natgillin/translations-raw huggingface dataset:
The amount of salbutamol depositing in the lung or in certain regions of the lung has clinical relevance and therefore single stages of the impactor represent a certain particle size or a size-range which correlates to the site of deposition.
Količina salbutamola, ki se odloži v pljučih ali v določenih predelih pljuč, ima klinični pomen, zato posamezne stopnje impaktorja predstavljajo določeno velikost delcev ali razpon velikosti delcev, ki ustreza mestu odlaganja.
The Applicant also included results from a comparative pharmacokinetic study evaluating systemic safety, which demonstrates equivalence and considered that the equivalence of the Cmax values as identified from the systemic safety study supports the prediction of equivalent lung bioavailability and equivalent lung deposition.
Predlagatelj je vključil tudi rezultate primerjalne farmakokinetične študije, v kateri so ovrednotili sistemsko varnost in ki je dokazala enakovrednost, ter menil, da enakovrednost vrednosti Cmax, kot so bile ugotovljene v študiji sistemske varnosti, podpira napoved enakovredne biološke razpoložljivosti v pljučih in enakovrednega odlaganja v pljučih.
The Applicant considered that the overall data demonstrate that spacer use results in the same high extent of in vitro equivalence as inhaler testing without this device.
Predlagatelj je menil, da skupni podatki dokazujejo, da pomeni uporaba podaljška enako veliko in vitro enakovrednost, kot je opažena pri testiranju inhalatorja brez tega pripomočka.
Particles >4.5 µm are swallowed and contribute by negligible amount to the early systemic bioavailability (as Cmax) and peak adverse events of inhaled salbutamol.
Delci, večji od 4,5 µm, se zaužijejo in imajo zanemarljiv prispevek k zgodnji sistemski biološki razpoložljivosti (kot Cmax) in najmočnejše neželene učinke zaradi inhaliranega salbutamola.
b) The Applicant indeed considered that it is the amount of respirable particles <4.7 µm that will ultimately determine bronchodilator efficacy, particularly for stages 3/4/5 (i.e. particle size 1.1-4.7 µm) which correspond to bronchial deposition where the airway smooth muscle beta-2 adrenoceptors are located.
b) Predlagatelj je menil, da je količina delcev, ki jih je mogoče vdihniti in so manjši od 4,7 µm, tista, ki v končni fazi določa bronhodilatacijski učinek, posebej na 3., 4. in 5. stopnji (tj. velikost delcev 1,1-4,7 µm), kar ustreza odlaganju v bronhijih, kjer se nahajajo beta-2-adrenoceptorji gladkih mišic dihalnih poti.
The Applicant stated that for pharmacokinetic studies, equivalence is conventionally demonstrated by applying a +/- 20% limit for the 90% CI and therefore applied these limits to the FDP comparison, despite the recent EMEA guidance recommending +/- 15% limits for in vitro equivalence and +/- 20% limits for in vivo pharmacokinetic equivalence.
Predlagatelj je navedel, da se pri farmakokinetičnih študijah enakovrednost navadno dokazuje z uporabo ±20 % omejitve za 90-odstotni interval zaupanja, zato je za primerjavo odmerkov drobnih delcev uporabil navedene omejitve, čeprav zadnja smernica agencije EMEA priporoča ±15 % omejitve za in vitro enakovrednost in ±20 % omejitve za in vivo farmakokinetično enakovrednost.
Based on the submitted expert report from study 2007-76-DOS-6, the Applicant concluded that “the presented in vitro data for fine particle dose and the in vivo data for lung bioavailability as Cmax clearly point to the presence of therapeutic equivalence within the 20% limits for both airway and systemic beta-2 adrenoceptor mediated peak effects.
Predlagatelj je na podlagi predloženega strokovnega poročila za študijo 2007-76-DOS-6 zaključil, da „predstavljeni in vitro podatki za odmerek drobnih delcev ter in vivo podatki za biološko razpoložljivost v pljučih v obliki Cmax jasno nakazujejo na obstoj terapevtske enakovrednosti znotraj 20-odstotne omejitve za najmočnejše učinke v dihalnih poteh in učinke, ki jih mediirajo sistemski beta-2 adrenoceptorji.
