FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis).
Maltese: Kura ta' infestazzjonijiet b'nematodi gastrointestinali adulti tal-ispeċi li ġejjin: roundworms (Toxocara canis u Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense u Ancylostoma ceylanicum ) u whipworm (Trichuris vulpis).
English: No adverse reactions were observed in eight-week old healthy puppies after 6 treatments at up to 5 times the maximum dose.
Maltese: 6 trattamenti sa 5 darbiet id-doża massima.
English: One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Maltese: kaxxa bi blister iffurmata bis-sħana li fiha 1, 3 jew 6 pilloli li jintmagħdu jew 15-il blister iffurmata bis-sħana li fia pillola waħda li tintmagħad.
English: The systemic absorption of afoxolaner is high.
Maltese: Afoxolaner għandu assorbiment sistemiku għoli.
English: A single treatment is effective for the treatment of gastrointestinal nematodes.
Maltese: Kura waħda hija effettiva kontra n-nematode gastrointestinali.
English: Bodyweight (kg) of dog
Maltese: Piż tal ġisem (kg) tal-kelb
English: The selective toxicity of afoxolaner between insects, acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors.
Maltese: It-tossiċità selettiva tal-Afoxolaner bejn insetti, akari u mammiferi tista' tiġi dedotta mis-sensittività differenzjali tar-riċetturi GABA tal-insetti u akari meta mqabbla mar-riċetturi GABA tal-mammiferi.
English: EU/2/14/177/001 - 9 mg/ 2 mg, 1 chewable tablet EU/2/14/177/002 - 9 mg/ 2 mg, 3 chewable tablets EU/2/14/177/003 - 9 mg/ 2 mg, 6 chewable tablets EU/2/14/177/016 - 9 mg/ 2 mg, 15 chewable tablets EU/2/14/177/004 - 19 mg/ 4 mg, 1 chewable tablet EU/2/14/177/005 - 19 mg/ 4 mg, 3 chewable tablets EU/2/14/177/006 - 19 mg/ 4 mg, 6 chewable tablets EU/2/14/177/017 - 19 mg/ 4 mg, 15 chewable tablets
Maltese: EU/2/14/177/016 - 9mg/2mg. 15-il pillola li jintmagħdu EU/2/14/177/004 - 19mg/4mg. pillola 1 li tintmagħad
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.
Maltese: heartworm disease (larvae tad-Dirofilaria immitis ), angiostrongylosis (tnaqqis fil-livell ta' adulti immaturi (L5) u adulti ta' Angiostrongylus vasorum),thelaiosis (adulta tat-Thelazia callipaeda) u/jew il-kura ta' infestazzjonijiet gastrointestinali bin-nematodi hija indikata.
English: NEXGARD SPECTRA kills Dirofilaria immitis larvae (heartworm) up to one month after their transmission by mosquitoes.
Maltese: NEXGARD SPECTRA joqtol il-larvae tad-Dirofilaria immitis (heartworm) sa xahar wara t trażmissjoni tagħhom min-nemus.
English: Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.
Maltese: Prevenzjoni ta' infezzjoni bil-thelaiosis (infezzjoni tal-ghajnejn bit-Thelazia callipaeda fil-forma adulta) b'amministrazzjoni ta' kull xahar.
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 mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu).
English: NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs >30-60 kg afoxolaner / milbemycin oxime Tablets
Maltese: NEXGARD SPECTRA 9 mg/ 2 mg klieb 2−3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg klieb >3.5−7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg klieb > 7.5−15 kg NEXGARD SPECTRA 75 mg/ 15 mg klieb > 15−30 kg NEXGARD SPECTRA 150 mg/ 30 mg klieb > 30−60 kg afoxolaner/milbemycin oxime Pilloli
English: Treatment schedule:
Maltese: Data tal-aħħar tiġdid:
English: Each chewable tablet contains the active substances:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines.
Maltese: Ipereċitazzjoni fit-tul indotta mill-afoxolaner tirriżulta f'attività mhux ikkontrollata tas-sistema nervuża ċentrali u l-mewt ta' insetti u akari.
