FrancophonIA/ELRC3.0 huggingface dataset:
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Maltese: Żidiet ħfief sa moderati li jerġgħu għan-normal, u mingħajr effetti kliniċi assoċjati, fil-uric acid u f'alkaline phosphatase kienu osservati b'mod mhux komuni; żidiet ħfief sa moderati li jerġgħu għannormal, u mingħajr effetti kliniċi assoċjati, f'lactate dehydrogenase, kienu osservati b'mod mhux komuni f'pazjenti li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
English: Single doses of 300 μg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Maltese: Dożi singoli ta' 300 μg/kg ġew amministrati taħt il-ġilda lil numru limitat ta' voluntiera b'saħħithom u pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun mingħajr effetti avversi serji.
English: Figure 1: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Maltese: Figura 1: Profil tal-konċentrazzjoni medjana fis-serum ta' pegfilgrastim u l-għadd assolut ta'
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Maltese: Pazjenti li jiżviluppaw sintomi ta' sindrome ta' tnixxija tal-kapillari għandhom jiġu mmonitorjati mill-qrib u jirċievu kura sintomatika standard, li jistgħu jinkludu ħtieġa għal kura intensiva (ara sezzjoni 4.8).
English: Pegfilgrastim Mundipharma is used in adult patients to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Maltese: Pegfilgrastim Mundipharma jintuża f'pazjenti adulti biex inaqqas id-dewmien ta' newtropenija (għadd baxx ta' ċelluli bojod fid-demm) u l-okkorrenza ta' newtropenija bid-deni (għadd baxx ta' ċelluli bojod fid-demm u deni) li jistgħu jkunu kkawżati minn kimoterapija ċitotossika (mediċini li jeqirdu ċċelluli li jikbru malajr).
English: Mundipharma
Maltese: FARMAĊEWTIKU
English: The safety and efficacy of Pegfilgrastim Mundipharma have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Maltese: Is-sigurtà u l-effikaċja ta' Pegfilgrastim Mundipharma ma ġewx evalwati f'pazjenti li qed jirċievu kimoterapija assoċjata ma' majelosoppressjoni ittardjata eż. nitrosurea.
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Maltese: Intwera li pegfilgrastim u filgrastim għandhom mekkaniżmu ta' azzjoni identiku, u jikkawżaw żieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b'żidiet minuri fil-monoċiti u/jew fil-limfoċiti.
English: - Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Maltese: - Fsada fil-pulmun (emoraġija pulmonari) - Sindrome ta' Stevens-Johnson, li tista' tidher bħala rqajja' ċirkulari ħomor li jixbhu l-bersalli, ħafna drabi b'infafet ċentrali fuq it-torso, tqaxxir tal-ġilda, ulċeri fil-ħalq, il-griżmejn, limnieħer, il-ġenitali u l-għajnejn u li tista' tibda b'deni u sintomi li jixbhu l-influwenza.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Għalhekk, id-daqs talmilsa għandu jiġi mmonitorjat b'attenzjoni (pereżempju b'eżaminazzjoni klinika, b'eżami ultrasoniku).
English: NN:
Maltese: Importanti:
English: For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting.
Maltese: Għal injezzjoni aktar komda, ħalli s-siringa mimlija għal-lest fit-temperatura tal-kamra għal madwar 30 minuta qabel tinjetta.
English: Acute
Maltese: Pożoloġija
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija rikombinanti tad-DNA segwita minn konjugazzjoni ma' polyethylene glycol (PEG). ** Il-konċentrazzjoni hija ta' 20 mg/mL jekk jiġi inkluż l-porzjon ta' PEG.
English: What Pegfilgrastim Mundipharma looks like and contents of the pack Pegfilgrastim Mundipharma is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Maltese: Kif jidher Pegfilgrastim Mundipharma u l-kontenut tal-pakkett Pegfilgrastim Mundipharma huwa soluzzjoni ċara u bla kulur għall-injezzjoni ġo siringa mimlija għallest (6 mg/0.6 ml).
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon
Maltese: - jekk int jkollok reazzjoni allerġika inkluż indeboliment, tbaxxija tal-pressjoni tad-demm, diffikultà biex tieħu nifs, nefħa fil-wiċċ (anafilassi), ħmura u fwawar, raxx tal-ġilda u partijiet tal-ġilda minfuħin li jqabbduk il-ħakk - jekk ikollok sogħla, deni u diffikultà biex tieħu nifs.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fi studji fl-annimali, l-għoti ta' pegfilgrastim ma' 5-fluorouracil (5-FU) jew anti-metaboliti oħra wera żieda fil-majelosoppressjoni.
