natgillin/translations-raw huggingface dataset:
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne pasivne imunosti, ni vključena v
Cardboard box with 1 PET bottle of 50 doses (100 ml).
Kartonska škatla z 1 PET-plastenko s 50 odmerki (100 ml).
Cardboard box with 1 PET bottle of 25 doses (50 ml).
Kartonska škatla z 1 PET-plastenko s 25 odmerki (50 ml).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles, (20 ml, 50 ml) and vials (20 ml, 50 ml)
Plastenke (20 ml, 50 ml), in viale (20 ml, 50 ml)
Name and address of the manufacturer responsible for batch release:
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
Avda.
OVOJNINAH
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI)
Ginseng.
Rp-Vet.
Conditions for lifting the suspension
Pogoji za preklic začasnega umika
The PRAC issued a recommendation to the CHMP on 10 January 2013.
PRAC je izdal priporočilo odboru CHMP dne 10. januarja 2013.
Scientific conclusions and grounds for suspension of the marketing authorisation presented by the European Medicines Agency
Znanstveni zaključki in podlaga za začasni umik dovoljenja za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
With regards to the risks observed, there were also strong new unfavourable safety signals.
V zvezi z ugotovljenimi tveganji so bili opaženi tudi izraziti novi neugodni znaki, povezani z varnostjo.
Grounds for CHMP opinion Whereas,
Razlogi za mnenje odbora CHMP Ob upoštevanju:
• The CHMP noted that no additional risk minimisation measures could be recommended at this point in time,
• da je CHMP ugotovil, da trenutno ni mogoče priporočiti nobenih dodatnih ukrepov za zmanjšanje tveganja;
1 HPS2-THRIVE: Hearth Protection Study 2 - Treatment of HDL (high density lipoprotein) to Reduce the Incidence of Vascular Events.
1 HPS2-THRIVE: Študija zaščite srca 2 - zdravljenje HDL (lipoproteina velike gostote) za zmanjšanje pojavnosti vaskularnih dogodkov.
The available evidence provided by the MAH in writing and at an oral explanation was reviewed by the Pharmacovigilance Risk Assessment Committee (PRAC).
Razpoložljive podatke, ki jih je imetnik dovoljenja za promet z zdravilom podal v obliki pisne dokumentacije in ustnih obrazložitev, je pregledal Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC).
Overall summary of the scientific evaluation of nicotinic acid/laropiprant
Splošni povzetek znanstvene ocene nikotinske kisline/laropipranta
Preliminary results of this study became available and were submitted by the MAH for review end of December 2012.
Imetnik dovoljenja za promet z zdravilom je predhodne rezultate študije objavil in predložil v pregled konec decembra 2012.
The HSP2-THRIVE study was a very large randomised trial, enrolling 25,673 patients considered to be at high risk of cardiovascular events.
Študija HSP2-THRIVE je bila zelo obsežno randomizirano preskušanje, ki je vključevalo 25 673 bolnikov, pri katerih naj bi obstajalo visoko tveganje za kardiovaskularne dogodke.
The product is authorised as modified release tablets containing 1000mg of nicotinic acid and 20mg of laropiprant.
Zdravilo je odobreno v obliki tablet s prirejenim sproščanjem, ki vsebujejo 1 000 mg nikotinske kisline in 20 mg laropipranta.
It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Kot monoterapija se lahko uporabi samo pri bolnikih, za katere zaviralci reduktaze HMG-CoA niso primerni ali ki jih bolniki ne prenašajo.
The HPS2-THRIVE study was conducted by the Clinical Trial Service Unit at the University of Oxford and funded by the MAH.
Študijo HPS2-THRIVE je izvedla enota službe za klinična preskušanja Univerze v Oxfordu, financiral pa jo je imetnik dovoljenja za promet z zdravilom.
Nicotinic acid/laropiprant (authorised in the EU as Tredaptive, Trevaclyn and Pelzont) is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia and in adult patients with primary hypercholesterolaemia in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Nikotinska kislina in laropiprant (odobrena v EU kot zdravila Tredaptive, Trevaclyn in Pelzont) sta indicirana za zdravljenje dislipidemije, zlasti pri odraslih bolnikih s kombinirano mešano dislipidemijo in pri odraslih bolnikih s primarno hiperholesterolemijo, v kombinaciji z zaviralci reduktaze HMG-CoA (statini), če monoterapija z zaviralci reduktaze HMG-CoA holesterola ne zniža v zadostni meri.
Previously available data on laropiprant/nicotinic acid included nine studies where a total of 5,782 patients were exposed to the medicine.
