natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zinplava's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Zinplava nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za njegovu primjenu u Europskoj uniji.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinplava have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zinplava nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
Why is Zinplava approved?
Zašto je lijek Zinplava odobren?
It is not intended to provide practical advice on how to use Zinplava.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Zinplava.
Other information about Zinplava
Ostale informacije o lijeku Zinplava
Zinplava has been shown to be effective at preventing recurrence of C. difficile infection, particularly in patients at high risk of the infection coming back (which occurs in about 15 to 35% of cases and is particularly difficult to treat).
Lijek Zinplava pokazao se djelotvornim u sprječavanju recidiva infekcije bakterijom C. difficile, osobito u bolesnika izloženih visokom riziku povratka infekcije (koja se javlja u približno 15 do 35 % slučajeva i koja se osobito teško liječi).
Similar effects have been seen in patients on placebo.
Slične su pojave zabilježene u bolesnika koji su primali placebo.
In the first study, 17% of patients given Zinplava (67 out of 386) had a new episode of diarrhoea in the 12 weeks after treatment compared with 28% of patients given placebo (109 out of 395).
U prvom se ispitivanju u 17 % bolesnika koji su primali lijek Zinplava (u 67 od 386 bolesnika) pojavila nova epizoda proljeva unutar 12 tjedana nakon liječenja, u usporedbi s 28 % bolesnika koji su primali placebo (u 109 od 395 bolesnika).
For more information about treatment with Zinplava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Zinplava pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
Zinplava is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Lijek Zinplava dostupan je kao koncentrat od kojeg se priprema otopina za infuziju (ukapavanje) u venu.
In the second study, figures were 16% (62 out of 395) for Zinplava and 26% (97 out of 378) for placebo.
U drugom ispitivanju te su vrijednosti bile 16 % (u 62 od 395 bolesnika) u skupini koja je primala lijek Zinplava, u usporedbi s 26 % (u 97 od 378 bolesnika) u skupini koja je primala placebo.
What benefits of Zinplava have been shown in studies?
Koje su koristi lijeka Zinplava dokazane u ispitivanjima?
antibody (a type of protein) that has been designed to attach to these toxins, blocking their action, thereby preventing further damage and diarrhoea from occurring.
monoklonsko protutijelo (vrsta proteina) koje se veže za te toksine i sprječava njihovo djelovanje, a time i daljnja oštećenja te pojavu proljeva.
It is used to prevent future episodes of diarrhoea in patients who are taking antibiotics to treat their C. difficile infection and who are at high risk of the infection coming back.
Primjenjuje se za sprječavanje budućih epizoda proljeva u bolesnika koji uzimaju antibiotike za liječenje infekcije uzrokovane bakterijom C. difficile i koji su izloženi visokom riziku povratka te infekcije.
Zinplava is a medicine used in adults who have infections due to bacteria called Clostridium difficile that cause severe diarrhoea.
Zinplava je lijek koji se primjenjuje u odraslih osoba s infekcijama uzrokovanima bakterijom Clostridium difficile, koja uzrokuje jak proljev.
Bezlotoxumab is a monoclonal
Bezlotoksumab je
C. difficile bacteria produce toxins that damage the lining of the gut causing diarrhoea which may be severe.
Bakterija C. difficile proizvodi toksine koji oštećuju stijenku crijeva i uzrokuju proljev koji može biti jak.
For practical information about using Zinplava, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Zinplava bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
The effect was mainly seen in patients at higher risk of C. difficile infection coming back (such as older patients or those with a weakened immune system).
Djelotvornost tog lijeka ponajprije je zabilježena u bolesnika koji su izloženi većem riziku povratka infekcije bakterijom C. difficile (na primjer u bolesnika starije dobi ili bolesnika oslabljenog imunosnog sustava).
How is Zinplava used?
Kako se Zinplava koristi?
Zinplava is generally well tolerated with side effects similar to those observed in patients on placebo.
Bolesnici općenito dobro podnose lijek Zinplava, a njegove su nuspojave slične nuspojavama zabilježenima u bolesnika koji su primali placebo.
