natgillin/translations-raw huggingface dataset:
The first dose should not be given before the age of 2 months and there should be a gap of at least four weeks between injections.
Med cepljenjem z vsakim odmerkom cepiva morajo miniti najmanj štirje tedni.
Menitorix can be used to boost protection in children who received Menitorix previously or in children who previously received other vaccines against these diseases (including children who received two doses of a MenC vaccine in early life).
26 Cepivo Menitorix se lahko uporabi za obnovitev odziva pri otrocih, ki so bili osnovno cepljeni s cepivom Menitorix, in otrocih, ki so bili osnovno cepljeni z drugim cepivom proti tem boleznim (vključno z otroci, ki so prejeli dva odmerka cepiva proti MenC v zgodnjem otroštvu).
26 If your child receives more Menitorix than he/ she should It is very unlikely that your child will receive too much or too little vaccine because each dose is provided in a separate vial and the vaccine is given by a doctor or nurse.
Če je otrok prejel večji odmerek cepiva Menitorix, kot bi smel Možnost, da bi otrok prejel prevelik ali premajhen odmerek cepiva je majhna, saj je vsak odmerek na voljo v posebni viali, cepivo pa bo otroku vedno dal zdravnik ali medicinska sestra.
Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated.
Po cepljenju s katerimkoli cepivom se lahko pojavijo hude alergijske reakcije, ki pa so običajno zelo redke in se pojavijo pri manj kot 1 od 10. 000 cepljenih oseb.
♦ Very common (in more than 1 per 10 doses of vaccine) • Pain, redness or swelling at the site of the injection • Fever (temperature of 38oC or above) • Irritability • Loss of appetite • Sleepiness
♦ Zelo pogosti (pri več kot 1 od 10 odmerkov cepiva)
♦ Uncommon (in less than 1 per 100 but more than 1 per 1,000 doses of vaccine) • Crying • Diarrhoea • Being sick • Generally feeling unwell • Fever of 39.5°C or above
Zvišana telesna temperatura (38 oC ali višja).
♦ Rare (in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine) • Rash
♦ Občasni (pri manj kot 1 od 100, vendar več kot 1 od 1. 000 odmerkov cepiva)
Other side effects which have occurred very rarely (in less than 1 per 10,000 doses of vaccine) in the days or weeks after vaccination with Menitorix include:
♦ Redki (pri manj kot 1 od 1. 000, vendar več kot 1 od 10. 000 odmerkov cepiva)
Allergic reactions (these can be recognised by itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing), swelling of the glands, dizziness, convulsions (fits) with high temperature, unusual muscle slackness, headache.
zelo
Some other side effects have been reported very rarely (in less than 1 per 10,000 doses of vaccine) in children who have received other MenC containing vaccines.
redki neželeni učinki (pri manj kot 1 od 10. 000 odmerkov cepiva), ki so se pojavili v nekaj
They include:
dneh ali tednih po cepljenju s cepivom Menitorix, so:
Collapse or shock, the child not responding to his or her parents for a time after vaccination, fainting, convulsions in
Alergijske reakcije (ki se lahko kažejo s srbečim izpuščajem po rokah ali nogah, oteklino oči in obraza, težkim dihanjem ali požiranjem), oteklina bezgavk, omotica, krči z visoko telesno temperaturo, neobičajna mlahavost mišic in glavobol.
27 children who have had them before, lack of sensation or an increased sensation (for example pain, pins and needles or itching at the injection site), joint pain, or purple spots or patches under the skin.
Ti so vključevali: kolaps ali šok, neodziv otroka na starše nekaj časa po cepljenju, omedlevico, krče pri otrocih, ki so jih imeli že prej, zmanjšano ali preveliko občutljivost (na primer bolečina, zbadanje ali srbenje na mestu injiciranja), bolečine v sklepih ali škrlatne pege ali zaplate pod kožo.
If you have previously been told by your doctor that your child suffers from nephrotic syndrome (a kidney disease which may result in swelling, particularly around the face or eyes, protein in the urine making it appear frothy and/ or weight gain) there may be an increased chance that this condition will reoccur within a few months after vaccination.
Če vam je zdravnik kdaj povedal, da ima otrok nefrotski sindrom (bolezen ledvic, ki ima lahko za posledico otekanje, še posebej obraza ali predela okrog oči, prisotnost beljakovin v urinu, kar povzroči penjenje urina in/ ali povečanje telesne mase), se lahko to stanje pri otroku v nekaj mesecih po cepljenju ponovi.
