FrancophonIA/ELRC3.0 huggingface dataset:
English: Don't mix Zinnat with hot liquids.
Slovenian: Zdravila Zinnat ne smete mešati z vročimi pijačami.
English: Turn the bottle and syringe into an upright position.
Slovenian: Stekleničko in odmerno brizgo obrnite v pokončni položaj.
English: It is important that you take the full course of Zinnat.
Slovenian: Pomembno je, da vzamete vso zdravilo Zinnat, ki vam je bilo predpisano.
English: 125 mg/5 mL, 250 mg/5 mL granules for oral suspension and 125 mg, 250 mg, 500 mg granules for oral suspension
Slovenian: 125 mg/5 ml, 250 mg/5 ml zrnca za peroralno suspenzijo in 125 mg, 250 mg, 500 mg zrnca za peroralno suspenzijo
English: • hydrolysis by beta-lactamases; including (but not limited to) by extended-spectrum beta-lactamases
Slovenian: • hidrolize z beta-laktamazami, vključno (a ne omejeno na) beta-laktamaze z razširjenim spektrom (ESBL - extended-spectrum beta-lactamases) in encimi Amp-C, ki so lahko inducirani ali stabilno dereprimirani v določenih aerobnih po Gramu negativnih bakterijskih sevih;
English: As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil.
Slovenian: Za določanje glukoze v krvi/plazmi bolnikov, ki prejemajo aksetilcefuroksimat, je priporočljivo uporabljati glukoza oksidazno ali heksokinazno metodo.
English: Use the oral dosing syringe supplied with the pack to measure your dose accurately:
Slovenian: Za natančno odmerjanje uporabite odmerno brizgo, ki je na voljo v pakiranju:
English: Tell your doctor before you take Zinnat:
Slovenian: Preden vzamete zdravilo Zinnat, morate svojega zdravnika obvestiti:
English: 500 mg twice daily
Slovenian: 500 mg dvakrat na dan cistitis
English: Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food.
Slovenian: Zdravila za znižanje želodčne kislosti lahko znižajo biološko uporabnost aksetilcefuroksimata v primerjavi z vrednostjo ob uporabi zdravila na tešče in tako izničijo sicer povečano absorpcijo zdravila po jedi.
English: (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
Slovenian: • razširjen izpuščaj z mehurji in lupljenjem kože (to so lahko znaki Stevens-Johnsonovega sindroma ali toksične epidermalne nekrolize);
English: The reconstituted suspension when refrigerated between 2 and 8°C can be kept for up to 10 days.
Slovenian: Pripravljena suspenzija je uporabna do 10 dni, če jo shranjujete v hladilniku pri temperaturi od 2°C do 8°C.
English: What you need to know before you take Zinnat Don't take Zinnat:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zinnat
English: Antibacterial agent-associated pseudomembranous colitis have been reported with nearly all antibacterial agents, including cefuroxime and may range in severity from mild to life threatening.
Slovenian: Med uporabo skoraj vseh protibakterijskih zdravil, vključno s cefuroksimom, je bil opisan psevdomembranozni kolitis, povezan s protibakterijskimi zdravili, ki po izrazitosti lahko sega od blagega do smrtno nevarnega.
English: Remove the syringe from the adapter.
Slovenian: Brizgo odstranite iz nastavka.
English: Don't stop Zinnat without advice
Slovenian: Ne prenehajte jemati zdravila Zinnat, ne da bi se prej o tem posvetovali.
English: 15 mg/kg twice daily to a maximum of 250 mg twice daily for 14 days (10 to 21 days)
Slovenian: 15 mg/kg dvakrat na dan do največ 250 mg dvakrat na dan, 14 dni (10 do 21 dni)
English: Pyelonephritis
Slovenian: • pielonefritis
English: Side effects that may show up in blood tests:
Slovenian: Neželeni učinek, ki se lahko pokaže pri preiskavah krvi:
English: 125 mg, 250 mg, 500 mg granules for oral suspension For step-by-step instructions on how to make up Zinnat sachets see Instructions for reconstitution at the end of this leaflet.
