FrancophonIA/ELRC3.0 huggingface dataset:
English: Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with nondystrophic myotonic disorders.
Maltese: Namuscla huwa indikat għal trattament sintomatiku ta' mijotonija f'pazjenti adulti b'disturbi mijotoniċi mhux distrofiċi.
English: Before starting mexiletine treatment, detailed and careful cardiac evaluation should be carried out; throughout treatment with mexiletine, cardiac monitoring needs to be continued and adapted as a function of the heart condition of the patient (see contraindications in section 4.3 and warning in section 4.4).
Maltese: Qabel ma jinbeda t-trattament b'mexiletine, għandha ssir evalwazzjoni kardijaka dettaljata u b'attenzjoni; matul it-trattament kollu b'mexiletine, jeħtieġ li l-monitoraġġ kardijaku jitkompla u jkun adattat bħala funzjoni tal-kundizzjoni tal-qalb tal-pazjent (ara lkontraindikazzjonijiet f'sezzjoni 4.3 u t-twissija f'sezzjoni 4.4).
English: • Atrial tachyarrhythmia, fibrillation or flutter
Maltese: • Takiarritmija atrijali, fibrillazzjoni jew taħbit irregolari tal-qalb
English: Co-administration of mexiletine and other classes of antiarrhythmics (class Ib: lidocaine, phenytoin, tocainide; class II: propranolol, esmolol, timolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol; class IV: verapamil, diltiazem) is not recommended, unless exceptionally, because of the increased risk of adverse cardiac reactions (see section 4.4).
Maltese: II: propranolol, esmolol, timolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol; klassi IV: verapamil, diltiazem) mhux rakkomandat, sakemm mhux f'każijiet eċċezzjonali, minħabba r-riskju akbar ta' reazzjonijiet kardijaċi avversi (ara sezzjoni 4.4).
English: Clinical Global Impression (CGI) Efficacy index Number of subjects
Maltese: Indiċi tal-Effikaċja tal-Impressjoni Globali Klinika (CGI, Clinical Global Impression)
English: Very common and common adverse reactions are derived from data from the MYOMEX study; less common adverse effects are derived from post-marketing data.
Maltese: Reazzjonijiet avversi komuni ħafna u komuni jinkisbu minn dejta tal-istudju dwar MYOMEX; effetti avversi anqas komuni jinkisbu minn dejta ta' wara t-tqegħid fis-suq.
English: 1 Clinical Study Report refers to 200 mg dose which is the amount of mexiletine hydrochloride (corresponding to 166.62mg mexiletine base)
Maltese: 1 Ir-Rapport tal-Istudju Kliniku jirreferi għal doża ta' 200 mg li hija l-ammont ta' mexiletine hydrochloride (li jikkorrispondi għal 166.
English: Prior to launch of Namuscla in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Maltese: Qabel it-tnedija ta' Namuscla f'kull Stat Membru (MS, Member State), id-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorisation Holder) irid jaqbel dwar il kontenut u l-format tal-programm edukattiv, li jinkludi media tal-komunikazzjoni, modalitajiet ta'distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali (NCA, National Competent Authority).
English: Before starting mexiletine treatment, detailed and careful cardiac evaluation (ECG, 24-48-hour Holtermonitoring and echocardiography) should be carried out in all patients in order to determine the cardiac tolerability of mexiletine.
Maltese: Qabel ma jinbeda t-trattament b'mexiletine, għandha ssir evalwazzjoni kardijaka dettaljata u b'attenzjoni (ECG, 24-48 siegħa monitoraġġ tat-tip Holter u ekokardjografija) fil-pazjenti kollha sabiex tkun iddeterminata t-tollerabilità kardijaka ta' mexiletine.
English: • Before starting treatment, HCPs should perform a detailed and careful cardiac evaluation in all patients, in order to determine the cardiac tolerability of Namuscla.