Podatki, ki so bili predhodno na voljo o laropiprantu/nikotinski kislini, so bili iz devetih študij, v katerih je zdravilo prejemalo skupno 5 782 bolnikov.
• The CHMP considered the notification under Article 20 of Regulation (EC) No 726/2004 for nicotinic acid/laropiprant (approved in the EU as Tredaptive, Trevaclyn and Pelzont) initiated by the European Commission,
• da je CHMP upošteval obvestilo v skladu s členom 20 Uredbe (ES) št. 726/2004 v zvezi z nikotinsko kislino in laropiprantom (odobrenih v EU kot zdravila Tredaptive, Trevaclyn in Pelzont), ki ga je izdala Evropska komisija;
Furthermore, no additional risk minimisation measures were identified or proposed by the marketing authorisation holder to minimise the newly identified safety concerns.
Poleg tega imetnik dovoljenja za promet z zdravilom ni razkril ali predlagal nobenih dodatnih ukrepov za zmanjšanje tveganja, s katerimi bi zmanjšali nove pomisleke glede varnosti.
Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP recommends the suspension of the marketing authorisations for nicotinic acid/laropiprant (see Annex A).
V skladu z določbami iz člena 20 Uredbe (ES) št. 726/2004 je CHMP priporočil začasni umik dovoljenja za promet z nikotinsko kislino/laropiprantom (glejte Prilogo A).
Although the population studied in HPS2-THRIVE was not selected based on high LDL cholesterol levels, the safety results observed in the 25,673 patients were considered to be of relevance to the current approved indication as there is no evidence to suggest that patients currently indicated for treatment with nicotinic acid/laropiprant would be protected from the adverse events observed in
Čeprav populacija bolnikov, vključena v študijo HPS2-THRIVE, ni bila izbrana na podlagi visokih ravni holesterola LDL, so bili rezultati o varnosti, opaženi pri 25 673 bolnikih, pomembni za trenutno odobreno indikacijo, saj ni dokazov, ki bi potrdili, da bolniki, za zdravljenje katerih je trenutno indicirana nikotinska kislina/laropiprant, ne bi bili izpostavljeni neželenim dogodkom, ki so jih opazili v študiji HPS2-THRIVE.
Important missing information, such as the effects of long-term exposure, bleeding and thrombotic cardiovascular events was expected to be clarified through routine pharmacovigilance and through monitoring of patients in clinical trials, in particular the HPS2-THRIVE study.
Pričakovano je bilo, da bodo pomembne manjkajoče informacije, na primer glede učinkov pri dolgotrajni izpostavljenosti, krvavitev in trombotičnih kardiovaskularnih dogodkov, pridobili z rednimi farmakovigilančnimi dejavnostmi in opazovanjem bolnikov v kliničnih preskušanjih, zlasti v študiji HPS2-THRIVE.
• The CHMP considered the totality of the data available for laropiprant/nicotinic acid, including the emerging preliminary data from the HPS2-THRIVE study, which was not available at the time of the original marketing authorisation, the MAH responses, the PRAC assessment and the discussions within the CHMP,
• da je CHMP upošteval vse podatke, ki so na voljo za laropiprant/nikotinsko kislino, vključno z novimi predhodnimi podatki iz študije HPS2-THRIVE, ki niso bili na voljo v času prvotne odobritve dovoljenja za promet, odgovore imetnika dovoljenja za promet z zdravilom, oceno odbora PRAC in razprave v odboru CHMP;
The PRAC concluded that data from the HPS2-THRIVE study has confirmed the previously known safety profile of nicotinic acid/laropiprant and additionally revealed new safety concerns.
PRAC je zaključil, da so podatki iz študije HPS2-THRIVE potrdili že znan varnostni profil nikotinske kisline/laropipranta in dodatno razkrili nove pomisleke glede varnosti.
This increase was driven by differences observed in the system organ class blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin, which all favoured placebo.
Na povečanje so močno vplivale razlike, opažene v organskih sistemih kri in limfatični sistem, prebavila, infekcijske bolezni, presnovne motnje, mišično-skeletni sistem, dihala in koža, ki so bile vse v korist placeba.
Identified risks were reflected in the product information and the risk management plan and included myopathy, glucose intolerance and abnormal liver function.
Ugotovljena tveganja so bila vključena v informacije o zdravilu in načrt za obvladovanje tveganja in so vključevala miopatijo, intoleranco za glukozo in motnje v delovanju jeter.
Having noted all of the above, the CHMP considers that the benefit-risk balance for nicotinic acid/laropiprant is not favourable in the approved indication and recommends the suspension of the marketing authorisation of the products containing laropiprant/nicotinic acid.
