FrancophonIA/ELRC3.0 huggingface dataset:
English: Colistimethate sodium (CMS) is a cyclic polypeptide antibacterial active substance that is derived from Bacillus polymyxa var. colistinus and belongs to the polymyxin group.
Maltese: Colistimethate sodium (CMS) huwa sustanza attiva antibatterika li tikkonsisti minn polypetide ċikliku li ġej minn Bacillus polymyxa var. colistinus u jappartjeni għal grupp ta' polymyxin.
English: There were 32 patients aged 6-12 years, 41 patients aged 13-17 years and 114 patients aged 18 years and older.
Maltese: 32 pazjent bejn l-etajiet ta' 6 snin -12-il sena, 41 pazjent bejn 13-17-il sena u 114-il pazjent li għalqu t-18-il sena u aktar.
English: The other ingredients are: Capsule Shell Gelatin polyethylene glycol sodium lauryl sulfate purified water
Maltese: Qoxra tal-kapsula Ġelatina polyethylene glycol sodium lauryl sulfate ilma ppurifikat
English: Cross resistance between colistimethate sodium and polymyxin B is expected.
Maltese: Reżistenza inkroċjata bejn colistimethate sodium u polymyxin B hija mistenni.
English: A systemic absorption study showed minimal urinary excretion with less than 3% of the dose of Colobreathe excreted in the urine as colistimethate sodium and colistin.
Maltese: Eliminazzjoni Studju dwar l-assorbiment sistemiku wera eliminazzjoni urinarja minimali b'inqas minn 3% tad-doża ta' Colobreathe eliminata fl-awrina bħala colistimethate sodium u colistin.
English: As 80% of a parenteral dose can be recovered unchanged in the urine, and there is no biliary excretion, it can be assumed that the remaining drug is inactivated in the tissues.
Maltese: Peress li sa 80% tad-doża parenterali tista' tiġi rkuprata mingħajr ma tinbidel fl-awrina, u m'hemm l-ebda eliminazzjoni biljari, wieħed jista' jassumi li l-mediċina li tibqa', tiġi inattivata fit-tessuti.
English: The most commonly reported adverse reactions as a percent of Colobreathe treated patients were: cough (55%), unpleasant taste (51%), throat irritation (34%), dyspnoea (10%) and dysphonia (10%).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati bħala perċentwali ta' pazjenti kkurati b'Colobreathe kienu: sogħla (55%) togħma ħażina (51%), irritazzjoni fil-griżmejn (34%),
English: Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).
Maltese: It-trattament fl-istess ħin b'colistimethate sodium u makrolidi bħal azithromycin u clarithomycin, jew fluoroquinolones bħal norfloxacin u ciprofloxacin għandu jsir b'attenzjoni f'pazjenti b'myasthenia gravis (ara sezzjoni 4.4).
English: In the 24 week clinical study, the following adverse reactions were observed across all ages.
Maltese: Fl-istudju kliniku ta' 24 ġimgħa, ir-reazzjonijiet avversi li ġejjin kienu osservati fl-etajiet kollha.
English: • if you/your child suffer from myasthenia gravis and are taking macrolide type antibiotics such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin.
Maltese: • jekk inti/it-tifel/it-tifla tiegħek tbati minn myasthenia gravis u qed tieħu antibijotiċi tat-tip makrolidi bħal azithromycin u clarithromycin, jew fluorquinolones bħal norfloxacin u ciprofloxacin.
English: • The “Physician DVD”
Maltese: • Id-“DVD tat-Tabib”
English: The adjusted treatment difference and 95% confidence interval have been back transformed from log transformed data.
Maltese: Id-differenza fil trattament aġġustat u intervall ta' kunfidenza ta' 95% kienu trasformati lura mit-tagħrif trasformat ta' log.
English: • The “Patient DVD”
Maltese: • Id-“DVD tal-Pazjent”
English: • Cough, throat irritation
Maltese: • Sogħla, irritazzjoni fil-griżmejn,
English: Clean the chamber using a tissue or cotton bud.
Maltese: Naddaf il-kompartament billi tuża tissue jew cotton bud.
English: Although the population PK analysis showed that age is a statistically significant covariate, the AUC 0-6 and dose adjusted AUC0-6 (AUC 0-6 /D) for total CMS and total free colistin were similar between children and adolescents, while higher AUC 0-6 was observed in the adult group.
