natgillin/translations-raw huggingface dataset:
EXP Discard pen 1 month after first use.
Mjesec dana nakon prve primjene brizgalicu baciti u otpad.
Non-cardiovascular death
Smrt uzrokovana kardiovaskularnim događajem
2 inhibitor (SGLT2i)) and/or insulin.
pioglitazon, sulfonilureja, inhibitor suprijenosnika natrija-glukoze 2 (inhibitor SGLT2)) i/ili inzulin.
• Headache
• Glavobolja
• Toothache
• Zubobolja
• Fasting plasma glucose
• Glukoza u plazmi natašte
Liraglutide in combination with metformin, glimepiride, metformin and rosiglitazone or SGLT2i ± metformin resulted in a statistically significant greater proportion of patients achieving an HbA1c ≤6.5% at 26 weeks compared with patients receiving these agents alone.
SGLT2 ± metforminom doveo je do statistički značajno većeg udjela bolesnika koji su postigli HbA1c ≤6,5% nakon 26 tjedana u usporedbi s bolesnicima koji su primali ove lijekove samostalno.
Name and address of the manufacturer responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Novo Nordisk A/S
• Immunogenicity
• Imunogenost
Vomiting Dyspepsia Abdominal pain upper
Bolovi u gornjem dijelu abdomena Konstipacija
Common: may affect up to 1 in 10 people
Često: mogu se javiti u do 1 na 10 osoba
Urticaria Pruritus
Mučnina Proljev
Cholelithiasis and cholecystitis
Kolelitijaza Kolecistitis
A mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed with liraglutide in long-term clinical trials including LEADER.
U dugotrajnim kliničkim ispitivanjima, uključujući ispitivanje LEADER, primijećena je srednja vrijednost porasta srčane frekvencije za 2-3 otkucaja u minuti u odnosu na početnu vrijednost.
ss
D.
Gender had no clinically meaningful effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic data analysis of male and female patients and a pharmacokinetic study in healthy subjects.
Prema rezultatima analize populacijskih farmakokinetičkih podataka bolesnika i bolesnica te farmakokinetičkog ispitivanja u zdravih ispitanika, spol nije imao klinički značajnog učinka na farmakokinetiku liraglutida.
Ethnic origin had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analysis which included patients of White, Black, Asian and Hispanic groups.
Prema rezultatima populacijske farmakokinetičke analize koja je obuhvatila bolesnike bijele, crne, azijske i hispano skupine, etničko podrijetlo nije imalo klinički značajnog utjecaja na farmakokinetiku liraglutida.
Add-on to SGLT2i5 ± metformin (≥1500 mg/day)
Dodatak inhibitoru SGLT25 ± metforminu (≥1500 mg/dan) Liraglutid 1,8 mg
At week 26, the estimated mean change in HbA1c was -1.4% and -0.5% for liraglutide and placebo, respectively, with an estimated treatment difference of -0.9 [-1.00; -0.70]95% CI.
uz liraglutid i -0,5% uz placebo, uz procijenjenu razliku između liječenja od -0,9 [-1,00; -0,70]95% CI.
One pre-filled pen contains 18 mg liraglutide.
Jedna napunjena brizgalica sadrži 18 mg liraglutida.
Add-on to metformin (2,000 mg/day) + rosiglitazone (4 mg twice daily) Liraglutide 1.2 mg 177 8.48
Dodatak metforminu (2000 mg/dan) + roziglitazonu (4 mg dvaput na dan)
• Indigestion
• Umor
No severe hypoglycaemic episodes occurred in the liraglutide treatment group.
U grupi liječenoj liraglutidom nisu zabilježene epizode teške hipoglikemije.
A single dose administration of digoxin 1 mg with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax decreased by 31%.
Digoksin Primjena jedne doze digoksina od 1 mg s liraglutidom rezultirala je smanjenjem AUC digoksina za
Liraglutide
Omaglica
- The active substance is liraglutide.
Što Victoza sadrži - Djelatna tvar je liraglutid.
Hypoglycaemia
Hipoglikemija
Victoza 6 mg/ml solution for injection in pre-filled pen Liraglutide
Victoza 6 mg/ml otopina za injekciju u napunjenoj brizgalici liraglutid
The reductions in HbA1c and superiority vs sitagliptin observed after 26 weeks of liraglutide treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (-1.29% and -1.51% vs -0.88%, p<0.0001).
