FrancophonIA/ELRC3.0 huggingface dataset:
English: Colistimethate sodium or colistin did not induce the activity of any P 450 (CYP) enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5) in in vitro studies in human hepatocytes.
Maltese: Colistimethate sodium jew colistin ma stimulaw lattività ta' xi enzima P 450 (CYP) ittestjata (CYP1A2, 2B6, 2C8, 2C9, 2C19 u 3A4/5) fi studji in vitro f'epatoċiti tal-bniedem.
English: Intraventricular route
Maltese: Mod intraventrikulari
English: Dose conversion table:
Maltese: Tabella ta' konverżjoni tad-doża:
English: Cross resistance between colistin (polymyxin E) and polymyxin B is expected.
Maltese: Hija mistennija reżistenza inkroċjata bejn colistin (polymyxin E) u polymyxin B.
English: Creatinine clearance (ml/min)
Maltese: Tneħħija tal-kreatinina (ml/min)
English: Haemodialysis and continuous haemo(dia)filtration Colistin appears to be dialyzable through conventional haemodialysis and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF).
Maltese: Colistin jidher li huwa dijaliżabbli permezz ta' emodijaliżi konvenzjonali u emo(dija)filtrazzjoni venovenuża kontinwa (CVVHF, CVVHDF).
English: Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials, polymyxins.
Maltese: Kategorija farmakoterapewtika: antibatteriċi għal użu sistemiku, antibatteriċi oħrajn, polymyxins.
English: Recommended dose range:
Maltese: Medda tad-doża rrakkomandata:
English: Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Maltese: Batterji Gram-negattivi reżistenti b'mod naturali, bħal Proteus mirabilis u Burkholderia cepacia, juru sostituzzjoni sħiħa tal-fosfati tal-lipidi tagħhom b'etanolamini jew aminoarabinose.
English: CMS is eliminated predominantly by the kidneys via glomerular filtration.
Maltese: CMS huwa prinċipalment eliminat mill kliewi permezz ta' filtrazzjoni glomerulari.
English: The information on the pharmacokinetics of colistimethate sodium (CMS) and colistin is limited.
Maltese: L-informazzjoni dwar il-farmakokinetika ta' colistimethate sodium (CMS) u colistin hija limitata.
English: [Product name] is indicated for the management in adult and paediatric of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (see section 5.1).
Maltese: [Isem tal-prodott] huwa indikat għall-ġestjoni fl-adulti u fil-pedjatriċi ta' infezzjonijiet pulmonari kroniċi minħabba Pseudomonas aeruginosa f'pazjenti b'fibrożi ċistika (ara sezzjoni 5.1).
English: In patients with very poor renal function (creatinine clearance <30 ml/min), the extent of conversion could be as high as 60 to 70%.
Maltese: <30 ml/min), il-firxa ta' konverżjoni tista' tilħaq bejn 60 u 70 %.
English: Susceptible (S) Resistant (R) a
Maltese: Reżistenti (R)
English: Serratia spp
Maltese: Proteus spp Providencia spp Serratia spp
English: Caution is advised when administering colistimethate sodium to infants < 1 year of age as renal function is not fully mature in this age group.
Maltese: Hija rrakkomandata kawtela meta colistimethate sodium jingħata lil tfal < 1 sena ta' età minħabba li l funzjoni renali mhijiex kompletament matura f'dan il-grupp ta' età.
English: High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea.
Maltese: Ġew irrapportati konċentrazzjonijiet għoljin ta' colistimethate sodium fis-serum, li jistgħu jkunu assoċjati ma' doża eċċessiva jew ma' nuqqas ta' suċċess f'li jitnaqqas id-dożaġġ f'pazjenti b'indeboliment renali, li jwasslu għal effetti newrotossiċi bħal parestesija tal-wiċċ, dgħjufija fil-muskoli, sturdament, kliem ma jiftehimx, instabbiltà vażomotorili, disturbi fil-vista, konfużjoni, psikożi u apnea.
