natgillin/translations-raw huggingface dataset:
In cases where oxygen toxicity is suspected, the fresh gas flow rate should be maintained, but the oxygen concentration of the inspired gas should be reduced to approximately 50 % or less if adequate oxygenation can be maintained.
V primerih, kjer obstaja sum zastrupitve s kisikom, mora biti ohranjena stopnja dotoka svežega plina, vendar pa mora biti koncentracija vdihnjenega kisika zmanjšana na približno 50 % ali manj, če se lahko ohranja ustrezno oksigenacijo.
Animals with pre-existing oxygen radical damage to the lung may have this damage exacerbated by oxygen therapy e.g. in the treatment of paraquat poisoning.
Pri živalih z obstoječo okvaro pljuč zaradi kisika se lahko okvara zaradi terapije s kisikom še poslabša, na primer pri zdravljenju zastrupitve s paraquatom.
Oxygen released at tissue level by oxyhaemoglobin is then used in mitochondria for the synthesis of ATP.
Kisik, ki ga v tkivu sprosti oksihemoglobinom, se v mitohondrijih uporabi za sintezo ATP.
6.5 Nature and composition of immediate packaging 15 l and 50 l metal cylinders with pressure control valves (body and nozzle painted in white).
15 l in 50 l kovinski cilinder s tlačnim ventilom (belo pobarvano telo in odprtina).
54181 Heillecourt Cedex FRANCE
54181 Heillecourt Cedex FRANCIJA
Marketing authorisation holder: AIR LIQUIDE Santé INTERNATIONAL 10, rue Cognacq-Jay
Imetnik dovoljenja za promet z zdravilom: AIR LIQUIDE Santé INTERNATIONAL 10, rue Cognacq-Jay
Due to the high partial pressure of oxygen inhaled by animals during the administration of the veterinary medicinal product, oxygen toxicity may be seen in animals after extended periods of use.
Glede na visoki delni pritisk kisika, ki ga vdahnejo živali med uporabo zdravila za uporabo v veterinarski medicini, je pri prekomerni uporabi le-tega na živalih vidna zastrupitev s kisikom.
Medicinal Oxygen Air Liquide Santé can be safely administered as a carrier gas for inhalation anaesthetics.
Medicinal Oxygen Air Liquide Santé se lahko varno uporablja kot nosilni plin med inhalacijsko anestezijo.
Whilst oxygen is non-flammable, it strongly supports combustion and no naked flames should be allowed near the container.
Čeprav kisik ni vnetljiv, močno pomaga pri gorenju, zato v bližini embalaže tega zdravila ni dovoljena uporaba odprtega ognja.
The animal must be monitored closely, preferably by means of a pulse oximeter, and the flow rate adapted during anaesthesia to meet their individual requirements.
Žival je treba ves čas nadzorovati, po možnosti s pulznim oksimetrom ter s prilaganjem stopnje dotoka kisika med anestezijo za dosego optimalnih individualnih potreb.
In-circuit oxygen meters can be used to measure the inspired oxygen fraction and depending on the individual animal, a level of 50 - 100 % of the veterinary medicinal product may be required.
Za merjenje vdihnjenega deleža kisika se lahko uporabi merilce kisika, s katerimi se lahko, glede na potrebe posamezne živali določi stopnjo potrebnega zdravila med 50 - 100 % .
Oxygen in concentration up to 100 % (FiO2 1.0) should not exceed 12 hours.
Posebni previdnostni ukrepi za uporabo pri živalih Kisik v koncentraciji do 100% (FiO2 1.0) ne sme preseči 12 ur.
The veterinary medicinal product can also be used for oxygen supplementation during recovery.
Zdravilo se uporablja tudi za dodajanje kisika med okrevanjem.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM ALI OMEJITVE GLEDE OSKRBE IN UPORABE
MARKETING AUTHORISATION NUMBER(S) EU/2/06/067/001 - 15 l
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/067/001 - 15 l
F-54181 Heillecourt France
F-54181 Heillecourt Cedex Francija
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega za sproščanje serije
MARKETING AUTHORISATION NUMBER(S) EU/2/06/067/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/067/001
PACKAGE LEAFLET Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs, cats and horses.
