natgillin/translations-raw huggingface dataset:
Nuwiq 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 4000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 4000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 IU simoctocog alfa (200 IU/mL after reconstitution).
1 viala s praškom vsebuje 500 i.e. simoktokoga alfa (200 i.e./mL po rekonstituciji).
Nuwiq 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 IU simoctocog alfa (400 IU/mL after reconstitution).
1 viala s praškom vsebuje 1000 i.e. simoktokoga alfa (400 i.e./mL po rekonstituciji).
Nuwiq 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Nuwiq 2500 i.e. vsebuje po rekonstituciji približno 1000 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 3000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Nuwiq 250 i.e. vsebuje po rekonstituciji približno 100 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Nuwiq 3000 i.e. vsebuje po rekonstituciji približno 1200 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 4000 IU contains approximately 1600 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Nuwiq 4000 i.e. vsebuje po rekonstituciji približno 1600 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
NAME OF THE MEDICINAL PRODUCT Nuwiq 250 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 250 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT Nuwiq 2500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 2500 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT Nuwiq 500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 500 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Nuwiq 1000 i.e. vsebuje po rekonstituciji približno 400 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Zdravilo Nuwiq 500 i.e. vsebuje po rekonstituciji približno 200 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 2500 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 4000 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
Median (range)
Kromogeni preizkus Mediana (razpon)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 250 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 250 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT Nuwiq 2000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 2000 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
Name and address of the manufacturer(s) of the biological active substance(s) Octapharma AB
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 2000 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT Nuwiq 3000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 3000 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 500 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 4000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 4000 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT Nuwiq 1000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Nuwiq 1000 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/005
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/005
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 3000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 3000 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 1000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
IME ZDRAVILA IN POT(I) UPORABE Nuwiq 1000 i.e. prašek za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII) Za intravensko uporabo po rekonstituciji.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/002
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/007
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/007
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/001
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/006
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/006
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/004
Animal reproduction studies have not been conducted with Nuwiq.
Študij vpliva na sposobnost razmnoževanja pri živalih ob uporabi faktorja VIII niso izvedli.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/003
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/936/003
What happened during the re-examination?
Kaj se je zgodilo med ponovnim pregledom?
At the request of the company, the CHMP re-examined its opinion.
Na zahtevo podjetja je odbor CHMP ponovno pregledal svoje mnenje.
Yervoy has been authorised since July 2011.
Zdravilo Yervoy je bilo odobreno julija 2011.
Opdivo has been authorised since June 2015.
Zdravilo Opdivo je bilo odobreno junija 2015.
What were the CHMP's main concerns that led to the initial negative opinion?
Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP prvotno izdal negativno mnenje?
What were the conclusions of the CHMP following the re-examination?
Kakšni so bili sklepi odbora CHMP po ponovnem pregledu?
It is used to treat adults with advanced melanoma.
Uporablja se za zdravljenje odraslih z napredovalim melanomom.
However, the company must conduct a study to determine the precise contribution of Yervoy in the combination and if the risks could be further minimised.
Podjetje pa bo moralo opraviti študijo, v kateri bo natančno določilo prispevek zdravila Yervoy k tej kombinaciji ter kako bi lahko tveganje dodatno zmanjšali.
Further information on Opdivo and Yervoy's current uses can be found on the Agency's website.
Več informacij o zdravilih Opdivo in Yervoy ter o njunih trenutnih uporabah je na voljo na spletni strani agencije.
During the re-examination, the CHMP looked again at all the data and consulted a group of cancer experts and patients with cancer.
Odbor CHMP je med ponovnim pregledom ponovno preučil vse podatke in se posvetoval s skupino strokovnjakov na področju rakavih obolenj ter z bolniki z rakom.
It is also used to treat the following other cancers: melanoma (a skin cancer), non-small cell lung cancer, classical Hodgkin lymphoma (a blood cancer), squamous cell cancer of the head and neck, and urothelial (bladder) cancer.
