natgillin/translations-raw huggingface dataset:
Footnote - cases of aggression were observed in post marketing experience Package Leaflet: 
Opomba - V okviru izkušenj v obdobju trženja so bili zabeleženi primeri agresivnosti.
Homeopathic products containing lithium are not affected by this PRAC recommendation. 
To priporočilo odbora PRAC ne velja za homeopatske izdelke, ki vsebujejo litij.
Following the variation of the marketing authorisation for these products, the MAHs for any product with the same active substance should submit a respective variation application. 
Po spremembi dovoljenja za promet za ta zdravila morajo imetniki dovoljenja za promet s katerim koli zdravilom z isto zdravilno učinkovino predložiti zadevno vlogo za spremembo.
Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408) 
Gadodiamid; gadopentetna kislina; gadoversetamidnefrogena sistemska fibroza pri bolnikih z akutno poškodbo ledvic (EPITT no 408)
In light of the data submitted by the marketing authorisation holders and the advice provided by the Pharmacogenomics Working Party, the PRAC concluded that the evidence is sufficient to support a causal association between valproate and aggravation of underlying mitochondrial diseases, including risk of hepatotoxicity occurring mainly in patients suffering from POLG (polymerase gamma) mutations. 
Na podlagi podatkov, ki so jih predložili imetniki dovoljenja za promet, in nasvetov delovne skupine za farmakogenomiko je odbor PRAC zaključil, da so na voljo zadostni dokazi v podporo vzročni povezavi med valproatom in poslabšanjem osnovnih mitohondrijskih bolezni, vključno s tveganjem za hepatotoksičnost, do katere prihaja predvsem pri bolnikih z mutacijami POLG (polimeraza gama).
Section 2: 
Poglavje 2:
POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy, cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura. 
Na motnje, povezane z genom POLG, je treba posumiti pri bolnikih s pozitivno družinsko anamnezo ali značilnimi simptomi za motnjo, povezano s POLG, kamor med drugim spadajo nepojasnjena encefalopatija, neodzivna epilepsija (fokalna, mioklonična), epileptični status pri pregledu, zaostanki v razvoju, psihomotorično nazadovanje, aksonalna senzorično-motorična nevropatija, miopatija, cerebralna ataksija, oftalmoplegija ali komplicirana migrena z okcipitalno avro.
In light of the data available, the PRAC has agreed that the evidence is sufficient to conclude that longterm use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas. 
Na podlagi razpoložljivih podatkov se je odbor PRAC strinjal, da so na voljo zadostni dokazi za zaključek, da dolgotrajna uporaba litija lahko povzroči mikrociste, onkocitome in karcinome Bellinijevih vodov.
Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases caused by mutations of mitochondrial DNA as well as the nuclear encoded POLG gene. 
Valproat lahko izzove ali poslabša klinične znake osnovnih mitohondrijskih bolezni, ki jih povzročajo mutacije mitohondrijske DNK in jedrnega gena POLG.
SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration 
Spremembe povzetka glavnih značilnosti za zdravilo Optimark (gadoversetamid) 4.2 Odmerjanje in način uporabe
Optimark is contraindicated in these patients (see section 4.3). 
Zdravilo Optimark je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment. 
Klinična znaka IMNM sta trdovratna oslabelost proksimalnih mišic in povišana vrednost serumske kreatin kinaze, ki kljub ukinitvi zdravljenja s statini ne izzvenita.
Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests. 
Pred apliciranjem zdravila Optimark je treba pri vseh bolnikih z laboratorijskimi preiskavami ugotoviti morebitno ledvično disfunkcijo.
Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. 
Pri bolnikih, pri katerih so opravili presaditev jeter, je tveganje še zlasti veliko, saj je v tej skupini pogostost akutne ledvične odpovedi visoka.
<invented name> is contraindicated in these patients (see section 4.3). 
Kontrastno sredstvo <izmišljeno ime> je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet: 
Neznana pogostnost: imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.)