English: Treatment of flea and tick infestations and gastrointestinal nematodes:
Maltese: Kura ta' infestazzjonijiet bi briegħed u qurdien u gastrointestinali bin-nematodi:
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg).
Maltese: Pilloli ħomor sa kannella fl-aħmar bid-dbabar, b'forma tonda (pilloli għal klieb 2−3.5 kg) jew b'forma rettangolari (pilloli għal klieb >3.5−7.5 kg, pilloli għal klieb >7.5−15 kg, pilloli għal klieb >15−30 kg u pilloli għal klieb > 30−60 kg).
English: This leads to hyperpolarisation of the neuromuscular membrane resulting in paralysis and death of the parasites.
Maltese: Dan jirriżulta f'iperpolarizzazzjoni tal-membrana newromuskolari u paraliżi u l-mewt tal-parassiti.
English: A single treatment is effective for gastrointestinal worms.
Maltese: Kura waħda hija effettiva kontra d-dud gastrointestinali.
English: Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.
Maltese: Prevenzjoni ta' angiostrongylosis (permezz ta' tnaqqis tal-livell tal-infezzjoni b'adult immaturi (L5) u stadji adulti ta' Angiostrongylus vasorum) b'amministrazzjoni ta' kull xahar.
English: It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: Jista' jintuża bħala parti minn strateġija ta' kura għall-kontroll ta' dermatite ta' allerġija għall-briegħed (FAD).
English: The veterinary medicinal product should be administered at a dose of 2.50-5.36 mg/kg of afoxolaner and 0.50-1.07 mg/kg of milbemycin oxime in accordance with the following table:
Maltese: Kull pillola li tintmagħad fiha 9.375 mg/ afoxolaner u 1.875 mg milbemycin oxime
English: When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with NEXGARD SPECTRA should start on the date when the former medication was due to have been administered.
Maltese: Meta prodott ieħor għall-prevenzjoni tal-heartworm jiġi sostitwit fi programm ta' prevenzjoni tal-heartworm,, l-ewwel kura b' NEXGARD SPECTRA għanda tinbeda fid-data meta l-mediċina ta' qabel kella tiġi amministrata.
English: Chewable tablets
Maltese: TWISSIJIET SPEĊJALI
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Maltese: Kura ta' infestazzjonijiet bil-qurdien (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) fil-klieb għal 4 ġimgħat.
English: Ancylostoma ceylanicum is reported as being endemic only in Southeast Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.
Maltese: Ancylostoma ceylanicum huwa rrappurtat bħala endemiku biss fix-xlokk tal-Asja, Ċina, Indja,
English: At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms.
Maltese: Skont id-diskrezzjoni tal-veterinarju, klieb infestati għandhom jiġu kkurati b'insettiċida għall-adulti biex jitneħħew il-heartworm adulti.
English: NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs >30-60 kg afoxolaner / milbemycin oxime
Maltese: NEXGARD SPECTRA 9 mg/ 2 mg pilloli li jintmagħdu għal klieb 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg pilloli li jintmagħdu għal klieb > 3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg pilloli li jintmagħdu għal klieb > 7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg pilloli li jintmagħdu għal klieb > 15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg pilloli li jintmagħdu għal klieb > 30-60 kg Afoxolaner / Milbemycin oxime
English: Monthly administration of the product prevents establishment of infection with adult Thelazia callipaeda eyeworm.
Maltese: Trattament kull xahar b' dan il-prodott jipprevjeni l-infezzjoni bil-parasita adulta tat-thelazia callipaeda fl-ghajnejn.
English: Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.
Maltese: Kura ta' infestazzjonijiet bi briegħed (Ctenocephalides felis u C. canis) fil-klieb għal 5 ġimgħat.
English: Veterinary medicinal product subject to prescription.
