croatian: • smanjen broj bijelih krvnih stanica
English: Risk factors for developing acute angle closure glaucoma may include a history of sulphonamide or penicillin allergy.
Croatian: Faktori rizika za razvoj akutnoga glaukoma zatvorenog kuta mogu uključivati i alergiju na sulfonamide ili penicilin u anamnezi.
English: Conversely, it is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Croatian: Nasuprot tome, predviđa se da prokinetički lijekovi, kao što su cisapridi, mogu smanjiti bioraspoloživost tiazidnih diuretika.
English: If Dafiro HCT is used during breast-feeding, doses should be kept as low as possible.
Croatian: Ako se Dafiro HCT uzima tijekom dojenja, doze moraju biti najmanje moguće.
English: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Croatian: Metformin treba oprezno primjenjivati zbog rizika od laktacidoze izazvane mogućim funkcionalnim zatajenjem bubrega povezanim s hidroklorotiazidom.
English: • skin and lip cancer (non-melanoma skin cancer)
Croatian: • rak kože i usana (nemelanomski rak kože)
English: Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Croatian: Temeljeno na farmakološkom mehanizmu djelovanja hidroklorotiazida, njegova primjena tijekom drugog i trećeg tromjesečja može ugroziti feto-placentnu perfuziju te može uzrokovati fetalne i neonatalne učinke poput žutice, poremećaja ravnoteže elektrolita i trombocitopenije.
English: Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Croatian: Hidroklorotiazid povećava izlučivanje mokraće, što također snižava krvni tlak.
English: • ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);
Croatian: • ciklosporinom (lijek koji se koristi u presađivanju radi sprečavanja odbacivanja organa ili za druga stanja, npr. reumatoidni artritis ili atopijski dermatitis);
English: • medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);
Croatian: • lijekovima koji se koriste za ublažavanje bolova ili upale, posebno nesteroidnim protuupalnim lijekovima (NSAILi), uključujući selektivne inhibitore ciklooksigenaze-2 (COX-2 inhibitore);
English: • fever (pyrexia)
Croatian: • vrućica (pireksija)
English: Respiratory distress, pulmonary oedema, pneumonitis
Croatian: Respiratorni distres, plućni edem, pneumonitis
English: Stopping your treatment with Dafiro HCT may cause your disease to get worse.
Croatian: Prestanak liječenja Dafiro HCT-om može dovesti do pogoršanja bolesti od koje bolujete.
English: Due to the hydrochlorothiazide component, Dafiro HCT is contraindicated in symptomatic hyperuricaemia.
Croatian: Zbog hidroklortiazidne komponente Dafiro HCT je kontraindiciran u simptomatskoj hiperuricemiji.
English: • cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood);
Croatian: • kolestiraminom, kolestipolom ili drugim smolama (tvari koje se uglavnom koriste za liječenje visokih razina masnoća u krvi);
English: In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve (AUC) and elimination half-life.
Croatian: U starijih bolesnika postoji sklonost smanjenju klirensa amlodipina, što uzrokuje povećanja površine ispod krivulje (AUC) i poluvijek eliminacije.
English: It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule.
Croatian: Pokazalo se da receptor visokog afiniteta u bubrežnoj kori je primarno mjesto vezanja za djelovanje tiazidnih diuretika i inhibiciju transporta NaCl-a u distalnom zavijenom tubulu.
English: Other: dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Croatian: Ostalo: dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS)
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides.
Croatian: Prijavljena su reverzibilna povećanja koncentracija litija u serumu i toksičnost tijekom istodobne primjene litija s ACE inhibitorima, antagonistima receptora angiotenzina II, uključujući valsartan ili tiazide.
English: Dafiro HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Croatian: Dafiro HCT je dostupan u pakiranjima koja sadrže 14, 28, 30, 56, 90, 98 ili 280 filmom obloženih tableta, u višestrukim pakiranjima od 280 tableta (koja sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta), i u bolničkim pakiranjima koja sadrže 56, 98 ili 280 tableta u perforiranim blisterima djeljivim na jedinične doze.