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Maltese: Pass 1: Preparazjoni A Neħħi it-trej tas-siringa mimlija għal-lest mill-pakkett u iġbor l-affarjiet li għandek bżonn għall-injezzjoni: biċċiet bl-alkoħol, ballun tat-tajjar jew garża, stikka u kontenitur għar-rimi ta' sharps (mhux inklużi).
English: There is no evidence that such an interaction would be harmful.
Maltese: M'hemm l-ebda evidenza li interazzjoni bħal din tista' tkun ta' ħsara.
English: In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy.
Maltese: Fi provi kliniċi, pegfilgrastim ingħata mingħajr problemi 14-il jum qabel il-kimoterapija.
English: - coughing up blood (haemoptysis).
Maltese: - tisgħol id-demm (empotisi)
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Maltese: Din iż-żieda taċ-ċelluli bojod hija temporanja, tipikament osservata 24 sa 48 siegħa wara l-għoti u hija konsistenti mal-effetti farmakodinamiċi ta' dan il-prodottt mediċinali.
English: - Bleeding from the lung (pulmonary haemorrhage).
Maltese: (pulmonite interstizjali, edema fil-pulmun,
English: mundipharma@mundipharma.dk
Maltese: OĦRAJN Mundipharma
English: Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Maltese: infiltrati fil-pulmun u fibrosi fil-pulmun) Emoptisi
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il-fattur uman li jistimola l-kolonji ta' granuloċiti (G-CSF) huwa glikoproteina li tirregola lproduzzjoni u l-ħelsien ta' newtrofili mill-mudullun.
English: Syringe label Used syring barrel
Maltese: Tarka protettiva tassiringa Molla protettiva tallabra
English: Renal and urinary Disorders
Maltese: Disturbi fil-kliewi jew sistema urinarja
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: Il-fattur li jistimola l-kolonji ta' granuloċiti jista' jippromwovi it-tkabbir ta ċelluli majelojdi in vitro u effetti simili jistgħu jiġu osservati f'xi ċelluli mhux majelojdi in vitro.
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF (see section 4.8).
Maltese: Fil-parti l-kbira tal-każijiet l-aortite kienet iddijanjostikata permezz ta' skan CT u ġeneralment għebet wara l-irtirar ta' G-CSF (ara sezzjoni 4.8).
English: (difference 0.23 days, 95 % CI −0.15, 0.63).
Maltese: (differenza ta' 0.23 jum, 95 % CI -0.15, 0.63). Matul l-istudju kollu, ir-rata ta' newtropenija bid-deni kienet ta' 13 % tal-pazjenti kkurati b'pegfilgrastim mqabbla ma' 20 % tal-pazjenti kkurati b'filgrastim (differenza ta' 7 %, 95 % CI ta' - 19 %, 5 %).
English: After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TALPRODOTT MEDIĊINALI
English: Other medicines and Pegfilgrastim Mundipharma
Maltese: INFORMAZZJONI BIL-BRAILLE Pegfilgrastim Mundipharma
English: Belly
Maltese: Sentejn
English: The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
Maltese: L-avvenimenti avversi kienu simili għal dawk f'individwi jirċievu dożi aktar baxxi ta' Pegfilgrastim.
English: For more information, see section 5.1
Maltese: Għal aktar informazzjoni, are sezzjoni 5.1. Eċċipjent b'effett magħruf
English: România Egis Pharmaceuticals PLC România Tel: +40
Maltese: Egis Pharmaceuticals PLC România Tel: +40 21 412 00 17 office@egis.ro
English: Upper arm
Maltese: Labra użata
English: • Pegfilgrastim Mundipharma is given as an injection into the tissue just under the skin (subcutaneous injection).
Maltese: • Pegfilgrastim Mundipharma jingħata bħala injezzjoni fit-tessut ta' taħt il-ġilda (injezzjoni taħt il-ġilda).
English: 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of −16.8 %,−1.1 %).
Maltese: Ir-rata totali ta newtropenija biddeni kienet ta' 9 % tal-pazjenti kkurati b'pegfilgrastim u 18 % tal-pazjenti kkurati b'filgrastim (differenza ta' 9 %, 95 % CI ta' -16.
English: Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ Pegfilgrastim Mundipharma should be administered at least 24 hours after administration of cytotoxic chemotherapy.
Maltese: Minħabba s-sensittività potenzjali għall-kimoterapija ċitotossika ta' ċelluli majelojdi li qed jiddividu malajr, Pegfilgrastim Mundipharma għandu jingħata mill-inqas 24 siegħa wara l-għoti ta' kimoterapija ċitotossika.
