FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: arthralgia (joint pain).
Maltese: Mhux komuni: artralġja (uġigħ fil-gogi).
English: Uncommon: (thrombo) phlebitis.
Maltese: Mhux komuni: (trombo) flebite.
English: Common: perverted sensation of taste (usually reversible upon discontinuation of treatment), dizziness, headache, insomnia, agitation, confusion.
Maltese: Komuni: sensazzjoni ta' togħma mibdula (normalment riversibbli mat-twaqqif tal-kura), sturdament, uġigħ ta' ras, nuqqas ta' rqad, aġitazzjoni, konfużjoni.
English: Rare: syncope (fainting), vasodilation (heat stress).
Maltese: Rari: sinkope (ħass ħażin), vasodilatazzjoni (stress minħabba s-sħana).
English: For the treatment of acute pulmonary infections caused by Pseudomonas aeruginosa bacteria in children and adolescents (5-17 years) with cystic fibrosis 15 mg of ciprofloxacin per kg body weight is administered twice daily or 10 mg ciprofloxacin per kg body weight is administered three times daily (maximum 1200 mg daily).
Maltese: Għal kura ta' infezzjonijiet pulmonari akuti kkawżati mill-batterji Pseudomonas aeruginosa fit-tfal u fl-adolexxenti (minn 5 sa 17-il sena) b'fibrożi ċistika, doża ta' 15 mg ta' ciprofloxacin għal kull kilogramm ta' piż tal-ġisem tingħata darbtejn kuljum jew 10 mg ta' ciprofloxacin kull kilogramm ta' piż tal-ġisem jingħataw tliet darbiet kuljum (massimu ta' 1200 mg kuljum).
English: Rare: taste loss (reduced taste), paraesthesia (peripheral paralgesia), tremor (shaking), convulsions, migraine.
Maltese: Rari:telf ta'togħma (nuqqas ta' togħma), parestesija (paralġesija periferali), rogħda (titriegħed), konvulżjonijiet, emigranja.
English: Since ciprofloxacin is associated with very rare cases of QT prolongation (see section 4.8) caution should be exercised when treating patients at risk for torsade de pointes arrhythmia.
Maltese: Minħabba li ciprofloxacin hu assoċjat ma' każijiet rari ħafna ta' titwil tal-QT (ara sezzjoni 4.8), għandha tingħata attenzjoni meta pazjenti li qegħdin f'riskju għal arritmija torsade de pointes ikunu ikkurati.
English: Uncommon: increase of blood creatinine levels, increased blood urea; abnormal liver function test results (increased SGOT and SGPT), bilirubinemia and increased alkaline phosphatase.
Maltese: Mhux komuni: żieda fil-livelli tal-creatine fid-demm, żieda fl-urea fid-demm; testijiet tal-funzjoni tal-fwied b'riżultat anormali (żieda fl-SGOT u SGPT), bilirubinemija u żieda fl-alkaline phosphatase.
English: The bioavailability is lower if antacids that contain aluminium and/or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Maltese: Il-bijodisponibilità hi iktar baxxa jekk l-antacids ikun fihom l-aluminium u/jew magnesium hydroxide, u jekk il-calcium u iron salts jintużaw fl-istess ħin.
English: Mechanism of resistance:
Maltese: Mekkaniżmu tar-reżistenza:
English: Common in more than 1 in 100 patients, but less than 1 in 10 patients
Maltese: Komuni f'iktar minn 1 f'kull 100 pazjent, iżda f'inqas minn 1 f'kull 10 pazjenti
English: • Pre-medicants (used before anaesthesia induction): it is recommended that opiate pre-medicants, (e.g. papaveretum) or opiate pre-medicants used with anticholinergic pre-medicants, (e.g. atropine or hyoscine) are not used concomitantly with ciprofloxacin, as the serum levels of ciprofloxacin are reduced.
Maltese: • Pre-medikanti (li jintużaw qabel l-induzzjoni tal-loppju): hu rakkomandat li l-pre-medikanti ta' l-opiate (eż. papaveretum) jew pre-medikanti ta' l-opiate li jintużaw ma' pre-medikanti antikolinerġiċi (eż. atropine jew hyoscine) ma jintużawx fl-istess ħin ma' ciprofloxacin, għax il-livelli ta' ciprofloxacin fis-serum jonqsu.