Maltese: aġġustati skont id-doża (AUC 0-6 /D) għal CMS totali u għal colistin totali ħieles kienu simili bejn it-tfal u l-adolexxenti, filwaqt li AUC 0-6 ikbar ġiet osservata fil-grupp tal-adulti.
English: If it is not empty, repeat steps 7, 8 and 9 until you have inhaled all of the contents.
Maltese: Jekk din ma tkunx vojta, irrepeti l-passi 7, 8 u 9 sakemm inti tkun ħadt il-kontenut kollu mannifs.
English: • 8 hard capsules and one Turbospin inhaler device sufficient for 4 days use.
Maltese: • 8 kapsuli iebsin - Turbospin wieħed trab Turbospin inalatur suffiċjenti għal 4 ijiem użu.
English: Of these, 187 patients aged 6 years and above were exposed to Colobreathe one capsule twice daily in a 24-week, phase 3 comparative study.
Maltese: Minn dawn, 187 pazjent minn età ta' 6 snin u aktar kienu esposti għal Colobreathe b'kapsula waħda darbtejn kuljum fi studju komparattiv ta' fażi 3 li dam sejjer 24 ġimgħa.
English: High concentrations of total free colistin (mean 23.5mg/L) and total colistimethate (mean 178mg/L) were observed in sputum at 1 hour post-dose on Day 8 following BID dosing for 7 days across all age groups.
Maltese: Konċentrazzjonijiet għoljin ta' colistin totali ħieles (medja ta' 23.5 mg/L) u ta' colistimethate totali (medja ta' 178 mg/L) kienu osservati fl-isputum siegħa wara l-għoti tad-doża f'Jum 8 wara dożaġġ
English: Elimination
Maltese: Disġewżja
English: Colistimethate sodium and colistin have been investigated in vitro to determine the effects on the expression of cytochrome P450 (CYP) enzymes on treating primary cultures of fresh human hepatocytes.
Maltese: Colistimethate sodium u colistin ġew mistħarrġa in vitro sabiex jiġu stabbiliti l-effetti fuq l-espressjoni tal-enzimi ta' cythochrome P450 (CYP) li jaġixxu biex jikkuraw kulturi primarji ta' epatoċiti friski talbniedem.
English: Colobreathe 1,662,500 IU inhalation powder colistimethate sodium
Maltese: Colobreathe 1,662,500 IU trab li jittieħed man-nifs colistimethate sodium
English: Colistimethate sodium is converted to the base in vivo.
Maltese: Colistimethate sodium jinbidel għall-bażi in vivo.
English: Caution should be taken with concomitant use of colistimethate sodium and potential nephrotoxic or neurotoxic medicinal products, including non-depolarising muscle relaxants (see section 4.5).
Maltese: Wieħed għandu joqgħod attent meta juża colistimethate sodium u prodotti mediċinali potenzjalment nefrotossiċi jew newrotossiċi fl-istess ħin, inkluż rilassanti tal-muskoli mhux depolarizzanti (ara sezzjoni 4.5).
English: This may be related to Candida albicans infection or hypersensitivity.
Maltese: Dan jista' jkun marbut ma' infezzjoni b'Candida albicans jew sensittività eċċessiva.
English: Colobreathe is used to control persistent lung infections caused by the bacterium Pseudomonas aeruginosa in adult patients and children aged 6 years and older with cystic fibrosis.
Maltese: Colobreathe jintuża biex jikkontrolla infezzjonijiet persistenti tal-pulmun ikkawżati mill-batterju Pseudomonas aeruginosa f'pazjenti adulti u tfal minn 6 snin u akbar b'fibrożi ċistika.
English: Polymyxins persist in the liver, kidney, brain, heart and muscle.
Maltese: Polymyxins jippersistu fil-fwied, il-kliewi, il-moħħ, il-qalb u fil-muskoli.
English: Haemoptysis is a complication in cystic fibrosis and is more frequent in adults.
Maltese: Emoptisi Emoptisi huwa kumplikazzjoni ta' fibrożi ċistika u hija l-aktar komuni fl-adulti.
English: One study in cystic fibrosis patients gives the steady-state volume of distribution as 0.09 l/kg.
Maltese: Studju wieħed fuq pazjenti b'fibrożi ċistika jagħti l-volum fi stat fiss ta' distribuzzjoni ta' 0.09 l/kg.
English: Colobreathe is available in packs containing either 8 or 56 hard capsules.
