natgillin/translations-raw huggingface dataset:
• if a patient during treatment shows signs or symptoms compatible with liver injury, treatment should be stopped, and the patient should be investigated immediately, and liver function tests performed.
• ako bolesnica tijekom liječenja pokaže znakove ili simptome koji odgovaraju oštećenju jetre,
ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETS PATIENT CARD
ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETE KARTICA ZA BOLESNICU
What Ulipristal Acetate Gedeon Richter contains - The active substance is ulipristal acetate.
Sadržaj pakiranja i druge informacije Što Ulipristal Acetate Gedeon Richter sadrži - Djelatna tvar je ulipristalacetat.
Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment (see sections 4.4 and 4.5).
tijekom liječenja se preporučuje nehormonska metoda kontracepcije (vidjeti dijelove 4.4 i 4.5).
Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Ulipristal Acetate Gedeon Richter treatment.
Gedeon Richter treba koristiti alternativnu pouzdanu metodu barijerne kontracepcije poput kondoma.
You should avoid drinking grapefruit juice while on treatment with Ulipristal Acetate Gedeon Richter.
Ulipristal Acetate Gedeon Richter s hranom i pićem Tijekom liječenja lijekom Ulipristal Acetate Gedeon Richter izbjegavajte piti sok od grejpa.
Do not take Ulipristal Acetate Gedeon Richter if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.
Recite svojem liječniku ako znate da imate problema s jetrom ili ako niste sigurni u stanje svoje jetre.
Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and
Nakon primjene umjerenog inhibitora CYP3A4 eritromicin propionata (500 mg dvaput dnevno tijekom 9 dana) kod zdravih ženskih dobrovoljaca, Cmax i AUC ulipristalacetata povećali su se za 1,2 odnosno 2,9 puta, a AUC aktivnog metabolita ulipristalacetata povećala se za 1,5 puta dok se Cmax aktivnog metabolita smanjila (za 0,52 puta).
NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets
NAZIV LIJEKA Ulipristal Acetate Gedeon Richter 5 mg tablete
Acne
- akne
• the need to inform the pathologist that patients were treated with Ulipristal Acetate Gedeon Richter if biopsy/surgical samples are to be sent for analysis.
• potrebu za informiranjem patologa da su bolesnice bile liječene lijekom Ulipristal Acetate
How to take Ulipristal Acetate Gedeon Richter
Ulipristal Acetate Gedeon Richter.
• Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Ulipristal Acetate Gedeon Richter
o Popratno pismo o Sažetak opisa svojstava lijeka o Vodič za liječnika za propisivanje lijeka Ulipristal Acetate Gedeon Richter
Headache*
I DOHVATA
Breastfeeding
omaglica
Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
- bol u mišićima i kostima (koštano-mišićna bol) - vrećica tekućine unutar jajnika (cista na jajnicima), osjetljivost/bol u dojkama, bol u donjem dijelu trbuha (zdjelici)
Marketing Authorisation Holder Gedeon Richter Plc.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter Plc.
MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Nositelj odobrenja za stavljanje lijeka u promet Gedeon Richter Plc.
Physician's guide to prescribing
OZNAČIVANJE I UPUTA O LIJEKU
See also section 2 Warnings and precautions.
Upozorenja i mjere opreza.
Menstrual periods generally return within 4 weeks after the end of each treatment course.
Vaša mjesečnica trebala bi se ponovno pojaviti unutar 4 tjedna nakon prekida liječenja lijekom
pain, hot flushes - tiredness (fatigue) - weight increase.
- premorenost (umor) - porast tjelesne težine.
Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation.
- Prvi ciklus liječenja treba početi tijekom prvog tjedna menstruacije.
Your period should generally return within 4 weeks after treatment with Ulipristal Acetate Gedeon Richter is stopped.
5. PRETRAGA (2 do 4 tjedna nakon prestanka uzimanja lijeka Ulipristal Acetate Gedeon Richter)
Rare (may affect up to 1 in 1,000 people) side effects: - nosebleed - indigestion, bloating - break of sac of fluid within the ovaries (ovarian cyst ruptured) - breast swelling.
Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - krvarenje iz nosa - probavne tegobe, nadutost
If you take more Ulipristal Acetate Gedeon Richter than you should Experience with Ulipristal Acetate Gedeon Richter when several doses are taken at once is limited.
Nisu prijavljeni ozbiljni štetni učinci prilikom uzimanja više doza lijeka Ulipristal Acetate Gedeon Richter istovremeno.
• inform the patients about the need for monitoring of liver function before starting each treatment course, monthly during treatment and within a few weeks after the treatment has stopped.
• informirati bolesnice da moraju pratiti jetrenu funkciju prije početka svakog ciklusa liječenja,
How to store Ulipristal Acetate Gedeon Richter
Drugi lijekovi i Ulipristal Acetate Gedeon Richter
If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted, investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Ako se opazi zadebljanje endometrija koje perzistira nakon ponovne pojave menstruacije tijekom razdoblja bez liječenja ili dulje od 3 mjeseca nakon završetka ciklusa liječenja i/ili ako se opazi promijenjeni uzorak krvarenja,
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
• vomiting
• mučninu • povraćanje
Dyspepsia Flatulence
Navale vrućine (valunzi)
Study 3
PRILOG III.
NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets Ulipristal acetate
Uputa o lijeku: Informacije za korisnika Ulipristal Acetate Gedeon Richter 5 mg tablete ulipristalacetat
Macrogol 8000
makrogol 8000
A double dose should not be taken on the same day.
U istom danu se ne smije uzeti dvostruka doza.
Age, gender, race, body weight
Dob, spol, rasa, tjelesna težina
It helps your body make better use of the insulin it produces.
On pomaže tijelu da bolje iskoristi inzulin kojeg stvara.
Your doctor will tell you how much Incresync you need to take and if you need to change the amount of other medicines you take.
Liječnik će Vam reći koliko Incresynca morate uzimati i trebate li promijeniti količinu drugih lijekova koje uzimate.
Combinations not studied
Kombinacije koje nisu ispitane
ATC code: A10BD09.
ATK oznaka: A10BD09.
Uncommon: - Difficulty sleeping
• teškoće sa spavanjem
Distribution The estimated volume of distribution in humans is 19 L.
Procijenjeni volumen distribucije u ljudi je 19 l.
Your blood sugar could fall below the normal level, but can be increased again by taking sugar.
Šećer u krvi može pasti ispod normalne razine, ali može se ponovno povisiti uzimanjem šećera.
The relevance of this finding is unknown.
Značaj ovog nalaza nije poznat.
Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.
Ponesite sa sobom ovu uputu ili nekoliko tableta kako bi liječnik točno znao što ste uzeli.
The magnitude of these reductions was not considered to be clinically relevant.
Smatra se da veličina tih sniženja nije klinički značajna.
- if you have blood in your urine that your doctor has not checked.
• ako imate krv u mokraći koju liječnik nije provjerio.
Your doctor will check whether Incresync is working 3 to 6 months after you start taking it.
Liječnik će provjeriti djelovanje lijeka Incresync 3 do 6 mjeseci nakon što ga počnete uzimati.
Change at Week 52 (n=303)
Promjena u 52. tjednu (n=303)
Before you start taking this medicine you will have a blood sample taken to check your liver and kidney function.
Prije nego što počnete uzimati ovaj lijek uzet će Vam uzorak krvi da bi se provjerila funkcija Vaše jetre i bubrega.
Other medicines and Incresync
Drugi lijekovi i Incresync
This medicinal product does not require any special temperature storage conditions.
Ovaj lijek ne zahtijeva posebne temperaturne uvjete čuvanja.
- if you are elderly and are taking insulin, because you may have an increased risk of heart problems.
• ako ste starije dobi i uzimate inzulin, jer možda imate povećani rizik srčanih problema.
Incresync should not be used in combination with insulin, as the safety and efficacy of this combination have not been established.