Maltese: Skont id-diskrezzjoni tal-veterinarju,
English: United Kingdom GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
Maltese: GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
English: MEDA OY Lemminkäisenkatu 32 20520 Turku Finland
Maltese: MEDA OY Lemminkäisenkatu 32 20520
English: CENTRAFARM SERVICES B.V.; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
Maltese: CENTRAFARM SERVICES B.V.; Nieuwe Donk 9; 4879 AC
English: MARVECSPHARMA SERVICES SrlVia Felice Casati, 16 - 20124 Milano, Italy Daverium
Maltese: MARVECSPHARMA SERVICES SrlVia Felice Casati, 16 - 20124
English: MEDA PHARMACEUTICALS LIMITED; Building 2000, Beach Drive, Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK
Maltese: Building 2000, Beach Drive, Cambridge Research Park, Waterbeach, Cambridgeshire, CB5 9PD, UK
English: RATIOPHARM Graf-Arco-Strasse 3, DE89079 Ulm, Germany
Maltese: Graf-Arco-Strasse 3, DE89079 Ulm, Germany
English: SANOFI-AVENTIS 1/13 boulevard Romain Rolland 75014 Paris, France
Maltese: SANOFI-AVENTIS 1/13 boulevard Romain Rolland 75014
English: NOVARTIS Pharma GmbH Roonstrasse 25, D-90429 Nurnberg, Germany
Maltese: Il-Lussemburgu NOVARTIS Pharma GmbH Roonstrasse 25, D-90429 Nurnberg, Germany
English: Podlipie 16, 95-010 Stryków, Poland
Maltese: Podlipie 16, 95-010
English: SCHERING SpA - Via E.Schering, 2120090 Segrate (MI), Italy
Maltese: SCHERING SpA - Via E.Schering, 2120090
English: MEDA PHARMA GmbH Liesinger-FlurGasse 2c, 1230 Wien, Austria
Maltese: MEDA PHARMA GmbH Liesinger-FlurGasse 2c, 1230
English: S.C. BIOFARM S.A., Str. Logofat Tautu nr. 99, sector 3, Bucharest, Romania
Maltese: Logofat Tautu nr. 99, sector 3, Bucharest, Romania
English: NOVARTIS Pharma Sofia 1164 Square "Dzhon Paul II" office centre "Bulgaria 2000", Bulgaria
Maltese: Square "Dzhon Paul II" office centre "Bulgaria 2000", Bulgaria
English: MEDA PHARMA GmbH, Benestrasse 1, D-61352 BAD Hambourg, Germany
Maltese: Il-Lussemburgu MEDA PHARMA GmbH, Benestrasse 1, D-61352 BAD Hambourg, Germany
English: POLICHEM S.A. 50, Val Fleuri, L-1526, Luxembourg
Maltese: S.A. 50, Val Fleuri, L-1526, Luxembourg
English: RATIOPHARM Arzneimittel VertriebsGmbH, Albert-Schweitzer Gasse 3 1140 Wien, Austria
Maltese: Arzneimittel VertriebsGmbH, Albert-Schweitzer Gasse 3 1140
English: SANDIPRO s.a. chaussée de Gand, 615 1080 Bruxelles, Belgium
Maltese: SANDIPRO s.a. chaussée de Gand, 615 1080
English: Czech Republic MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
Maltese: MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
English: NOVARTIS PHARMA nv. Medialaan 40
Maltese: NOVARTIS PHARMA nv.
English: Novartis Pharmaceuticals Ltd., Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, UK
Maltese: Ltd., Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, UK
English: LABO LISA pharm 9 bis boulevard J. Jaures 92100 Boulogne Billancourt, France
Maltese: Jaures 92100 Boulogne Billancourt, France
English: Kliment Ohridski" №3, Bulgaria
Maltese: SOPHARMA - Sofia 1797 bul." Kliment Ohridski" №3, Bulgaria
English: MEDA Health Sales Ireland Ltd, Office 10 Dunboyne Business Park, Dunboyne, Co. Meath, Ireland
Maltese: MEDA Health Sales Ireland Ltd, Office 10
English: Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial, Edifício 8, Quinta da Beloura, 2710-44 Sintra, Portugal
Maltese: - Rua do Centro Empresarial, Edifício 8, Quinta da Beloura, 2710-44
English: Gastro-Resistant Tablet
Maltese: Pillola gastro-reżistenti
English: Oral Drops
Maltese: Soluzzjoni orali
English: D-51674 Wiehl, Germany
Maltese: D-51674
English: Novartis Farma S.P.A. Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
Maltese: Largo Umberto Boccioni 1 21040
English: Finland
Maltese: Turku Finland
English: Intramuscular Use
Maltese: L-Applikant
English: MEDA PHARMA GmbH & Co. KG, Benzstr.
