natgillin/translations-raw huggingface dataset:
You should not take Epidyolex while you are pregnant unless the doctor decides the benefits outweigh the potential risks.
Epidyolex ne smijete uzimati tijekom trudnoće, osim ako liječnik odluči kako su koristi veće od mogućih rizika.
Dose reduction should be considered for concomitant medicinal products that are sensitive CYP2C19 substrates or that have a narrow therapeutic index.
Treba razmotriti smanjenje doze za istovremeno primijenjene lijekove koji su osjetljivi supstrati CYP2C19 ili koji imaju uski terapijski indeks.
Hypersensitivity to the active substance, to sesame oil, or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar, ulje sezama ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Effects of alcohol in children under the age of 6 years old may include sleepiness, behavioural changes, and problems with concentration and taking part in school activities.
Učinci alkohola u djece mlađe od 6 godina mogu uključivati pospanost, promjene ponašanja, te probleme s koncentracijom i sudjelovanjem u školskim aktivnostima.
The plasma clearance of cannabidiol following a single 1500 mg dose of cannabidiol is about 1,111 L/h.
Klirens kanabidiola iz plazme nakon jedne doze od 1500 mg kanabidiola je oko 1111 l/h.
Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted: - other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam,
Recite svom liječniku ako uzimate neke od sljedećih lijekova, jer bi Vašu dozu možda trebalo prilagoditi: - drugi lijekovi za epilepsiju i liječenje napadaja, poput karbamazepina, klobazama, lamotrigina,
To minimise the variability in the bioavailability of cannabidiol in the individual patient, administration of cannabidiol should be standardised in relation to food intake including a ketogenic diet (high-fat meal).
Kako bi se varijabilnost u biodostupnosti kanabidiola u pojedinog bolesnika svela na minimum, primjenu kanabidiola treba standardizirati u vezi unosa hrane, uključujući ketogenu prehranu (obroci bogati mastima).
Push the bottle adaptor firmly into the neck of the bottle, and make sure it is fully inserted.
Čvrsto pritisnite adapter na vrat bočice, pazeći da je potpuno umetnut.
Epidyolex with food
Epidyolex s hranom
Taking Epidyolex with certain other medicines may cause side effects, affect how the other medicines work, or affect how Epidyolex works.
Uzimanje Epidyolexa s određenim lijekovima može uzrokovati nuspojave, utjecati na to kako ti lijekovi djeluju, odnosno kako djeluje Epidyolex.
No effect on clobazam levels.
Nema utjecaja na razine klobazama.
Fill a cup with warm soapy water and clean the oral syringe by drawing water in and out using the plunger.
Napunite čašu toplom sapunicom i vodom i očistite štrcaljku za usta uvlačenjem i izvlačenjem vode pomoću klipa.
Effects of alcohol in children less than 6 years old may include sleepiness, behavioural changes, and impaired ability to concentrate and participate in school activities.
Učinci alkohola kod djece mlađe od 6 godina mogu uključivati pospanost, promjene ponašanja i smanjenu sposobnost koncentracije i sudjelovanja u školskim aktivnostima.
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
Your doctor will calculate the dose according to your body weight.
Vaš će liječnik izračunati dozu na temelju
Decreased growth, delayed sexual maturation, behavioural changes (decreased activity), and adverse effects on male reproductive organ development (small testes in adult offspring) and fertility were observed in the offspring at doses ≥ 150 mg/kg/day.
Smanjen rast, kasnije spolno dozrijevanje, promjene ponašanja (smanjena aktivnost) i štetni učinci na razvoj muških reproduktivnih organa (mali testisi u odraslih potomaka) i plodnost kod potomaka uočeni su pri dozi od ≥ 150 mg/kg/dan.
Line up the end of the plunger with the volume marking required, as shown opposite.
Poravnajte kraj klipa s oznakom za potrebnu količinu, kako je prikazano na slici.
Always take Epidyolex according to your doctor's instructions and consistently either with or without food including high-fat meals (such as ketogenic diet).