English: CVVHF/ CVVHDF As in patients with normal renal function.
Maltese: CVVHF/ CVVHDF
English: Based on limited data, the following dose is recommended in adults:
Maltese: Abbażi ta' dejta limitata, hija rrakkomandata d-doża li ġejja fl-adulti:
English: The usual dose for children less than 2 years old is 0.5-1 million units twice daily (maximum 2 million units per day).
Maltese: Id-doża tas-soltu għat-tfal li għandhom inqas minn sentejn hija ta' 0.5-1 miljun unità darbtejn kuljum (massimu ta' 2 miljun unità kuljum).
English: [Product name] is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options (see sections 4.2, 4.4, 4.8 and 5.1).
Maltese: [Isem tal-prodott] huwa indikat f'adulti u tfal inkluż trabi tat-twelid għall-kura ta' infezzjonijiet serji minħabba patoġeni ajrobiċi magħżula Gram-negattivi f'pazjenti b'għażliet ta' kura limitati (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.1).
English: Respiratory arrest has been reported following intramuscular administration of colistimethate sodium.
Maltese: Ġie rrapportat arrest respiratorju wara għoti ġol-muskolu ta' colistimethate sodium.
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: Il-kura flimkien ma' colistimethate sodium u makrolidi bħal azithromycin u clarithromycin, jew fluoroquinolones bħal norfloxacin u ciprofloxacin għandha titwettaq b'kawtela f'pazjenti b'myasthenia gravis (ara sezzjoni 4.4).
English: The usual dose for adults, adolescents and children aged 2 years or older is 1-2 million units two to three times per day (maximum 6 million units per day).
Maltese: Id-doża tas-soltu għall-adulti, l-adolexxenti u t-tfal li għandhom sentejn jew aktar hija ta' 1-2 miljun unità darbtejn sa tliet darbiet kuljum (massimu ta' 6 miljun unità kuljum).
English: Haemodialysis
Maltese: Emodijaliżi
English: There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium.
Maltese: Hemm dejta klinikament limitata dwar l-effikaċja u s-sigurtà ta' colistimethate sodium ġol-vini.
English: IU
Maltese: a
English: The mechanism of conversion of colistimethate sodium to the active substance, colistin, is not characterised.
Maltese: Il-mekkaniżmu ta' konverżjoni ta' colistimethate sodium għas-sustanza attiva, colistin, mhuwiex ikkaratterizzat.
English: Dose adjustment is not considered necessary, however caution is advised in patients with renal impairment (see sections 4.4 and 5.2).
Maltese: Aġġustament fid-doża mhuwiex meqjus meħtieġ, madankollu hija rakkomandata kawtela f'pazjenti b'indeboliment renali (ara sezzjonijiet 4.4 u 5.2).
English: The usual daily dose in children weighing up to 40 kg is 75.000 to 150.000 units per kilogram body weight, divided into three doses.
Maltese: Id-doża ta' kuljum tas-soltu fit-tfal li jiżnu sa 40 kg hija ta' 75.000 sa 150.
English: Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
Maltese: Il-polymyxins huma selettivi għal batterji ajrobiċi Gram-negattivi li għandhom il membrana ta' barra idrofobika.
English: Maintenance dose 9MIU/day in 2-3 divided doses
Maltese: Doża ta' manteniment 9 MIU/jum f'2-3 dożi maqsumin.
English: Burkholderia cepacia and related species Proteus spp
Maltese: Organiżmi intrinsikament reżistenti Burkholderia cepacia u speċijiet relatati
English: Section 4.1 Therapeutic indication
Maltese: Sezzjoni 4.1 Indikazzjonijiet terapewtiċi
English: 5.5-7.5 MIU
Maltese: Doża ta' kuljum 5.5-7.5
English: Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin (see sections 4.5 and 4.8).
Maltese: Il-pazjenti li huma ipovolemiċi jew dawk li jirċievu mediċini potenzjalment nefrotossiċi oħrajn huma f'riskju miżjud ta' nefrotossiċita minn colistin (ara sezzjonijiet 4.5 u 4.8).
