natgillin/translations-raw huggingface dataset:
IMPORTANT: - Take off the previous patch before putting ONE new patch on. - Only one patch per day.
POMEMBNO: - Najprej odstranite prejšnji obliž in šele nato namestite EN nov obliž.
Dose escalation
Zviševanje odmerka
How to apply your Rivastigmine 3M Health Care Ltd. transdermal patch Rivastigmine 3M Health Care Ltd. patches are transparent to translucent, plastic patches that stick to the skin.
Obliži Rivastigmin 3M Health Care Ltd. so prozorni ali prosojni plastični obliži, ki jih prilepite na kožo.
Package Leaflet: Information for the user Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Navodilo za uporabo Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž rivastigmin
PHARMACEUTICAL FORM
IME ZDRAVILA
• Take off the previous patch before putting ONE new patch on.
• Najprej odstranite prejšnji obliž in šele nato namestite EN nov obliž.
No specific interaction studies have been performed with Rivastigmine 3M Health Care Ltd. transdermal patches.
S transdermalnimi obliži Rivastigmin 3M Health Care Ltd. niso izvedli specifičnih študij medsebojnega delovanja.
No study was conducted with rivastigmine transdermal patches in subjects with renal impairment.
Pri osebah z okvaro ledvic niso opravili nobene študije s transdermalnimi obliži z rivastigminom.
- to patients with a history of asthma or obstructive pulmonary disease.
- bolnikom, ki so nagnjeni k zapori sečnih izvodil in k epileptičnim napadom, ker holinomimetiki lahko sprožijo te bolezni ali njihovo poslabšanje - bolnikom z anamnezo astme ali obstruktivne pljučne bolezni.
Unchanged rivastigmine is found in trace amounts in the urine; renal excretion of the metabolites is the major route of elimination after transdermal patch administration.
Nespremenjeni rivastigmin najdemo v urinu samo v sledovih.
After a minimum of four weeks of treatment and if well tolerated according to the treating physician, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
Če bolnik ta odmerek po presoji lečečega zdravnika dobro prenaša, je treba po najmanj štirih tednih odmerek 4,6 mg/24 h zvišati na 9,5 mg/24 h, kar je priporočeni dnevni učinkoviti odmerek.
Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž rivastigmin
Urinary tract infection Metabolism and nutrition disorders Common
- urinska inkontinenca (nezmožnost zadrževanja urina)
No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and oral rivastigmine.
Pri sočasni uporabi digoksina in peroralnega rivastigmina niso opazili neželenih učinkov na srčno prevodnost.
INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h
How to store Rivastigmine 3M Health Care Ltd.
Kako jemati zdravilo Rivastigmin 3M Health Care Ltd.
The percentages decreased in both rivastigmine 13.3 mg/24 h transdermal patch and rivastigmine 9.5 mg/24 h transdermal patch treatment groups over time (>24 weeks): application site erythema (0.8% vs. 1.6%) and application site pruritus (0.4% vs. 1.2%), respectively.
Odstotek bolnikov z navedenimi težavami se je sčasoma ( po več kot 24-tedenski uporabi) znižal tako v skupini, v kateri so uporabljali transdermalni obliž z rivastigminom 13,3 mg/24 h, kot tudi v skupini, v kateri so uporabljali transdermalni obliž z rivastigminom 9,5 mg/24 h: rdečina na mestu aplikacije (0,8 % v primerjavi z 1,6 %) in srbenje na mestu aplikacije (0,4 % v primerjavi z 1,2 %).
• Press the patch firmly in place for at least 30 seconds using the palm of the hand.
• Obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund.
Rivastigmine 3M Health Care Ltd. is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Zdravilo Rivastigmin 3M Health Care Ltd. uporabljamo za zdravljenje odraslih bolnikov z blago do zmerno hudo Alzheimerjevo demenco.
- Do not cut the patch into pieces.
- Samo en obliž na dan. - Obliža ne smete rezati na manjše dele.
Rivastigmine 9.5 mg/24 h
Rivastigm in 9,5 mg/24 h n povpre čje
Aggression
Rivastigmin
You should not breast-feed during treatment with Rivastigmine 3M Health Care Ltd. transdermal patches.
Med zdravljenjem s transdermalnimi obliži Rivastigmin 3M Health Care Ltd. ne smete dojiti.
NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Pri bolnikih z Alzheimerjevo demenco so opazovali razmerje med telesno maso in izpostavljenostjo zdravilni učinkovini (rivastigminu in presnovku NAP226-90) v stanju dinamičnega ravnovesja.