NAVODILO ZA UPORABO Medicinal Oxygen Air Liquide Santé 100% kisikov inhalator za pse, mačke in konje
Alternatively, supplementary oxygen can be given to an animal breathing air, and the flow rate adjusted to provide the appropriate inspired concentration.
Kot altrenativna možnost se lahko kisik doda zraku, ki ga vdihava žival, pri čemer je potrebno prilagoditi delež kisika za dosego primerne vdihane koncentracije.
The precise fresh gas flow rate required by an animal during anaesthesia and recovery should be determined by a suitably experienced veterinarian, taking into consideration the bodyweight and health status of the animal and the anaesthetic equipment and agents being used.
Natančno kličino dotoka svežega plina pri živali med anestezijo in okrevanjem, mora določiti ustrezno izkušen veterinar.
Precautions to be taken by the person administering the veterinary medicinal product to animals Medicinal Oxygen Air Liquide Santé should only be used by persons who have been fully trained to use pressure regulators and associated equipment.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo To zdravilo lahko uporabljajo samo osebe, ki so popolnoma usposobljene za uporabo aparatov na pritisk in pripadajoče opreme.
Pregnancy and lactation Medicinal Oxygen Air Liquide Santé can be used during pregnancy and lactation.
Brejost in laktacija Medicinal Oxygen Air Liquide Santé se lahko uporablja med brejostjo in laktacijo.
D. STATEMENT OF THE MRLs Not applicable
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
WITHDRAWAL PERIOD Zero days.
Cilindre shranjujte v pokončnem položaju.
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
Deprivation of oxygen, resulting in tissue hypoxia, results in a rapid deterioration of myocardial and central nervous activity.
pomanjkanje kisika povzroča hipoksijo tkiv in se odraža v poslabšanju delovanja srca in na aktivnosti osrednjega živčevja.Zdravljenje s kisikom je bistvenega pomena za ponovno vzpostavitev primerne oksigenacije tkiv.
Lot {Number}
Ga ni.
4.11 Withdrawal period(s)
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
Whereas,
Trenutno ni
Overall summary of the scientific evaluation of vancomycin-containing products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo vankomicin (glejte Prilogo I)
It is also used in patients who are allergic to penicillins and cephalosporins.
Uporablja se tudi pri bolnikih, ki so alergični na peniciline in cefalosporine.
The emergence of multidrug-resistant pathogens is a growing problem worldwide.
Pojav bolezenskih povzročiteljev, odpornih na več zdravil, je čedalje večja težava po vsem svetu.
Furthermore, the role of selective intestinal decontamination is controversial.
Poleg tega je vloga selektivne dekontaminacije črevesja sporna.
• Treatment of acute bacterial meningitis.
• Zdravljenje akutnega bakterijskega meningitisa.
The data submitted in support of the vancomycin use for decontamination were not deemed as sufficiently robust.
Podatki, predloženi v podporo uporabi vankomicina za dekontaminacijo, ne štejejo za dovolj zanesljive.
Vancomycin containing products are commercially available as:
Zdravila, ki vsebujejo vankomicin, so komercialno na voljo v obliki:
• Vancomycin-containing medicinal products has an increasingly important role in the treatment of Gram-positive bacterial infections,
• Zdravila, ki vsebujejo vankomicin, imajo čedalje pomembnejšo vlogo pri zdravljenju okužb z grampozitivnimi bakterijami;
Due to insufficient elements establishing the efficacy and safety of this the CHMP does not recommend this indication.
Zaradi nezadostnih elementov, ki dokazujejo učinkovitost in varnost uporabe pri tej indikaciji, je odbor CHMP ne priporoča.