Smanjenje HbA1c i superiornost naspram sitagliptina opažena nakon 26 tjedana liječenja liraglutidom (1,2 mg i 1,8 mg)
Read the package leaflet before use.
NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
The incidence of withdrawal due to adverse reactions was 7.8% for liraglutide-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer).
U dugotrajnim kontroliranim ispitivanjima (26 tjedana ili duže) incidencija prestanka primjene lijeka zbog nuspojava bila je 7,8% u bolesnika liječenih liraglutidom i 3,4% u bolesnika liječenih lijekom usporedbe.
EXP
Osip
Summary of the safety profile
4.8 Nuspojave Sažetak sigurnosnog profila
• Inflamed gallbladder
• Upala žučnog mjehura
Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of Victoza.
Nakon stavljanja lijeka Victoza na tržište, prijavljeno je nekoliko slučajeva anafilaktičkih reakcija s dodatnim simptomima kao što su hipotenzija, palpitacije, dispneja i edem.
Acute pancreatitis has been observed with the use of GLP-1 receptor agonists.
Kod primjene agonista receptora GLP-1 primijećen je akutni pankreatitis.
Digoxin median tmax was delayed from 1 h to 1.5 h. No adjustment of digoxin dose is required based on these results.
Medijan tmax digoksina bio je odgođen sa 1 h na 1,5 h.
Monotherapy
Monoterapija
Fatigue Injection site reactions
Opći poremećaji i reakcije na mjestu primjene
Victoza 6 mg/ml solution for injection in pre-filled pen
Victoza 6 mg/ml otopina za injekciju u napunjenoj brizgalici
Placebo Victoza
UPUTE ZA UPORABU BRIZGALICE VICTOZA
Uncommon: may affect up to 1 in 100 people
Manje često: mogu se javiti u do 1 na 100 osoba
In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg once daily and exenatide 10 mcg twice daily in patients inadequately controlled on metformin and/or sulfonylurea therapy (mean HbA1c 8.3%), liraglutide was statistically superior to exenatide treatment in reducing HbA1c after 26 weeks (-1.12% vs -0.79%; estimated treatment difference: -0.33; 95% CI: -0.47 to -0.18).
U otvorenom ispitivanju u kojem je uspoređivana djelotvornost i sigurnost liraglutida 1,8 mg jednom dnevno i eksenatida 10 µg dvaput dnevno u bolesnika koji nisu odgovarajuće kontrolirani liječenjem metforminom i/ili sulfonilurejom (srednja vrijednost HbA1c 8,3%), liraglutid je bio statistički superiorniji u odnosu na liječenje eksenatidom u smanjenju HbA1c nakon 26 tjedana (-1,12%
Favours Victoza Favours Placebo
U korist placeba
Liraglutide did not change the overall exposure of paracetamol following a single dose of 1000 mg. Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.
Cmax paracetamola smanjio se za 31%, dok je medijan tmax bio odgođen do 15 min.
Liraglutide 1.8 mg 203 8.00
Liraglutid 1,8 mg
• Dizziness
Dispepsija
Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Liraglutid se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 niti za liječenje dijabetičke ketoacidoze.
Investigations
Pretrage
The dose selector clicks when you turn it. Do not use these clicks to select your dose.
Nemojte koristiti taj zvuk za odabir doze.
Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change.
Liraglutid nije promijenio ukupnu izloženost grizeofulvinu nakon primjene jedne doze grizeofulvina od 500 mg.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Novo Nordisk A/S
When you have found the most convenient time of the day it is preferred that you inject Victoza around the same time of the day.
Vam je najprikladnije, poželjno je lijek Victoza injicirati otprilike u isto vrijeme svakog dana.
The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Stoga se smatra kako istodobna primjena liraglutida ne utječe na kontraceptivni učinak tih lijekova.
In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with Victoza alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.