How does Zinplava work?
Kako djeluje Zinplava?
Zinplava given during antibiotic treatment was shown to be more effective than placebo (a dummy treatment) at preventing a new episode of diarrhoea caused by C. difficile infection in 2 main studies involving a total of 2,655 patients.
U dvama glavnim ispitivanjima, u kojima je sudjelovalo ukupno 2 655 bolesnika, primjena lijeka Zinplava tijekom liječenja antibioticima pokazala se djelotvornijom od primjene placeba (slijepo liječenje) u sprječavanju nove epizode proljeva prouzročenog infekcijom bakterijom C. difficile.
For the full list of all side effects and restrictions with Zinplava, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Zinplava potražite u uputi o lijeku.
--1Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
--1 Živi atenuirani goveđi respiratorni sincicijski virus (BRSV), soja Lym-56 . 104.7 - 6.5 CCID50* * Infektivna doza kulture stanica 50%
Route of administratio n
Put primjene Unutarnjem pakovanju
Intravenous use vial (glass)
Intravenska primjena bočica (staklena)
(Invented) name Strength Pharmaceutical Form Route of Administration
Jačina Farmaceutski oblik
hours before taking the other.
3 sata prije uzimanja drugog.
After taking one of them, wait at least 2 to 3
Poslije uzimanja jednog od njih pričekajte najmanje 2 do
When Comtess is given at higher doses:
Kad je Comtess primijenjen u visokim dozama:
Other medicines and Comtess
Drugi lijekovi i Comtess
Experience with Comtess in patients under 18 years is limited.
Iskustvo s Comtessom u bolesnika mlađih od 18 godina je ograničeno.
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
• nekontrolirano prejedanje (jedenje velikih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje više hrane nego što je normalno i potrebno za utaživanje gladi).
What Comtess is and what it is used for
Što je Comtess i za što se koristi
Talk to your doctor or pharmacist before taking Comtess:
Obratite se svom liječniku ili ljekarniku prije nego uzmete Comtess:
If you stop taking Comtess Do not stop taking Comtess unless your doctor tells you to.
Ako prestanete uzimati Comtess Comtess nemojte prestati uzimati, osim ako Vam to ne kaže liječnik.
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive;
• promijenjeno ili povećano zanimanje za spolnost i spolne odnose te ponašanje koje u značajnoj mjeri zabrinjava Vas ili druge, primjerice, pojačani seksualni nagon.
Date of first authorisation: 16 September 1998 Date of latest renewal: 3 September 2008
Datum posljednje obnove: 3. rujna 2008.
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess);
• ako uzimate određene lijekove protiv depresije (upitajte svog liječnika ili ljekarnika može li se Vaš lijek protiv depresije uzimati zajedno s Comtessom);
What Comtess is and what it is used for What you need to know before you take Comtess How to take Comtess
Što je Comtess i za što se koristi Što morate znati prije nego počnete uzimati Comtess Kako uzimati Comtess
There are large intra- and interindividual variations in the absorption of entacapone.
Postoje velike intra- i interindividualne razlike u apsorpciji entakapona.
EU/1/98/082/001 30 film-coated tablets EU/1/98/082/002 60 film-coated tablets EU/1/98/082/003 100 film-coated tablets EU/1/98/082/005 175 film-coated tablets
EU/1/98/082/001 30 filmom obloženih tableta EU/1/98/082/002 60 filmom obloženih tableta EU/1/98/082/003 100 filmom obloženih tableta EU/1/98/082/005 175 filmom obloženih tableta
What you need to know before you take Comtess
Što morate znati prije nego počnete uzimati Comtess
Comtess may make it harder for you to digest iron.
Comtess može otežati probavu željeza.
Therefore, the use of Comtess in children or adolescents cannot be recommended.
Stoga se ne preporučuje primjena Comtessa u djece ili adolescenata.
yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
žuti željezov oksid (E 172), crveni željezov oksid (E 172) i titanijev dioksid (E 171).
Do not take Comtess
Nemojte uzimati Comtess
If you forget to take Comtess
Ako ste zaboravili uzeti Comtess
The safety and efficacy of Comtess in children below age 18 have not been established.
