natgillin/translations-raw huggingface dataset:
The primary efficacy assessment was the TWSTRS Total score, and secondary efficacy assessments included VAS assessment of change evaluated by patient and investigator, conducted at 4, 8 and 12 weeks after treatment.
Kao primarna procjena djelotvornosti služio je ukupni rezultat na ljestvici TWSTRS za procjenu spazmodičnog tortikolisa, a sekundarne procjene djelotvornosti uključivale su VAS procjene promjene koje su dali bolesnik i ispitivač, provedene u 4., 8. i 12. tjednu nakon liječenja.
NeuroBloc will be given to you by a doctor with specialist experience in the treatment of cervical dystonia and in the use of botulinum toxins.
NeuroBloc će Vam dati liječnik specijalist s iskustvom u liječenju cervikalne distonije i primjeni botulinskih toksina.
In addition to improved function as demonstrated by a reduction in TWSTRS-total score, treatment with NeuroBloc was associated with a significant reduction in TWSTRS-Pain and pain VAS scores at each treatment session at weeks 4, 8 and 12 relative to baseline.
Osim poboljšanja funkcije dokazanog smanjenjem ukupnog rezultata na ljestvici TWSTRS, liječenje NeuroBlocom bilo je povezano sa značajnim smanjenjem rezultata za bol na ljestvici TWSTRS i rezultata za bol na ljestvici VAS u svakom ciklusu liječenja u 4., 8. i 12. tjednu u odnosu na početne vrijednosti.
General disorders and administration site conditions injection site pain neck pain influenza like illness
Opći poremećaji i reakcije na mjestu primjene bol na mjestu injiciranja bol u vratu bolest nalik gripi
For storage conditions after dilution of the medicinal product, see section 6.3.
Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3.
Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.
Podaci iz kliničkih ispitivanja pokazuju da je djelotvornost ovisna o dozi, ali ta ispitivanja, budući da nisu uključivala usporedbu, ne pokazuju značajnu razliku između 5000 U i 10 000 U.
NeuroBloc is provided in vials for single use only.
NeuroBloc je raspoloživ samo u bočicama za jednokratnu upotrebu.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
Solution for injection 1 vial
Otopina za injekciju 1 bočica
The units expressed are Type B Units, which are not interchangeable with the units used to express the potency of other Botulinum toxin preparations.
Te se jedinice odnose isključivo na tip B i ne smiju se zamijeniti za jedinice kojima se izražava jačina drugih pripravaka s botulinskim toksinom.
In the development studies, the No Observed Adverse Effect Dose Level (NOAEL) in rats was 1000 U/kg/day for maternal effects and 3000 U/kg/day for foetal effects.
U razvojnim ispitivanjima doza bez opaženih štetnih učinaka (No Observed Adverse Effect Dose Level, NOAEL) iznosila je u štakora 1000 U/kg/dan za maternalne učinke i 3000 U/kg/dan za fetalne učinke.
Post marketing experience
Iskustvo nakon stavljanja lijeka u promet
Co. Louth
Louth
Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach -2 ml (0.5%): 1 litre water) solution.
U slučaju prolijevanja, dekontaminirajte površinu s 10% kaustične otopine ili otopinom natrijevog hipoklorita (klorno bjelilo za domaćinstvo - 2 ml (0,5%): 1 litra vode).
Two Phase III randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
U bolesnika s cervikalnom distonijom provedena su dva randomizirana, multicentrična, dvostruko slijepa, placebom kontrolirana ispitivanja faze III.
Single dose intramuscular toxicology studies have been performed in cynomolgus monkeys.
Intramuskularna toksikološka ispitivanja jedne doze provedena su na makaki majmunima.
NeuroBloc is recommended for intramuscular administration only.
NeuroBloc se preporučuje samo za intramuskularnu primjenu.
It contains the active ingredient ‘Botulinum Toxin Type B'.
Lijek sadrži djelatni sastojak „botulinski toksin tipa B“.
The other ingredients are disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid (for pH adjustment) and water for injections.
Drugi sastojci su dinatrijev sukcinat, natrijev klorid, otopina humanog serumskog albumina, kloridna kiselina (za podešavanje pH) i voda za injekcije.