English: Pegfilgrastim Mundipharma contains sorbitol (E 420) and sodium acetate This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.
Maltese: Pegfilgrastim Mundipharma fih sorbitol (E 420) u sodium acetate.
English: Norge Mundipharma AS Tlf:
Maltese: Fuljett ta' tagħrif:
English: Accidental exposure to freezing temperatures for two periods of less than 72 hours each does not adversely affect the stability of Pegfilgrastim Mundipharma.
Maltese: Esponiment aċċidentali għal temperaturi tal-friża għal żewġ perijodi ta' inqas minn 72 siegħa l-wieħed ma jaffettwax ħażin l-istabbilità ta' Pegfilgrastim Mundipharma.
English: Thrombocytope nia1
Maltese: - problemi biex tieħu n-nifs.
English: Luxembourg/Luxemburg Mundipharma Comm. VA Tél/Tel: +32 15 45 11 80 info@mundipharma.be
Maltese: Luxembourg/Luxemburg Mundipharma Comm. VA Tél/Tel:
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 tal-effett addittiv ta' prodotti mogħtija fl-istess ħin li jkun fihom sorbitol (jew fructose) u l-konsum fid-dieta ta' sorbitol (jew fructose).
English: office@egis.ro
Maltese: F'dan il-fuljett
English: How to store Pegfilgrastim Mundipharma 6.
Maltese: Kif għandek tuża Pegfilgrastim Mundipharma?
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq it-tikketta tas-siringa (wara EXP).
English: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).
Maltese: Pegfilgrastim ma affettwax il-ħila riproduttiva jew il-fertilità fil-ġrieden irġiel jew nisa b'dożi kumulattivi ta' kull ġimgħa ta' madwar 6 sa 9 darbiet ogħla mid-doża rakkomandata fil-bniedem (ibbażat fuq l-erja superfiċjali tal-ġisem) (ara sezzjoni 5.3).
English: Non-cardiac chest pain 1
Maltese: Uġigħ fis-sit talinjezzjoni, Uġigħ fis-sider li mhux kardijaku 1
English: In such circumstances Pegfilgrastim Mundipharma should be discontinued at the discretion of the physician and the appropriate treatment given (see section 4.8).
Maltese: F'ċirkostanzi bħal dawn Pegfilgrastim Mundipharma għandu jitwaqqaf skont il-parir tattabib u għandha tingħata l-kura addattata (ara sezzjoni 4.8).
English: The safety and efficacy of Pegfilgrastim Mundipharma have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Maltese: Is-sigurtà u l-effikaċja ta' Pegfilgrastim Mundipharma ma ġewx investigati f'pazjenti b'sindrome majelodisplastiku, lewkimja majeloġenika kronika, u f'pazjenti b'AML sekondarja; għalhekk, Pegfilgrastim Mundipharma m'għandux jintuża f'dawn il-pazjenti.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Maltese: Tagħrif ta' qabel l-użu kliniku miġbur minn studji konvenzjonali tal-effett tossiku minn dożi riptetuti, wera l-effetti farmakoloġiċi mistennija fosthom żidiet fl-għadd ta' lewkoċiti, iperplasija majelojde filmudullun, ematopojesi ekstramedullari u tkabbir tal-milsa.
English: Elevations in lactate dehydrogenase and alkaline phosphatase1; Transient elevations in LFT's for ALT or AST1 1 See section “Description of selected adverse reactions” below.
Maltese: Żidiet f'lactate dehydrogenase u alkaline phosphatase 1;
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Maltese: L-eliminazzjoni ta' pegfilgrastim mhux lineari mad-doża; u r-rata ta' tneħħija mis-serum ta' pegfilgrastim tonqos hekk kif tiżdied id-doża.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Maltese: B IMBOTTA l-planġer bil-mod u b'pressjoni konstanti sakemm tħoss u tisma “tfaqqiha”.
English: (See section 6.6)
Maltese: (Ara sezzjoni 6.6)
English: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne FRANCE
Maltese: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne Franza
English: Date of latest renewal: 27/08/2018
Maltese: Data tal-aħħar tiġdid: 27/08/2018
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/156/001-035
Maltese: EU/2/13/156/001-035
English: Permethrin is a synthetic pyrethroid.
Maltese: Permethrin huwa pyrethroid sintetiku.
English: 1 spot-on applicator 3 spot-on applicators 4 spot-on applicators 6 spot-on applicators 12 spot-on applicators 24 spot-on applicators 48 spot-on applicators
Maltese: 3 applikaturi lokalizzati 4 applikaturi lokalizzati 6 applikaturi lokalizzati 12-il applikatur lokalizzat 24 applikatur lokalizzat 48 applikatur lokalizzat
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04/12/2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04/12/2013
English: Dinotefuran is an insecticide.