The data clearly shows that the spacer induces a significant depletion of large particles in the throat and an increase in fine particle dose (< 5 µm particles), with the confidence intervals for the single impactor stages within the +/- 20% limit, except for stage 0.
Podatki jasno kažejo, da uporaba podaljška povzroči znatno zmanjšanje količine velikih delcev v grlu in povečanje odmerka drobnih delcev (manjših od 5 µm), intervali zaupanja za posamezne stopnje impaktorja pa so z izjemo 0. stopnje znotraj ±20-odstotne omejitve.
The Applicant provided single issue specific protocols for test and generic products, demonstrating that the approach for demonstration of in vitro equivalence followed a planned and sound concept.
Predlagatelj je za testno in generično zdravilo priskrbel protokole, specifične za posamezen zadržek, in s tem pokazal, da je pristop za dokazovanje in vitro enakovrednosti temeljil na načrtovani in trdni zasnovi.
Question 4 - Raw data of the comparison with spacer have not been provided and neither the raw data nor results in humid conditions have been provided and discussed.
Četrto vprašanje - Predlagatelj ni predložil neobdelanih podatkov o primerjavi ob uporabi podaljška niti neobdelanih podatkov in rezultatov v vlažnih pogojih.
The CHMP was of the opinion that based on the totality of the data submitted, including the data from the pulmonary deposition study (Study 2007-76-DOS-6), a similar particle size distribution between the test and the reference product could be demonstrated.
Odbor CHMP je menil, da je na podlagi vseh predloženih podatkov, vključno s podatki iz študije odlaganja v pljučih (študija 2007-76-DOS-6), mogoče dokazati podobno porazdelitev velikosti delcev tako pri testnem kot tudi referenčnem zdravilu.
As stated earlier, the Applicant provided initial repriming studies on the test product which were complemented with a repriming study with the reference product and the CHMP considered that while the data demonstrate the effect of the position of the MDI on the deposited dose, this effect is observed in both the test and the reference product.
Kot je bilo že ugotovljeno, je predlagatelj predložil začetne študije ponovnega polnjenja testnega zdravila, ki jih je dopolnil s študijo ponovnega polnjenja z referenčnim zdravilom, odbor CHMP pa je menil, da je kljub dokazanemu vplivu položaja inhalatorja na odmerjeni odmerek ta vpliv na odložen odmerek opazen tako pri testnemu kot tudi referenčnemu zdravilu.
The Applicant was able to present data from the pulmonary deposition study (Study 200776-DOS-6) were presented and interpreted and this new in vitro data (without spacer in a normal and humid environment and with spacer in a normal environment) suggested a similar particle size distribution between the test and the reference product.
Predstavil in obrazložil je podatke iz študije odlaganja v pljučih (študija 2007-76-DOS-6), ti novi in vitro podatki (brez uporabe podaljška v normalnem in vlažnem okolju in z uporabo podaljška v normalnem okolju) pa nakazujejo na enako porazdelitev velikosti delcev tako pri testnem kot tudi referenčnem zdravilu.
The Applicant stated that the presented in vitro data can be predictive of pharmacokinetic bioequivalence for Cmax and for peak airway and systemic beta-2 adrenoceptor mediated responses, which are mainly determined by lung bioavailability.
Predlagatelj je izjavil, da lahko predstavljeni in vitro podatki nakazujejo na farmakokinetično biološko enakovrednost za Cmax in za največje odzive dihalnih poti in odzive, ki jih mediirajo sistemski beta-2-adrenoceptorji, kar v glavnem določa biološka razpoložljivost v pljučih.
The amount of salbutamol impacted on stages comprising throat/0/1/2 are non respirable (i.e. >4.7 µm) and will correspond to larger particles deposited on the oropharynx (throat stage) and upper airway (stages 0/1/2).
Količine salbutamola, zaustavljene na stopnjah, ki obsegajo 0., 1. in 2. stopnjo grla, ni mogoče vdihniti (tj. delci večji od 4,7 µm), in ustrezajo večjim delcem, ki se nalagajo na mezofarinks (stopnja grla) in v zgornjih dihalnih poteh (0., 1. in 2. stopnja).
