natgillin/translations-raw huggingface dataset:
There may be special local laws regarding how you should throw away used needles and syringes.
Možda postoje posebni lokalni propisi o zbrinjavanju igala i štrcaljki.
Onset of the reduction was rapid with separation from placebo seen as early as 4 weeks and maximum response seen at 12 weeks, with clinically and statistically significant triglyceride reduction maintained over 52 weeks (Figure 1).
Nastup smanjenja bio je brz s odvajanjem od placeba uočenim već od 4. tjedna te maksimalnim odgovorom uočenim u tjednu 12, s klinički i statistički značajnim smanjenjem razine triglicerida koja se održala tijekom 52 tjedna (slika 1).
Prior to initiating Waylivra, secondary causes of hypertriglyceridemia (e.g. uncontrolled diabetes, hypothyroidism) should be excluded or appropriately addressed.
Prije početka terapije lijekom Waylivra, potrebno je isključiti ili pravilno zbrinuti sekundarne uzroke hipetrigliceridemije (npr. nekontrolirani dijabetes, hipotiroidizam).
If you see blood where you've injected, press the site lightly with the sterile cotton ball or gauze and bandage if needed (Figure O).
Ako uočite krv na mjestu davanja injekcije, pritisnite lagano mjesto davanja injekcije sterilnom pamučnom vaticom i stavite flaster ako je potrebno (slika O).
Waylivra may be given after you have already received other medicines used to lower the levels of triglycerides in blood without them having much effect.
Waylivra se može dati nakon što ste već primili druge lijekove za snižavanje razina triglicerida u krvi,
Look at the liquid in the syringe.
Pogledajte lijek u štrcaljki.
This binding prevents translation of the protein apoC-III, thus removing an inhibitor of triglyceride clearance and enabling metabolism through an LPL-independent pathway.
Vezivanje sprječava translaciju proteina apoC-III uklanjajući tako inhibitor klirensa triglicerida i omogućavajući metabolizam kroz put neovisan o LPL.
A history of documented acute pancreatitis was reported for 76% of patients and a history of diabetes was reported for 15% of patients; 21% of patients had a recorded history of lipaemia retinalis and 23% of patients had a recorded history of eruptive xanthomas.
Anamneza dokumentiranog akutnog pankreatitisa prijavljena je u 76% bolesnika, a anamneza dijabetesa prijavljena je u 15% bolesnika; 21% bolesnika imalo je anamnezu dokumentirane lipemije retinalis, a 23% bolesnika imalo je anamnezu dokumentiranih eruptivnih ksantoma.
After 6 months of treatment with volanesorsen, increase of dose frequency to 285 mg weekly should be considered if response has been inadequate in terms of serum triglyceride reduction as evaluated by the supervising experienced specialist and in the condition that platelet counts are in the normal range.
Nakon 6 mjeseci liječenja volanesorsenom, potrebno je uzeti u obzir povećanje učestalosti doziranja na 285 mg tjedno ako odgovor nije prikladan u smislu sniženja razine serumskih triglicerida prema procjeni nadležnog iskusnog specijalista te pod uvjetom da je broj trombocita u normalnom rasponu.
Pregnancy There are no data on the use of volanesorsen in pregnant women.
Nema podataka o primjeni volanesorsena u trudnica.
Waylivra is very commonly associated with reductions in platelet count in patients with FCS, which may result in thrombocytopenia (see section 4.8).
Waylivra je vrlo često povezana sa smanjenjem broja trombocita u bolesnika s FCS-om, što može rezultirati trombocitopenijom (vidjeti dio 4.8).
After commencing treatment, patients should have platelet levels monitored at least every two weeks, depending on the platelet levels.
Nakon početka liječenja bolesnicima treba pratiti razine trombocita barem svaka dva tjedna, ovisno o razinama trombocita.
In this 6-week period, it can be kept as needed between refrigerated and room temperature (up to 30 °C).
U ovom 6-tjednom razdoblju može se čuvati prema potrebi na temperaturi između one u hladnjaku i sobne temperature (do 30 °C).
It is important that you maintain this triglyceride-lowering diet whilst using Waylivra.
Važno je da se pridržavate ove dijete za snižavanje triglicerida dok primjenjujete Waylivru.
