FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms may vary from CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to CNS stimulation (insomnia, hallucination, tremors, convulsions) with possible fatal outcome.
Danish: Symptomerne kan variere fra CNS-depression (sedation, apnø, nedsat mental parathed, cyanose, koma, kadiovaskulært kollaps) til CNS-stimulering (søvnløshed, hallucination, tremor, kramper) med muligt fatalt forløb.
English: Summary of the safety profile
Danish: Opsummering af bivirkningsprofilen
English: Aerinaze tablets relieve symptoms associated with seasonal allergic rhinitis (hay fever), such as, sneezing, runny or itchy nose, and eyes, when accompanied by nasal congestion in adults and adolescents 12 years of age and older.
Danish: Aerinaze-tabletter lindrer symptomer, der er forbundet med sæsonbetinget allergisk rhinitis (høfeber), såsom nysen, løbende eller kløende næse og øjne i forbindelse med tilstoppet næse hos voksne og teenagere i alderen 12 år og ældre.
English: Blue and white bilayer oval tablet with “D12” branded to blue layer.
Danish: Blå og hvid oval tablet i to lag med ”D12” præget på det blå lag.
English: Fertility There is no data available on male/female fertility.
Danish: Frugtbarhed Der er ingen information tilgængelig om virkningen på mandlig/kvindelig frugtbarhed.
English: Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction of the vesical cervix.
Danish: Anvendes med forsigtighed til patienter med stenotisk mavesår, pyloroduodenal obstruktion og blærehalsobstruktion.
English: Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Danish: I kliniske undersøgelser påvirkede desloratadin ved en daglig dosis på 7,5 mg ikke den psykomotoriske præstation.
English: Desloratadine and pseudoephedrine sulphate have been identified in breastfed newborns/infants of treated women.
Danish: Både desloratadin og pseudoephedrinsulfat er blevet sporet hos behandlede kvinders ammede nyfødte/spædbørn.
English: In addition, the decongestant efficacy of Aerinaze tablets, as measured by nasal stuffiness/congestion, was significantly greater than desloratadine alone over the 2-week treatment period.
Danish: Derudover var dekongestant-virkningen af Aerinaze-tabletter, målt som nasal tilstopning, signifikant bedre end behandling med desloratadin alene i en periode på 2 uger.
English: In both trials, the antihistaminic efficacy of Aerinaze tablets as measured by total symptom score, excluding nasal congestion, was significantly greater than pseudoephedrine sulphate alone over the 2-week treatment period.
Danish: I begge undersøgelser viste det sig, at antihistamin-effekten af Aerinaze-tabletter, målt som total symptom-score uden nasal tilstopning, var signifikant bedre end behandling med pseudoephedrinsulfat alene i en periode på 2 uger.
English: Ingredients in the white, sustained-release layer: hypromellose 2208, microcrystalline cellulose, povidone K30, silicon dioxide and magnesium stearate.
Danish: - Indholdsstoffer i det hvide lag til modificeret udløsning: hypromellose 2208, mikrokrystallinsk cellulose, povidon K30, silicadioxid og magnesiumstearat.
English: Hyperkinesia, confusional state
Danish: Hyperkinese, forvirring
English: Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
Danish: Det er derfor at foretrække at afbryde behandlingen 24 timer før anæstesi i forbindelse med planlagt kirurgi.
English: Desloratadine and pseudoephedrine sulphate are both excreted in human milk.
Danish: Både desloratadin og pseudoephedrinsulfat udskilles i modermælk.
English: • Patients receiving digitalis (see section 4.5)
Danish: • patienter, der får digoxin (se pkt.
English: Rhinitis, sinusitis, epistaxis, nasal discomfort, rhinorrhea, dry throat, hyposmia
Danish: Rhinitis, sinuitis, epistaxis, ubehag i næsen, rinorré, tørhed i svælget, hyposmi
English: OUTER CARTON OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
Danish: YDERKARTON MED 2, 4, 7, 10, 14, 20 TABLETTER MED MODIFICERET UDLØSNING
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Ikke kendt
English: Other medicines and Aerinaze
Danish: Brug af anden medicin sammen med Aerinaze
English: Do not take Aerinaze: - if you are allergic to desloratadine, pseudoephedrine sulphate, adrenergic medicines, or any of the other ingredients of this medicine (listed in section 6) or to loratadine - if you have high blood pressure, heart or blood vessel disease or a history of stroke - if you have glaucoma, difficulty in urinating, urinary tract blockage, or an overactive thyroid - if you are taking monoamine oxidase (MAO) inhibitor (a class of antidepressant medicines)
Danish: Tag ikke Aerinaze: - hvis du er allergisk over for desloratadin, pseudoephedrinsulfat, adrenergika eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) eller over for loratadin - hvis du har højt blodtryk, hjerte-karsygdomme eller tidligere har haft slagtilfælde - hvis du har glaukom, vandladningsbesvær, forsnævret urinrør eller en overaktiv skjoldbruskkirtel - hvis du får behandling med monoaminoxidase-hæmmere (MAO-hæmmere) (en type antidepressive lægemidler) eller er stoppet med at tage denne type medicin inden for de sidste 14 dage.