Maltese: • Qabel ma jinbeda t-trattament, l-HCPs għandhom jagħmlu evalwazzjoni kardijaka dettaljata u b'attenzjoni, sabiex jiddeterminaw it-tollerabbiltà kardijaka ta' Namuscla.
English: Not known: leukopenia, thrombocytopenia Immune system disorders
Maltese: Mhux magħruf: lewkopenija, tromboċitopenija
English: In order to prevent and / or minimise the important identified risks of Cardiac Arrhythmia in patients with Dystrophic Myotonia (off-label use) and Decreased Namuscla clearance, thus the risk of adverse reactions in patients with hepatic impairment, the MAH shall ensure that in each MS where Namuscla is marketed, all healthcare professionals (HCPs) and patients are provided, respectively, with:
Maltese: Sabiex jiġu pprevenuti u/jew minimizzati r-riskji identifikati importanti ta' Arritmija Kardijaka f'pazjenti b'Mijotonija Distrofika (użu mingħajr approvazzjoni) u tneħħija mnaqqsa ta' Namuscla, u għalhekk ir-riskju ta' reazzjonijiet avversi f'pazjenti b'indeboliment tal-fwied, l-MAH għandu jiżgura li f'kull MS fejn Namuscla qiegħed fis-suq, il-professjonisti tal-kura tas-saħħa (HCPs, healthcare professionals) u l-pazjenti kollha jiġu pprovduti, rispettivament, bi:
English: Patients who are CYP2D6 poor metabolisers may exhibit higher mexiletine blood levels (see section 5.2).
Maltese: Il-pazjenti li huma metabolizzaturi batuti ta' CYP2D6 jistgħu juru livelli ogħla ta' mexiletine fiddemm (ara sezzjoni 5.2).
English: Examples of such medicines are digoxin (for heart problems), lithium (mood stabiliser), phenytoin (for treating epilepsy), theophylline (against asthma) and warfarin (against blood clots).
Maltese: Eżempji ta' mediċini bħal dawn huma digoxin (għal problemi tal-qalb), lithium (jistabilizza l-burdati), phenytoin (għat-trattament tal-epilessija), theophylline (kontra l-ażżma) u warfarina (kontra l-emboli fid-demm).
English: A cardiac evaluation is also recommended shortly after starting Namuscla (e.g. within 48 hours).
Maltese: Hija rakkomandata wkoll evalwazzjoni kardijaka ftit wara li jinbeda Namuscla (eż. fi żmien 48 siegħa).
English: DRESS refers to a syndrome which includes in its complete form severe cutaneous eruptions, fever, lymphadenopathy, hepatitis, haematological abnormalities with eosinophilia and atypical lymphocytes, and can involve other organs.
Maltese: DRESS tirreferi għal sindrome li jinkludi fil-forma sħiħa tiegħu nfafet kutaneji severi, deni, limfadenopatija, epatite, anormalitajiet ematoliġiċi b'eosinofilija u limfoċiti atipiċi, u jista' jinvolvi organi oħra.
English: Median VAS absolute change from baseline Percentage of Patients with an Absolute VAS Change from Baseline ≥ 50 mm at Day 18 Effect of treatment (Mixed Effect Linear Model)
Maltese: Il-Perċentwali ta' Pazjenti b'VAS Assoluta Bidla mil-Linja Bazi ≥ 50 mm f'Jum 18
English: After at least 1 week of treatment, based on the clinical response, the daily dose can be increased to 333 mg daily (2 capsules per day).
Maltese: Wara millinqas ġimgħa ta' trattament, abbażi tar-rispons kliniku, id-doża ta' kuljum tista' tiżdied għal 333 mg kuljum (2 kapsuli kuljum).
English: Symptoms typically occur 1-8 weeks after exposure to the medicinal product.
Maltese: Is-sintomi jseħħu tipikament 1-8 ġimgħat wara l-esponiment għall-prodott mediċinali.
English: Mexiletine is rapidly distributed in the body; its volume of distribution is large and varies from 5 to 9 L/kg in healthy individuals.