Having reviewed all available data, and taking into account the current clinical practice and current clinical guideline recommendations, the CHMP considered that vancomycin is an important therapeutic option in the following indications:
Po pregledu vseh razpoložljivih podatkov in ob upoštevanju trenutne klinične prakse ter priporočil v trenutnih kliničnih smernicah je odbor CHMP menil, da je vankomicin pomembna terapevtska možnost pri naslednjih indikacijah:
Vancomycin is a glycopeptide antibiotic authorised around six decades ago.
Vankomicin je glikopeptidni antibiotik, za katerega je bilo izdano dovoljenje za promet pred približno šestimi desetletji.
- powder for solution for injection or infusion (500 mg and 1000 mg) used by intravenous administration.
- praška za raztopino za injiciranje ali infundiranje (500 mg in 1000 mg) za intravensko dajanje.
The active substance is obtained mainly by fermentation.
Zdravilna učinkovina je pridobljena zlasti s fermentacijo.
CHMP agreed that these risks can be minimised by appropriate warnings and recommendations in the product information.
Odbor se je strinjal, da je ta tveganja mogoče zmanjšati z ustreznimi opozorili in priporočili v informacijah o zdravilu.
Vancomycin hydrochloride is defined as the hydrochloride salt of a mixture of related glycopeptides for which the characteristics are defined in the European Pharmacopeia 1058 monograph (currently under revision).
Vankomicinijev klorid je opredeljen kot klorovodikova sol zmesi sorodnih glikopeptidov, katerih značilnosti so opredeljene v monografiji 1058 Evropske farmakopeje (trenutno v pregledu).
Among other issues, the CHMP discussed the need for updating the wording of the product information.
Med drugim je odbor CHMP obravnaval tudi potrebo po posodobitvi besedila informacij o zdravilu.
Moreover, existing data (including comparative) on the use of a continuous vs. an intermittent infusion are not conclusive.
Poleg tega obstoječi podatki (vključno s primerjalnimi podatki) o primerjavi uporabe neprekinjenega in intermitentnega infundiranja niso prepričljivi.
Its effect is mainly bactericidal and it is exerted mainly by the inhibition of the cell wall peptidoglycan synthesis.
Njegov učinek je predvsem baktericidni in se v glavnem kaže kot zaviranje sinteze peptidoglikana v celični steni.
Trough-only monitoring may be not sufficient to guide vancomycin dosing in all cases, because peak levels (Cmax) are primarily influenced by the volume of distribution.
Spremljanje zgolj vrednosti Ctrough morda ne zadostuje za določanje odmerjanja vankomicina v vseh primerih, ker na najvišje koncentracije (Cmax) v prvi vrsti vpliva volumen porazdelitve.
It is also noted that staphylococcal enterocolitis is a rare entity and that its diagnosis is controversial.
Prav tako je treba opozoriti, da je stafilokokni enterokolitis redka bolezen in da je njegova diagnoza sporna.
The Annex 3 of the CHMP guideline on setting specifications for related impurities in antibiotics would apply to new active substances and for new sources of existing active substances.
Priloga 3 smernic odbora CHMP o določitvi specifikacij za sorodne nečistoče v antibiotikih bi veljala za nove zdravilne učinkovine in nove vire obstoječih zdravilnih učinkovin.
The potential usefulness of model-based methods in the prediction of individual dose requirements to reach an adequate AUC is also addressed.
Obravnavana je tudi potencialna uporabnost metod na osnovi modelov za napovedovanje potreb po odmerkih za posameznega bolnika, da se doseže ustrezna vrednost AUC.
Vancomycin treatment is recommended in severe or recurrent cases.
Zdravljenje z vankomicinom je priporočljivo v primerih hude ali ponavljajoče se okužbe.
In these cases, continuous infusions were used due to a failure of response to treatment or to a persistence of subtherapeutic vancomycin levels despite optimizing dosing and frequency during intermittent vancomycin administration.
V teh primerih so neprekinjeno infundiranje uporabili zaradi neodzivanja na zdravljenje ali perzistence subterapevtskih ravni vankomicina kljub optimizaciji odmerjanja in pogostnosti pri intermitentnem dajanju vankomicina.
Therefore, in light of the above the Spanish Medicines Agency (AEMPS) considered in the interest of the Union to refer the matter to the CHMP and request that its gives its opinion under Article 31 of Directive 2001/83/EC on the benefit-risk of vancomycin-containing products and on the need for regulatory measures to be taken.
Glede na zgoraj navedeno je španska agencija za zdravila (AEMPS) menila, da je v interesu Unije napotitev zadeve na odbor CHMP, in odbor zaprosila za mnenje v skladu s členom 31 Direktive 2001/83/ES o razmerju med koristmi in tveganji pri zdravilih, ki vsebujejo vankomicin, in o potrebnih regulativnih ukrepih.
Furthermore, the CHMP noted that updated clinical guidelines for staphylococcal enterocolitis (diagnosis or treatment) do not mention this use of vancomycin.
Poleg tega je odbor CHMP ugotovil, da posodobljene klinične smernice za stafilokokni enterokolitis (diagnozo ali zdravljenje) ne omenjajo takšne uporabe vankomicina.
In addition, significant differences between the product information of vancomycin-containing medicines across the EU Member States were identified in particular in the indications, posology and method of administration, but also in other sections of the product information.
Poleg tega so bile med državami članicami EU ugotovljene bistvene razlike v informacijah o zdravilu za zdravila, ki vsebujejo vankomicin, zlasti glede indikacij, odmerjanja in načina uporabe ter v drugih poglavjih informacij o zdravilu.
The CHMP noted that no update of the EUCAST breakpoints is warranted at this time.
Odbor je ugotovil, da trenutno ni treba posodobiti mejnih vrednosti EUCAST.
Finally, revisions were made to sections 5.1 and 5.2 to reflect current pharmacokinetic and pharmacodynamic data, and to sections 1 and 2 to reflect the amount of active substance in the finished product (based on the potency expressed in IU), and the dose and strength of vancomycin containing products (to be expressed in milligrams).
Na koncu sta bili popravljeni poglavji 5.1 in 5.2, da odražata trenutne farmakokinetične in farmakodinamične podatke, ter poglavji 1 in 2, da odražata količino zdravilne učinkovine v končnem zdravilu (na podlagi potence, izražene v mednarodnih enotah - i.e.) ter odmerek in jakost zdravil, ki vsebujejo vankomicin (izraženo v miligramih).
Therefore, the CHMP discussed different alternative approaches to estimate the vancomycin exposure.
Zato je odbor CHMP razpravljal o različnih alternativnih pristopih za oceno izpostavljenosti vankomicinu.
For this specific group, the PDCO recommended one possible dosing regimen based on post-menstrual age (similar to the recommended dosing regimen by the British National Formulary (BNF) for children), but overall CHMP agreed that no universal recommendations on the dosage regimen in neonates could be made and that for establishing the dosing regimen in this population, the advice of a physician experienced in the management of neonates should be sought.
Za to posebno skupino je odbor PDCO priporočil možno shemo odmerjanja, ki temelji na pomenstrualni starosti (podobno priporočeni shemi odmerjanja publikacije British National Formulary (BNF) za otroke), vendar se je odbor CHMP na splošno strinjal, da ni mogoče določiti univerzalnih priporočil za odmerjanje pri novorojenčkih in da se je treba pri določitvi sheme odmerjanja pri tej populaciji posvetovati z zdravnikom, ki ima izkušnje z obravnavanjem novorojenčkov.
• With regards to the “treatment of staphylococcal enterocolitis”, the CHMP concluded that the MAHs did not provide data establishing the efficacy and safety of oral vancomycin in this indication.
• V zvezi z „zdravljenjem stafilokoknega enterokolitisa“ je odbor CHMP zaključil, da imetniki dovoljenj za promet niso predložili podatkov, ki dokazujejo učinkovitost in varnost peroralnega vankomicina pri tej indikaciji.
- and capsules, for oral administration.
- in kapsul za peroralno uporabo.
Vancomycin spectrum includes a wide range of pathogens including Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococus pneumoniae, Listeria monocytogenes and Clostridium difficile.
Spekter delovanja vankomicina obsega številne bolezenske povzročitelje, vključno s Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococcus pneumoniae, Listeria monocytogenes in Clostridium difficile.
10 Bauer MP. et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI).
10 Bauer MP. et al., Evropsko združenje za klinično mikrobiologijo in infekcijske bolezni (ESCMID): dokument s smernicami za zdravljenje okužbe s Clostridium difficile (CDI).
In view of the importance of ensuring the availability of efficacious antibiotics for the EU patients, in the interest of public health and in order to contribute to tackling the threat posed by the spread of antimicrobial resistance, a critical review of the benefit-risk of vancomycin containing products in the approved indications, including the relevant posology, was considered needed.
Zaradi pomembnosti zagotavljanja razpoložljivosti učinkovitih antibiotikov za bolnike v EU, interesa varovanja javnega zdravja in zagotavljanja prispevka k obravnavanju grožnje zaradi širjenja protimikrobne odpornosti, je bil potreben kritičen pregled razmerja med koristmi in tveganji pri zdravilih, ki vsebujejo vankomicin, za odobrene indikacije, vključno z ustreznim odmerjanjem.
• the CHMP considered the available data to be sufficient to support revisions of the indication for both oral use and parenteral use, as well as the posology in adults and paediatrics populations, in line with clinical experience and current therapeutic guidelines,
• odbor CHMP je menil, da razpoložljivi podatki zadostno podpirajo revizijo indikacije za peroralno in parenteralno uporabo, kot tudi odmerjanje pri odraslih in pediatrični populaciji, v skladu s kliničnimi izkušnjami in trenutnimi terapevtskimi smernicami;
The wording on therapeutic drug monitoring in section 4.2 of the SmPC has been amended accordingly by the CHMP.
Besedilo o terapevtskem spremljanju zdravila v poglavju 4.2 povzetka glavnih značilnosti zdravila je odbor CHMP ustrezno spremenil.
The antibacterial activity of vancomycin is confined to Gram-positive microorganisms.
Vankomicin deluje protibakterijsko samo proti grampozitivnim mikroorganizmom.
• the existing product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for vancomycin-containing products in the EU need to be revised in accordance with the latest available information,
• obstoječe informacije o zdravilu, vključno z indikacijami, priporočili za odmerjanje ter farmakokinetičnimi in farmakodinamičnimi podatki za zdravila, ki vsebujejo vankomicin v EU, je treba popraviti v skladu z najnovejšimi razpoložljivimi informacijami;
For certain medicinal vancomycin-containing products, the intraperitoneal route and oral route of administration are authorised,
Določena zdravila, ki vsebujejo vankomicin, je dovoljeno dajati po intraperitonealni in peroralni poti;
• Concerning the “decontamination of the GI tract in immune-compromised patients when combined with an aminoglycoside”, the CHMP reviewed the available data submitted throughout this procedure.
• Glede „dekontaminacije prebavil pri bolnikih z oslabljenim imunskim sistemom v kombinaciji z aminoglikozidom“ je odbor CHMP pregledal razpoložljive podatke, predložene v postopku.
Currently, there is no evidence that medical prophylaxis for CDI is efficacious and therefore there is not recommended prophylactic antibiotics.
dokazov, da je medicinska profilaksa za okužbe s Clostridium difficile učinkovita in zato ni priporočljivih profilaktičnih antibiotikov.
In addition, in line with the outcome of the MSWG consultation, the CHMP concluded that Bayesian methods could be clinically useful for more accurate dose predictions as a complementary part of routine therapeutic drug monitoring (TDM), especially for the patient groups with altered pharmacokinetic (PK) profile (i.e. children, haemodynamically unstable patients, intensive care), and acknowledged that this is already in clinical use.
Poleg tega je odbor CHMP v skladu z izidom posvetovanj z delovno skupino MSWG zaključil, da bi Bayesove metode lahko bile klinično uporabne za bolj natančne napovedi odmerka kot dopolnilo rutinskemu terapevtskemu spremljanju zdravila, zlasti za skupine bolnikov s spremenjenim farmakokinetičnim (PK) profilom (tj. otroke, hemodinamsko nestabilne bolnike, bolnike na intenzivni negi), in priznava, da se že uporabljajo v klinični praksi.
In the case of mild CDI clearly induced by the use of antibiotics, it is acceptable to discontinue the inducing antibiotic and observe the clinical response.
V primeru blage oblike okužbe s Clostridium difficile, ki jo je nedvomno sprožila uporaba antibiotikov, je sprejemljiva prekinitev uporabe antibiotikov, ki so sprožili okužbo, in opazovanje kliničnega odziva.
The CHMP also reviewed the dosage regimen for vancomycin for the various approved indications and patient subpopulations.
Odbor CHMP je pregledal tudi shemo odmerjanja vankomicina pri različnih odobrenih indikacijah in podskupinah bolnikov.
The CHMP noted that the European Society of Clinical Microbiology and Infection (ESCMID) issued a treatment guidance document9,10 for Clostridium difficile infection in 2009 that is currently being updated.
Odbor CHMP je ugotovil, da je Evropsko združenje za klinično mikrobiologijo in infekcijske bolezni (ESCMID) leta 2009 izdalo smernice za zdravljenje9,10 okužb s Clostridium difficile, ki jih trenutno posodabljajo.
However, to ensure that the established therapeutic dose in terms of IU (potency) is maintained, and as indicated in the Question and Answer on expression/declaration of potency in quantitative and qualitative composition for vancomycin products (EMA/CHMP/QWP/667469/2015), the amount (mg) of active substance in the drug product should be adjusted to achieve the declared product strength in terms of IU.
Da pa bi zagotovili, da se vzdržuje uveljavljen terapevtski odmerek, izražen v mednarodnih enotah (potenca), in zagotovi skladnost z vprašanji in odgovori glede izražanja/navajanja jakosti pri kvalitativni in kvantitativni sestavi za zdravila, ki vsebujejo vankomicin (EMA/CHMP/QWP/667469/2015), mora biti količina (mg) zdravilne učinkovine v zdravilu prilagojena tako, da doseže navedeno jakost zdravila v smislu števila mednarodnih enot.
However, continuous vancomycin infusions have a few disadvantages such as that there may be compatibility issues with other IV medications or solutions that are given concurrently; practical problems associated with reduced line availability when infusions are given over a 24-h period; increased risk of infusing a bolus dose of vancomycin when the intravenous solution is changed or when another medication is infused into the same intravenous tubing which is filled with vancomycin 24 h/day etc.
Vendar ima neprekinjeno infundiranje vankomicina nekaj slabosti, kot so nekompatibilnost z drugimi intravenoznimi zdravili ali raztopinami, ki se dajejo sočasno; praktične težave, povezane z zmanjšano razpoložljivostjo cevk, če se infuzije dajejo v 24-urnem obdobju; povečano tveganje za infundiranje bolusnega odmerka vankomicina pri menjavi intravenske raztopine ali kadar se drugo zdravilo infundira v intravensko cevko, ki je napolnjena z vankomicinom 24 ur/dan itd.
• the CHMP considered that the pharmacokinetic and pharmacodynamic data in the product information need to be updated,
• odbor CHMP je menil, da je treba posodobiti farmakokinetične in farmakodinamične podatke v informacijah o zdravilu;
The SmPC has been amended accordingly, including the dosing regimen in children based on post-menstrual age as a possible way of dosing vancomycin in this population.
Povzetek glavnih značilnosti zdravila je bil ustrezno spremenjen, vključno s shemo odmerjanja pri otrocih, ki temelji na pomenstrualni starosti kot možnem načinu odmerjanja vankomicina pri tej populaciji.
A statement in the section 4.2 had been included accordingly by the CHMP.
Odbor CHMP je dodal ustrezno navedbo v poglavje 4.2.