U pet velikih dugotrajnih kliničkih ispitivanja faze 3a više od 2500 odraslih bolesnika primalo je lijek
How to use Victoza
U korist lijeka Victoza
Add-on to metformin (2,000 mg/day) + glimepiride (4 mg/day) Liraglutide 1.8 mg 230 8.3
Dodatak metforminu (2000 mg/dan) + glimepiridu (4 mg/dan)
Liraglutide 1.2 mg 251 8.18
Liraglutid 1,2 mg Liraglutid 1,8 mg Placebo
- If you get any side effects, talk to your doctor, pharmacist or nurse.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Liraglutide lowered ethinyloestradiol and levonorgestrel Cmax by 12 and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Nakon primjene jedne doze oralnog kontraceptiva, liraglutid je smanjio Cmax etinilestradiola za 12%, a levonorgestrela za 13%.
No dose adjustment of lisinopril is required based on these results.
Na osnovi ovih rezultata, nije potrebno prilagođavanje doze lizinoprila.
• Bowel obstruction.
• Opstrukcija crijeva.
In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (-1.83% vs -1.21%, p<0.0001).
U otvorenom ispitivanju u kojem je uspoređivana djelotvornost i sigurnost liraglutida 1,8 mg i liksisenatida 20 µg u 404 bolesnika koji nisu odgovarajuće kontrolirani liječenjem metforminom (srednja vrijednost HbA1c 8,4%), liraglutid je bio superioran liksisenatidu u smanjenju HbA1c nakon
Biotransformation
Koronarna revaskularizacija
Headache Dizziness
Poremećaji srca
Subcutaneous use
Za supkutanu primjenu
• Malaise (feeling unwell)
• Opće loše stanje (malaksalost)
≤5.5 mmol/l (≤100 mg/dl) Target
Samoodređivanje glukoze u plazmi natašte Povećanje doze glargin inzulina (IU) ≤5,5 mmol/l (≤100 mg/dl) ciljno
Tabulated list of adverse reactions
Tablični prikaz nuspojava
Marketing Authorisation Holder and Manufacturer
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Novo Nordisk A/S
Very few episodes (0.001 events/patient year) were observed with administration of liraglutide in combination with oral antidiabetics other than sulfonylureas.
zabilježeno je kad se liraglutid primjenjivao u kombinaciji s drugim oralnim antidijabeticima osim sulfonilureje.
1 ml of solution contains 6 mg of liraglutide*.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 6 mg liraglutida*.
No episodes of severe hypoglycaemia were observed in the trial with liraglutide used as monotherapy.
U ispitivanju liraglutida u monoterapiji nisu zapažene epizode teške hipoglikemije.
• Tiredness
• Omaglica
Withdrawal
Povraćanje
In a double-blind trial comparing the efficacy and safety of liraglutide 1.8 mg versus placebo as addon to insulin and/or OAD in patients with type 2 diabetes and moderate renal impairment, liraglutide was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.05% vs -0.38%).
U dvostruko slijepom ispitivanju koje je usporedilo djelotvornost i sigurnost 1,8 mg liraglutida u usporedbi s placebom kao dodatka terapiji inzulinom i/ili OAD u bolesnika sa šećernom bolešću tipa 2
Liraglutide 1.2 mg 228 8.5
Liraglutid 1,2 mg
Liraglutide 1.8 mg 234 8.5
Roziglitazon 4 mg/dan 231 8,4
Digoxin
Gastritis
140 (2 x 70) tablets (multipack)
140 (2 x 70) tableta (višestruko pakiranje)
Strength
Sastav
MA (EU) number (Invented) name
Broj (EU) odobrenja
Pharmaceutical Form
Zaštićeno ime Doza Farmaceutski oblik Put primjene Unutarnje pakiranje
• At the request of the European Medicines Agency;
• Na zahtjev Europske agencije za lijekove;
Keep the bottle tightly closed.
Bočicu čuvati čvrsto zatvorenu.
This may take up to 2 years.
Za to može biti potrebno i do dvije godine.
Interactions studies have only been performed in adults.
Ispitivanja interakcija provedena su samo u odraslih.
The mechanism of this effect is unclear.
Nije jasan mehanizam tog učinka.
Check with your doctor or pharmacist if you are not sure.
Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.
After this, most patients need a dose of:
Nakon toga većini bolesnika treba sljedeća doza:
There is no preferential uptake in erythrocytes.
Nema preferencijalnog preuzimanja u eritrocitima.
Aluminium / Aluminium blister.
