FrancophonIA/ELRC3.0 huggingface dataset:
English: No additions should be made to the mixed final ciprofloxacin suspension.
Maltese: M'għandu jiżdied xejn mas-suspensjoni rikostitwita finali ta' ciprofloxacin.
English: Prothrombin level abnormal
Maltese: Livell ta' prothrombin mhux normali
English: Ciprofloxacin Bayer solution for infusion contains 5 g glucose in 100 mL solution for infusion.
Maltese: Soluzzjoni għall-infużjoni ta' ciprofloxacin fiha 5 g ta' glucose f'100 mL ta' soluzzjoni għallinfużjoni.
English: • Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1).
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għal quinolones oħra jew għal xi sustanzi mhux attivi (ara sezzjoni 6.1).
English: 6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.
Maltese: 6 mg/kg ta' piż tal-ġisem sa 10 mg/kg ta' piż talġisem tlitt darbiet kuljum b'massimu ta' 400 mg kull doża.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING FLEXIBLE PO/PVC BAG (200 mg / 100 mL solution for infusion)
Maltese: TAL-PO/PVC (200 mg / 100 mL soluzzjoni għall-infużjoni)
English: - inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Take special care with Ciprofloxacin Bayer) - changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bonemarrow depression which may also be fatal (see Section 2: Take special care with Ciprofloxacin Bayer) - allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see Section 2: Take special care with Ciprofloxacin Bayer) - increased blood sugar (hyperglycemia) - anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see Section 2: Take special care with Ciprofloxacin Bayer) - decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders) - tinnitus, impaired hearing - fainting, inflammation of the blood vessel (vasculitis) - shortness of breath including asthmatic symptoms - pancreatitis
Maltese: infjammazzjoni tal-musrana (kolite) marbuta ma' l-użu ta' antibijotiċi (f'każijiet rari tista' tkun fatali) (ara Sezzjoni 2: Oqgħod attent ħafna b'Ciprofloxacin Bayer) bidliet fl-għadd tad-demm (lewkopenija, lewkoċitosi, newtropenija, anemija), tnaqqis finnumru ta' ċelluli ħomor u bojod tad-demm u ta' plejtlits (panċitopenija), li tista' tkun fatali, depressjoni tal-mudullun ta' l-għadam li tista' tkun fatali wkoll (ara Sezzjoni 2: Oqgħod attent ħafna b'Ciprofloxacin Bayer) reazzjoni allerġika, nefħa (edima) allerġika, nefħa f'daqqa fil-ġilda u l-membrani mukużi (anġjoedima), reazzjoni allerġika severa (xokk anafilattiku) li tista' tkun ta' periklu għall-ħajja (ara Sezzjoni 2: Oqgħod attent ħafna b'Ciprofloxacin Bayer) żjieda fiz-zokkor fid-demm (ipergliċemija)
English: 500 mg twice daily to 750 mg twice daily at least 14 days
Maltese: 500 mg darbtejn kuljum sa 750 mg darbtejn kuljum ta' l-inqas 14-il ġurnata
English: Anaphylactic reaction Anaphylactic shock (lifethreatening) (see section 4.4) Serum sicknesslike reaction
Maltese: Reazzjoni anafilattika Xokk anafilattiku (ta' periklu għallħajja) (ara sezzjoni 4.4) Reazzjoni bħallmarda tas-serum
English: Ciprofloxacin Bayer 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Maltese: Ciprofloxacin Bayer 250 mg pilloli miksija b'rita huma ndikati għall-kura ta' l-infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1).
English: CIPROXIN 1000 mg modified release tablets oral use
Maltese: CIPROXIN 1000 mg pilloli li jerħu l-mediċina b'mod modifikat użu orali
English: Tizanidine must not be administered together with Ciprofloxacin (see section 4.3).
Maltese: L-għoti flimkien ta' ciprofloxacin u tizanidine (ara sezzjoni 4.5).
English: CIPROXIN 250 mg film-coated tablets oral use
Maltese: CIPROXIN 250 mg pilloli miksija b'rita użu orali
English: Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/mL grani (granules) u solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Glucose Load
Maltese: użu orali
English: In particular, the Applicant/MAH did not discuss its benefit-risk ratio in comparison to the other longer treatment duration (3 day treatment).
