FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination is useful in patients whose blood pressure is not adequately controlled by valsartan monotherapy.
Slovenian: Kombinacija je uporabna pri bolnikih, pri katerih krvni tlak ni zadostno nadzorovan z monoterapijo z valsartanom.
English: Due to the hydrochlorothiazide component, Diovan Comp is contraindicated in patients with severe renal impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Zaradi vsebnosti hidroklorotiazida je zdravilo Diovan Comp kontraindicirano za bolnike s hudo okvaro ledvic (glejte poglavja 4.3, 4.4 in 5.2).
English: Novartis s.r.o.
Slovenian: Slovaška Novartis s.r.o.
English: Diovan Comp film-coated tablets contain two active substances called valsartan and hydrochlorothiazide.
Slovenian: Filmsko obložene tablete Diovan Comp vsebujejo dve zdravilni učinkovini, imenovani valsartan in hidroklorotiazid.
English: • medicines that may increase the amount of potassium in your blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
Slovenian: • zdravila, ki lahko zvišajo količino kalija v krvi, kot so kalijevi nadomestki, nadomestki soli, ki vsebujejo kalij, zdravila, ki varčujejo s kalijem, heparin
English: • irregular heart beat
Slovenian: • nepravilno bitje srca
English: Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
Slovenian: Poročali so, da tiazidni diuretiki, med katere sodi tudi hidroklorotiazid, poslabšajo ali aktivirajo sistemski eritematozni lupus.
English: • Others (e.g. bepridil, cisapride, diphemanil, erythromycin i.v., halofantrin, ketanserin,
Slovenian: • druga zdravila (na primer bepridil, cisaprid, difemanil, eritromicin i.v., halofantrin, ketanserin,
English: • Some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Slovenian: • nekateri antipsihotiki (na primer tioridazin, klorpromazin, levomepromazin, trifluoperazin,
English: • fever (cutaneous lupus erythematosus)
Slovenian: • zvišana telesna temperatura (kožni eritematozni lupus)
English: The combination led to kidney damage (nephropathy with tubular basophilia, rises in plasma urea, plasma creatinine and serum potassium, increases in urine volume and urinary electrolytes from 30 mg/kg/day valsartan + 9 mg/kg/day hydrochlorothiazide in rats and 10 + 3 mg/kg/d in marmosets), probably by way of altered renal haemodynamics.
Slovenian: Uporaba kombinacije je povzročila okvaro ledvic (nefropatijo s tubulno bazofilijo, zvišane koncentracije sečnine in kreatinina v plazmi ter kalija v serumu, povečan volumen urina in povečano količino elektrolitov v urinu pri odmerkih 30 mg/kg/dan valsartana in 9 mg/kg/dan hidroklorotiazida pri podganah in pri 10 mg/kg/dan valsartana in 3 mg/kg/dan hidroklorotiazida pri marmozetkah), verjetno zaradi spremenjene ledvične hemodinamike.
English: Diovan Comp should not be used to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, since blood urea and serum creatinine may increase in such patients.
Slovenian: Bolniki z enostransko ali obojestransko stenozo ledvične arterije ali s stenozo arterije solitarne ledvice za zdravljenje hipertenzije ne smejo uporabljati zdravila Diovan Comp, saj pri njih lahko pride do zvišanja koncentracij sečnine v krvi in kreatinina v serumu.
English: • low level of white cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Slovenian: • zmanjšano število levkocitov v krvi (s simptomi, kot so zvišana telesna temperatura, kožne okužbe, boleče grlo oziroma žrelo ali razjede v ustih zaradi okužbe, oslabelost)
English: The clinical response to Diovan Comp should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Diovan Comp 320 mg/25 mg.
Slovenian: Po začetku zdravljenja naj se ovrednoti klinični odziv na zdravilo Diovan Comp in če ostane krvni tlak izven nadzora, lahko povečamo odmerek tako, da povečamo eno od sestavin zdravila Diovan Comp do najvišjega odmerka 320 mg/ 25 mg.
English: The difference in systolic BP reduction between the 320/25 mg and 320/12.5 mg doses also reached statistical significance.
Slovenian: Tudi razlika znižanja sistoličnega krvnega tlaka med uporabo odmerkov 320/25 mg in 320/12,5 mg je bila statistično značilna.
English: Methyldopa
Slovenian: Metildopa
English: Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides and uric acid.
Slovenian: Tiazidni diuretiki, med katere sodi tudi hidroklorotiazid, lahko vplivajo na toleranco za glukozo in zvišajo koncentracije holesterola, trigliceridov in sečne kisline v serumu.