English: Other xanthine derivatives
Maltese: Derivattivi oħrajn ta' xanthine
English: Hikma Farmacêutica (Portugal) Lda.
Maltese: Hikma Farmacêutica (Portugal)
English: HOW TO USE CIPROFLOXACIN HIKMA
Maltese: X'fih Ciprofloxacin Hikma
English: • certain anti-inflammatory agents (e.g. ibuprofen, naproxen, but not acetylsalicylic acid), if ciprofloxacin is given in very high doses.
Maltese: • ċerti mediċini kontra l-infjammazzjoni (eż. ibuprofen, naproxen, iżda mhux acetylsalicylic acid), jekk ciprofloxacin jingħata f'dożi qawwijin ħafna.
English: Resistance to ciprofloxacin develops in stages through genomic mutations (multiple-step type).
Maltese: Ir-reżistenza għal ciprofloxacin tiżviluppa fi stadji permezz ta' mutazzjonijiet ġenomiċi (tat-tip multiple-step).
English: Renal and urinary disorders:
Maltese: Disturbi tal-kliewi u tas-sistema urinarja:
English: Local reaction:
Maltese: Reazzjoni lokali:
English: • significant renal impairment.
Maltese: • indeboliment sinifikanti tal-kliewi.
English: Ciprofloxacin Hikma 200 mg/100 ml, solution for infusion [To be completed nationally] ciprofloxacin
Maltese: Ciprofloxacin Hikma 200 mg/100 ml, soluzzjoni għall-infużjoni [Biex timtela nazzjonalment] ciprofloxacin
English: The above-mentioned substances are converted by a specific enzyme (CYP1A2).
Maltese: Is-sustanzi msemmija hawn fuq jinbidlu minn enzima speċifika (CYP1A2).
English: Ciprofloxacin Hikma can also be used for the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa bacteria in children and adolescents aged 5-17 years with cystic fibrosis (also called mucoviscidosis), a hereditary disease of specific glands.
Maltese: Infezzjonijiet akuti tal-passaġġ respiratorju t'isfel ikkawżati minn Pseudomonas aeruginosa fit-tfal u fl-adolexxenti (5-17-il sena) b'fibrożi ċistika:
English: • In children aged below 5 years
Maltese: • Fi tfal taħt l-età ta' 5 snin
English: Very rare: tendinitis (in particular of the Achilles tendon), partial or total tendon ruptures (in particular of the Achilles tendon), worsening of the symptoms of myasthenia, muscular pains, inflammation of tendon sheaths (tenosynovitis).
Maltese: Rari ħafna: tendinite (b'mod partikulari t-tendine ta' Achilles), ftuq parzjali jew tat-tendini (b'mod partikulari tat-tendine ta' Achilles), sintomi ta' mijastenja li jmorru għall-agħar, uġigħ fil-muskoli, infjammazzjoni ta' l-għantijiet tat-tendini (tenosinovite).
English: • oral anticoagulants (used to prevent blood from clotting, e.g. warfarin).
Maltese: • mediċini orali kontra l-koagulazzjoni tad-demm (jintużaw biex jiġi evitat it-tagħqid tad-demm, eż. warfarin).
English: - complicated skin and soft tissue infections - osteomyelitis
Maltese: - infezzjonijiet kumplikati tal-ġilda u tat-tessut artab - osteomjelite:
English: This may cause epileptic seizures.
Maltese: Dan jista' jikkawża puplesiji epilettiċi.