Contusion (3, 3%)
Kontuzija (3, 3%)
Table 5: Additional Results for Changes in Triglycerides in the APPROACH study (Primary endpoint at Month 3)
Tablica 5: Dodatni rezultati za promjene razine triglicerida u ispitivanju APPROACH (primarna mjera ishoda u 3. mjesecu)
- Other medicines that may change how your blood clots, including non-steroidal antiinflammatory medicines like ibuprofen, medicines used to prevent heart attacks and strokes such as clopidogrel, ticagrelor and prasugrel, antibiotics such as penicillin, medicines such as ranitidine (used to reduce stomach acid), and quinine (used to treat malaria).
- Drugim lijekovima koji mogu promijeniti način zgrušavanja Vaše krvi, uključujući nesteroidne protuupalne lijekove poput ibuprofena, lijekova za sprječavanje srčanih i moždanih udara poput klopidogrela, tikagrelora i prasugrela, antibiotika poput penicilina,
Injection site reactions defined as any local cutaneous reaction at the injection site persisting more than 2 days occurred in 82% of volanesorsen-treated patients in the APPROACH study and its openlabel extension (CS7).
Reakcije na mjestu injekcije definirana kao bilo koja lokalna kutana reakcija na mjestu injekcije koja traje dulje od 2 dana, javila se u 82% bolesnika koja su primala volanesorsen u ispitivanju APPROACH te njegovom otvorenom produžetku (CS7).
The mean fasting triglyceride percent change was significantly different between volanesorsen and placebo arms at 3, 6, and 12 months; the volanesorsen arm included patients who did not complete dosing but who returned for assessments over the 52-week study.
Srednja vrijednost postotka promjene u trigliceridima natašte bila je značajno različita između skupina s volanesorsenom i placebom u 3., 6. i 12. mjesecu; skupina koja je primala volanesorsen uključivala je bolesnike koji nisu dovršili doziranje ali koji su se vratili na procjenu tijekom ispitivanja od 52 tjedna.
None of these patients had any major bleeding events and all recovered to normal platelet count following drug discontinuation and administration of glucocorticosteroids where medically indicated.
. Nijedan od ovih bolesnika nije imao događaj velikog krvarenja i u svih se broj trombocita vratio na normalne vrijednosti nakon prekida primjene lijeka te nakon primjene glukokortikosteroida u bolesnika kod kojih je to bilo medicinski indicirano.
If necessary, your doctor may change how often you use this medicine, or may stop it for a period.
Prema potrebi, Vaš liječnik može izmijeniti učestalost primjene vašeg lijeka ili uporabu može privremeno prekinuti.
Treatment should be discontinued if: proteinuria of ≥ 500 mg/24 hour is recorded, or an increase in serum creatinine ≥ 0.3
Liječenje treba prekinuti ako je zabilježena proteinurija ≥ 500 mg/24 sata ili porast vrijednosti serumskog kreatinina ≥ 0,3 mg/dl (26,5
During this 6 week period, this medicine can be stored at either room temperature or put back in the refrigerator.
Tijekom ovog razdoblja od 6 tjedana, ovaj lijek se može čuvati ili na sobnoj temperaturi ili vratiti u hladnjak.
Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg volanesorsen.
Jedan ml sadrži 200 mg volanesorsen natrija, što odgovara 190 mg volanesorsena.
Platelet Count (x109/L)
Broj trombocita (x 109/l)
Pause treatment for ≥4 weeks and resume treatment after platelet levels ≥ 100 x 109/L
Pauzirajte najmanje 4 tjedna, nastavite liječenje nakon što razine trombocita budu ≥ 100 x109/l
Out of the 13, 5 had a dose pause, 5 had a dose adjustment and 3 had both a dose pause and dose adjustment.
Od 13 bolesnika, 5 ih je pauziralo, 5 ih je imalo prilagodbu doziranja, a troje ih je imalo i pauzu u doziranju i prilagodbu doziranja.
It is not known if Waylivra passes into breast milk.
Nije poznato izlučuje li se Waylivra u majčino mlijeko.
Table 6: Summary of Fasting Triglycerides (Mean (SD, SEM), mg/dL) Over Time in Study CS7
Tablica 6: Sažetak razine triglicerida natašte (srednja vrijednost (SD, SEM), mg/dl) tijekom vremena u ispitivanju CS7
During this time this medicine may be kept at either room temperature or put back into the refrigerator, as needed.
