FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 1.07 ml of solution contains: Fipronil 67 mg, (S)-Methoprene 60.3 mg, Amitraz 80 mg
Maltese: Kull 1.07 ml ta' soluzzjoni fih: Fipronil 67mg, (S)-Methoprene 60.3 mg, Amitraz 80mg
English: Dose:
Maltese: Doża eċċessiva:
English: The mean maximum concentration (Cmax): 19 ng/ml in plasma found after 5 days (Tmax).
Maltese: Il-konċentrazzjoni massima medja (Cmax): 19 ng/ml fil-plażma li nstabet wara 5 ijiem (Tmax).
English: (S)-Methoprene is extensively degraded into carbon dioxide and acetate that are subsequently incorporated into endogenous materials.
Maltese: (S)-Methoprene jiġi degradat b'mod estensiv f'carbon dioxide u acetate li sussegwentament jiġu
English: Each unit dose (dual cavity pipette) delivers:
Maltese: Kull doża tal-unità (pipetta b'kavità doppja) tforni:
English: BATCH NUMBER {number}
Maltese: NUMRU TAL-LOTT {numru}
English: CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg
Maltese: CERTIFECT 67 mg/ 60.3 mg/ 80 mg soluzzjoni spot-on għal klieb 2-10 kg
English: The combination of amitraz and fipronil acts on multiple sites of the nervous systems of ticks.
Maltese: Il-kombinazzjoni ta' amitraz u fipronil taġixxi fuq siti multipli tas-sistemi nervużi tal-qurdien.
English: Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family.
Maltese: Fipronil huwa insettiċida u akariċida li jappartjeni għall-familja ta' phenylpyrazole.
English: dogs 2-10 kg dogs 10-20 kg dogs 20-40 kg dogs 40-60 kg
Maltese: klieb 2-10 kg klieb 10-20 kg klieb 20-40 kg klieb 40-60 kg
English: Dogs 10-20 kg Dogs 20-40 kg Dogs 40-60 kg
Maltese: Klieb 10-20 kg Klieb 20-40 kg Klieb 40-60 kg
English: Spot-on application only.
Maltese: Mhux Applikabbli.
English: Fipronil and its metabolite fipronil sulfone act at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA) as well as desensitising (D) and nondesensitising (N) channels gated by glutamate (Glu, unique invertebrate ligand-gated chloride channels), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Maltese: Fipronil u l-metabolit fipronil sulfone jaġixxu fil-kanali ta' ligand-gated chloride, b'mod partikulari dawk miftuħa min-newrotrasmettitur gamma-aminobutyric acid (GABA) kif ukoll minn kanali ta' desensitizzazzjoni (D) u nondesensitizzazzjoni (N) miftuħa minn glutamate (Glu, kanali ta' ligand-gated chloride ta' invertebrati), b'hekk jiġi mblukkat it-trasferiment tal-joni tal-chloride tul il-membrani taċ-ċelluli qabel u wara t-trasferiment sinattiku.
English: Low levels of N-methyl-N'-(2,4-xylyl) formamidine were detectable for 30 days after dosing.
Maltese: Livelli baxxi ta' N-methyl-N'-(2,4-xylyl) formamidine baqgħu jiġu intraċċati għal 30 jum wara d-dożaġġ.
English: Each 2.14 ml of solution contains: Fipronil 134 mg, (S)-Methoprene 120.6 mg, Amitraz 160 mg Each 4.28 ml of solution contains: Fipronil 268 mg, (S)-Methoprene 241.2 mg, Amitraz 320 mg Each 6.42 ml of solution contains: Fipronil 402 mg, (S)-Methoprene 361.8 mg, Amitraz 480 mg
Maltese: Kull 2.14 ml ta' soluzzjoni fih: Fipronil 134mg, (S)-Methoprene 120.6 mg, Amitraz 160mg Kull 4.28 ml ta' soluzzjoni fih: Fipronil 268mg, (S)-Methoprene 241.2 mg, Amitraz 320mg Kull 6.42 ml ta' soluzzjoni fih: Fipronil 402mg, (S)-Methoprene 361.8 mg, Amitraz 480mg
English: Studies have demonstrated that there is no pharmacodynamic and pharmacokinetic interaction in mammals between fipronil, (S)-methoprene and amitraz.