English: Whereas
Maltese: {xxxxxx}
English: - inflammation of blood vessels (vasculitis) characterised by: small spots caused by bleeding in the skin (petechiae), bloody blisters (haemorrhagic bullae), skin nodes (papules), formation of eschar (dead tissue that sheds (sloughs-off) from healthy skin) - fungal infection in the gastrointestinal system (gastrointestinal moniliasis), pancreas inflammation (pancreatitis) - liver inflammation (hepatitis), destruction of liver tissue (liver cell necrosis, very rarely resulting in lifethreatening liver failure) - rash with red (moist) irregular spots (erythema (exsudativum) multiforme), tender bluish red bumps in the skin (erythema nodosum), severe condition with (high) fever, red spots on the skin, joint pains and/or eye infection (Stevens-Johnson syndrome), severe condition with fever and blisters on the skin/peeling of the skin (Lyell syndrome), small purplish red spot (petechia) - inflammation of the tendons (tendinitis, in particular of the Achilles tendon), partial or total tendon ruptures (in particular of the Achilles tendon), exacerbation of the symptoms of myasthenia gravis (a particular type of muscle weakness), muscular pains, inflammation of tendon sheaths (tenosynovitis) - increased blood level of amylase (enzyme that breaks down starch) and lipase (enzyme that breaks down fats).
Maltese: Dawn l-effetti sekondarji jseħħu l-biċċa l-kbira f'pazjenti li jkunu f'riskju għal ċertu mard tal-qalb. - infjammazzjoni ta' vini jew arterji (vaskulite) ikkaratterizzata minn: tikek żgħar ikkawżati minn ħruġ ta' demm fil-ġilda (tbenġil), infafet bid-demm (infafet emorraġiċi), għoqod fil-ġilda (bżieżaq żgħar), formazzjoni ta' eschar (tessut mejjet li jaqa' minn ġilda b'saħħitha) - infezzjoni fungali fis-sistema gastrointestinali (moniliasi gastrointestinali), infjammazzjoni tal-pankreas (pankreatite) - infjammazzjoni tal-fwied (epatite), il-qerda ta' tessut tal-fwied (nekrosi taċ-ċelluli tal-fwied, li b'mod rari ħafna tirriżulta f'kollass tal-fwied li jkun ta' periklu għall-ħajja) - raxx b'tikek (umdi) irregolari ħomor (eritema (exsudativum) multiforme), ħotob rotob blu-ħomor fuq il-ġilda (eritema nodosum), kundizzjoni severa bid-deni (qawwi), tikek ħomor fuq il-ġilda, uġigħ fil-gogi u/jew infezzjoni fl-għajnejn (sindrome ta' Stevens-Johnson), kundizzjoni severa biddeni u nfafet fuq il-ġilda/tqaxxir tal-ġilda (sindrome ta' Lyell), tikek żgħar vjola-ħomor (tbenġil) - infjammazzjoni tat-tendini (tendinite, b'mod partikulari tat-tendine ta' Achilles), ftuq parzjali jew totali tat-tendini (b'mod partikulari tat-tendine ta' Achilles), aggravament tas-sintomi ta' mijastenja gravis (tip partikulari ta' dgħjufija fil-muskoli), uġigħ fil-muskoli, infjammazzjoni ta' l-għantijiet tat-tendini tenosinovite) - żieda fil-livell ta' amylase fid-demm (enzima li tkisser l-istarch) u lipase (enzima li tkisser ix-xaħmijiet). - dgħjufija (astenja), indeboliment temporanju tal-funzjoni tal-kliewi sa kollass temporanju tal-kliewi, sensittività għad-dawl.
English: The elimination half-life of ciprofloxacin does not change with age.
Maltese: Il-half-life ta' l-eliminazzjoni ta' ciprofloxacin ma tinbidilx ma' l-età.
English: Uncommon in more than 1 in 1,000 patients, but less than 1 in 100 patients
Maltese: Mhux Komuni f'iktar minn 1 f'kull 1,000 pazjent, iżda f'inqas minn 1 f'kull 100 pazjent
English: How to store Ciprofloxacin Hikma 6.
Maltese: Ciprofloxacin Hikma fiha 15.
English: Mutagenicity of ciprofloxacin has not been indicated in mutagenicity studies.
Maltese: Il-mutaġeniċità ta' ciprofloxacin ma kinitx indikata fi studji dwar il-mutaġeniċità.
English: If creatinine clearance is ≤ 30 ml/minute/1.73 m2 or the serum creatinine concentration is ≥ 175 µmol/l, the maximum daily intravenous dose is 400 mg.