Ob upoštevanju vsega navedenega je CHMP menil, da razmerje med tveganji in koristmi za nikotinsko kislino/laropiprant ni ugodno za odobreno indikacijo, in je priporočil začasni umik dovoljenja za promet z zdravili, ki vsebujejo laropiprant/nikotinsko kislino.
In addition, the failure of the HPS2-THRIVE study to meet the primary efficacy endpoints raised serious concerns regarding the efficacy of nicotinic acid/laropiprant in the indicated patient population, as overlap between this and the study populations is expected.
Poleg tega so se zaradi dejstva, da študija HPS2-THRIVE ni dosegla primarnega cilja učinkovitosti, pojavili resni pomisleki glede učinkovitosti nikotinske kisline/laropipranta pri indicirani populaciji bolnikov, saj naj bi omenjena populacija sovpadala s populacijo v študiji.
The studies were not designed to evaluate cardiac effects but it was noted that serious cardiac disorders occurred more often in the nicotinic acid/laropiprant group compared to placebo.
Študije niso bile zasnovane za oceno učinkov na srce, vendar pa so opazili, da so se v skupini, ki je prejemala nikotinsko kislino/laropiprant, pogosteje pojavila resna srčna obolenja v primerjavi s skupino, ki je prejemala placebo.
Based on the known safety profile of the product, some adverse events were expected, such as elevations in transaminases, myopathy, some skin and gastrointestinal events and impaired glucose tolerance.
Na podlagi znanega varnostnega profila zdravila so bili pričakovani nekateri neželeni dogodki, na primer porast transaminaz, miopatija, nekateri neželeni dogodki, povezani s kožo in prebavili, ter motena toleranca za glukozo.
Considering the lack of clinically relevant efficacy and the negative safety profile (including the newly identified serious safety concerns) associated with the use of nicotinic acid/laropiprant, the PRAC considered that the benefit-risk balance has shifted towards a negative balance.
PRAC je upošteval pomanjkanje klinično pomembne učinkovitosti in negativen varnostni profil (vključno z novimi resnimi pomisleki glede varnosti), povezan z uporabo nikotinske kisline/laropipranta, in je menil, da je razmerje med tveganji in koristmi postalo negativno.
As part of the pharmacovigilance activities included in the adopted risk management plan, the marketing authorization holder (MAH) agreed to report on a randomised clinical study (HPS2-THRIVE1) designed to assess the incremental benefit of nicotinic acid/laropiprant versus placebo as add-on to simvastatin 40mg, with or without ezetimibe.
Imetnik dovoljenja za promet z zdravilom se je strinjal, da bo v sklopu farmakovigilančnih dejavnosti, vključenih v načrt za obvladovanje tveganja, poročal o rezultatih randomizirane klinične študije (HPS2THRIVE1), namenjene oceni dodatnih koristi nikotinske kisline/laropipranta, ki se dodajata simvastatinu 40 mg, z ezetimibom ali brez njega, v primerjavi s placebom.
• The CHMP considered that the failure of the HPS2-THRIVE study to meet the primary efficacy endpoints raises serious concerns regarding the efficacy of laropiprant/nicotinic acid,
• da je CHMP menil, da zaradi dejstva, da študija HPS2-THRIVE ni dosegla primarnega cilja učinkovitosti, obstajajo resni pomisleki glede učinkovitosti laropipranta/nikotinske kisline;
• The CHMP therefore considered that a patient population in which nicotinic acid/laropiprant has a clear favourable benefit-risk cannot be identified based on the current data.
• je CHMP menil, da na podlagi trenutno razpoložljivih podatkov ni mogoče opredeliti populacije bolnikov, pri kateri ima nikotinska kislina/laropiprant jasno ugodno razmerje med tveganji in koristmi.
The risk of blood and lymphatic disorders was greater in the study drug group compared to the placebo group.
Tveganje za pojav bolezni krvi in limfatičnega sistema je bilo večje v skupini, ki je prejemala preskušano zdravilo, kot v skupini, ki je prejemala placebo.
• The CHMP concluded that the statistically significant increase in the incidence of serious adverse events observed in the nicotinic acid/laropiprant group compared to the placebo group of the HPS2-THRIVE study raises serious concerns,
• da je CHMP zaključil, da obstajajo resni zadržki zaradi statistično pomembnega povečanja pojava resnih neželenih dogodkov, ki so ga v študiji HPS2-THRIVE opazili v skupini, ki je prejemala nikotinsko kislino/laropiprant, v primerjavi s skupino, ki je prejemala placebo;
However, the new unexpected higher incidence of bleeding and infections in the study drug group compared to the placebo group was of concern.
