FrancophonIA/ELRC3.0 huggingface dataset:
English: Loperamid Evolan loperamide
Swedish: Loperamid Evolan loperamid
English: The Netherlands Sandoz B.V.
Swedish: Nederländerna Sandoz B.V.
English: Bendro-flumetiazid Alternova bendro-flumethiazide 2.5 mg Tablet
Swedish: Bendro-flumetiazid Alternova bendroflumetiazid 2,5 mg Tablett
English: United Kingdom Strides Arcolab International
Swedish: Storbritannien Strides Arcolab International
English: Alternova A/S Hydrokortison Alternova hydrocortisone
Swedish: Alternova A/S Hydrokortison Alternova hydrokortison
English: Loperamid Orifarm loperamide
Swedish: Loperamid Orifarm loperamid
English: Alternova A/S Baklofen Alternova baclofen
Swedish: Alternova A/S Baklofen Alternova baklofen
English: Dicloxacillin Alternova dicloxacillin
Swedish: Dicloxacillin Alternova dikloxacillin
English: Alternova A/S Etodolac Alternova etodolac
Swedish: Alternova A/S Etodolac Alternova etodolak
English: Metoklopramid Alternova metoclopramide
Swedish: Metoklopramid Alternova metoklopramid
English: EG LABOLaboratoires Eurogenerics
Swedish: Frankrike EG LABOLaboratoires
English: SANDOZ FARMACEUTICA, SA
Swedish: Spanien SANDOZ FARMACEUTICA, SA
English: Loperamid Apofri loperamide
Swedish: Loperamid Apofri loperamid
English: Morysa memantine
Swedish: Morysa memantin
English: AUROVITAS SPAIN, SAU
Swedish: Spanien AUROVITAS SPAIN, SAU
English: Memantine Pharmascope memantine
Swedish: Memantine Pharmascope memantin
English: Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-acid-ethyl esters 90
Swedish: Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-fettsyra-etyl-estrar
English: Arrow Génériques
Swedish: Frankrike Arrow Génériques
English: hydrocortisone
Swedish: hydrokortison
English: dutasteride
Swedish: dutasterid
English: Mylan Dura GmbH
Swedish: Tyskland Mylan Dura GmbH
English: voriconazol
Swedish: vorikonazol
English: The Netherlands Pharmascope Ltd.
Swedish: Nederländerna Pharmascope Ltd.
English: Slovak Republic SVUS Pharma a.s.
Swedish: Slovakien SVUS Pharma a.s.
English: memantine
Swedish: memantin
English: Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90
Swedish: Omega 3 Strides Arcolab International omega-3-fettsyra-etyl-estrar
English: Belgium Aurobindo Pharma BV
Swedish: Belgien Aurobindo Pharma BV
English: Medreich PLC Gliclazide 40 mg tablets gliclazide
Swedish: Medreich PLC Gliclazide 40 mg tablets gliclazid
English: 1A Pharma GmbH
Swedish: Österrike 1A Pharma GmbH
English: Sodium Cromoglicate 100mg hard Capsules sodium cromoglicate 100 mg Capsule, hard Oral use
Swedish: Sodium Cromoglicate 100mg hard Capsules natriumkromoglikat
English: Gliclazide 80mg Tablets gliclazide
Swedish: Gliclazide 80mg Tablets gliclazid
English: Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzine hydrochloride
Swedish: Hydroxyzine hydrochloride 25mg film-coated tablets hydroxizinhydroklorid
English: Teva Sante
Swedish: Frankrike Teva Sante
English: Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol / levonorgestrel mg/0.15 mg neuraxpharm Arzneimittel GmbH
Swedish: Maexeni 30 0,03 mg/0,15 mg Filmtabletten etinylestradiol/levonorgestrel 0,03 mg/0,15 mg
English: Mylan SAS
Swedish: Frankrike Mylan SAS
English: United Kingdom HEC Pharm GmbH
Swedish: Storbritannien HEC Pharm GmbH
English: Hydroxyzine EQL Pharma hydroxyzine
Swedish: Hydroxyzine EQL Pharma hydroxizin
English: loperamide
Swedish: loperamid
English: Naproxen Orion
Swedish: Naproxen Orion naproxen
English: Gliclazide 40mg Tablets gliclazide
Swedish: Gliclazide 40mg Tablets gliclazid
English: Sandoz GmbH
Swedish: Slovenien Sandoz GmbH
English: The Netherlands Aurobindo Pharma B.V.
Swedish: Nederländerna Aurobindo Pharma B.V.