Epidyolex uvijek uzimajte u skladu s uputama liječnika i dosljedno s hranom ili bez nje, uključujući obroke bogate mastima (poput ketogene prehrane).
The clinical relevance of this is unknown, but the patient should be closely monitored for adverse drug reactions.
Klinička relevantnost tog povećanja nije poznata, ali bolesnika treba pomno pratiti zbog nuspojava.
- If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
- Ako Vam se češće događaju napadaji ili ako tijekom uzimanja lijeka Epidyolex imate jako težak napad.
Convulsive seizures were defined as atonic, tonic, clonic, and tonic-clonic seizures.
Konvulzivni napadaji su definirani kao atonički, tonički, klonički i toničko-klonički napadaji.
Potential interactions between cannabidiol (750 mg twice daily in healthy volunteers and 20 mg/kg/day in patients) and other AEDs were investigated in drug-drug interaction studies in healthy volunteers and in patients and in a population pharmacokinetic analysis of plasma drug concentrations from placebo-controlled studies in the treatment of patients with LGS.
Moguće interakcije između kanabidiola (750 mg dva puta dnevno u zdravih dobrovoljaca i 20 mg/kg/dan u bolesnika) i drugih antiepileptika su istraživane u ispitivanjima interakcija među lijekovima na zdravim dobrovoljcima i bolesnicima, te u analizi populacijske farmakokinetike za koncentracije lijeka u plazmi iz ispitivanja kontroliranih placebom u liječenju bolesnika koji imaju LGS.
In an uncontrolled study in patients in a different non-epilepsy indication, 2 elderly patients experienced elevations of alkaline phosphatase levels above 2 times the ULN in combination with transaminase elevations.
U nekontroliranom ispitivanju u bolesnika u drugačijoj ne-epileptičnoj indikaciji 2 su starija bolesnika imala povišene razine alkalne fosfataze za oko 2 puta više od GGN u kombinaciji s povišenim razinama transaminaza.
Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Liječenje Epidyolexom trebaju započeti i pratiti liječnici iskusni u liječenju epilepsije.
The responder rate analysis also showed a correlation in the exposure-response relationship for the active metabolite of cannabidiol (7-OH-CBD).
Analiza stope odgovora je također pokazala korelaciju u odnosu izloženost-odgovor za aktivni metabolit kanabidiola (7-OH-CBD).
The Cmax and AUC of cannabidiol are close to dose-proportional over the therapeutic dose range.
Vrijednosti Cmax i AUC kanabidiola su blizu proporcionalnih dozi u terapijskom rasponu doza.
The alcohol content should be taken into account in pregnancy and high-risk groups such as patients with liver disease.
Udio alkohola treba uzeti u obzir tijekom trudnoće i u grupama visokog rizika, poput bolesnika s bolesti jetre.
Twenty-seven percent (27%) of cannabidiol-treated patients developed a new laboratory-defined anaemia during the course of the study (defined as a normal haemoglobin concentration at baseline, with a reported value less than the lower limit of normal at a subsequent time point).
Dvadeset sedam posto (27%) bolesnika koji su uzimali kanabidiol je razvilo novu laboratorijski potvrđenu anemiju tijekom ispitivanja (definirana kao normalna koncentracija hemoglobina na početku, uz prijavljenu vrijednost nižu od donje granice normalne vrijednosti na sljedećoj vremenskoj točci).
A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation.
Meta-analiza randomiziranih ispitivanja kontroliranih placebom s antiepileptičnim lijekovima je pokazala malo povećani rizik od suicidalnog ponašanja i suicidalnih primisli.
Decreased appetite and weight loss may result in slightly reduced height gain.
Smanjenje teka i gubitak težine mogu dovesti do blagog smanjenja porasta visine.
In about one-third of the cases, transaminase elevations resolved during continued treatment with cannabidiol, without dose reduction.
U otprilike jednoj trećini slučajeva povišenja transaminaza povukla su se tijekom nastavka liječenja kanabidiolom, bez smanjenja doze.