English: The prevalence of this poor metabolizer phenotype was greater among Black adults than Caucasian adults (18 % vs. 2 %) however the safety profile of these subjects was not different from that of the general population.
Danish: Prævalensen af denne fænotype med dårligt stofskifte var større blandt sorte voksne end hos voksne kaukasere (h.h.v.
English: Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Danish: In vitro-undersøgelser har ligeledes vist, at lægemidlet ikke hæmmer CYP2D6 og hverken er et substrat eller en hæmmer af P-glycoprotein.
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products.
Danish: Alvorlige hudreaktioner, såsom akut generaliseret eksantematøs pustulose (AGEP), kan forekomme med pseudoephedrin-holdige lægemidler.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, apoteket eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • inflammation of the nose
Danish: • betændelse i næsen
English: Caution should be exercised in patients suffering from migraine who are currently being treated with ergot alkaloid vasoconstrictors (see section 4.5).
Danish: Der skal udvises forsigtighed med migrænepatienter, som bliver behandlet med sekalealkaloid vasokonstriktorer (se pkt.
English: • dry throat
Danish: • tør hals
English: This is especially important if you are taking: - digitalis, a medicine used to treat certain heart disorders - medicines for blood pressure (e.g. α-methyldopa, mecamylamine, reserpine, veratrum alkaloids and guanethidine) - decongestants by oral or nasal route (such as phenylpropanolamine, phenylephrine, ephedrine,
Danish: Dette er især vigtigt, hvis du tager: - digitalis, et lægemiddel til behandling af visse hjertesygdomme - lægemidler for blodtrykket (f.eks. methyldopa, mecamylamin, reserpin, veratrum alkaloider og guanetidin - dekongestanter, der gives via næse eller mund (f.eks. phenylpropanolamin, phenylephedrin,
English: Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Danish: Sympatomimetika kan forårsage stimulering af centralnervesystemet med kramper eller kardiovaskulært kollaps med ledsagende hypotension.
English: • hallucination
Danish: • hallucinationer
English: Cases of severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.
Danish: Tilfælde af alvorlige hudreaktioner, såsom akut generaliseret eksantematøs pustulose (AGEP), er rapporteret med pseudoephedrin-holdige lægemidler.
English: - Pseudoephedrine sulphate
Danish: • Pseudoephedrinsulfat
English: • dry mouth
Danish: • tørhed i munden
English: Aerinaze should not be used during breast-feeding.
Danish: Aerinaze bør ikke anvendes under amning.
English: - if you have intestinal ulcers leading to the narrowing of the stomach, small intestine or esophagus (stenosing peptic ulcer) - if you have intestinal blockage (pyloral or duodenal blockage) - if you have bladder neck blockage (vesical cervix blockage) - if you have a history of difficulty breathing due to tightening of the lung muscles
Danish: (stenotisk mavesår) - hvis du har blokade af tarmene (pyloral eller duodenal blokade) - hvis du har blokade af blæremunden (vesikal cervix blokade) - hvis du tidligere har haft vejrtrækningsbesvær pga. stramning af lungemusklerne
English: Following oral administration of Aerinaze for 14 days in normal healthy volunteers, steady-state conditions were reached on day 10 for desloratadine, 3-hydroxydesloratadine and pseudoephedrine sulphate.
Danish: Efter peroral administration af Aerinaze i 14 dage hos normale, raske frivillige, blev steady-state betingelser for desloratadin, 3-hydroxydesloratadin og pseudoephedrinsulfat nået på dag 10. For desloratadin blev der set middel steady-state topplasmakoncentrationer ( Cmax og AUC (0-12 timer)) på h.h.v.