Maltese: Mexiletine jiġi ddistribwit b'mod mgħaġġel fil-ġisem, il-volum ta' distribuzzjoni tiegħu huwa kbir u jvarja bejn 5 għal 9 L/kg f'individwi b'saħħithom.
English: - Pulmonary fibrosis (disease of the lung) - Diarrhoea - Vomiting - Injury of the oesophagus (food pipe)
Maltese: - Konvulżjonijiet (puplesiji) - Problemi fid-diskors - Taħbit tal-qalb bil-mod
English: Musculoskeletal and connective tissue disorders Common: pain in the extremities
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni: uġigħ fl-estremitajiet
English: Smoking and Namuscla
Maltese: X'fih Namuscla
English: A period of at least 7 days before dose increase must be respected to ensure that steady-state levels are reached, irrespective of the patient's CYP450 polymorphism.
Maltese: Għandu jiġi rrispettat perjodu ta' titrazzjoni ta' mill-inqas 7 ijiem qabel ma tiżdied id-doża sabiex wieħed ikun ċert li jintlaħqu l-livelli ta' stat fiss, irrispettivament millpolimorfiżmu f'CYP450 tal-pazjent.
English: The symptoms of mexiletine overdose include neurological disorders (paresthesia, confusion, hallucination, seizure) and cardiac disorders (sinusal bradycardia, hypotension, collapse, and in extreme cases, cardiac arrest).
Maltese: Is-sintomi ta' doża eċċessiva b'mexiletine jinkludu disturbi newroloġiċi (parestesija, konfużjoni, alluċinazzjoni, puplesija) u disturbi fil-qalb (bradikardija tas-sinus, pressjoni baxxa, kollass, u f'każijiet estremi, waqfien kardijaku)
English: In a clinical study, 51% of the mexiletine dose was excreted via the kidney at a urinary pH of 5, compared to 10% at normal pH. Changes in urinary pH are not expected to affect efficacy or safety.
Maltese: Fi studju kliniku, 51% tad-doża ta' mexiletine ġiet imneħħija permezz tal-kliewi b'pH tal-awrina ta' 5, meta mqabbla mal-10% b'pH normali.
English: Effect of other medicinal products on mexiletine
Maltese: L-effett ta' prodotti mediċinali oħrajn fuq mexiletine
English: Therefore, clinical and ECG monitoring, as well as adaptation of mexiletine dosage may be indicated throughout and after treatment with a CYP1A2 or CYP2D6 inhibitor.
Maltese: Għalhekk, il-monitoraġġ kliniku u bl-ECG, kif ukoll l-adattament tad-dożaġġ ta' mexiletine jista' jkun indikat matul u wara it-trattament b'inibitur ta' CYP1A2 jew CYP2D6.
English: The concomitant use of mexiletine and antiarrhythmic medicines inducing torsades de pointes is contraindicated (see section 4.3).
Maltese: L-użu fl-istess ħin ta' mexiletine u mediċini antiarritmiċi li jinduċu torsades de pointes huwa kontraindikat (ara sezzjoni 4.3).
English: Limited clinical data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta and reaches the foetus.
Maltese: Dejta klinika limitata dwar l-użu ta' mexiletine f'nisa tqal turi li mexiletine jaqsam il-plaċenta u jilħaq il-fetu.
English: You may take Namuscla during a meal to avoid belly pain (see section “Possible side effects”).
Maltese: Tista' tieħu Namuscla waqt l-ikel biex tevita wġigħ fiż-żaqq (ara sezzjoni “Effetti sekondarji possibbli”).
