FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibaflin 30 mg tablets for dogs Ibaflin 150 mg tablets for dogs Ibaflin 300 mg tablets for dogs Ibaflin 900 mg tablets for dogs
Maltese: Ibaflin 30 mg pilloli għall-klieb Ibaflin 150 mg pilloli għall-klieb Ibaflin 300 mg pilloli għall-klieb Ibaflin 900 mg pilloli għall-klieb
English: - Carton box with 20 or 100 tablets in PVC/aluminium heat sealed blisters 150 mg tablets: - Carton box with 10, 20 or 100 tablets in PVC/aluminium heat sealed blisters - Carton box with 10, 20 or 100 tablets in PVC/PVDC/aluminium blisters
Maltese: Pilloli 150 mg: - Kaxxa tal-kartun b'10, 20 jew 100 pillola fi strixxi tal-PVC/aluminju issiġillati bis sħana.
English: Marketing Authorisation number(s) EU/2/00/022/001-008
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/00/022/001-008
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TAL-KARTUN GĦAL SIRINGA 1 IBAFLIN 7.5% ĠELL ORALI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats Ibaflin 7.5% oral gel for dogs
Maltese: VETERINARJU Ibaflin 3% ġell orali għall-klieb u qtates Ibaflin 7.5% ġell orali għall-klieb
English: Date of first authorisation/renewal of the authorisation
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI
English: - Dermal infections (soft tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp, E. coli, Proteus spp.
Maltese: - Infezzjonijiet tal-ġilda (infezzjonijiet tat-tessuti rotob - feriti, axxessi) ikkawżati minn forom suxxettibbli bħal Staphylococcus spp, E. coli, Proteus spp.
English: Acute, uncomplicated urinary tract infections, caused by susceptible strains of Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
Maltese: Infezzjonijiet akuti u mhux ikkumplikati tas-sistema urinarja ikkawżati minn forom suxxettibbli ta' Staphylococci, Proteus spp., Enterobacter spp., E. coli u Klebsiella spp.
English: 150mg and 300mg tablets: 4 years 30mg and 900mg tablets: 3 years 6.4 Special precautions for storage Do not store above 25°C.
Maltese: Pilloli 150 mg u 300 mg: 4 snin Pilloli 30 mg u 900 mg: 3 snin.
English: The safety of the veterinary medicinal product has not been established in lactating dog.
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġiex stabbilit fi żmien ilħalib.
English: Cats and dogs Ibaflin 3% Oral Gel
Maltese: Qtates u klieb Ibaflin 3% Ġell Orali
English: 6.2 Incompatibilities Not applicable.
Maltese: .2 Inkompatibilitajiet Mhux Applikabbli.
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 3% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 3% ORAL GEL
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TAL-KARTUN GĦAL SIRINGA 1 IBAFLIN 3% ĠELL ORALI
English: The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active .
Maltese: Il-metabolu l-aktar abbundanti huwa 8-hydroxy-ibafloxacin li għandu wkoll attività mikrobijoloġika.
English: When administered over a period of 30 days to healthy cats, Ibaflin oral gel produced vomiting/regurgitation and salivation at doses of 15 to 75 mg/kg.
Maltese: Meta ġie amministrat għal perjodu ta' 30 ġurnata fi qtates b'saħħithom, Ibaflin ġell orali ipproduċa remettar/rigurġitazzjoni u produzzjoni għolja ta' bżieq f'dożi ta' 15 sa 75 mg/kg.
English: Intervet GesmbH.
Maltese: PARIR SABIEX
English: Ibaflin 30 mg
Maltese: 30 ml
English: The main excretory routes are via urine and faeces.
Maltese: Ir-rotta prinċipali ta' eliminazzjoni hija mal-urina u l ippurgar.
English: / Carton box containing 5 adjustable pre-filled multidose syringes, containing 30 ml Ibaflin 7.5% oral gel.
Maltese: / Kaxxa tal-kartun fiha 5 siringi mimlija bil-lest b'ħafna dożi, li jistgħu jiġu aġġustati, kull waħda fiha 30 ml Ibaflin 7.5% ġell orali.