Sigurnost i djelotvornost Comtessa u djece u dobi do 18 godina nisu ustanovljene.
If you experience such effects at the start of treatment with Comtess you should contact your doctor who may decide to adjust your dosage of levodopa.
Ako osjetite te nuspojave na početku liječenja Comtessom, trebate se obratiti svom liječniku, koji može odlučiti o prilagođavanju doziranja levodope.
Comtess in association with levodopa may have a major influence on the ability to drive and use machines.
Comtess udružen s levodopom može imati velik utjecaj na sposobnost upravljanja vozilima i strojevima.
Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtess and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Neuroleptički maligni sindrom (NMS) je ozbiljna ali rijetka reakcija na neke lijekove, i može se javiti naročito kada se naglo prekine uzimanje Comtessa i drugih lijekova za terapiju Parkinsonove bolesti, ili se njihova doza naglo smanji.
Comtess and iron supplements at the same time.
Zbog toga ne uzimajte Comtess i preparate željeza u isto vrijeme.
Comtess has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Comtess nema učinak ublažavanja simptoma Parkinsonove bolesti ako nije uzet s levodopom.
Do not use Comtess during pregnancy or if you are breast-feeding.
Comtess nemojte koristiti tijekom trudnoće i dojenja.
White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60, 100 or 175 tablets.
Bijele polietilenske (HDPE) bočice visoke gustoće s bijelim sigurnosnim polipropilenskim (PP) zatvaračem koje sadrže 30, 60, 100 ili 175 tableta.
Comtess taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Comtess uzet zajedno s levodopom može sniziti Vaš krvni tlak, zbog čega možete osjetiti laganu ošamućenost ili omaglicu.
The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtess.
Najveća preporučena doza je 10 tableta na dan, odnosno 2000 mg Comtessa.
If you forget to take the Comtess tablet with your levodopa dose, you should continue the treatment by taking the next Comtess tablet with your next levodopa dose.
Ako uz dozu levodope zaboravite uzeti Comtess, nastavite liječenje uzimanjem sljedeće Comtess tablete sa svojom sljedećom dozom levodope.
Usually side effects caused by Comtess are mild to moderate.
Nuspojave izazvane Comtessom obično su blage do umjerene.
comtess 200 mg [carton only]
comtess 200 mg [samo na kutiji]
Comtess contains soya lecithin.
Comtess sadrži sojin lecitin.
Comtess contains soya lecithin Comtess contains soya lecithin.
Comtess sadrži sojin lecitin Comtess sadrži sojin lecitin.
As Comtess tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
S obzirom da se Comtess tablete uzimaju zajedno s lijekovima na bazi levodope, molimo da pažljivo pročitate upute o lijeku i tih drugih lijekova.
Comtess tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Comtess tablete sadrže entakapon i primjenjuju se zajedno s levodopom za liječenje Parkinsonove bolesti.
Your doctor may advise you to slowly discontinue the treatment with Comtess and other medicines to treat Parkinson's disease.
Liječnik Vam može savjetovati polagano prekidanje liječenja Comtessom i drugim lijekovima za terapiju Parkinsonove bolesti.
• dizziness, tiredness, increased sweating, fall ;
• omaglica, umor, pojačano znojenje, padanje;
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine,
Međutim, još uvijek je ograničeno iskustvo kliničke primjene entakapona s nekoliko lijekova, uključujući MAO-A inhibitore, tricikličke antidepresive, inhibitore ponovne pohrane noradrenalina kao što su dezipramin, maprotilin i venlafaksin te lijekove koji se metaboliziraju putem COMT-a (npr. spojevi s kateholskom strukturom: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa, apomorfin i paroksetin).
The recommended dose of Comtess is one 200 mg tablet with each levodopa dose.
Peporučena doza Comtessa je jedna tableta od 200 mg, uz svaku dozu levodope.
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtess in association with levodopa (see section 4.4).
