FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format.
Maltese: Il-MAH(s) għandu(hom) jissottometti(u) l-elementi ewlenin (inkluż deskrizzjoni ta' DUS, PASS u materjal edukattiv) ta' pjan għallġestjoni tar-riskju f'format tal-UE.
English: Outline of the education materials within 3 months after the EC decision
Maltese: Deskrizzjoni tal-materjal edukattiv fi żmien 3 xhur mid-deċiżjoni tal-KE
English: The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal product during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) fil-preżentazzjoni tal-pjan għall-ġestjoni tar-riskju, protokoll għall-istudju dwar l-użu talmediċina biex jiġu kkaraterizzati l-prattiki ta' preskrizzjoni għallprodott mediċinali matul użu kliniku tipiku fi gruppi rappreżentanti ta' min jippreskrivi u biex jiġu vvalutati r-raġunijiet ewlenin għarriċetta ta' tabib.
English: The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) protokoll ta' PASS filpreżentazzjoni tal-pjan għall-ġestjoni tar-riskju, biex tiġi evalwata leffikaċja tal-attivitajiet għall-minimizzazzjoni tar-riskji.
English: The MAH(s) should provide within the risk management plan Educational material for prescribers and patients.
Maltese: Il-MAH(s) għandu(hom) jipprovdi(u) fil-preżentazzjoni tal-pjan għall-ġestjoni tar-riskju Materjal edukattiv għal min jippreskrivi u għall-pazjenti.
English: This will be included in the risk management plan, highlighting the risks, warnings and monitoring of hepatotoxicity
Maltese: Dan se jkun inkluż fil-pjan għall-ġestjoni tar-riskju, u jenfasizza r-riskji, t-twissijiet u l-monitoraġġ ta' epatotossiċità
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-awtoritajiet nazzjonali kompetenti tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin jiġu sodisfati mill-MAH(s):
English: Safety limit
Maltese: Limitu tas-sigurtà
English: Sodium-containing effervescent, dispersible and soluble medicines - Cardiovascular events ” (EMA/PRAC/234960/2015).
Maltese: “1.3. Sodium-containing effervescent, dispersible and soluble medicinesCardiovascular events ” (EMA/PRAC/234960/2015).
English: Latex Natural Rubber (latex)
Maltese: Latex Lastku naturali (Latex)
English: Topical, parenteral Zero
Maltese: Topiku, parenterali
English: Parenteral
Maltese: Parenterali
English: EMA/CHMP/302620/2017/EN Rev. 1
Maltese: EMA/CHMP/302620/2017/MT Rev.
English: 1 mmol of sodium (Na) = 23 mg Na = 58.4 mg salt (NaCl).
Maltese: 1 mmol ta' sodium (Na) = 23 mg Na = 58.4 mg melħ (NaCl).
English: Substance
Maltese: Sustanza
English: Various adverse events, such as hyperosmolality, lactic acidosis; renal dysfunction (acute tubular necrosis), acute renal failure; cardiotoxicity (arrhythmia, hypotension); central nervous system disorders (depression, coma, seizures); respiratory depression, dyspnoea; liver dysfunction; haemolytic reaction (intravascular haemolysis) and haemoglobinuria; or multisystem organ dysfunction, have been reported with high doses or prolonged use of propylene glycol.
Maltese: Episodji avversi varji, bħal iperosmolalità, aċidożi lattika; disfunzjoni renali (nekrożi tubulari akuta), insuffiċjenza renali akuta; kardjotossiċità (arritmija, pressjoni baxxa); disturbi tas-sistema nervuża ċentrali (depressjoni, koma, aċċessjonijiet); depressjoni respiratorja, qtugħ ta' nifs; disfunzjoni tal-fwied; reazzjoni emolitika (emolisi intravaskulari) u emoglobinurja; jew disfunzjoni multisistemika tal-organi, ġew irrapportati b'dożi għoljin jew użu fit-tul ta' propylene glycol.
English: <Benzoic acid/Benzoate salt> may cause local irritation.
Maltese: <Benzoic acid/ benzoate salt> jista' jikkawża irritazzjoni lokali.
English: Calorific value 2.3 kcal/g <maltitol><isomalt>.
Maltese: Valur kalorifiku 2.3 kcal/g <maltitol><isomalt>.