English: Biogaran hydroxyzine BIOGARAN hydroxyzine
Swedish: Frankrike Biogaran hydroxyzine BIOGARAN hydroxizin
English: Hydroxyzinhydrochlorid EQL Pharma hydroxyzine
Swedish: Hydroxyzinhydrochlorid EQL Pharma hydroxizin
English: BBS Consult Aps Hydrokortison BBS
Swedish: Hydrokortison BBS
English: metformin hydrochloride
Swedish: metforminhydroklorid
English: 1000 mg Capsule, soft Oral use
Swedish: 1 000 mg Kapsel, mjuk Oral användning
English: 0.5 mg Capsule, soft Oral use
Swedish: 0,5 mg Kapsel, mjuk Oral användning
English: Hormosan Pharma GmbH
Swedish: Tyskland Hormosan Pharma GmbH
English: Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90
Swedish: Esters ethyliques d'acides omega-3 Strides omega-3-fettsyra-etyl-estrar
English: Metformine Almus metformin hydrochloride
Swedish: Metformine Almus metforminhydroklorid
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg
Swedish: Frankrike ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 4 mg/1,25 mg
English: Carbimazole 5mg Tablets carbimazole
Swedish: Carbimazole 5mg Tablets karbimazol
English: Hydroxyzine ARROW hydroxyzine
Swedish: Hydroxyzine ARROW hydroxizin
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 8 mg / 2.5 mg
Swedish: Frankrike ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 8 mg/2,5 mg
English: PUREN Pharma GmbH & Co. KG
Swedish: Tyskland PUREN Pharma GmbH & Co.
English: ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 2 mg/ 0.625 mg
Swedish: Frankrike ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 2 mg/0,625 mg
English: Metformina Almus metformin hydrochloride
Swedish: Metformina Almus metforminhydroklorid
English: Dawa Limited Carbimazole 5mg Tablets carbimazole
Swedish: Dawa Limited Carbimazole 5mg Tablets karbimazol
English: Metformin 1000 mg Filmcoated tablet metformin hydrochloride
Swedish: Metformin 1000 mg Filmcoated tablet metforminhydroklorid
English: Voriconazol Glob voriconazol
Swedish: Voriconazol Glob vorikonazol
English: Corporation, Finland
Swedish: Danmark Orion Corporation, Finland
English: Naproxeno Aurobindo
Swedish: Naproxeno Aurobindo naproxen
English: Vzole 200 mg film-coated tablets voriconazol
Swedish: Vzole 200 mg film-coated tablets vorikonazol
English: Vzole 50 mg film-coated tablets voriconazol
Swedish: Vzole 50 mg film-coated tablets vorikonazol
English: Hydroxyzine Sandoz hydroxyzine
Swedish: Hydroxyzine Sandoz hydroxizin
English: Naproxen Aurobindo 250 mg, tabletten
Swedish: Naproxen Aurobindo 250 mg, tabletten naproxen
English: Voriconazolo Aurobindo voriconazol
Swedish: Voriconazolo Aurobindo vorikonazol
English: Voriconazole Milpharm 200 mg film-coated tablets voriconazol
Swedish: Voriconazole Milpharm 200 mg film-coated tablets vorikonazol
English: Metformin 850 mg Film-coated tablet metformin hydrochloride
Swedish: Metformin 850 mg Film-coated tablet metforminhydroklorid
English: Voriconazole Milpharm 50 mg film-coated tablets voriconazol
Swedish: Voriconazole Milpharm 50 mg film-coated tablets vorikonazol
English: Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel
Swedish: Maexeni 150/30 microgram Film Coated Tablets etinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: Voriconazol Aurobindo 200 mg, filmomhulde tabletten voriconazol
Swedish: Voriconazol Aurobindo 200 mg, filmomhulde tabletten vorikonazol
English: Carbimazole 20 mg Tablets carbimazole
Swedish: Carbimazole 20 mg Tablets karbimazol
English: Cristers
Swedish: Frankrike Cristers
English: Voriconazol PUREN 200 mg Filmtabletten voriconazol
Swedish: Voriconazol PUREN 200 mg Filmtabletten vorikonazol
English: voriconazole Arrow voriconazol
Swedish: voriconazole Arrow vorikonazol
English: omega-3-acid-ethyl esters 90
Swedish: omega-3-fettsyra-etyl-estrar
English: Betahistin Sandoz 8 mg betahistine
Swedish: Betahistin Sandoz 8 mg betahistin
English: Czech Republic Proenzi s.r.o.
Swedish: Tjeckien Proenzi s.r.o.