Maltese: MEDA PHARMA GmbH & Co.
English: Oral Drops, Solution Oral Use
Maltese: Qtar orali, soluzzjoni
English: 0,3 mg/1 m Solution for Injection Intravenous use
Maltese: 0,3 mg/1 m Soluzzjoni għallinjezzjoni
English: Belgium
Maltese: Bruxelles, Belgium
English: Czech Republic
Maltese: Ir-Repubblika
English: D-76204 Karlsruhe, Germany
Maltese: Karlsruhe, Germany
English: Bromocriptine containing medicinal products with Marketing Authorisation in the European Union
Maltese: Prodotti mediċinali li fihom bromocriptine b'Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea Stat Membru Id-Detentur ta' l-Awtorizzazzjoni għattqegħid fis-suq
English: Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union
Maltese: Prodotti mediċinali li fihom dihydroergocryptine b'Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea
English: BETAPHARM Arzneimittel GmbH; Kobelweg 95; D-86156 Augsburg, Germany
Maltese: Arzneimittel GmbH; Kobelweg 95;
English: 3 pre-filled syringes + 3 needles
Maltese: 3 siringi mimlijin għallest + 3 labar
English: 1 pre-filled syringe + 1 needle
Maltese: 1 siringa mimlija għallest + 1 labra
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: <Content (concentration)>
Maltese: Mnejn jingħata Il-pakkett Kontenut (konċentrazzjoni)
English: European Medicines Agency Veterinary Medicines
Maltese: Għamla Farmaċewtika
English: ©EMEA 2007
Maltese: Qawwa
English: Page 2/2
Maltese: 60 ml
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: EU/2/99/011/001 Locatim >2.8log10 /ml Konċentrat tallattoserum talbovini
English: What is Locatim?
Maltese: Perjodu ta' Tiżmim
English: Locatim is an oral solution produced from colostrum which is given to calves in the first 12 hours of life.
Maltese: Soluzzjoni orali Għoġġiela li għadhom jitwieldu li għandhom anqas minn 12-il siegħa
English: The natural uptake of colostrum within the first hours of life induces passive immunisation.
Maltese: Speċi li fuqhom għandu jintuża lprodott
English: How does Locatim work?
Maltese: Mod ta' Amministrazzjoni
English: There are no major side effects with Locatim.
Maltese: IppakkjarKontenut Daqs talpakkett
English: Other information about Locatim:
Maltese: Numru ta' l-UE Isem kummerċjali
English: F-69007 Lyon
Maltese: F - 69007 LYON Franza
English: Date of latest renewal: 02/08/2004
Maltese: Data ta' l-aħħar tiġdid: 02/08/2004
English: Rarely : anaphylaxis, angioedema, urticaria, erythema multiforme.
Maltese: Rari: anafilassi, anġioedema, urtikarja, eritema multiformi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/1999
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 07/05/1999
English: Anti-PRP Responses to PROCOMVAX in Infants
Maltese: Reazzjonijiet anti-PRP għal PROCOMVAX fit-Trabi
English: Take special care with PROCOMVAX:
Maltese: Oqgħod attent ħafna bi PROCOMVAX:
English: Not applicable.
Maltese: Mhux relevanti.
English: PROCOMVAX has been generally well tolerated in clinical trials.
Maltese: Ġeneralment PROCOMVAX kien ittollerat sewwa fil-provi kliniċi.