Maltese: Jekk it-tneħħija tal-creatine hi ta' ≤ 30 ml/minuta/1.73 m2 jew il-konċentrazzjoni tal-creatine fis-serum hi ta' ≥ 175 µmol/l, id-doża massima ta' kuljum ġol-vina hi ta' 400 mg.
English: Type I, clear glass vial, fitted with a chlorobutyl rubber stopper and aluminium flip-off caps.
Maltese: Kunjett magħmul minn ħġieġ ċar ta' tip I, mgħammar b'tapp tal-chlorobutyl tal-lastku u għatjien flip-off ta' l-aluminju.
English: The CHMP has recommended that the indication should be complicated urinary tract infections with a recommended dose of 200 - 400 mg twice daily.
Maltese: Is-CHMP irrakkomanda li l-indikazzjoni għandha tkun infezzjonijiet mhux komplikati fil-pajp ta' lawrina b'doża rakkomandata ta' bejn 200 u 400 mg darbtejn kuljum.
English: The following infections may be treated intravenously (via the blood) with Ciprofloxacin Hikma:
Maltese: L-infezzjonijiet li ġejjin jistgħu jkunu kkurati minn ġol-vina (permezz tad-demm) b'Ciprofloxacin Hikma:
English: Very rare: pulmonary oedema in case of shock (anaphylactic; life-threatening), itching rash, serum sickness-like symptoms.
Maltese: Rari ħafna: edema pulmonari f'każ ta' xokk (anafilattiku; ta' periklu għall-ħajja), raxx bil-ħakk, sintomi tas-serum sickness.
English: The Ciprofloxacin Hikma dosage is based on the severity and type of the infection, the sensitivity of the pathogen(s), your age, weight and kidney function.
Maltese: Id-dożaġġ ta' Ciprofloxacin Hikma hu bbażat fuq is-severità u t-tip ta' l-infezzjoni, tas-sensittività tal-patoġenu(i), l-età, il-piż u l-funzjoni tal-kliewi tiegħek.
English: • liver impairment in the past.
Maltese: • indeboliment tal-fwied fil-passat.
English: The usual dose in adults is 200-400 mg of ciprofloxacin twice daily.
Maltese: Id-dożaġġ fl-adulti hu ta' 200-400 mg ta' ciprofloxacin darbtejn kuljum.
English: The interaction between theophylline and ciprofloxacin is potentially life-threatening.
Maltese: L-interazzjoni bejn theophylline u ciprofloxacin hi potenzjalment ta' periklu għall-ħajja.
English: Elderly:
Maltese: Treddigħ:
English: Rare: tachycardia.
Maltese: Rari: ipergliċemija.
English: Non-species related breakpoints are ≤ 0,5 µg/ml for susceptible, and > 1 µg/ml for resistant organisms.
Maltese: Il-breakpoints assoċjati mhux ta' l-ispeċi huma ta' ≤ 0,5 µg/ml għal organiżmi suxxettibbli, u ta' > 1 µg/ml għal organiżmi reżistenti.
English: The applicant/MAH did not submit any clinical data to address the CHMP questions related to the risk/benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″generic″ application (reference product/originator Ciproxin from Bayer).
Maltese: L-applikant/MAH ma ssottometta l-ebda tagħrif kliniku li jindirizza l-mistoqsijiet tas-CHMP dwar ilbenefiċċju/riskju tad-doża proposta għal infezzjonijiet fil-pajp ta' l-awrina u d-doża massima ta' kuljum f'pazjenti adulti, għax din l-applikazzjoni hija “ġenerika” (prodott ta' referenza/oriġinatur Ciproxin tal-Bayer).
English: • pregnancy and lactation
Maltese: • tqala u treddigħ
English: Twice daily intravenous administration of 15 mg/kg bodyweight, or 10 mg/kg bodyweight three times daily (maximum of 1200 mg per day).
Maltese: Għoti darbtejn kuljum ġol-vina ta' 15 mg/kg ta' piż tal-ġisem, jew ta' 10 mg/kg piż tal-ġisem tliet darbiet kuljum (massimu ta' 1200 mg kuljum).