Aluminij/aluminij blister.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
The duration may be modified depending on clinical or laboratory variables.
Trajanje postupka može se promijeniti ovisno o kliničkim ili laboratorijskim varijablama.
Do not take a double dose to make up for a forgotten dose.
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
• Additional risk minimisation measures
• Dodatne mjere minimizacije rizika
Fertility was not reduced.
Fertilnost nije bila smanjena.
Procreation (recommendations for men)
Planiranje obitelji (preporuke za muškarce)
Always take this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
CYP450 inhibitors and inducers
CYP450 inhibitori i induktori
If possible, take your tablets or the box with you to show the doctor.
Ako je moguće, ponesite tablete ili kutiju sa sobom i pokažite je liječniku.
The elimination half-life in patients is approximately 2 weeks.
Poluvijek eliminacije u bolesnika iznosi približno 2 tjedna.
For more information on these, please read section 4 (Possible side effects).
Za daljnje informacije o tome molimo pročitajte dio 4 (Moguće nuspojave).
Use of alternative contraceptive methods is recommended.
Preporučuje se primjena alternativnih metoda kontracepcije.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
For washout procedures and other recommended actions in case of desired or unintended pregnancy, see section 4.6.
Za postupak ispiranja i ostale preporučene aktivnosti u slučaju željene ili neplanirane trudnoće vidjeti dio 4.6.
This leaflet was last revised in {MM/YYYY} Other sources of information
Ova uputa je zadnji puta revidirana u {MM/GGGG} Drugi izvori informacija
An updated RMP should be submitted:
Nadopunjeni RMP treba dostaviti:
Most of the cases occurred within the first 6 months of treatment.
Većina slučajeva pojavila se tijekom prvih 6 mjeseci liječenja.
This includes medicines obtained without a prescription.
To uključuje lijekove koje ste nabavili bez recepta.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found.
U štakora i pasa nađena su Heinzova tjelešca i/ili Howell-Jolly tjelešca.
Infections may be more severe in nature and may, therefore, require early and vigorous treatment.
Infekcije mogu biti teže prirode i stoga može biti potrebno rano i intenzivno liječenje.
Duration of a complete washout is usually 11 days.
Potpuno ispiranje postiže se obično za 11 dana.
• every two weeks during the first six months of treatment, and
• svaka dva tjedna tijekom prvih šest mjeseci liječenja, te
U kabelovny 130 102 37 Prague 10 Czech Republic
U kabelovny 130 102 37 Prague 10 Češka Republika
If you are affected, do not drive, or use machines.
Ako se to dogodi, nemojte voziti ni upravljati strojevima.
In such cases patients should refrain from driving cars and using machines.
U tim slučajevima bolesnici trebaju izbjegavati upravljanje vozilima i strojevima.
Before starting treatment, all patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Prije početka liječenja za sve bolesnike potrebno je utvrditi imaju li aktivnu ili neaktivnu („latentnu“) tuberkulozu, prema lokalnim preporukama.
Your doctor may perform additional tests for differential diagnosis.
Vaš liječnik treba provesti dodatna testiranja za postavljanje diferencijalne dijagnoze.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
- if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
- ako ste ikad imali upalu pluća (intersticijsku plućnu bolest) - ako ste ikad imali tuberkulozu ili ako ste bili u bliskom kontaktu s nekim tko ima ili je imao tuberkulozu.
Warfarin and other coumarine anticoagulants
Varfarin i drugi kumarinski antikoagulansi
Peripheral neuropathy
Periferna neuropatija
However, animal studies to evaluate this specific risk have not been conducted.
Nisu, međutim, provedena ispitivanja na životinjama kojima bi se procijenio taj rizik.
There is no indication that these effects are of clinical relevance.
Nema indicija da su ti učinci klinički značajni.
A more than 3-fold increase was seen in another 5 patients.
Više nego trostruko povećanje vrijednosti zabilježeno je u drugih 5 bolesnika.
• every 8 weeks thereafter (see section 4.4).
• nakon toga svakih 8 tjedana (vidjeti dio 4.4).
It is considered essential that monitoring recommendations are strictly adhered to.
Najvažnije je strogo se pridržavati preporučenih kontrola.