English: • syncope (fainting)
Slovenian: • sinkopa (kratkotrajna izguba zavesti)
English: Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes.
Slovenian: Zaradi tveganja za hipokaliemijo je potrebna previdnost pri sočasni uporabi hidroklorotiazida in zdravil, ki lahko sprožijo torsades de pointes.
English: Furthermore, concomitant use of Diovan Comp and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Slovenian: Poleg tega lahko sočasna uporaba zdravila Diovan Comp in nesteroidnih protivnetnih zdravil poslabša delovanje ledvic in zviša koncentracijo kalija v serumu.
English: • Tell your doctor if you are breast-feeding or about to start breast-feeding Diovan Comp 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.
Slovenian: Uporaba zdravila Diovan Comp ni priporočena za matere, ki dojijo, zato lahko vaš zdravnik izbere drugo zdravljenje, če želite dojiti, še zlasti, če gre za novorojenčka ali nedonošenčka.
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (P <0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9% respectively).
Slovenian: V kliničnih preskušanjih, v katerih so valsartan primerjali z zaviralcem ACE, je bila pogostnost suhega kašlja pri bolnikih, ki so prejemali valsartan, statistično značilno manjša kot pri tistih, ki so prejemali zaviralec ACE (2,6 % v primerjavi s 7,9 %, p <0,05).
English: • noises (e.g. hissing, buzzing) in ears
Slovenian: • zvoki (na primer sikanje ali brenčanje) v ušesih
English: • if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus
Slovenian: • če imate zvišano telesno temperaturo, izpuščaj in bolečine v sklepih, kar so lahko znaki sistemskega eritematoznega lupusa (avtoimunske bolezni, ki ji rečemo tudi SLE).
English: In order to evaluate a possible removal of the current restriction the CHMP assessed efficacy and safety data from a sub-group analyses in patients with baseline MSDBP < 100 mmHg and MSDBP ≥100 mmHg.
Slovenian: Da bi ovrednotil možno odstranitev trenutne omejitve, je CHMP na podlagi analiz podskupin bolnikov z mejno vrednostjo srednjega diastolnega tlaka v sedečem položaju < 100 mmHg in bolnikom z mejno vrednostjo srednjega diastolnega tlaka v sedečem položaju ≥100 mmHg ovrednotil podatke o učinkovitosti in varnosti.
English: Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Diovan Comp:
Slovenian: Neželeni učinki, ki so jih opisovali pri uporabi valsartana ali hidroklorotiazida posamezno, niso pa jih opažali pri uporabi zdravila Diovan Comp:
English: Marked hypercalcaemia may be evidence of underlying hyperparathyroidism.
Slovenian: Znatna hiperkalciemija je lahko znak že prej prisotnega hiperparatiroidizma.
English: • medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines
Slovenian: • zdravila, ki vplivajo na raven kalija v krvi ali pa raven kalija v krvi lahko vpliva na njihovo delovanje, na primer, digoksin, zdravila za uravnavanje srčnega ritma, nekateri antipsihotiki
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan Comp should be used with caution (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter brez holestaze je treba zdravilo Diovan Comp uporabljati previdno (glejte poglavji 4.2 in 5.2).
English: The combination also led in the kidney to hyperplasia of the afferent aterioles (at 600 + 188 mg/kg/d in rats and from 30 + 9 mg/kg/d in marmosets).
Slovenian: Uporaba kombinacije je povzročila tudi hiperplazijo aferentnih arteriol v ledvicah (pri podganah pri odmerkih 600 + 188 mg/kg/dan, pri marmozetkah pa pri odmerkih 30 + 9 mg/kg/dan).
English: The CHMP finding a little rationale to support this proposal of switch from HCTZ monotherapy to a combination therapy containing 160 or 320 mg of valsartan, found preferable a step-wise dose titration.
Slovenian: Ker ni videl prave osnove za podporo tega predloga prehoda z monoterapije s hidroklorotiazidom na kombinacijsko zdravljenje s 160 ali 320 mg valsartana, je CHMP dal prednost postopni titraciji odmerka.
English: If you forget to take Diovan Comp
Slovenian: Če ste pozabili vzeti zdravilo Diovan Comp
English: Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatraemia and hypochloraemic alkalosis.
Slovenian: Zdravljenje s tiazidnimi diuretiki, med katere sodi tudi hidroklorotiazid, je bilo povezano s hiponatriemijo in hipokloremično alkalozo.