English: It is recommended that opiate premedicants, (e.g. papaveretum) or opiate premedicants used with anticholinergic premedicants, (e.g. atropine or hyoscine) are not used concomitantly with ciprofloxacin, as the serum levels of ciprofloxacin are reduced.
Maltese: Hu rakkomandat li l-pre-medikanti ta' l-opiate (eż. papaveretum) jew pre-medikanti ta' l-opiate li jintużaw ma' pre-medikanti antikolinerġiċi (eż. atropine jew hyoscine) ma jintużawx fl-istess ħin ma' ciprofloxacin, għax il-livelli ta' ciprofloxacin fis-serum jonqsu.
English: • local reactions after administration of this medicine.
Maltese: • reazzjonijiet lokali wara l-għoti ta' din il-mediċina.
English: Ciprofloxacin Hikma is used for the treatment of severe and/or life-threatening infections caused by ciprofloxacin-sensitive microorganisms.
Maltese: Ciprofloxacin Hikma hu indikat għall-kura ta' infezzjonijiet serji u/jew ta' periklu għall-ħajja kkawżati minn mikroorganiżmi li huma sensittivi għal ciprofloxacin.
English: Following concomitant administration of ciprofloxacin and cyclosporine a transient increase of the serum creatinine concentration has been observed in separate cases.
Maltese: Wara l-għoti fl-istess ħin ta' ciprofloxacin u cyclosporine, żieda temporanja tal-konċentrazzjoni tal-creatine fis-serum kienet osservata f'każijiet separati.
English: This may increase the risk of methotrexate associated toxic reactions.
Maltese: Dan jista' jżid ir-riskju ta' methotrexate marbut ma' reazzjonijiet tossiċi.
English: This has to be taken into consideration for patients on a controlled sodium diet.
Maltese: Dan għandu jiġi kkunsidrat għal pazjenti li qegħdin fuq dieta kkontrollata tas-sodium.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN HIKMA AND ASSOCIATED NAMES (see Annex I)
Maltese: III għal Ciprofloxacin u ismijiet assoċjati (ara l-Anness I).
English: Common: nausea, diarrhoea.
Maltese: Komuni: dardir, dijarea
English: Due to the risk of arthropathy and other potentially severe toxicity in the infant, ciprofloxacin is contraindicated during lactation (see section 4.3).
Maltese: Minħabba r-riskju ta' artropatija u tossiċità potenzjalment severa oħra fit-tarbija, ciprofloxacin hu kontra-indikat matul it-treddigħ (ara sezzjoni 4.3).
English: ≤ 0.5 µg/ml for susceptible, > 1 µg/ml for resistant;
Maltese: - Pseudomonas spp. ≤ 0.5 µg/ml għas-suxxettibbli, > 1 µg/ml għar-reżistenti;
English: Compatibility with these solutions has been proven in ciprofloxacin concentrations of 1 mg/ml.
Maltese: Il-kompatibilità ma' dawn is-soluzzjonijiet kienet ippruvata f'konċentrazzjonijiet ta' ciprofloxacin ta' 1 mg/ml.
English: The duration of treatment with Ciprofloxacin Hikma is based on the severity of the infection, the effect of the treatment and the sensitivity of the pathogen(s).
Maltese: It-tul ta' żmien tal-kura b'Ciprofloxacin Hikma hu bbażat fuq is-severità ta' l-infezzjoni, l-effett tal-kura u tas-sensittività tal-patoġenu(i).
English: Ciprofloxacin Hikma contains 15.4 mmol (354 mg) sodium per 100 ml of solution for infusion.
Maltese: 4 mmol (ekwivalenti għal 354 mg) ta' sodium.
English: with cystic fibrosis:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate.
Maltese: Il-metaboliti kollha huma attivi, iżda fi grad inqas minn ciprofloxacin.
English: Anaerobes are generally less sensitive.
Maltese: Ġeneralment, l-anerobi huma inqas sensittivi.
English: Paediatric patients:
Maltese: Pazjenti pedjatriċi:
English: Hepato-biliary disorders:
Maltese: Indeboliment fil-funzjoni tal-fwied:
English: There are insufficient data available with regard to the use of ciprofloxacin in children and adolescents.