Incresync se ne smije koristiti u kombinaciji s inzulinom jer sigurnost i djelotvornost te kombinacije nisu ustanovljene.
The relevance of such a mechanism in humans is unclear.
Značaj takvog mehanizma u ljudi nije jasan.
You may experience visual disturbances while taking this medicine.
Možete imati smetnje vida dok uzimate ovaj lijek.
The majority of these episodes were mild to moderate in intensity.
Većina tih epizoda bila je blagog do umjerenog intenziteta.
If this happens, do not drive or use any tools or machines.
Ako se to dogodi, ne upravljajte vozilima i strojevima.
It is important that you continue to follow the advice on diet and exercise that your nurse or doctor has given you.
Važno je da nastavite slijediti savjete o dijeti i tjelovježbi koje ste dobili od medicinske sestre ili liječnika.
Both of these groups of medicines are “oral anti-diabetics”.
Obje ove skupine lijekova su „oralni antidijabetici“.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 September 2013
Datum prvog odobrenja: 19. rujna 2013.
What Incresync is and what it is used for What you need to know before you take Incresync How to take Incresync
Što je Incresync i za što se koristi Što morate znati prije nego počnete uzimati Incresync Kako uzimati Incresync
If you take more Incresync than you should
Ako uzmete više Incresynca nego što ste trebali
Glycaemic control should be monitored closely.
Kontrolu glikemije treba pomno pratiti.
A risk to the suckling child cannot be excluded.
Rizik za dojenče se ne može isključiti.
If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.
Ako uzimate protuupalne lijekove koji također mogu prouzročiti zadržavanje tekućine i oticanje, morate o tome obavijestiti svog liječnika.
On this basis, M-IV contribution to efficacy is approximately 3-fold that of pioglitazone whilst the relative efficacy of M-II is minimal.
Na temelju toga, doprinos M-IV djelotvornosti približno je trostruko veći od pioglitazona, dok je relativna djelotvornost M-II minimalna.
The tablets should be swallowed whole with water.
Tablete treba progutati cijele s vodom.
Although in very rare cases, fatal outcome has been reported, causal relationship has not been established.
Premda je smrtni ishod prijavljen u vrlo rijetkim slučajevima, uzročno-posljedični odnos nije utvrđen.
- if you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes).
• ako imate dijabetičku ketoacidozu (ozbiljna komplikacija loše kontrolirane šećerne bolesti).
In patients who fail to show an adequate response, Incresync should be discontinued.
U bolesnika u kojih ne nastupi odgovarajući odgovor, Incresync treba obustaviti.
Your doctor may discuss the results with you.
Liječnik će Vam objasniti nalaze.
Liver enzymes should be checked prior to the initiation of therapy in all patients.
Jetrene enzime treba provjeriti prije početka terapije u svih bolesnika.
- if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
• ako ste imali ozbiljnu alergijsku reakciju na bilo koji drugi lijek koji uzimate radi kontrole šećera u krvi.
Three of the six identified pioglitazone metabolites are active (M-II, M-III, and M-IV).
Tri od šest identificiranih metabolita pioglitazona su aktivni (M-II, M-III i M-IV).
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Pioglitazon i svi aktivni metaboliti opsežno se vežu za proteine plazme (> 99%).
What Incresync is and what it is used for
Što je Incresync i za što se koristi
Incresync is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Incresync se ne preporučuje djeci i adolescentima u dobi do 18 godina starosti zbog nedostatka podataka u tih bolesnika.
Incresync should be discontinued if any deterioration in cardiac status occurs.
Liječenje Incresyncom treba prekinuti ako nastupi bilo kakvo pogoršanje srčanog statusa.
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 ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any clinically relevant effect on the pharmacokinetics of alogliptin.
Dob (65-81 godine starosti), spol, rasa (bijelci, crnci ili Azijati) i tjelesna težina nisu imali klinički značajan učinak na farmakokinetiku alogliptina.
Reductions in HbA1c were similar across different subgroups including renal impairment, age, gender and body mass index, while differences between races (e.g. White and non-White) were small.