Maltese: Colobreathe jiġi f'pakketti li fihom jew 8 kapsuli ibsin jew 56 kapsula iebsa.
English: • 56 hard capsules and one Turbospin powder inhaler device sufficient for 4 weeks use.
Maltese: • 56 kapsuli iebsin - Turbospin wieħed trab inalatur suffiċjenti għall-4 ġimgħat użu.
English: Each 56 capsule pack contains one Turbospin powder inhaler device and 7 blisters of 8 capsules or one Turbospin powder inhaler device and 4 blisters of 14 capsules (56 hard capsules) sufficient for 4 weeks use.
Maltese: Kull pakkett kapsula 56 fih wieħed Turbospin inalatur trab u, 7 folji ta' 8 kapsuli jew kull strixxa jew inalatur trab Turbospin waħda u 4 folji ta' 14-il kapsula (56 kapsula iebsa) biżżejjed għall-4 ġimgħat użu.
English: Each capsule contains 1,662,500 IU (approximately equivalent to 125 mg) of colistimethate sodium.
Maltese: Kull kapsula fiha 1,662,500 IU (ekwivalenti għal madwar 125 mg) ta' colistimethate sodium.
English: • if you/your child are allergic to colistimethate sodium, colistin sulphate or polymyxins.
Maltese: • jekk inti/it-tifel/it-tifla tiegħek intom allerġiċi għal colistimethate sodium, colistin sulphate jew polymyxins.
English: Breathe out slowly.
Maltese: Klipp Għatu
English: Do not store Colobreathe above 25oC.
Maltese: Taħżinx Colobreathe f'temperatura 'l fuq minn 25oC.
English: Dyspnoea, cough, dysphonia, throat irritation
Maltese: Emoptisi, bronkospażmu, ażma,
English: Colobreathe 1,662,500 IU inhalation powder, hard capsules colistimethate sodium
Maltese: Colobreathe 1,662,500 IU trab li jittieħed man-nifs, kapsuli ibsin. colistimethate sodium
English: If acute respiratory exacerbations develop additional intravenous or oral antibacterial agent therapy should be considered.
Maltese: Aggravar ta' kundizzjonijiet respiratorji akuti ikun hemm aggravar ta' kundizzjonijiet respiratorji akuti, terapija b'sustanza antibatterika intravenuża jew orali għandha tiġi kkunsidrata.
English: Each capsule contains 1,662,500 IU (approximately equal to 125 mg) of colistimethate sodium
Maltese: Kull kapsula fiha 1,662,500 IU (ekwivalenti għal madwar 125 mg) ta' colistimethate sodium
English: • Discussion about common side effects and in particular cough and taste abnormality: Explanation that:
Maltese: • Diskussjoni dwar effetti sekondarji komuni u b'mod partikulari s-sogħla u anormalità fit-togħma:
English: • Coughing up blood, wheezing, chest discomfort, asthma, productive cough (a cough which brings up mucus), infection of the lungs, lung crackles (your doctor would hear this when listening to your lungs using a stethoscope)
Maltese: • Sogħla bid-demm, tħarħir, skonfort fis-sider, ażżma, sogħla produttiva (sogħla li ttella' l-mukus) infezzjoni fil-pulmun, ħsejjes fil-pulmun, (it-tabib tiegħek ser jisma' dan meta jisma' l-pulmun tiegħek permezz ta' stetoskopju)
English: If you/your child experience signs of an allergic reaction you should seek urgent medical attention.
Maltese: reazzjoni allerġika, għandkom tfittxu attenzjoni medika urġenti.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http:/www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Other inhaled medicinal products
Maltese: TAL-PRODOTT MEDIĊINALI
English: However, overdose may possibly result in higher systemic exposure.
Maltese: Madankollu, doża eċċessiva tista' tirriżulta possibbilment f'espożizzjoni sistemika ogħla.
English: EU/1/11/747/001 56 hard capsules (4 strips of 14 capsules) EU/1/11/747/002 8 hard capsules (1 strip of 8 capsules) EU/1/11/747/003 56 hard capsules (7 strips of 8 capsules)
Maltese: EU/1/11/747/001 56 kapsula iebsa (4 strixxi ta' 14-il kapsula)
English: In embryo-fetal development studies in mice, resorptions and reduced ossification were seen, and in rats reduced fetal weights, reduced ossification and at the high dose of 10 mg colistin base per day, reduced post-natal survival.
