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.
Slovenian: Simptomi prevelikega odmerjanja so večinoma simpatikomimetične narave in so lahko zelo različni, od depresije osrednjega živčevja (sedacija, apneja, zmanjšana miselna zbranost, cianoza, koma, srčnožilni kolaps) do prekomerne stimulacije osrednjega živčevja (nespečnost, halucinacije, tremor, konvulzije) z možnim smrtnim izidom.
English: Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine sulphate contained in this medicine.
Slovenian: Pri določenih boleznih ali motnjah lahko postane bolnik izjemno občutljiv za dekongestiv psevdoefedrinijev sulfat, ki se nahaja v tem zdravilu.
English: OUTER CARTON OF 2, 4, 7, 10, 14, 20 MODIFIED-RELEASE TABLETS
Slovenian: ZUNANJA ŠKATLA Z 2, 4, 7, 10, 14 ali 20 TABLETAMI S PODALJŠANIM SPROŠČANJEM
English: There is insufficient information on the effects of desloratadine and pseudoephedrine sulphate in newborns/infants.
Slovenian: Podatki o učinku desloratadina in psevdoefedrinijevega sulfata na dojene novorojence/otroke so nezadostni.
English: Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood pressure.
Slovenian: Reverzibilen(-ni) in ireverzibilen(-ni) zaviralec (ci) MAO lahko povzročijo tveganje za vazokonstrikcijo in zvišan krvni tlak.
English: Ingredients in the white, sustained-release layer: hypromellose 2208, microcrystalline cellulose, povidone K30, silicon dioxide and magnesium stearate.
Slovenian: - Sestavine v beli plasti za podaljšano sproščanje: hipromeloza 2208, mikrokristalna celuloza, povidon K30, silicijev dioksid in magnezijev stearat.
English: • weight increased, increased appetite
Slovenian: • povečana telesna masa, povečan tek
English: • hallucination
Slovenian: • halucinacije
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).
Slovenian: - Druge sestavine zdravila so: - Sestavine v modri plasti za takojšnje sproščanje: koruzni škrob, mikrokristalna celuloza, dinatrijev edetat, citronska kislina, stearinska kislina in barvilo (indigotin E132).
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.
Slovenian: Srednji čas od zaužitja odmerka do doseganja največje plazemske koncentracije (Tmax) pri desloratadinu je znašal približno 4 do 5 ur, njegova srednja največja plazemska koncentracija (Cmax) približno 1,09 ng/ml, površina pod krivuljo koncentracije proti času (AUC) pa približno 31,6 ng•h/ml.
English: Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Slovenian: Simpatikomimetični amini lahko povzročijo stimulacijo centralnega živčevja s konvulzijami ali srčnožilnim kolapsom s spremljajočo hipotenzijo.
English: • Patients with cardiac arrhythmias
Slovenian: • pri bolnikih s srčnimi aritmijami,
English: When Aerinaze should be used
Slovenian: Kdaj naj se uporabi zdravilo Aerinaze
English: Desloratadine and pseudoephedrine sulphate are both excreted in human milk.
Slovenian: Desloratadin in psevdoefedrinijev sulfat se izločata v materino mleko.
English: • abnormal stool
Slovenian: • nenormalno blato
English: Sympathomimetics
Slovenian: Simpatikomimetiki
English: Palpitation, supraventricular extrasystoles
Slovenian: Srčne bolezni pogosti občasni tahikardija palpitacije, supraventrikularne ekstrasistole
English: - Desloratadine and Pseudoephedrine sulphate:
Slovenian: • Desloratadin in psevdoefedrinijev sulfat:
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,
Slovenian: To je še posebej pomembno, če jemljete: - digitalis, zdravilo za zdravljenje določenih srčnih bolezni - zdravila za krvni tlak (npr. alfa -metildopo, mekamilamin, rezerpin, alkaloide čmerike ali gvanetidin) - dekongestive (zdravila za zmanjšanje oteklosti nosne sluznice) za peroralno ali nosno uporabo
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate, a component of Aerinaze.
Slovenian: Pri doječih materah so pri jemanju psevdoefedrinijevega sulfata, ki je sestavina zdravila Aerinaze, poročali o zmanjšanem nastajanju mleka.
English: Blue, immediate-release layer maize starch microcrystalline cellulose edetate disodium citric acid stearic acid colorant (Indigo carmine E132 Aluminium lake).