Hepatocellular injury
Hepatocelularna ozljeda
In controlled studies in healthy adults and in patients with LGS and DS, an increase in serum creatinine of approximately 10% was observed within 2 weeks of starting cannabidiol.
U kontroliranim ispitivanjima u zdravih odraslih osoba i bolesnika koji imaju LGS i DS uočeno je povećanje serumskog kreatinina od oko 10% unutar 2 tjedna od početka uzimanja kanabidiola.
You may get the following side effects with this medicine.
Uz ovaj lijek možete imati sljedeće nuspojave.
Pneumoniaa, Bronchitis, Nasopharyngitis, Urinary tract infection
Upala plućaa, bronhitis, nazofaringitis, infekcije mokraćnoga sustava
Turn the bottle the right side up, and carefully remove the oral syringe from the adaptor.
Okrenite bočicu uspravno, te pažljivo skinite štrcaljku za usta s adaptera.
Caution should be used in patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C).
Treba biti oprezan kod primjene u bolesnika s umjerenim (Child-Pugh B) ili teškim oštećenjem funkcije jetre (Child-Pugh C).
In the phase 3 clinical trials, the observed frequency of status epilepticus was similar between the cannabidiol and placebo groups.
U kliničkim ispitivanjima faze 3 primijećena učestalost epileptičnog statusa bila je slična u skupinama s kanabidiolom i placebom.
What Epidyolex is and what it is used for
Što je Epidyolex i za što se koristi
Detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
Across both randomised LGS studies, 99.5% of patients who completed the studies were enrolled into the long-term open-label extension study (GWPCARE5).
U oba randomizirana LGS ispitivanja, 99,5% bolesnika koji su dovršili ispitivanja uključeno je u dugotrajni produžetak ispitivanja otvorenog tipa (GWPCARE5).
Patients with end-stage renal disease were not studied.
Bolesnici sa završnom fazom bolesti bubrega nisu proučavani.
Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN.
Manje od 1% bolesnika liječenih kanabidiolom je imalo razine ALT-a ili AST-a više od 20 puta GGN.
Decreased weight
Smanjena tjelesna težina
A corresponding decrease in haematocrit was also observed, with a mean change of −1.4% in cannabidiol-treated patients.
Uočeno je i odgovarajuće smanjenje hematokrita, uz srednju vrijednost promjene od −1,4% u bolesnika koji su uzimali kanabidiol.
Phenytoin has a narrow therapeutic index, so combining cannabidiol with phenytoin should be initiated with caution and if tolerability issues arise, dose reduction of phenytoin should be considered.
Fenitoin ima uski terapijski indeks, pa bi kombiniranje kanabidiola s fenitoinom trebalo započeti s oprezom te, u slučaju pojave problema s podnošljivošću, razmotriti smanjenje doze fenitoina.
Given that there was no consistent dose response between 10 mg/kg/day and 20 mg/kg/day in the LGS and DS studies, cannabidiol should be titrated initially to the recommended maintenance dose of 10 mg/kg/day (see Section 4.2).
S obzirom da nije bilo dosljednog odgovora na doze između 10 mg/kg/dan i 20 mg/kg/dan u ispitivanjima sa stanjima LGS i DS, kanabidiol na početku treba titrirati na preporučenu dozu održavanja od 10 mg/kg/dan (vidjeti dio 4.2).
Therefore, dose adjustments of cannabidiol or clobazam may be required.
Stoga može biti potrebna prilagodba doze kanabidiola ili klobazama.
Steady-state plasma concentrations are attained within 2-4 days of twice daily dosing based on pre-dose (Ctrough) concentrations.
Koncentracije u plazmi u stanju dinamičke ravnoteže su dostignute unutar 2-4 dana uz doziranje od dva puta dnevno, na temelju koncentracije (Ctrough) prije doziranja.
Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioural responses, including generalisation to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study.
Ispitivanja povezana sa zloporabom kod životinja pokazuju kako kanabidiol ne uzrokuje reakcije u ponašanju karakteristične za kanabinoide, uključujući generaliziranje na delta-9-tetrahidrokanabinolu (THC) u ispitivanju s diskriminacijom lijekova.