English: - Transient confusion (a temporary inability to think clearly or concentrate) - Double vision - Altered sense of taste - Disorders of heart rhythm - Collapse - Hot flushes
Maltese: - Konfużjoni temporanja (inabilità temporanja li taħseb b'mod ċar jew li tikkonċentra) - Vista doppja - Sens tat-togħma mibdul - Disturbi tar-ritmu tal-qalb - Kollass - Fwawar ta' sħana - Fibrożi fil-pulmun (marda tal-pulmun) - Dijarea - Rimettar
English: Mexiletine is a substrate for the metabolic pathways involving hepatic enzymes; inhibition or induction of these enzymes is expected to alter mexiletine plasma concentrations.
Maltese: Mexiletine huwa substrat għall-passaġġi metaboliċi li jinvolvu enzimi tal-fwied; l-inibizzjoni jew linduzzjoni ta' dawn l-enzimi hija mistennija li tibdel il-konċentrazzjonijiet ta' mexiletine fil-plażma.
English: Median VAS value at Baseline Median VAS value at Day 18
Maltese: Valur medjan f'Jum 18
English: • Co-administration with medicinal products with narrow therapeutic index (see section 4.5).
Maltese: • L-għoti flimkien ma' prodotti mediċinali b'indiċi terapewtiku dejjaq (ara sezzjoni 4.5).
English: An appropriate adjustment in the dose of the CYP1A2 substrate should be considered.
Maltese: Wieħed għandu jikkunsidra aġġustament xieraq fid-doża tas-substrat ta' CYP1A2.
English: Common: nausea
Maltese: Komuni: ngħas
English: Do not take more than 3 capsules a day.
Maltese: M'għandekx tieħu aktar minn 3 kapsuli kuljum.
English: The Educational guide for HCPs, which should always be read in conjunction with the Summary of Product Characteristics (SmPC) before prescribing Namuscla, should contain the following key elements:
Maltese: Il-Gwida edukattiva għall-HCPs, li dejjem għandha tinqara flimkien mas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) qabel jiġi preskritt Namuscla, għandha tinkludi l-elementi ewlenin li ġejjin:
English: In case of seizure, benzodiazepines should be used.
Maltese: F'każ ta' puplesija, għandhom jintużaw il-benzodiazepines.
English: • Information about symptoms of cardiac arrhythmias, which can be life-threatening, and when patients should seek HCP attention;
Maltese: • Informazzjoni dwar is-sintomi ta' arritmiji kardijaċi, li jistgħu jkunu ta' theddida għall-ħajja, u meta l-pazjenti għandhom ifittxu l-attenzjoni ta' HCP;
English: Mexiletine is excreted in human milk.
Maltese: Mexiletine hu eliminat fil-ћalib tas-sider tal-bniedem.
English: Mexiletine is rapidly and almost completely absorbed following oral administration with a bioavailability of about 90% in healthy subjects.
Maltese: Mexiletine jiġi assorbit malajr u kważi kompletament wara l-għoti orali b'bijodisponibbiltà ta' madwar 90% f'individwi b'saħħithom.
English: How to store Namuscla
Maltese: • Matul it-trattament b'Namuscla:
English: • Highlight the risk of decreased Namuscla clearance in patients with hepatic impairment and provide guidance on how to treat those patients in order to prevent it, ensuring Namuscla cautious titration in patients with mild or moderate hepatic impairment (increasing the dose after at least 2 weeks of treatment).
Maltese: • Jiġi enfasizzat ir-riskju ta' tnaqqis fit-tneħħija ta' Namuscla f'pazjenti b'indeboliment tal-fwied u tiġi pprovduta gwida dwar kif għandhom jiġu ttrattati dawk il-pazjenti sabiex dan jiġi pprevenut, u tiġi żgurata titrazzjoni b'attenzjoni ta' Namuscla f'pazjenti b'indeboliment talfwied ħafif jew moderat (żieda fid-doża wara tal-inqas ġimagħtejn ta' trattament).
English: The negative genotoxicity potential does not indicate an increased carcinogenic risk of treatment with mexiletine.
Maltese: Il-potenzjal negattiv ta' effett tossiku fuq il-ġeni ma jindikax riskju ta' kanċer miżjud tat-trattament b'mexiletine.