In conclusion, the CHMP considered that the Applicant responses to the List of Outstanding Issues did allow the committee to conclude that the test and the reference product are similar when used without a spacer, with regards to safety aspects.
Odbor CHMP je menil, da lahko na podlagi odgovorov predlagatelja na seznam nerešenih vprašanj pride do zaključka, da sta testno in referenčno zdravilo, kar zadeva varnost, podobni pri uporabi brez podaljška.
The pharmacokinetic bioequivalence study also confirmed that both products possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown.
Farmakokinetična študija biološke enakovrednosti je potrdila tudi, da imata obe zdravili enak profil sistemske varnosti, saj je bila dokazana biološka enakovrednost na sistemskih ravneh (AUC in Cmax).
Although the claim of the Applicant that the PK bioequivalence study demonstrated equivalence without spacer was endorsed, the CHMP did not support the assumption that the data with the use of a spacer would provide the same evidence of equivalence and therefore considered that a PK study with a spacer is mandatory.
Čeprav je odbor CHMP sprejel trditev predlagatelja, da je farmakokinetična študija biološke enakovrednosti dokazala enakovrednost brez uporabe podaljška, pa ni mogel podpreti predpostavke, da bi podatki ob uporabi podaljška pomenili enak dokaz enakovrednosti, zato je menil, da je farmakokinetična študija o uporabi podaljška obvezna.
- the CHMP considered that Sabumalin and the reference product possess the same systemic safety profile, as demonstrated by the bioequivalence in systemic levels (AUC and Cmax),
- CHMP je menil, da imata zdravilo Sabumalin in referenčno zdravilo enak profil sistemske varnosti, kot je bilo dokazano z biološko enakovrednostjo na sistemskih ravneh (AUC in Cmax),
For stages representing extra fine particles (<1.1µm), equivalence was also shown, with the exception of deposition in the filter stage (outside +15% but within +20%).
Enakovrednost je bila dokazana tudi za stopnje, ki predstavljajo posebej drobne delce (manjše od 1,1µm), z izjemo odlaganja v filtrirni stopnji (zunaj ±15 %, vendar znotraj ±20 %).
However, equivalence between the test and reference products has still not been fully demonstrated although this may be addressed by submitting an analysis of the data from the ongoing study 2007-76-DOS-6, the CHMP addressed two outstanding issues to be discussed by the Applicant during an oral explanation:
Vendar enakovrednost testnega in referenčnega zdravila še vedno ni bila popolnoma dokazana, čeprav lahko predlagatelj na to odgovori s predložitvijo analize podatkov iz tekoče študije 2007-76-DOS-6.
a. Why the comparison of all the individual stages is not more discriminative to detect differences between formulations that may have clinical relevance b. Why the particles of 6 µm or up to 8 µm, which are deposited in stage 1, are considered with regards to safety only.
b. Zakaj se delci velikosti 6 µm ali do 8 µm, ki se odlagajo na 1. stopnji, obravnavajo le glede na varnost?
The Applicant concluded that the in vitro data and the negligible clinical relevance of the differences detected were supported by the provided in vivo study.
Predlagatelj je zaključil, da predložena študija in vivo podpira podatke in vitro in zanemarljiv klinični pomen odkritih razlik.
The pharmacokinetic bioequivalence data also confirmed that Sabumalin and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown, when used with or without a spacer.
Farmakokinetični podatki o biološki enakovrednosti so prav tako potrdili, da imata zdravilo Sabumalin in referenčno zdravilo, ob uporabi podaljška ali brez njega, enak profil sistemske varnosti, saj je bila dokazana biološka enakovrednost na sistemskih ravneh (AUC in Cmax).
SalbuLEK
Jakost
presción EFG
Nemčija pressurizzata per
Invented name Strength Pharmaceutical form Route of administration Packaging
Farmacevtska oblika
The European Commission granted a marketing authorisation valid throughout the European Union for Orbactiv on 19 March 2015.
Evropska komisija je dovoljenje za promet z zdravilom Orbactiv, veljavno po vsej Evropski uniji, izdala 19. marca 2015.
What measures are being taken to ensure the safe and effective use of Orbactiv?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Orbactiv?