English: Voriconazol PUREN 50 mg Filmtabletten voriconazol
Swedish: Voriconazol PUREN 50 mg Filmtabletten vorikonazol
English: 375 mg Capsule, hard Oral use
Swedish: 375 mg Kapsel, hård Oral användning
English: Voriconazol Aurobindo 50 mg, filmomhulde tabletten voriconazol
Swedish: Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonazol
English: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel
Swedish: Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů etinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: Metformin 500 mg Film-coated tablet metformin hydrochloride
Swedish: Metformin 500 mg Film-coated tablet metforminhydroklorid
English: Naproxen Aurobindo 500 mg, tabletten
Swedish: Naproxen Aurobindo 500 mg, tabletten naproxen
English: Memantine Dawa 20mg filmcoated tablets memantine
Swedish: Memantine Dawa 20mg filmcoated tablets memantin
English: Dawa Limited Carbimazole 20mg Tablets carbimazole
Swedish: Dawa Limited Carbimazole 20mg Tablets karbimazol
English: Betahistin Sandoz 16 mg betahistine
Swedish: Betahistin Sandoz 16 mg betahistin
English: Ethinylestradiol / Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette ethinylestradiol / levonorgestrel
Swedish: Ethinylestradiol / Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette etinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: Voriconazol Aurovitas voriconazol
Swedish: Voriconazol Aurovitas vorikonazol
English: Carbimazole 20mg Tablets carbimazole
Swedish: Carbimazole 20mg Tablets karbimazol
English: 300 mg modified-release tablet
Swedish: 300 mg Tablett med modifierad frisättning
English: 300 mg Modified-release tablet
Swedish: 300 mg tablett med modifierad frisättning
English: Aripiprazole 30 mg tablets aripiprazole
Swedish: Aripiprazole 30 mg tablets aripiprazol
English: Naproxen Aurobindo
Swedish: Naproxen Aurobindo naproxen
English: Memantine Dawa 10mg filmcoated tablets memantine
Swedish: Memantine Dawa 10mg filmcoated tablets memantin
English: Slovak Republic Proenzi s.r.o.
Swedish: Slovakien Proenzi s.r.o.
English: HEC Pharm GmbH
Swedish: Tyskland HEC Pharm GmbH
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/160 mg
Swedish: Arrow Génériques amlodipin/valsartan Arrow amlodipin/valsartan mg/160 mg
English: Beta- histina Bluefish betahistine dihydrochloride
Swedish: Beta- histina Bluefish betahistindihydroklorid 24 mg Tablett
English: Atyxine hydroxyzine
Swedish: Atyxine hydroxizin
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /160 mg
Swedish: Amlodipina + Valsartan Aurovitas amlodipin/valsartan mg/160 mg
English: Betahistine Sandoz 24 mg betahistine
Swedish: Betahistine Sandoz 24 mg betahistin
English: Aripiprazole 5 mg tablets aripiprazole
Swedish: Aripiprazole 5 mg tablets aripiprazol
English: Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol / levonorgestrel
Swedish: Oralcon 30 Microgramm/125 Microgramm Tabletten etinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: Aripiprazole 10 mg tablets aripiprazole
Swedish: Aripiprazole 10 mg tablets aripiprazol
English: Betahistin Sandoz 24 mg betahistine
Swedish: Betahistin Sandoz 24 mg betahistin
English: 1 g
Swedish: KG
English: 250 mg Capsule, hard Oral use
Swedish: 250 mg Kapsel, hård Oral användning
English: Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/160 mg
Swedish: Amlodipine-Valsartan AB amlodipin/valsartan mg/160 mg
English: 150 mg Capsule, hard Oral use
Swedish: 150 mg Kapsel, hård Oral användning
English: 500 mg Capsule, hard Oral use
Swedish: 500 mg Kapsel, hård Oral användning
English: Sarpin amlodipine / valsartan 10 mg /160 mg
Swedish: Sarpin amlodipin/valsartan mg/160 mg
English: 2 mg /0.625 mg
Swedish: perindopril/indapamid 2 mg/0,625 mg
English: 0.03 mg / 0.125 mg
Swedish: etinylestradiol/levonorgestrel 0,03 mg/0,125 mg
English: LABORATORIOS AUROBINDO, SLU
Swedish: Spanien LABORATORIOS AUROBINDO,
English: Capsule, soft Oral use
Swedish: 1 g Kapsel, mjuk Oral användning
English: Memantin Pharmascope 20 mg Filmtabletten memantine
Swedish: Memantin Pharmascope 20 mg Filmtabletten memantin
English: Memantin Pharmascope 10 mg Filmtabletten memantine
Swedish: Memantin Pharmascope 10 mg Filmtabletten memantin
English: Aripiprazole 15 mg tablets aripiprazole
Swedish: Aripiprazole 15 mg tablets aripiprazol
English: Memantine Pharmascope 10 mg filmomhulde tabletten memantine
Swedish: Memantine Pharmascope 10 mg filmomhulde tabletten memantin
English: Memantine Pharmascope 20 mg filmomhulde tabletten memantine
Swedish: Memantine Pharmascope 20 mg filmomhulde tabletten memantin