Slovenian: 125 mg, 250 mg, 500 mg zrnca za peroralno suspenzijo Za navodila, kako pripraviti Zinnat suspenzijo korak za korakom, glejte Navodila za pripravo na koncu tega navodila.
English: INSTRUCTIONS ON USE [To be completed nationally]
Slovenian: NAVODILA ZA UPORABO <[izpolni država članica]
English: 125 mg, 250 mg, 500 mg film-coated tablets Film-coated tablet (tablet) [To be completed nationally]
Slovenian: 125 mg, 250 mg, 500 mg filmsko obložene tablete Filmsko obložena tableta (tableta) [izpolni država članica]
English: • severe diarrhoea (pseudomembranous colitis)
Slovenian: • huda driska (psevdomembranozni kolitis);
English: 125 mg film-coated tablets
Slovenian: 125 mg filmsko obložene tablete
English: The usual dose of Zinnat is 250 mg to 500 mg twice daily depending on the severity and type of infection.
Slovenian: Običajni odmerek zdravila Zinnat znaša, odvisno od resnosti in vrste okužbe, od 250 mg do 500 mg dvakrat na dan.
English: Medicines like Zinnat can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush).
Slovenian: • glivične okužbe; v redkih primerih lahko zdravila, kakršno je zdravilo Zinnat, povzročijo čezmeren razrast kvasovk (Candida), kar lahko vodi v glivične okužbe (npr. sor).
English: 125 mg, 250 mg, 500 mg film-coated tablets Oral use
Slovenian: 125 mg, 250 mg, 500 mg filmsko obložene tablete Peroralna uporaba.
English: 250 mg film-coated tablets
Slovenian: 250 mg filmsko obložene tablete
English: EXPIRY DATE EXP {MM YYYY}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {MM YYYY}
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY} [To be completed nationally]
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM [izpolni država članica] DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM {DD. mesec YYYY} [izpolni država članica]
English: • middle ear
Slovenian: • srednjega ušesa;
English: An MIC with a comment but without an accompanying S or R-categorization may be reported.
Slovenian: Poročali so o minimalni inhibitorni koncentraciji (MIK) z opombami ampak brez spremljajoče razdelitve na občutljive ali odporne.
English: Zinnat can also be used: • to treat Lyme disease (an infection spread by parasites called ticks).
Slovenian: • zdravljenje lymske bolezni (okužbe, ki jo širijo zajedavci, imenovani klopi).
English: There is no experience of using Zinnat in children under the age of 3 months.
Slovenian: Pri dojenčkih, mlajših od treh mesecev, ni izkušenj o uporabi zdravila Zinnat.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Zinnat Vsebina pakiranja in dodatne informacije
English: 125 mg, 250 mg, 500 mg granules for oral suspension Directions for making up suspension from sachets Empty granules from sachet into a glass.
Slovenian: 125 mg, 250 mg, 500 mg zrnca za peroralno suspenzijo Navodila za pripravo suspenzije iz vrečk Zrnca iz vrečke stresite v kozarec.
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Slovenian: SEZNAM POMOŽNIH SNOVI [izpolni država članica]
English: 180 to 250 7.5 to 10
Slovenian: 180 do 250
English: 125 mg/5 mL, 250 mg/5 mL granules for oral suspension Shake the bottle before use.
Slovenian: 125 mg/5 ml, 250 mg/5 ml zrnca za peroralno suspenzijo Pred uporabo stekleničko pretresite.
English: Invert the bottle and syringe.
Slovenian: Stekleničko in brizgo obrnite navzdol.
English: Slowly push the plunger in, allowing time to swallow.
Slovenian: Počasi pritisnite na brizgin bat, da boste imeli čas zdravilo pogoltniti.
English: 125 mg, 250 mg, 500 mg granules for oral suspension Granules for oral suspension [To be completed nationally]
Slovenian: 125 mg, 250 mg, 500 mg zrnca za peroralno suspenzijo Zrnca za peroralno suspenzijo [izpolni država članica]
English: - Keep this leaflet.
Slovenian: Ponovno namestite pokrovček.
English: Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis
Slovenian: Streptococcus pyogenes Streptococcus agalactiae Po Gramu negativni aerobi: Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis
English: 250 mg twice daily
Slovenian: 250 mg dvakrat na dan pielonefritis
English: 125 mg/5 mL, 250 mg/5 mL granules for oral suspension Granules for oral suspension [To be completed nationally]
Slovenian: 125 mg/5 ml, 250 mg/5 ml zrnca za peroralno suspenzijo Zrnca za peroralno suspenzijo [izpolni država članica]
English: Cefuroxime axetil oral suspension was not bioequivalent to cefuroxime axetil tablets when tested in healthy adults and therefore is not substitutable on a milligramper-milligram basis (see section 4.2).The pharmacokinetics of cefuroxime is linear over the oral dosage range of 125 to 1000 mg. No accumulation of cefuroxime occurred following repeat oral doses of 250 to 500 mg.
Slovenian: Testiranje na zdravih odraslih ni izkazalo bioekvivalence med aksetilcefuroksimat peroralno suspenzijo in aksetilcefuroksimat tabletami, zato zamenjava na osnovi miligram-za-miligram ni mogoča (glejte poglavje 4.2).
English: Note4
Slovenian: opomba 4
English: 125 mg, 250 mg, 500 mg granules for oral suspension Directions for reconstituting suspension from sachets 1.
Slovenian: 125 mg, 250 mg, 500 mg zrnca za peroralno suspenzijo Navodila za pripravo suspenzije iz vrečk.
English: 125 mg/5 mL granules for oral suspension
Slovenian: 125 mg/5 ml zrnca za peroralno suspenzijo
English: 250 mg/5 mL granules for oral suspension
Slovenian: 250 mg/5 ml zrnca za peroralno suspenzijo
English: Allow the plunger and the barrel to dry naturally.
Slovenian: Bat in valj posušite na zraku.
English: Gram-negative aerobes: Acinetobacter spp.
Slovenian: Acinetobacter spp.
English: 15 mg/kg twice daily to a maximum of 250 mg twice daily
Slovenian: 15 mg/kg dvakrat na dan do največ 250 mg dvakrat na dan cistitis
English: 500 mg film- coated tablets
Slovenian: 500 mg filmsko obložene tablete
English: Note3
Slovenian: opomba 3
English: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Finland, Ireland, Italy, Luxembourg, Malta, Poland, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
Slovenian: Avstrija, Belgija, Bolgarija, Češka, Ciper, Finska, Irska, Italija, Luksemburg, Malta, Poljska, Slovaška, Slovenija, Španija, Združeno kraljestvo - Zinnat
English: Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension [See Annex I - To be completed nationally]
Slovenian: Zinnat in povezana imena (glejte Prilogo I) 125 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 500 mg zrnca za peroralno suspenzijo [glejte Prilogo I - izpolni država članica]
English: Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with Zinnat for Lyme disease.
Slovenian: • Jarisch-Herxheimerjeva reakcija; pri nekaterih bolnikih se lahko med uporabo zdravila Zinnat za zdravljenje lymske bolezni pojavi zvišana telesna temperatura (vročina), mrzlica, glavobol, bolečine v mišicah in kožni izpuščaj, znano kot Jarisch-Herxheimerjeva reakcija.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS/STRIPS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Clostridium difficile overgrowth
Slovenian: Infekcijske in parazitske bolezni razrast kandide razrast Clostridium difficile
English: Contains 2.3 g of sucrose per 5 mL dose
Slovenian: 250 mg/5 ml zrnca za peroralno suspenzijo Vsebujejo 2,3 g saharoze na 5 ml odmerek.
English: Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, United Kingdom - Zinnat Germany - Elobact
Slovenian: Češka, Danska, Finska, Francija, Nemčija, Madžarska, Irska, Litva, Nizozemska, Poljska, Romunija, Slovaška, Španija, Združeno kraljestvo - Zinnat
English: Immune system drug fever, serum sickness,
Slovenian: Bolezni imunskega sistema povišana telesna temperatura zaradi zdravljenja z zdravilom (t. i. drug fever), serumska bolezen, anafilaksa, Jarisch-Herxheimerjeva reakcija
English: • Acute otitis media.
Slovenian: • akutno vnetje srednjega ušesa;
English: Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs' test (which can interfere with crossmatching of blood) and very rarely haemolytic anaemia.
Slovenian: Posledično lahko pride do pozitivnega Coombsovega testa (kar lahko vpliva na navzkrižni preizkus) in zelo redko tudi do hemolitične anemije.
English: Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Zinnat in povezana imena (glejte Prilogo I) 125 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 250 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 500 mg filmsko obložene tablete [glejte Prilogo I - izpolni država članica]
English: Remove the bottle cap and insert the syringe-collar assembly into the neck of the bottle.
Slovenian: Snemite pokrovček s stekleničke in vanjo vstavite brizgo z nastavkom.
English: Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets Zinnat and associated names (see Annex I) 125 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 250 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension
Slovenian: Zinnat in povezana imena (glejte Prilogo I) 125 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 250 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 500 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 125 mg/5 ml zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg/5 ml zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 125 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 500 mg zrnca za peroralno suspenzijo
English: Contains 6.1 g of sucrose per unit dose
Slovenian: 250 mg zrnca za peroralno suspenzijo Vsebujejo 6,1 g saharoze na enoto odmerka.
English: Commonly susceptible species Gram-positive aerobes:
Slovenian: Po Gramu pozitivni aerobi:
English: Contains 12.2 g of sucrose per unit dose
Slovenian: 500 mg zrnca za peroralno suspenzijo Vsebujejo 12,2 g saharoze na enoto odmerka.
English: • diarrhoea
Slovenian: • glavobol;
English: Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets Zinnat and associated names (see Annex I) 125 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 250 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension [SeeAnnex I - To be completed nationally]
Slovenian: Zinnat in povezana imena (glejte Prilogo I) 125 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 250 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 500 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 125 mg/5 ml zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg/5 ml zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 125 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 500 mg zrnca za peroralno suspenzijo [glejte Prilogo I - izpolni država članica]
English: NAME OF THE MEDICINAL PRODUCT Zinnat and associated names (see Annex I) 125 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 250 mg/5 mL granules for oral suspension [See Annex I - To be completed nationally] Cefuroxime
Slovenian: Zinnat in povezana imena (glejte Prilogo I) 250 mg/5 ml zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg/5 ml zrnca za peroralno suspenzijo [glejte Prilogo I - izpolni država članica] cefuroksim
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally]
Slovenian: 6.4 Posebna navodila za shranjevanje [izpolni država članica]
English: Replace the cap.
Slovenian: Ponovno namestite pokrivček.
English: 125 mg/5mL, 250 mg/5mL granules for oral suspension
Slovenian: 125 mg/5 ml in 250 mg/5 ml zrnca za peroralno suspenzijo Navodila za pripravo suspenzije
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Slovenian: Nastavek pustite na steklenički in stekleničko dobro zaprite s pokrovčkom.
English: Austria, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat
Slovenian: Avstrija, Bolgarija, Češka, Danska, Estonija, Francija, Nemčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Malta, Nizozemska, Poljska, Romunija, Slovaška, Slovenija, Španija, Švedska, Združeno kraljestvo - Zinnat
English: Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension
Slovenian: Zinnat in povezana imena (glejte Prilogo I) 125 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 250 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 500 mg filmsko obložene tablete Zinnat in povezana imena (glejte Prilogo I) 125 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 250 mg zrnca za peroralno suspenzijo Zinnat in povezana imena (glejte Prilogo I) 500 mg zrnca za peroralno suspenzijo
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat Germany - Elobact
Slovenian: Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Estonija, Finska, Francija, Nemčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Romunija, Slovaška, Slovenija, Španija, Švedska, Združeno kraljestvo - Zinnat Nemčija - Elobact
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
Slovenian: Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Estonija, Francija, Nemčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Romunija, Slovaška, Slovenija, Španija, Združeno kraljestvo - Zinnat
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [izpolni država članica]
English: With the patient seated in an upright position, place the tip of the syringe just inside the patient's mouth, pointing towards the inside of the cheek.
Slovenian: Brizgo mu vstavite v usta, tako da bo njena konica usmerjena proti notranji strani lica.
English: 6.6 Special precautions for disposal and other handling
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
English: • being sick • skin rashes.
Slovenian: • bruhanje; • kožni izpuščaji.
English: Cystitis
Slovenian: Dojenje
English: 6 (3 x 2) prefilled pens (multipack)
Slovenian: 6 (3 x 2) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: 2 pre-filled pens
Slovenian: 2 napolnjena injekcijska peresnika
English: Initiation pack: 1 pre-filled syringe (63 µg) + 1 pre-filled syringe (94 µg)
Slovenian: Velikost pakiranja začetno pakiranje: 1 napolnjena injekcijska brizga (63 µg)
English: European Medicines Agency recommends changes to the use of metoclopramide
Slovenian: Evropska agencija za zdravila priporoča spremembe pri uporabi metoklopramida
English: Patients who have any questions should discuss them with their doctor or pharmacist.
Slovenian: Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravnikom ali farmacevtom.
English: Detailed recommendations for patients and healthcare professionals are available below.
Slovenian: Podrobna priporočila za bolnike in zdravstvene delavce so na voljo v nadaljevanju.
English: The review of metoclopramide-containing medicines was initiated in December 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo metoklopramid, je bil sprožen decembra 2011 na zahtevo Francije v skladu s členom 31 Direktive 2001/83/ES.
English: Metoclopramide-containing medicines have been authorised by national procedures in all the Member States of the EU and have been available for many years under different trade names.
Slovenian: Zdravila, ki vsebujejo metoklopramid, so bila odobrena po nacionalnih postopkih v vseh državah članicah EU in so že več let na voljo pod različnimi trgovskimi imeni.
English: Changes aim mainly to reduce the risk of neurological side effects
Slovenian: Spremembe so namenjene predvsem zmanjšanju tveganja za nevrološke neželene učinke
English: Use is contraindicated in children under 1 year of age.
Slovenian: Uporaba je kontraindicirana pri otrocih, mlajših od 1 leta.
English: • Metoclopramide should no longer be used in children under 1 year old.
Slovenian: • Metoklopramid se ne sme več uporabljati pri otrocih, mlajših od 1 leta.
English: • Extrapyramidal disorders constituted nearly half of all spontaneously reported adverse effects in a manufacturer database (1749 cases out of 4005, up to December 2011).
Slovenian: • Skoraj polovico vseh spontanih poročil o neželenih učinkih v podatkovni zbirki izdelovalca so predstavljale ekstrapiramidne motnje (1749 primerov od 4005, zabeleženih do decembra 2011).
English: The product information has been amended appropriately, and prescribers sent further communication at a national level.
Slovenian: Informacije o zdravilu so bile ustrezno spremenjene, zdravstvenim delavcem, ki predpisujejo ta zdravila, pa so poslali dodatno obvestilo na nacionalni ravni.
English: The reporting rate for these disorders was calculated to be 6 times higher in children than in adults, although it was not possible to accurately account for usage patterns in different age-groups.
Slovenian: Stopnja poročanja, izračunana za te motnje, je bila 6-krat višja pri otrocih kot pri odraslih, čeprav pri izračunu ni bilo mogoče natančno upoštevati vzorcev uporabe pri različnih starostnih skupinah.