English: • Guidance to identify (and exclude) patients at a greater risk of developing arrhythmias due to Namuscla treatment;
Maltese: • Gwida biex jiġu identifikati (u esklużi) pazjenti f'riskju akbar li jiżviluppaw arritmiji minħabba t-trattament b'Namuscla;
English: Not known (frequency cannot be estimated from the available data): - Decrease in white blood cells or in platelets - Lupus syndrome (disease of the immune system) - Redness and peeling of the skin - Stevens-Johnson syndrome: a severe allergic reaction with skin rashes, often in the form of blisters and sores in the mouth and eyes, and other mucous membranes - Blisters of the skin, malaise and fever in the context of a condition called DRESS - Hallucinations (seeing or hearing something that is not present).
Maltese: - Tnaqqis fl-għadd taċ-ċelluli tad-demm bojod jew fil-plejtlits - Sindrome li jixbah lil dak tal-lupus (marda tas-sistema immuni) - Tiħmar jew titqaxxar il-ġilda - Is-sindrome ta' Stevens-Johnson: reazzjoni allerġika severa b'raxxijiet tal-ġilda, ħafna drabi fil forma ta' nfafet jew feriti fil-ħalq jew fl-għajnejn, u membrani mukużi oħra
English: A period of at least 7 days before dose increase must be respected to ensure that steady-state levels are reached and that mexiletine is well tolerated in all patients, irrespective of CYP450 polymorphism.
Maltese: Għandu jiġi rrispettat perjodu ta' mill-inqas 7 ijiem qabel ma tiżdied id-doża sabiex wieħed ikun ċert li jintlaħqu l-livelli ta' stat fiss u li mexiletine jkun ittollerat sew fil-pazjenti kollha, irrispettivament mill-polimorfiżmu f'CYP450.
English: The experience with mexiletine in patients with severe hepatic impairment is limited.
Maltese: L-esperjenza b'mexiletine f'pazjenti b'indeboliment sever tal-kliewi hija limitata.
English: Weight In population pharmacokinetic analyses, weight was found to influence mexiletine pharmacokinetics.
Maltese: Fl-analiżijiet farmakokinetiċi tal-popolazzjoni, instab li l-piż tal-ġisem jinfluwenza ilfarmakonkientika ta' mexiletine.
English: See section “Warnings and precautions”.
Maltese: Ara s-sezzjoni “Twissijiet u prekawzjonijiet”.
English: In case of modification of the mexiletine dose, or if medicinal products susceptible to affect cardiac conduction are co-administered with mexiletine, patients should be closely monitored by ECG (especially patients with conduction anomalies) (see sections 4.3 and 4.4).
Maltese: F'każ ta' modifika fid-doża ta' mexiletine, jew jekk prodotti mediċinali suxxettibbli li jaffettwaw ilkonduzzjoni tal-qalb jingħataw flimkien ma' mexiletine, il-pazjenti għandhom ikunu mmonitorjati mill-qrib bl-ECG (ECG, electrocardiogram) (speċjalment pazjenti b'anomaliji tal-konduzzjoni talqalb) (ara sezzjonijiet 4.3 u 4.4).
English: EUCAST Clinical MIC Breakpoints for Piperacillin / Tazobactam (2009-12-02, v 1).
Maltese: EUCAST Breakpoints MIC Kliniċi għal Piperacillin / Tazobactam (2009-12-02, v 1).
English: See section 6.2 for incompatibilities.
Maltese: Ara sezzjoni 6.2 għal inkompatibilitajiet.
English: Adult and adolescent patients
Maltese: Pazjenti adulti u adolexxenti
English: Species-related breakpoints (S≤/R>)
Maltese: Breakpoints relatati ma' speċi (S≤/R>)
English: Complicated intra-abdominal infections*
Maltese: Infezzjonijiet ikkumplikati intra-addominali*
English: For reconstitution instructions, see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni, ara sezzjoni 6.6.