English: • changes in frequency of urination
Danish: • ændring i vandladningshyppighed
English: For pseudoephedrine sulphate, mean steady state peak plasma concentrations (Cmax and AUC (0-12 h)) of 459 ng/ml and 4,658 ng•hr/ml were observed.
Danish: For pseudoephedrinsulfat blev der set middel steady-state topplasmakoncentrationer (Cmax) og AUC (0-12 timer)) på 459 ng/ml og 4.658 ng•time/ml.
English: Vomiting, diarrhoea
Danish: Meget sjælden Opkastning, diarré
English: Dyspepsia, nausea, abdominal pain, gastroenteritis, abnormal faeces
Danish: Dyspepsi, kvalme, mavesmerter, gastroenteritis, unormal afføring
English: As a precautionary measure, it is preferable to avoid the use of Aerinaze during pregnancy.
Danish: For en sikkerheds skyld bør Aerinaze undgås under graviditeten.
English: • feeling sick (nausea)
Danish: • utilpashed (kvalme)
English: • irritability
Danish: • irritabilitet
English: Therefore absorption of pseudoephedrine sulphate was not affected by the Aerinaze formulation.
Danish: Derfor påvirker Aerinaze-formuleringen ikke absorptionen af pseudoephedrinsulfat.
English: How to take Aerinaze
Danish: Sådan skal du tage Aerinaze
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate.
Danish: Der er rapporteret nedsat produktion af human mælk hos ammende kvinder med pseudoephedrinsulfat.
English: Pseudoephedrine sulphate carries the risk of abuse.
Danish: Pseudoephedrinsulfat kan misbruges.
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Danish: Derfor kan visse interaktioner med andre lægemidler ikke udelukkes fuldstændigt.
English: Older adults may be more sensitive to the effects of this medicine - if you have diabetes
Danish: Ældre voksne kan være mere følsomme over for virkningen af dette lægemiddel - hvis du har diabetes - hvis du har intestinale mavesår, der fører til indsnævring af maven, tyndtarmen eller spiserøret
English: Pharyngitis
Danish: Faryngitis
English: After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if necessary.
Danish: Behandlingen kan om nødvendigt vedligeholdes med desloratadin alene efter bedring af den tilstoppede tilstand i slimhinderne i de øvre luftveje.
English: • antihypertensive medicinal products
Danish: • antihypertensiva
English: How Aerinaze works
Danish: Sådan virker Aerinaze
English: • decreased sense of smell
Danish: • nedsat lugtesans
English: This is due to the alpha-mimetic activity of pseudoephedrine sulphate in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…).
Danish: Dette skyldes den alfa-mimetiske virkning af pseudoephedrinsulfat, i kombination med andre vasokontriktorer som bromocriptin, pergolid, lisurid, cabergolin, ergotamin, dihydroergotamin eller andre dekongestanter brugt til næsen enten peroralt eller nasalt (phenylpropanolamin,
English: • Patients with cardiac arrhythmias
Danish: • patienter med hjertearytmi
English: • narrow-angle glaucoma,
Danish: • snævervinkel glaukom,
English: • abnormal liver function tests
Danish: • unormal leverfunktionstest
English: oxymetazoline, naphazoline) - diet pills (appetite suppressants) - amphetamines - medicines for migraines e.g. ergot alkaloids (such as, dihydroergotamine, ergotamine, or methylergometrine) - medicines for Parkinson's disease or for infertility e.g. bromocriptine, cabergoline, lisuride and pergolide - antacids for indigestion or stomach problems - a medicine for diarrhoea called kaolin.
Danish: ephedrin, oxymetazolin, naphazolin) - slankepiller (appetitnedsættende) - amfetaminer - lægemidler mod migræne, f.eks. sekalealkaloider (såsom dihydroergotamin, ergotamin eller methylergometrin) - lægemidler mod Parkinsons sygdom eller for ufrivillig barnløshed f.eks. bromocriptin,
English: Marketing Authorisation Holder: Merck Sharp & Dohme B.V. Waarderweg 39
Danish: Indehaver af markedsføringstilladelsen: Merck Sharp & Dohme B.V.
English: Aerinaze 2.5 mg/120 mg modified-release tablets desloratadine/pseudoephedrine sulphate
Danish: Aerinaze 2,5 mg/120 mg tabletter med modificeret udløsning desloratadin/pseudoephedrinsulfat
English: Drinking alcohol while taking Aerinaze is not recommended.