Poremećaji kontrole impulsa: Patološko kockanje, pojačan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, nekontrolirano prejedanje i kompulzivno jedenje mogu se javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergicima poput Comtessa zajedno s levodopom (vidjeti dio 4.4).
General characteristics of the active substance Absorption
Opća svojstva djelatne tvari
Comtess aids levodopa in relieving the symptoms of Parkinson's disease.
Comtess pomaže levodopi u ublažavanju simptoma Parkinsonove bolesti.
How to take Comtess
Kako uzimati Comtess
Comtess taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Comtess uzet s levodopom može izazvati pospanost i može dovesti do toga da ponekad iznenada utonete u san.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtess in association with levodopa.
Bolesnici i osobe koje se brinu o njima trebaju biti svjesni da se simptomi poremećaja ponašanja kontrole impulsa kao što su patološko kockanje, pojačan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, nekontrolirano prejedanje i kompulzivno jedenje mogu javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergicima poput Comtessa u kombinaciji s levodopom.
If you take more Comtess than you should In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
U slučaju predoziranja, odmah se obratite svom liječniku, ljekarniku ili najbližoj bolnici.
Comtess is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Comtess se uzima zajedno s lijekovima koji sadrže levodopu (ili kombinacija levodope/karbidope ili kombinacija levodope/benzerazida).
Comtess 200 mg film-coated tablets
Comtess 200 mg filmom obložene tablete
Suddenly stopping Comtess and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Nagli prekid primjene Comtessa, i drugih lijekova za terapiju Parkinsonove bolesti, može dovesti do nuspojava.
In addition, Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Dodatno, Comtess uzet s levodopom može izazvati jaku pospanost ili se može dogoditi da iznenada utonete u san.
What Comtess looks like and contents of the pack Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Comtess 200 mg filmom obložene tablete su smećkasto-narančaste, ovalne tablete s utisnutim „COMT“ na jednoj strani.
How to store Comtess
Kako čuvati Comtess
Comtess 200 mg film-coated tablets entacapone
Comtess 200 mg filmom obložene tablete entakapon
• Comtess taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
• u rijetkim slučajevima, nakon istodobnog uzimanja Comtessa i levodope, može se dogoditi da tijekom dana osjetite prekomjernu pospanost ili da naglo utonete u san;
The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Comtess.
Kada počnete uzimati Comtess, može biti potrebno prilagođavanje doze drugih lijekova u terapiji Parkinsonove bolesti.
United Kingdom Orion Pharma (UK) Ltd. Tel: +44 1635 520 300
Orion Pharma Poland Sp. z o.o. Tel.: +48 22 8333177
• At the request of the European Medicines Agency.
• na zahtjev Europske agencije za lijekove.
Terminal half life (t½) is 3.5-4 hours.
Terminalni poluvijek (t½) iznosi 3,5-4,0 sata.
Take Circadin after you have eaten.
Uzmite Circadin nakon obroka.
Circadin with food, drink and alcohol
Circadin s hranom, pićem i alkoholom
No special treatment is required.
Nije potrebno posebno liječenje.
- If you have been told you suffer from an autoimmune disease (where the body is ‘attacked' by its own immune system).
- Ako Vam je rečeno da patite od autoimune bolesti (u kojoj tijelo „napada“ vlastiti imunološki sustav).
The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.
Sigurnost i djelotvornost Circadina u djece u dobi od 0 do 18 godina nisu još ustanovljene.
Date of latest renewal: 20 April 2012
Datum posljednje obnove odobrenja: 20. travnja 2012.
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 established from the available data).
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 ustanoviti iz dostupnih podataka).
These medicines include:
Ti lijekovi obuhvaćaju sljedeće:
Patients were re-randomised at 3 weeks.
Bolesnici su bili ponovno randomizirani nakon 3 tjedna.
Do not give this medicine to children between the ages of 0 to 18 years as it has not been tested and its effects are unknown.
Ovaj lijek nemojte davati djeci u dobi između 0 i 18 godina jer takva primjena još nije ispitana i njegovi učinci nisu poznati.
This dosage may be continued for up to thirteen weeks.
Ovo doziranje se može nastaviti do trinaest tjedana.