English: Dose reductions are recommended for patients with creatinine clearance < 50 ml/min: Twice daily dosing is recommended.
Maltese: Huwa rrakkomandat tnaqqis fid-doża għal pazjenti bi tneħħija tal-kreatinina < 50 ml/min: Huwa rrakkomandat dożaġġ ta' darbtejn kuljum.
English: - If you suffer from myasthenia gravis - If you suffer from porphyria
Maltese: - Jekk tbati minn myasthenia gravis - Jekk tbati minn porfirja
English: Commonly susceptible species Acinetobacter baumannii
Maltese: Acinetobacter baumannii Haemophilus influenzae Klebsiella spp Pseudomonas aeruginosa
English: [Product name] is administered intravenously as a slow infusion over 30 - 60 minutes.
Maltese: Metodu ta' kif għandu jingħata [Isem tal-prodott] jingħata ġol-vina bħala infużjoni bil-mod għal 30 - 60 minuta.
English: There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy.
Maltese: Hemm dejta estremament limitata mill-istudji PK talpopolazzjoni minn numru żgħir ħafna ta' pazjenti fuq terapija ta' sostituzzjoni renali.
English: Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group.
Maltese: Colistin huwa aġent antibatteriku li huwa polipeptid ċikliku li jagħmel parti mill-grupp ta' polymyxins.
English: R>4 mg/L a Breakpoints apply to dosage of 2-3 MIU x 3.
Maltese: a Breakpoints japplikaw għad-dożaġġ ta' 2-3 MIU x 3. Jaf tkun meħtieġa doża ta' introduzzjoni (9 MIU).
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Maltese: Batterji reżistenti huma kkaratterizzati minn modifika tal-gruppi tal-fosfati ta' lipopolysaccharide, li jiġu sostitwiti minn etanolamini jew aminoarabinose.
English: The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity (mg CBA).
Maltese: Id-doża hija mfissra fl-Istati Uniti, u partijiet oħrajn tad-dinja, bħala milligrammi ta' attività ta' bażi ta' colistin (mg CBA).
English: If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking [Product name] further increases the risk of muscle weakness and breathing difficulties.
Maltese: Jekk tbati minn myasthenia gravis u qed tieħu wkoll antibijotiċi oħra msejħa makrolidi (bħal azithromycin, clarithromycin jew erythromycin) jew antibijotiċi msejħa fluoroquinolones (bħal ofloxacin, norfloxacin u ciprofloxacin), it-teħid ta' [Isem tal-prodott] ikompli jżid ir-riskju ta' dgħjufija fil-muskoli u diffikultajiet fin-nifs.
English: The most commonly observed adverse effect of CMS administration was aseptic meningitis (see section 4.8).
Maltese: L-effett avvers l-aktar komuni osservat ta' għoti ta' CMS kien meninġite asettika (ara sezzjoni 4.8).
English: Confusion and medication errors have occurred because of the different expressions of dose in terms of potency.
Maltese: Kien hemm konfużjoni u żbalji fil-medikazzjoni minħabba l-espressjonijiet differenti tad-doża f'termini ta' potenza.
English: Both CMS and colistin display linear PK in the clinically relevant dose range.
Maltese: Kemm is-CMS kif ukoll colistin juru PK lineari fil-firxa ta' doża klinikament rilevanti.
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium.
Maltese: Ġew irrapportati colitis u pseudomembranous colitis assoċjati mal-antibijotiċi bi kważi kull sustanza kontra l-batterji u dawn jistgħu jseħħu b'colistimethate sodium.
English: The dose is expressed in international units (IU) of colistimethate sodium (CMS).
Maltese: Id-doża hija mfissra f'unitajiet internazzjonali (IU) ta' colistimethate sodium (CMS).
English: After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin.