English: Diovan Comp is used to treat high blood pressure which is not adequately controlled by a single substance alone.
Slovenian: Zdravilo Diovan Comp je namenjeno zdravljenju visokega krvnega tlaka, ki ga ni mogoče uravnati z uporabo posameznih učinkovin zdravila.
English: In controlled clinical trials with valsartan/hydrochlorothiazide the potassium lowering effect of hydrochlorothiazide was attenuated by the potassium-sparing effect of valsartan.
Slovenian: V kontroliranih kliničnih preskušanjih s kombinacijo valsartan/ hidroklorotiazid je valsartan, ki varčuje s kalijem, ublažil zniževanje koncentracije kalija, ki ga povzroča hidroklorotiazid.
English: Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Slovenian: Sočasna uporaba tiazidnih diuretikov, med katere sodi tudi hidroklorotiazid, in vitamina D ali kalcijevih soli lahko stopnjuje zviševanje koncentracije kalcija v serumu.
English: − Severe hepatic impairment, biliary cirrhosis and cholestasis.
Slovenian: - Huda okvara jeter, biliarna ciroza in holestaza.
English: If you stop taking Diovan Comp
Slovenian: Če prenehate jemati zdravilo Diovan Comp
English: Thiazides, including hydrochlorothiazide, increase the urinary excretion of magnesium, which may result in hypomagnesaemia.
Slovenian: Tiazidi, med katere sodi tudi hidroklorotiazid, povečujejo izločanje magnezija z urinom, kar lahko pripelje do hipomagneziemije.
English: Non-depolarising skeletal muscle relaxants (e.g. tubocurarine) Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.
Slovenian: Nedepolarizacijski relaksanti skeletnih mišic (na primer tubokurarin) Tiazidi, vključno s hidroklorotiazidom, lahko povečajo učinek derivatov kurara.
English: Diovan Comp is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Diovan Comp pri otrocih pod 18 let ni priporočljiva.
English: You must tell your doctor if you think you are (or might become) pregnant.
Slovenian: Zdravniku morate povedati če mislite, da ste noseči (ali da bi lahko zanosili).
English: • if you suffer from a narrowing of the kidney artery.
Slovenian: • če imate zožanje ledvične arterije.
English: The effect of the treatment can be influenced if Diovan Comp is taken together with certain other medicines.
Slovenian: Sočasno jemanje nekaterih drugih zdravil lahko vpliva na učinek zdravljenja z zdravilom Diovan Comp.
English: • if you have liver or kidney disease.
Slovenian: • če imate bolezen jeter ali ledvic.
English: • muscle disorder
Slovenian: • bolezen mišic
English: Investigations Not known
Slovenian: Pogostnost neznana
English: • [Storage conditions statements-To be completed nationally].
Slovenian: • [Pogoji shranjevanja - izpolni država članica]
English: Frequency of adverse reactions with valsartan/hydrochlorothiazide
Slovenian: Pogostnosti neželenih učinkov valsartana/hidroklorotiazida
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Slovenian: V študiji MARVAL (Zmanjšanje mikroalbuminurije z valsartanom - Micro Albuminuria Reduction with Valsartan) so ocenili zmanjšanje izločanja albumina z urinom (urinary albumin excretion - UAE) z valsartanom (v odmerku 80-160 mg/enkrat na dan) v primerjavi z amlodipinom (v odmerku 5-10 mg/enkrat na dan), pri 332 bolnikih s sladkorno boleznijo tipa 2 (povprečna starost: 58 let; 265 moških) z mikroalbuminurijo (v skupini z valsartanom: 58 µg/min; v skupini z amlodipinom: 55,4 µg/min), z normalnim ali zvišanim krvnim tlakom in z ohranjenim delovanjem ledvic (koncentracija kreatinina v krvi <120 µmol/l).
English: High doses of the valsartan - hydrochlorothiazide combination caused falls in red blood cell indices (red cell count, haemoglobin, haematocrit, from 100 + 31 mg/kg/d in rats and 30 + 9 mg/kg/d in marmosets).
Slovenian: Uporaba visokih odmerkov kombinacije valsartan - hidroklorotiazid je povzročila zmanjšanje parametrov rdeče krvne slike (koncentracij eritrocitov, hemoglobina in hematokrita pri odmerkih 100 + 31 mg/kg/dan pri podganah in pri odmerkih 30 + 9 mg/kg/dan pri marmozetkah).
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during first trimester of pregnancy (see section 4.4).The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Slovenian: Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3 in 4.4).