Maltese: L-istudji wrew li m'hemm l-ebda interazzjoni farmakodinamika u farmakokinetika f'mammali bejn fipronil, (S)-methoprene u amitraz.
English: CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg
Maltese: CERTIFECT 134 mg/ 120.6 mg/ 160 mg soluzzjoni spot-on għal klieb 10-20 kg CERTIFECT 268 mg/ 241.2 mg/ 320 mg soluzzjoni spot-on għal klieb 20-40 kg CERTIFECT 402 mg/ 361.8 mg/ 480 mg soluzzjoni spot-on għal klieb 40-60 kg
English: Lethargy, ataxia, emesis, anorexia, diarrhoea, excessive salivation, hyperglycaemia, increased sensitivity to stimulation, bradycardia or bradypnea may be observed.
Maltese: Jistgħu jiġu osservati letarġija, ataksja, dardir, anoreksja, dijarea, salivazzjoni eċċessiva, , ipergliċemija, sensittività miżjuda għal stimulazzjoni, bradikardija jew bradipneja.
English: Amitraz is a formamidine acaricide that acts as an agonist on octopamine receptors causing an overstimulation of octopaminergic synapses in acari, resulting in tremors and convulsions.
Maltese: Amitraz huwa formamidine acaricide li jaġixxi bħala agonista fuq riċetturi octopamine u dan jikkawża stimulazzjoni eċċessiva ta' sinapsi oktopaminerġiċi f'akari, li jwassal għal rogħda u konvulżjonijiet.
English: Excipients essential for proper administration: butylhydroxyanisole (0.02 %) and butylhydroxytoluene
Maltese: Butylhydroxyanisole (E320) Butylhydroxytoluene (E321) Ethanol, anidruż
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: METHOD AND ROUTE OF ADMINISTRATION Spot-on use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu spot-on.
English: CERTIFECT spot-on solution
Maltese: CERTIFECT soluzzjoni għall-użu lokalizzat
English: EXPIRY DATE {month/year}
Maltese: DATA TA' SKADENZA {xahar/sena}
English: 5.2 Pharmacokinetic particulars
Maltese: TAL-PRODOTT MEDIĊINALI
English: They may consist of hypersalivation, vomiting, lethargy, hyperglycaemia, bradycardia or bradypnea.
Maltese: Jistgħu jikkonsistu minn salivazzjoni eċċessiva, rimettar, letarġija, ipergliċemija, bradikardija jew bradipneja.
English: Avoid direct contact with the application site.
Maltese: Evita kuntatt dirett mas-sit tal-applikazzjoni.
English: Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during the first month after treatment).
Maltese: Fipronil sulfone jiġi prodott fuq il-pil (konċentrazzjonijiet medji ta' < 16 % ta' fipronil matul
English: For the full list of excipients, see section 6.1.
Maltese: Għal- lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOIcontaining medication should take particular care and avoid direct contact with the product.
Maltese: Amitraz huwa monoamine oxidase inhibitor (MAOI); għaldaqstant, nies li jieħdu medikazzjoni li fiha MAOI għandhom joqogħdu attenti ħafna u jevitaw kuntatt dirett mal-prodott.
English: Volume of unit dose (ml)
Maltese: Volum ta' doża unika (ml)
English: This veterinary medicinal product contains amitraz, which can lead to neurological side-effects in
Maltese: Dan il-prodott mediċinali veterinarju fih amitraz, li jista' jwassal għal effetti sekondarji newroloġiċi fin-nies.
English: Fipronil sulfone decreased to concentrations of < 0.6 μg/g by 58 days after topical application.
Maltese: Fipronil sulfone naqas għal konċentrazzjonijiet ta' < 0.6 μg/g wara 58 jum wara l-applikazzjoni fuq il-ġilda.
English: The risk of developing canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis for 4 weeks is thereby
Maltese: Ir-riskju ta' żvilupp ta' canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis u borreliosis għal 4 ġimgħat huwa għaldaqstant imnaqqas b'mod indirett.
English: The recommended minimum dose is 6.7 mg/kg bodyweight (b.w.)