What Menitorix contains
Kaj vsebuje cepivo Menitorix
Haemophilus type b polysaccharide
Polisaharid hemofilusa influence tipa b
Powder: trometamol, sucrose Solvent: sodium chloride, water for injections.
Vehikel: natrijev klorid in voda za injekcije.
What Menitorix looks like and contents of the pack
Izgled cepiva Menitorix in vsebina pakiranja
Menitorix is supplied as a white powder of Hib-MenC vaccine in a glass vial, together with half a millilitre (0.5 ml) of clear colourless sodium chloride solvent in a pre-filled syringe for a 1 dose vaccine.
28 En odmerek cepiva Menitorix je na voljo v obliki belega praška (Hib- MenC sestavina cepiva) v stekleni viali in napolnjeni injekcijski brizgi, ki kot vehikel vsebuje pol mililitra (0, 5 ml) bistre in brezbarvne raztopine natrijevega klorida.
28 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Manufacturer GlaxoSmithKline Biologicals s. a.
Izdelovalec GlaxoSmithKline Biologicals s. a.
Detailed information on this medicine is available on the web site of:
Podrobne informacije o zdravilu so objavljene na spletni strani:
--------------------------------------------------------------------------------------------------------------------------- -- The following information is intended for medical or healthcare professionals only:
---------------------------------------------------------------------------------------------------------------------------
29 ANNEX IV
29 DODATEK IV
30 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
30 Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica, zagotovijo, da imetniki dovoljenja za promet z zdravilom izpolnjujejo naslednje pogoje:
The Applicant/ MAH is requested to commit to submitting for assessment, to the relevant national competent authorities, the results from the long-term antibody persistence data from the ongoing studies with Menitorix i. e. subjects from booster studies 013 and 022 are being followed up for antibody persistence as follows: o Over 4 years of follow up of subjects from study 013 in studies 027, 028 and 029. o Five years follow-up from 010/ 022 in subsequent studies 023, 024, 025 and 026.
Predlagatelj/ imetnik dovoljenja za promet z zdravilom se mora obvezati, da bo pristojnim nacionalnim organom predložil rezultate podatkov o dolgotrajni prisotnosti protiteles iz trenutno potekajočih študij z zdravilom Menitorix, tj. pri osebah iz študij poživitvenega cepljenja 013 in 022 se spremlja prisotnost protiteles, kot sledi: o več kot štiri leta spremljanja oseb iz študije 013 v študijah 027, 028 in 029; o pet let spremljanja iz študij 010/ 022 v naknadnih študijah 023, 024, 025 in 026.
London, 01 April 2008 EMEA/ CHMP/ 180097/ 2008
London, 01. 04. 08 EMEA/ 180095/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Menitorix
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA Menitorix
Common Name:
Splošno ime:
Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate) conjugated to tetanus toxoid and Neisseria meningitidis serogroup C (MenC) polysaccharide conjugated to tetanus toxoid
Haemophilus influenzae tipa b polisaharid (poliribosil ribitol fosfat) konjugiran na toksoid tetanusa in Neisseria meningitidis serogroup C (MenC) polisaharid konjugiran na toksoid tetanusa
Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of Powder and Solvent for Solution for Injection is a vaccine, indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) in infants from the age of 2 months and children up to the age of 2 years.
Menitorix, 5 mikrogramov PRP z 12, 5 mikrograma TT, 5 mikrogramov PSC s 5 mikrogrami TT v obliki praška in vehikla za raztopino za injiciranje je cepivo, namenjeno za preprečevanje invazivnih bolezni, ki jih povzročata Haemophilus influenzae tipa b (Hib) in Neisseria meningitidis skupine C (MenC) pri dojenčkih, starejših od dveh mesecev, in otrocih do drugega leta starosti.
GlaxoSmithKline Biologicals submitted applications for mutual recognition of Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of powder and solvent for solution for injection, on the basis of the marketing authorisation granted by the United Kingdom on 19 December 2005.
Družba GlaxoSmithKline Biologicals je predložila vlogo za medsebojno priznavanje cepiva Menitorix, 5 mikrogramov PRP z 12, 5 mikrogrami TT, 5 mikrogramov PSC s 5 mikrogrami TT v obliki praška in vehikla za raztopino za injiciranje, na podlagi dovoljenja za promet z zdravilom, ki ga je izdalo Združeno kraljestvo dne 19. decembra 2005.
