natgillin/translations-raw huggingface dataset:
Side effects reported with amlodipine or valsartan alone and either not observed with Exforge or observed with a higher frequency than with Exforge:
Prijavljene nuspojave s amlodipinom ili valsartanom primjenjenima samostalno ili uopće nisu opažene s Exforgeom ili su opažene s većom učestalošću nego s Exforgeom:
Hepatic impairment Exforge is contraindicated in patients with severe hepatic impairment (see section 4.3).
Oštećenje jetre Exforge je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
• Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
• Istodobna primjena Exforgea s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i
There are no clinical studies on fertility with Exforge.
Ne postoje klinička ispitivanja djelovanja Exforgea na plodnost.
Frequency Exforge Amlodipine Valsartan
Učestalost Exforge Amlodipin Valsartan
In this study (baseline blood pressure 171/113 mmHg), an Exforge regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
U tom ispitivanju (početni krvni tlak 171/113 mmHg), liječenje Exforgeom 5 mg/160 mg titriranim do 10 mg/160 mg snizilo je krvni tlak u sjedećem položaju za 36/29 mmHg, u usporedbi s 32/28 mmHg kod liječenja lizinoprilom/hidroklorotiazidom 10 mg/12,5 mg titriranim do 20 mg/12,5 mg.
Exforge is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Exforge se primjenjuje za liječenje povišenog krvnog tlaka u odraslih osoba čiji krvni tlak nije dovoljno kontroliran bilo samo amlodipinom ili samo valsartanom.
If any of the above applies to you, do not take Exforge and talk to your doctor.
Ako se bilo što od navedenog odnosi na Vas, nemojte uzeti Exforge i obavijestite svog liječnika.
Exforge is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Exforge je indiciran u odraslih osoba čiji krvni tlak nije odgovarajuće kontroliran monoterapijom amlodipinom ili valsartanom.
There is no experience of overdose with Exforge.
Nema iskustva s predoziranjem Exforgeom.
When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Exforge, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Prilikom prebacivanja starijih hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) na amlodipin ili Exforge, treba se koristiti najniža dostupna doza amlodipina u monoterapiji ili amlodipina kao komponente.
How to store Exforge
Kako čuvati Exforge
Exforge should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Bolesnici u kojih se razvije angioedem trebaju odmah prekinuti primjenu Exforgea i više ga ne smiju ponovo uzimati.
Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.
U placebo-kontroliranim ispitivanjima, u 0,4% bolesnika s nekompliciranom hipertenzijom liječenih Exforgeom viđena je izražena hipotenzija.
No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m2) doziranje
When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Exforge, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Prilikom prebacivanja hipertenzivnih bolesnika koji ispunjavaju uvjete za liječenje (vidjeti dio 4.1) s oštećenjem jetre na amlodipin ili Exforge, treba se koristiti najniža dostupna doza amlodipina u monoterapiji ili amlodipina kao komponente.
Infections and infestations
Infekcije i infestacije Nazofaringitis
This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Exforge.
Grejp i sok od grejpa u nekih bolesnika može dovesti do povećanja razina djelatne tvari amlodipina u krvi, što može uzrokovati neočekivano pojačani učinak na snižavanje krvnog tlaka.
Caution should be exercised when administering Exforge to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Nužan je oprez kod primjene Exforgea bolesnicima s oštećenjem jetre ili opstruktivnim bolestima žučnog sustava (vidjeti dio 4.4).
Exforge 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Exforge 5 mg/80 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 80 mg.
Exforge 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg/160 mg.
Exforge 10 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 10 mg ili valsartanom 160 mg ili s Exforge 5 mg/160 mg.
Particular caution should be exercised when administering Exforge to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Nužan je poseban oprez kod primjene Exforgea bolesnicima s blagim do umjerenim oštećenjem jetre ili opstruktivnim poremećajima žučnog sustava.
Exforge 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Exforge 10 mg/160 mg tablete su ovalne, svijetložute tablete, s oznakom „NVR“ na jednoj strani i „UIC“ na drugoj strani.
Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light headedness; excessive sweating; skin rash all over your body; itching; muscle spasm.If any of these affect you severely, tell your doctor.
Rijetke (mogu se javiti kod 1 na 1000 osoba): Osjećaj tjeskobe; zvonjava u ušima (tinitus); nesvjestica; pojačano mokrenje ili pojačan nagon na mokrenje; nemogućnost postizanja ili održavanja erekcije; osjećaj težine; niski krvni tlak sa simptomima poput omaglice, omamljenosti; pojačanog znojenja; kožni osip po čitavom tijelu; svrbež; grč mišića.
Exforge 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Exforge 5 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 160 mg.
Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets
Exforge 5 mg/80 mg filmom obložene tablete Exforge 5 mg/160 mg filmom obložene tablete Exforge 10 mg/160 mg filmom obložene tablete
Exforge 5 mg/80 mg film-coated tablets
Exforge 5 mg/80 mg filmom obložene tablete
Exforge 10 mg/160 mg film-coated tablets
Exforge 10 mg/160 mg filmom obložene tablete
Exforge 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Exforge 5 mg/160 mg tablete su ovalne, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „ECE“ na drugoj strani.
Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan
Exforge 5 mg/80 mg filmom obložene tablete Exforge 5 mg/160 mg filmom obložene tablete Exforge 10 mg/160 mg filmom obložene tablete amlodipin/valsartan
Grapefruit and grapefruit juice should not be consumed by people who are taking Exforge.
Bolesnici koji uzimaju Exforge ne smiju konzumirati grejp ili sok od grejpa.
Exforge 5 mg/160 mg film-coated tablets
Exforge 5 mg/160 mg filmom obložene tablete
If you think you may be allergic, talk to your doctor before taking Exforge.
Ako mislite da biste mogli biti alergični, porazgovarajte sa svojim liječnikom prije uzimanja Exforgea. ako imate teške probleme s jetrom ili probleme sa žuči, poput bilijarne ciroze ili kolestaze.
EU/1/06/370/035 280 film-coated tablets (4x70) EU/1/06/370/038 280 film-coated tablets (20x14)
EU/1/06/370/035 280 filmom obloženih tableta (4x70) EU/1/06/370/038 280 filmom obloženih tableta (20x14)
Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan
Exforge 10 mg/160 mg filmom obložene tablete amlodipin/valsartan
EU/1/06/370/036 280 film-coated tablets (4x70) EU/1/06/370/039 280 film-coated tablets (20x14)
EU/1/06/370/036 280 filmom obloženih tableta (4x70) EU/1/06/370/039 280 filmom obloženih tableta (20x14)
EU/1/06/370/034 280 film-coated tablets (4x70) EU/1/06/370/037 280 film-coated tablets (20x14)
EU/1/06/370/034 280 filmom obloženih tableta (4x70) EU/1/06/370/037 280 filmom obloženih tableta (20x14)
Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan
Exforge 5 mg/80 mg filmom obložene tablete amlodipin/valsartan
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
(Također je bolje izbjegavati Exforge u ranoj trudnoći, vidjeti dio Trudnoća). ako imate jako nizak krvni tlak (hipotenzija). ako imate suženje aortnog zaliska (stenoza aorte) ili kardiogeni šok (stanje u kojem Vaše srce ne može opskrbiti tijelo dovoljnom količinom krvi). ako patite od zatajivanja srca nakon srčanog udara.
Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan
Exforge 5 mg/160 mg filmom obložene tablete amlodipin/valsartan
EU/1/06/370/001 7 film-coated tablets EU/1/06/370/002 14 film-coated tablets EU/1/06/370/003 28 film-coated tablets EU/1/06/370/004 30 film-coated tablets EU/1/06/370/005 56 film-coated tablets EU/1/06/370/006 90 film-coated tablets EU/1/06/370/007 98 film-coated tablets EU/1/06/370/008 280 film-coated tablets EU/1/06/370/025 56x1 film-coated tablet (unit dose) EU/1/06/370/026 98x1 film-coated tablet (unit dose) EU/1/06/370/027 280x1 film-coated tablet (unit dose)
EU/1/06/370/001 7 filmom obloženih tableta EU/1/06/370/002 14 filmom obloženih tableta EU/1/06/370/003 28 filmom obloženih tableta EU/1/06/370/004 30 filmom obloženih tableta EU/1/06/370/005 56 filmom obloženih tableta EU/1/06/370/006 90 filmom obloženih tableta EU/1/06/370/007 98 filmom obloženih tableta EU/1/06/370/008 280 filmom obloženih tableta EU/1/06/370/025 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/370/026 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/370/027 280x1 filmom obloženih tableta (jedinična doza)
EU/1/06/370/017 7 film-coated tablets EU/1/06/370/018 14 film-coated tablets EU/1/06/370/019 28 film-coated tablets EU/1/06/370/020 30 film-coated tablets EU/1/06/370/021 56 film-coated tablets EU/1/06/370/022 90 film-coated tablets EU/1/06/370/023 98 film-coated tablets EU/1/06/370/024 280 film-coated tablets EU/1/06/370/031 56x1 film-coated tablet (unit dose) EU/1/06/370/032 98x1 film-coated tablet (unit dose) EU/1/06/370/033 280x1 film-coated tablet (unit dose)
EU/1/06/370/017 7 filmom obloženih tableta EU/1/06/370/018 14 filmom obloženih tableta EU/1/06/370/019 28 filmom obloženih tableta EU/1/06/370/020 30 filmom obloženih tableta EU/1/06/370/021 56 filmom obloženih tableta EU/1/06/370/022 90 filmom obloženih tableta EU/1/06/370/023 98 filmom obloženih tableta EU/1/06/370/024 280 filmom obloženih tableta EU/1/06/370/031 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/370/032 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/370/033 280x1 filmom obloženih tableta (jedinična doza)