Tijekom ovog razdoblja ovaj lijek se može čuvati ili na sobnoj temperaturi ili vratiti natrag u hladnjak prema potrebi.
Out of the 50 patients still on treatment, 8 have had a dose pause, 8 have had a dose adjustment and 29 have had both a dose pause and a dose adjustment.
Od 50 bolesnika koji su još uvijek na liječenju, 8 ih je imalo pauzu u doziranju, 8 ih je imalo prilagodbu doziranja te ih je 29 imalo i pauzu u doziranju i prilagodbu doziranja.
Do not hold the plunger rod or the plunger head while removing the needle cap.
Nemojte držati za klip ili glavu klipa dok skidate kapicu s igle.
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections.
Natrijev hidroksid (za prilagodbu pH) Kloridna kiselina (za prilagodbu pH) Voda za injekcije.
In nonclinical studies, levels of volanesorsen in milk were very low in lactating mice.
U nekliničkim ispitivanjima su razine volanesorsena u mlijeku bile vrlo niske u ženki miša u laktaciji.
Waylivra led to a statistically significant reduction in triglyceride levels as compared to placebo at the primary efficacy endpoint, defined as percent change from baseline to Month 3 in fasting triglycerides, in addition to a lower incidence of pancreatitis over the 52-week treatment period in a post-hoc analysis (Table 4).
Waylivra je uzrokovala statistički značajnu redukciju razine triglicerida u usporedbi s placebom u primarnoj mjeri ishoda djelotvornosti, a koja se definira kao postotak promjene u 3. mjesecu u odnosu na početnu vrijednost triglicerida natašte, dodatno uz nižu incidencije pankreatitisa tijekom razdoblja liječenja od 52 tjedna u post-hoc analizi (Tablica 4).
Do not dispose of your used sharps disposal container in your household waste.
Nemojte zbrinjavati svoj spremnik s oštrim predmetima u svoj kućni otpad.
Percent of patientsc with ≥ 40% reduction in fasting triglycerides** a The Month 3 endpoint was defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.
Postotak bolesnikac sa smanjenjem triglicerida natašte ≥ 40%** a Mjera ishoda u 3. mjesecu definirana je kao prosjek pretraga natašte za 12. tjedan (dan 78) i 13. tjedan (dan 85).
Volanesorsen is not a substrate for CYP metabolism, and is metabolised in tissues by endonucleases to form shorter oligonucleotides that are then substrates for additional metabolism by exonucleases.
Biotransformacija Volanesorsen nije supstrat za metabolizam posredovan CYP-om te se metabolizira u tkivima putem endonukleaza kako bi nastali kraći oligonukleotidi koji su onda supstrati za dodatni metabolizam putem egzonukleaza.
APPROACH study in patients with FCS
Ispitivanje APPROACH u bolesnika s FCS-om
Waylivra can be stored at room temperature (8 °C-30 °C), in the outer carton to protect from light, for up to 6 weeks.
Waylivra se može čuvati na sobnoj temperaturi (od 8 °C do 30 °C), u vanjskoj kutiji radi zaštite od svjetlosti, do 6 tjedana.
If you have any questions about how to use Waylivra, please contact your doctor or pharmacist.
Ako imate pitanja o načinu uporabe lijeka Waylivra, obratite se svom liječniku ili ljekarniku.
Diagnosis of FCS required documentation of at least one of the following: a) Confirmed homozygote, compound heterozygote, or double heterozygote for known loss-offunction mutations in Type 1-causing genes (such as LPL, APOC2, GPIHBP1, or LMF1)
a) Potvrđeni homozigot, kombinirani heterozigot ili dvostruki heterozigot za poznate mutacije s gubitkom funkcije u genima koji uzrokuju tip 1 (poput LPL, APOC2, GPIHBP1 ili LMF1)
Main inclusion criteria were a diagnosis of FCS (Type 1 hyperlipoproteinemia) in combination with a history of chylomicronemia evidenced by documentation of lactescent serum or documentation of fasting TG measurement ≥ 880 mg/dl.
Glavni kriteriji uključivanja bili su dijagnoza FCS-a (hiperlipoproteinemija tipa 1) u kombinaciji s anamnezom hilomikronemije dokazane zabilježenim mliječnim izgledom seruma ili zabilježenim mjerenjem triglicerida natašte ≥ 880 mg/dl.