Maltese: Id-doża minima rrakkomandata hija 6.7 mg/kg ta' piż tal-ġisem (b.w.) għal fipronil, 6 mg/kg għal
English: The veterinary medicinal product is an insecticidal and acaricidal solution for topical use, containing adulticidal active ingredients, fipronil and amitraz, in combination with an ovicidal and larvicidal
Maltese: Il-prodott mediċinali veterinarju huwa soluzzjoni insettiċidjali u akariċidjali għall-użu fuq il-ġilda, li fiha s-sustanzi attivi adultiċidjali, fipronil u amitraz, f'kombinazzjoni ma' sustanza attiva oviċidjali u
English: If symptoms are severe or persist, alternatively the antidote alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used.
Maltese: Jekk is-sintomi jkunu severi jew jippersistu, minflok ikun jista' jintuża l-antidotu alpha-2-adreno-receptor antagonist atipamezole hydrochloride.
English: The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Maltese: Il-prodott jista' jintuża bħala parti minn strateġija ta' kura għall-kontroll ta' Dermatite ta' Allerġija għall-Briegħed (FAD - Flea Allergy Dermatitis).
English: This results in uncontrolled activity of the central nervous system and death of insects or acari.
Maltese: Dan jirriżulta f'attività mhux ikkontrollata tas-sistema nervuża ċentrali u l-mewt ta' insetti u akari.
English: (S)-Methoprene and Amitraz: Dermal absorption is very low and all plasma concentrations were below the limit of quantification (10 ng/ml) for (S)-methoprene and were undetectable for amitraz (< 0.75 ng/ml) in most samples.
Maltese: L-assorbiment mill-ġilda huwa baxx ħafna u l-konċentrazzjonijiet kollha tal-plażma kienu taħt il-limitu ta' kwantifikazzjoni (10 ng/ml) għal (S)-methoprene u ma setgħux jiġu osservati għal amitraz (< 0.75 ng/ml) fil-biċċa l-kbira mill-kampjuni.
English: carton box 3 pipettes
Maltese: Mhux applikabbli
English: The recommended minimum dose is 6.7 mg/kg bodyweight for fipronil, 6 mg/kg for (S)-methoprene and 8 mg/kg for amitraz.
Maltese: Id-doża minima rrakkomandata hija 6.7 mg/kg piż tal-ġisem għal fipronil, 6 mg/kg għal
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Maltese: Aħżen fil-pakkett oriġinali
English: The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for 4 weeks.
Maltese: Il-kura tnaqqas indirettament ir-riskju ta' trasmissjoni ta' mard li jinġarr mill-qurdien (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis u borreliosis) minn qurdien infettat għal
English: For the 2.14 ml, 4.28 ml or 6.42 ml pipette: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Maltese: Għall-pipetta ta' 2.14 ml, 4.28 ml jew 6.42 ml:
English: Signs are transitory and generally resolve without treatment within 24 hours.
Maltese: Is-sinjali huma temporanji u ġeneralment jgħibu mingħajr kura fi żmien 24 siegħa.
English: Treatment of infestations by chewing lice (Trichodectes canis).
Maltese: Kura ta' infestazzjonijiet b'qamel li jgerrem (Trichodectes canis).
English: If symptoms are severe or persist alternatively use antidote (atipamezole hydrochloride).
Maltese: Jekk is-sintomi jkunu severi jew jippersistu, uża antidotu (atipamezole hydrochloride).
English: 4.1 Target species
Maltese: 6.1 Lista ta' ingredjenti
English: This veterinary medicinal product may cause skin sensitisation, allergic reactions and mild eye irritation in humans.
Maltese: Dan il-prodott mediċinali veterinarju jista' jikkawża sensitizzazzjoni tal-ġilda, reazzjonijiet allerġiċi u irritazzjoni ħafifa fl-għajnejn fil-bnedmin.
English: In very rare instances, certain sensitive dogs may develop skin irritation at the application site.
Maltese: F'każijiet rari ħafna, ċerti klieb sensittivi jistgħu jiżviluppaw irritazzjoni tal-ġilda fis-sit tal-applikazzjoni.
English: Clear amber to yellowish solution.
Maltese: Soluzzjoni ċara kulur l-ambra sa tagħti fl-isfar.