English: Ibaflin gel is indicated in cats for treatment of the following conditions:
Maltese: Ibaflin ġell huwa indikat fil-qtates għat-trattament tal-kundizzjonijiet li ġejjin:
English: PHARMACOLOGICAL PARTICULARS
Maltese: TAL-PRODOTT MEDIĊINALI
English: TARGET SPECIES Dog
Maltese: Kodici ATĊ veterinarja:
English: ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily (i.e. 0.5 ml of gel per kg body weight).
Maltese: Użu mill-ħalq, 15 mg għal kull kg piż darba kuljum (i.e. 0.5 ml ġell għal kull kg piż).
English: The main excretory route is via urine and faeces.
Maltese: Ir-rotta prinċipali ta' eliminazzjoni hija mal-urina u l-ippurgar.
English: Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible strains such as Staphylococci, E. coli, Proteus mirabilis.
Maltese: Infezzjonijiet tal-ġilda (pijoderma - superfiċjali u fonda, feriti, axxessi) ikkawżati minn forom suxxettibbli ta' Staphylococci, E. coli u Proteus mirabilis.
English: Ibaflin gel should only be used based on susceptibility testing.
Maltese: Ibaflin għandu jintuża fuq bażi ta' testijiet tas-suxxettibilità.
English: Yeast
Maltese: Awstrija
English: - Upper respiratory tract infections caused by susceptible pathogens such as Staphylococcus spp, E. coli, Klebsiella spp.
Maltese: - Infezzjonijiet tas-sistema respiratorja tan-naħa ta' fuq ikkawżati minn forom suxxettibbli bħal Staphylococcus spp, E. coli, Klebsiella spp.
English: Ibafloxacin 30 mg
Maltese: 30 mg ibafloxacin f'kull ml ġell
English: Oral use, 15 mg ibafloxacin/kg bodyweight once daily.
Maltese: Użu mill-ħalq, 15 mg ibafloxacin/kg piż darba kuljum.
English: Antacids can interfere with gastro-intestinal absorption of quinolones.
Maltese: Antacids jistgħu ifixklu l-assorbiment ta' quinolones mill-imsaren.
English: IBAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
Maltese: SIRINGI IBAFLIN 3% ĠELL ORALI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats
Maltese: VETERINARJU Ibaflin 3% ġell orali għall-klieb u qtates
English: PACKAGE INSERT FOR INCLUSION WITH THE 7.5 % ORAL GEL SYRINGE PACKAGES
Maltese: FIL-PAKKETT PAKKETTI TA' SIRINGI TA' 7.5% ĠELL ORALI
English: ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily (i.e. 1 ml of gel per 5 kg body weight).
Maltese: Użu mill-ħalq, 15 mg għal kull kg piż darba kuljum (i.e. 1 ml ġell għal kull 5 kg piż).
English: Oral use, 15 mg ibafloxacin/kg once daily.
Maltese: Użu mill-ħalq, 15 mg ibafloxacin/kg darba kuljum.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each (pre-filled syringe of) Ibaflin Oral Gel contains:
Maltese: Ibaflin ġell huwa indikat fil-klieb għat-trattament tal-kundizzjonijiet li ġejjin:
English: - Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp, E. coli and Proteus mirabilis.
Maltese: - Infezzjonijiet tal-ġilda (pijoderma - superfiċjali u fonda, feriti, axxessi) ikkawżati minn forom suxxettibbli bħal Staphylococcus spp, E. coli u Proteus mirabilis.
English: 0.5 ml of gel per kg body weight
Maltese: 0.5 ml ta' ġell għal kull kg piż
English: IBAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
Maltese: IBAFLIN 7.5% ĠELL ORALI
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 75 mg of ibafloxacin per ml of gel
Maltese: 75 mg ibafloxacin f'kull ml ġell
English: Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Maltese: Fluorquinolones m'għandhomx jintużaw flimkien ma mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs) fi klieb li għandhom storja ta' eċċessjonijiet.
English: Its action results from inhibition of bacterial DNA gyrase.
Maltese: biotransformation enzymes.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/022/09
Maltese: NUMRU/I TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/00/022/09
English: A strain which is resistant to a fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Maltese: Forma ta' mikrobu li tkun reżistenti għal ibafloxacin tkun reżistenti wkoll għall-membri l-oħra tal klassi tal-fluoroquinolones.