Maltese: Dinotefuran huwa insettiċida.
English: Pack sizes:
Maltese: Mekkaniżmi ta' azzjoni:
English: Each spot-on applicator contains dinotefuran 44 mg / pyriproxyfen 3.9 mg / permethrin 317 mg Each spot-on applicator contains dinotefuran 87 mg / pyriproxyfen 7.7 mg / permethrin 635 mg Each spot-on applicator contains dinotefuran 196 mg / pyriproxyfen 17.4 mg / permethrin 1429 mg Each spot-on applicator contains dinotefuran 256 mg / pyriproxyfen 22.7 mg / permethrin 1865 mg Each spot-on applicator contains dinotefuran 436 mg / pyriproxyfen 38.7 mg / permethrin 3175 mg
Maltese: Kull applikatur lokalizzat fih dinotefuran 44 mg / pyriproxyfen 3.9 mg / permethrin 317 mg Kull applikatur lokalizzat fih dinotefuran 87 mg / pyriproxyfen 7.7 mg / permethrin 635 mg Kull applikatur lokalizzat fih dinotefuran 196 mg / pyriproxyfen 17.4 mg / permethrin 1429 mg Kull applikatur lokalizzat fih dinotefuran 256 mg / pyriproxyfen 22.7 mg / permethrin 1865 mg Kull applikatur lokalizzat fih dinotefuran 436 mg / pyriproxyfen 38.7 mg / permethrin 3175 mg
English: Pyriproxyfen is a photostable insect growth regulator (IGR).
Maltese: Pyriproxyfen huwa r-regolatur ta' żvilupp fotostabbli tal-insett (IGR-Insect Growth Regulator).
English: 1 applicator of
Maltese: Applikatur 1 ta'
English: Cardboard box of 1, 3, 4, 6, 12, 24 or 48 spot-on applicators of 0.8 ml, 1.6 ml, 3.6 ml, 4.7 ml or 8.0 ml.
Maltese: Kaxxa tal-kartun b'applikatur lokalizzat 1, 3, 4, 6, 12, 24, jew 48 ta' 0.8 ml, 1.6 ml, 3.6 ml, 4.7 ml jew 8.0 ml
English: Permethrin is acaricide and insecticide.
Maltese: Permethrin huwa akariċida u insettiċida.
English: Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg permethrin.
Maltese: Kull ml fih 54 mg dinotefuran, 4.84 mg pyriproxyfen u 397 mg permethrin.
English: Spot-on use.
Maltese: Użu lokalizzat.
English: ADVICE ON CORRECT ADMINISTRATION Administration:
Maltese: B'MOD KORRETT Amministrazzjoni:
English: for dogs 1.5-4 kg
Maltese: għal klieb 1.5-4 kg
English: Treatment and prevention of flea infestation (Ctenocephalides felis and Ctenocephalides canis).
Maltese: Kura u prevenzjoni għall-infestazzjoni minn briegħed (Ctenocephalides felis u Ctenocephalides canis).
English: A synergistic effect was observed in vitro when dinotefuran was administered in conjunction with permethrin, leading to a faster onset of insecticidal activity in vivo.
Maltese: Effett sinerġistiku ġie osservat in vitro meta dinotefuran kien amministrat flimkien ma' permethrin, li wassal għal dħul aktar ta' malajr ta' attività insettiċida in vivo.
English: Transient cosmetic effects (wet appearance, spiking of hair coat and deposits) at the application site have been reported very rarely, however these effects are usually not noticeable after 48 hours.
Maltese: Effetti kosmetiċi temporanji (dehra mxarrba, ix-xagħar tal-ġilda jiġi f'ponta u depożiti) fis-sit t'applikazzjoni ġew rapportati b'mod rari ħafna, madanakollu dawn l-effetti ġeneralment ma jiġux innotati wara 48 siegħa.
English: Teal
Maltese: Isfar
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Maltese: U KWANTITATTIVA Sustanzi attivi:
English: N-methylpyrrolidone, an excipient in the veterinary medicine, has been shown to cause foetal malformations leading to birth defects in laboratory animals.
Maltese: N-methylpyrrolidone, eċċipjent fil-mediċina veterinarja, intwera li jista' jikkaġuna mankamenti lillfetu li jwasslu għal difetti mit-twelid f'annimali tal-laboratorju.
English: It prevents biting from sand flies (Phlebotomus perniciosus), mosquitoes (Culex pipiens, Aedes aegypti) and from stable flies (Stomoxys calcitrans) for one month post-application.