English: 3 pipettes
Maltese: FIL-PAKETT
English: Fipronil's major metabolite on the haircoat of the dog and in the blood stream is the sulfone derivative.
Maltese: Il-metabolit maġġuri ta' fipronil fuq il-pil tal-kelb u fiċ-ċirkolazzjoni tad-demm huwa d-derivattiv ta' sulfone.
English: Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses up to 3 times the maximum recommended dose.Safety has been also demonstrated with up to 5 times the recommended dose in healthy adult dogs (treated up to 6 times at two-week intervals) and in puppies (aged 8 weeks treated once).
Maltese: Is-sigurtà ntweriet b'sa 5 darbiet id-doża rakkomandata fi klieb adulti b'saħħithom ikkurati sa 6 darbiet f'intervalli ta' kull ġimagħtejn) u fi ġriewi (ta' 8 ġimgħat ikkurati darba).
English: 6.5 Nature and composition of immediate packaging Purple dual chamber pipette: The primary packaging is composed of two heat-formed polyolefin chambers with a central polyolefin-coated aluminium partition.
Maltese: L-ippakkjar ewlieni hu magħmul minn żewġ kompartimenti tal-polyolefin iffurmati bis-sħana b'partition ċentrali tal-aluminju miksija bil-polyolefin.
English: Overdose:
Maltese: U KWANTITATTIVA
English: For dogs over 60 kg, use the appropriate combination of two pipettes that most closely matches the bodyweight.
Maltese: Għal klieb li jiżnu iktar minn 60 kg, uża l-kombinazzjoni xierqa ta' żewġ pipetti li l-aktar li taqbel mal-piż tal-ġisem.
English: Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses up to 3 times the maximum recommended dose.
Maltese: Is-sigurtà ntweriet f'annimali tat-tnissil, annimali tqal u annimali li jkunu qegħdin ireddgħu kkurati f'intervalli ta' 28 jum b'dożi konsekuttivi multipli ta' sa 3 darbiet id-doża massima rakkomandata.
English: Plasma concentrations were below 1 ng/ml (limit of quantification) by approximately 33 days following topical administration.
Maltese: Il-konċentrazzjonijiet fil-plażma kienu taħt 1 ng/ml (limitu ta' kwantifikazzjoni) b'madwar 33 jum wara l-applikazzjoni fuq il-ġilda.
English: ATCvet code: QP53AX65.
Maltese: Agħżel id-daqs xieraq tal-pipetta għall-piż tal-kelb.
English: This veterinary medicinal product contains amitraz, which is a monoamine oxidase inhibitor (MAOI); therefore, in the absence of studies, this veterinary medicinal product should not be used on dogs treated with MAOI.
Maltese: Dan il-prodott mediċinali veterinarju fih amitraz, li huwa monoamine oxidase inhibitor (MAOI) għaldaqstant, fin-nuqqas tas-studju dwaru, dan il-prodott mediċinali veterinarju m'għandux jintuża filklieb ikkurati bil-MAOI.
English: Prevention of environmental flea contamination by inhibiting the development of all flea immature
Maltese: Prevenzjoni ta' kontaminazzjoni ambjentali bil-briegħed bl-inibizzjoni tal-iżvilupp tal-fażijiet
English: This veterinary medicinal product contains amitraz, which is a monoamine oxidase inhibitor (MAOI); therefore, in the absence of studies, this veterinary medicinal product should not be used on dogs
Maltese: Dan il-prodott mediċinali veterinarju fih amitraz, li huwa monoamine oxidase inhibitor (MAOI) għaldaqstant, fin-nuqqas tas-studju dwaru, dan il-prodott mediċinali veterinarju m'għandux jintuża fil
English: Elimination of fleas and ticks within 24 hours.
Maltese: L-eliminazzjoni ta' briegħed u qurdien fi żmien 24 siegħa.
English: Safety was also demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses of up to 3 times the maximum recommended dose.
Maltese: Is-sigurtà ntweriet ukoll f'annimali li kien qed jiġu mgħammra, annimali tqal u annimali li jkunu qegħdin ireddgħu ikkurati f'intervalli ta' 28 jum b'dożi konsekuttivi multipli ta' sa 3 darbiet id-doża massima rrakkomandata.