No study was conducted with rivastigmine transdermal patches in subjects with hepatic impairment.
Pri osebah z okvaro jeter niso opravili nobene študije s transdermalnimi obliži z rivastigminom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
IME ZDRAVILA IN POT(I) UPORABE Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž
- Treatment usually starts with Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h. - The recommended daily dose is Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h (this high strength is currently not available from 3M but may be available from other Marketing
- Zdravljenje se običajno začne z obližem Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h. - Priporočeni običajni dnevni odmerek zdravila Rivastigmin 3M Health Care Ltd. je 9,5 mg/24 h.
INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h
Application site skin reactions (e.g. application site erythema, application site pruritus, application site oedema, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue,
Bolezni sečil pogosti urinska inkontinenca Splošne težave in spremembe na mestu aplikacije pogosti kožne reakcije na mestu aplikacije (npr. rdečina na mestu aplikacije, srbenje na mestu aplikacije, oteklina na mestu aplikacije, dermatitis na mestu aplikacije, draženje na mestu aplikacije), astenična stanja (npr. utrujenost, astenija), zvišana telesna temperatura, zmanjšanje telesne mase redki padec
ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
DLSM - razlika po metodi najmanjših kvadratov (angl. difference in least square means) LOCF - metoda prenosa zadnje ocene naprej (angl. Last Observation Carried Forward) ocene pri lestvici ADAS-cog: negativna vrednost razlike po metodi najmanjših kvadratov pomeni večje izboljšanje pri uporabi obliža Rivastigmin 13,3 mg/24 h kot pri uporabi obliža Rivastigmin 9,5 mg/24 h. ocene pri lestvici ADCS-IADL: pozitivna vrednost razlike po metodi najmanjših kvadratov pomeni večje izboljšanje pri uporabi obliža Rivastigmin 13,3 mg/24 h kot pri uporabi obliža Rivastigmin 9,5 mg/24 h.
Only one patch should be worn at a time (see section 4.9).
Nameščen sme biti samo en obliž naenkrat (glejte
- Press the patch firmly in place for at least 30 seconds using the palm of the hand.
- Obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund.
The patient's weight should be monitored during therapy with Rivastigmine 3M Health Care Ltd. transdermal patches.
Med zdravljenjem s transdermalnimi obliži Rivastigmin 3M Health Care Ltd. je treba spremljati bolnikovo telesno maso.
Skin application site reactions
Večina kožnih reakcij je bila omejena na mesto aplikacije.
NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
IME ZDRAVILA Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž
NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
IME ZDRAVILA Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž
Rivastigmine 13.3 mg/24 h N = 265
Rivastigmin transdermalni obliži 9,5 mg/24 h N = 251
BATCH NUMBER
vrednost p
How to use Rivastigmine 3M Health Care Ltd.
Kako odstraniti transdermalni obliž Rivastigmin 3M Health Care Ltd.
PHARMACOLOGICAL PROPERTIES
Imetnik dovoljenja za promet z zdravilom
The backing layer is transparent to translucent, labelled with “R10” in a repeated pattern.
Krovna plast je prozorna do prosojna in označena z oznako
PHARMACEUTICAL PARTICULARS
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:
Če opazite katerega od naslednjih neželenih učinkov, ki bi lahko postali resni, takoj snemite
Carefully remove the existing patch before putting on a new one.
Previdno odstranite obliž, ki je že na koži, in šele potem
- Carefully remove any existing patch before putting on a new one.
- Preden namestite nov obliž, previdno odstranite prešnjega.
4.6 mg
vrednost p a
Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Če opazite katerega od zgoraj navedenih neželenih učinkov, takoj snemite obliž in obvestite svojega
Otherwise your doctor will restart your treatment on Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h.
Če zdravljenja s transdermalnim obližem niste prekinili za več kot tri dni, lahko nadaljujete z enakim odmerkom, v nasprotnem primeru pa vam bo zdravnik ponovno uvedel zdravilo Rivastigmin 3M Health Care Ltd. v odmerku 4,6 mg/24 h.
This summary was last updated in 04-2016.
Povzetek je bil nazadnje posodobljen 04-2016.
The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.
Evropska komisija je dovoljenje za promet z zdravilom Bonviva, veljavno po vsej Evropski uniji, izdala 23. februarja 2004.
What measures are being taken to ensure the safe and effective use of Bonviva?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bonviva?
(In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.)