Vendar pa je bil nov in nepričakovan pogostejši pojav krvavitev in okužb v skupini, ki je prejemala preskušano zdravilo, v primerjavi s
The CHMP therefore concluded that the benefit-risk balance of nicotinic acid/laropiprant is affected adversely by the results from the HPS2-THRIVE study and is considered no longer favourable.
Zato je CHMP zaključil, da so rezultati študije HPS2-THRIVE negativno vplivali na razmerje med tveganji in koristmi nikotinske kisline/laropipranta in da je razmerje postalo neugodno.
There was a statistically significant increase in the incidence of non-fatal serious adverse events in the nicotinic acid/laropiprant (study drug) group compared to the placebo group.
V skupini, ki je prejemala nikotinsko kislino/laropiprant (preiskovano zdravilo), se je statistično pomembno povečala pojavnost resnih neželenih dogodkov brez smrtnega izida v primerjavi s skupino, ki je prejemala placebo.
For the suspension to be lifted, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study.
Za preklic začasnega umika mora imetnik dovoljenja za promet z zdravilom predložiti prepričljive podatke za opredelitev populacije bolnikov, pri kateri se lahko dokaže učinkovitost nikotinske kisline/laropipranta in pri kateri koristi jasno odtehtajo tveganja, vključno z novimi tveganji, ki jih je razkrila študija HPS2-THRIVE.
To lift the suspension, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study (see Annex II).
Za preklic začasnega umika dovoljenja mora imetnik dovoljenja za promet z zdravilom predložiti prepričljive podatke za opredelitev populacije bolnikov, pri kateri se lahko dokaže učinkovitost nikotinske kisline/laropipranta in pri kateri koristi jasno odtehtajo tveganja, vključno z novimi tveganji, ki jih je razkrila študija HPS2-THRIVE (glejte Prilogo II).
Over the 3.9 years median follow-up, treatment with nicotinic acid/laropiprant compared to placebo did not achieve its primary endpoint.
V medianem času spremljanja 3,9 let zdravljenje z nikotinsko kislino/laropiprantom, ki je bilo primerjano s placebom, ni doseglo primarnega cilja.Zato je PRAC menil, da rezultati niso pokazali dodatne učinkovitosti nikotinske kisline/laropipranta kot dodatnega zdravljenja k statinom v smislu kardiovaskularnega izida.
Paroxetine
paroksetin
The final opinion was converted into a Decision by the European Commission on 29 March 2005.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 29. marca 2005.
BACKGROUND INFORMATION*
OSNOVNE INFORMACIJE*
International Non-Proprietary Name (INN): paroxetine
Mednarodno nelastniško ime (INN): paroksetin
The referral procedure started on 26 June 2003.
Napotitveni postopek se je začel 26. junija 2003.
Written explanations were provided by the Marketing Authorisation Holder by 1 September 2003, 13 February 2004, 2 April 2004 and 16 April 2004.
Pisne obrazložitve je imetnik dovoljenja za promet predložil do 1. septembra 2003, 13. februarja 2004, 2.aprila 2004 in 16. aprila 2004.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 31 REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 31
Paroxetine was first approved in 1990 as an antidepressant in the U.K.
Paroksetin so prvič odobrili leta 1990 v Združenem kraljestvu kot antidepresiv.
Oral explanations were given on 20 April
Ustna obrazložitev je bila podana dne 20. aprila 2004.
Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 8 December 2004.
* Opombe: Informacije, podane v tem dokumentu in Dodatkih, odražajo samo mnenje CHMP datirano z 8. decembrom 2004.
On 13 June 2003, UK referred the matter to the EMEA under Article Article 31 of Directive 2001/83/EC, as amended, for paroxetine containing medicinal products.
Dne 13. junija 2003 je Združeno kraljestvo napotilo zadevo na EMEA po 31. členu Direktive 2001/83/ES, kot je bila dopolnjena, za zdravila, vsebujoča paroksetin.
Paroxetine containing medicinal products are approved for the treatment of:
Zdravila, vsebujoča paroksetin, so odobrena za zdravljenje:
Paroxetine is a phenylpiperidine derivative and is a selective inhibitor of the presynaptic 5hydroxytryptamine (5-HT) reuptake.
Paroksetin je fenilpiperidinski derivat ter selektivni zaviralec presinaptičnega ponovnega privzema 5hidroksitriptamina (5-HT).