During their November 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Menitorix, that the objections raised by Greece, Poland and Spain should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem novembra 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Menitorix ugodno, ter da ugovori, ki so jih podale Grčija, Poljska in Španija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom, ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
A positive opinion was adopted by consensus on 15 November 2007.
Pozitivno mnenje je bilo soglasno sprejeto dne 15. novembra 2007.
LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH IN ISLANDIJI
1 Member State MAH name and address
1 Država članica
Product Name
Izmišljeno ime
Austria Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Moxifloxacin hydrochloride
Moksifloksacinijev klorid
Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Bayer Austria GmbH Herbststraße 6- 10 1160 Wien Avstrija
Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Avenue Louise 143 Louizalaan B- 1050 Bruxelles Belgija
Rue Egide Van Ophem 108 1180 Bruxelles Belgium
Rue Egide Van Ophem 108 1180 Bruxelles Belgija
Sorou 18-20 151 25 Marousi - Athens Greece
Sorou 18- 20 151 25 Marousi - Athens Grčija
2 Member State MAH name and address
2 Država članica
Germany Bayer Vital GmbH 51368 Leverkusen Germany
Bayer Vital GmbH 51368 Leverkusen Nemčija
Oral use
Nemčija
Germany Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Oral use
Danska
Denmark Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Denmark Teva Denmark A/ S, Parallelvej 10, 2800 Kongens Lyngby Denmark
Teva Denmark A/ S, Parallelvej 10, 2800 Kongens Lyngby Danska
Denmark Teva UK Limited Brampton Road BN22 9AG East Sussex United Kingdom
Teva UK Limited Brampton Road BN22 9AG East Sussex Velika Britanija
Oral use
Estonija
Estonia Bayer Health Care AG 51368 Leverkusen Germany
Bayer Health Care AG 51368 Leverkusen Nemčija
3 Member State MAH name and address
3 Država članica
Greece Bayer Hellas Abee Sorou 18-20 15125 Maroussi - Athens Greece
Bayer Hellas Abee Sorou 18- 20 15125 Maroussi - Athens Grčija
Oral use
Grčija
Greece Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom
Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Velika Britanija
Baix Llobregat, 3 y 5 hydrochloride 08970 Sant Joan Despi Barcelona Spain
Baix Llobregat, 3 y 5 08970 Sant Joan Despi Barcelona Španija
Procter and Gamble Pharmaceuticals Iberia, SL Moxifloxacin WTC Almeda park, Edif 1, 2º planta hydrochloride 08940 Cornellá de Llobregat Barcelona Spain
Procter and Gamble Pharmaceuticals Iberia, SL WTC Almeda park, Edif 1, 2º planta 08940 Cornellá de Llobregat Barcelona Španija
RECORDATI ESPAÑA, SL Moxifloxacin Carretera De Zeneta, 149 hydrochloride 30588 Beniel (Murcia) Spain
RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Španija
Mare de Déu de Montserrat, 221 hydrochloride 08041 Barcelona Spain
Mare de Déu de Montserrat, 221 08041 Barcelona Španija
Oral use
400 mg
4 Member State MAH name and address
Filmsko obložena tableta
Product Name
Peroralna uporaba
Strength
Finska
Finland Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
France BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX France
BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX Francija
France BAYER HEALTHCARE AG 51368 Leverkusen Germany
BAYER HEALTHCARE AG 51368 Leverkusen Nemčija
OCTEGRA 400 mg, comprimé pelliculé
OCTEGRA 400 mg, comprimé 400 pelliculé
400 mg
mg
Oral use
Madžarska
Hungary Bayer Hungária Kft Alkotás ut.50 1123 Budapest Hungary
Bayer Hungária Kft Alkotás ut. 50 1123 Budapest Madžarska
Oral use
Islandija
Iceland Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Italy Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Nemčija
Italy Innova pharma S. p. A.
Innova Pharma S. p. A.