Maltese: Hemm informazzjoni insuffiċjenti disponibbli fir-rigward ta' l-użu ta' ciprofloxacin fit-tfal u fl-adolexxenti.
English: Dosage
Maltese: Endovenosa
English: The renal clearance occurs through glomerular filtration and active tubular secretion.
Maltese: It-tneħħija mill-kliewi sseħħ permezz tal-filtrazzjoni glomerulari u tnixxija tubulari attiva.
English: administration 62% is excreted unchanged in the urine and 15% is excreted in the faeces.
Maltese: Wara l-għoti minn ġol-vina, 62% jitneħħa mhux mibdul fl-awrina u 15% jitneħħa fl-ippurgar.
English: Teratogenic effects have not been observed in animal experimental research.
Maltese: Effetti teratoġeniċi ma kienux osservati matul riċerka sperimentali fuq l-annimali.
English: Ciprofloxacin inhibits this enzyme.
Maltese: Ciprofloxacin jinibixxi din l-enzima.
English: Impaired renal and hepatic function:
Maltese: Disturbi marbut mal-metaboliżmu u n-nutrizzjoni:
English: As with all other antibiotics, the patient should be monitored during therapy for the development of resistant strains of initially sensitive bacteria, especially P. aeruginosa and S. aureus (see the relevant statements in section
Maltese: Bħal fil-każ ta' l-antibijotiċi l-oħrajn kollha, il-pazjent għandu jkun immonitorjat matul it-terapija għall-iżvilupp ta' razez reżistenti ta' batterji li jkunu inizjalment sensittivi, speċjalment P. aeruginosa u S. aureus (ara d-dikjarazzjonijiet rilevanti f'sezzjoni 5.1).
English: Twice daily intravenous administration of 15 mg/kg bodyweight, or 10 mg/kg bodyweight three times daily (maximum of 1200 mg per day), then twice daily oral administration.
Maltese: Għoti darbtejn kuljum ġol-vina ta' 15 mg/kg ta' piż tal-ġisem, jew ta' 10 mg/kg ta' piż tal-ġisem tliet darbiet kuljum (massimu ta' 1200 mg kuljum), imbagħad għoti mill-ħalq darbtejn kuljum.
English: Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione Endovenosa
Maltese: Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione
English: IT
Maltese: Tqala
English: • feeling depressed or confused after administration of Ciprofloxacin Hikma.
Maltese: • tħossok dipress/a jew konfuż/a wara l-għoti ta' Ciprofloxacin Hikma.
English: There is a linear correlation between dose on the one hand and plasma concentration and AUC on the other.
Maltese: Hemm korrelazzjoni lineari bejn id-doża fuq naħa, u l-konċentrazzjoni fil-plażma u l-AUC fuq in-naħa l-oħra.
English: Ciprofloxacin Hikma may also be administered in the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children aged 5-17 years with cystic fibrosis.
Maltese: Ciprofloxacin Hikma jista' wkoll jingħata fil-kura ta' infezzjonijiet akuti tal-passaġġ respiratorju t'isfel ikkawżati minn Pseudomonas aeruginosa fit-tfal li jkollhom bejn 5 u 17-il sena b'fibrożi ċistika.
English: The reconstituted solution is clear.
Maltese: Idratazzjoni adegwata għandha tkun aċċertata.
English: Oral administration of 20 mg/kg twice daily to children with cystic fibrosis gives an exposure that is comparable to that in adults following an oral dose of 750 mg twice daily.
Maltese: L-għoti mill-ħalq ta' 20 mg/kg darbtejn kuljum lil tfal b'fibrożi ċistika tagħti espożizzjoni li hi komparabbli għal dik fl-adulti wara doża mill-ħalq ta' 750 mg darbtejn kuljum.