The full EPAR and risk management plan summary for Orbactiv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Orbactiv sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These also included infections caused by MRSA.
Med njimi so bile tudi okužbe, ki jih povzroča bakterija MRSA.
The recommended dose is a single infusion of 1,200 mg over three hours.
Priporočeni odmerek je 1 200 mg v obliki ene 3-urne infuzije.
The study also looked at the number of patients whose infection was cured after treatment.
V študijah so merili tudi število bolnikov, pri katerih je bila okužba po zdravljenju ozdravljena.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Orbactiv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Orbactiv večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria.
Deluje tako, da prepreči, da bi si določene bakterije zgradile celične stene, s čimer bakterije uniči.
This is a summary of the European public assessment report (EPAR) for Orbactiv.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Orbactiv.
In both studies, the main measure of effectiveness was the number of patients who responded within 3 days of starting treatment with an improvement in their skin in the infected area, lack of fever and no need for additional antibiotic.
V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se v treh dneh po začetku zdravljenja nanj odzvali z izboljšanjem kože na okuženem območju ter odsotnostjo povišane telesne temperature in potrebe po dodatnih antibiotikih.
Other information about Orbactiv
Druge informacije o zdravilu Orbactiv
A risk management plan has been developed to ensure that Orbactiv is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Orbactiv je bil pripravljen načrt obvladovanja tveganj.
What benefits of Orbactiv have been shown in studies?
Kakšne koristi je zdravilo Orbactiv izkazalo v študijah?
In addition, 82.7% of patients treated with Orbactiv in the first study and 79.6% in the second study were cured, compared with 80.5% and 80.0% respectively of patients treated with vancomycin.
Poleg tega je bilo v prvi študiji ozdravljenih 82,7 % bolnikov, zdravljenih z zdravilom Orbactiv, v drugi študiji pa 79,6 %, v primerjavi z 80,5 oziroma 80,0 % bolnikov, zdravljenih z vankomicinom.
What is Orbactiv and what is it used for?
Kaj je zdravilo Orbactiv in za kaj se uporablja?
The CHMP considered that these side effects were manageable and adequately addressed in the product information.
Menil je, da so ti neželeni učinki obvladljivi in da so ustrezno obravnavani v informacijah o zdravilu.
Why is Orbactiv approved?
Zakaj je bilo zdravilo Orbactiv odobreno?
The active substance in Orbactiv, oritavancin, is a type of antibiotic called a glycopeptide.
Zdravilna učinkovina v zdravilu Orbactiv, oritavancin, je vrsta antibiotika, ki se imenuje glikopeptid.
Orbactiv has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Zdravilo Orbactiv je dokazano učinkovito proti bakterijam (na primer proti na meticilin odporni bakteriji Staphylococcus aureus (MRSA)), proti katerim običajni antibiotiki ne delujejo.
What are the risks associated with Orbactiv?
Kakšna tveganja so povezana z zdravilom Orbactiv?
Before using Orbactiv, doctors should consider official guidance on the appropriate use of antibiotics.
Preden zdravnik predpiše zdravilo Orbactiv, mora pretehtati njegovo uporabo glede na uradne smernice za ustrezno uporabo antibiotikov.
The most common side effects with Orbactiv (which may affect 5 people or more in 100) are nausea (feeling sick), hypersensitivity (allergy) reactions or reactions at the site of infusion and headache.
Najpogostejši neželeni učinki zdravila Orbactiv (ki lahko prizadenejo 5 ali več oseb od 100) so navzeja (slabost), preobčutljivostne (alergijske) reakcije ali reakcije na mestu infundiranja ter glavobol.
The most common side effects that resulted in treatment being stopped were cellulitis and osteomyelitis (bone infection).
Najpogostejša neželena učinka, ki sta privedla do prekinitve zdravljenja, sta bila celulit in osteomielitis (okužba kosti).
It is not intended to provide practical advice on how to use Orbactiv.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It contains the active substance oritavancin.
Vsebuje zdravilno učinkovino oritavancin.
Although Orbactiv's safety profile overall is similar to that of other glycopeptides, the CHMP noted that some side effects occurred more frequently such as abscesses and bone infections.
Čeprav je varnostni profil zdravila Orbactiv na splošno podoben varnostnemu profilu drugih glikopeptidov, je odbor CHMP opozoril, da se nekateri neželeni učinki, kot so abscesi in kostne okužbe, pojavljajo pogosteje.
For the full list of all side effects and restrictions with Orbactiv, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Orbactiv glejte navodilo za uporabo.
Orbactiv was at least as effective as vancomycin at treating the infection: 80.1% of patients treated with Orbactiv in the first study and 82.3% in the second study responded to treatment, compared with 82.9% and 78.9% respectively of patients treated with vancomycin.
Zdravilo Orbactiv je bilo pri zdravljenju okužbe vsaj tako učinkovito kot vankomicin: v prvi študiji se je na zdravljenje odzvalo 80,1 % bolnikov, zdravljenih z zdravilom Orbactiv, v drugi študiji pa 82,3 %, v primerjavi z 82,9 oziroma 78,9 % bolnikov, zdravljenih z vankomicinom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orbactiv, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
A list of bacteria against which Orbactiv is active can be found in the summary of product characteristics (also part of the EPAR).
Seznam bakterij, proti katerim je zdravilo Orbactiv učinkovito, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
Orbactiv, given as a single infusion, was compared with a 7 to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Zdravilo Orbactiv v obliki ene infuzije so primerjali s 7- do 10-dnevnim zdravljenjem z vankomicinom (drugim glikopeptidom) v dveh glavnih študijah, v kateri je bilo vključenih skupno približno 1 959 bolnikov z akutnimi bakterijskimi okužbami kože in kožnih struktur, kot so celulit, kožni abscesi in okužbe ran.
For more information about treatment with Orbactiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Orbactiv preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP considered that Orbactiv, which can be given as a single dose, could be a valuable alternative treatment option for acute bacterial infections of the skin and of skin structures.
Menil je, da bi zdravilo Orbactiv, ki se lahko daje v enkratnem odmerku, lahko bilo dragocena druga možnost zdravljenja bakterijskih okužb kože in kožnih struktur.
Patients who have received Orbactiv must not be given an infusion of unfractionated heparin (a medicine used to prevent blood clots) for 120 hours after the infusion of Orbactiv.
Bolnikom, ki so prejeli zdravilo Orbactiv, se še vsaj 120 ur po infuziji tega zdravila ne sme infundirati nefrakcioniranega heparina (zdravila za preprečevanje krvnih strdkov).
Orbactiv is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Zdravilo Orbactiv je antibiotik, ki se uporablja pri odraslih za zdravljenje akutnih (kratkotrajnih) bakterijskih okužb kože in kožnih struktur (podkožnega tkiva), kot so celulit (vnetje globokega podkožnega tkiva), kožni abscesi in okužbe ran.
For practical information about using Orbactiv, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Orbactiv naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Orbactiv is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription.
Zdravilo Orbactiv je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno in se izdaja le na recept.
How is Orbactiv used?
Kako se zdravilo Orbactiv uporablja?
How does Orbactiv work?
Kako zdravilo Orbactiv deluje?
Week 1
Teden 1
Date of latest renewal: 22 May 2014
Datum zadnjega podaljšanja dovoljenja za promet: 22 maj 2014
• You should tell your doctor if a surgery (including dental) is planned.
• morate zdravniku povedati, če imate predvideno kakšno operacijo (tudi zobozdravstveni poseg);
Secondary prevention of atherothrombotic events
Sekundarno preprečevanje aterotrombotičnih dogodkov
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Priložnostna uporaba acetilsalicilne kisline (ne več kot 1.000 mg v katerem koli 24 urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati z zdravnikom.
Clopidogrel has been evaluated for safety in more than 44,000 patients, who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Varnost klopidogrela so vrednotili pri več kot 44.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 12.000 bolniki, ki so se zdravili eno leto ali več.
• if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Their frequency is defined using the following conventions: 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 estimated from the available data).
Njihova pogostnost je navedena po naslednjem dogovoru: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Some other medicines may influence the use of Clopidogrel Mylan or vice versa.
Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel Mylan in obratno.