Cannabidiol does not require dose adjustment in patients with mild hepatic impairment (Child-Pugh A).
Kanabidiol ne zahtijeva prilagodbe doze u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh A).
Patients should be monitored for signs of suicidal behaviour and ideation and appropriate treatment should be considered.
Kod bolesnika treba pratiti znakove suicidalnog ponašanja i suicidalnih primisli, te razmisliti o odgovarajućem liječenju.
Do not drive, operate machinery, or take part in activities that require you to be alert and have fine control, such as cycling, until you know how Epidyolex affects you.
Nemojte voziti, upravljati strojevima ili sudjelovati u aktivnostima koje od Vas zahtijevaju budnost i finu kontrolu, poput vožnje bicikla, dok ne budete znali kako Epidyolex djeluje na Vas. - naglo prestanete uzimati Epidyolex.
The calculated dose should be rounded to the nearest graduated increment.
Izračunatu dozu treba zaokružiti na najbližu oznaku na štrcaljki.
The occurrence was higher for those patients on concomitant clobazam (see sections 4.5 and 4.8).
Incidencija je bila veća u bolesnika koji su istovremeno liječeni klobazamom (vidjeti dijelove 4.5 i 4.8).
Clobazam (separate analysis) was a significant covariate which caused the probability of GGT to increase, loss of appetite to decrease, and somnolence to increase.
Klobazam (odvojena analiza) predstavljao je značajnu kovarijatu koja je uzrokovala mogućnost povećanja GGT-a, smanjenje gubitka teka i povećanje somnolencije.
Given that cannabidiol is highly protein bound and will likely pass freely from plasma into milk, as a precaution, breast-feeding should be discontinued during treatment.
Uzevši u obzir da se kanabidiol snažno veže na bjelančevine, vjerojatno će lako prelaziti iz plazme u mlijeko, pa tijekom liječenja kao mjeru opreza treba prekinuti dojenje.
Studies in animals have shown toxicological changes in lactating animals, when the mother was treated with cannabidiol (see section 5.3).
Ispitivanja na životinjama su pokazala toksikološke promjene u životinja u laktaciji, dok je majka liječena kanabidiolom (vidjeti dio 5.3).
Cannabidiol can cause elevations in serum creatinine.
Kanabidiol može uzrokovati povišenje serumskog kreatinina.
Dose reduction of cannabidiol and/or the inhibitor may be necessary when given in combination.
Može biti potrebno smanjenje doze kanabidiola i/ili inhibitora ako se primjenjuju zajedno.
Epidyolex contains cannabidiol, a medicine which can be used to treat epilepsy, a condition where someone has seizures or fits.
Epidyolex sadrži kanabidiol, lijek koji se može primjenjivati za liječenje epilepsije, stanja u kojem osoba ima napadaje.
The alcohol content should be taken into account in pregnant women, children and high-risk groups such as patients with liver disease.
Udio alkohola treba uzeti u obzir kod trudnica, djece i skupina visokog rizika, poput bolesnika s bolesti jetre.
Epidyolex is an oral solution (a liquid to be swallowed).
Epidyolex je oralna otopina (tekućina koju treba progutati).
Cannabidiol can cause somnolence and sedation, which occur more commonly early in treatment and may diminish with continued treatment.
Kanabidiol može uzrokovati somnolenciju i sedaciju, što se češće događa na početku liječenja i može nestati s njegovim nastavkom.
Food may increase cannabidiol levels and therefore it should be taken consistently either with or without food, including the ketogenic diet (see section 5.2).
Hrana može povisiti razinu kanabidiola, pa se lijek treba uzimati dosljedno sa ili bez hrane, uključujući ketogenu prehranu (vidjeti dio 5.2).
Inhibition of P-gp mediated efflux by cannabidiol in the intestine cannot be ruled out.
Inhibicija kanabidiolom izbacivanja posredovanog P-glikoproteinom u crijevima ne može se isključiti.