It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Može biti potrebno približno 4 tjedana ili više da se počnete osjećati bolje.
Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Prema podacima iz istraživanja s 14C, najmanje 82% do 95% doze se apsorbira.
mild increase in blood pressure
blagi porast krvnog tlaka
No special requirements for disposal.
Nema posebnih zahtjeva za zbrinjavanje.
Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Bolesnike je potrebno pomno pratiti zbog znakova i simptoma pretjerane izloženosti lijekovima i potrebno je razmotriti smanjenje doze tih lijekova.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.
Podaci o farmakokinetici u starijih bolesnika (> 65 godina) ograničeni su, ali odgovaraju farmakokinetici u mlađih odraslih osoba.
Patients with a history of tuberculosis should be carefully monitored because of the possibility of reactivation of the infection.
Bolesnici s tuberkulozom u anamnezi moraju biti pozorno praćeni zbog mogućnosti reaktivacije infekcije.
The tablets are packed in blisters or bottles.
Tablete su pakirane u blistere ili bočice.
For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Za dodatne informacije o ispitivanju uzorka obratite se nositelju odobrenja za stavljanje lijeka u promet ili njegovom lokalnom predstavniku (vidjeti dio 7.).
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
granično (reverzibilno) smanjenje koncentracije spermija, ukupnog broja spermija i brze progresivne pokretljivosti
This includes any possible side effects not listed in this leaflet.
Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel)
Učinak na oralne kontraceptive (0,03 mg etinilestradiol i 0,15 mg levonorgestrel)
• The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
• Rizik od infekcija, uključujući i oportunističke infekcije, i kontraindikacija za primjenu u imunokompromitiranih bolesnika.
• Patients with serious infections (see section 4.4).
• Bolesnici s ozbiljnim infekcijama (vidjeti dio 4.4).
No dose adjustment is required in patients above 65 years of age.
Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina.
Infections and infestations Rare:
Infekcije i infestacije Rijetko:
Falsely low levels of calcium can be detected.
Mogu se utvrditi lažno niske razine kalcija.
Waiting period
Razdoblje čekanja
Tell your doctor if you have unexplained chronic diarrhoea.
Obratite se svom liječniku ako imate neobjašnjivi kronični proljev.
NSAIDS/Corticosteroids
NSAIL/Kortikosteroidi
However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Međutim, nije zabilježen očiti utjecaj ovog povećanja izloženosti rosuvastatinu u plazmi na aktivnost HMG-CoA reduktaze.
If used together, the dose of rosuvastatin should not exceed 10 mg once daily.
Ako se koriste zajedno, doza rosuvastatina ne smije prijeći 10 mg jedanput dnevno.
In study MN302 leflunomide was significantly less effective than methotrexate.
U ispitivanju MN302 leflunomid je bio značajno manje učinkovit od metotreksata.
What Leflunomide Zentiva is and what it is used for
Što je Leflunomide Zentiva i za što se koristi
For further information on the laboratory testing please contact your doctor.
Za dodatne informacije o laboratorijskim pretragama obratite se svome liječniku.
While this interaction is not expected to adversely impact the efficacy of oral contraceptives, consideration should be given to the type of oral contraceptive treatment.
Iako se ne očekuje negativan utjecaj ove interakcije na djelotvornost oralnih kontraceptiva, potrebno je razmotriti vrstu terapije oralnim kontraceptivima.
leucopenia (leucocytes >2 G/L)
leukopenija (leukociti > 2 g/l).
No difference was observed between leflunomide and sulphasalazine (study MN301).
Nije bilo značajnih razlika između leflunomida i sulfasalazina (ispitivanje MN301).
These data do not allow an effective and safe dose recommendation.
Iz tih podataka nije moguće preporučiti učinkovitu i sigurnu dozu.
Store in the original package.
Čuvati u originalnom pakiranju.
The effect of leflunomide on improvement of function and on reduction of skin lesions was modest.
Učinak leflunomida na poboljšanje funkcionalne sposobnosti i smanjenje kožnih lezija bio je skroman.
These washout procedures may be repeated if clinically necessary.
Navedeni postupci ispiranja mogu se ponoviti ako je klinički potrebno.
Date of latest renewal: 08 January 2015
Datum posljednje obnove: 08. siječnja 2015.