Such dilutions with sodium chloride should be done in a syringe, pulling out the desired amount of NeuroBloc into the syringe first, and then adding sodium chloride to the syringe.
Takva razrjeđenja s natrijevim kloridom treba provoditi u štrcaljki, i to tako da se najprije u štrcaljku izvuče željena količina NeuroBloca, a zatim se u štrcaljku doda natrijev klorid.
Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.
Materijal s apsorbiranim toksinom stavite u vrećicu za autoklav, nepropusno je zatvorite i zbrinite kao opasni medicinski otpad u skladu s lokalnim propisima.
NeuroBloc must only be administered by intramuscular injection.
NeuroBloc se smije primjenjivati samo kao intramuskularna injekcija.
The potency of Neurobloc is 5000 U/ml.
Jačina NeuroBloca iznosi 5000 U/ml.
Disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid and water for injections.
dinatrijev sukcinat, natrijev klorid, otopina humanog serumskog albumina, kloridna kiselina i voda za injekcije
Adverse reactions related to spread of toxin distant from the site of administration have been reported: exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases (see section 4.4).
Nuspojave koje su prijavljene povezano sa širenjem toksina udaljeno od mjesta primjene bile su: pretjerana mišićna slabost, disfagija, dispneja, aspiracijska pneumonija sa smrtnim ishodima u nekim slučajevima (vidjeti dio 4.4).
Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4).
Prijavljene su nuspojave povezane sa širenjem toksina dalje od mjesta primjene (pretjerana mišićna slabost, disfagija, dispneja, aspiracijska pneumonija sa smrtnim ishodima u nekim slučajevima) (vidjeti dio 4.4).
NeuroBloc 5000 U/ml solution for injection.
NeuroBloc 5000 U/ml otopina za injekciju.
And
SAD
Eye disorders blurred vision
Poremećaji oka zamagljen vid
Pregnancy, breast-feeding and fertility you will not normally be given NeuroBloc if you are pregnant or breast-feeding.
U normalnim okolnostima nećete primiti NeuroBloc ako ste trudni ili dojite.
Read the package leaflet before use.
Prije uporabe pročitajte Uputu o lijeku.
Studies have not been carried out in patients with hepatic or renal impairment.
Nisu provedena ispitivanja u bolesnika s oštećenjem funkcije jetre ili bubrega.
Very Common
Često
Individuals with known neuromuscular diseases (e.g. amyotrophic lateral sclerosis or peripheral neuropathy) or known neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome) must not be given NeuroBloc.
NeuroBloc se ne smije davati osobama s ustanovljenom neuromuskularnom bolešću (npr. amiotrofičnom lateralnom sklerozom ili perifernom neuropatijom) ili s ustanovljenim poremećajima neuromuskularne sinapse (npr. miastenijom gravis ili Lambert-Eatonovim sindromom).
Children (non approved use) and patients with underlying neuromuscular disorders including swallowing disorders are at increased risk of these adverse reactions.
Rizik od tih nuspojava povećan je u djece (neodobrena primjena) i bolesnika s već postojećim neuromuskularnim poremećajima uključujući poremećaje gutanja.
In the first study, type A resistant patients (A-non responders) were randomised to receive placebo or 10,000 U of NeuroBloc and in the second, type A toxin responsive patients (A-responders) were randomised to receive placebo, 5000 U or 10,000 U of toxin.
U prvom ispitivanju bolesnici rezistentni na tip A (bez odgovora na A) bili su randomizirani u skupinu koja je primala placebo ili u skupinu koja je primala 10 000 U NeuroBloca, a u drugom ispitivanju, bolesnici s odgovorom na toksin tipa
Lack of interchangeability between botulinum toxin products The initial starting dose of 10,000 U (or 5000 U) is relevant only to NeuroBloc (Botulinum Toxin Type B).
Početna doza od 10 000 U (ili 5000 U) odnosi se samo na NeuroBloc (botulinski toksin tipa B).
This may occur when higher doses of up to 15,000 units are given if you have difficulty breathing or you are worried by any symptoms you develop away from the place of the injection, talk to your doctor immediately.
Ako imate poteškoća s disanjem ili ste zabrinuti zbog nekog simptoma koji se razvio daleko od mjesta injekcije, odmah se obratite liječniku.