• in patients who have had liver transplantation or 
• pri bolnikih, pri katerih so opravili presaditev jeter, ali
Possible side effects: 
Možni neželeni učinki:
If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome) Warnings and precautions 
Če imate genetsko motnjo, ki povzroča mitohondrijsko bolezen(npr. sindrom Alpers-Huttenlocher).
Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. 
Pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter, je tveganje še zlasti veliko, saj je v tej skupini incidenca akutne ledvične odpovedi visoka.
Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome, and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4). 
Valproat je kontraindiciran pri bolnikih z ugotovljenimi mitohondrijskimi motnjami, ki jih povzročajo mutacije jedrnega gena, ki kodira mitohondrijski encim polimerazo γ (POLG), npr. sindromom AlpersHuttenlocher, in pri otrocih, starih manj kot dve leti, pri katerih sumijo na motnjo, povezano s POLG (glejte poglavje 4.4).
SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid) 
Spremembe povzetka glavnih značilnosti za zdravili Omniscan (gadodiamid) in Magnevist (gadopentetna kislina)
Prior to administration of <invented name>, all patients should be screened for renal dysfunction by obtaining laboratory tests. 
Pred uporabo kontrastnega sredstva <izmišljeno ime> je treba pri vseh bolnikih na podlagi laboratorijskih preiskav oceniti delovanje ledvic.
Musculoskeletal disorders: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva:
Lithium - Solid renal tumours (EPITT no 18090) 
Litij - čvrsti ledvični tumorji (EPITT no 18090)
Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma). 
Ledvični tumorji: Pri bolnikih s hudo okvaro ledvic, ki so jemali litij več kot 10 let, lahko obstaja povečano tveganje za razvoj benignega ali malignega tumorja ledvic (mikrocist, onkocitomov ali karcinomov Bellinijevih vodov).
Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined): 
Po preučitvi razpoložljivih dokazov v literaturi se je odbor PRAC strinjal, da morajo imetniki dovoljenja za promet z zdravili, ki vsebujejo atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin ali lovastatin v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano):
Patients with known or suspected mitochondrial disease 
Bolniki z ugotovljeno mitohondrijsko boleznijo ali sumom nanjo
Package leaflet: 
Bolezni sečil:
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3). 
Zato se zdravilo Optimark pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter, in pri novorojenčkih ne sme uporabljati (glejte poglavje 4.3).
Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy). 
Neznana pogostnost:benigni/maligni ledvični tumorji (mikrociste, onkocitomi in karcinomi Bellinijevih vodov (pri dolgotrajnem zdravljenju).
Section 4 Possible side effects: 
Poglavje 4 Možni neželeni učinki:
In particular, valproateinduced acute liver failure and liver-related deaths have been reported at a higher rate in patients with hereditary neurometabolic syndromes caused by mutations in the gene for the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome. 
O akutni odpovedi jeter in smrti, povezani z jetri, ki ju je povzročil valproat, so pogosteje poročali pri bolnikih z dednimi nevrometabolnimi motnjami, ki jih povzročajo mutacije gena za mitohondrijski encim polimerazo γ (POLG), npr. sindromom AlpersHuttenlocher.
Therefore <invented name> must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period and in neonates (see section 4.3). 
Kontrastno sredstvo <izmišljeno ime> se ne sme uporabljati pri bolnikih s hudo okvaro ledvic, pri bolnikih v perioperativnem obdobju presaditve jeter in pri novorojenčkih (glejte poglavje 4.3).
• in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury. 
• pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic,
Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4). 
Neznana pogostnost: mikrociste, onkocitomi in karcinomi Bellinijevih vodov (pri dolgotrajnem zdravljenju) (glejte poglavje 4.4).
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins. 
Med zdravljenjem z nekaterimi statini oziroma po njem so zelo redko poročali o imunsko posredovani nekrotizirajoči miopatiji (IMNM).
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of <invented name> and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury. 
