natgillin/translations-raw huggingface dataset:
Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections
POPIS POMOĆNIH TVARI Natrijev klorid, glicin, polisorbat 80, citratna kiselina hidrat, natrijev hidroksid, voda za injekcije
Side effects in combination with other anticancer treatments
Nuspojave u kombinaciji s drugim lijekovima protiv karcinoma
When cetuximab is used in combination with chemotherapeutic agents, also refer to their respective product information.
Kad se cetuksimab koristi u kombinaciji s kemoterapeuticima treba proučiti odgovarajuću uputu o lijeku.
In combination with platinum-based chemotherapy, the frequency of severe leukopenia or severe neutropenia may be increased, and thus may lead to a higher rate of infectious complications such as febrile neutropenia, pneumonia and sepsis compared to platinum-based chemotherapy alone (see section 4.4).
U kombinaciji s kemoterapijom na bazi platine učestalost pojave teške leukopenije ili teške neutropenije može biti povećana u odnosu na samostalnu primjenu kemoterapije na bazi platine i tako voditi do povećane stope infekcijskih komplikacija kao što su febrilna neutropenija, pneumonija i sepsa (vidjeti dio 4.4.).
Erbitux 5 mg/mL solution for infusion Cetuximab
Erbitux 5 mg/ml otopina za infuziju cetuksimab
Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Spojite infuzijsku liniju na štrcaljku te započnite infuziju nakon što se liniju ispuni Erbituxom ili 0,9%-tnom (9 mg/ml) sterilnom otopinom natrijeva klorida.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
Ako primate Erbitux u kombinaciji s lijekovima protiv karcinoma koji uključuju platinu, vjerojatnije je da ćete imati pad broja bijelih krvnih stanica.
Frequency not known:Superinfection of skin lesions*.
Nepoznata učestalost: Superinfekcija kožnih lezija.* Opći poremećaji i reakcije na mjestu primjene Vrlo često:
continue slow infusion and immediately administer treatment for symptoms c) Grade 3 and 4:
nastavite sporu infuziju i odmah uvedite terapiju za simptome c) Stupanj 3 i 4: odmah prekinite infuziju, agresivno liječite simptome i kontraindicirajte daljnju primjenu cetuksimaba
Erbitux may cause side effects concerning the skin.
Erbitux može uzrokovati nuspojave vezane za kožu.
Each mL of the solution for infusion contains 5 mg cetuximab.
Jedan ml otopine za infuziju sadrži 5 mg cetuksimaba.
• CA225025: This randomised study in patients with metastatic colorectal cancer who had received prior oxaliplatin-, irinotecan- and fluoropyrimidine-based treatment for metastatic disease compared the addition of cetuximab as a single agent to best supportive care (BSC) (287 patients) with best supportive care (285 patients).
• CA225025: Ovo randomizirano ispitivanje u bolesnika s metastatskim kolorektalnim karcinomom koji su za liječenje metastatske bolesti prethodno primali terapiju baziranu na oksaliplatinu, irinotekanu i fluoropirimidinu uspoređivalo je dodatak cetuksimaba kao samostalnog lijeka najboljoj suportivnoj terapiji (BSC) (287 bolesnika) s najboljom suportivnom terapijom (285 bolesnika).
Cetuximab plus FOLFIRI
Cetuksimab i FOLFIRI
CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
CI = interval pouzdanosti, OxMdG = oksaliplatin i infuzijski 5-FU/FA, OS (overal survival time) = ukupno vrijeme preživljenja, PFS (progression-free survival time) = vrijeme preživljenja bez napredovanja bolesti
How to store Erbitux
Kako čuvati Erbitux
No clinical benefit could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
U bolesnika s KPS ≤ 80, starosti 65 godina i starijih, klinička korist nije dokazana.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Udio bolesnika s „divljim tipom“ tumora KRAS-a u populaciji bolesnika kod kojih se mogao odrediti KRAS status iznosio je 58%.