Maltese: Fi studji tal-iżvilupp embrijofetali fil-ġrieden, assorbimenti mill-ġdid u ossifikazzjoni mnaqqsa ġew osservati, u fil-firien kien hemm tnaqqis fil-piż tal-fetu, ossifikazzjoni mnaqqsa u fid-doża għolja ta' 10 mg ta' bażi ta' colistin kuljum, tnaqqis fis-sopravivenza ta' wara t-twelid.
English: Each capsule contains 1,662,500 IU, which is approximately equal to 125 mg of colistimethate sodium.
Maltese: Kull kapsula fiha 1,662,500 IU, li huma ekwivalenti għal madwar 125 mg ta' colistimethate sodium.
English: The dose interval should be as close as possible to 12 hours.
Maltese: L-intervall tad-doża għandu jkun qrib kemm jista' jkun ta' 12-il siegħa.
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Maltese: Il-batterji reżistenti huma kkaraterizzati minn modifikazzjoni għal gruppi tal-phosphate ta' lipopolysaccharide, li jiġu ssostitwiti b'ethanolamine jew aminoarabinose.
English: Colobreathe capsules should only be administered using the Turbospin inhaler device.
Maltese: Il-kapsuli Colobreathe għandhom jingħataw biss bl-użu tal-apparat inalatur Turbospin.
English: player
Maltese: TIKKETTAR
English: After administration of 1,662, 500IU twice daily for 7 days in adult, adolescent and paediatric cystic fibrosis patients mean C max values of total colistimethate of up to 455ng/ml (adult mean) were observed.
Maltese: adolexxenti u tfal, ġew osservati valuri medji tas-C max ta' colistimethate totali sa 455 ng/ml (medja fl adulti).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Colobreathe in one or more subsets of the paediatric population in Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis (see section 4.2 for information on paediatric use).
Maltese: /kolonizzazzjoni b'Pseudomonas aeruginosa f'pazjenti b'fibrożi ċistika (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Protein binding is low.
Maltese: Proteina fl-awrina
English: You may see a small amount of powder released from the capsule chamber after the capsule is pierced, this is normal.
Maltese: Taf tara ammont żgħir ta' trab li joħroġ mit toqba tal-kapsula wara li ttaqqab il-kapsula, dan hu normali.
English: If you do not hear the capsule spinning, the capsule may be stuck in the compartment.
Maltese: Jekk ma tismax il-kapsula ddur, jista' jkun li l-kapsula tkun weħlet fil-kompartiment.
English: The capsules are contained in oPA/aluminium/pvc blisters with a peelable lidding foil composed of polyester/aluminium of either 8 or 14 hard capsules in each blister.
Maltese: Il-kapsuli jinżammu f'folji magħmula minn oPA/aluminju/pvc b'fojl b'kisja li titqaxxar magħmula minn polyester/aluminju ta' 8 jew 14-il kapsula iebsa f'kull folja.
English: The Turbospin is an inspiratory flow driven dry powder inhaler made of polypropylene and stainless steel.
Maltese: Turbospin huwa inalatur magħmul minn polypropylene u stainless steel li jiġbed it-trab xott 'il ġewwa man-nifs.
English: Physico-chemical data suggest excretion of colistimethate sodium in human milk.
Maltese: Dejta fiżiko-kimika tagћti ћjiel ta' eliminazzjoni ta' colistimethate sodium fil-ħalib tas-sider tal bniedem.
English: Unscrew the mouthpiece, exposing the chamber of the Turbospin inhaler.
Maltese: Biex tuża ma' inalatur Turbospin biss.
English: An allergic reaction with Colobreathe is possible (typically serious allergic reactions may cause rashes, swelling of the face, tongue and neck, inability to breathe due to narrowing of the airways and loss of consciousness).
Maltese: Reazzjoni allerġika b'Colobreathe hija possibbli (reazzjonijiet allerġiċi serji ġeneralment jistgħu jikkawżaw raxx, nefħa fil-wiċċ, fl-ilsien u fl-għonq, ma tkunx tista' tieħu in-nifs sew minħabba t-tidjiq tal-passaġġi tal-arja u tista' tintilef minn sensik).
English: How to store Colobreathe
Maltese: Tużax Colobreathe
English: • Toothache
Maltese: • Togħma ħażina
English: Based on the safety profile of colistimethate sodium, neurotoxity may occur with the possibility of dizziness, confusion or visual disturbances.