English: Cetostearyl alcohol including Cetyl alcohol
Maltese: Cetostearyl alcohol inkluż Cetyl alcohol
English: Balsam of Peru
Maltese: Balzmu ta' Perù
English: See Q&A document (EMA/CHMP/619104/2013) for further calculations.
Maltese: Ara d-dokument Q & A (EMA/CHMP/619104/2013) għal aktar kalkoli.
English: Intravenous (IV) 30 mmol/l
Maltese: 30 mmol/l
English: Contains x g lactose (x/2 g glucose and x/2 g galactose) per dose.
Maltese: Fih x g lactose (x 2 g glucose u x/2 g galactose) f'kull doża.
English: *< >: fragrance allergens listed in appendix.
Maltese: *< >: fragrance allergens (allerġeni tal-fwieħa) elenkati fl-appendiċi.
English: SmPC: contraindication.
Maltese: Kontra- indikazzjoni.
English: 3 mg B/day < 18 years** 7 mg B/day ≥ 18 years** 10 mg B/day
Maltese: 1 mg B/jum < 12-il sena 3 mg B/jum < 18-il sena** 7 mg B/jum ≥ 18-il sena** 10 mg B/jum
English: Maltitol (E 965) Isomalt (E 953) (isomaltitol) Maltitol liquid (hydrogenated glucose syrup)
Maltese: Maltitol (E 965) Isomalt (E 953) (Isomaltitol)
English: Parenteral Inhalation
Maltese: Parenterali Respiratorji
English: Propylene glycol (E 1520) and esters of propylene glycol
Maltese: Propylene glycol (E 1520) u esters ta' propylene glycol
English: Sulphites including metabisulphites e.g.:
Maltese: Sulphites inklużi metabisulphites
English: 09/10/2017 Parenteral
Maltese: 09/10/2017 Parenterali
English: Sorbic acid (E 200) and salts
Maltese: Sorbic acid (E 200) u mlieħ
English: (See appendix)
Maltese: (Ara l-appendiċi)
English: Calorific value 2.1 kcal/g lactitol.
Maltese: Valur kalorifiku 2.1 kcal/g lactitol.
English: A dose of (select maximum dose) of this medicine administered to (a child A years of age and weighing B kg or an adult weighing 70 kg) would result in exposure to C mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about D mg/100 ml (see Appendix 1 of report EMA/CHMP/43486/2018).
Maltese: Doża ta' (agħżel doża massima) ta' din il-mediċina mogħtija lil (tifel ta' A età ta' sena u li tiżen B kg jew adult li jiżen 70 kg) tirriżulta f'espożizzjoni għal C mg / kg ta' ethanol li jista' jikkawża żieda fl-alkoħol fid-demm konċentrazzjoni (BAC) ta' madwar D mg / 100 ml (ara lAppendiċi 1 tar-rapport EMA / CHMP / 43486/2018).
English: Not for application to mucosa.
Maltese: Mhux għal applikazzjoni lil-mukoża.
English: Benzoic acid (E 210) and benzoates e.g.:
Maltese: Benzoic acid (E 210) and benzoates
English: For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.
Maltese: Għall-paragun, għal adult li jixrob tazza inbid jew 500 ml birra, il-BAC x'aktarx ikun ta' madwar 50 mg / 100 ml.
English: Wheat starch (containing gluten)
Maltese: Wheat starch (fih ilgluten)
English: Cyclodextrins e.g.:
Maltese: Cyclodextrins
English: 17 mmol (391 mg) in the maximum daily dose
Maltese: 17 mmol (391 mg) fid-doża massima ta' kuljum
English: 5 mg/kg/day Sorbitol is a source of fructose.
Maltese: 5 mg/kg/jum Sorbitol huwa sors ta' fructose.
English: Bergamot oil (containing bergapten)
Maltese: Żejt tal-bergamott (bergamot oil) li fih bergapten
English: 17 mmol (391 mg) is approximately 20% of the WHO adult recommended maximum daily dietary intake of 2 g sodium and is considered to represent ‘high' sodium.
Maltese: 17 mmol (391 mg) huwa bejn wieħed u ieħor 20% talammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed mad-dieta kuljum minn adult u huwa meqjus li jirrappreżenta sodium "għoli".