Danish: Det frarådes at drikke alkohol under behandling med Aerinaze.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to adrenergic medicinal products or to loratadine.
Danish: 6.1, eller over for adrenergika eller loratadin.
English: Sympathomimetics
Danish: Sympatomimetika
English: • pounding or irregular heart beat
Danish: • hamrende eller uregelmæssigt hjerteslag
English: In a series of pharmacokinetic and clinical trials, 6 % of the subjects reached a higher concentration of desloratadine.
Danish: 6% af forsøgspersonerne nåede en højere desloratadinkoncentration i en række farmakokinetiske og kliniske undersøgelser.
English: No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol.
Danish: Ved administration alene eller sammen med alkohol sås ingen signifikante forskelle i de psykomotoriske testresultater mellem desloratadin og placebogrupperne.
English: Talk to your doctor, pharmacist or nurse before taking Aerinaze: - if you are 60 years of age or older.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Aerinaze:
English: • digitalis (see section 4.4)
Danish: • digoxin (se pkt.
English: The clinical efficacy and safety of Aerinaze tablets was evaluated in two, 2-week multicentre, randomized parallel group clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received Aerinaze tablets.
Danish: Grupperne involverede 1.278 patienter i alderen 12-78 år, som alle led af sæsonbetinget allergisk rhinitis.
English: In a multiple-dose pharmacokinetic study conducted with the tablet formulation in healthy adult subjects, four subjects were found to be poor metabolisers of desloratadine.
Danish: Disse blev fundet i en multidosis farmakokinetisk undersøgelse, udført med tabletformuleringen på raske, voksne personer.
English: Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate.
Danish: Hver tablet indeholder 2,5 mg desloratadin og 120 mg pseudoephedrinsulfat.
English: - The other ingredients are: Ingredients in the blue, immediate-release layer: maize starch, microcrystalline cellulose, edetate disodium, citric acid, stearic acid and colorant (Indigo Carmine E132, Aluminum lake).
Danish: Aerinaze indeholder: - Aktive stoffer: desloratadin og pseudoephedrinsulfat - Hver tablet indeholder 2,5 mg desloratadin og 120 mg pseudoephedrinsulfat - Øvrige indholdsstoffer: - Indholdsstoffer i det blå lag til umiddelbar udløsning: majsstivelse, mikrokrystallinsk cellulose, edetatdinatrium, citronsyre, stearinsyre og farvestof (Indigo Carmin E132, Aluminium lake).
English: Aerinaze 2.5 mg/120 mg modified-release tablets
Danish: Aerinaze 2,5 mg/120 mg tabletter med modificeret udløsning.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl så spørg lægen, på apoteket eller sundhedspersonalet.
English: What Aerinaze is and what it is used for What you need to know before you take Aerinaze How to take Aerinaze
Danish: Det skal du vide, før du begynder at tage Aerinaze Sådan skal du tage Aerinaze Bivirkninger
English: Blue, immediate-release layer maize starch microcrystalline cellulose edetate disodium citric acid stearic acid colorant (Indigo carmine E132 Aluminium lake).
Danish: Farvestof (indigo carmin E132 Aluminium lake).
English: - Desloratadine
Danish: • Desloratadin
English: • liver inflammation
Danish: • hurtige hjerteslag
English: In addition, if you experience or are diagnosed with any of the following conditions you should talk to your doctor, pharmacist or nurse as they may advise you to stop taking Aerinaze: - high blood pressure - a fast or pounding heart beat - abnormal heart rhythm - feeling sick and headache or increase headache while using Aerinaze.
Danish: De vil da muligvis råde dig til at stoppe behandlingen med Aerinaze: - højt blodtryk - hurtig eller bankende hjerterytme - unormal hjerterytme - føler dig syg, får hovedpine eller forværret hovedpine mens du bruger Aerinaze - hvis du tidligere har haft krampeanfald eller nogen i familien har haft det - alvorlige hudreaktioner, inklusive tegn og symptomer såsom rødme i huden, mange små bumser
English: Musculoskeletal and connective tissue disorders
Danish: Mikrokrystallinsk cellulose Edetatdinatrium
English: For pseudoephedrine sulphate, the mean Tmax occurred at 6-7 hours post dose and mean peak plasma concentrations (Cmax and AUC) of approximately 263 ng/ml and 4,588 ng•hr/ml, respectively, were observed.