Poročali so o nefrogeni sistemski fibrozi (NSF), povezani z uporabo kontrastnega sredstva <izmišljeno ime> in nekaterih drugih kontrastnih sredstev, ki vsebujejo gadolinij, pri bolnikih z akutno ali kronično hudo okvaro ledvic (GFR < 30 ml/min/1,73 m2) in/ali akutno poškodbo ledvic.
Patients with iImpaired renal function 
Bolniki z Okvarjeno delovanje okvarjenim delovanjem ledvic
Package Leaflet 
Okvara ledvic
Having considered the available evidence the PRAC has agreed that the MAH of Omniscan, Optimark and Magnevist should submit a variation within 2 months, to amend the product information as described below (new text underlined / text to be removed strikethrough). 
Po preučitvi razpoložljivih dokazov se je odbor PRAC strinjal, da morajo imetniki dovoljenja za promet z zdravili Omniscan, Optimark in Magnevist v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano/besedilo za izbris prečrtano).
Taken into account all available data PRAC agreed that all MAHs for paroxetine containing products should submit a variation within 2 months to amend the product information (section 4.8 of the SmPC and package leaflet) as described below (new text underlined). 
Ob upoštevanju vseh razpoložljivih podatkov se je odbor PRAC strinjal, da morajo vsi imetniki dovoljenja za promet z zdravili, ki vsebujejo paroksetin, v 2 mesecih predložiti vlogo za spremembo informacij o zdravilu (poglavja 4.8 v povzetku glavnih značilnosti zdravila in navodila za uporabo), kot je opisano spodaj (novo besedilo je podčrtano).
Talk to your doctor <or> , <pharmacist> <or nurse> before <taking> <using> <product name>: You know that there is a genetic problem causing a mitochondrial disorder in your family. 
Pred začetkom <jemanja> <uporabe> <ime zdravila> se posvetujte <z> zdravnikom <ali> <farmacevtom> <ali> <medicinsko sestro>.
The marketing authorisation holders for valproate (and related substances) containing medicinal products should submit a variation within 2 months to amend the product information as described below (new text underlined). 
Imetniki dovoljenja za promet z zdravili, ki vsebujejo valproat (in sorodne učinkovine), morajo v 2 mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
Renal tumours: Cases of microcysts, oncocytomas and collecting duct renal carcinoma have been reported in patients with severe renal impairment who received lithium for more than 10 years (see Section 4.8). 
Ledvični tumorji: Pri bolnikih s hudo okvaro ledvic, ki so prejemali litij več kot 10 let, so poročali o mikrocistah, onkocitomih in karcinomih Bellinijevih vodov (glejte poglavje 4.8).
Therefore, the Marketing Authorisation Holders of lithium containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined). 
Imetniki dovoljenja za promet z zdravili, ki vsebujejo litij (in sorodne učinkovine), morajo zato v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano).
4.3 Contraindications <invented name> is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury, in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4). 
Kontrastno sredstvo <izmišljeno ime> je kontraindicirano pri bolnikih s hudo okvaro ledvic (glomerularna filtracija GFR < 30 ml/min/1,73 m2) in/ali akutno poškodbo ledvic, pri bolnikih v perioperativnem obdobju presaditve jeter in pri novorojenčkih do 4. tedna starosti (glejte poglavje 4.4).
Renal impairment <invented name> is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury and in patients in the perioperative liver transplantation period (see section 4.3). 
Kontrastno sredstvo <izmišljeno ime> je kontraindicirano pri bolnikih s hudo okvaro ledvic (glomerulna filtracija (GFR) < 30 ml/min/1,73 m2) in/ali akutno poškodbo ledvic in pri bolnikih v perioperativnem obdobju presaditve jeter (glejte poglavje 4.3).
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3). 
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativnem obdobju presaditve jeter (glejte poglavje 4.3).
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m²) and/or acute kidney injury. 
Pri bolnikih s hudo akutno ali kronično ledvično okvaro (GFR < 30 ml/min/1,73 m2 ) in/ali akutno poškodbo ledvic so poročali o nefrogeni sistemski fibrozi (NSF), povezani z uporabo zdravila Optimark in nekaterih kontrastnih sredstev, ki vsebujejo gadolinij.
• The medicine should be taken at the same time each day, usually in the morning. 
• Zdravilo je treba vzeti vsak dan ob istem času, običajno je to zjutraj.
Member State EU / EEA 
Država članica EU/EGP
This especially applies to the following medicines: 
To še posebno velja za naslednja zdravila:
The fourth issue was regarding the time of maximal effects. 
Četrto vprašanje se je nanašalo na čas največjih učinkov.
Invented name Name 
Izmišljeno ime
• Swallow the tablet with a glass of water. 
• Tableto zaužijte s kozarcem vode.
Also, the safety profile of the components could be considered well known. 
Prav tako se lahko upošteva, da je varnostni profil sestavin dobro znan.
No interaction 
Brez interakcij
• if you are unable to urinate. 
• če ne morete urinirati.
There were significant divergences in the contraindications. 
V kontraindikacijah so bila pomembna razhajanja.
2 & 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France 
2 & 4, rue Lionel Terray 92500 RUEIL-MALMAISON, Francija
The inclusion of syncope in section 4.8 is also justified. 
Prav tako je utemeljena vključitev sinkope v poglavje 4.8.
You should see your doctor immediately if you experience symptoms of angioedema, such as: 
Takoj morate k zdravniku, če pride do simptomov angioedema, kot so:
But according to the European hypertension treatment Guidelines (Mancia et al., Eur Heart J 2007;28(12):1462-536) it is no longer warranted. 
Vendar pa glede na Evropske smernice zdravljenja hipertenzije (Mancia et al., Eur Heart J 2007;28(12):1462-536) to ni več utemeljeno.
Also, a paragraph regarding interaction with tetracycline has been deleted. 
Poleg tega je bil izbrisan odstavek o medsebojnem delovanju s tetraciklinom.
The terminal half-life is 6-15 h. 
Končni razpolovni čas je 6-15 ur.
In most patients, maximal effects are observed within 4 weeks. 
Pri večini bolnikov so največji učinki opazni v štirih tednih.
This makes it all the more important for you to keep your appointments with your doctor even if you are feeling well. 
Zato je zelo pomembno, da hodite na preglede k svojemu zdravniku, tudi če se počutite dobro.
However, in some patients, 4-8 weeks treatment may be required. 
Vendar pa nekateri bolniki utegnejo potrebovati 4-8-tedensko zdravljenje.
If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. 
Če med zdravljenjem pride do fotosenzitivnostne reakcije, je priporočena prekinitev zdravljenja.
• it may cause increased sensitivity of the skin to sun. 
• ker lahko povzroči povečano občutljivost kože na sončno svetlobo.
Your doctor may need to check the amount of potassium in your blood regularly. 
Zdravnik vam bo moral verjetno redno pregledovati količino kalija v krvi.
Your doctor will tell you exactly how many tablets of Diovan Comp to take. 
Zdravnik vam bo povedal točno koliko tablet zdravila Diovan Comp morate jemati.
Norway Novartis Norge AS Postboks 237 Økern 0510 Oslo 
Norveška Novartis Norge AS Postboks 237 Økern 0510 Oslo
Other metabolic disturbances 
Druge metabolične motnje
The magnitude of these effects is small and has minimal clinical importance. 
Vendar so te razlike majhne in imajo le majhen klinični pomen.
Hungary Novartis Hungaria Kft. Bartók Béla út 43-47 
Madžarska Novartis Hungaria Kft. Bartók Béla út 43-47
If any of the above apply to you, do not take this medicine and speak to your doctor. 
Če karkoli od zgoraj navedenega velja za vas, ne jemljite tega zdravila in se pogovorite s svojim zdravnikom.
In conclusion, the CHMP agreed the following: "The antihypertensive effect is substantially present within 2 weeks. 
Za zaključek je CHMP sprejel sledeče: „Antihipertenzivni učinek je močno prisoten v dveh tednih.
Avoid taking alcohol until you have talked to your doctor. 