Maltese: B'mod partikolari, l-Applikant/MAH ma ddiskutiex il-proporzjon ta' benefiċċju-riskju meta mqabbel ma' tul ta' żmien itwal (trattament ta' 3 ijiem).
English: Ciprofloxacin Bayer 100 mg/50 mL solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Maltese: Ciprofloxacin Bayer 100 mg/50 mL soluzzjoni għall-infużjoni huwa ndikat għall-kura ta' linfezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1).
English: Propionibacterium acnes INHERENTLY RESISTANT ORGANISMS Aerobic Gram-positive micro-organisms Actinomyces
Maltese: Mikro-organiżmi aerobiċi Gram-positive Actinomyces
English: Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
Maltese: Sintomi ta' doża eċċessiva jikkonsistu minn sturdment, tregħid, uġigħ ta' ras, għeja, aċċessjonijiet, alluċinazzjonijiet, konfużjoni, skomdu addominali, indeboliment tal-kliewi u tal-fwied kif ukoll kristallurja u ematuria.
English: Daily dose in mg Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
Maltese: Tul totali tal-kura (potenzjalment inkluż bidu ta' kura parenterali b'ciprofloxacin)
English: Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 50 mg/mL grani (granules) u solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Section 2: Take special care with Ciprofloxacin Bayer) - increased blood sugar (hyperglycemia) - anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see
Maltese: żjieda fiz-zokkor fid-demm (ipergliċemija) reazzjoni ta' ansjetà, ħolm stramb, depressjoni, disturbi mentali (reazzjonijiet psikotiċi) (ara Sezzjoni 2:
English: CIPROBAY 500 mg film-coated tablets oral use
Maltese: CIPROBAY 500 mg pilloli miksija b'rita użu orali
English: 5-mL twice daily to 10 mL twice daily (one 5-mL measuring spoonful twice daily up to two 5-mL measuring spoonfuls twice daily)
Maltese: 5 mL darbtejn kuljum sa 10 mL darbtejn kuljum (mgħarfa tal-kejl ta' 5-mL darbtejn kuljum sa żewġ mgħaref tal-kejl ta' 5-mL darbtejn kuljum)
English: This can lead to theophylline-induced side effects that may rarely be life threatening or fatal.
Maltese: Din tista' twassl għall-effetti sekondarji indotti minn theophylline li rarament jistgħu jkunu ta' periklu għall-ħajja jew fatali.
English: NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Ciprofloxacin
English: Belgium:
Maltese: Slovenja:
English: 100 mg/50 ml solution for infusion intravenous use
Maltese: 100 mg/50 ml soluzzjoni għall-infużjoni użu għal ġol-vini
English: Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għallinfużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg/100 mL soluzzjoni għallinfużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: 20 mg/kg body weight twice daily with a maximum of 750 mg per dose.
Maltese: 20 mg/kg ta' piż tal-ġisem darbtejn kuljum b'massimu ta' 750 mg kull doża.
English: Probenecid interferes with renal secretion of ciprofloxacin.
Maltese: Probenecid jinterferixxi mas-sekrezzjoni renali ta' ciprofloxacin.
English: Ciproxina OD 500 mg modified release tablets oral use
Maltese: Ciproxina OD 500 mg pilloli li jerħu l-mediċina b'mod modifikat użu orali
English: Pharmacokinetics of ciprofloxacin were linear over the dose range up to 400 mg administered intravenously.
Maltese: Il-farmakokinetika ta' ciprofloxacin kienet lineari tul il-firxa tad-doża sa 400 mg mogħtija fil-vini.
English: • lung and bronchial infections in children and adolescents suffering from cystic fibrosis
Maltese: • infezzjonijiet fil-pulmun u fil-bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika
English: 7.5 mL twice daily (one and a half 5-mL measuring spoonfuls twice daily)
Maltese: 5 mL darbtejn kuljum sa 7.5 mL darbtejn kuljum (mgħarfa
English: Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 750 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING FLEXIBLE PO/PVC BAG (400 mg / 200 mL solution for infusion)
Maltese: TAL-PO/PVC (400 mg / 200 mL soluzzjoni għall-infużjoni)
English: Therefore the following wording was recommended: “Lower respiratory tract infections due to Gram negative bacteria: - exacerbations of chronic obstructive pulmonary disease - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - pneumonia”
Maltese: Infezzjonijiet ta' l-apparat respiratorju ta' isfel ikkawżati minn batterja Gram-negative - irkadar tal-marda pulmonari ostruttiva kronika - infezzjonijiet bronko-pulmonari f'fibrożi ċistika - jew f'bronkjektasi - pnewmonja
English: NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 500 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Ciprofloxacin
English: Plasmid-mediated resistance encoded by qnr-genes has been reported.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs) irrapportati b'mod komuni huma tqalligħ u dijarea.