Slovenian: Modra plast za takojšnje sproščanje koruzni škrob mikrokristalna celuloza dinatrijev edetat citronska kislina stearinska kislina barvilo (indigotin E132)
English: Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents.
Slovenian: Če med zdravljenjem z indirektnimi simpatikomimetiki uporabljate hlapne halogenirane anestetike, lahko nastopi perioperativna akutna hipertenzija.
English: Aerinaze is a blue and white oval bilayer modified-release tablet with “D12” debossed in the blue layer.
Slovenian: Zdravilo Aerinaze je modro-bela ovalna dvoplastna tableta s podaljšanim sproščanjem z oznako “D12” na modri plasti tablete.
English: How Aerinaze works
Slovenian: Kako deluje zdravilo Aerinaze
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of the combination of desloratadine and pseudoephedrine sulphate in pregnant women.
Slovenian: Podatkov o uporabi kombinacije desloratadina in pseudoefedrinijevega sulfata pri nosečnicah ni oziroma so omejeni (manj kot 300 izidov nosečnosti).
English: It has an indirect sympathomimetic effect due primarily to the release of adrenergic mediators from the post-ganglionic nerve endings.
Slovenian: Psevdoefedrinijev sulfat ima po peroralni uporabi zaradi svojega vazokonstrikcijskega delovanja predvsem dekongestivne učinke na nosno sluznico, poleg tega pa ima tudi posredne simpatikomimetične učinke, predvsem zaradi sproščanja adrenergičnih mediatorjev iz postganglijskih živčnih končičev.
English: Aerinaze 2.5 mg/120 mg modified-release tablets desloratadine/pseudoephedrine sulphate
Slovenian: Aerinaze 2,5 mg/120 mg tablete s podaljšanim sproščanjem desloratadin/psevdoefedrinijev sulfat
English: • feeling sick (nausea)
Slovenian: • slabost (siljenje na bruhanje)
English: Decongestants help to clear nasal congestion (blocked/stuffy nose).
Slovenian: Dekongestivi pomagajo zmanjšati oteklost nosne sluznice (zamašen nos).
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.
Slovenian: Pri psevdoefedrinijevem sulfatu je bila srednja vrednost Tmax dosežena od 6 do 7 ur po zaužitju odmerka, njegova srednja največja plazemska koncentracija (Cmax) je znašala približno 263 ng/ml, njegova vrednost AUC pa 4588 ng•h/ml.
English: Aerinaze 2.5 mg/120 mg modified-release tablets
Slovenian: Aerinaze 2,5 mg/120 mg tablete s podaljšanim sproščanjem
English: Cases of severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.
Slovenian: Pri uporabi zdravil, ki vsebujejo psevdoefedrin, so poročali o primerih hudih kožnih reakcij, kot je akutna generalizirana eksantematozna pustuloza (AGEP).
English: The rate of excretion is accelerated and the duration of action decreased in acidic urine (pH5).
Slovenian: Pri kislem urinu (pH 5) je izločanje zdravila pospešeno in trajanje njegovega delovanja skrajšano.
English: Insomnia, somnolence, sleep disorder, nervousness
Slovenian: Psihiatrične motnje pogosti občasni nespečnost, somnolenca, motnje spanja, živčnost vznemirjenost, tesnoba, razdražljivost
English: • inflammation of the sinus
Slovenian: • vnetje sinusov
English: • antihypertensive medicinal products
Slovenian: • antihipertenzivi,
English: Therefore absorption of pseudoephedrine sulphate was not affected by the Aerinaze formulation.
Slovenian: To pomeni, da formulacija zdravila Aerinaze ne vpliva na absorpcijo psevdoefedrinijevega sulfata.
English: Hypersensitivity (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Slovenian: Bolezni imunskega sistema zelo redki preobčutljivost (kot so anafilaksija, angioedem, dispneja, pruritus, izpuščaj in urtikarija)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni pruritus
English: However, in a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Slovenian: Medsebojnega delovanja zdravila Aerinaze in alkohola niso proučevali, vendar v kliničnem farmakološkem preskušanju desloratadin ob uživanju alkohola ni okrepil učinkov alkohola na zmanjšanje psihofizičnih sposobnosti.
English: Stop taking Aerinaze at least 48 hours before you have any skin tests since antihistamines may influence the result of the skin test.
Slovenian: Ker lahko antihistaminiki vplivajo na rezultat kožnega testa, morate najmanj 48 ur pred kakršnim koli kožnim testom prenehati jemati zdravilo Aerinaze.
English: Apnoea is treated with respiratory assistance.
Slovenian: Apnejo zdravite z asistirano ventilacijo.
English: • increased body movement
Slovenian: • povečani telesni gibi
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products.
Slovenian: Pri uporabi zdravil, ki vsebujejo psevdoefedrin, se lahko pojavijo hude kožne reakcije, kot je akutna generalizirana eksantematozna pustuloza (AGEP).
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.
Slovenian: (kot so fenilpropanolamin, fenilefrin, efedrin, oksimetazolin, nafazolin) - tablete za hujšanje (zaviralce teka) - amfetamine - zdravila proti migreni kot so ergot alkaloidi (kot so dihidroergotamin, ergotamin ali metilergometrin) - zdravila za zdravljenje Parkinsonove bolezni ali neplodnosti, npr. bromokriptin, kabergolin,
English: Rhinitis, sinusitis, epistaxis, nasal discomfort, rhinorrhea, dry throat, hyposmia
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti občasni faringitis rinitis, sinusitis, epistaksa, draženje nosne sluznice, rinoreja, suho grlo, hipozmija
English: No clinically relevant interactions or changes in desloratadine plasma concentrations were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered.
Slovenian: V kliničnih preskušanjih z desloratadinom, v katerih so bolniki sočasno jemali tudi eritromicin ali ketokonazol, niso opazili klinično pomembnih interakcij ali sprememb plazemske koncentracije desloratadina.
English: Distribution Pseudoephedrine sulphate is presumed to cross the placenta and the haematoencephalic barrier.
Slovenian: Porazdelitev Predpostavljajo, da psevdoefedrinijev sulfat prehaja skozi placento in krvnomožgansko pregrado.
English: Blue and white bilayer oval tablet with “D12” branded to blue layer.
Slovenian: tableta s podaljšanim sproščanjem modro-bela ovalna dvoplastna tableta z oznako “D12” na modri plasti tablete
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo redki mialgija
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
Slovenian: (peptični ulkus s stenozo) - če imate zaporo črevesja (zaporo pilorusa ali dvanajsternika) - če imate zaporo vratu sečnega mehurja (zaporo v vratnem delu mehurja) - če ste imeli v preteklosti težave z dihanjem zaradi krča mišic v pljučih (bronhospazem) - če imate težave z jetri, ledvicami ali sečnim mehurjem.
English: - Pseudoephedrine sulphate
Slovenian: • Psevdoefedrinijev sulfat
English: - Desloratadine
Slovenian: • Desloratadin
English: • stomach flu
Slovenian: • trebušna gripa
English: • decreased appetite • constipation
Slovenian: • zmanjšan tek • zaprtje
English: What Aerinaze is
Slovenian: Kaj je zdravilo Aerinaze
English: - Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate.
Slovenian: - Ena tableta vsebuje 2,5 mg desloratadina in 120 mg psevdoefedrinijevega sulfata.
English: Dizziness, psychomotor hyperactivity
Slovenian: Bolezni živčevja pogosti občasni omotica, psihomotorična hiperaktivnost hiperkinezija, stanje zmedenosti
English: Cases of severe skin reactions, including signs and symptoms such as fever, reddening of the skin, or many small pimples, have been reported with pseudoephedrine-containing products.
Slovenian: Pri uporabi zdravil, ki vsebujejo psevdoefedrin, so poročali o primerih hudih kožnih reakcij, vključno z znaki in simptomi, kot so zvišana telesna temperatura, rdečina na koži ali večje število majhnih mozoljev.
English: Headache, fatigue, dry mouth
Slovenian: Očesne bolezni občasni zamegljen vid, suho oko
English: Aerinaze is supplied in blisters comprised of laminate blister film and foil lidding.
Slovenian: Zdravilo Aerinaze je pakirano v pretisne omote, ki so izdelani iz ustrezne laminatne folije s prekrivno folijo.
English: • irritability
Slovenian: • razdražljivost
English: • pounding or irregular heart beat
Slovenian: • razbijanje srca ali nepravilna frekvenca srčnega utripa
English: Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate.
Slovenian: Ena tableta vsebuje 2,5 mg desloratadina in 120 mg psevdoefedrinijevega sulfata.
English: Aerinaze tablets are packed as 2, 4, 7, 10, 14, or 20 tablets in blisters comprised of laminate blister film and foil lidding.
Slovenian: Aerinaze tablete so pakirane v pretisnih omotih iz laminatne folije s prekrivno folijo, ki vsebujejo po 2, 4, 7, 10, 14 ali 20 tablet.
English: Marketing Authorisation Holder: Merck Sharp & Dohme B.V. Waarderweg 39
Slovenian: Imetnik dovoljenja za promet z zdravilom: Merck Sharp & Dohme B.V.
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)
Slovenian: - če imate zvišan krvni tlak, bolezni srca ali ožilja ali če ste imeli kdaj možgansko kap - če imate glavkom, težave z uriniranjem, zamašene sečne poti ali prekomerno delovanje žleze ščitnice - če jemljete zaviralce monoaminooksidaze (MAO) (skupina zdravil za zdravljenje depresije) ali če ste katero od teh zdravil prenehali jemati v zadnjih 14 dneh.
English: If you are breast-feeding taking Aerinaze is not recommended.
Slovenian: Če dojite, jemanje zdravila Aerinaze ni priporočljivo.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Slovenian: Študije z desloratadinom in loratadinom so pokazale, da nista kancerogena.
English: Dyspepsia, nausea, abdominal pain, gastroenteritis, abnormal faeces
Slovenian: Bolezni prebavil pogosti občasni zaprtje dispepsija, navzea, bolečine v trebuhu, gastroenteritis, nenormalno blato
English: There were no significant differences in the efficacy of Aerinaze tablets across subgroups of patients defined by gender, age, or race.
Slovenian: Med posameznimi podskupinami bolnikov, razdeljenimi po spolu, starosti ali rasi, niso opažali bistvenih razlik v učinkovitosti zdravila Aerinaze tablete.
English: Dysuria, micturition disorder
Slovenian: Bolezni sečil občasni disurija, motnje uriniranja
English: • nervousness
Slovenian: • živčnost
English: Hepatic enzymes increased
Slovenian: Preiskave občasni zvišani jetrni encimi
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.
Slovenian: Pri desloratadinu so izmerili srednjo največjo plazemsko koncentracijo v stanju dinamičnega ravnovesja Cmax približno 1,7 ng/ml, njegova vrednost AUC (0-12 h) pa je znašala 16 ng•h/ml, medtem ko je bila pri psevdoefedrinu srednja največja plazemska koncentracija v stanju dinamičnega ravnovesja (Cmax) 459 ng/ml, vrednost AUC (0-12 h)) pa je znašala 4658 ng•h/ml.
English: - tricyclic antidepressants (such as nortriptyline), antihistamines (such as cetirizine,
Slovenian: lizurid in pergolid - antacide pri slabi prebavi ali težavah z želodcem - zdravilo za zdravljenje driske imenovano kaolin - triciklične antidepresive (kot je nortriptilin), antihistaminike (kot sta cetirizin, feksofenadin).
English: Other
Slovenian: Ostalo
English: How to store Aerinaze
Slovenian: Shranjevanje zdravila Aerinaze
English: • liver inflammation
Slovenian: • želodčne bolečine
English: If you stop taking Aerinaze If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Slovenian: Če bo potrebno, vam bo namreč svetoval, da prenehate jemati to zdravilo: - zvišan krvni tlak - pospešen srčni utrip ali razbijanje srca - srčna aritmija - občutek slabosti ter glavobol ali poslabšanje glavobola - če ste imeli v preteklosti vi ali kdo v vaši družini epileptične napade - hude kožne reakcije, vključno z znaki in simptomi, kot so rdečina na koži, večje število majhnih mozoljev; z zvišano telesno temperaturo ali brez.
English: Nervous system disorders
Slovenian: Bolezni živčevja zelo redki konvulzije
English: In adults, tap water can be used.
Slovenian: Pri otrocih lahko opravite izpiranje želodca s fiziološko raztopino, pri odraslih pa lahko za ta namen uporabite kar vodo iz pipe.
English: • runny nose
Slovenian: • vnetje nosu
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate.
Slovenian: Pri doječih materah, ki so jemale psevdoefedrinijev sulfat, so poročali o zmanjšanem nastajanju mleka.
English: • stomach ache
Slovenian: • suha usta
English: • diarrhoea
Slovenian: • mrzlica
English: • cabergoline
Slovenian: • srbenje
English: • decongestants
Slovenian: • izpuščaji
English: • hot flush
Slovenian: • navali vročine
English: Pseudoephedrine sulphate carries the risk of abuse.
Slovenian: Psevdoefedrinijev sulfat bi lahko vodil do zlorabe tega zdravila, večji odmerki pa so lahko toksični.
English: • urinary retention,
Slovenian: • dekongestivi,
English: • bromocriptine
Slovenian: • tesnoba
English: • chills
Slovenian: • krči
English: QT prolongation
Slovenian: Srčne bolezni neznana pogostnost podaljšanje QT intervala
English: Renal and urinary disorders Uncommon
Slovenian: Presnovne in prehranske motnje neznana pogostnost povečan tek
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.
Slovenian: --1 Sev* virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza)*: sevu A/turkey/Turkey/1/2005 (H5N1) - podoben sev, (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov** na 0,5 ml odmerka * namnožen v oplojenih kokošjih jajcih iz jat zdravih piščancev ** izraženo v mikrogramih hemaglutinina
English: Adjuvant MF59C.1 containing: squalene
Slovenian: Adjuvans MF59C.1 vsebuje:
English: Pack size
Slovenian: sorbitantrioleat
English: The MAHs shall identify a specific patient population for which the benefits of the product outweigh the risk.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo opredeliti specifično populacijo bolnikov, pri kateri koristi zdravila odtehtajo ugotovljeno tveganje.
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):
Slovenian: Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je to ustrezno, bodo zagotovili, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Slovenian: Priloga IV
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex
Slovenian: 52 Boulevard du Parc 92521 NEUILLY SUR SEINE cedex France
English: Roche (Hungary) Ltd. Edison utca 1
Slovenian: Madžarska Roche (Hungary) Ltd. Edison utca 1
English: Roche Latvija SIA 8b G.Astras Street, Riga, LV1082,
Slovenian: Roche Latvija SIA 8b G.Astras Street, Riga, LV1082, Latvia
English: N.V. Roche S.A. Rue Dante 75 1070 Bruxelles Belgium
Slovenian: Roche S.A. Rue Dante 75 1070 Bruxelles Belgium
English: Roche Farmacêutica Química, Lda., Estrada Nacional 249-1, 2720-413 Amadora, Portugal
Slovenian: Estrada Nacional 249-1, 2720-413 Amadora, Portugal
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
Slovenian: Clădirea City GateTurnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România.
English: Rocephin zur Infusion 2 g 2 g
Slovenian: Rocephin zur Infusion 2 g
English: 1 g
Slovenian: 1g 1 g
English: Roche (Hellas) SA 4, Alamanas & Delfon Str., Maroussi 15125, Attiki
Slovenian: Roche (Hellas) SA 4, Alamanas & Delfon Str.,
English: Intravenous use or subcutaneous use
Slovenian: Intravenska ali subkutana uporaba
English: Roche Oy Klovinpellontie 3 PL 12
Slovenian: Roche Oy PL 12
English: Roche Pharma AG Emil-Barell-Str. 1
Slovenian: Roche Pharma AG Emil-Barell-Str. 1 79639 GrenzachWyhlen
English: Intramuscular use or subcutaneous use
Slovenian: Intramuskularna ali subkutana uporaba
English: Roche Nederland B.V. Beneluxlaan 2a, 3446 GR Woerden Netherlands
Slovenian: Nizozemska Roche Nederland B.V.
English: Rocephalin 500 mg
Slovenian: Intravenska uporaba 500 mg
English: Powder for solution for injection/infusion
Slovenian: Prašek za raztopino za injiciranje/infundiranje
English: Powder for solution for injection or infusion
Slovenian: Prašek za raztopino za injiciranje ali infundiranje
English: Intramuscular use
Slovenian: injiciranje
English: 1g
Slovenian: Priloga I
English: Powder and solvent for solution for IM injection Intramuscular use
Slovenian: Prašek za raztopino za injiciranje