EXP After dilution, use immediately
Upotrijebiti odmah nakon razrjeđivanja.
The second study enrolled patients who continued to respond to type A toxin (A-responders).
Drugo ispitivanje uključilo je bolesnike u kojih se i dalje postizao odgovor na toksin tipa
Any unused solution, all vials of expired NeuroBloc and equipment used in the administration of the medicinal product should be carefully discarded as Medical Biohazardous Waste in accordance with local requirements.
Svu neupotrijebljenu otopinu, sve bočice lijeka NeuroBloc kojima je istekao rok valjanosti i pribor upotrijebljen za primjenu lijeka treba pažljivo zbrinuti kao opasan medicinski otpad u skladu s lokalnim propisima.
However, the clinical relevance of the presence of antibodies as determined by the mouse neutralisation / mouse protection assay is uncertain.
Međutim, kliničko značenje prisutnosti protutijela, kako je određeno testom neutralizacije u miševa/zaštite miševa, nije pouzdano ustanovljeno.
To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and the solution used immediately.
Da bi bilo moguće raspodijeliti ukupnu dozu na nekoliko injekcija, NeuroBloc se može razrijediti 0,9%-tnom otopinom natrijevog klorida za injekcije (9 mg/ml), a otopinu je potrebno upotrijebiti odmah.
NeuroBloc 5000 U/ml Solution for Injection Botulinum Toxin Type B
NeuroBloc 5000 U/ml otopina za injekciju botulinski toksin tipa B
NeuroBloc should only be administered by a physician who is familiar with and experience in the treatment of cervical dystonia and in the use of botulinum toxins.
NeuroBloc smiju primjenjivati samo liječnici sa znanjem i iskustvom u liječenju cervikalne distonije te primjeni botulinskih toksina.
Gastrointestinal disorders dysphagia dyspepsia
Poremećaji probavnog sustava disfagija dispepsija
How to use NeuroBloc
Kako primjenjivati NeuroBloc
However, the clinical relevance of the presence of antibodies as determined by the mouse neutralisation/ mouse protection assay is uncertain.
Međutim, kliničko značenje prisutnosti protutijela ustanovljeno testom neutralizacije u miševa/zaštita miševa ostaje nedovoljno razjašnjeno.
To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2).
Da bi se omogućila raspodjela ukupne doze na nekoliko injekcija, NeuroBloc se može razrijediti 0,9%-tnom otopinom natrijevog klorida za injekcije (9 mg/ml) (vidjeti dio 4.2).
Analysis of the TWSTRS sub scales revealed significant effects on the severity of cervical dystonia and its associated pain and disability.
Rezultati usporedbi primarnih i sekundarnih varijabli djelotvornosti sažeto su prikazani u tablici 1. Analiza podljestvica TWSTRS pokazala je značajne učinke na težinu cervikalne distonije i pridruženu bol i invalidnost.
How to store NeuroBloc
Kako čuvati NeuroBloc
To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2 of Summary of Product Characteristics).
Kako bi se ukupna doza mogla razdijeliti na nekoliko injekcija, NeuroBloc se može razrijediti 0,9%-tnom otopinom natrijevog klorida za injekcije (9 mg/ml) (vidjeti dio 4.2 Sažetka opisa svojstava lijeka).
Respiratory thoracic and mediastinal disorders dysphonia
Poremećaji dišnog sustava, prsišta i sredoprsja disfonija
How NeuroBloc is given
Kako se daje NeuroBloc
System Organ Class
Klasifikacija organskih sustava Vrlo često
Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic effects of Botulinum Toxin Type B, were observed in 12% of adverse reaction cases reported during the post-marketing experience (including the following adverse reactions: dry mouth, dysphagia and blurred vision).
B opaženi su u 12% slučajeva nuspojava prijavljenih tijekom iskustva nakon stavljanja lijeka u promet (uključujući sljedeće nuspojave: suha usta, disfagija i zamagljen vid).
Do not freeze keep the vial in the outer carton in order to protect from light within its shelf-life, NeuroBloc may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25oC.