Hazard Ratio (95% CI) p-value
Omjer hazarda (95% CI) p-vrijednost
A careful benefit/risk assessment should be undertaken including consideration whether the patient may have preformed IgE antibodies before a subsequent infusion is given.
Prije davanja sljedeće infuzije treba provesti pažljivu procjenu koristi i rizika te uzeti u obzir i mogućnost da je bolesnik stvorio IgE protutijela.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
Udio bolesnika s „divljim tipom“ tumora KRAS-a u populaciji bolesnika kod kojih se mogao odrediti KRAS status iznosio je 57%.
1082 MA Amsterdam The Netherlands
Merck Europe B.V. 1082 MA Amsterdam Nizozemska
An increased frequency of severe and sometimes fatal cardiovascular events and treatment emergent deaths has been observed in the treatment of non-small cell lung cancer, squamous cell carcinoma of the head and neck and colorectal carcinoma.
Pri liječenju karcinoma pluća nemalih stanica, karcinoma pločastih stanica glave i vrata te kolorektalnog karcinoma opažena je povećana učestalost teških i ponekad smrtnih kardiovaskularnih poremećaja i iznenadnih smrti.
• with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets,
• infuzijskim sustavima od polietilena (PE), poliuretana (PUR), etilvinilacetata (EVA),
How to use Erbitux
Kako primjenjivati Erbitux
Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe.
Blage do umjerene reakcije povezane s infuzijom (vidjeti dio 4.4); mukozitis, u pojedinim slučajevima teškog oblika, koji može dovesti do epistakse.
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI)
OS mjeseci, medijan (95% CI) Omjer hazarda (95% CI) p-vrijednost PFS mjeseci, medijan (95% CI)
• nail disorders, for example inflammation of the nail bed
• poremećaji nokata npr. upala korijena nokta
• CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients).
• CA225006: Ovo randomizirano ispitivanje kod bolesnika s metastatskim kolorektalnim karcinomom koji su na početku liječenja metastatske bolesti primili kombinaciju oksaliplatina i fluoropirimidina uspoređivalo je kombinaciju cetuksimaba i irinotekana (648 bolesnika) i samo irinotekana (650 bolesnika).
For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population.
Za procjenu RAS statusa, na svim procjenjivim uzorcima tumora unutar populacije „divljeg tipa“ eksona 2 KRAS-a utvrđene su druge mutacije osim onih na eksonu 2 gena KRAS.
• EMR 62 202-007: This randomised study in patients with metastatic colorectal cancer after failure of irinotecan-based treatment for metastatic disease as the last treatment before study entry compared the combination of cetuximab and irinotecan (218 patients) with cetuximab monotherapy (111 patients).
• EMR 62 202-007: ovo randomizirano ispitivanje u bolesnika s metastatskim kolorektalnim karcinomom nakon neuspjeha terapije metastatske bolesti bazirane na irinotekanu, kao posljednje terapije davane prije ulaska u ispitivanje, uspoređivalo je kombinaciju cetuksimaba i irinotekana (218 bolesnika) s cetuksimabom u monoterapiji (111 bolesnika).
Of these, 342 patients had RAS wild-type tumours while RAS mutations were identified in 65 patients.
RAS-a, dok su mutacije RAS-a bile utvrđene u 65 bolesnika.
Rare ( 1/10,000 to < 1/1,000)
Rijetko (≥1/10 000 i <1/1000)
• EMR 62 202-002: This randomised study in patients with recurrent and/or metastatic squamous cell cancer of the head and neck who had not received prior chemotherapy for this disease compared the combination of cetuximab and cisplatin or carboplatin plus infusional 5-fluorouracil (222 patients) to the same chemotherapy alone (220 patients).
• EMR 62 202-002: ovo randomizirano ispitivanje kod bolesnika s recidivirajućim i/ili metastatskim karcinomom pločastih stanica glave i vrata koji ranije nisu primali kemoterapiju za ovu bolest usporedilo je kombinaciju cetuksimaba i cisplatine ili karboplatine zajedno s infuzijskim 5 -fluorouracilom (222 bolesnika) s kemoterapijom (220 bolesnika).
For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products.