(Na območjih s trdo vodo, kjer voda iz pipe vsebuje veliko raztopljenega kalcija, se lahko uporabi ustekleničena voda z nizko vsebnostjo mineralov).
The full EPAR for Bonviva 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 Bonviva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Bonviva
Druge informacije o zdravilu Bonviva
Gradually, the bones become thin and fragile, and more likely to break.
Kosti se tako postopoma redčijo in postajajo krhkejše ter posledično bolj lomljive.
Blocking the action of these cells leads to less bone loss.
Zaviranje delovanja teh celic povzroči manjšo izgubo kostne mase.
Bonviva has been studied in three main studies involving women with osteoporosis.
Zdravilo Bonviva so raziskovali v treh glavnih študijah, v katere so bile vključene ženske z osteoporozo.
This is a summary of the European public assessment report (EPAR) for Bonviva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bonviva.
Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
Bolnice, ki jemljejo zdravilo Bonviva, bi morale jemati tudi dodatke vitamina D in kalcija, če teh ne dobivajo v zadostni količini s prehrano.
What benefit has Bonviva shown during the studies?
Kakšne koristi je zdravilo Bonviva izkazalo med študijami?
For more information about treatment with Bonviva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Bonviva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour.
Tablet ne smejo jemati bolnice z nepravilnostmi v požiralniku ali bolnice, ki ne morejo stati ali sedeti vzravnano vsaj eno uro.
Bonviva ibandronic acid
Bonviva ibandronska kislina
The most serious side effects with Bonviva are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut) irritation and eye inflammation.
Najresnejši neželeni učinki zdravila Bonviva so anafilaktične reakcije (hude alergijske reakcije), neznačilni zlomi stegnenice (neobičajne vrste zloma kosti v stegnu), osteonekroza čeljusti (poškodba čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih in majanje zob), gastrointestinalno razdraženost (razdražen želodec in črevesje) ter vnetje oči.
If the tablet is used, the dose is one tablet every month, preferably on the same date each month.
Pri uporabi tablet je odmerek ena tableta na mesec, zaželeno na isti dan v mesecu.
A risk management plan has been developed to ensure that Bonviva is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Bonviva je bil pripravljen načrt obvladovanja tveganj.
The 2.5-mg once-daily tablets used in the studies are no longer authorised.
V študiji uporabljene 2,5-miligramske tablete, ki se jemljejo enkrat na dan, niso več odobrene.
The dose by injection is 3 mg once every three months.
V primeru injiciranja se daje en 3-miligramski odmerek vsake tri mesece.
The CHMP decided that Bonviva's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Bonviva večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
Učinek zdravila pri zmanjševanju tveganja za zlome hrbtenice je bil dokazan v študijah, medtem ko njegov učinek na tveganje za zlom stegneničnega vratu (zgornjega dela stegnenice) ni bil dokazan.
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Zavira dejavnost osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
The studies looked at the change in the density of the bones in the spine and the hip over two years.
V študijah so primerjali spremembo gostote kosti v hrbtenici in kolkih v dveletnem obdobju.
It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
Na voljo je v obliki tablet (150 mg) in raztopine za injiciranje v napolnjeni injekcijski brizgi (3 mg).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bonviva, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bonviva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bonviva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The patient should not lie down for one hour after taking the tablet.
Bolnica vsaj eno uro po zaužitju tablete ne sme leči.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena, ki prispeva k ohranjanju zdravih kosti, pade.
What is the risk associated with Bonviva?
Kakšna tveganja so povezana z zdravilom Bonviva?
In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Poleg tega bo družba, ki trži zdravilo Bonviva, pripravila kartico, s katero bo bolnike seznanila s tveganjem pojava osteonekroze čeljusti in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Najpogostejši neželeni učinki zdravila Bonviva (opaženi pri 1 do 10 bolnic od 100) so artralgija (bolečine v sklepih) in gripi podobni simptomi.
Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels).
Zdravilo se ne sme uporabljati pri bolnicah, ki imajo hipokalciemijo (nizke ravni kalcija).
Bonviva is a medicine that contains the active substance ibandronic acid.
Bonviva je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
Bonviva can be given either as a tablet or as an injection into a vein.
Zdravilo Bonviva se daje bodisi s tabletami ali injiciranjem v veno.
Why has Bonviva been approved?
Zakaj je bilo zdravilo Bonviva odobreno?
In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
V prvi študiji je dnevno zdravljenje z 2,5-miligramskimi tabletami Bonviva v primerjavi s placebom za 62 % zmanjšalo tveganje za nove zlome hrbtenice.
Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
V dveh letih se je gostota kosti v hrbtenici povečala za 7 % pri uporabi mesečnih tablet in za 6 % pri uporabi injekcij, pri uporabi dnevnih tablet pa za 5 %.
The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Bonviva, ibandronska kislina, je difosfonat.
Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Zdravilo Bonviva se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
V kolkih se je gostota kosti povečala za 4 % pri uporabi mesečnih tablet in za 3 % pri uporabi injekcij, pri uporabi dnevnih tablet pa za 2 %.
The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets.
V drugih dveh študijah so mesečne odmerke 150-miligramskih tablet (pri 1 609 bolnicah) in injekcije (pri 1 395 bolnicah) primerjali z 2,5-miligramskimi tabletami, ki so jih bolnice jemale enkrat na dan.
For the full list of all side effects reported with Bonviva, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bonviva, glejte navodilo za uporabo.
The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip.
Drugi dve študiji sta pokazali, da so 150-miligramske mesečne tablete in injekcije pri povečevanju kostne gostote v hrbtenici in kolkih učinkovitejše od 2,5-miligramskih tablet, ki se jemljejo enkrat na dan.
The first study compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
V prvi študiji so zdravilo Bonviva v obliki 2,5-miligramskih tablet, ki so jih bolnice jemale enkrat dnevno, primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 3 000 bolnicah in ugotavljali število novih zlomov hrbtenice pri bolnicah v triletnem obdobju študije.
For the full list of restrictions with Bonviva, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Bonviva glejte navodilo za uporabo.
What is Bonviva used for?
Za kaj se zdravilo Bonviva uporablja?
How has Bonviva been studied?
Kako je bilo zdravilo Bonviva raziskano?
What is Bonviva?
Kaj je zdravilo Bonviva?
How is Bonviva used?
Kako se zdravilo Bonviva uporablja?
How does Bonviva work?
Kako zdravilo Bonviva deluje?
Next steps
Naslednji koraki
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
V zaključni fazi postopka pregleda bo Evropska komisija sprejela pravno zavezujoč sklep, ki bo veljal v vseh državah članicah EU.
• Patients were not given information about risks.
• Bolniki niso dobili informacij o tveganjih.
Public hearings are conducted according to the rules of procedure for public hearings.
Javne obravnave potekajo po postopkovnih pravilih za javne obravnave.
Healthcare professionals and academia
Zdravstveni delavci in akademiki
Public hearing held on 13 June 2018
Datum obravnave: 13. junij 2018
They also stressed the importance of microbial testing to make sure the medicines are only used when necessary.
Poudarjajo tudi pomembnost mikrobnega testiranja za zagotavljanje, da se zdravila uporabljajo samo po potrebi.
In closing the discussions, Dr Raine praised the courageous testimonies from patients and other participants.
V zaključku razprave je dr. Raine pohvalila pogumna pričevanja bolnikov in drugih udeležencev.
General public (patient representatives, carers, families) Speaker 1:
Splošna javnost (predstavniki bolnikov, negovalci, družinski člani) 1. govornik:
More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu
Več informacij o delu Evropske agencije za zdravila je na voljo na njenem spletnem mestu: www.ema.europa.eu
As time permitted, the Chair invited additional comments from the floor.
Ker je čas to dopuščal, je predsednica zaprosila udeležence obravnave za dodatne pripombe.
The legal basis for public hearings is Article 107j of Directive 2001/83/EC of the pharmacovigilance legislation, which gives the PRAC the possibility to hold public hearings for safety reviews conducted by the Committee under Article 20 of Regulation (EC) No 726/2004, and Articles 31 or 107i of Directive 2001/83/EC.
Pravna podlaga za javne obravnave je člen 107j Direktive 2001/83/ES o farmakovigilančni zakonodaji, ki odboru PRAC daje možnost, da organizira javne obravnave za namen pregledov varnosti, ki jih Odbor izvaja skladno s členom 20 Uredbe (ES) št. 726/2004 ter člena 31 ali člena 107i Direktive 2001/83/ES.
List of Speakers
Seznam govornikov
Many other members of the public who could not attend sent submissions in writing, which will all be taken into account during the review.
Številni drugi člani javnosti, ki se obravnave niso mogli udeležiti, so poslali pisne prispevke, ki bodo vsi upoštevani pri pregledu.
The recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion.
Priporočila bodo nato poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki je odgovoren za vprašanja o zdravilih za uporabo v humani medicini in bo upošteval mnenje Agencije za zdravila.