English: Section 4 Possible side effects
Maltese: Sezzjoni 4 Effetti sekondarji possibbli
English: ‘QR code to be included' + <URL>
Maltese: “Għandu jiġi inkluż il-kodiċi QR” + <URL>
English: {Active substance(s)}
Maltese: {Sustanza(i) attiva(i)} TWISSIJA
English: A contraindication should be added as follows: Section 4.3 Contraindications:
Maltese: Sezzjoni 4.3 Kontraindikazzjonijiet:
English: - Pregnancy (see section 4.6) - Women planning a pregnancy
Maltese: - Tqala (ara sezzjoni 4.6) - Nisa li qed jippjanaw tqala
English: Section 4.6 Fertility, pregnancy and breastfeeding:
Maltese: Sezzjoni 4.6 Fertilità, tqala u treddigħ:
English: {(Invented) name strength pharmaceutical form}
Maltese: {Isem (ivvintat) qawwa għamla farmaċewtika}
English: The same information is also available on the following URL: [URL to be included] <and the <NCA> website >>.
Maltese: L-istess informazzjoni hija disponibbli wkoll fuq il-URL li ġej: [għandu jiġi inkluż il-URL] <u s-sit web ta' <NCA> >>.
English: • She understands the teratogenic risk.
Maltese: • Hija tifhem ir-riskju teratoġeniku.
English: For more information on pregnancy and contraception, see section 2 ”Pregnancy and prevention programme”.
Maltese: Għal aktar informazzjoni dwar it-tqala u l-kontraċettiv, ara sezzjoni 2 ”Tqala u programm għall prevenzjoni”.
English: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including <INN>.
Maltese: Ġew irrappurtati dipressjoni, dipressjoni aggravata, ansjetà u bidliet fil-burdata f'pazjenti kkurati b'retinojdi sistemiċi, inkluż <INN>.
English: Mental problems
Maltese: Problemi ta' saħħa mentali
English: The following adverse reaction(s) should be included under the SOC Psychiatric disorders: Rare (may affect up to 1 in 1,000 people):
Maltese: Disturbi psikjatriċi: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000):
English: • Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.
Maltese: • Sinjali ta' psikożi: telf ta' kuntatt mar-realtà, bħal li tisma' vuċijiet jew tara affarijiet li ma jkunux hemm.
English: • Becoming violent or aggressive
Maltese: • Issir vjolenti jew aggressiva
English: You must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom).
Maltese: Inti għandek taqbel li tuża tal-inqas metodu wieħed affidabbli ħafna ta' kontraċettiv (pereżempju apparat ġol-utur jew impjant kontraċettiv), jew żewġ metodi effettivi li jaħdmu b'modi differenti (pereżempju pillola kontraċettiva ormonali u kondom).
English: [for acitretin: ‘every 1 to 3 months for 3 years after stopping <TRADENAME>']
Maltese: [għal acitretin: “kull xahar sa 3 xhur għal 3 snin wara t-twaqqif ta' <ISEM
English: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with <INN> (see section 4.8).
Maltese: sintomi psikotiċi, u f'każijiet rari ħafna, ħsibijiet ta' suwiċidju, tentattivi ta' suwiċidju u suwiċidju f'pazjenti kkurati b'<INN> (ara sezzjoni 4.8).
English: • Depression or related disorders.
Maltese: • Dipressjoni jew disturbi relatati.
English: Pregnancy, breastfeeding and fertility:
Maltese: Tqala, treddigħ u fertilità:
English: • Negative pregnancy test results have been obtained before, during and periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Maltese: • Inkisbu riżultati negattivi tat-tqala qabel, waqt u perjodikament b'intervalli ta' 1-3 kull xahar għal perjodu ta' 3 snin wara t-twaqqif tal-kura.
English: Follow-up visits should be arranged at regular intervals, ideally monthly.
Maltese: Il-visti ta' segwitu għandhom jiġu organizzati f'intervalli regolari, idealment kull xahar.
English: Pregnancy prevention programme
Maltese: Prevenzjoni fit-Tqala Programm għall-Prevenzjoni fit-Tqala
English: Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.