Maltese: Wara l-infużjoni ta' colistimethate sodium, il-pro-mediċina inattiva tiġa kkonvertita f'colistin attiv.
English: For special precautions for disposal and handling of reconstituted solutions, see section 6.6.
Maltese: Għal prekawzjonijiet speċjali għar-rimi u l-immaniġġar ta' soluzzjonijiet rikostitwiti, ara sezzjoni 6.6.
English: - medicines which can affect your nervous system.
Maltese: - mediċini li jistgħu jaffettwaw is-sistema nervuża.
English: In the absence of meningeal inflammation, penetration into the cerebrospinal fluid (CSF) is minimal, but increases in the presence of meningeal inflammation.
Maltese: Fin nuqqas ta' infjammazzjoni meninġeali, il-penetrazzjoni fil-fluwidu ċerebrospinali (CSF) hija minima, iżda tiżdied fil-preżenza ta' infjammazzjoni meninġeali.
English: Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS.
Maltese: It-tneħħija ta' colistin tonqos f'indeboliment renali, possibbilment minħabba żieda fil-konverżjoni ta' CMS.
English: Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered.
Maltese: Għandu jiġi kkunsidrat it-twaqqif tat-terapija u l-għoti ta' kura speċifika għal Clostridium difficile.
English: The recommended doses in all subpopulations are equally based on limited data (clinical and pharmacokinetic/ pharmacodynamics data).
Maltese: Id-dożi rakkomandati fis-sottopopolazzjonijiet huma bbażati bl-istess mod fuq dejta limitata (dejta klinika u farmakokinetika/ farmakodinamika).
English: Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution.
Maltese: Colistimethate sodium jgħaddi minn idroliżi għas-sustanza attiva colistin f'soluzzjoni akweja.
English: Posology
Maltese: Pożoloġija
English: Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen(s) under treatment.
Maltese: Għandha tingħata konsiderazzjoni biex colistimethate sodium jingħata flimkien ma' sustanza antibatterjali oħra kull meta dan ikun possibbli, filwaqt li jitqiesu s-suxxettibbiltajiet li jifdal tal-patoġen(i) ikkurat(i).
English: The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity.
Maltese: Il-benefiċċju ta' perjodu ta' kura fit-tul għandu jiġi bbilanċjat mar-riskju potenzjali miżjud tat-tossiċità renali.
English: Taking such medicines at the same time as [Product name] can increase the risk of damage to the kidneys - medicines which can affect your nervous system.
Maltese: It-teħid ta' tali mediċini fl-istess ħin ma' [Isem tal prodott] jista' jżid ir-riskju ta' effetti fis-sistema nervuża tiegħek
English: Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
Maltese: Colistin jgħaddi minn reassorbiment tubulari renali estensiv u jista' jew jitneħħa mhux mill-fwied jew jgħaddi minn metaboliżmu renali bil potenzjal għal akkumulazzjoni renali.
English: No in vivo interaction studies have been performed.
Maltese: Ma twettaq ebda studju ta' interazzjoni in vivo.
English: If you are quite unwell, you will be given a higher dose of 9 million units once at the start of treatment.
Maltese: Id-doża ta' kuljum tas-soltu fl-adulti hija ta' 9 miljun unità, maqsuma f'żewġ jew tliet dożi.
English: In healthy subjects, 60% to 70% of CMS is excreted unchanged in the urine within 24 hours.
Maltese: F'individwi b'saħħithom, bejn 60% u 70 % ta' CMS jitneħħa kif inhu fl-awrina fi żmien 24 siegħa.
English: Note: The following intrathecal and intraventricular administration posology recommendations should be included in the SmPC as the current pharmaceutical formulation of all products included in this procedure is suitable for these routes of administration (based on the pH, absence of preservatives and antioxidant and volume for injection).