English: Cytotoxic agents (e.g. cyclophosamide, methotrexate) Thiazides, including hydrochlorothiazide, may reduce renal excretion of cytotoxic agents and potentiate their myelosuppressive effects.
Slovenian: Citotoksična sredstva (na primer ciklofosfamid, metotreksat) Tiazidi, vključno s hidroklorotiazidom, lahko zmanjšajo izločanje citotoksičnih zdravil preko ledvic in stopnjujejo njihov mielosupresiven učinek.
English: Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Slovenian: Novartis Pharmaceuticals UK Ltd Trading as Ciba Laboratories Frimley Business Park Frimley, Camberley Surrey GU16 7SR Velika Britanija
English: The third issue was discussed that the current MRP SPC restricts the use of both valsartan/HCTZ 160/25 and 320/25 mg to patients whose mean sitting diastolic blood pressure (MSDBP) is ≥100 mmHg.
Slovenian: V okviru tretjega vprašanja so razpravljali, da trenutni postopek medsebojnega priznavanja povzetka glavnih značilnosti zdravila omejuje uporabo valsartana/hidroklorotiazida 160/25 in 320/25 mg na bolnike, katerih srednji diastolni krvni tlak v sedečem položaju je ≥100 mmHg.
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse effects caused by amantadine.
Slovenian: Tiazidi, vključno s hidroklorotiazidom, lahko povečajo tveganje za neželene učinke, ki jih povzroča amantadin.
English: • if you have diarrhoea or severe vomiting.
Slovenian: • če imate drisko ali hudo bruhate.
English: No dosage adjustment is required for patients with renal impairment with a creatinine clearance ≥30 ml/min (see section 4.2).
Slovenian: Pri bolnikih z okvaro ledvic z očistkom kreatinina ≥30 ml/min ni treba prilagajati odmerka (glejte poglavje 4.2).
English: Important information about some of the ingredients of Diovan Comp [To be completed nationally]
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Diovan Comp [Izpolni država članica]
English: Frequent monitoring of serum potassium is recommended.
Slovenian: Priporočeno je pogosto določanje koncentracije kalija v serumu.
English: Take special care with Diovan Comp
Slovenian: Bodite posebno pozorni pri uporabi zdravila Diovan Comp
English: Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol) Dose adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Slovenian: Zdravila za zdravljenje protina (probenecid, sulfinpirazon in alopurinol) Ker hidroklorotiazid lahko zviša koncentracijo sečne kisline v serumu, je včasih treba prilagoditi odmerjanje urikozurikov.
English: Valsartan is an orally active angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ) is a diuretic.
Slovenian: Valsartan je zaviralec receptorjev angiotenzina II , ki učinkuje oralno, hidroklorotiazid pa je diuretik.
English: • swelling mainly of the face and throat; rash; itching
Slovenian: • otekanje pretežno v obraz in žrelo oziroma grlo, izpuščaj, srbenje
English: • rash, purplished-red spots, fever, itching (symptoms of inflammation of blood vessels)
Slovenian: • izpuščaj, vijolično rdeče lise, zvišana telesna temperatura, srbenje (simptomi vnetja krvnih žil)
English: Diovan Comp should not be used in these patients.
Slovenian: Ti bolniki ne smejo uporabljati zdravila Diovan Comp.
English: • high level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)
Slovenian: • zvišana raven kalija v krvi (včasih z mišičnimi krči, nenormalnim ritmom bitja srca)
English: Adverse reactions reported in clinical trials and laboratory findings occurring more frequently with valsartan plus hydrochlorothiazide versus placebo and individual postmarketing reports are presented below according to system organ class.
Slovenian: Spodaj so navedeni in po organskih sistemih razvrščeni neželeni učinki, ki so jih opisovali v kliničnih študijah, in laboratorijski izvidi, ki so se pojavljali pogosteje pri uporabi kombinacije valsartana in hidroklorotiazida v primerjavi z uporabo placeba, ter neželeni učinki na podlagi posameznih poročil iz obdobja po prihodu zdravila na trg.