Prav tako se uporablja za zdravljenje drugih vrst raka: melanoma (kožnega raka), nedrobnoceličnega raka pljuč, klasičnega Hodgkinovega limfoma (raka krvi), ploščatoceličnega karcinoma glave in vratu ter urotelnega raka (raka mehurja).
The study looked at the patients' response to treatment and how long patients lived, or lived without their disease getting worse.
V študiji so opazovali odziv bolnikov na zdravljenje in čas preživetja oziroma čas brez poslabšanja bolezni.
Therefore, at that point in time, the CHMP considered that the combination could not be approved because of the lack of knowledge of the contribution of Yervoy.
Zato je odbor CHMP takrat presodil, da te kombinacije ne bo odobril zaradi pomanjkanja informacij o prispevku zdravila Yervoy.
The company presented the results of a main study involving 1,096 patients with previously untreated advanced renal cell carcinoma.
Podjetje je predstavilo rezultate glavne študije, ki je vključevala 1 096 predhodno nezdravljenih bolnikov z napredovalim karcinomom ledvičnih celic.
This means that the CHMP had no way to know if the addition of Yervoy to Opdivo treatment produced additional benefit.
To pomeni, da odbor CHMP nikakor ni mogel vedeti, ali je dodajanje zdravila Yervoy doprineslo dodatno korist.
Although the precise contribution of Yervoy was not clear, the CHMP reassessed data from other non-clinical and clinical studies, including studies with the combination in relevant other cancer types, and considered that the benefit of Yervoy in the combination has been sufficiently demonstrated.
Čeravno ni bilo povsem jasno, kakšen je prispevek zdravila Yervoy, je odbor CHMP ponovno ocenil podatke iz drugih nekliničnih in kliničnih študij, vključno s študijami kombinacije v zvezi z drugimi ustreznimi vrstami raka, ter menil, da je bila koristnost zdravila Yervoy v kombinaciji dovolj dobro dokazana.
The company that applied for the change to the authorisation is Bristol-Myers Squibb Pharma EEIG.
Vlogo za spremembo dovoljenja za promet z zdravilom je vložilo podjetje Bristol-Myers Squibb Pharma EEIG.
Following the re-examination, the CHMP adopted a final positive opinion on 15 November 2018 recommending that the change to the marketing authorisation be granted for Opdivo and Yervoy, but requested the company to conduct a study to collect further data.
Odbor CHMP je 15. novembra 2018 po ponovnem pregledu sprejel končno pozitivno mnenje, v katerem je priporočil, da se dovoli sprememba dovoljenja za promet za zdravili Opdivo in Yervoy, a je od podjetja zahteval, naj izvede študijo, v kateri bo zbralo dodatne podatke.
The CHMP also discussed the possibility to request that further data be collected following the authorisation of the combination.
Prav tako je obravnaval možnost, da bi po izdaji dovoljenja za uporabo kombinacije zahteval pridobitev dodatnih podatkov.
Opdivo and Yervoy are to be used together in patients with previously untreated advanced renal cell carcinoma that is considered to be of moderate or high risk of worsening.
Zdravili Opdivo in Yervoy naj bi se uporabljali skupaj pri predhodno nezdravljenih bolnikih z napredovalim karcinomom ledvičnih celic, za katere obstaja zmerno ali veliko tveganje za poslabšanje bolezni.
On 15 November 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended that a change to the marketing authorisation for the medicinal products Opdivo (nivolumab) and Yervoy (ipilimumab) be granted.
Odbor za zdravila za uporabo v humani medicini (CHMP) je 15. novembra 2018 priporočil odobritev spremembe dovoljenja za promet z zdraviloma Opdivo (novolumab) in Yervoy (ipilimumab).
At the same time it was clear that combination with Yervoy resulted in more side effects than are seen with Opdivo alone.
Hkrati je bilo jasno, da je kombinacija z zdravilom Yervoy povzročila več neželenih učinkov kot pri samostojnem zdravilu Opdivo.