Civitali, 1 20148 Milano Italy
Civitali, 1 20148 Milano Italija
Bayer Limited The Atrium Blackthorn Road, Dublin 18 Ireland
Bayer Limited The Atrium Blackthorn Road, Dublin 18 Irska
Moxafloxacin hydrochloride
Moksifloksacinijev klorid
Bayer Healthcare AG 51368 Leverkusen Germany
Bayer Healthcare AG 51368 Leverkusen Nemčija
Avenue Louise 143 Louizalaan 1050 Bruxelles Belgium
Avenue Louise 143 Louizalaan 1050 Bruxelles Belgija
Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles Belgium
Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles Belgija
Product Name
Nizozemska
Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht Nederland
Bayer BV Energieweg 1 3641 RT Mijdrecht Nizozemska
Oral use
Nizozemska
Netherlands Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Poland Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Oral use
Portugalska
Portugal Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Nemčija
Oral use
Romunija
Romania Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Sweden Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Nemčija
Strength
Švedska
Bravnič arjeva 13 1000 Ljubljana Slovenia
Bravničarjeva 13 1000 Ljubljana Slovenija
Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom
Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Velika Britanija
THE SCIENTIFIC CONCLUSIONS AND THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
1 SCIENTIFIC CONCLUSIONS
1 ZNANSTVENI ZAKLJUČKI
In the European Union (EU), Moxifloxacin film coated tablet are indicated for the treatment of acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community acquired pneumonia (CAP) except severe cases, at the dose of 400 mg daily for 7 days for ABS, 5-10 days for AECB and for 10 days for CAP.
V Evropski uniji (EU) so filmsko obložene tablete, ki vsebujejo moksifloksacin, indicirane za zdravljenje akutnega bakterijskega vnetja obnosnih votlin (sinuzitis, vnetje paranazalnih sinusov) (ABS), akutne eksacerbacije (nenadnega poslabšanja) kroničnega bronhitisa in pljučnice, pridobljene v domačem okolju, razen hudih oblik, z odmerkom 400 mg na dan 7 dni za zdravljenje akutnega bakterijskega vnetja obnosnih votlin, 5– 10 dni za zdravljenje akutne eksacerbacije kroničnega bronhitisa in 10 dni za zdravljenje pljučnice, pridobljene v domačem okolju.
Severe hepatotoxicity, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity (including rhabdomyolysis) are important identified risks of the treatment with moxifloxacin which are already described in the product information (PI) and under close monitoring.
Med najpomembnejša ugotovljena tveganja, povezana z zdravljenjem z moksifloksacinom, ki so že opisana in navedena v navodilu za uporabo ter so pozorno nadzorovana, spadajo hude oblike hepatotoksičnosti, srčna toksičnost, vključno s podaljšanim intervalom QTc (specifična nenormalnost v EKG- ju), hude kožne reakcije, kolitis (vnetje sluznice debelega črevesja), povezan s Clostridium difficile, in toksičnost kit in mišic (vključno z rabdomiolizo).
A cumulative review up to 30 September 2007 of all hepatic reactions (serious and non-serious) and an overall assessment of the benefit/ risk ratio of moxifloxacin treatment was performed.
Izveden je bil celovit pregled vseh reakcij jeter (hudih in manj hudih) do 30. septembra 2007 ter splošna ocena razmerja med koristmi in tveganji pri zdravljenju z moksifloksacinom.
Based on the above, on 2 June 2008, the UK issued a Rapid Alert informing Members States, the European Medicines Agency (EMEA) and the European Commission (EC) in accordance with Article 107 of Directive 2001/ 83/ EC, as amended of its intention to vary the marketing authorisation of all oral formulations of moxifloxacin containing medicinal products to remove the indications in ABS and AECB and to restrict the indication in CAP.
Na podlagi navedenega je Velika Britanija dne 2. junija 2008 izdala nujno opozorilo, s katerim je druge države članice, Evropsko agencijo za zdravila (EMEA) in Evropsko komisijo (EK) v skladu s členom 107 Direktive 2001/ 83/ ES, kakor je bila spremenjena, obvestila, da namerava spremeniti dovoljenje za promet za vse peroralne pripravke za zdravila, ki vsebujejo moksifloksacin, in sicer izbris indikacij akutnega bakterijskega vnetja obnosnih votlin, akutne eksacerbacije kroničnega bronhitisa ter omejitev indikacije za pljučnico, pridobljeno v domačem okolju.
ABS ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Akutno bakterijsko vnetje obnosnih votlin Akutno bakterijsko vnetje obnosnih votlin ni huda okužba in je povezana z visoko stopnjo spontanega okrevanja (90%).
However, the benefit risk of moxifloxacin may be favourable if other antibiotherapy has failed or cannot be used.
Čeprav se je moksifloksacin izkazal kot učinkovit, so razpoložljivi podatki omejeni, saj so bile študije predvsem izvedene v primerjavi z drugimi primerjalnimi zdravili, edina študija s placebo kontrolnimi skupinami pa ni uspela dokazati statistično boljših rezultatov v
2 show equivalence between medicinal products did not demonstrate clinical superiority of any class of antibiotics over another.