Maltese: Huwa jipprevjeni gdim minn sand flies (Phlebotomus perniciosus), żunżan (Culex pipiens, Aedes aegypti) u minn żunżan tal-istalel (Stomoxys calcitrans) għal xahar wara l-applikazzjoni.
English: Blue for dogs > 25-40 kg
Maltese: Blu għal klieb > 25-40 kg
English: Incompatibilities: None known.
Maltese: Inkompatibilitajiet:
English: N-methylpyrrolidone, an excipient in the veterinary medicinal product, has shown to be teratogenic in laboratory animals.
Maltese: N-methylpyrrolidone, eċċipjent fil-prodott mediċinali veterinarju, intwera li jista' jikkaġuna mankamenti lill-fetu f'annimali tal-laboratorju.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' reazzjonijiet avversi huma mfissra permezz tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn 1 f'10 annimali trattati li juri reazzjoni(jiet) avvers(a/i)) - komuni (aktar minn 1 imma inqas minn 10 annimali f'100 annimal trattat) - mhux komuni (aktar minn 1 imma inqas minn 10 annimali f'1,000 annimal trattat) - rari (aktar minn 1 imma inqas minn 10 annimali f'10,000 annimal trattat) - rari ħafna (inqas minn animal 1 f'10,000 animal, li jinkludu rapporti iżolati trattat)
English: Remove the spot-on applicator from the pack.
Maltese: Neħħi l-applikatur lokalizzat minn ġol-pakkett.
English: Vectra 3D for dogs > 40 kg
Maltese: Vectra 3D għal klieb > 40 kg
English: Behavioural disorders such as hyperactivity, vocalisation or anxiety, systemic signs such as lethargy or anorexia, and neurological signs such as muscle tremor have been reported in rare cases.
Maltese: Disturbi komportamentali bħal iperattività, vokalizzazzjoni jew ansjetà, sinjali sistemiċi bħal letarġija jew anoressija, u sinjali newroloġiċi bħal rogħda fil-muskoli ġew rapportati b'mod rari.
English: Permethrin repels and kills parasites by targeting their nervous system, leading to hyperexcitability (hot-foot effect for ticks), and resulting to knock-down, anti-attachment and anti-feeding actions against parasites.
Maltese: Permethrin jbiegħed u joqtol il-parasiti billi jimmira għas-sistema nervuża tagħhom, li jwassal għal ipereċitabilità (effett ta' saqajn sħan fil-qurdien), u li jirriżulta f'waqgħa f'zopptu, nuqqas ta' twaħħil u azzjonijiet kontra t-teħid ta' ikel kontra l-parasiti.
English: OR
Maltese: IEĦOR
English: Following topical application, dinotefuran and pyriproxyfen are partially absorbed through the dog's skin leading to systemic exposure.
Maltese: Wara applikazzjoni topika, dinotefuran u pyriproxyfen huma assorbiti parzjalment minn ġol-ġilda tal-kelb li jwassal għal esponiment sistemiku.
English: The minimum recommended dose is 6.4 mg dinotefuran/kg body weight, 0.6 mg pyriproxyfen/kg body weight and 46.6 mg permethrin/kg body weight, equivalent to 0.12 ml of the veterinary medicine per kg body weight.
Maltese: Id-doża minima rakkomandata hi ta' 6.4 mg dinotefuran/kg ta' piż tal-ġisem, 0.6 mg pyriproxyfen/kg piż tal-ġisem u 46.6 mg permethrin/kg piż tal-ġisem, ekwivalenti għal 0.
English: Red For the full list of excipients, see section 6.1.
Maltese: Aħmar Għal-lista sħiħa tal-ingredienti (mhux attivi), ara sezzjoni 6.1
English: Purple for dogs > 40 kg
Maltese: Vjola għal klieb > 40 kg
English: To avoid adverse reactions:
Maltese: Biex tevita reazzjonijiet avversi:
English: Applicator to be used for dogs 1.5-4 kg
Maltese: Applikatur li għandu jintuża għal klieb 1.5-4 kg
English: The veterinary medicine repels (prevents biting) flying insects such as sand flies (Phlebotomus perniciosus), mosquitoes (Culex pipiens, Aedes aegypti) and stable flies (Stomoxys calcitrans) for one month after use.
Maltese: Sand flies, nemus u żunżan tal-istalel Il-prodott mediċinali veterinarju jbiegħed (jevita l-gdim) insetti li jtiru bħal sand flies (Phlebotomus perniciosus), nemus (Culex pipens, Aedes aegypti) u żunżan tal-istalel (Stomoxys calcitrans) għal xahar wara l-użu).