English: Sodium laurilsulfate 09/10/2017
Maltese: Sodium laurilsulfate 09/10/2017 Rettifika
English: Calorific value 2.4 kcal/g xylitol.
Maltese: Valur kalorifiku 2.4 kcal/g xylitol.
English: Rectal
Maltese: Rettifika
English: This medicine contains x mmol (or y mg) potassium per <dose>.
Maltese: Din il-mediċina fiha x mmol (jew y mg) ta' potassium f'kull <doża>.
English: This medicine contains fragrance with <allergen(s)>*.
Maltese: Din il-mediċina fiha fwieħa b '<allergen(s)> *.
English: 75 mg/kg per dose
Maltese: 75 mg/kg f'kull doża
English: Phosphate buffers
Maltese: Buffers tal-fosfat
English: Boric acid (and borates) 09/10/2017 All
Maltese: Boric acid (and borates) 09/10/2017 Kollha
English: To calculate the equivalent volume of beer and wine, assume the ethanol content of beer to be 5% v/v (alcohol by volume, ABV), which is equivalent to 4% w/v, and of wine to be 12.5% v/v or 10% w/v (the specific gravity of ethanol has been approximated as 0.8).
Maltese: Biex tikkalkula l-volum ekwivalenti ta' birra u inbid, assumi li l-kontenut ta' etanol ta' birra huwa ta' 5% v / v (alkoħol skond il-volum, ABV), li huwa ekwivalenti għal 4% w / v, u ta nbid huwa ta' 12.5% v / v jew 10% w / v (il-gravità speċifika ta' l-ethanol ġiet approssimata bħala
English: 200 mg/kg/day Cyclodextrins may cause digestive problems such as diarrhoea.
Maltese: 200 mg/kg/jum Cyclodextrins jista' jikkawżaw problemi diġestivi bħal dijarea.
English: 15 mg/kg per dose
Maltese: 15 mg/kg f'kull doża
English: 1 mmol (23 mg) per dose
Maltese: 1 mmol (23 mg) f'kull doża
English: Benzalkonium chloride may cause local irritation.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni lokali.
English: 09/10/2017 Topical
Maltese: 09/10/2017 Topiku
English: Soya oil Hydrogenated soya oil
Maltese: Żejt tas-Sojja Żejt tas-Sojja idroġenat
English: Where relevant, the interactions of ethanol should be stated in the SmPC (section 4.5).
Maltese: Fejn relevanti, l-interazzjonijiet ta' ethanol għandhom jiġu ddikjarati fl-SmPC (sezzjoni 4.5).
English: Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Maltese: Benzyl alcohol gie marbut mar-riskju ta' effetti sekondarji severi inklużi problemi tan-nifs (imsejħa "gasping syndrome ") fi tfal żgħar.
English: May rarely cause severe hypersensitivity reactions and bronchospasm.
Maltese: F'każijiet rari jista' jikkawża reazzjonijiet serji ta'sensittività eċċessiva u bronkospażmu.
English: From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Maltese: Mid-data limita li teżisti, m'hemm l-ebda differenza flprofil ta' effett avvers fit-tfal meta mqabbla ma' adulti.
English: Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
Maltese: Monitoraġġ mediku huwa meħtieġ f'pazjenti b'funzjonijiet renali jew epatiċi indeboliti minħabba li ġew irrappurtati diversi episodji avversi attribwiti għal propylene glycol bħal disfunzjoni renali (nekrożi tubulari akuta), insuffiċjenza renali akuta u disfunzjoni tal-fwied.
English: See EMEA Public Statement, 8 July 1999, Ref. EMEA/20962/99
Maltese: Ara Dikjarazzjoni Pubblika ta'l-EMEA, 8 Lulju 1999, Ref.
English: <Medicinal product> contains soya oil.
Maltese: <Prodott mediċinali> fih żejt tas-sojja.
English: The container of this medicinal product contains latex rubber.
Maltese: Il-kontenitur ta' dan il-prodott mediċinali fih illastku latex.