English: There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Maltese: Hemm tagħrif limitat dwar l-effikaċja ta' ciprofloxacin fil-kura ta' infezzjonijiet intra-addominali ta' wara kirurġija.
English: Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules for oral suspension [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/mL grani għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Then tear the sachet open as indicated and take the contents directly.
Maltese: Wara, iftaħ ilqartas kif indikat u ħu l-kontenut direttament.
English: • a polymeric phosphate binder (e.g. sevelamer)
Maltese: Uġigħ muskoluskeltrali (e.ż. uġigħ fl
English: 100 mg film-coated tablet oral use
Maltese: kuljum sa 400 mg tlitt darbiet kuljum il-perijodu kollu tannewtropenija
English: Daily dose in mg Daily dose in mL (Number of 5-mL measuring spoonfuls)
Maltese: 15 mL darbtejn kuljum (tliet mgħaref talkejl ta' 5-mL darbtejn kuljum)
English: Ciprofloxacin is present in plasma largely in a nonionized form and has a large steady state distribution volume of 2-3 L/kg body weight.
Maltese: Ciprofloxacin huwa preżenti fil-plażma fil-biċċa l-kbira fil-forma mhux jonizzata u għandha volum ta' distribuzzjoni fi stat fiss kbir ta' 2-3 L/kg piż tal-ġisem.
English: The CHMP raised concerns on the following wording in Section 4.1 of the SPC : “Other severe infections in accordance with Official guidance, after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.” It was deemed to describe clinical situations in which the use of ciprofloxacin may be considered in spite of a missing indication, in children and adolescents.
Maltese: Infezzjonijiet severi oħrajn skont gwida Uffiċjali, wara evalwazzjoni bir-reqqa ta' benefiċċju-riskju meta kuri oħrajn ma jkunux jistgħu jintużaw, jew wara li terapija konvenzjonali ma tkunx irnexxiet u meta d-dokumentazzjoni mikrobijoloġika tista' tiġġustifika l-użu ta' ciprofloxacin.”
English: Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 200 mL soluzzjoni għallinfużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Ciprofloxacin Bayer and associated names (see Annex I) 400 mg / 200 mL solution for infusion [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg/200 mL soluzzjoni għallinfużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: 500 mg twice daily
Maltese: 500 mg bħala doża waħda
English: 400 mg/200 ml solution for infusion intravenous use
Maltese: 400 mg/200 ml soluzzjoni għall-infużjoni użu għal ġol-vini
English: Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/50 mL soluzzjoni għallinfużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Bayer and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Ciprofloxacin
English: film-coated tablets oral use
Maltese: Disturbi fil-vista Disturbi fil-kuluri visivi
English: Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, as soon as the first 48 hours of treatment.
Maltese: Tendinite u tiċirit tat-tendon (speċejalment Achilles tendon), xi kultant bilaterali, jistgħu jseħħu b'ciprofloxacin, anki fl-ewwle 48 siegħa ta' kura.
English: Complicated and uncomplicated pyelonephritis
Maltese: Pijelonefrite komplikata u mhux komplikata
English: As the oral suspension contains sucrose, it should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.
Maltese: Peress li s-suspensjoni orali fiha sucrose, m'għandhiex tintuża għall-pazjenti b'intolleranza għal fructose, assorbiment ħażin ta' glucose-galactose jew nuqqas ta' sucrose-isomaltase.
English: Typically, the infection spreads to the basis of the skull and mastoid, resulting in cranial neuropathies, and rarely, brain abscess, sphenoidal sinusitis.
Maltese: Tipikament, l-infezzjoni tinfirex għall-bażijiet tal-kranju u l-mastojde, li tirriżulta f'newropatiji kraniċi u rarament, f'axxessi tal-moħħ, sinożite sfenojdali.