Maltese: Ibbażat fuq il-profil tas-sigurtà ta' colistimethate sodium, jista' jkun hemm newrotossiċità bil possibbiltà ta' sturdament, konfużjoni jew disturbi viżwali.
English: Rinsing may reduce the risk of developing oral fungal super-infection during treatment and may also reduce the unpleasant taste associated with colistimethate sodium.
Maltese: It-tlaħliħ ser inaqqas ir-riskju li tiżviluppa superinfezzjoni orali fungali matul il-kura u jista' wkoll inaqqas t-togħma ħażina marbuta ma' colistimethate sodium.
English: Polymyxins are selective for Gram-negative bacteria that have a hydrophobic outer membrane.
Maltese: Polymyxins huma selettivi għall-batterji Gram negattivi li għandhom il-membrana ta'
English: Inhalation powder, hard capsule.
Maltese: M'għandekx tibla' l-kapsuli.
English: Subjects were randomised to receive either one 1,662,500 IU capsule of colistimethate sodium twice daily, or 300 mg of tobramycin, twice daily.
Maltese: L-individwi ġew magħżula b'mod każwali sabiex jirċievu jew kapsula ta' 1,662,500 IU ta' colistimethate sodium, darbtejn kuljum, jew 300 mg ta' tobramycin, darbtejn kuljum.
English: Other medicines and Colobreathe
Maltese: Mediċini oħra u Colobreathe
English: Do not swallow Colobreathe capsules.
Maltese: M'għandekx tibla' l-kapsuli ta' Colobreathe.
English: Each 8 capsule pack contains one Turbospin powder inhaler device and 1 blister of 8 hard capsules sufficient for 4 days use.
Maltese: 8 kapsuli ma' inalatur Turbospin wieħed (strixxa waħda ta' 8 kapsuli)
English: • Chest physiotherapy
Maltese: • Uġigħ fis-sider
English: Taking Colobreathe using the Turbospin inhaler
Maltese: Kif tieħu Colobreathe permezz tal-inalatur Turbospin
English: Dosage
Maltese: Tfal
English: The Turbospin device should be discarded after completion of the treatment pack.
Maltese: Armi l-inalatur Turbospin wara li tlesti mill-pakkett ta' kura.
English: Inhalation powder, hard capsule (inhalation powder) Hard transparent PEG-gelatin capsules containing a fine white powder.
Maltese: Kapsuli tal-ġelatina-PEG ibsin u trasparenti li fihom trab abjad fin.
English: Single dose intravenous studies in human pregnancy show that colistimethate sodium crosses the placenta and consequently there is potential for foetal toxicity if administered during pregnancy.
Maltese: colistimethate sodium f'pazjenti b'emoptisi klinika sinifikanti għandu jsir jew jitkompla biss meta s siwi ta' trattament huwa kkonsidrat li jisboq ir-riskji li jinduċi aktar emorraġiji.
English: Chest physiotherapy
Maltese: Fiżjoterapija tas-sider
English: 8 capsules with 1 Turbospin inhaler (1 strip of 8 capsules) 56 capsules with 1 Turbospin inhaler (4 strips of 14 capsules) 56 capsules with 1 Turbospin inhaler (7 strips of 8 capsules)
Maltese: 56 kapsula ma' inalatur Turbospin wieħed (7 strixxi ta' 8-il kapsula)
English: To inhale Colobreathe from the capsule through the Turbospin inhaler follow the procedure described below.
Maltese: Biex tieħu Colobreathe man-nifs mill-kapsula permezz tal-inalatur Turbospin segwi l-proċedura deskritta hawn taħt.
English: Weight fluctuation, decreased appetite
Maltese: aggravar ta' dispnea,
English: Colobreathe inhalation powder, hard capsule (inhalation powder) is supplied as small, hard, transparent gelatin capsules containing a fine white powder.
Maltese: Colobreathe trab li jittieħed man-nifs, kapsula iebsa (trab li jittieħed man-nifs) jiġi f'kapsuli tal-ġelatina żgħar, ibsin u trasparenti li fihom trab bajdani fin.
English: Skin rash may also indicate hypersensitivity and if this occurs treatment should be withdrawn.
Maltese: Raxx tal-ġilda jista' wkoll jindika sensittività eċċessiva u, jekk dan iseħħ il-kura għandha titwaqqaf.
English: In the 24-week clinical study, where Colobreathe was administered twice daily to adults and children aged 6-17, the adverse reactions identified in the paediatric population were similar to that for the overall population.