Pri istodobnoj primjeni kemoterapeutika, za njihovo doziranje ili promjenu preporučene doze pogledajte upute za dotični lijek.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 63%.
Udio bolesnika s KRAS „divljim tipom“ tumora u populaciji bolesnika kod kojih se mogao odrediti KRAS status iznosio je 63%.
Common ( 1/100 to < 1/10)
Često (≥1/100 i <1/10)
(95% CI) p-value BSC = best supportive care, CI = confidence interval, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
BSC (best supportive care) = najbolja suportivna terapija, CI = interval pouzdanosti, ORR (objective response rate) = stopa objektivnog odgovora (bolesnici s potpunim ili djelomičnim odgovorom), OS (overal survival time)= ukupno vrijeme preživljenja, PFS (progression-free survival time) = vrijeme preživljenja bez napredovanja bolesti
Odds Ratio (95% CI) p-value
Omjer vjerojatnosti (95% CI) p-vrijednost
Before starting treatment for metastatic cancer of the large intestine your doctor will test your cancer cells if they contain the normal (wild-type) or mutant form of RAS. You must not receive Erbitux in combination with other anticancer treatment containing oxaliplatin if your cancer cells contain the mutant form of RAS.
Prije početka liječenja metastatskog karcinoma debelog crijeva liječnik će ispitati stanice Vašeg karcinoma na prisutnost normalnog („divljeg tipa“) ili mutiranog tipa RAS-a.
Each vial of 20 mL contains 100 mg cetuximab.
Jedna bočica od 20 ml sadrži 100 mg cetuksimaba.
CI = confidence interval, FOLFOX4 = oxaliplatin plus continuous infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time, NE = not estimable
CI = interval pouzdanosti, FOLFOX4 = oksaliplatin i infuzijski 5-FU/FA, ORR = (objective response rate) stopa objektivnog odgovora (bolesnici s potpunim ili djelomičnim odgovorom), OS (overal survival time) = ukupno vrijeme preživljenja, PFS (progression-free survival time) = vrijeme preživljenja bez napredovanja bolesti, NE = nije procjenjivo
CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
CI = interval pouzdanosti, FOLFIRI = irinotekan i infuzijski 5-FU/FA, ORR = (objective response rate) stopa objektivnog odgovora (bolesnici s potpunim ili djelomičnim odgovorom), OS (overal survival time) = ukupno vrijeme preživljenja, PFS (progression-free survival time) = vrijeme preživljenja bez napredovanja bolesti
For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population (65%).
Za procjenu RAS statusa, na svim procjenjivim uzorcima tumora unutar populacije „divljeg tipa“ eksona 2 KRAS-a (65%) utvrđene su i druge mutacije osim onih na eksonu 2 gena KRAS.
• EMR 62 202-013: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI) (599 patients) to the same chemotherapy alone (599 patients).
• EMR 62 202-013: Ovo randomizirano ispitivanje u bolesnika s metastatskim kolorektalnim karcinomom koji ranije nisu primali terapiju za metastatsku bolest uspoređivalo je kombinaciju cetuksimaba i irinotekana te infuzijskog 5-fluorouracila/folne kiseline (FOLFIRI) (599 bolesnika) s jednakom samostalnom kemoterapijom (599 bolesnika).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Erbitux 5 mg/mL solution for infusion
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Erbitux 5 mg/ml otopina za infuziju cetuksimab
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value Best overall response rate
OS mjeseci, medijan (95% CI) Omjer hazarda (95% CI) p-vrijednost PFS mjeseci, medijan (95% CI) Omjer hazarda (95% CI) p-vrijednost Najbolja ukupna stopa odgovora
1 vial of 100 mg/20 mL
1 bočica od 100 mg/20 ml 1 bočica od 500 mg/100 ml
• EMR 62 202-047: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid (FOLFOX4) (169 patients) to the same chemotherapy alone (168 patients).