English: PROCOMVAX suspension for injection
Maltese: PROCOMVAX sospensjoni għall-injezzjoni
English: Respiratory, thoracic and mediastinal disorders Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Apneja fi trabi prematuri ħafna (≤ 28 ġimgħa ta' ġestazzjoni) (ara sezzjoni 4.4).
English: Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) Vaccine.
Maltese: Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis B (Recombinant) Vaccine.
English: Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
Maltese: Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis B (Recombinant) Vaccine
English: For excipent, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: PROCOMVAX can be administered simultaneously with the primary series of diphtheria, tetanus, pertussis vaccine (DTP) and oral polio vaccine (OPV).
Maltese: PROCOMVAX jista' jingħata simultanjament mas-serje primarja tal-vaċċin kontra d-difterite, it-tetnu u s-sogħla konvulsiva (DTP) u l-vaċċin orali kontra l-poljo (OPV).
English: In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12-15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic complaints.
Maltese: F'wieħed minn dawn it-testijiet, studju b'għażla każwali f'aktar minn ċentru mediku wieħed, 882 tarbija ġew assenjati fi proporzjon ta' 3:1 biex jirċievu jew PROCOMVAX jew Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) u Merck Hepatitis B (Recombinant) Vaccine ta' 2, 4, u 12 - 15-il xahar, bit-tfal jiġu mmonitorjati kuljum għal ħamest ijiem wara kull injezzjoni għal reazzjonijiet lokali u disturbi sistemiċi.
English: Infants born of HBsAg negative mothers should be vaccinated with three 0.5 ml doses of PROCOMVAX, ideally at 2, 4, and 12-15 months of age.
Maltese: Trabi mwielda minn ommijiet HBsAg negattivi għandhom jiġu mlaqqma bi tliet dożi ta' 0.5 ml ta' PROCOMVAX, idealment ta' 2, 4, u 12 -15-il xahar.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC 7.5 µg Neisseria meningitidis OMPC (outer membrane protein complex
Maltese: U KWANTITATTIVA Polyribosylribitol phosphate (PRP) minn Haemophilus influenzae tat-tip b bħala PRP-OMPC 7.5 µg Neisseria meningitidis OMPC (complex tal-proteina tal-membrana ta' barra
English: The following local reactions and systemic complaints were reported in ≥1.0 % of children within five days after any injection of PROCOMVAX: pain/soreness, erythema, swelling/induration at the injection site; fever (>38.3 °C, rectal equivalent); anorexia, vomiting, diarrhoea; irritability, somnolence, crying including unusual high-pitched crying, prolonged crying (>4hrs), and crying not otherwise specified; otitis media.
Maltese: Ir-reazzjonijiet lokali u d-disturbi sistemiċi li ġejjin kienu rrapportati f'≥ 1.0 % tat-tfal fi żmien ħamest ijiem minn kwalunkwe injezzjoni ta' PROCOMVAX: uġigħ, eritema, nefħa/ebusija fil-post ta' linjezzjoni; deni (> 38.3°C, ekwivalenti tar-rektum); anoreksja, rimettar, dijarea; irritabilità, ħedla tanngħas, biki fosthom biki jgħajjat mhux tas-soltu, biki fit-tul (> 4 sigħat), u biki mhux speċifikat mod ieħor; otite tal-widna tan-nofs.
English: Merck Sharp & Dohme B.V. (Merck Manufacturing Division) Waarderweg 39,
Maltese: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN.
English: Hypersensitivity
Maltese: FARMAKOLOĠIKU
English: 125 µg of the B11 strain of Neisseria meningitidis subgroup B) Adsorbed hepatitis B surface antigen produced in recombinant yeast cells
Maltese: 125 µg tar-razza B11 ta' Neisseria meningitidis sottogrupp B) Antiġen tal-wiċċ assorbit ta' l-epatite B prodott f'ċelloli rikombinanti tal-ħmira
English: PROCOMVAX - single dose in vial - Pack of 1
Maltese: KARTUNA TA' BARRA PROCOMVAX - doża waħda fil-kunjett - Pakkett ta' 1
English: Post-dose 3, 96 % to 100 % of infants developed a protective level of anti-HBs and the GMTs ranged from 897 mIU/ml to 4467 mIU/ml.