Maltese: Nota: Ir-rakkomandazzjonijiet tal-pożoloġija li ġejjin għall-għoti ġot-teka u intraventrikulari għandhom jiġu inklużi fl-SmPC peress li l-formulazzjoni farmaċewtika attwali tal-prodotti kollha inklużi f'din ilproċedura hija adatta għal dawn il-metodi ta' għoti (abbażi tal-pH, nuqqas ta' preservattivi u antiossidanti u l-volum għall-injezzjoni).
English: The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.
Maltese: Id-doża ta' introduzzjoni tapplika għal pazjenti b'funzjonijiet renali normali jew b'indeboliment tagħhom inkluż dawk fuq terapija ta' sostituzzjoni renali.
English: The use of intrathecal or intraventricular administration of colistimethate sodium in the treatment of meningitis was not systematically investigated in clinical trials and is supported by case reports only.
Maltese: L-użu ta' għoti ġot-teka jew intraventrikulari ta' colistimethate sodium fil-kura ta' meninġite ma kienx investigat sistematikament fi provi kliniċi u huwa appoġġjat minn rapporti ta' każijiet biss.
English: Further, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known.
Maltese: Barra minn hekk, l-effett ta' funzjoni renali u metabolika immatura fuq il-konverżjoni ta' colistimethate sodium għal colistin mhuwiex magħruf.
English: A conversion table from CMS in IU to mg of CMS as well as to mg of colistin base activity (CBA) is included at the end of this section.
Maltese: Fi tmiem din is sezzjoni hemm inkluża tabella ta' konverżjoni minn CMS f'IU għal mg ta' CMS kif ukoll għal mg tal attività ta' bażi ta' colistin (CBA).
English: Impaired renal function increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium.
Maltese: Indeboliment talfunzjoni renali jżid il-possibbiltà ta' apnea u imblokk newromuskolari wara l-għoti ta' colistimethate sodium.
English: Do not <take><use> [Product name] - If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Maltese: <Tiħux><tużax> [Isem tal-prodott] - Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal colistimethate sodium, colistin jew għal polymyxins oħra.
English: There are no data in patients with hepatic impairment.
Maltese: M'hemm ebda dejta dwar pazjenti b'indeboliment epatiku.
English: [Product name] is used when these infections are cause by specific bacteria called Pseudomonas aeruginosa.
Maltese: [Isem tal-prodott] jista' jżid l-effetti ta' dawn il-mediċini.
English: The dose of colistimethate sodium should be adjusted according to creatinine clearance (see section 4.2).
Maltese: Id-doża ta' colistimethate sodium għandha tiġi aġġustata skont it-tneħħija tal-kreatinina (ara sezzjoni 4.2).
English: Data supporting the posology are very limited.
Maltese: Dejta li tappoġġja l-pożoloġija hija limitata ħafna.
English: Older people No dose adjustments in older patients with normal renal function are considered necessary.
Maltese: Persuni anzjani Ma huwa meħtieġ ebda aġġustament f'pazjenti anzjani b'funzjoni renali normali.
English: HD days: 3 MIU/day on haemodialysis days, to be given after the HD session.
Maltese: Jiem b'HD: 3 MIU/jum f'jiem b'emodijaliżi, li għandu jingħata wara s-sessjoni ta' HD.
English: The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid (ECF).
Maltese: Il-volum ta' distribuzzjoni ta' colistin f'individwi b'saħħithom huwa baxx u jikkorrispondi bejn wieħed u ieħor għall-fluwidu extra-ċellulari (ECF).
English: There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from those in healthy volunteers.
Maltese: Hemm indikazzjonijiet li l-farmakokinetika f'pazjenti morda sew hija differenti minn dik f'pazjenti b'disordni fiżjoloġika inqas severa u minn dik f'voluntiera b'saħħithom.
English: Colistimethate sodium is known to reduce the presynaptic release of acetyl-choline at the neuromuscular junction and should be used in patients with myasthenia gravis with the greatest caution and only if clearly needed.
Maltese: Colistimethate sodium huwa magħruf li jnaqqas ir-rilaxx presinattiku ta' acetyl-choline fil-konġunġiment newromuskolari u għandu jintuża f'pazjenti b'myasthenia gravis bl-akbar kawtela u jekk ikun meħtieġ b'mod ċar biss.