Due to the poor oral bioavailability of this medicinal product, it is considered unlikely that these low milk concentrations would result in systemic exposure from nursing.
Zbog niske oralne bioraspoloživosti ovog lijeka ne smatra se vjerojatnim da će te niske koncentracije u majčinom mlijeku uzrokovati sistemsku izloženost pri dojenju.
In clinical studies in patients with FCS, the most commonly reported adverse reactions during treatment were platelet count decreased (see section 4.4), occurring in 40% of patients during the pivotal studies, and injection site reactions, occurring in 82% of patients.
U kliničkim ispitivanjima na bolesnicima s FCS-om, najčešće prijavljene nuspojave tijekom liječenja bile su snižen broj trombocita (vidjeti dio 4.4) koje su se dogodile u 40% bolesnika tijekom pivotalnih ispitivanja te reakcije na mjestu injekcije koje su se pojavile u 82% bolesnika.
In the Phase 3 clinical studies (CS16 and APPROACH), 16% and 30% of volanesorsen-treated patients tested positive for anti-drug antibodies during 6-month and 12-month treatment, respectively.
U kliničkim ispitivanjima faze 3 (CS16 i APPROACH), 16% volanesorsenom liječenih bolesnika imalo je pozitivan test na protutijela na lijek tijekom liječenja koje je trajalo 6 mjeseci odnosno 30% bolesnika tijekom liječenja koje je trajalo 12 mjeseci.
Patients and/or caregivers should be trained in the administration of this medicinal product in accordance with the patient information leaflet.
Bolesnici i/ili njegovatelji moraju biti obučeni u primjeni ovog lijeka u skladu s uputom o lijeku.
Due to the poor oral bioavailability of volanesorsen, it is considered unlikely that these low milk concentrations would result in systemic exposure from nursing (see section 4.6).
Zbog niske oralne bioraspoloživosti volanesorsena ne smatra se vjerojatnim da će te niske koncentracije u mlijeku uzrokovati sistemsku izloženost pri dojenju (vidjeti dio 4.6).
Thrombocytopenia (10, 12%)
Trombocitopenija (10, 12%)
Water for injections, hydrocloric acid and sodium hydroxide.
Voda za injekcije, kloridna kiselina i natrijev hidroksid.
- Severe tiredness (fatigue), weakness or lack of energy, fluid retention, chest pain unrelated to the heart o
Teški umor, slabost ili gubitak energije, zadržavanje tekućine, bol u prsima koja nije povezana sa srcem.
After a 6-week diet run-in period, the mean fasting triglyceride level at baseline was 2,209 mg/dL (25.0 mmol/L).
Nakon 6-tjednog, dijetnog uvodnog razdoblja, prosječna početna razina triglicerida natašte iznosila je 2209 mg/dL (25,0 mmol/l).
Monitoring of inflammation should be assessed through quarterly assessment of erythrocyte sedimentation rate (ESR).
Praćenje upale treba procijeniti kroz kvartalne procjene brzine sedimentacije eritrocita.
Treatment with these medicinal products must be discontinued at platelet levels < 50 x 109/L (see section 4.5).
Liječenje ovim lijekovima mora se prekinuti pri razini trombocita < 50 x 109/l (vidjeti dio 4.5).
Percent of patientsb with fasting plasma triglyceride < 750 mg/dL (8.5 mmol/L)*
Postotak bolesnikab s trigliceridima u plazmi natašte < 750 mg/dl (8,5 mmol/l)*
Chronic or unexplained thrombocytopenia.
Kronična ili nerazjašnjena trombocitopenija.
Waylivra is an injection given under the skin with a single-use, disposable, pre-filled syringe.
Waylivra je injekcija koja se daje pod kožu (supkutano) s napunjenom štrcaljkom za jednokratnu uporabu.
Non-HDL-C
Ne-HDL-C
If you stop using Waylivra
Ako prestanete primjenjivati Waylivru
As a precautionary measure, it is preferable to avoid the use of this medicinal product during pregnancy.
Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Waylivra tijekom trudnoće.
Decreased platelet counts were also observed in rodent repeated dose studies.
Smanjene razine trombocita uočene su također u ispitivanjima ponovljene doze na glodavcima.
Treatment should be discontinued if there is a single increase in ALT or AST > 8 x ULN, or an increase > 5 x ULN, which persists for ≥ 2 weeks, or lesser increases in ALT or AST that are associated with total bilirubin > 2 x ULN or INR > 1.5.
> 8 x GGN ili porast > 5 x GGN koji traje najmanje 2 tjedna ili manji porasti u ALT ili AST koji su povezani s ukupnim bilirubinom > 2 x GGN ili INR > 1,5.
Waylivra can be kept at room temperature (up to 30 °C) in the original carton for up to 6 weeks after removing from the refrigerator.
Waylivra se može čuvati na sobnoj temperaturi (na temperaturi do 30 °C) u originalnoj kutiji do 6 tjedana nakon vađenja iz hladnjaka.
Before you are given this medicine other causes of high levels of triglycerides, such as diabetes or problems with your thyroid, will be ruled out by your doctor.
Prije nego dobijete ovaj lijek Vaš će liječnik isključiti druge uzroke visokih razina triglierida, poput dijabetesa ili problema s Vašom štitnom žlijezdom.
Following a dose of 285 mg once weekly in patients with FCS, the estimated geometric mean (coefficient of variation % of geometric mean) steady-state Cmax is 8.92 µg/ml (35%), AUC0-168h is 136 µg*h/ml (38%), and Ctrough is 127 ng/ml (58%) in patients who remain negative for anti-drug antibody.
Nakon doze od 285 mg jednom na tjedan u bolesnika s FSC-om, procijenjena geometrijska srednja vrijednost (koeficijent varijacije % geometrijske srednje vrijednosti) Cmax u stanju dinamičke ravnoteže iznosi 8,92 µg/ml (35%), AUC0-168h je 136 µg*h/ml (38%), i Ctrough je 127 ng/ml (58%) u bolesnika koji su ostali negativni na protutijela na lijek.
The parent drug and 5- to 7-mer chain-shortened metabolites accounted for approximately 26% and 55% of oligonucleotides recovered in urine, respectively.
Nepromijenjeni lijek te metaboliti skraćenog, 5- do 7-mernog lanca čine približno 26% odnosno 55% oligonukleotida koji su nađeni u urinu.
In APPROACH, the Phase 3 clinical study in patients with FCS, Waylivra reduced fasting triglycerides, total cholesterol, non-HDL cholesterol, apoC-III, apoB-48, and chylomicron triglyceride levels and increased LDL-C, HDL-C, and apoB (see Table 3).
U kliničkom ispitivanju faze 3 APPROACH u bolesnika s FCS-om, Waylivra je smanjila razinu triglicerida natašte, ukupni kolesterol, ne-HDL kolesterol, apoC-III, apoB-48 te razine hilomikronskih triglicerida te povisila LDL-C, HDL-C te apoB (vidjeti Tablicu 3).
It is available as either a carton containing 1 pre-filled syringe, or as a multipack of 4 (4 packs of 1-pack cartons) pre-filled syringes.
Dostupna je kao jedna napunjena štrcaljka u kutiji ili kao višestruko pakiranje od 4 (4 pakiranja od 1 kutije) napunjene štrcaljke.
If platelet count remains below 140 x 109/L upon a second measurement, Waylivra should not be initiated (see section
Ako broj trombocita ostane ispod 140 x109/l po drugom mjerenju, terapija lijekom Waylivra ne smije se započinjati (vidjeti dio 4.3).
Both volanesorsen and shorter oligonucleotide metabolites (predominantly 7-mer metabolites (generated either from 3′-deletions or 5′-deletions))
I volanesorsen i kraći oligonukleotidni metaboliti (pretežno 7-merni metaboliti (generirani ili iz 3´-delecija ili 5´-delecija)) identificirani su u ljudskom urinu.
• Capable of being closed with a tight-fitting, Puncture resistant lid, without sharps being able to come out,
• načinjen od tvrde i otporne plastike, • koji se može čvrsto zatvoriti poklopcem, čiji je poklopac otporan na probijanje tako da oštri predmeti ne mogu proviriti van,
Volanesorsen is an antisense oligonucleotide designed to inhibit the formation of apoC-III, a protein that is recognised to regulate both triglyceride metabolism and hepatic clearance of chylomicrons and other triglyceride-rich lipoproteins.
Volanesorsen je antisense oligonukleotid osmišljen za inhibiciju stvaranja apoC-III, proteina za kojeg je utvrđeno da regulira i metabolizam triglicerida i jetreni klirens hilomikrona i drugih trigliceridima bogatih lipoproteina.