Maltese: Wara t-3 doża, 96% sa 100% tat-trabi żviluppaw livelli protettiv ta' anti-HBs u l-GMTs varjaw minn 897 mIU/ml sa 4467 mIU/ml.
English: Excipients: Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9 % sodium chloride
Maltese: Amorphous aluminium hydroxyphosphate sulphate u sodium borate f'0.9 %
English: Post-dose 2, 77% to 96% of infants developed a protective level of anti-HBs (≥ 10 mIU/ml) and the GMTs ranged from 30 mIU/ml to 190 mIU/ml.
Maltese: Wara t-2 doża, 77% sa 96% tat-trabi żviluppaw livell protettiv ta' anti-HBs (≥ 10 mIU/ml) u l-GMTs varjaw minn 30mIU/ml sa 190mIU/ml.
English: EXP:
Maltese: Manifatturat minn:
English: 2003 PC Haarlem
Maltese: Haarlem, L-Olanda
English: Post-dose 3, 98 % to 100 % of infants developed a protective level of anti-HBs and the GMTs ranged from 1509 mIU/ml to 3913 mIU/ml.
Maltese: Wara t-tielet doża, 98% sa 100% tat-trabi żviluppaw livell protettiv ta' anti-HBs u l-GMTs varjaw minn 1509 mIU/ml sa 3913 mIU/ml.
English: Pharmacotherapeutic group : anti infectious, ATC code : J07CA PROCOMVAX is a sterile bivalent vaccine made of the antigenic components used in producing Merck PRP-OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
Maltese: J07CA PROCOMVAX huwa vaċċin sterili bivalenti magħmul mill-komponenti antiġeniċi wżati filproduzzjoni ta' Merck PRP-OMPC Vaccine u Merck Hepatitis B (Recombinant) Vaccine.
English: Post-dose 3, 92 % to 99 % of infants developed >1.0 µg/ml of anti-PRP, a level associated with longterm protection against invasive Hib disease, and the GMTs ranged from 7.7 µg/ml to 14.0 µg/ml.
Maltese: Wara t-tielet doża, 92% sa 99% tat-trabi żviluppaw >1.0 µg/ml ta' anti-PRP, livell assoċjat ma' protezzjoni fuq perjodu fit-tul kontra mard invażiv ta' l-Hib, u l-GMTs varjaw minn 7.7 µg/ml sa 14.0 µg/ml.
English: Post-dose 2, 93 % to 100 % of infants developed a protective level of anti-HBs (≥ 10 mIU/ml) and the GMTs ranged from 125 mIU/ml to 417 mIU/ml.
Maltese: Wara t-tieni doża, 93% sa 100% tat-trabi żviluppaw livell protettiv ta' anti-HBs (≥ 10 mIU/ml) u lGMTs varjaw minn 125 mIU/ml sa 417 mIU/ml.
English: The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines.
Maltese: L-effikaċja protettiva tal-komponenti ta' PROCOMVAX ġiet stabbilita fi provi tal-prodott f'sitwazzjonijiet attwali mwettqa bil-vaċċini monovalenti.
English: The remaining 1,816 infants were involved in trials where PROCOMVAX was administered concomitantly with either an investigational pneumococcal polysaccharide protein conjugate vaccine or an investigational preparation of diphtheria, tetanus, pertussis, and inactivated poliovirus vaccine and were under surveillance for serious adverse experiences.
Maltese: L-1,816-il tarbija l-oħra kienu involuti f'testijiet fejn PROCOMVAX ingħata flimkien ma' pneumococcal polysaccharide protein conjugate vaccine mhux ippruvat jew ma' preparazzjoni mhux ippruvata ta' vaċċin mhux attivat kontra d-difterite, it-tetnu, is-sogħla konvulsiva u l-virus tal-poljo u kienu taħt sorveljanza għal esperjenzi avversi serji.
English: 8, rue Jonas Salk
Maltese: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F