English: The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġiex stabbilit fi żmien il-ħalib.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel for dogs.
Maltese: VETERINARJU Ibaflin 7.5% ġell orali għall-klieb.
English: Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in dogs with a history of seizures.
Maltese: Quinolones m'għandhomx jintużaw flimkien ma mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs) fi klieb li għandhom storja ta' eċċessjonijiet.
English: - Immunodeficiency.
Maltese: - Immunodefiċjenza.
English: 2132 WT Hoofddorp The Netherlands
Maltese: 2132 WT Hoofddorp
English: - Assessment of respiratory system.
Maltese: - Stima tas-sistema respiratorja.
English: 9) The injection lasts for a maximum of 10 seconds.
Maltese: 9) L-injezzjoni tieħu massimu ta' 10 sekondi.
English: QPharma AB Agneslundsvagen 27 P.O.
Maltese: QPharma AB Agneslundsvagen 27 P.O. Box 590
English: The active substance is methotrexate.
Maltese: Is-sustanza attiva hi methotrexate.
English: ATC code: L04AX03
Maltese: L04AX03
English: SE-201 25 Malmo Sweden
Maltese: SE-201 25 Malmo L-Iżvezja
English: Date of first authorisation: 18 August 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 18 t'Awwissu 2016
English: The major metabolite is 7-hydroxymethotrexate.
Maltese: Il-metabolit ewlieni hu 7-hydroxymethotrexate.
English: Very rare: Impaired vision, Retinopathy.
Maltese: Rari ħafna: Vista indebolita, Retinopatija.
English: Very rare: Hepatic failure.
Maltese: Rari ħafna: Falliment epatiku.
English: Approx. 5-20% of methotrexate and 1-5% of 7hydroxymethotrexate are eliminated via the bile.
Maltese: Madwar 5-20% ta' methotrexate u 1-5% ta' 7-hydroxymethotrexate jiġi eliminat permezz tal-bilja.
English: However, a risk cannot be completely excluded.
Maltese: Madanakollu, riskju ma jistax jiġi kompletament eskluż.
English: reactivation of inactive chronic infection), sepsis, conjunctivitis.
Maltese: Infezzjoni (li tinkludi r-riattivazzjoni ta' infezzjoni kronika inattiva), sepsis, konġunktivite.
English: Common: Leukopenia, anaemia, thrombopenia.
Maltese: Komuni: Lewkopenija, anemija, tromboċitopenija.
English: At the start of your treatment, Nordimet may be injected by medical staff.
Maltese: Fil-bidu tat-trattament tiegħek, Nordimet jista' jiġi injettat mill-personel mediku.
English: For contraception advice for men, see section 4.6.
Maltese: Għal pariri dwar kontraċezzjoni fl-irġiel, ara sezzjoni 4.6.
English: Nordimet with food, drink and alcohol
Maltese: Nordimet ma' ikel, xorb u alkoħol
English: BSA), methotrexate has a mean bioavailability of approximately 70%, although considerable inter- and intra-subject variations are possible (25-100%).
Maltese: BSA), methotrexate għandu bijodisponibilità ta' madwar 70%, għalkemm jista' jkun hemm varjabilità konsiderevoli bejn individwi u fl-istess individwu (25-100%).
English: Psychiatric disorders Uncommon: Depression, confusion.
Maltese: Mhux komuni: Depressjoni, konfużjoni.
English: Common: Oral ulcers, diarrhoea.
Maltese: Komuni: Ulċeri orali, dijarea.
English: Average terminal half-life is 6-7 hours and demonstrates considerable variation (3-17 hours).
Maltese: Half-life terminali medju hu ta' 6-7 sigħat u juri varjabilità konsiderevoli (3-17-il siegħa).
English: Methotrexate induces gene and chromosome mutations both in vitro and in vivo.
Maltese: Methotrexate jinduċi mutazzjonijiet ta' ġeni u kromosomi kemm in vitro u in vivo.
English: - Liver function tests.
Maltese: - Testijiet tal-funzjoni tal-fwied.
English: Name and address of the manufacturers responsible for batch release Cenexi - Laboratoires Thissen S.A.