English: 1 A Pharma GmbH, Germany
Swedish: Tyskland 1 A Pharma GmbH,
English: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg
Swedish: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipin/valsartan mg/160 mg
English: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg
Swedish: Amlodipine/Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipin/valsartan mg/160 mg
English: acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet
Swedish: acide ursodesoxycholique Inopharm ursodeoxicholsyra
English: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg
Swedish: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipin/valsartan
English: Napritum
Swedish: Fantasinamn
English: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg
Swedish: Amlodipine/Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipin/valsartan
English: amlodipine / valsartan 10 mg / 160 mg
Swedish: amlodipin/valsartan mg/160 mg
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg
Swedish: Arrow Génériques amlodipin/valsartan Arrow amlodipin/valsartan
English: 20 mg Oro-dispersible tablet
Swedish: 20 mg Munsönderfallande tablett
English: 15 mg Oro-dispersible tablet
Swedish: 15 mg Munsönderfallande tablett
English: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg
Swedish: Amlodipine/Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipin/valsartan
English: 5 mg Oro-dispersible tablet
Swedish: 5 mg Munsönderfallande tablett
English: Proenzi s.r.o
Swedish: Lettland Proenzi s.r.o
English: 10 mg Oro-dispersible tablet
Swedish: 10 mg Munsönderfallande tablett
English: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg
Swedish: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipin/valsartan
English: Sandoz
Swedish: Frankrike Sandoz
English: Betahistyna Bluefish betahistine dihydrochloride
Swedish: Betahistyna Bluefish betahistindihydroklorid 24 mg Tablett
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack)
Swedish: 6 (3 x2) förfyllda injektionspennor (flerpack)
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack)
Swedish: 6 (3 x2) förfyllda sprutor med nålskyddsanordning (flerpack)
English: 21 March 2014
Swedish: 21 mars 2014
English: The European Commission issued a decision on 21 March 2014.
Swedish: Europeiska kommissionen utfärdade ett beslut den 21 mars 2014.
English: The company that markets these medicines is Roche.
Swedish: Företaget som marknadsför dessa läkemedel är Roche.
English: Rocephin is authorised in the EU via national procedures.
Swedish: Rocephin har godkänts i EU genom nationella förfaranden.
English: Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland.
Swedish: Rocephin är godkänt i följande EU-länder: Belgien, Danmark, Finland, Frankrike, Grekland, Irland, Italien, Lettland, Luxemburg, Malta, Nederländerna, Portugal, Rumänien, Storbritannien, Sverige, Tyskland, Ungern, samt i Island.
English: What is Rocephin?
Swedish: Vad är Rocephin?
English: Why was Rocephin reviewed?
Swedish: Varför granskades Rocephin?
English: Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)
Swedish: Frågor och svar om Rocephin och associerade namn (ceftriaxon, 250 mg, 500 mg, 1 g, 2 g, pulver till injektions- eller infusionsvätska, lösning)
English: It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Swedish: Det finns också i EU under andra produktnamn: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Swedish: Bakterien hindras då från att bygga sina cellväggar och dör slutligen till följd av detta.
English: Rocephin is a medicine that contains the active substance ceftriaxone.
Swedish: Rocephin är ett läkemedel som innehåller den aktiva substansen ceftriaxon.
English: On 23 January 2014, the European Medicines Agency completed a review of Rocephin.
Swedish: Den 23 januari 2014 avslutade Europeiska läkemedelsmyndigheten sin granskning av Rocephin.
English: The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).
Swedish: CHMP harmoniserade även andra avsnitt i produktresumén, däribland avsnitt 4.3 (kontraindikationer), 4.4 (varningar och försiktighet) och 4.6 (graviditet och amning).
English: In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat.
Swedish: Hos vuxna och barn över 12 års ålder varierar den rekommenderade dosen mellan 1 och 4 g Rocephin en gång om dagen beroende på tillståndet som ska behandlas.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children.
Swedish: Efter att ha harmoniserat indikationerna harmoniserade CHMP även rekommendationerna om hur Rocephin ska användas hos vuxna och barn.