Together with a controlled low-fat diet, Waylivra helps to lower the levels of triglycerides in your blood.
Skupa s kontroliranom dijetom sa smanjenim unosom masnoća, Waylivra pomaže sniziti razine triglicerida u
Observed Value change from Baseline in CS7 n
Uočena vrijednost promjene od početka u CS7 n
Do not use the pre-filled syringe if the liquid is cloudy or has floating particles.
Nemojte upotrebljavati napunjenu štrcaljku ako je tekućina zamućena ili u njoj plutaju čestice.
mg/dL (26.5 μmol/L) that is >ULN is recorded, or creatinine clearance estimated by the CKD-EPI equation is ≤ 30 mL/min/1.73m2.
μmol/l) koji je > GGN ili je klirens kreatinina procijenjen uz pomoć CKD-EPI jednadžbe ≤ 30 ml/min/1,73 m2.
Prior to launch of Waylivra in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Prije puštanja u promet lijeka Waylivra u svakoj državi članici, nositelja odobrenja za stavljanje lijeka u promet mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i format edukacijskog programa,
The pre-filled syringe should be allowed to reach room temperature prior to injection.
Napunjenu štrcaljku treba ostaviti da dosegne sobnu temperaturu prije davanja injekcije.
In individual monkeys, severe thrombocytopenia was noted in the 9 month study of drug treated groups at clinically relevant exposures and has also been observed in clinical studies.
Kod pojedinih majmuna u 9-mjesečnom ispitivanju skupina liječenih lijekom uočena je teška trombocitopenija pri klinički relevantnoj izloženosti, a isto je uočeno i u kliničkim ispitivanjima.
- Injection site reactions (pain, redness, heat, dryness, swelling, itching, tingling, hardening, pimpling, bruising, bleeding, numbness, change in colour or a burning feeling at the injection site).
- Reakcije na mjestu injekcije (bol, crvenilo, vrućina, suhoća, oticanje, svrbež, trnci, otvrdnuće, stvaranje prištića, nastanak modrica, krvarenje, utrnulost, promjene boje ili osjećaj pečenja na mjestu davanja injekcije).
This medicinal product can be removed from refrigeration and stored, in the original carton, at room temperature (below 30 °C) for up to 6 weeks.
Ovaj lijek može se izvaditi iz hladnjaka i pohraniti u originalnom pakiranju pri sobnoj temperaturi (ispod 30 °C) do 6 tjedana.
The APPROACH study is a randomised, double-blind placebo-controlled 52-week multicentre clinical study in 66 patients with FCS, evaluating volanesorsen 285 mg administered as a subcutaneous injection (33 treated with volanesorsen, 33 with placebo).
Ispitivanje APPROACH je randomizirano, dvostruko slijepo, placebom kontrolirano multicentrično ispitivanje u 66 bolesnika s FCS-om koje je trajalo 52 tjedna, a procjenjivalo je volanesorsen 285 mg primijenjen u obliku supkutane injekcije (33 bolesnika su liječena volanesorsenom, a 33 placebom).
A population pharmacokinetic analysis suggests that mild and moderate renal impairment has no clinically relevant effect on the systemic exposure of volanesorsen.
Farmakokinetička populacijska analiza ukazuje da blago i umjereno oštećenje funkcije bubrega nema klinički značajan učinak na sistemsku izloženost volanesorsenu.
At study entry, 55% of patients were on lipid lowering therapies (48% on fibrates, 29% on fish oils, 20% HMG-CoA reductase inhibitors), 27% were on pain medications, 20% were on platelet aggregation inhibitors, and 14% were on nutritional supplements.
Prilikom ulaska u ispitivanje, 55% bolesnika primalo je terapije za snižavanje lipida (48% primalo je fibrate, 29% riblja ulja, 20% inhibitore reduktaze HMG-CoA), 27% uzimalo je analgetike, 20% uzimalo je inhibitore agregacije trombocita, a 14% uzimalo je dodatke prehrani.
Table 2: Summary of adverse reactions in clinical studies in patients with FCS (N=86) System Organ Class
Tablica 2: Sažetak nuspojava u kliničkim ispitivanjima u bolesnika s FCS (N=86)
Keep the syringe in the outer carton in order to protect from light.
Štrcaljku čuvati u vanjskoj kutiji radi zaštite od svjetlosti.