Sniženja HbA1c bila su slična u različitim podskupinama uključujući oštećenje bubrega, dob, spol i indeks tjelesne mase, dok su razlike između rasa (npr bijelci i ne-bijelci) bile male.
In some cases, weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
U nekim slučajevima povećanje težine može biti simptom zatajenja srca pa se težina mora pomno pratiti.
Any macroscopic haematuria should be investigated before starting therapy.
Svaku makroskopsku hematuriju treba ispitati prije početka terapije.
This has also been observed with other DPP-4 inhibitors.
Isto je također primijećeno i s drugim DPP-4 inhibitorima.
If you are already taking both alogliptin and pioglitazone as single tablets, Incresync can replace them in one tablet.
Ako već uzimate alogliptin i pioglitazon kao zasebne tablete, Incresync ih može zamijeniti u jednoj tableti.
STOP taking Incresync and contact a doctor immediately if you notice any of the following serious side effects:
PREKINITE uzimanje Incresynca i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
Incresync should be taken once daily with or without food.
Incresync treba uzeti jedanput na dan s hranom ili bez nje.
You can take this medicine with or without food.
Ovaj lijek možete uzeti s hranom ili bez nje.
The physician educational pack should contain:
Edukacijski paket za liječnike treba sadržavati:
Alogliptin was not carcinogenic in 2-year carcinogenicity studies conducted in rats and mice.
Alogliptin nije bio karcinogen u 2-godišnjim ispitivanjima karcinogenosti provedenim na štakorima i miševima.
Pioglitazone was associated with significant weight gain.
Pioglitazon je bio povezan sa značajnim povećanjem težine.
Frequencies are defined as 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 available data).
Nuspojave su razvrstane po organskim sustavima i MedDRA kategorijama učestalosti: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti na temelju dostupnih podataka).
What you need to know before you take Incresync
Što morate znati prije nego počnete uzimati Incresync
The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Najviša prijavljena doza od 120 mg/dan tijekom četiri dana, a potom od 180 mg/dan tijekom sedam dana nije bila povezana ni sa kakvim simptomima.
However, patients who experience visual disturbance should be cautious when driving or using machines.
Međutim, bolesnici koji osjete poremećaj vida moraju biti oprezni prilikom upravljanja vozilima i rada sa strojevima.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and toxicology.
Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksikologije.
Inhibition of DPP-4 remained above 81% at 24 hours after 14 days of dosing.
Inhibicija DPP-4 zadržala se iznad 81% tijekom 24 sata i nakon 14 dana uzastopne primjene.
(-infinity, -0.35)
(-beskonačno; -0,35)
Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery
Proizvođač Takeda Ireland Limited Bray Business Park Kilruddery
• Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
• Kriterije za odabir bolesnika uključujući da se pioglitazon ne smije primjenjivati kao prva linija terapije, naglašavajući potrebu za redovitim provjerama koristi od liječenja.
These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Ovi su nalazi bili primijećeni u svih vrsta pri koncentracijama u plazmi koje su bile ≤ 4 puta od kliničke izloženosti.
Your blood sugar will be checked and your dose of Incresync may need to be changed.
Potrebno je provjeriti šećer u krvi i možda će trebati promijeniti dozu Incresynca.
Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Primjena DPP-4 inhibitora povezana je s rizikom razvoja akutnog pankreatitisa.
Many of these patients reported concurrent peripheral oedema.
Mnogi od tih bolesnika istodobno su prijavili i periferne edeme.
If pancreatitis is suspected, Incresync should be discontinued; if acute pancreatitis is confirmed, Incresync should not be restarted.
Posumnja li se na pankreatitis, liječenje lijekom Incresync treba prekinuti; ako se potvrdi akutni pankreatitis, Incresync se ne smije ponovno primjenjivati.
(-infinity, -0.28)
(-beskonačno; -0,28)
Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical studies.
Edem je bio prijavljen u 6-9% bolesnika liječenih pioglitazonom tijekom jedne godine u kontroliranim kliničkim ispitivanjima.
Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Približno je polovica ispitivane populacije zadovoljila najmanje dva kriterija uključenja u pogledu kardiovaskularne bolesti u anamnezi.
Elderly (≥ 65 years old)
Stariji bolesnici (≥ 65 godina starosti)
The mean serum elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Srednja vrijednost poluvijeka eliminacije neizmijenjenog pioglitazona iz seruma u čovjeka iznosi 5 do 6 sati, a za njegove ukupne aktivne metabolite 16 do 23 sata.
Incresync is not a substitute for insulin in insulin-requiring patients.
Incresync nije zamjena za inzulin u bolesnika kojima je on potreban.
The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Prijavljeni slučajevi edema bili su općenito blagi do umjereni i obično nisu zahtijevali prekid liječenja.
Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Neka su epidemiološka ispitivanja ukazala na sličan povećani rizik od prijeloma u muškaraca i u žena.
If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Ako razine ALT ostanu povišene > 3 puta iznad gornje granice normale, terapiju treba prekinuti.
Time-dependency
Vremenska ovisnost
- if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
• ako imate posebnu vrstu dijabetičke očne bolesti koja se zove makularni edem (otok stražnjeg dijela oka).
It is recommended that you carry some sugar lumps, sweets,
Preporučuje se da uz sebe imate kocke šećera, slatkiše, kekse ili slatki voćni sok.
Common (may affect up to 1 in 10 people): - Sudden and severe bone pain or immobility (particularly in women).
Često (može se javiti kod manje od 1 na 10 osoba): • iznenadna i jaka bol u kostima ili nepokretnost (posebno u žena).
Pioglitazone or placebo was added to existing anti-diabetic and cardiovascular therapy for up to 3.5 years.
Pioglitazon ili placebo bili su dodani postojećoj antidijabetičkoj i kardiovaskularnoj terapiji u trajanju do 3,5 godine.
- if you have or have ever had bladder cancer.
• ako imate ili ste ikada imali rak mokraćnog mjehura.
The effect of Incresync on fertility in humans has not been studied.
Učinak Incresynca na plodnost u ljudi nije ispitan.
However, this did not lead to an increase in mortality in this study.
Međutim, u tom ispitivanju to nije dovelo do povećanja smrtnosti.
Incresync is available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 tablets.
Incresync je dostupan u blister pakiranjima koja sadrže 10, 14, 28, 30, 56, 60, 90, 98 ili 100 tableta.
If you stop taking Incresync
Ako prestanete uzimati Incresync
Elimination Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Alogliptin se eliminira sa srednjim terminalnim poluvijekom (T1/2) od približno 21 sat.
Alogliptin exists predominantly as the (R)-enantiomer (> 99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Alogliptin pretežno postoji kao (R)-enantiomer (>99%) i in vivo ne prolazi ili u manjoj mjeri prolazi kiralnu konverziju u (S)-enantiomer.
Patients should, therefore, be made aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, Incresync treatment should be discontinued (see section 4.6).
Bolesnice trebaju biti svjesne rizika od trudnoće, a ako žele zatrudnjeti ili ako nastupi trudnoća, liječenje lijekom Incresync treba prekinuti (vidjeti dio 4.6).
Repeated dosing does not result in accumulation of the compound or metabolites.
Ponovljeno doziranje ne rezultira nakupljanjem lijeka ili metabolita.
Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Viša početna vrijednost HbA1c bila je povezana s većim sniženjem HbA1c.
Taking Incresync in combination with other anti-diabetic medicines can cause low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Uzimanje lijeka Incresync u kombinaciji s drugim antidijabetičkim lijekovima može uzrokovati preniske razine šećera u krvi (hipoglikemija), što može utjecati na sposobnost upravljanja vozilima i strojevima.
In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient's clinical status.
U slučaju predoziranja potrebno je poduzeti odgovarajuće potporne mjere koje odgovaraju kliničkom statusu bolesnika.
Interactions with CYP inhibitors are thus not expected and have not been shown.
Interakcije sa CYP inhibitorima se stoga ne očekuju niti su dokazane.