If you are affected, you should not drive or operate machinery.
Ako ju osjećate, ne biste smjeli voziti niti upravljati strojevima.
If you take more Circadin than you should
Ako uzmete više Circadin nego što ste trebali
What Circadin is and what it is used for
Što je Circadin i za što se koristi
The combination should be avoided.
Kombinacija ovih lijekova mora se izbjegavati.
Do not take Circadin - if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Circadin - ako ste alergični na melatonin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
The clinical relevance of the finding is unknown.
Klinička važnost ovog nalaza nije poznata.
Tmax occurs after 3 hours in a fed state.
Tmax nastupa nakon 3 sata u stanju sitosti.
This leaflet was last revised in { month/YYYY}.
Ova uputa je zadnji puta revidirana u {mjesec/GGGG}.
35039 Marburg
35039 Marburg Njemačka
The blisters are then packed in cardboard boxes.
Blisteri su pakirani u kartonskim kutijama.
Do not take Circadin if you are pregnant, think you may be pregnant, trying to become pregnant or breast-feeding.
Nemojte uzimati Circadin ako ste trudni, mislite da biste mogli biti trudni, pokušavate ostati trudni ili dojite.
Another medicine containing melatonin may be more appropriate for administration to children between the ages of 2 to 18 - please ask your doctor or pharmacist for advice.
Drugi lijek koji sadržava melatonin može biti primjereniji za primjenu u djece u dobi između 2 i 18 godina - obratite se svom liječniku ili ljekarniku za savjet.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Primjena drugih farmaceutskih oblika/jačina može biti primjerenija u ovoj populaciji.
Not known: (Cannot be established from the available data)
Nepoznato: (Ne može se ustanoviti iz dostupnih podataka)
• Loss of consciousness or fainting
• gubitak svijesti ili nesvjestica
The study showed that the benefit observed after 3 weeks is maintained for up to 3 months but failed the primary analysis set at 6 months.
Ispitivanje je pokazalo da je korist uočena nakon 3 tjedna zadržana sve do 3 mjeseca, ali više nije prisutna kod primarne analize učinjene nakon 6 mjeseci.
Ask your doctor or pharmacist for advice before taking this medicine.
Upitajte svojeg liječnika ili ljekarnika za savjet prije uzimanja ovog lijeka.
If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.
Ako ste zaboravili uzeti tabletu, uzmite ju čim se sjetite, prije odlaska na spavanje, ili pričekajte vrijeme kada biste trebali uzeti sljedeću dozu te nastavite uzimati tablete na uobičajen način.
Other medicines and Circadin
Drugi lijekovi i Circadin
It is also associated with a hypnotic effect and increased propensity for sleep.
Ujedno je povezan s hipnotičkim učinkom i pojačanom potrebom za snom.
‘Primary' means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
"Primarno" znači da nesanica nema određeni uzrok, uključujući medicinski, mentalni ili uvjetovan okolišem.
There are no known harmful effects if treatment is interrupted or ended early.
Nema poznatih štetnih učinaka u slučaju prekida ili preranog završetka liječenja.
Do not drink alcohol before, during or after taking Circadin, because it reduces the effectiveness of Circadin.
Nemojte piti alkohol prije, tijekom ili nakon uzimanja Circadina, zato što smanjuje učinkovitost Circadina.
- If you suffer from liver or kidney problems.
- ako imate problema s jetrom ili bubrezima.
EU/1/07/392/001 21 tablets EU/1/07/392/002 20 tablets EU/1/07/392/003 30 tablets EU/1/07/392/004 7 tablets
EU/1/07/392/001 21 tableta EU/1/07/392/002 20 tableta EU/1/07/392/003 30 tableta EU/1/07/392/004 30 tableta
The carcinogenicity study in the rat did not reveal any effect which may be relevant for humans.
Ispitivanje kancerogenosti na štakorima nije pokazalo učinke koji bi mogli biti važni za ljude.
A five-fold variability in Cmax between different members of the same sex has also been observed.
Opazila se i peterostruka razlika u vrijednostima Cmax između osoba istog spola.