On 26 July 2018, the CHMP had originally adopted a negative opinion for the use of Opdivo and Yervoy for the treatment of renal cell carcinoma.
Odbor CHMP je 26. julija 2018 najprej sprejel negativno mnenje o uporabi zdravili Opdivo in Yervoy pri zdravljenju karcinoma ledvičnih celic.
It is already used on its own to treat renal cell carcinoma in patients who have previously been treated with other cancer medicines.
Uporablja se kot samostojno zdravilo za zdravljenje karcinoma ledvičnih celic pri bolnikih, ki so se predhodno že zdravili z drugimi zdravili proti raku.
The active substance in both medicines, nivolumab and ipilimumab, are monoclonal antibodies, a type of protein that has been designed to recognise and attach to a specific structure.
Učinkovini v obeh zdravilih, nivolumab in ipilimumab, sta monoklonski protitelesi (vrsti beljakovine), ki sta bili zasnovani tako, da prepoznata specifično prijemališče in se nanjo pritrdita.
The CHMP considered that the results from the main study comparing Opdivo and Yervoy with sunitinib showed a clinically important increase in patients' survival with the combination, and side effects were considered acceptable.
Odbor CHMP je presodil, da so rezultati študije, v kateri so primerjali zdravili Opdivo in Yervoy s sunitibom, dokazali klinično pomembno podaljšanje preživetja bolnikov s kombinacijo, medtem ko so bili neželeni učinki opredeljeni kot sprejemljivi.
The change concerns the use of both medicines together to treat renal cell carcinoma (kidney cancer).
Sprememba zadeva skupno uporabo teh zdravil pri zdravljenju karcinoma ledvičnih celic (rak ledvic).
The CHMP was of the opinion that the benefits of the combination largely outweigh its risks and therefore recommended granting the change to the marketing authorisation.
Posledično je odbor CHMP tedaj menil, da koristi kombinacije obeh zdravil odtehtajo z njima povezana tveganja, in priporočil odobritev vloge za spremembo dovoljenja za promet.
Although improvements in survival were seen in previously untreated patients given the combination of Opdivo and Yervoy compared with sunitinib, there was no evidence showing if Yervoy contributed to these results and if so, how much.
Čeprav je bilo pri primerjavi med zdraviloma Optivo in Yervoy ter sunitibom opaženo izboljšanje pri preživetju predhodno nezdravljenih bolnikih, ni bilo podatkov, ki bi dokazali, da je zdravilo Yervoy prispevalo k omenjenim rezultatom in če že, v kolikšni meri.
By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Z vezavo na receptor učinkovina nivolumab prepreči, da bi beljakovini PD-L1 in PD-L2 onemogočili delovanje celic T, s čimer poveča sposobnost imunskega sistema za uničevanje rakavih celic.
The study compared treatment with Opdivo and Yervoy versus treatment with another cancer medicine, sunitinib.
V njej so primerjali zdravljenje z zdravili Opdivo in Yervoy z zdravljenjem z drugim zdravilom za raka, sunitibom.
It is known that Opdivo alone produces benefit in previously treated patients with renal cell carcinoma.
Znano je, da samostojno zdravilo Opdivo koristi bolnikom s predhodno zdravljenim karcinomom ledvičnih celic.
How do Opdivo and Yervoy work?
Kako zdravili Opdivo in Yervoy delujeta?
Opdivo and Yervoy are cancer medicines.
Zdravili Opdivo in Yervoy sta zdravili za zdravljenje raka.
What are Opdivo and Yervoy?
Kaj sta zdravili Opdivo in Yervoy?
By blocking CTLA-4, ipilimumab causes activation and increase of T cells, which enter into tumours and kill the tumour cells.
Ipilimumab z zaviranjem delovanja beljakovine CTLA-4 spodbuja delovanje in širjenje celic T, ki prodrejo v tumor in uničijo tumorske celice.
They contain the active substances nivolumab and ipilimumab respectively.
Prvo vsebuje učinkovino nivolumab, drugo pa ipilimumab.