English: 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose.
Maltese: 10 mg/kg ta' piż tal-ġisem darbtejn kuljum sa 15 mg/kg ta' piż tal-ġisem darbtejn kuljum b'massimu ta' 500 mg kull doża.
English: From the data presented, ciprofloxacin prescriptions in “bone and joint infections” were supported by several clinical studies and an extensive use in clinical practice.
Maltese: Mid-dejta ppreżentata, riċetti għal ciprofloxacin f'“infezzjonijiet tal-għadam u l-ġoġi” kienu appoġġjati minn diversi studji kliniċi u użu estensiv fil-prattika klinika.
English: Bayer HealthCare AG 51368 Leverkusen, Germany
Maltese: Bayer HealthCare AG 51368 Leverkusen, Il-Ġermanja
English: Chelation Complex Formation
Maltese: Ċistite mhux komplikata
English: Other micro-organisms
Maltese: Mikro-organiżmi oħra
English: Ciprofloxacin should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit juice (e.g. calcium-fortified orange juice) (see section 4.5).
Maltese: Waqt u eżatt wara l-għoti flimkien ma' ciprofloxacin, huma rrakkomandati sorveljanza ta' effetti sekondarji relatati ma' ropinirole u aġġustament xieraq fid-doża (ara sezzjoni 4.4).
English: Some medicines reduce the effect of Ciprofloxacin Bayer.
Maltese: Xi mediċini jnaqqsu l-effett ta' Ciprofloxacin Bayer.
English: Overall, the CHMP harmonised this section, providing particular attention to the available information on resistance to ciprofloxacin for each indication.
Maltese: Ġeneralment, is-CHMP armonizza din is-sezzjoni, b'attenzjoni partikolari għat-tagħrif disponibbli fuq ir-reżistenza għal ciprofloxacin għal kull indikazzjoni.
English: Posology in the treatment of upper respiratory tract infections The CHMP asked the applicant/MAH to further substantiate the efficacy/risk of the lower dosage proposed (500 mg BID) in the treatment of upper respiratory tract infection, especially with regard to malignant external otitis.
Maltese: Is-CHMP staqsa lill-applikant/MAH biex jissostanzja l-effikaċja/riskju tad-dożaġġ l-iktar baxx propost (500 mg BID) fit-trattament ta' infezzjonijiet fil-parti ta' fuq tal-passaġġi respiratorji, speċjalment firrigward ta' otite esterna malinna.
English: Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans.
Maltese: Trattament ta' xahrejn fl-adulti b'ciprofloxacin orali mogħtija fid-doża li ġejja, 500 mg bid, hija kkunsidrata ugwalment effettiva biex timpedixxi infezzjoni b'anthrax fil-bnedmin.
English: Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules for oral suspension [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 50 mg/mL grani għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari] Ciprofloxacin
English: From the data submitted the CHMP considered that 500 mg bid could be used in the oral treatment of upper respiratory tract infections such as acute exacerbations of chronic sinusitis and chronic suppurative otitis media.
Maltese: Mid-dejta sottomessa, is-CHMP ikkunsidra li 500 mg bid jista' jintuża f'trattament orali ta' infezzjonijiet fil-parti ta' fuq tal-passaġġi respiratorji bħalma huma taħrixiet akuti ta' sinożite kronika u otite tan-nofs kronika ta' appoġġ.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING HDPE BOTTLE 100 mg/mL
Maltese: TAL-HDPE ta' 100 mg/mL
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Maltese: Studji fuq il-bhejjem ma jurux effetti ħżiena diretti jew indiretti rigward tossiċità riproduttiva.
English: Do not take Ciprofloxacin Bayer together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "Do not take Ciprofloxacin Bayer").
Maltese: Tieħux Ciprofloxacin Bayer flimkien ma' tizanidine, għax dan jista' jikkawża effetti sekondarji bħal pressjoni tad-demm baxxa u ngħas (ara Sezzjoni 2: "Tieħux Ciprofloxacin Bayer").
English: Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 250 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Swallow the tablets with plenty of fluid.