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Cenexi - Laboratoires Thissen S.A.
English: Approximately 50% of methotrexate is bound to serum proteins.
Maltese: Madwar 50% ta' methotrexate huwa marbut ma' proteini tas-serum.
English: Sodium chloride Sodium hydroxide Water for injections
Maltese: Sodium chloride Sodium hydroxide Ilma għal injezzjonijiet
English: It requires 30-60 seconds to be effective.
Maltese: Hu meħtieġ 30-60 sekonda biex ikun effettiv.
English: Persistent anomalies of liver-related enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity.
Maltese: Anomaliji persistenti ta' enzimi relatati mal-fwied u/jew tnaqqis ta' albumina fis-serum jista' jkunu indikattivi ta' epatotossiċità severa.
English: Clear, yellow solution with a pH of 8.0-9.0 and an osmolality of approximately 300 mOsm/kg.
Maltese: Soluzzjoni safranija, ċara b'pH ta' 8.0-9.0 u b'osmolalità ta' madwar 300 mOsm/kg.
English: Rare: Acute hepatitis.
Maltese: Epatite akuta.
English: Uncommon: Gastrointestinal ulcers and bleeding, enteritis, vomiting, pancreatitis.
Maltese: Mhux komuni: Ulċeri gastrointestinali u emorraġija, enterite, remetter, pankreatite.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunosuppressants.
Maltese: Sustanzi antineoplastiċi u immunomodulanti, immunosuppressivi oħra.
English: Administration of additional haematotoxic medicinal products (e.g. metamizole) increases the probability of severe haematoxic effects of methotrexate.
Maltese: L-għoti ta' prodotti mediċinali ematotossiċi addizzjonali (eż. metamizole) iżidu l-probabilità ta' effetti ematossiċi severi ta' methotrexate.
English: Methotrexate is contraindicated if bilirubin values are > 5 mg/dl (85.5 µmol/L) (see section 4.3).
Maltese: Methotrexate huwa kontraindikat jekk il-valuri ta' bilirubina huma > 5 mg/dl (85.5 µmol/L) (ara sezzjoni 4.3).
English: One should be aware of pharmacokinetic interactions between methotrexate, anticonvulsant medicinal products (reduced methotrexate blood levels), and 5-fluorouracil (increased t½ of 5--fluorouracil).
Maltese: Wieħed għandu jkun konxju dwar interazzjonijiet farmakokinetiċi bejn methotrexate, prodotti mediċinali antikonvulsanti (livelli ta' methotrexate fid demm imnaqqsa), u 5-fluorouracil (żieda fil-t½ ta' 5-fluorouracil).
English: Creatinine clearance (ml/min)
Maltese: Tneħħija ta' kreatinina (ml/min) Doża
English: The recommended dose is 10-15 mg/m² body surface area (BSA) per week.
Maltese: Id-doża rakkomandata hi ta' 10-15 mg/m² f'erja superfiċjali tal-ġisem (BSA - Body Surface Area) filġimgħa.
English: Temporary increases in transaminases to two or three times the upper limit of normal have been reported in patients at a frequency of 13-20 %.
Maltese: Żidiet temporanji fi transaminases għal darbtejn jew tliet darbiet il-limitu ta' fuq tan-normal ġew rapportati f'pazjenti bi frekwenza ta' 13-20%.
English: Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), increased pigmentary changes of the nails, acute paronychia, furunculosis, telangiectasia.
Maltese: Rari ħafna: Sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika (Sindrome ta' Lyell), żieda filbidliet pigmentarji tad-dwiefer, paronikja akuta,furunkulosi, telanġiektasja.
English: Frequencies are defined using the following convention: very common (≥ 1/10) common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Frekwenzi huma mfissra permezz tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa <1/100); rari (≥ 1/10,000 sa 1/1,000), rari ħafna (< 1/10,000); mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: Salicylates, phenylbutazone, phenytoin, barbiturates, tranquillisers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulfonamides and p-aminobenzoic acid displace methotrexate from serum albumin binding and thus increase bioavailability (indirect dose increase).