What are Opdivo and Yervoy to be used for?
Za kaj naj bi se zdravili Opdivo in Yervoy uporabljali?
Ipilimumab attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells.
Ipilimumab se veže na beljakovino CTLA-4, ki nadzira delovanje celic T, in zavira njeno delovanje.
Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Učinkovina nivolumab se pritrdi na receptor PD-1, ki se nahaja v nekaterih celicah imunskega sistema, imenovanih celice T. Rakave celice lahko tvorijo beljakovine (PD-L1 in PD-L2), ki se vežejo na ta receptor in onemogočijo delovanje celic T, tako da te ne morejo napasti rakavih celic.
Gastro-resistant tablet
Gastrorezistentne tablete
4.5 mg (1:1:1) film-coated tablet
4.5 mg (1:1:1) Filmsko obložena tableta
Defiante Farmacêutica, S.A. PRT
Portugalska Defiante Farmacêutica, S.A. PRT
CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule soft capsule
CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule mehka kapsula
Verovskova 57, SI-1526 Ljubljana, Slovenia
Verovškova 57, SI-1526 Ljubljana, Slovenia
Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) oral drops, solution oral use
Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) peroralne kapljice, raztopina
Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) oral drops, solution oral use
Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) peroralne kapljice, raztopina
27 May 2019
27. maj 2019
It must also not be given to patients with epilepsy who are not adequately controlled by treatment.
Prav tako se ne sme dajati bolnikom z epilepsijo, ki ni ustrezno nadzorovana z zdravljenjem.
It is given by injection.
Daje se z injiciranjem.
Why was Septanest reviewed?
Zakaj je bilo zdravilo Septanest pregledano?
The package leaflet has been updated accordingly.
Navodilo za uporabo je bilo ustrezno posodobljeno.
Septanest has been authorised in the EU via national procedures.
Zdravilo Septanest je bilo v EU odobreno z nacionalnimi postopki.
After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data or were considered redundant.
Po pregledu razpoložljivih podatkov je bilo za več drugih kontraindikacij, ki so veljale samo v nekaterih državah, ugotovljeno, da niso podprte z zadostnimi podatki ali so odvečne.
The maximum recommended dose in all ages is 7 mg of articaine per kg body weight, up to a maximum total dose of 500 mg in adults and 385 mg in children.
Največji priporočeni odmerek za vse starosti je 7 mg artikaina na kilogram telesne mase do najvišjega skupnega odmerka 500 mg pri odraslih in 385 mg pri otrocih.
A European Commission decision valid throughout the EU was issued on 27/05/2019.
Sklep Evropske komisije, ki velja po vsej EU, je bil izdan 27. maja 2019.
Septanest is also available in the EU under other trade names including Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest with Adrenaline, Septanestepi and Septocaine.
Zdravilo Septanest je v EU na voljo tudi pod drugimi trgovskimi imeni, med drugim Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest z adrenalinom, Septanestepi in Septocaine.
The recommended dose of Septanest depends on the patient's body weight.
Priporočeni odmerek zdravila Septanest je odvisen od bolnikove telesne mase.
This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information - that is, the summary of product characteristics (SmPC), labelling and package leaflet - in the countries where the medicine is marketed.
To je med državami članicami povzročilo nedoslednosti v načinu, kako se zdravilo proizvaja in lahko uporablja, kar se odraža v razlikah med informacijami o predpisovanju, tj. v povzetkih glavnih značilnosti zdravila, označevanjih in navodilih za uporabo), v državah, v katerih se zdravilo trži.
In addition, parts of Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) have also been harmonised.
Poleg tega sta bila usklajena modul 3 dokumentacije o zdravilu (v katerem je opisano, kako je zdravilo proizvedeno in kako se nadzoruje njegova kakovost).
On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Evropska agencija za zdravila (EMA) je 28. marca 2019 zaključila pregled zdravila Septanest (znanega tudi pod drugimi imeni) ter priporočila spremembe informacij o predpisovanju, da bi se uskladil način uporabe zdravila v EU.