Maltese: Formulazzjoni ta' Pilloli
English: - inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see
Maltese: Kolite assoċjata ma' antibijotiċi (rari ħafna b'possibiltà ta' riżultat fatali) (ara sezzjoni
English: Ear and Labyrinth Disorders
Maltese: fis-Sistema Labirintika
English: The indication was reworded to state ciprofloxacin's utility in Gram negative bacterial infections of the lower respiratory track causing exacerbations of chronic obstructive pulmonary disease, bronchopulmonary infections in cystic fibrosis or in bronchiectasis and pneumonia.
Maltese: L-indikazzjoni nkitbet mill-ġdid biex tistqarr l-utilità ta' ciprofloxacin f'infezzjonijiet batteriċi Gram negattivi fil-parti t'isfel tal-passaġġi respiratorji li jikkaġunaw taħrixiet ta' mard kroniku pulmonari okklussiv, infezzjonijiet bronkopulmonari f'fibrożi ċistika jew fi bronkjektażi u pulmonite.
English: 20 mg/kg body weight twice daily with a maximum of 750 mg per dose, corresponding to a 0.2 mL/kg body weight twice daily with a maximum of 7.5 mL per dose
Maltese: 20 mg/kg ta' piż tal-ġisem darbtejn kuljum b'massimu ta' 750 mg kull doża, li jikkorrispondu għal 0.2 mL/kg ta' piż tal-ġisem darbtejn kuljum b'massimu ta' 7.5 mL kull doża.
English: Ciprofloxacin Bayer 100 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Maltese: Ciprofloxacin Bayer 100 mg pilloli miksija b'rita huma ndikati għall-kura ta' l-infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1).
English: Ciprofloxacin Bayer), urinary tract inflammation - fluid retention or excessive sweating - abnormal levels of a clotting factor (prothrombin) or increased levels of the enzyme amylase
Maltese: Oqgħod attent ħafna b'Ciprofloxacin Bayer), infjammazzjoni fl-apparat urinarju għaraq eċċessiv livelli mhux normali ta' fattur tat-tagħqid (prothrombin), żjieda fil-livelli ta' l-enżima amylase
English: 200 mg /100 ml solution for infusion intravenous use
Maltese: 200 mg/100 ml soluzzjoni għall-infużjoni użu għal ġol-vini
English: 200 mg/100 ml solution for infusion intravenous use
Maltese: 200 mg /100 ml soluzzjoni għall-infużjoni użu għal ġol-vini
English: 5 mL twice daily (one 5-mL measuring spoonful twice daily)
Maltese: 5 mL darbtejn kuljum (mgħarfa waħda tal-kejl ta' 5-mL darbtejn kuljum)
English: Bayer Healthcare AG D-51368 Leverkusen, Germany
Maltese: Bayer HealthCare AG D-51368 Leverkusen, IlĠermanja
English: Pack size
Maltese: Mnejn għandu jingħat
English: The marketing authorisation holder is Astellas Pharma Europe B.V.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq huwa Astellas Pharma Europe B.V.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ADVAGRAF EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) ADVAGRAF Sommarju ta' l-EPAR għall-pubbliku
English: The percentages were 15% in the patients treated with Prograf/Prograft, and 17% in those treated with ciclosporin.
Maltese: Il-perċentwali kienu ta' 15% filpazjenti trattati bi Prograf/Prograft, u 17% ta' dawk trattati biċ-ċiklosporina.
English: The European Commission granted a marketing authorisation valid throughout the EU for Advagraf on 23 April 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Advagraf fit-23 ta' April 2007.
English: Tacrolimus, the active substance in Advagraf, is an immunosuppressive agent.
Maltese: Tacrolimus, is-sustanza attiva f'Advagraf, hu aġent immunosoppressiv.
English: Advagraf is a medicine containing the active substance tacrolimus.
Maltese: Advagraf hu mediċina li fiha s-sustanza attiva tacrolimus.
English: It is available as prolongedreleased capsules containing tacrolimus (0.5 mg: yellow and orange; 1 mg: white and orange; 5 mg: greyish-red and orange).
Maltese: Jiġi bħala kapsuli li jerħu l-mediċina bilmod li jkun fihom tacrolimus (0.5 mg: sofor u oranġjo; 1 mg: bojod u oranġjo; 5 mg: ħomor fil-ġriż u oranġjo).