English: In this leaflet:
Maltese: Kunjetti mhux miftuħa:
English: Dextran 6% in 0.9% sodium chloride
Maltese: Dextran 6% f'0.9% sodium chloride
English: Tazocin (recommended dose)
Maltese: Tazocin (doża rakkomandata)
English: Aminoglycoside TAZOCIN Dose
Maltese: Aminoglycoside TAZOCIN doża
English: Mycoplasma pneumonia $ Species showing natural intermediate susceptibility.
Maltese: Mycoplasma pneumonia $ Speċi li juru suxxettibbilità naturali intermedja.
English: 0.9% sodium chloride or 5% glucose
Maltese: 0.9% sodium chloride jew 5% glucose
English: Infections and infestations candidal superinfection
Maltese: Infezzjonijiet u infestazzjonijiet superinfezzjoni candidali
English: Aminoglycoside concentration range* (mg/ml)
Maltese: Aminoglycoside medda ta' konċentrazzjoni* (mg/ml)
English: Streptococcus pneumonia Streptococcus viridans group Aerobic Gram-negative micro-organisms Acinetobacter baumannii$
Maltese: Streptococcus pneumonia Grupp Streptococcus viridans Mikroorganiżmi aerobiċi Gram-negattivi Acinetobacter baumannii$
English: Peptostreptococcus species
Maltese: Speċi Peptostreptococcus
English: Packs containing 1, 5, 10, 12 or 25 vials.
Maltese: Pakketti li jkun fihom 1, 5, 10, 12 jew 25 kunjett.
English: Porphyromonas species
Maltese: Speċi Porphyromonas
English: Eubacterium species
Maltese: Speċi Eubacterium
English: Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported.
Maltese: Kienu rrappurtati reazzjonijiet inkroċjati ma' non-Aspergillus polysaccharides u polyfuranoses bil-Bio-Rad Laboratories Platelia Aspergillus.
English: These include: medicine for gout (probenecid).
Maltese: Dawn jinkludu: mediċina għal gotta (probenecid).
English: Fusobacterium species
Maltese: Speċi Fusobacterium
English: LIST OF EXCIPIENTS Edetate disodium (EDTA) and citric acid monohydrate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Edetate disodium (EDTA) u citric acid monohydrate.
English: Pack sizes: 1, 5, 10, 12 or 25 vials per carton.
Maltese: Daqsijiet tal-pakkett: 1, 5, 10, 12 jew 25 kunjetti f'kull kaxxa tal-kartun.
English: You will be given TAZOCIN until the sign of infection has gone completely (5 to 14 days).
Maltese: Ser tingħata TAZOCIN sakemm kwalunkwe sinjal ta' infezzjoni jkun sparixxa kompletament (minn 5 sa 14-il jum).
English: 70 mg piperacillin / 8.75 mg tazobactam / kg every 8 hours.
Maltese: 70 mg ta' piperacillin / 8.75 mg ta' tazobactam/kg kull 8 sigħat.
English: Staphylococcus species, coagulase negative, methicillin-susceptible Streptococcus pyogenes
Maltese: Speċi Staphylococcus, coagulase negattiv, suxxettibbli għal methicillin Streptococcus pyogenes
English: Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”.
Maltese: Piperacillin jappartjeni għall-grupp ta' mediċini magħrufa bħala “antibijotiċi broad-spectrum talpenicillin”.
English: Paediatric population (2-12 years of age)
Maltese: Popolazzjoni pedjatrika (minn 2 sa 12-il sena)
English: Lactated Ringers injection
Maltese: Injezzjoni ta' Ringers lactated
English: Prevotella species
Maltese: Speċi Prevotella
English: Piperacillin is metabolised to a minor microbiologically active desethyl metabolite.
Maltese: Piperacillin jiġi metabolizzat għal metabolit minuri mikrobijoloġikament attiv ta' desethyl.