English: 09/10/2017 Intravenous (IV) Zero
Maltese: 09/10/2017 Ġol-vina (IV)
English: Appendix: European Union list of fragrance allergens requiring labelling on cosmetic and detergent products
Maltese: Lista ta' l-Unjoni Ewropea ta' Fragrance Allergens (allerġeni tal fwieħa) li Jeħtieġu Tikkettar fuq Prodotti Kosmetiċi u Deterġenti.
English: Suggestion for information in the SmPC:
Maltese: Test propost għall-SmPC:
English: Contains x g of sucrose per dose.
Maltese: Fih x g ta' sucrose f'kull doża.
English: 09/10/2017 Oral, parenteral (other than IV)
Maltese: 09/10/2017 Orali, parenterali (li mhuwiex IV)
English: Aspartame is hydrolysed in the gastrointestinal tract when orally ingested.
Maltese: Aspartame hu idrolizzat fil-passaġġ gastrointestinali wara inġestjoni orali.
English: Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“gasping syndrome”).
Maltese: L-amministrazzjoni ġol-vina ta' benzyl alcohol ġiet assoċjat ma' avvenimenti avversi serji u l-mewt fi trabi tat-twelid ("gasping syndrome ").
English: Not a typical excipient, but a warning is considered necessary.
Maltese: M'huwiex sustanza mhux attiva tipika, imma twissija hija meqjusa neċessarja.
English: Benzalkonium chloride may irritate the skin.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni talġilda.
English: Volumes of beer and wine (A and B) should be rounded up to the next whole number.
Maltese: Il-volumi tal-birra u l-inbid (A u B) għandhom jiġu aġġustati għan-numru sħiħ li jmiss.
English: 7 mg B/day* Do not give to a child less than 18 years old as this medicine contains boron and may impair fertility in the future.
Maltese: 7 mg B/jum* Tagħtix lil tifel / tifla ta' inqas minn 18-il sena peress li din il-mediċina fiha boron u tista' tfixkel ilfertilità fil-futur.
English: May increase sensitivity to UV light (natural and artificial sunlight).
Maltese: Jista' jżid is-sensittività għad-dawl UV (dawl taxxemx naturali jew artifiċjali).
English: This medicine contains only very low levels of gluten (from wheat starch)<.
Maltese: Din il-mediċina fiha biss livelli baxxi ħafna ta 'glutina (minn-wheat starch)<.
English: 3 mg B/day* Do not give to a child less than 12 years old as this medicine contains boron and may impair fertility in the future.
Maltese: 3 mg B/jum* Tagħtix lil tifel / tifla ta' inqas minn 12-il sena peress li din il-mediċina fiha boron u tista' tfixkel ilfertilità fil-futur.
English: May cause local skin reactions (e.g. contact dermatitis).
Maltese: Jistgħu jikkawżaw reażżjonijiet lokali fil-ġilda (eż dermatite tal-kuntatt).
English: Parahydroxybenzoates and their esters e.g.: Ethyl p-hydroxybenzoate (E
Maltese: Ethyl p-hydroxybenzoate (E
English: Macrogolglycerol hydroxystearate (castor oil polyoxyl hydrogenated)
Maltese: Żejt ir-riġnu polyoxyl Żejt ir-riġnu polyoxyl hydrogenated
English: 1 mmol per dose
Maltese: 1 mmol f'kull doża
English: 140 mg/kg/day Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Maltese: 140 mg/kg/jum Sorbitol jista' jikkawża skumdita' gastrointestinali u effett lassattiv ħafif.
English: This medicine contains potassium, less than 1 mmol (39 mg) per <dose>, i.e. essentially ‘potassium-free'.
Maltese: Din il-mediċina fiha ammont ta' potassium, anqas minn 1 mmol (39 mg) f'kull <doża>, jiġifieri essenzjalment 'ħieles mill-potassium'.
English: 22/11/2019 Cutaneous
Maltese: 22/11/2019 Użu għall-ġilda Żero
English: Oral liquids, lozenges and chewable tablets
Maltese: Likwidi orali, mustardini u pilloli li tomogħdhom
English: Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Maltese: Phenylalanine jista' jkun ta' ħsara jekk inti għandek fenilketonurja (phenylketonuria , PKU), disturb ġenetiku rari fejn il-phenylalanine jakkumula għaliex il-ġisem ma jistax ineħħih sewwa.
English: The PhEur monograph does not contain a test for residual protein.