English: Serum uric acid increased, Serum bilirubin and Serum creatinine increased, Hypokalaemia, Hyponatraemia, Elevation of Blood Urea Nitrogen, Neutropenia
Slovenian: Preiskave pogostnost neznana zvišana koncentracija sečne kisline v serumu, zvišana koncentracija bilirubina v serumu, zvišana koncentracija kreatinina v serumu, hipokaliemija, hiponatriemija, zvišana koncentracija dušika sečnine v krvi, nevtropenija
English: Antidiabetic agents (oral agents and insulin)
Slovenian: (peroralna zdravila ali insulini)
English: Similar findings were seen with valsartan/hydrochlorothiazide in rats and rabbitsIn embryo-fetal development (Segment II) studies with valsartan/hydrochlorothiazide in rat and rabbit, there was no evidence of teratogenicity; however, fetotoxicity associated with maternal toxicity was observed.
Slovenian: V študijah embriofetalnega razvoja (segmenta II) pri uporabi kombinacije valsartan/hidroklorotiazid na podganah in kuncih niso zasledili teratogenosti, opažali pa so toksično delovanje na plod pri odmerkih, ki so bili toksični za mater.
English: Amantadine
Slovenian: Amantadin
English: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Slovenian: Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR Velika Britanija
English: • the level of uric acid in blood increased (which can, in severe cases, trigger gout)
Slovenian: • zvišana raven sečne kisline v krvi (kar v hujših primerih lahko sproži protin)
English: The CHMP agreed including the ADR Renal failure as listed in the SPC of Diovan.
Slovenian: CHMP se je strinjal glede vključitve ledvične odpovedi med neželene učinke zdravila, kot je navedeno v povzetku glavnih značilnosti zdravila Diovan.
English: • low level of blood platelets (sometimes with unusual bleeding or bruising)
Slovenian: • znižano število trombocitov (včasih z neobičajno krvavitvijo ali modrico)
English: No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (z očistkom kreatinina ≥30 ml/min) ni treba prilagajati odmerka.
English: In each case, up-titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.
Slovenian: Pri zvišanju odmerka posamezne učinkovine je treba vsakega bolnika spremljati, da ne bi prišlo do hipotenzije in drugih neželenih učinkov.
English: The recommended dose of Diovan Comp X mg/Y mg is one film-coated tablet once daily.
Slovenian: Priporočeni odmerek zdravila Diovan Comp X mg/Y mg je ena filmsko obložena tableta enkrat na dan. Priporočeno je prilagajanje odmerkov posameznih učinkovin zdravila.
English: • Class Ia antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide)
Slovenian: • antiaritmiki skupine Ia (na primer kinidin, hidrokinidin, dizopiramid),
English: • low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
Slovenian: • znižano število trombocitov (včasih s krvavitvijo ali z modrico pod kožo)
English: D-90429 Nürnberg provas 80 comp 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral
Slovenian: D-90429 Nürnberg provas 80 comp 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
English: D-90429 Nürnberg provas 160 maxx 160/25 mg 160 mg / 25 mg film-coated tablets oral
Slovenian: D-90429 Nürnberg provas 160 maxx 160/25 mg 160 mg / 25 mg filmsko obložene tablete
English: Iodine contrast media
Slovenian: Jodirana kontrastna sredstva
English: The treatment with a thiazide may influence the glucose tolerance.
Slovenian: Antidiabetična zdravila (peroralne oblike in insulin) Zdravljenje s tiazidi lahko vpliva na toleranco za glukozo.
English: Pharmaceutical Form
Slovenian: Farmacevtska oblika Pot uporabe zdravila
English: HOW TO STORE DIOVAN COMP
Slovenian: SHRANJEVANJE ZDRAVILA DIOVAN COMP
English: D-90429 Nürnberg provas 320 maxx 320/25 mg 320 mg / 25 mg film-coated tablets oral
Slovenian: D-90429 Nürnberg provas 320 maxx 320/25 mg 320 mg / 25 mg filmsko obložene tablete
English: • difficulty breathing
Slovenian: • oteženo dihanje
English: Immune system disorders Very rare
Slovenian: Bolezni imunskega sistema zelo redki preobčutljivostne reakcije
English: Necrotising vasculitis and toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Slovenian: Bolezni kože in podkožja pogosti urtikarija in druge vrste izpuščajev redki fotosenzitivnost zelo redki nekrotizirajoči vaskulitis in toksična epidermalna nekroliza, reakcije podobne kožnemu eritematoznemu lupusu, reaktivacija kožnega eritematoznega lupusa
English: Do not take Diovan Comp:
Slovenian: Ne jemljite zdravila Diovan Comp
English: What Diovan Comp looks like and contents of the pack
Slovenian: Izgled zdravila Diovan Comp in vsebina pakiranja [Izpolni država članica]
English: AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also section 5.3).
Slovenian: zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte tudi poglavje 5.3).