Maltese: snin u 17-il sena, ir-reazzjonijiet avversi identifikati fil-popolazzjoni pedjatrika kienu simili għal dawk tal-popolazzjoni globali.
English: porphyria
Maltese: FOLJA
English: Dysgeusia
Maltese: xi proċedura
English: Animal studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction, employing routes assuring systemic exposure, showed no particular hazard.
Maltese: Studji fl-annimali dwar sigurtà farmakoloġika, tossiċità b'doża ripetuta jew tossiċità għal riproduzzjoni, li użaw rotot li jiżguraw l-espożizzjoni sistemika, ma wrew l-ebda periklu partikolari.
English: More common signs and symptoms of intravenous overdose include unsteadiness, paraesthesia and dizziness.
Maltese: Aktar sinjali u sintomi komuni ta' doża eċċessiva fil-vini jinkludu żbilanċ, parasteżija u sturdament.
English: Colobreathe 1,662,500 IU inhalation powder, hard capsules
Maltese: Colobreathe 1,662,500 IU trab li jittieħed man-nifs, kapsuli ibsin.
English: Chest pain, dyspnoea exacerbated, pharyngolaryngeal pain, epistaxis, sputum purulent, abnormal chest sound, increased upper airway secretion
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: • Hold the inhaler with the mouthpiece upright, gently push the piston upwards until the visible line is reached - you will feel resistance at this point and this will lock the capsule in place ready for piercing.
Maltese: Jekk inti /it-tifel/it-tifla tiegħek aċċidentalment tqaxxru il-fojl, u jekk xi kapsuli jiġu esposti, jekk jogħġbok armi dawn il-kapsuli.
English: Common: may affect up to 1 in 10 people
Maltese: Komuni: li jistgħu jaffettwaw sa persuna 1 f'10:
English: • Information on the need to comply with the treatment in order to maximise the potential benefits.
Maltese: • Informazzjoni dwar il-ħtieġa li tkun konformi mal-kura sabiex timmassimizza l-benefiċċji potenzjali.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: Sensittività eċċessiva għall-mediċina
English: Teva Pharma Belgium S.A. /AG Tel/Tél: +32 3 820 73 73
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 22 345 93 00
English: • Joint pains
Maltese: • Fiżjoterapija tas-sider
English: Vomiting, nausea Diarrhoea, toothache, salivary hypersecretion, flatulence
Maltese: Hekk kif tkun qed tieħu nifs 'il ġewwa bil-mod, inti tiġbed l-arja mill-parti ewlenija tal-inalatur
English: Discard the Turbospin inhaler after the completion of a treatment pack.
Maltese: Turbospin għal ġewwa l-kompartiment tal-kapsula.
English: • There should be a 12 hour gap between doses.
Maltese: • Għandu jkun hemm intervall ta' 12-il siegħa bejn doża u oħra.
English: Haemoptysis, bronchospasm, asthma, wheezing, chest discomfort, lower respiratory tract infection, productive cough, crackles lung
Maltese: tħarħir, skonfort fis-sider, infezzjoni fil-parti t'isfel talapparat respiratorju, sogħla bil-katarru,
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR
English: Colobreathe contains colistimethate sodium, a type of antibiotic called a polymyxin.
Maltese: X'inhu Colobreathe u għalxiex jintuża Colobreathe fih colistimethate sodium li huwa tip t'antibijotiku msejjaħ polymyxin.
English: Colistimethate sodium is not recommended during pregnancy and in women of childbearing potential not using contraception.
Maltese: L-użu ta' Colistimethate sodium mhux irrikkmandat waqt it-tqala u fin-nisa li mhumiex jużaw kontraċettivi.
English: Explanation that using inhaled antibiotics can reduce the need for intravenous antibiotics.
Maltese: Spjegazzjoni li l-użu ta' antibijotiċi li jinġibdu man-nifs jista' jnaqqas il-ħtieġa għal antibijotiċi ġol-vina.
English: Adjusted Treatment difference
Maltese: Differenza aġġustata ta'
English: What Colobreathe is and what it is used for What you need to know before you use Colobreathe How to use Colobreathe
Maltese: Sintomi Attwalment m'hemm l-ebda esperjenza ta‘ doża eċċessiva bl-użu ta' Colobreathe.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: RIGWARD TAL-UŻU SIGUR U EFFETTIV TALPRODOTT MEDIĊINALI