2 primerjavi s placebom.
Additionally, most of the phase III studies designed for non-inferiority for moxifloxacin did not use the recommended agent of choice.
Glede na visoko pojavnost resnih in celo življenjsko nevarnih tveganj pri zdravljenju okužb, za katere je značilna visoka stopnja spontanega okrevanja brez uporabe antibiotikov, je zaskrbljujoča.
Therefore, since the impact of the choice of an antibiotic therapy for AECB on the outcome of the patients remains unclear, the safety profile of the different antibiotherapy options must be considered.
Kljub temu pa je treba opozoriti, da do nedavnega nobene primerjalne študije v zvezi z akutno eksacerbacijo kroničnega bronhitisa, zasnovane za potrditev enakovrednosti zdravil, niso pokazale klinične superiornosti katere koli skupine antibiotikov nad drugimi.
In line with the safety profile, and considering that AECB can be a less severe infection, with high spontaneous resolution rate for which bacteria can be found in only 50% of all exacerbations, the benefit risk can only be considered favourable if moxifloxacin is not used as the first line treatment option.
V skladu z varnostnim profilom in glede na to, da je lahko akutna eksacerbacija kroničnega bronhitisa manj huda okužba, z visoko stopnjo spontanega okrevanja, pri kateri so bakterije prisotne v 50% primerov vseh eksacerbacij, je razmerje med koristmi in tveganji pri uporabi moksifloksacina pozitivno le v primeru, kadar ni uporabljeno kot primarna izbira zdravljenja.
CAP Clinical trial and published data indicate that moxifloxacin generally has benefits in the indication CAP.
Pljučnica, pridobljena v domačem okolju Klinični preskusi in objavljeni podatki kažejo, da je moksifloksacin pri zdravljenju pljučnice, pridobljene v domačem okolju, na splošno koristen.
In view of the above, the CHMP recommended the restriction to 2nd line treatment in the indications for moxifloxacin containing medicinal products (oral formulation) and further amendments to the PI, to include fatal hepatotoxicity cases, risk factors for QTc interval prolongation, and strengthen the warnings on Clostridium difficille-associated colitis and bullous skin reactions.
CHMP je v skladu z zgoraj navedenim priporočil omejitev na sekundarno zdravljenje z zdravili (peroralnimi pripravki), ki vsebujejo moksifloksacin, in dodatna dopolnila navodila za uporabo, ki naj vključujejo smrtne primere hepatotoksičnosti, dejavnike tveganja za podaljšanje intervala QTc in močnejša opozorila za uporabo pri zdravljenju kolitisa, povezanega s Clostridium difficille, in buloznih kožnih reakcij.
CHARACTERISTICS AND PACKAGE LEAFLETS
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
The Committee considered the procedure under Article 107 of Directive 2001/ 83/ EC, as amended, for medicinal products containing moxifloxacin in oral formulations.
Odbor je preučil napotitev v skladu s členom 107 Direktive 2001/ 83/ ES, kakor je bila spremenjena, za zdravila s peroralnimi pripravki, ki vsebujejo moksifloksacin.
In view of the safety available data the Committee concluded that cases of fatal hepatotoxicity, risk factors for QTc interval prolongation should be reflected in the product information, and that the warnings on Clostridium difficille-associated colitis and bullous skin reactions should be strengthen.
3 Glede na razpoložljive podatke o varnosti je Odbor zaključil, da je treba smrtne primere hepatotoksičnosti in dejavnike tveganja za podaljšanje intervala QTc vključiti v navodilo za uporabo ter da je treba povečati opozorila za uporabo pri zdravljenju kolitisa, povezanega s Clostridium difficille, in buloznih kožnih reakcij.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Pfizer Corporation Austria Gesellschaft m. b. H Floridsdorfer Hauptstraße 1 1210 Wien, Austria
Pfizer Corporation Austria Gesellschaft m. b. H Floridsdorfer Hauptstraße 1 1210 Wien, Avstrija
Boulevard de la Plaine, 17 B-1050 Bruxelles Belgium
Boulevard de la Plaine, 17 B- 1050 Bruxelles Belgija
243, Messoghion Ave., Neo Psychiko 154 51 Greece
243, Messoghion Ave., Neo Psychiko 154 51 Grčija
Gabapentin “ Pfizer”
Gabapentin
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ UK
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ UK
Pfizer Europe MA EEIG
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent, CT 13 9NJ UK