Unutar roka valjanosti, NeuroBloc može biti izvan hladnjaka tijekom jednokratnog razdoblja do 3 mjeseca na temperaturi koja ne prelazi 25°C.
This means it is essentially “sodium free”.
To znači da zapravo ne sadrži natrij.
Standard tests to investigate the mutagenicity of NeuroBloc have not been performed.
Standardni testovi za istraživanje mutagenosti
PHARMACEUTICAL FORM
NAČIN PRIMJENE LIJEKA
The extent and time course of seroconversion were similar in patients with prior toxin A exposure and those who were toxin A naïve, and between toxin A resistant and toxin A responsive patients.
Opseg i tijek serokonverzije bili su slični u bolesnika s prethodnim izlaganjem toksinu
Human serum albumin Hydrochloric acid (for pH adjustment) Water for injections
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari dinatrijev sukcinat natrijev klorid humani serumski albumin kloridna kiselina (za podešavanje pH) voda za injekcije
NeuroBloc 5000 U/ml solution for injection IM
NeuroBloc 5000 U/ml otopina za injekciju i.m.
This is because it is not known how NeuroBloc affects patients who are pregnant and it is not known if NeuroBloc passes into a nursing mother's breast milk if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego što primite ovaj lijek.
Both studies enrolled adult patients (³ 18 years) who had a history of receiving Botulinum Toxin Type A. The first study enrolled patients who were clinically resistant to type A toxin (A-non responders), confirmed by a Frontalis Type A test.
Prvo ispitivanje uključilo je bolesnike klinički rezistentne na toksin tipa A (bez odgovora na A), potvrđeno testom Frontalis tip A.
If there are any visible signs of deterioration, the medicine should not be used, but discarded any unused solution should be discarded due to the special nature of NeuroBloc, the doctor will ensure that all used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements
Zbog posebne naravi lijeka NeuroBloc, liječnik će paziti da se sa svim upotrijebljenim bočicama, iglama i štrcaljkama postupa kao s opasnim medicinskim otpadom u skladu s lokalnim propisima.
Each ml contains 5000 U Botulinum Toxin Type B.
Jedan ml sadrži 5000 U botulinskog toksina tipa B.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 0.5 ml vial
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA, bočica od 0,5 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1.0 ml vial
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA, bočica od 1,0 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 0.5 ml vial
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE OD 0,5 ml
There have been spontaneous reports of dysphagia, aspiration pneumonia and/or potentially fatal respiratory disease, after treatment with Botulinum Toxin Type A/B.
Nakon liječenja botulinskim toksinom tipa A/B bilo je spontanih izvještaja o disfagiji, aspiracijskoj pneumoniji i/ili potencijalno smrtonosnoj respiratornoj bolesti.
MARKETING AUTHORISATION HOLDER
Nositelj odobrenja za stavljanje lijeka u promet
Marketing Authorisation holder
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 1.0 ml vial
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE OD 1,0 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2.0 ml vial
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA, bočica od 2,0 ml
Each 0.5 ml vial contains 2500 U Botulinum Toxin Type B.
Jedna bočica od 0,5 ml sadrži 2500 U botulinskog toksina tipa B.
Physician Global
Liječnička opća procjena
At the end of this period, the product should not be put back in the refrigerator and should be disposed of the date at which the medicine was taken out from the refrigerator will be put on the outer carton if the medicine is diluted, the doctor will use it immediately before using the medicine the doctor will check that the solution is clear and colourless/light yellow.
Prije primjene lijeka liječnik će provjeriti je li otopina bistra i bezbojna/svijetložuta.
Each 2.0 ml vial contains 10,000 U Botulinum Toxin Type B.
Jedna bočica od 2,0 ml sadrži 10 000 U botulinskog toksina tipa B.
Each 1.0 ml vial contains 5000 U Botulinum Toxin Type B.
Jedna bočica od 1,0 ml sadrži 5000 U botulinskog toksina tipa B.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: aminoglycoside antibiotics for an infection medicines to stop blood clotting, such as warfarin
aminoglikozidni antibiotici za liječenje infekcije lijekovi za sprječavanje razvoja krvnih ugrušaka poput varfarina.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 2.0 ml vial
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNIICA BOČICE OD 2,0 ml
How to store NeuroBloc keep this medicine out of the sight and reach of children do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP store in a refrigerator (2°C-8°C).