English: Enterobacter species
Maltese: Speċi Enterobacter
English: Group B streptococci
Maltese: Streptococci ta' Grupp B
English: • Alteration of penicillin-binding proteins (PBPs), which results in the reduction of the affinity of piperacillin for the molecular target in bacteria.
Maltese: • Il-bidla ta' proteini li jeħlu ma' penicillin (PBPs), li tirriżulta fit-tnaqqis tal-affinità ta' piperacillin għall-mira molekulari fil-batterji.
English: 0.9% (9 mg/ml) sodium chloride solution for injection Sterile water for injections(1)
Maltese: 0.9% (9 mg/ml) soluzzjoni ta' sodium chloride għall-injezzjoni Ilma sterilizzat għall-injezzjonijiet(1)
English: The population mean (SE) for piperacillin volume of distribution is 0.243 (0.011) l/kg and is independent of age.
Maltese: Il-medja tal-popolazzjoni (SE) għall-volum tad-distribuzzjoni ta' piperacillin hu ta' 0.243 (0.011) l/kg u hu indipendenti mill-età.
English: * Compatible solvents for reconstitution:
Maltese: *Solventi kompatibbli għar-rikostituzzjoni:
English: The active substances are piperacillin and tazobactam.
Maltese: Is-sustanzi attivi huma piperacillin and tazobactam.
English: Common ≥ 1/100 to
Maltese: Komuni ≥ 1/100 sa
English: Musculoskeletal and connective tissue disorders arthralgia, myalgia
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi artralġja, mijalġja
English: Tazocin 4 g / 0.5 g Severe pneumonia
Maltese: Tazocin 4 g/0.5
English: Indication / condition
Maltese: Indikazzjoni/kundizzjoni
English: Hartmann's solution
Maltese: Soluzzjoni ta' Hartmann
English: The peak piperacillin and tazobactam concentrations after 4 g / 0.5 g administered over 30 minutes by intravenous infusion are 298 µg/ml and 34 µg/ml respectively.
Maltese: Il-konċentrazzjonijiet massimi ta' piperacillin u tazobactam wara 4 g/0.5 g mogħtija fuq perjodu ta' 30 minuta permezz ta' infużjoni ġol-vini kienu 298 µg/ml u 34 µg/ml rispettivament.
English: Effect on laboratory tests
Maltese: Effett fuq testijiet tal-laboratorju
English: No difference in piperacillin or tazobactam pharmacokinetics was observed between Asian (n=9) and Caucasian (n=9) healthy volunteers who received single 4 g / 0.5 g doses.
Maltese: Ma kienet osservata l-ebda differenza fil-farmakokinetika ta' piperacillin jew tazobactam bejn voluntiera b'saħħithom Asjatiċi (n=9) u Kawkasi (n=9) li rċivew dożi ta' 4 g/0.5 g waħidhom.
English: Pseudomonas aeruginosa Serratia species
Maltese: Pseudomonas aeruginosa
English: Fertility of the F1 generation and embryonic development of F2 generation were not impaired.
Maltese: Ilfertilità tal-ġenerazzjoni F1 u l-iżvilupp embrijoniku ta' ġenerazzjoni F2 ma ġewx indeboliti.
English: The other ingredients are citric acid monohydrate and edetate disodium (EDTA).
Maltese: Is-sustanzi l-oħra huma citric acid monohydrate u edetate disodium (EDTA).
English: Haemodialysis removes 30% to 50% of piperacillin / tazobactam, with an additional 5% of the tazobactam dose removed as the tazobactam metabolite.
Maltese: L-emodijalisi tneħħi minn 30% sa 50% ta' piperacillin / tazobactam, b'5% addizzjonali tad-doża ta' tazobactam li titneħħa bħala l-metabolit ta' tazobactam.
English: Children 2 to 12 years of age - Complicated intra-abdominal infections
Maltese: Tfal li għandhom minn sentejn sa 12-il sena - Infezzjonijiet ikkumplikati intra-addominali