EU/1/06/370/009 7 film-coated tablets EU/1/06/370/010 14 film-coated tablets EU/1/06/370/011 28 film-coated tablets EU/1/06/370/012 30 film-coated tablets EU/1/06/370/013 56 film-coated tablets EU/1/06/370/014 90 film-coated tablets EU/1/06/370/015 98 film-coated tablets EU/1/06/370/016 280 film-coated tablets EU/1/06/370/028 56x1 film-coated tablet (unit dose) EU/1/06/370/029 98x1 film-coated tablet (unit dose) EU/1/06/370/030 280x1 film-coated tablet (unit dose)
EU/1/06/370/009 7 filmom obloženih tableta EU/1/06/370/010 14 filmom obloženih tableta EU/1/06/370/011 28 filmom obloženih tableta EU/1/06/370/012 30 filmom obloženih tableta EU/1/06/370/013 56 filmom obloženih tableta EU/1/06/370/014 90 filmom obloženih tableta EU/1/06/370/015 98 filmom obloženih tableta EU/1/06/370/016 280 filmom obloženih tableta EU/1/06/370/028 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/370/029 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/370/030 280x1 filmom obloženih tableta (jedinična doza)
What Exforge looks like and contents of the pack Exforge 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Exforge 5 mg/80 mg tablete su okrugle, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „NV“ na drugoj strani.
The full EPAR for Clopidogrel Acino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Acino nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This summary was last updated in 02-2012.
Sažetak je posljednji put ažuriran u 01.2016.
This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Nakon toga slijedi standardna doza od 75 mg jedanput na dan tijekom najmanje četiri tjedna (u slučaju infarkta miokarda s „elevacijom ST-segmenta”) ili do 12 mjeseci (u slučaju nestabilne angine ili „non-Q” infarkta miokarda).
This means that Clopidogrel Acino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To znači da je Clopidogrel Acino sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Plavix.
For more information about treatment with Clopidogrel Acino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Clopidogrel Acino pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
• patients with peripheral arterial disease (problems with blood flow in the arteries);
• boluju od bolesti perifernih arterija (problemi s protokom krvi u arterijama);
• patients who have recently had a myocardial infarction (heart attack).
• su nedavno pretrpjeli infarkt miokarda (srčani udar).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Acino.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Clopidogrel Acino.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
To sprečava „lijepljenje” trombocita, čime se smanjuje rizik od formiranja krvnih ugrušaka i pomaže pri sprečavanju infarkta miokarda ili moždanog udara.
The standard dose of Clopidogrel Acino is one 75 mg tablet once a day.
Acino je jedna tableta od 75 mg jedanput dnevno.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino on 28 July 2009.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Clopidogrel Acino vrijedi na prostoru Europske unije od 28. srpnja 2009.
Clopidogrel Acino can be started between seven days and six months after the stroke;
Terapija lijekom Clopidogrel Acino može se započeti u razdoblju od sedam dana do šest mjeseci nakon udara;
Clopidogrel Acino is a ‘generic medicine'.
Clopidogrel Acino je „generički lijek”.
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
• su nedavno pretrpjeli ishemijski moždani udar (moždani udar uzrokovan nedovoljnom opskrbom krvi u nekom dijelu mozga).
This is a summary of the European public assessment report (EPAR) for Clopidogrel Acino.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Clopidogrel Acino.
EPAR summary for the public clopidogrel
EPAR, sažetak za javnost
Because Clopidogrel Acino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine.
Budući da je Clopidogrel Acino generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
Clopidogrel Acino can be started between a few days and 35 days after the attack;
Terapija lijekom Clopidogrel Acino može se započeti u razdoblju od nekoliko dana do 35 dana nakon infarkta;
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Acino has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za lijekove za humanu uporabu (CHMP) zaključio je da je, u skladu sa zahtjevima EU-a, potvrđeno kako Clopidogrel Acino posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Plavix.
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Clopidogrel sprečava nakupljanje trombocita tako što inhibira tvar naziva ADP od vezanja na posebni receptor na površini.
In acute coronary syndrome, Clopidogrel Acino is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
U slučaju akutnog koronarnog sindroma, terapija načelno započinje udarnom dozom od četiri tablete od 75 mg.
What are the benefits and risks of Clopidogrel Acino?
Koje su koristi i rizici lijeka Clopidogrel Acino?
Other information about Clopidogrel Acino
Ostale informacije o lijeku Clopidogrel Acino
The Committee recommended that Clopidogrel Acino be given marketing authorisation.
Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Clopidogrel Acino.
Because Clopidogrel Acino is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Budući da je Clopidogrel Acino generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje je li lijek bioekvivalentan referentnom lijeku Plavix.
When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Krv se gruša zbog nakupljanja (povezivanja) posebnih stanica u krvi koje se zovu trombociti.
The active substance in Clopidogrel Acino, clopidogrel, is an inhibitor of platelet aggregation.
Djelatna tvar lijeka Clopidogrel Acino, Clopidogrel, je inhibitor nakupljanja trombocita.
Why has Clopidogrel Acino been approved?
Zašto je Clopidogrel Acino odobren?
• patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
• boluju od poremećaja naziva „akutni koronarni sindrom”, pri čemu se treba davati s aspirinom (drugi lijek koji sprječava stvaranje krvnih ugrušaka).
Clopidogrel Acino is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel Acino koristi se za sprječavanje problema uzrokovanih stvaranjem krvnih ugrušaka u odraslih bolesnika koji:
What is Clopidogrel Acino?
Što je Clopidogrel Acino?
Clopidogrel Acino is a medicine that contains the active substance clopidogrel.
Acino je lijek koji sadrži djelatnu tvar Clopidogrel.
Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Stoga je stav CHMP-a kako koristi nadmašuju utvrđeni rizik, kao i u slučaju lijeka Plavix.
How is Clopidogrel Acino used?
Kako se Clopidogrel Acino koristi?
How has Clopidogrel Acino been studied?
Kako je Clopidogrel Acino ispitivan?
How does Clopidogrel Acino work?
Kako djeluje Clopidogrel Acino?
Cholib fenofibrate / simvastatin
Cholib fenofibrat / simvastatin
The recommended dose is one tablet a day to be swallowed whole with a glass of water.
Preporučena doza je jedna tableta dnevno, koja se treba progutati cijela s čašom vode.
Fenofibrate is a ‘PPARα agonist'.
Fenofibrat je „agonist PPARα“.
The full EPAR for Cholib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Cholib može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Cholib on 26 August 2013.
Europska komisija izdaje odobrenje za stavljanje u promet koje za Cholib vrijedi na prostoru Europske unije od 26. kolovoza 2013.
A risk management plan has been developed to ensure that Cholib is used as safely as possible.
Razvijen je plan upravljanja rizikom kako bi se osiguralo da se lijek Cholib koristi što je sigurnije moguće.
Other information about Cholib
Druge informacije o lijeku Cholib
Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg).
Cholib se izdaje samo na liječnički recept i dostupan je kao tablete (145/20 mg i 145/40 mg).
What is Cholib and what is it used for?
Što je Cholib i za što se koristi?
It is not intended to provide practical advice on how to use Cholib.
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Cholib.
The cholesterol drawn out of the blood in this way is the ‘bad' cholesterol.
Kolesterol izvučen iz krvi na ovaj način jest „loš“ kolesterol.
What measures are being taken to ensure the safe and effective use of Cholib?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cholib?
Why is Cholib approved?
Zašto je Cholib odobren?
It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates.
Također se ne smije upotrebljavati u trudnica ili dojilja, u osoba za koje je poznato da imaju fototoksične reakcije na fibrate ili ketoprofen, ili osobe koje boluju od bolesti jetre ili žučnog mjehura, pankreatitisa, odnosno umjereno ili ozbiljno smanjene funkcije bubrega, ili koje su prethodno imale poteškoća s mišićima prilikom uzimanja statina ili fibrata.
What are the risks associated with Cholib?
Koji su rizici povezani s lijekom Cholib?
This means that it activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha' (PPARα), which is involved in breaking down fats from diet, especially triglycerides.
To znači da aktivira tip receptora naziva „peroksisomski proliferator aktivirajućih receptora alfa" (PPARα), koji je uključen u razgradnju masti iz prehrane, posebice triglicerida.
The second active substance, simvastatin, belongs to the group called ‘statins'.
Druga djelatna tvar, simvastatin, ubraja se u grupu naziva „statini“.
With regard to the safety of Cholib, the side effects reported in the studies were consistent with what is known about the two active substances and there were no major concerns.
S obzirom na sigurnost lijeka Cholib, nuspojave prijavljene u ispitivanjima bile su konzistentne s nuspojavama koje su poznate za dvije djelatne tvari, te ne postoje veći razlozi za zabrinutost.