Maltese: Il-monografija fil-Ph Eur ma fihx test għarresidwi tal-proteina.
English: Contains x g galactose per dose.
Maltese: Fih x g galactose f'kull doża.
English: <Medicinal product> contains arachis oil (peanut oil).
Maltese: <Prodott Mediċinali> fih iż-żejt ta' l-Arakis (żejt talkarawett).
English: Benzalkonium chloride 09/10/2017 Inhalation
Maltese: Benzalkonium chloride 09/10/2017 Inalazzjoni
English: [* The statement 'gluten-free' applies only if the gluten content in the medicinal product is less than 20 ppm.]
Maltese: [*Id-dikjarazzjoni “mingħajr gluten” tapplika biss jekk il-kontenut ta' gluten fil-prodott mediċinali huwa anqas minn 20 ppm.]
English: Proposed wording for SmPC: “This medicinal product contains x mg sodium per <dosage unit>, equivalent to y% of the WHO recommended maximum daily intake of 2 g sodium for an adult.”
Maltese: "Dan il-prodott mediċinali fih x mg sodium f'kull <doża>, ekwivalenti għal y% tal-ammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult."
English: Benzyl alcohol is listed as one of the 26 fragrance allergens but can also be used as an excipient.
Maltese: Benzyl alcohol huwa elenkat bħala wieħed mis-26 allerġeni tal-fwieħa imma jista' jintuża wkoll bħala eċċipjent.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Maltese: Għandu jittieħed kont ta' l-effett addittiv ta' prodotti amministrati b'mod konkomitanti li fihom fructose (jew sorbitol) u l-konsum fid-dieta ta' fructose (jew sorbitol).
English: Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI).
Maltese: It-trabi u t-tfal żgħar (taħt is-sentejn) għadhom ma jistgħux jiġu dijanjostikati bi intolleranza ereditarja għallfruttożju (HFI).
English: Increased risk due to accumulation in young children.
Maltese: Żieda fir-riskju minħabba l-akkumulazzjoni fit-tfal żgħar.
English: Cyclodextrins (CDs) are excipients which can influence the properties (such as toxicity or skin penetration) of the active substance and other medicines.
Maltese: Cyclodextrins (CDs) huma eċċipjenti li jistgħu jinfluwenzaw il-proprjetajiet (bħal tossiċità jew penetrazzjoni tal-ġilda) tas-sustanza attiva u ta' mediċini oħra.
English: SmPC proposal: Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia<, or glucosegalactose malabsorption> should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose eż galattożimja, <jew malassorbiment tal-glucosegalactose> m'għandhomx jieħdu din il-mediċina.
English: Invert sugar
Maltese: Zokkor invers
English: 09/10/2017 Cutaneous
Maltese: 09/10/2017 Kollha
English: 1 mg B/day* Do not give to a child less than 2 years old as this medicine contains boron and may impair fertility in the future.
Maltese: 1 mg B/jum* Tagħtix lil tifel / tifla ta' inqas minn sentejn peress li din il-mediċina fiha boron u tista' tfixkel il-fertilità fil-futur.
English: This medicine contains x mg <benzoic acid/benzoate salt> in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
Maltese: Din il-mediċina fiha x mg ta' <benzoic acid/benzoate salt> f'kull <doża><volum> <li hu ekwivalenti għal x mg/<piż><volum>>.
English: Benzalkonium chloride 09/10/2017 Nasal
Maltese: Benzalkonium chloride 09/10/2017 Nasali
English: May cause severe allergic reactions.
Maltese: Jista' jikkawża reażżjonijiet allerġiċi serji.
English: SmPC proposal: Patients with rare hereditary problems of fructose intolerance, galactose intolerance, galactosaemia or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose, intolleranza għall-galactose, galattożimja jew malassorbiment talglukocose-galactose m'għandhomx jieħdu din il-mediċina.
English: Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.
Maltese: L-għoti flimkien ma' mediċini li fihom eż. propylene glycol jew ethanol jista' jwassal għal akkumulazzjoni ta' ethanol u jinduċi effetti avversi, partikolarment fi tfal żgħar b'kapaċità metabolika baxxa jew immatura.
English: Patients with HFI cannot break down fructose in this medicine, which may cause serious side effects.
Maltese: Pazjenti b'HFI ma jistgħux ikissru fructose f'din il-mediċina, li tista' tikkawża effetti sekondarji serji.
English: Oral Ocular Topical
Maltese: Sustanzi koloranti Azo
English: It is regarded as ‘gluten-free'*> and is very unlikely to cause problems if you have coeliac disease.
Maltese: Huwa meqjus bħala “mingħajr glutina”*> u huwa improbabbli ħafna li jikkawża problemi jekk għandek mard ta 'celiac.
English: 20 mg/kg/day This medicine contains x mg cyclodextrin(s) in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
Maltese: 20 mg/kg/jum Din il-mediċina fiha x mg ta' cyclodextrin (s) f'kull <doża><volum> <li hu ekwivalenti għal x mg/<piż><volum>>.
English: <Z doses> reflects the lowest number of dosage units for which the threshold of 17 mmol (391 mg) of sodium is reached/ exceeded.
Maltese: <Z dożi> tirrifletti l-aktar numru baxx ta' dożi li bihom jintlaħaq / jinqabeż il-limitu ta'17 mmol (391 mg) ta' sodium.
English: The thickness of the skin varies considerably according to the body site and with age and can be an important factor in the sensitivity to sodium laurilsulfate (SLS).
Maltese: Il-ħxuna tal-ġilda tvarja b'mod konsiderevoli skont is-sit tal-ġisem u l-età u tista' tkun fattur importanti fissensittività għal sodium laurilsulfate (SLS).
English: Sensitivity to SLS will also vary according the type of formulation (and effects of other excipients), the concentration of SLS, contact time and patient population (children, hydration level, skin color and disease).
Maltese: Sensittività għal SLS se tvarja wkoll skont it-tip ta' formulazzjoni (u effetti ta' eċċipjenti oħra), ilkonċentrazzjoni ta' SLS, ħin ta' kuntatt u l-popolazzjoni tal-pazjent (tfal, livell ta' idratazzjoni, kulur tal-ġilda u mard).
English: 500 mg/kg/day Propylene glycol may cause skin irritation.
Maltese: 09/10/2017 Użu għall-ġilda 500 mg/kg/jum Propylene glycol jista' jikkawża irritazzjoniji filġilda.
English: Benzalkonium chloride 09/10/2017 Cutaneous
Maltese: Benzalkonium chloride 09/10/2017 Kollha
English: Medicines (containing fructose) given intravenously may be life-threatening and must be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Maltese: Mediċini (li fihom fructose) mogħtija ġolvini jistgħu jkunu ta' periklu għall-ħajja u għandhom ikunu kontra-indikati f'din il-popolazzjoni sakemm ma jkunx hemm ħtieġa klinika kbira u l-ebda alternattiva ma tkun disponibbli.
English: Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni jew nefħa fl-imnieħer, speċjalment jekk jintuża għal żmien twil.
English: Adverse events usually reverse following weaning off of propylene glycol, and in more severe cases following hemodialysis.
Maltese: L-episodji avversi normalment jieqfuu wara li propylene glycol jitnaqqas bil-mod u jitwaqqaf, u f'każijiet aktar severi wara l-emodijaliżi.
English: This medicine contains less than 1 mmol sodium (23 mg) per <dosage unit><unit volume>, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull <doża><volum>, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Purified arachis oil may contain peanut protein.
Maltese: Żejt ta' l-Arakis purifikat jista' jkun fih il-proteina talkarawett.
English: 1 mg/kg/day This medicine contains x mg propylene glycol in each <dosage unit><unit volume> <which is equivalent to x mg/<weight><volume>>.
Maltese: 1 mg/kg/jum Din il-mediċina fiha x mg propylene glycol f'kull <doża><volum> <li hu ekwivalenti għal x mg/<piż><volum>>.
English: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: Benzalkonium chloride jista jigi assorbit mil-lentijiet tal-kuntatt rotob u jista ibiddel l-kulur tal-lentijiet tal-kuntatt.
English: Heparin (as an excipient)
Maltese: Heparin (bħala sustanza mhux attiva)
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Maltese: Pazjenti b'HFI ma jistgħux jkissru l-fructose, li jista jikkawża effetti sekondarji serji.