29 March 2005 CHMP/187488/2004
29. marec 2005 CHMP/187488/2004
For more information please refer to: http://www.emea.eu.int/pdfs/human/referral/SSRIs/29783705en.pdf http://www.emea.eu.int/pdfs/human/referral/SSRIs/EMEA-H-A-31-651-SSRIs-en.pdf
Za dodatne informacije glejte: http://www.emea.eu.int/pdfs/human/referral/SSRIs/29783705en.pdf http://www.emea.eu.int/pdfs/human/referral/SSRIs/EMEA-H-A-31-651-SSRIs-en.pdf
- Panic disorder with and without agoraphobia
- panične motnje z agorafobijo ali brez nje
The reasons for referral concerned the risk of emotional lability, including hostility and suicidal behaviour in children and adolescents and withdrawal reactions with paroxetine.
Razlog za napotilo je bilo tveganje za čustveno labilnost, vključujoč sovražno in samomorilno vedenje pri otrocih in mladostnikih ter odtegnitvene reakcije, povezane s paroksetinom.
An updated warning in relation to children and adolescents was recommended to be included in the Product Information.
Priporočeno je bilo, da se v informacije o zdravilu vključi posodobljeno opozorilo v zvezi z otroki in mladostniki.
- Social anxiety disorders / social phobia
- motenj socialne anksioznosti/socialne fobije
Subsequently national Marketing Authorisations have been granted in all EU Member States for the treatment of various psychiatric disorders.
Kasneje je bil odobren za zdravljenje različnih duševnih motenj v vseh državah članicah EU.
The Rapporteur and Co-Rapporteur appointed were: Dr. F. Lekkerkerker and Dr. P. Arlett, respectively.
Poročevalec (Rapporteur) in so-poročevalec (Corapporteur) sta bila dr. F. Lekkerkerker in dr. P. Arlett.
Following the adoption of the CHMP Opinion for paroxetine, the CHMP further reviewed the risk of suicidal behaviour in children and adolescents treated with this type of medicines.
Po sprejetju mnenja CHMP o paroksetinu je CHMP še nadalje obravnaval tveganje za samomorilno vedenje pri otrocih in mladostnikih, zdravljenih s to vrsto zdravil.
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III ter pogoji dovoljenja za promet z zdravilom v Dodatku IV.
- Post-traumatic stress disorder
- posttravmatske stresne motnje
Paroxetine inhibits the neuronal uptake of serotonin and thereby facilitates serotonergic transmission.
Paroksetin zavira privzem serotonina v nevrone in tako pospešuje serotonergično prevajanje.
During the referral procedure Dr. B. van Zwieten Boot took over the Rapporteurship from Dr. F. Lekkerkerker and Dr. F. Rotblat took over from Dr. P. Arlett.
Med samim postopkom je dr. B. van Zwieten Boot prevzela poročevalsko nalogo od dr. F. Lekkerkerkerja, dr. F. Rotblat pa je nadomestila dr. P. Arletta.
Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of paroxetine containing medicinal products remains favourable.
Na podlagi ovrednotenja razpoložljivih podatkov in na podlagi poročil o oceni zdravila (Rapporteurs' assesment reports), je CHMP menil, da razmerje med tveganji in koristmi za zdravila, vsebujoča paroksetin, ostaja ugodno.
- Obsessive compulsive disorder
- obsesivno kompulzivne motnje
- Major depressive episode
- velike depresivne epizode
The final CHMP opinion was adopted on 8 December 2004 recommending the variation of the Marketing Authorisations in accordance with the Summary of Product Characteristics for paroxetine containing medicinal products.
CHMP je mnenje sprejel dne 22. aprila 2004. 8. decembra 2004 pa je bilo sprejeto končno mnenje CHMP, ki priporoča spremembo dovoljenja za promet z zdravilom v skladu s Povzetkom glavnih značilnosti zdravila za zdravila, vsebujoča paroksetin.
- Generalised anxiety disorder
- motnje generalizirane anksioznosti
This summary was last updated in 09/2013.
Povzetek je bil nazadnje posodobljen 09/2013.
The main measure of effectiveness was the change in symptoms.
Glavno merilo učinkovitosti je bilo izboljšanje simptomov.
The company will also carry out studies to confirm the long-term safety of the medicine.
Prav tako bo družba izvedla študije za potrditev dolgoročne varnosti zdravila.
The dose is 5 mg per kilogram for the other diseases.
Odmerek pri ostalih boleznih je 5 mg na kilogram.
Some side effects, including infections, may be more common in children than in adults.
Nekateri neželeni učinki, vključno z okužbami, so lahko pogostejši pri otrocih kot pri odraslih.
The full EPAR for Inflectra 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) za zdravilo Inflectra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Inflectra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inflectra?