English: The renal clearance is composed of passive filtration and active secretion into the renal tubule.
Croatian: Bubrežni klirens se sastoji od pasivne filtracije i aktivne sekrecije u bubrežne tubule.
English: Other anti-hypertensive medicinal products
Croatian: Ostali antihipertenzivni lijekovi
English: Patients with mild to moderate renal impairment may therefore receive the usual initial dose (see sections 4.2 and 4.4).
Croatian: Bolesnici s blagim do umjerenim oštećenjem bubrega mogu stoga primati uobičajenu početnu dozu (vidjeti dijelove 4.2 i 4.4).
English: Multipacks of 280 tablets, comprising 20 cartons, each containing 14 tablets.
Croatian: Višestruka pakiranja od 280 tableta, koja sadrže 20 kutija, od kojih svaka sadrži 14 tableta.
English: • hair loss
Croatian: • ispadanje kose
English: The dose of Dafiro HCT should be based on the doses of the individual components of the combination at the time of switching.
Croatian: Dozu Dafiro HCT-a treba temeljiti na dozama pojedinih komponenata kombinacije u vrijeme prelaska.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and if appropriate, alternative therapy should be started.
Croatian: Kada se trudnoća utvrdi, liječenje AIIRA-om treba odmah prekinuti te, ako je prikladno, započeti alternativnu terapiju.
English: Some side effects can be serious and need immediate medical attention.
Croatian: Neke nuspojave mogu biti ozbiljne i zahtijevati neodgodivo liječenje.
English: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Croatian: Postoje izolirana izvješća o hemolitičkoj anemiji prilikom istodobne primjene hidroklorotiazida i metildope.
English: Dafiro HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Croatian: Osobe u dobi od 65 i više godina mogu uzimati Dafiro HCT u istoj dozi kao i druge odrasle osobe i na isti način na koji su do sada već uzimale tri djelatne tvari zvane amlodipin, valsartan i hidroklorotiazid.
English: Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Croatian: Zbog rizika od hipokalijemije potreban je oprez prilikom primjene hidroklorotiazida kad je povezan s lijekovima koji mogu izazvati pojavu torsades de pointes, osobito antiaritmicima klase Ia i klase III i nekim antipsihoticima.
English: Elderly patients, particularly those taking the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Croatian: Starijim bolesnicima, posebno onima koji uzimaju najvišu dozu Dafiro HCT-a (10 mg/320 mg/25 mg), treba redovito kontrolirati krvni tlak.
English: Non-steroidal antiinflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid (>3 g/day), and nonselective NSAIDs
Croatian: Nesteroidni protuupalni lijekovi (NSAILi), uključujući selektivne inhibitore ciklooksigenaze-2 (COX-2 inhibitore), acetilsalicilatnu kiselinu (>3 g/dan) i neselektivne NSAIL-e
English: Haemodynamically unstable heart failure after acute myocardial infarction.
Croatian: Hemodinamički nestabilno zatajivanje srca nakon akutnog infarkta miokarda.
English: Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
Croatian: Opstrukcija istisnog dijela lijevog ventrikula (npr. hipertrofična opstruktivna kardiomiopatija i aortalna stenoza visokog stupnja).
English: If you think you may be allergic, do not take Dafiro HCT and talk to your doctor.
Croatian: Ako mislite da biste mogli biti alergični, nemojte uzeti Dafiro HCT i porazgovarajte sa svojim liječnikom.
English: If these medicinal products are to be prescribed with the amlodipine /valsartan /hydrochlorothiazide combination, monitoring of potassium plasma levels is advised.
Croatian: Ako će se ti lijekovi propisivati s kombinacijom amlodipin/valsartan/hidroklorotiazid, savjetuje se praćenje razina kalija u plazmi.
English: After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6-12 hours.
Croatian: Nakon peroralne primjene terapijskih doza samog amlodipina, vršne koncentracije amlodipina u plazmi postižu se za 6-12 sati.
English: • heart attack
Croatian: • srčani udar
English: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Dafiro HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Dafiro HCT for clinical use in humans.
Croatian: U nizu nekliničkih ispitivanja sigurnosti, provedenih na nekoliko vrsta životinja s amlodipinom, valsartanom, hidroklorotiazidom, valsartanom/hidroklorotiazidom, amlodipinom/valsartanom te amlodipinom/valsartanom/hidroklorotiazidom (Dafiro HCT), nije bilo dokaza sistemske toksičnosti ili toksičnosti za pojedini ciljni organ koji bi negativno utjecali na razvoj Dafiro HCT-a za kliničku primjenu u ljudi.
English: • sudden, temporary loss of consciousness
Croatian: • nagli, prolazni gubitak svijesti
English: The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Dafiro HCT are the same as when administered as individual dosage forms.
Croatian: Brzina i opseg apsorpcije amlodipina, valsartana i hidroklorotiazida iz Dafiro HCT-a jednaki su onima pri primjeni pojedinačnih dozirnih oblika.
English: Clinically significant hypotension due to Dafiro HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Croatian: Klinički značajna hipotenzija zbog predoziranja Dafiro HCT-om zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
English: The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Croatian: Rezultati in vitro ispitivanja na ljudskom tkivu jetre pokazuju da je valsartan supstrat jetrenog unosnog prijenosnika OATP1B1 i jetrenog efluksnog prijenosnika MRP2.
English: Preclinical safety studies of up to 13 weeks in duration were conducted with amlodipine/valsartan/hydrochlorothiazide in rats.
Croatian: Neklinička ispitivanja sigurnosti, u trajanju do 13 tjedana, provedena su s amlodipinom/ valsartanom/hidroklorotiazidom u štakora.
English: Hypokalaemia may result in muscle spasms and or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Croatian: Hipokalijemija može rezultirati spazmima mišića i/ili pojačati aritmiju povezanu s istodobnom primjenom glikozida digitalisa ili određenih antiaritmijskih lijekova.
English: Amlodipine
Croatian: Amlodipin
English: Abasia, gait disturbance
Croatian: Abazija, poremećaj načina hoda
English: Photosensitivity
Croatian: Fotosenzitivnost
English: Dafiro HCT can be taken with or without food.
Croatian: Dafiro HCT se može uzimati s hranom ili bez nje.
English: Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Dafiro HCT.
Croatian: Budući da je bubrežni klirens litija smanjen s tiazidima, rizik od toksičnosti litija vjerojatno se može povećati s Dafiro HCT-om.
English: Two large randomised, controlled trials (ONTARGET [ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial] and VA NEPHRON-D [The Veterans Affairs Nephropathy in Diabetes]) have examined the use of the combination of an ACE inhibitor with an ARB.
Croatian: ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s ARB-ovima.
English: The amlodipine component of Dafiro HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Croatian: Amlodipinska komponenta Dafiro HCT-a inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
English: • worsening of the diabetic metabolic state
Croatian: • pogoršanje dijabetičkog metaboličkog stanja
English: High hydrochlorothiazide use (≥50000 mg cumulative) was associated with an adjusted odds ratio (OR) of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Croatian: Velika primjena hidroklorotiazida (≥50 000 mg kumulativno) bila je povezana s prilagođenim omjerom izgleda (eng. odds ratio, OR) od 1,29 (95% CI: 1,23-1,35) za BCC i 3,98 (95% CI: 3,68-4,31) za SCC.
English: • high level of sugar in the blood
Croatian: • visoka razina šećera u krvi
English: Dafiro HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Croatian: Dafiro HCT kombinira tri antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, valsartan pripada skupini antagonista angiotenzina II, a hidroklorotiazid pripada skupini tiazidnih diuretika.
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Croatian: Poznato je da izloženost terapiji AIIRA-ima tijekom drugog i trećeg tromjesečja u ljudi izaziva fetotoksičnost (smanjenu funkciju bubrega, oligohidramnione, retardaciju okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenziju, hiperkalijemiju) (vidjeti dio 5.3).
English: Dantrolene (infusion) In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Croatian: U životinja su opaženi letalna ventrikularna fibrilacija i kardiovaskularni kolaps povezani s hiperkalijemijom nakon primjene verapamila i intravenskog dantrolena.