English: The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:
Swedish: CHMP fann att Rocephin bör användas vid följande indikationer hos vuxna och barn, som redan var godkända i flera men inte alla medlemsstater i EU:
English: Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.
Swedish: Rocephin ska helst ges genom injektion i en ven under 5 minuter eller genom infusion (dropp) under minst 30 minuter, eller annars genom djup intramuskulär injektion.
English: Ceftriaxone belongs to the group ‘cephalosporins'; it works by attaching to proteins on the surface of bacteria.
Swedish: Ceftriaxon tillhör gruppen ”cefalosporiner”; det verkar genom att fästa till proteiner på bakteriens yta.
English: • hospital- and community-acquired pneumonia (infection of the lungs caught in or outside the hospital);
Swedish: • sjukhus- och samhällsförvärvad pneumoni (en infektion i lungorna som man fått i eller utanför sjukhuset),
English: On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU.
Swedish: Den 9 december 2011 hänsköt Europeiska kommissionen ärendet till CHMP för harmonisering av godkännandena för försäljning av Rocephin inom EU.
English: • bacterial endocarditis (an infection in the heart).
Swedish: • bakteriell endokardit (en infektion i hjärtat).
English: • the sexually transmitted infections gonorrhoea and syphilis;
Swedish: • de sexuellt överförda infektionerna gonorré och syfilis,
English: Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.
Swedish: Rocephin kan användas för att behandla patienter med neutropeni (låga halter av neutrofiler, en typ av vita blodkroppar) som också har feber som man misstänker har orsakats av en bakterieinfektion, patienter med bakteriemi (när bakterierna spåras i blodet) som man misstänker har orsakats av någon av de ovanstående infektionerna, samt för att preoperativt förebygga infektioner på platsen för det kirurgiska ingreppet.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Swedish: Mot bakgrund av inlämnade data och den vetenskapliga diskussionen inom kommittén ansåg CHMP att produktresuméerna, märkningen och bipacksedlarna skulle harmoniseras inom EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).
Swedish: Myndighetens kommitté för humanläkemedel (CHMP) fann att förskrivningsinformationen för Rocephin behöver harmoniseras inom Europeiska unionen (EU).
English: It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.
Swedish: Det kan också användas för att behandla disseminerad Lyme-borrelios (en bakterieinfektion som överförs till människor av infekterade fästingar) hos vuxna och barn inräknat nyfödda från 15 dagars ålder.
English: Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults.
Swedish: Rocephin kan användas för att behandla exacerbationer (anfall) av kronisk obstruktiv lungsjukdom hos vuxna.
English: It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine).
Swedish: Det är ett antibiotikaläkemedel som används för att behandla många olika bakterieinfektioner, inräknat pneumoni (infektion i lungorna) och meningit (infektion i membranen runt hjärnan och ryggmärgen).
English: In children below 12 years of age, the recommended dose of Rocephin depends on body weight and the condition it is used to treat.
Swedish: Hos barn under 12 års ålder är den rekommenderade dosen beroende av kroppsvikten och tillståndet som ska behandlas.
English: • intra-abdominal infections (infections within the abdomen);
Swedish: • intra-abdominella infektioner (infektioner inuti buken),
English: • complicated urinary tract infections, including pyelonephritis (kidney infection);
Swedish: • komplicerade urinvägsinfektioner, däribland pyelonefrit (njurinfektion),
English: The CHMP agreed that Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications.
Swedish: CHMP fann att Rocephin inte längre bör användas för att behandla sinusit (inflammation i bihålorna), faryngit (halsont) och prostatit (inflammation i prostatan, en körtel i mannens reproduktionsorgan) eftersom det inte finns tillräckligt med kliniska uppgifter till stöd för dessa indikationer.
English: • acute otitis media (infection of the middle ear);
Swedish: • akut otitis media (infektion i mellanörat),
English: • complicated skin and soft tissue infections;
Swedish: • komplicerade hud- och mjukvävnadsinfektioner,
English: • bacterial meningitis;
Swedish: • bakteriell meningit,
English: • infections of bones and joints;
Swedish: • infektioner i ben och leder,
English: Rocephin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Swedish: Samordningsgruppen för förfarandet för ömsesidigt erkännande och decentraliserat förfarandehumanläkemedel (CMD(h)) har fastställt att Rocephin behöver harmoniseras.
English: Only healthy animals should be vaccinated.
Swedish: Endast friska djur skall vaccineras.
English: 1 dose 5 x 1 dose 10 x 1 dose
Swedish: 1 dos 5 x 1 dos 10 x 1 dos