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza Rok valjanosti/EXP.
Having more injections of NeuroBloc the effects of NeuroBloc will usually last about 12 to 16 weeks your doctor will decide if you need another injection and how much to give you
Učinci lijeka NeuroBloc obično traju oko 12 do 16 tjedana.
These dose units are specific to NeuroBloc only and are not relevant to preparations of Botulinum Toxin Type A. The unit dose recommendations for Botulinum Toxin Type A are significantly lower than those for NeuroBloc and administration of Botulinum Toxin Type A at the unit dose recommended for NeuroBloc may result in systemic toxicity and life-threatening clinical sequelae.
Te jedinične doze vrijede isključivo za NeuroBloc i ne odnose se na pripravke botulinskog toksina tipa A.
Musculoskeletal connective tissue and bone disorders myasthenia
Poremećaji mišićno-koštanog sustava vezivnog tkiva miastenija
Renal and hepatic impairment
Oštećenje funkcije jetre i bubrega
Further information on Pazenir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pazenir.
Više informacija o lijeku Pazenir nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/pazenir.
The medicine is given once a day on days 1, 8 and 15 of each cycle.
Lijek se daje jednom dnevno 1., 8. i 15. dana svakog ciklusa.
Information on the reference medicine can also be found on the Agency's website.
Informacije o referentnom lijeku također se nalaze na internetskim stranicama Agencije.
What is Pazenir and what is it used for?
Što je Pazenir i za što se koristi?
The recommended dose depends on the patient's height and weight.
Preporučena doza ovisi o tjelesnoj težini i visini bolesnika.
What measures are being taken to ensure the safe and effective use of Pazenir?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pazenir?
Paclitaxel has been available as a cancer medicine since 1993.
Paklitaksel je dostupan kao lijek protiv raka od 1993.
Pazenir is used to treat the following cancers in adults:
Pazenir se koristi za liječenje sljedećih vrsta raka u odraslih osoba:
Pazenir received a marketing authorisation valid throughout the EU on 6 May 2019.
Lijek Pazenir dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 6. svibnja 2019.
It should not be interchanged with other medicines containing paclitaxel.
Lijek se ne smije zamijeniti drugim lijekovima koji sadrže paklitaksel.
This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Time se olakšava priprema suspenzije paklitaksela koji se može ubrizgavati u venu.
Pazenir (paclitaxel)
Pazenir (paklitaksel)
Immediately after giving Pazenir, gemcitabine should be given.
Odmah nakon davanja lijeka Pazenir potrebno je dati i gemcitabin.
Pazenir also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Pazenir također djeluje na ostale stanice koje nisu stanice raka, kao što su krvne i živčane stanice, što može prouzročiti nuspojave.
Pazenir is given as an infusion into a vein over a period of 30 minutes.
Pazenir se daje kao intravenska infuzija tijekom 30 minuta.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Abraxane, and do not need to be repeated for Pazenir.
Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Abraxane i stoga ih nije potrebno ponavljati za Pazenir.
What are the benefits and risks of Pazenir?
Koje su koristi i rizici od lijeka Pazenir?
Why is Pazenir authorised in the EU?
Zašto je lijek Pazenir odobren u EU-u?
For more information on generic medicines, see the question-and-answer document here.
Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
Side effects reported with Pazenir are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Pazenir pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
By keeping this structure intact, the cells cannot divide and they eventually die.
Budući da ta struktura ostaje cjelovita, stanice se ne mogu dijeliti te naposljetku odumiru.
Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Paklitaksel blokira fazu diobe stanica tijekom koje se unutarnji „kostur” stanice raspada kako bi se stanica mogla razdijeliti.
There was no need for ‘bioequivalence' studies to investigate whether Pazenir is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Pazenir slično referentnom lijeku da bi proizveo istu razinu djelatne tvari u krvi.
The European Medicines Agency concluded that, in accordance with EU requirements, Pazenir has been shown to be comparable to Abraxane.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je lijek Pazenir usporediv s lijekom Abraxane.
An overview of Pazenir and why it is authorised in the EU
Pregled informacija o lijeku Pazenir i zašto je odobren u EU-u