Maltese: Salicylates, phenylbutazone, phenytoin, barbiturates, sedattivi, kontraċettivi orali, tetracyclines, derivati ta' amidopyrine, sulfonamides u p-aminobenzoic acid jissostitwixxu methotrexate mill-irbit mal-albumina fis-serum u hekk iżidu l-bijodisponibilità (żieda indiretta tad-doża).
English: If clinically indicated, exclude tuberculosis and hepatitis.
Maltese: Jekk indikat klinikament, eskludi t-tuberkolosi u l-epatite.
English: • Spontaneous abortions have been reported in 42.5% of pregnant women exposed to lowdose methotrexate treatment (less than 30 mg/week), compared to a reported rate of 22.5% in disease-matched patients treated with drugs other than methotrexate.
Maltese: • Aborti spontanji ġew rapportati f'42.5% ta' nisa tqal esposti għal trattament b'doża baxxa ta' methotrexate (inqas minn 30 mg/ġimgħa) meta mqabbla ma' rata rapportata ta' 22.5% f'pazjenti mqabbla bil-mard trattati b'mediċini li mhumiex methotrexate.
English: - Serious, acute or chronic infections such as tuberculosis and HIV.
Maltese: - Infezzjonijiet serji, akuti jew kroniċi bħal tuberkolosi u HIV.
English: 1 ml of solution contains 25 mg methotrexate.
Maltese: 1 ml ta' soluzzjoni fih 25 mg methotrexate.
English: A rise in the toxicity of methotrexate is generally not anticipated when methotrexate is used concomitantly with other antirheumatic agents (e.g. gold compounds, penicillamine, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporin).
Maltese: Ġeneralment, żieda fit-tossiċità ta' methotrexate ma tkunx antiċipata meta methotrexate jintuża flistess waqt ma' sustanzi antirewmatiċi oħra (eż. komposti tad-deheb, penicillamine, hydroxychloroquinine, sulfasalazine, azathioprine, cyclosporin).
English: Uncommon: Dizziness.
Maltese: Mhux komuni: Farinġite.
English: Not known: Osteonecrosis of jaw (secondary to lymphoproliferative disorders)
Maltese: Mhux magħruf: osteonekrożi tax-xedaq (sekondarja għal disturbi limfoproliferattivi)
English: Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Maltese: Reazzjonijiet avversi l-aktar frekwenti (komuni ħafna) osservati b'methotrexate jinkludu disturbi gastroinetstinali (eż. stomatite, dispepsja, uġigħ addominali, dardir, nuqqas t'aptit) u testijiet tal-funzjoni tal-fwied abnormali (eż. żieda f'alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubina, alkaline phosphatase).
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Maltese: Calcium folinate huwa l-antidot speċifiku biex jinnewtralizza l-effetti tossiċi avversi ta' methotrexate.
English: Limited clinical evidence does not indicate an increased risk of malformations or miscarriage following paternal exposure to low-dose methotrexate (less than 30 mg/week).
Maltese: Evidenza klinika ristretta ma tindikax riskju ogħla ta' malformazzjonijiet jew korriment fit-tqala wara esponiment paternali għal doża baxxa ta' methotrexate (inqas minn 30 mg/ġimgħa).
English: - Renal function should be monitored via renal function tests and urinanalysis (see sections 4.2 and 4.3).
Maltese: - Il-funzjoni tal-kliewi trid tiġi monitorata permezz tat-testijiet tal-funzjoni tal-kliewi u b'urinanaliżi (ara sezzjonijiet 4.2 u 4.3).
English: Nordimet contains sodium
Maltese: Nordimet fih is-sodium
English: The combined use of methotrexate and leflunomide may increase the risk for pancytopenia.
Maltese: L-użu kombinat ta' methotrexate u leflunomide jista' jżid ir-riskju ta' panċitopenija.
English: - Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease.
Maltese: - Stomatite, ulċeri tal-kavità orali u mard ta' ulċeri gastrointestinali attivi magħrufa.
English: Approximately 10% of the administered methotrexate is metabolised intrahepatically.
Maltese: Madwar 10% ta' methotrexate mogħti jiġi metabolizzat ġol-fwied.
English: Symptoms include leukocytopenia, thrombocytopenia, anaemia, pancytopenia, neutropenia, bone marrow depression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration and gastrointestinal bleeding.