Maternal plasma cannabidiol exposures at the no observed-adverse-effect-level (NOAEL) for embryofoetal developmental toxicity in rabbits were less than that in humans at 20 mg/kg/day.
Izloženosti kanabidiolu u plazmi majke pri razini bez uočenih štetnih učinaka (engl. no observed adverse effect level, NOAEL) za embriofetalnu razvojnu toksičnost u zečeva bila je manja od one u ljudi pri 20 mg/kg/dan.
The half-life of cannabidiol in plasma was 56-61 hours after twice daily dosing for 7 days in healthy volunteers.
U zdravih dobrovoljaca, poluvijek kanabidiola u plazmi je bio 56-61 sati nakon doziranja dvaput dnevno tijekom 7 dana.
Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule (see section 4.4).
Svako povećanje doze iznad 10 mg/kg/dan, do maksimalne preporučene doze od 20 mg/kg/dan, trebalo bi se uvesti uzimajući u obzir individualne koristi i rizike i u skladu s punim rasporedom praćenja (vidjeti dio 4.4).
In clinical trials, the majority of ALT elevations occurred in patients taking concomitant valproate.
U kliničkim se ispitivanjima većina povećanja ALT-a pojavila kod bolesnika koji su istovremeno uzimali valproat.
Cannabidiol reduces neuronal hyper-excitability through modulation of intracellular calcium via G protein-coupled receptor 55 (GPR55) and transient receptor potential vanilloid 1 (TRPV-1) channels, as well as modulation of adenosine-mediated signalling through inhibition of adenosine cellular uptake via the equilibrative nucleoside transporter 1 (ENT-1).
Kanabidiol smanjuje pretjeranu podražljivost neurona putem modulacije unutarstaničnog kalcija preko receptora 55 vezanog na G-protein (GPR55) i kanala vaniloidnog receptora 1 (TRPV1), kao i modulacije signalizacije adenozinom kroz inhibiciju staničnog preuzimanja adenozina putem ekvilibrativnog nukleozidnog prijenosnog proteina 1 (ENT1).
In addition, there was an increased exposure to 7-hydroxy-cannabidiol (7-OH-CBD; an active metabolite of cannabidiol), for which plasma area under the curve (AUC) increased by 47% (see section 5.2).
Osim toga, pojavila se i povećana izloženost 7-hidroksi-kanabidiolu (7-OH-CBD; aktivni metabolit kanabidiola), za koju se područje ispod krivulje (AUC) povećalo za 47% (vidjeti dio 5.2).
Cannabidiol does not interact with the major renal and hepatic transporters in a way that is likely to result in relevant drug-drug interactions.
Kanabidiol nema interakcija s glavnim bubrežnim i jetrenim prijenosnicima na način koji bi vjerojatno doveo do relevantnih interakcija među lijekovima.
Potential for cannabidiol to affect other medicinal products
Mogućnost utjecaja kanabidiola na druge lijekove:
Valproate
Valproat
Results of the subgroup analysis of patients treated with clobazam compared to patients treated without clobazam, indicated that there is residual statistical uncertainty regarding the treatment effect of cannabidiol in patients not taking clobazam.
Rezultati analiza podskupina bolesnika liječenih klobazamom u usporedbi s bolesnicima liječenim bez klobazama pokazali su da postoji preostala statistička nesigurnost u vezi s učinkom liječenja kanabidiolom u bolesnika koji ne uzimaju klobazam.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOČICA
This medicinal product contains 10% by volume ethanol (alcohol), i.e. up to 700 mg per dose (for an adult weighing 70 kg), equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Ovaj lijek sadrži 10% volumena etanola (alkohola), tj. do 700 mg po dozi (za odraslu osobu tjelesne težine 70 kg), što odgovara 14 mililitara (ml) piva ili 6 ml vina po dozi.
Strong inducers of CYP3A4, such as carbamazepine, enzalutamide, mitotane, St. John's wort, and/or strong inducers of CYP2C19, such as rifampin, administered concomitantly with cannabidiol may decrease the plasma concentrations of cannabidiol and decrease the effectiveness of cannabidiol.