Izogibajte se uživanju alkohola, dokler se ne posvetujete s svojim zdravnikom.
Dose titration with the individual components is recommended. 
Priporoča se titracija odmerka s posameznimi sestavinami.
Calcium salts and vitamin D 
Kalcijeve soli in vitamin D
The use of Diovan Comp in children and adolescents (below the age of 18 years) is not recommended. 
Uporaba zdravila Diovan Comp pri otrocih in mladostnikih (starih manj kot 18 let) ni priporočena.
These contraindications were deleted in the revised PI as the CHMP found enough justifications and agreed about the four exclusion. 
Te kontraindikacije so bile izbrisane v popravljenih informacijah o zdravilu, saj je CHMP ugotovil dovolj utemeljitev in se je strinjal glede teh štirih izključitev.
The increase in mean AUC is linear and dose proportional in the therapeutic range. 
Večanje povprečne AUC je linearno in sorazmerno odmerkom v terapevtskem območju.
The following contra-indications were not included in all Member States: - Hepatic encephalopathy - Biliary obstruction - Gout -Addison's disease 
Sledeče kontraindikacije niso bile vključene v vseh državah članicah: - jetrna encefalopatija - biliarna obstrukcija - protin - Addisonova bolezen
Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h). 
Valsartan kaže multieksponentno kinetiko upadanja (t½α <1 ura in t½ß približno 9 ur).
Both of these substances help to control high blood pressure (hypertension). 
Obe učinkovini pomagata uravnavati visok krvni tlak (hipertenzijo).
The second issue raised in the LoOI was about the step titration. 
Drugo vprašanje, postavljeno na spisek odprtih vprašanj, je bilo glede postopne titracije.
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, 
- Povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, so bilo ovrednoteni na podlagi predložene dokumentacije in znanstvenih razprav znotraj Odbora.
• Do not change the dose or stop taking the tablets without consulting your doctor. 
• Ne spreminjajte odmerka in ne prenehajte jemati tablet, ne da bi se prej pogovorili z zdravnikom.
“Treatment of essential hypertension in adults” 
„Zdravljenje esencialne hipertenzije pri odraslih“
• The usual dose of Diovan Comp is one tablet per day. 
• Običajni odmerek zdravila Diovan Comp je ena tableta na dan.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DIOVAN COMP AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA DIOVAN COMP IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Section 4.2 - Posology and Method of Administration Under this section the CHMP identified several area of disagreement. 
Poglavje 4.2 - Odmerjanje in način uporabe CHMP je v tem poglavju ugotovil več področij neskladja.
Lowering your blood pressure to normal reduces the risk of developing these disorders. 
Z znižanjem krvnega tlaka se običajno zmanjša tveganje za razvoj teh bolezni.
No information is available regarding the use of valsartan during breastfeeding. 
Ni podatkov o uporabi valsartana med dojenjem.
A specific warning for athletes was to be deleted as the CHMP considered that drugs should not be taken for sport purposes. 
CHMP je dal izbrisati posebno opozorilo za športnike, saj je mnenja, da se zdravila ne smejo uporabljati v športne namene.
Clinical data, however, demonstrate that the antihypertensive effect of all doses of valsartan/HCTZ is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. 
Vendar pa klinični podatki dokazujejo, da je antihipertenzivni učinek vseh odmerkov valsartana/hidroklorotiazida močno prisoten v dveh tednih in da so največji učinki doseženi v štirih tednih.
• if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal despite treatment. 
• če sta vaši ravni kalija ali natrija v krvi nižji od normalnih ali če je vaša raven kalcija v krvi višja od normalne kljub zdravljenju.
In conclusion, the CHMP recommended, in line with the recently finalized referral procedure for Cozaar Comp, that “angiotensin-II-antagonist” is changed to “valsartan” in this indication. 
Za zaključek je CHMP priporočil, da se, v skladu z nedavno zaključenim napotitvenim postopkom za zdravilo Cozaar Comp, za to indikacijo „antagonist angiotenzina II spremeni v „valsartan