Maltese: Is-sintomi jinkludu lewkoċitopenija, tromboċitopenija, anemija, panċitopenija, newtropenija, depressjoni tal-mudullun, mukosite, stomatite, ulċerazzjoni orali, dardir, remettar, ulċerazzjoni gastrointestinali u emorraġija gastrointestinali.
English: See also section “Pregnancy, breast-feeding and fertility”.
Maltese: Ara wkoll it-taqsima “Tqala, treddigħ u fertilità”.
English: Very common: Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and bilirubin).
Maltese: Komuni ħafna: Testijiet tal-funzjoni tal-fwied abnormali (żieda fil-livelli ta' ALAT, ASAT, alkaline phosphatase u bilirubina).
English: The adverse toxic effects of methotrexate mainly affect the haematopoietic and gastrointestinal system.
Maltese: L-effetti tossiċi avversi ta' methotrexate jaffettwaw prinċipalment is-sistema ematopojetika u gastrointestinali.
English: Very rare: Agranulocytosis, severe courses of bone marrow depression, lymphoproliferative disorders (see “description below”).
Maltese: Rari ħafna: Agranuloċitosi, korsijiet severi ta' depressjoni tal-mudullun, disturbi limfoproliferattivi (ara d-“deskrizzjoni hawn isfel”.
English: Prior to using folic acid products, monitoring of vitamin B12 levels is recommended, since folic acid may mask an existing vitamin B12 deficiency, particularly in adults over 50 years of age.
Maltese: B12 hu rakkmandat, peress li folic acid jista' jaħbi d-defiċjenza ta' vitamina B12, partikolarment f'adulti li għandhom aktar minn 50 sena.
English: Other medicines and Nordimet
Maltese: Mediċini oħra u Nordimet
English: - Pregnancy and breast-feeding (see section 4.6).
Maltese: - Tqala u treddigħ (ara sezzjoni 4.6).
English: - Severe renal impairment (creatinine clearance less than 30 ml/min) (see sections 4.2 and 4.4).
Maltese: - Indeboliment sever tal-kliewi (tneħħija ta' kreatinina inqas minn 30 ml/min) (ara sezzjonijiet 4.2
English: Rare: Pulmonary fibrosis, Pneumocystis jiroveci pneumonia, shortness of breath and bronchial asthma, pleural effusion.
Maltese: Fibrożi pulmonari, Pneumocystis jiroveci pnewmonja, qtugħ ta' nifs u ażma bronkjali, effużjoni plewrali.
English: Special caution is required in patients with impaired pulmonary function.
Maltese: Attenzjoni speċjali hi meħtieġa f'pazjenti b'funzjoni pulmonari indebolita.
English: It acts by the competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Maltese: Huwa jaġixxi bl-impediment kompettitiv tal-enzima dihydrofolate reductase u b'hekk jimpedixxi s-sintesi ta' DNA.
English: Half-life may be prolonged to 4 times the normal length in patients with third spaces (pleural effusion, ascites).
Maltese: Il-half-life jista' jiġi mtawwal sa 4 darbiet it-tul normali f'pazjenti bit-tielet spazju (effużjoni plewrali, axxite).
English: Rare: Visual disturbances.
Maltese: Disturbi vaskulari Rari:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http//www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 f'10,000):
English: Hepatobiliary disorders (see section 4.4)
Maltese: Disturbi fil-fwied u fil-marrara (ara sezzjoni 4.4)
English: - Alcohol abuse.
Maltese: - Abbuż mill-alkoħol.
English: Very rare: Loss of libido, impotence, gynaecomastia, oligospermia, impaired menstruation, vaginal discharge.
Maltese: Nuqqas ta' ħajra sesswali, impotenza, ginekomastja, oligospermja, menstruwazzjoni indebolita, tnixxija vaġinali.
English: 12) Discard the used syringe into the sharps bin provided.
Maltese: 2) Poġġi bilqegħda f'pożizzjoni rilassata u komda.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Very rare: lymphoma (see “description” below)
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (li jinkludu ċesti u polipi) Rari ħafna: limfoma (ara “deskrizzjoni” isfel)