English: Ciprofloxacin Hikma 200 mg/100 ml, solution for infusion [To be completed nationally]
Maltese: Ciprofloxacin Hikma 200 mg/100 ml, soluzzjoni għall-infużjon [Biex timtela nazzjonalment]
English: Uncommon: - fungal infection (mobilises) - increase in eosinophilic cells (eosinophilia), reduction in white blood cells (leucopenia) which makes infections more likely - inflammation of a vein related to a blood clot (thrombophlebitis); the vein is often sensed as a tender hard strand covered with red skin - vomiting, digestive disorders, gassiness (flatulence), loss of appetite, abdominal pain - itching (pruritus), spot-shaped rash (maculopapular rash), hives (urticaria) - joint pain (arthralgia) - general sensation of weakness, fatigue (asthenia), irritation or pain at the injection site - increase of the creatinine or urea level in the blood, abnormal liver function test results, bile pigment in the blood (bilirubinaemia) and increased blood level of a certain enzyme (alkaline phosphatase) - pulmonary embolism, laboured breathing (dyspnoea), pulmonary oedema, nosebleed (epistaxis),
Maltese: Mhux komuni: - infezzjoni fungali (moniliasi) - żieda fiċ-ċelluli eosinofiliċi (eosinofilja), tnaqqis fi ċelluli bojod tad-demm (lewkopenja) li jagħmel l-infezzjonijiet iktar probabbli - infjammazzjoni ta' vina relatata ma' embolu tad-demm (tromboflebite); il-vina ta' spiss tinħass iebsa u sensittiva, miksija b'ġilda ħamra - rimettar, mard diġestiv, ikollok il-gass, telf ta' aptit, uġigħ addominali - ħakk, raxx f'forma ta' tikek (raxx makulopapulari), urtikarja - uġigħ fil-gogi (artralġja) - sensazzjoni ġenerali ta' dgħjufija, għeja kbira (astenja), irritazzjoni jew uġigħ fis-sit ta' l-injezzjoni - żieda fil-livell tal-creatine jew ta' l-urea fid-demm, testijiet tal-funzjoni tal-fwied b'riżultat anormali, kulur tal-bila fid-demm (bilirubinemija) u żieda fil-livell tad-demm ta' ċerta enzima
English: Rare: myalgia (muscular pain), joint disorder (swollen joints).
Maltese: Rari: mijalġja (uġigħ fil-muskoli), mard tal-ġogi (ġogi minfuħin).
English: Orion Corporation, ORION PHARMA,Tengströminkatu 8, P.O.Box 425, 20101 Turku, Finland
Maltese: Orion Corporation, ORION PHARMA,Tengströminkatu 8, P.O.Box 425, 20101 Turku, Il-Finlandja
English: D-51381 Leverkusen Germany
Maltese: D-51381 Leverkusen
English: Boehringer Ingelheim Finland Ky, Tammasaarenkatu 5, 00180 Helsinki, Finland
Maltese: Boehringer Ingelheim Finland Ky, Tammasaarenkatu 5, 00180 Helsinki, il-Finlandja
English: 40 mg Tablets
Maltese: 40 mg Pilloli
English: Belgium SCS Boehringer Ingelheim Comm.V., Avenue Ariane 16
Maltese: SCS Boehringer Ingelheim Comm.V., Avenue Ariane 16
English: 6 g/ 100 g Oral drops, solution kohlpharma GmbH Im Holzhau 8 d-66663 Merzig Germany
Maltese: 6 g/ 100 g Qtar orali, soluzzjoni kohlpharma GmbH Im Holzhau 8 d-66663 Merzig Il-Ġermanja
English: Rofatuss Saft 400 mg/ 100 ml
Maltese: Saft 400 mg/ 100 ml
English: 0.40% Syrup
Maltese: 0.40% Ġulepp
English: 4 mg/1 ml Oral solution
Maltese: 4 mg/1 ml Soluzzjoni orali
English: Czech Republic Boehringer Ingelheim GmbH Binger Strasse 173
Maltese: Boehringer Ingelheim GmbH Binger Strasse 173
English: 20mg/5ml Syrup
Maltese: 20mg/5ml Ġulepp
English: Boehringer Ingelheim Austria GmbH Dr.Boehringer-Gasse 5-11 A-1121 Wien
Maltese: Boehringer Ingelheim Austria GmbH Dr.Boehringer-Gasse 5-11
English: 60mg Oral solution
Maltese: 60 mg Soluzzjoni orali
English: Rofatuss forte 80 mg Capsule, hard
Maltese: Rofatuss forte 80 mg Kapsula, iebsa