Snažni induktori CYP3A4, poput karbamazepina, enzalutamida, mitotana, gospine trave, i/ili snažni induktori CYP2C19, poput rifampina, koji se uzimaju zajedno s kanabidiolom, mogu uzrokovati smanjenje plazmatske koncentracije kanabidiola i smanjenje učinkovitosti kanabidiola.
Co-administration of cannabidiol with a high-fat/high calorie meal increased the rate and extent of absorption (5-fold increase in Cmax and 4-fold increase in AUC) and reduced the total variability of exposure compared with the fasted state in healthy volunteers.
Istovremena primjena kanabidiola s obrocima bogatima masnoćom/kalorijama je povećala brzinu i intenzitet apsorpcije (5-struko povećanje Cmax i 4-struko povećanje AUC-a) i smanjila ukupnu varijabilnost izloženosti u usporedbi sa stanjem gladovanja u zdravih dobrovoljaca.
The potential for drug-drug interactions with other concomitant AEDs has been assessed in healthy volunteers and patients with epilepsy for clobazam, valproate and stiripentol.
Potencijalne interakcije s drugim istovremeno primijenjenim antiepilepticima procijenjene su na zdravim dobrovoljcima i bolesnicima s epilepsijom koji su uzimali klobazam, valproat i stiripentol.
Missed doses
Preskočene doze
Interaction resulting in an approximate 28% increase in Cmax and 55% increase in AUC.
Interakcija koja dovodi do povećanja Cmax od 28% i AUC-a od 55%.
There is no experience in patients with end-stage renal disease.
Nema iskustava u bolesnika u završnoj fazi bolesti bubrega.
Remove the plunger from the barrel of the syringe, and rinse both parts under tap water.
Izvadite klip iz cilindra štrcaljke, te isperite oba dijela tekućom vodom iz slavine.
If clinically significant increases of transaminases occur, cannabidiol and/or concomitant valproate should be reduced or discontinued in all patients until a recovery of transaminase elevations are observed (see section 4.4).
Ako dođe do klinički značajnog porasta transaminaza, kanabidiol i/ili valproat koji se uzima istovremeno treba smanjiti ili prekinuti kod svih bolesnika dok se ne primijeti normalizacija povišenih transaminaza (vidjeti dio 4.4).
- feeling drowsy or sleepy - decreased appetite - diarrhoea - fever - feeling tired - vomiting
- osjećaj mamurluka ili pospanosti - smanjeni apetit - proljev - groznica - osjećaj umora - povraćanje
In patients, there is a potential additive anticonvulsant effect from the bi-directional pharmacokinetic interaction between cannabidiol and clobazam, which leads to increases in circulating levels of their respective active metabolites, 7-OH-CBD (approximately 1.5-fold) and N-CLB (approximately 3-fold) (see sections 4.5, 5.1 and 5.2).
U bolesnika postoji potencijalno aditivan antikonvulzivni učinak koji potječe iz dvosmjerne farmakokinetičke interakcije između kanabidiola i klobazama, što vodi do povećanja razina njihovih pripadajućih aktivnih metabolita u cirkulaciji. 7-OH-CBD (oko 1,5-struko) i N-CLB (oko 3-struko) (vidjeti dijelove 4.5, 5.1 i 5.2).
Management of overdose
Upravljanje predoziranjem
Table 2: Tabulated list of adverse reactions
Tablica 2: Tablični popis nuspojava
Interaction resulting in approximately 3-fold increase in N-desmethylclobazam metabolite exposure.
Interakcija koja dovodi do približno 3-strukog porasta izloženosti metabolitu
No effect on reproductive ability of male or female rats was noted with an oral dose of up to 150 mg/kg/day cannabidiol (see section 5.3).
Nije primijećen učinak na reproduktivnu sposobnost mužjaka ili ženki štakora pri oralnoj dozi kanabidiola do 150 mg/kg/dan (vidjeti dio 5.3).