English: The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4):
Maltese: Pożoloġija Ir-rakkomandazzjonijiet li ġejjin dwar id-dożi huma bbażati fuq dejta farmakokinetika limitata tal popolazzjoni f'pazjenti morda b'mod kritiku (ara sezzjoni 4.4):
English: In the EU, the dose of colistimethate sodium (CMS) must be prescribed and administered only as International Units (IU).
Maltese: Fl-UE, id-doża ta' colistimethate sodium (CMS) għandha tiġi preskritta u tingħata biss bħala Unitajiet
English: Adults, adolescents and children ≥ 2 years 1-2 MIU two to three times per day (max 6 MIU/day)
Maltese: 1-2 MIU darbtejn sa tliet darbiet kuljum (massimu 6
English: Section 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Children < 2 years 0.5-1 MIU twice daily (max 2 MIU/ day)
Maltese: MIU darbtejn kuljum (massimu 2 MIU/jum)
English: Half-life of colistin in healthy subjects and those with cystic fibrosis is reported to be around 3h and 4h, respectively, with a total clearance of around 3L/h.
Maltese: Il-half-life ta' colistin f'individwi b'saħħithom u dawk b'fibrożi ċistika hija rrapportata li hija madwar 3 sigħat u 4 sigħat, rispettivament, bi tneħħija totali ta' madwar 3 L/siegħa.
English: Higher doses have occasionally been given in cystic fibrosis.
Maltese: IU/kg/jum ġie rrapportat fi tfal b'fibrożi ċistika.
English: Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited.
Maltese: Huma meħtieġa aġġustamenti fid-doża f'indeboliment renali, iżda d-dejta farmakokinetika disponibbli b'indeboliment tal-funzjoni renali hija limitata ħafna.
English: *Tachycardia.
Maltese: *Takikardija.
English: They normally recede upon therapy discontinuation.
Maltese: Dawn normalment jitilqu meta titwaqqaf it-terapija.
English: Tocolysis
Maltese: Tokolożi
English: *Hypotension (see section 4.4) *Peripheral vasodilatation.
Maltese: *Pressjoni baxxa (ara sezzjoni 4.4) *Vażodilazzjoni periferali.
English: *Cardiac arrhythmias, e.g. atrial fibrillation, Myocardial ischaemia (see section 4.4)
Maltese: *Arritmiji tal-qalb, eż. fibrillazzjoni atrijali, iskemija mijokardijaka (ara sezzjoni 4.4)
English: Pulmonary oedema
Maltese: Edema pulmonari
English: Falls in diastolic pressure are usually within the range of 10 to 20mmHg.
Maltese: Tnaqqis fil-pressjoni dijastolika normalment ikun filmedda ta' 10 sa 20mmHg.
English: A. Oral formulation medicinal products and suppositories
Maltese: Prodotti mediċinali ta' formolazzjoni orali u suppożitorji
English: Metabolism and nutrition disorders Common - *Hypokalaemia Rare - *Hyperglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni - *Ipokalimja
English: A controlled infusion device should be used, preferably a syringe pump.
Maltese: Għandu jintuża mezz tal-infużjoni kkontrollat, preferibbilment pompa tassiringa.
English: B. Parenteral medicinal products for obstetric indications
Maltese: B. Prodotti mediċinali parenterali għal indikazzjonijiet ostetriċi
English: Increases in maternal heart rate of the order of 20 to 50 beats per minute usually accompany infusion of beta-agonists.
Maltese: Żidiet fir-rata tal-qalb tal-omm ta' bejn l-20 u l-50 taħbita fil-minuta normalment jakkumpanjaw linfużjoni ta' agonisti beta.
English: Important side effects to look out for when treated for premature labour:
Maltese: Effetti sekondarji importanti li għandek toqgħod attent għalihom meta tirċievi kura għal ħlas prematur: