FrancophonIA/ELRC3.0 huggingface dataset:
English: Please also review the Summary of Product Characteristics for the particular boosted PI.
Croatian: Molimo također pročitati Sažetak opisa svojstava lijeka za određeni IP čija se farmakokinetika pospješuje.
English: For further information, physicians should refer to the Summary of Product Characteristics for fosamprenavir.
Croatian: Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za fosamprenavir.
English: 200 q12 h
Croatian: 200 svakih 12 h
English: In intent to treat analyses, 50% and 57% of patients in the 350 and 450 mg/m2 dose groups, respectively, achieved reduction in plasma HIV-1 RNA to ≤ 400 copies/ml at Week 48.
Croatian: ITT analiza je pokazala da se broj kopija HIV-1 RNA nakon 48 tjedana smanjio na ≤ 400/ml u, redom, 50% i 57% bolesnika koji su primali 350 odnosno 450 mg/m² ritonavira.
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4 te se stoga očekuje da će povećati koncentracije fentanila u plazmi.
English: Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported in patients taking ritonavir.
Croatian: U bolesnika koji su uzimali ritonavir bilo je prijava poremećenih nalaza jetrene funkcije, hepatitisa (upala jetre) i rijetko žutice.
English: Concomitant use of avanafil or vardenafil with ritonavir is contraindicated (see section 4.3).
Croatian: Istodobna primjena avanafila sa ritonavirom je kontraindicirana (vidjeti dio 4.3)
English: Paediatric Use
Croatian: Pedijatrijska primjena
English: For specific dosing information in patients with renal impairment, refer to the Summary of Product Characteristics (SPC) of the co-administered protease inhibitor.
Croatian: Za specifične informacije o doziranju bolesnicima s oslabljenom funkcijom bubrega vidjeti Sažetak opisa svojstava lijeka (SPC, engl.
English: For further information, physicians should refer to the Summary of Product Characteristics for amprenavir.
Croatian: Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za amprenavir.
English: Refer to the darunavir Summary of Product Characteristics for further information on once daily dosing in ART experienced patients.
Croatian: Za više informacija o doziranju jedanput na dan kod bolesnika koji su prethodno primali ART treba pročitati Sažetak opisa svojstava lijeka za darunavir.
English: 200 q12 h, 2 days
Croatian: 1, jednokratna doza 200 svakih 12 h, 2 dana
English: Due to CYP3A inhibition by ritonavir, concentrations of lomitapide are expected to increase.
Croatian: Zbog inhibicije CYP3A ritonavirom, očekuje se povećanje koncentracije lomitapida.
English: Methadone1
Croatian: Atazanavir1
English: Ritonavir increases the serum levels of atazanavir as a result of CYP3A4 inhibition.
Croatian: Ritonavir povisuje serumske razine atazanavira zbog inhibicije CYP3A4.
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of loratadine.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A, zbog čega se očekuje povećanjekoncentracije loratadina u plazmi.
English: Refer to the Summary of Product Characteristics for atazanavir for further details.
Croatian: Za ostale detalje molimo pročitati Sažetak opisa svojstava lijeka za atazanavir.
English: Ritonavir co-administration is likely to result in increased plasma concentrations of cisapride and is therefore contraindicated (see section 4.3).
Croatian: Istodobno primijenjeni ritonavir vjerojatno bi povećao koncentracije cisaprida u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
English: • muscle aches (pain), tenderness or weakness
Croatian: • bol, osjetljivost ili slabost mišića
English: Hyperplasia of the retinal pigment epithelium (RPE) and retinal degeneration have been seen in all of the rodent studies conducted with ritonavir, but have not been seen in dogs.
Croatian: U svim ispitivanjima ritonavira u glodavaca, ali ne i u pasa, zamijećene su hiperplazija pigmentnog epitela mrežnice i degeneracija mrežnice.
English: • joint pain and back pain
Croatian: Vrlo često Artralgija i bol u leđima Često
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of carbamazepine.
Croatian: Ritonavir doziran kao antiretrovirusni lijek ili kao farmakokinetički pojačivač inhibira CYP3A4 te se zbog toga može očekivati povećanje koncentracija karbamazepina u plazmi.
English: ↑ 2.4fold ↑ 11 fold
Croatian: ↑ 11 puta ↑ 29 puta
English: AUC
Croatian: EXP
English: 500q12h ↑ 3.4-fold ↑ 55% Ritonavir inhibits CYP3A-mediated metabolism of ketoconazole.
Croatian: Ritonavir inhibira metabolizam ketokonazola posredovan enzimom CYP3A.
English: 600 q24 h
Croatian: 200, 4 doze
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of erythromycin and itraconazole.
Croatian: Eritromicin, itrakonazol Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4, zbog čega se očekuje povećanje koncentracije eritromicina i itrakonazola u plazmi.
English: Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition.
Croatian: Ritonavir povisuje serumske razine indinavira zbog inhibicije CYP3A4.
English: Tipranavir must be given with low dose ritonavir to ensure its therapeutic effect.
Croatian: Da bi se osigurao terapijski učinak, tipranavir se mora davati s malim dozama ritonavira.
English: Ritonavir increases the serum levels of nelfinavir as a result of CYP3A4 inhibition.
Croatian: Ritonavir povisuje serumske razine nelfinavira zbog inhibicije CYP3A4.
English: Extra monitoring is recommended when diarrhoea occurs.
Croatian: Pojavi li se proljev, preporučuje se osobito pažljivo praćenje.
English: Ritonavir co-administration is likely to result in increased plasma concentrations of astemizole and terfenadine and is therefore contraindicated (see section 4.3).
Croatian: Antihistaminici Astemizol, terfenadin Istodobno primijenjeni ritonavir vjerojatno bi povećao koncentracije astemizola i terfenadina u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
English: Pethidine, piroxicam, propoxyphene Ritonavir co-administration is likely to result in increased plasma concentrations of pethidine, piroxicam, and propoxyphene and is therefore contraindicated (see section 4.3).
Croatian: Istodobno primijenjeni ritonavir vjerojatno bi povećao plazmatske koncentracije petidina, piroksikama i propoksifena te je stoga kontraindiciran (vidjeti dio 4.3).
English: Ritonavir co-administration is likely to result in increased plasma concentrations of ergot derivatives and is therefore contraindicated (see section 4.3).
Croatian: Istodobno primijenjeni ritonavir vjerojatno povećava koncentracije derivata ergota u plazmi te je stoga kontraindiciran (vidjeti dio 4.3).
English: For further information, physicians should refer to the Summary of Product Characteristics for saquinavir.
Croatian: Daljnje informacije liječnik treba potražiti u Sažetku opisa svojstava lijeka za sakvinavir.
English: 1,250 q12 h 750, single
Croatian: 750, jednokratno 500 svakih 12 h Nelfinavir
English: Antimycobacterial
Croatian: Antimikotici
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of buspirone.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A te se zbog toga može očekivati povećanje koncentracija buspirona u plazmi.
English: 500 q12 h ↑ 4-fold
Croatian: 5, jednokratna doza 600 svakih 12h ↑49puta
English: Zidovudine
Croatian: Prednizolon
English: Co-administration of ritonavir and raltegravir results in a minor reduction in raltegravir levels.
Croatian: 400 jednokratno 100 svakih 12h Raltegravir Istodobna primjena ritonavira i raltegravira dovodi do blagog sniženja razina raltegravira.
English: GI motility agent
Croatian: • učestalije mokrenje
English: Taking Ritonavir Mylan with food and drink
Croatian: Uzimanje hrane i pića s lijekom Ritonavir Mylan
English: 100 q12 h Indinavir3 Ritonavir
Croatian: 800 svakih 12 h 100 svakih 12 h Indinavir3
English: The reduction of the rifabutin dose to 150 mg 3 times per week may be indicated for select PIs when co-administered with ritonavir as a pharmacokinetic enhancer.
Croatian: Pri primjeni ritonavira kao farmakokinetičkog pojačivača istodobno s određenim IP može biti indicirano smanjenje doze rifabutina na 150 mg triput na tjedan.
English: Ritonavir increases the serum levels of saquinavir as a result of CYP3A4 inhibition.
Croatian: Ritonavir povisuje serumske razine sakvinavira zbog inhibicije CYP3A4.
English: See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Croatian: Za istodobnu primjenu sildenafila bolesnicima s erektilnom disfunkcijom vidjeti dio 4.4 i dio 4.5.
English: Cmax recommended when these medicines are concomitantly administered with antiretroviral doses of ritonavir (see section 4.4).
Croatian: Preporučuje se pažljivo praćenje njihovih serumskih razina i terapijskih učinaka kada se ti lijekovi primjenjuju istodobno s ritonavirom doziranim kao antiretrovirusnim lijekom (vidjeti dio 4.4).
English: Haemophilia
Croatian: Hiperglikemija
English: Hepatic impairment
Croatian: Bolest bubrega
English: When ritonavir is used as a pharmacokinetic enhancer at the 100 mg and 200 mg level it cannot be assumed that the following warnings and precautions will also apply.
Croatian: Ta upozorenja i mjere opreza ne moraju vrijediti ako se ritonavir daje kao farmakokinetički pojačivač u dozama od 100 mg i 200 mg.
English: 400 q8 h
Croatian: ↑ 2.4 puta
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of dexamethasone.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A te se zbog toga može očekivati povećanje koncentracija deksametazona u plazmi.
English: Generics UK Limited Station Close Potters Bar Hertfordshire EN6 1TL
Croatian: Generics UK Limited Station Close
English: In intent to treat analyses, 72% and 36% of patients achieved reduction in plasma HIV-1 RNA of ≤ 400 copies/ml at Week 16 and 104, respectively.
Croatian: ≤ 400/ml u 73% bolesnika nakon 16 tjedana, a u 36% bolesnika nakon 104 tjedna.
English: Fatigue including asthenia, flushing, feeling hot
Croatian: Vrlo često Umor uključujući asteniju, crvenilo uz osjećaj vrućine Često
English: ND: Not determined 1 Based on a parallel group comparison 2 Sulfamethoxazole was co-administered with trimethoprim
Croatian: 2 Sulfametoksazol se davao istodobno s trimetoprimom.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
Croatian: A i B liječenih inhibitorima proteaza bilo je prijava pojačanog krvarenja, uključujući spontane kožne hematome i hemartroze.
English: 175 mg (2.2 ml) twice daily 200mg in the morning and 200mg in the evening 350 mg (4.4 ml) twice daily 400mg in the morning and 300mg in the evening 437.5 mg (5.5 ml) twice daily 500mg in the morning and 400mg in the evening 525 mg (6.6 ml) twice daily 500mg in the morning and 500mg in the evening
Croatian: 437,5 mg (5,5 ml) dva puta na dan
English: Amlodipine, diltiazem, nifedipine Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of calcium channel antagonists.
Croatian: Ritonavir doziran kao farmakokinetički pojačivač ili kao antiretrovirusni lijek inhibira CYP3A4, zbog čega se očekuje povećanje koncentracije antagonista kalcijevih kanala u plazmi.
English: Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole is used concomitantly administered with ritonavir.
Croatian: Kada se eritromicin ili itrakonazol daju istodobno s ritonavirom, preporučuje se pažljivo praćenje terapijskih učinaka i mogućih nuspojava.
English: What is Dutrebis and what is it used for?
Croatian: Što je Dutrebis i za što se koristi?
English: Other information about Dutrebis
Croatian: Ostale informacije o lijeku Dutrebis
English: The full EPAR and risk management plan summary for Dutrebis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Dutrebis nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The effectiveness and safety are taken to be the same as that for the two individual active substances, which are well characterised and do not raise any particular concern.
Croatian: Pretpostavka je da su djelotvornost i sigurnost podjednaki kao i u slučaju dvije individualne aktivne tvari, koje su dobro okarakterizirane i ne predstavljaju nikakav poseban razlog za zabrinutost.
English: The main measure of effectiveness was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml, which was 68.8%.
Croatian: Glavna mjera djelotvornosti bio je omjer bolesnika sa smanjenim koncentracijama virusa u krvi (viralno opterećenje) na manje od 50 HIV-RNK kopija po ml, što iznosi 68,8%.
English: Dutrebis is a medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Croatian: Dutrebis je lijek koji se koristi za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Dutrebis is available as tablets containing 150 mg of lamivudine and 300 mg of raltegravir, and the recommended dose is one tablet twice a day.
Croatian: Dutrebis je dostupan kao tablete koje sadrže 150 mg lavudina i 300 mg retegravira, a preporučena doza je jedna tableta dva puta na dan.
English: The Committee noted that the two active substances in Dutrebis are frequently taken together in clinical practice.
Croatian: Odbor je zaključio kako se dvije djelatne tvari lijeka Dutrebis često uzimaju zajedno u kliničkoj praksi.
English: The active substances in Dutrebis are already available in the European Union (EU) as singlecomponent medicines: lamivudine as Epivir since 1996, and raltegravir as Isentress since 2007.
Croatian: Djelatne tvari lijeka Dutrebis već su dostupne u Europskoj uniji (EU) kao lijekovi s jednom komponentom: lamivudin kao Epivir od 1996. i raltegravir kao Isentress od 2007.
English: It is used together with other HIV medicines and can be used in patients from 6 years of age and weighing at least 30 kg.
Croatian: Koristi se zajedno s drugim lijekovima za terapiju protiv HIV-a te se može primjenjivati u bolesnika od 6 godina starosti i tjelesne težine od najmanje 30 kg.
English: Because lamivudine and raltegravir are already approved individually to treat HIV infection, the company presented data from the studies used to approve these medicines, including a study involving 160 patients given raltegravir with lamivudine (plus another HIV medicine, tenofovir) for a total of 240 weeks.
Croatian: Budući da su lamivudin i raltegravir već pojedinačno odobreni za liječenje infekcije HIV-om, tvrtka je dostavila podatke iz ispitivanja korištenih za odobravanje ovih lijekova, uključujući ispitivanje koje je obuhvatilo 160 bolesnika koji su primili raltegravir s lamivudinom (plus drugi lijek protiv HIV-a, tenofovir) tijekom ukupno 240 tjedana.
English: Dutrebis reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Dutrebis smanjuje količinu HIV-a u krvi i održava ga u malim koncentracijama.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dutrebis on 26 March 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Dutrebis na snazi u Europskoj uniji od 26. ožujka 2015.
English: It is not intended to provide practical advice on how to use Dutrebis.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Dutrebis.
English: It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Croatian: Djeluje inhibirajući djelovanje reverzne transkriptaze, enzima koji je potreban HIV-u da proizvede genetske upute za stvaranje više virusa nakon što je stanica zaražena.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Dutrebis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Dutrebis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: A risk management plan has been developed to ensure that Dutrebis is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Dutrebis.
English: The other active substance, raltegravir, is an ‘integrase inhibitor'.
Croatian: Druga djelatna tvar, reltegravir, je "inhibitor integraze".
English: What are the risks associated with Dutrebis?
Croatian: Koji su rizici povezani s lijekom Dutrebis?
English: Dutrebis contains the active substances lamivudine and raltegravir and is only for use in patients whose infection is not resistant to these medicines or certain related antiviral medicines.
Croatian: Dutrebis sadrži djelatne tvari lamivudin i raltegravir te je predviđen samo za uporabu u bolesnika čija infekcija nije rezistentna na ove lijekove ili na određene povezane antivirotike.
English: Other common side effects with lamivudine are malaise (feeling generally unwell), tiredness, nasal signs and symptoms, diarrhoea and cough.
Croatian: Druge česte nuspojave povezane s lamivudinom su slabost (opće loše stanje), umor, nazalni znakovi i simptomi, proljev i kašalj.
English: The two active substances in Dutrebis act by blocking different stages of the process by which the HIV virus replicates itself in the body.
Croatian: Dvije djelatne tvari u lijeku Dutrebis djeluju tako što blokiraju različite faze procesa kojim se virus HIVa umnožava u tijelu.
English: This is a summary of the European public assessment report (EPAR) for Dutrebis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Dutrebis.
English: The company also looked at the way Dutrebis was absorbed in the body in comparison with two separate tablets containing lamivudine and raltegravir.
Croatian: Tvrtka je također istražila način na koji se Dutrebis apsorbira u tijelu u usporedbi s dvije zasebne tablete koje sadrže lamivudin i raltegravir.
English: One active substance, lamivudine, is a ‘nucleoside reverse transcriptase inhibitor' (NRTI).
Croatian: Jedna djelatna tvar, lamivudin, je "nukleozidni inhibitor reverzne transkriptaze" (NRTI).
English: The most common side effects with lamivudine or raltegravir (which may affect up to 1 in 10 people) are headache and nausea (feeling sick).
Croatian: Najčešće nuspojave lamivudina ili raltegravira (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja i mučnina (osjećaj slabosti).
English: The results of the studies showed that Dutrebis produced similar levels lamivudine in the body to lamivudine taken separately; although the levels of raltegravir were slightly different, Dutrebis was shown to produce levels of raltegravir that were similarly effective in controlling the virus.
Croatian: Rezultati ispitivanja su pokazali da je Dutrebis proizveo slične razine lamivudina u tijelu kao kada se lamivudin uzimao zasebno; iako je koncentracija raltegravira bila neznatno drugačija, dokazano je kako je Dutrebis proizveo razine raltegravira koje su bile gotovo podjednako djelotvorne u kontroliranju virusa.
English: Dutrebis can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
Croatian: Dutrebis se izdaje samo na liječnički recept, a liječenje treba nadzirati liječnik iskusan u upravljanju infekcijama HIV-om.
English: For more information about treatment with Dutrebis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Dutrebis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite se svom liječniku ili ljekarniku.
English: It blocks an enzyme called integrase that is needed for the subsequent stage of virus replication.
Croatian: Inhibira enzim naziva integraza koji je potreban za naredne faze umnožavanja virusa.
English: What measures are being taken to ensure the safe and effective use of
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dutrebis?
English: Dutrebis must be used in combination with other HIV medicines.
Croatian: Dutrebis se mora primjenjivati u kombinaciji s drugim lijekovima za liječenje HIV-a.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Dutrebis, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Dutrebis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Dutrebis allows them to be taken as a single tablet, although this will have to be taken twice daily and with other medicines for HIV.
Croatian: Dutrebis omogućuje istovremeno uzimanje u jednoj tableti, iako se tableta uzima dva puta dnevno i s drugim lijekovima protiv HIV-a.
English: What benefits of Dutrebis have been shown in studies?
Croatian: Koje su koristi lijeka Dutrebis utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Dutrebis, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Dutrebis potražite u uputi o lijeku.
English: For practical information about using Dutrebis, patients should read the package leaflet or contact their
Croatian: Praktične informacije o korištenju lijeka Dutrebis pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Of these 319 cases, almost all (98%) are from Sweden (67%) and Australia (31%).
Croatian: Od tih 319 slučajeva, gotovo svi slučajevi (98 %) zabilježeni su u Švedskoj (67 %) i Australiji (31 %).
English: Diliban retard is not yet placed in the EU market.
Croatian: Lijek Diliban Retard još uvijek nije stavljen na tržište u EU-u.
English: However, this has to be put in perspective of the limited exposure.
Croatian: Međutim, to treba postaviti u kontekst ograničene izloženosti.
English: Seven cases were reported to be unintentional but none of them were fatal.
Croatian: Za sedam slučajeva prijavljeno je da su bili nenamjerni, no nijedan nije bio sa smrtnim ishodom.
English: The PRAC adopted a recommendation on 30 November 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Croatian: PRAC je 30. studenog 2017. usvojio preporuku koju je zatim razmatrao CMDh u skladu s člankom 107.k Direktive 2001/83/EZ.
English: There were 5 fatal cases reported out of the 319 cases.
Croatian: Od 319 slučajeva zabilježeno je pet slučajeva sa smrtnim ishodom.