Maltese: Ġew irrappurtati dipressjoni, dipressjoni aggravata, ansjetà, tendenzi aggressivi, bidliet fil-burdata,
English: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mUI/mL are recommended to be performed, as follows.
Maltese: Ittestjar tat-tqala Skont il-prassi lokali, huwa rakkomandat li jsiru testijiet tat-tqala sorveljati medikament b'sensittività minima ta' 25mUI/mL, kif ġej.
English: • She understands the need and accepts to undergo regular pregnancy testing before, ideally monthly during treatment and periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Maltese: • Hija tifhem il-ħtieġa u taċċetta li jsirilha ttestjar tat-tqala regolari qabel, idealment waqt il-kura u perjodikament b'intervalli ta' 1-3 kull xahar għal perjodu ta' 3 snin wara t-twaqqif tal-kura.
English: For women of childbearing potential, the prescription duration of [TRADENAME] should ideally be limited to 30 days in order to support regular follow up, including pregnancy testing and monitoring.
Maltese: Għal nisa li jistgħu joħorġu tqal, id-durata tal-preskrizzjoni ta' [ISEM KUMMERĊJALI] idealment għandha tiġi limitata għal 30 jum sabiex tappoġja s-segwitu, inkluż ittestjar u monitoraġġ tat-tqala.
English: This medicine can seriously harm an unborn baby (the medicine is said to be ‘teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland).
Maltese: KUMMERĊJALI> Din il-mediċina tista' tagħmel ħsara serja lil tarbija mhux imwielda (il-mediċina hija magħrufa li hija “teratoġenika”) - din tista' tikkawża anormalitajiet serji tal-moħħ, wiċċ, widna, għajn, qalb u ċerti glandoli
English: Suicide, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour Package leaflet
Maltese: Suwiċidju, tentattiv ta' suwiċidju, ħsibijiet ta' suwiċidju, disturb psikotiku, imġiba anormali Fuljett ta' tagħrif
English: For all topical retinoids containing adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Maltese: Għar-retinojdi topiċi kollha li fihom dapalene, alitretinoin, isotretinoin, tretinoin u tazarotene, l informazzjoni eżistenti dwar il-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir tat-test, kif xieraq) biex tirrifletti l-kliem maqbul kif previst hawn taħt.
English: Very rare effects (may affect up to 1 in every 10,000 people)
Maltese: Effetti rari ħafna (jistgħu jaffettwaw persuna 1 minn kull 10,000)
English: 1 month after stopping treatment, women should undergo a final pregnancy test.
Maltese: Tmiem il-kura Xahar wara t-twaqqif tal-kura, in-nisa għandu jsirilhom test tat-tqala finali.
English: • The potential for pregnancy must be assessed for all female patients.
Maltese: • Il-potenzjal għat-tqala għandu jiġi vvalutat għall-pazjenti nisa kollha.
English: [TRADENAME] is strictly contraindicated in: - Pregnant women - Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met Pregnancy Prevention Programme This medicinal product is TERATOGENIC [INN] is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Programme are met:
Maltese: Dan il-prodott mediċinali huwa TERATOĠENIKU [INN] huwa kontraindikat f'nisa li jistgħu joħorġu tqal sakemm ma jiġux issodisfati l-kundizzjonijiet li ġejjin tal-Programm għall-Prevenzjoni fit-Tqala: • [indikazzjonijiet approvati] (ara sezzjoni 4.1 “Indikazzjonijiet terapewtiċi”).
English: <Detailed and updated information on this product is available by scanning the QR code included in the PL with a smartphone.
Maltese: <Informazzjoni ddettaljata u aġġornata dwar dan il-prodott hija disponibbli billi tiskennja l-kodiċi QR inkluż fil-fuljett ta' tagħrif bi smartphone.
English: Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Maltese: Fejn indikat, testijiet tat-tqala ta' segwitu għandhom isiru fil-jum tal-vista tar-riċetta jew fit-3 ijiem qabel ilvista lill-preskrivent.
English: The following boxed warning should be included in the PL for the oral retinoids acitretin, alitretinoin and isotretinoin, under the invented name:
Maltese: Għandha tiġi inkluża s-sentenza li ġejja fi tmiem il-fuljett ta' tagħrif (l-aħħar sentenza):