Danish: For pseudoephedrinsulfat sås middel-Tmax 6-7 timer efter dosering, og der er set middeltopplasmakoncentrationer (Cmax og AUC) på h.h.v.
English: Chills, flushing, hot flush
Danish: Kuldegysninger, rødmen, hedeture
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Aerinaze til dig personligt.
English: • cabergoline
Danish: • cabergolin
English: Convulsion
Danish: Obstipation
English: • abnormal stool
Danish: • unormal afføring
English: If you stop taking Aerinaze If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Hvis du holder op med at tage Aerinaze Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget du er i tvivl om.
English: Vision blurred, dry eye
Danish: Ikke almindelig Sløret syn, tørre øjne
English: Dysuria, micturition disorder
Danish: Ikke almindelig Dysuri, vandladningsforstyrrelser
English: • decongestants
Danish: • svimmelhed
English: Pruritus
Danish: Amning
English: White, sustained-release layer hypromellose 2208 microcrystalline cellulose povidone K30 silicon dioxide magnesium stearate.
Danish: Hvidt, modificeret udløsning lag Hypromellose 2208
English: If you take more Aerinaze than you should If you take more Aerinaze than you were told to, tell your doctor, pharmacist or nurse immediately.
Danish: Hvis du har taget for mange Aerinaze tabletter Kontakt straks lægen, apoteket eller sundhedspersonalet, hvis du har taget for mange Aerinazetabletter.
English: The mean time to maximum plasma concentrations (Tmax) for desloratadine occurred at approximately 4-5 hours post dose and mean peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC) of approximately 1.09 ng/ml and 31.6 ng•hr/ml, respectively, were observed.
Danish: Middeltiden til maksimal plamakoncentration (Tmax) for desloratadin opstod ca. 4-5 timer efter dosering.
English: - tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine,
Danish: cabergolin, lisurid og pergolid - syreneutraliserende midler mod fordøjelsesbesvær eller maveproblemer - et lægemiddel kaldet kaolin mod diarré - tricykliske antidepressiva (f.eks. nortriptylin), antihistaminer (f.eks. cetirizin, fexofenadin)
English: --1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/turkey/Turkey/1/2005 (H5N1) - like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Danish: --1 Influenzavirus-overfladeantigener (hæmagglutinin og neuraminidase)* fra stammen: A/turkey/Turkey/1/2005 (H5N1) - lignende stamme (NIBRG-23) (clade 2.2.1) 7,5 mikrogram** pr. dosis på 0,5 ml * formeret i befrugtede hønseæg fra sunde hønsehold ** udtrykt som mikrogram hæmagglutinin.
English: Adjuvant MF59C.1 containing: squalene
Danish: Adjuvans MF59C.1, som indeholder: squalen polysorbat 80
English: 10 pre-filled syringes
Danish: 10 fyldte injektionssprøjter
English: The MAHs shall identify a specific patient population for which the benefits of the product outweigh the risk.
Danish: Indehaverne af markedsføringstilladelse udpeger en konkret patientpopulation, for hvem produktets fordele overstiger risikoen.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten (-staterne) eller i givet fald i referencemedlemsstaten (-staterne) sikrer, at indehaveren (indehaverne) af markedsføringstilladelse opfylder følgende betingelser:
English: Conditions for lifting the suspension of the marketing authorisation
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Danish: Bilag IV Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelser i medlemstaterne
English: Roche România SRL Piaţa Presei Libere, Nr. 3-5, Clădirea City Gate-Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România
Danish: Rumænien Roche România SRL Piaţa Presei Libere, Nr. 3-5, Clădirea City Gate-Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România.
English: Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal
Danish: Estrada Nacional 249-1, 2720-413 Amadora, Portugal
English: N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium
Danish: Roche S.A. Rue Dante 75 1070 Bruxelles Belgium
English: Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125, Attiki
Danish: Grækenland Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125,
English: Rocephin zur Infusion 2 g 2 g
Danish: Rocephin zur Infusion 2 g
English: Intravenous use or subcutaneous use
Danish: Intravenøs anvendelse eller subkutan anvendelse
English: Rocephalin cum lidocain 1 g
Danish: Rocephalin cum lidocain
English: Intramuscular use or subcutaneous use
Danish: Intramuskulær anvendelse eller subkutan anvendelse
English: Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands
Danish: Nederlandene Roche Nederland B.V.