• EMR 62 202-047: Ovo randomizirano ispitivanje u bolesnika s metastatskim kolorektalnim karcinomom koji ranije nisu primali terapiju za metastatsku bolest uspoređivalo je kombinaciju cetuksimaba i oksaliplatina te infuzijskog 5-fluorouracila/folne kiseline (FOLFOX4) (169 bolesnika) s jednakom samostalnom kemoterapijom (168 bolesnika).
RAS mutant population
RAS-a populacija mutiranog RAS-a varijabla/statistika
NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion
NAZIV LIJEKA Erbitux 5 mg/ml otopina za infuziju
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
OS mjeseci, medijan (95% CI) Omjer hazarda (95% CI) p-vrijednost PFS mjeseci, medijan (95% CI) Omjer hazarda (95% CI) p-vrijednost ORR
NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion Cetuximab
NAZIV LIJEKA Erbitux 5 mg/ml otopina za infuziju cetuksimab
• decrease in blood levels of calcium
• pad razine kalcija u krvi
Each vial of 100 mL contains 500 mg cetuximab.
Jedna bočica od 100 ml sadrži 500 mg cetuksimaba.
• diarrhoea
• zimica
Uncommon ( 1/1,000 to < 1/100)
Manje često (≥ 1/1000 i < 1/100)
A doctor experienced in the use of anticancer medicines will supervise your Erbitux therapy.
Vaše liječenje Erbituxom nadzirati će liječnik iskusan u korištenju lijekova protiv karcinoma.
Hypomagnesaemia is reversible following discontinuation of cetuximab.
Po ukidanju cetuksimaba, hipomagnezijemija je reverzibilna.
KRAS mutant population
KRAS-a populacija mutiranog KRAS-a varijabla/statistika
Cetuximab as a single agent
Cetuksimab kao samostalni lijek
• chest pain (a symptom of side effects on your heart) If such symptoms occur, speak to a doctor immediately.
• bol u prsnom košu (simptom nuspojave koja je zahvatila srce)
If you have any further questions on the use of this medicine, ask your doctor.
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom Erbituxa, obratite se svom liječniku ili ljekarniku.
Radiation therapy + cetuximab
OxMdG Cetuksimab i OxMdG
• chills
• proljev
Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion.
Tijekom infuzije, i najmanje 1 sat nakon infuzije, potrebno je pomno pratiti bolesnika.
The following definitions apply to the frequency terminology used hereafter: Very common ( 1/10)
Učestalost pojavljivanja opisana je sljedećom terminologijom:
• The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
• PRAC je zaključio da je povećan rizik od pneumonije potrebno uključiti u informacije o proizvodu svih lijekova koji sadrže ICS indiciranih u liječenju KOPB-a, s upozorenjem za zdravstvene radnike i pacijente da budu na oprezu u pogledu mogućeg razvoja pneumonije kod
Scientific conclusions
Farmaceutski oblik
Content (concentration)
Sadržaj (koncent racija)
Strength Pharmaceutical form
Farmaceutsk i oblik
5 (5 x 1) vials (multipack)
5 (5 x 1) bočica (višestruko pakiranje)
1 pre-filled pen + 7 NovoTwist needles
1 napunjena brizgalica + 7 igala NovoTwist
1 pre-filled pen + 7 NovoFine Plus needles
1 napunjena brizgalica + 7 igala NovoFine Plus
1 pre-filled pen + 7 NovoFine needles
1 napunjena brizgalica + 7 igala NovoFine
Pregabalin Sandoz GmbH is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Pregabalin Sandoz GmbH dostupan je obliku kapsula (25, 50, 75, 100, 150, 200, 225 i 300 mg), a izdaje se samo na recept.
This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Ovo smanjuje djelovanje pojedinih živčanih stanica u mozgu i kralježničnoj moždini, smanjujući otpuštanje drugih neurotransmitora koji su uključeni u bol, epilepsiju i anksioznost.
Stopping treatment with Pregabalin Sandoz GmbH should also be done gradually, over at least a week.
Prekid terapije lijekom Pregabalin Sandoz treba također provoditi postepeno, tijekom najmanje jednog tjedna.
The active substance in Pregabalin Sandoz GmbH, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Djelatna tvar lijeka Pregabalin Sandoz, pregabalin, je sličan po strukturi neurotransmiteru tijela gamaaminobutiričnoj kiselini (GABA), no ima vrlo drugačije biološko djelovanje.
Pregabalin Sandoz GmbH is a medicine used to treat adults with the following conditions:
Pregabalin Sandoz je lijek koji se koristi za liječenje odraslih osoba sa sljedećim stanjima:
The Committee recommended that Pregabalin Sandoz GmbH be approved for use in the EU.
Povjerenstvo je preporučilo odobrenje lijeka Pregabalin Sandoz za korištenje u EU-u.
This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz GmbH.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Pregabalin Sandoz.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz GmbH has been shown to have comparable quality and to be bioequivalent to Lyrica.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Pregabalin Sandoz posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Lyrica.
This means that Pregabalin Sandoz GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
To znači da je Duloxetine Sandoz sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Cymbalta.
What measures are being taken to ensure the safe and effective use of Pregabalin Sandoz GmbH?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pregabalin Sandoz?
• epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
• epilepsijom, kada se koristi kao „dodatna” terapija postojećoj terapiji u bolesnika koji imaju djelomične napadaje (epileptične napadaje u jednom specifičnom djelu mozga) koji se ne može kontrolirati s njihovim aktualnim liječenjem;
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Sandoz GmbH, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Pregabalin Sandoz nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
A risk management plan has been developed to ensure that Pregabalin Sandoz GmbH is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pregabalin Sandoz.
For practical information about using Pregabalin Sandoz GmbH, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o korištenju lijeka Pregabalin Sandoz bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
Because Pregabalin Sandoz GmbH is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Budući da je Pregabalin Sandoz je generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Lyrica.
Because Pregabalin Sandoz GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je lijek Pregabalin Sandoz generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
The full EPAR and risk management plan summary for Pregabalin Sandoz GmbH can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Pregabalin Sandoz nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Pregabalin Sandoz pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
What are the benefits and risks of Pregabalin Sandoz GmbH?
Koje su koristi i rizici od lijeka Pregabalin Sandoz?
The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz GmbH on 19 June 2015.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Lumark na snazi u Europskoj uniji od 19. lipnja 2015.
It is not intended to provide practical advice on how to use Pregabalin Sandoz GmbH.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Pregabalin Sandoz.
What is Pregabalin Sandoz GmbH and what is it used for?
Što je Pregabalin Sandoz i za što se koristi?
Pregabalin Sandoz GmbH is a ‘generic medicine'.
Ibandronatna kiselina Sandoz je „generički lijek”.
Other information about Pregabalin Sandoz GmbH
Ostale informacije o lijeku Pregabalin Sandoz
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 Pregabalin Sandoz sadrži djelatnu tvar pregabalin.
Why is Pregabalin Sandoz GmbH approved?
Zašto je Pregabalin Sandoz odobren?
How has Pregabalin Sandoz GmbH been studied?
Kako je Pregabalin Sandoz ispitivan?
How is Pregabalin Sandoz GmbH used?
Kako se koristi Pregabalin Sandoz?
How does Pregabalin Sandoz GmbH work?
Kako djeluje Pregabalin Sandoz?
There are no active patients;
Ne postoje aktivni bolesnici;
It was noted that three Clinical studies are currently ongoing:
Navedeno je da se trenutačno provode tri klinička ispitivanja:
This is potentially a plausible mechanism which needs to be further investigated.
Ovo je potencijalno plauzibilni mehanizam koji je potrebno dalje istražiti.
It is administered as 150 mg dose subcutaneously once a month.
Primjenjuje se u dozi od 150 mg supkutano jednom mjesečno.
It is ongoing in 9 countries with more than 400 patients.
Provodi se u 9 zemalja i obuhvaća više od 400 bolesnika.
ZEUS: non-interventional study in Germany with 609 patients enrolled currently.
ZEUS: neintervencijsko ispitivanje u Njemačkoj s trenutačno upisanih 609 bolesnika.