FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (1/100 to <1/10)
Maltese: Komuni ħafna (1/10) Komuni (1/100 sa <1/10)
English: Immune response in children aged 9 to 10 months
Maltese: Rispons immuni fi tfal minn 9 sa 10 xhur
English: INSTRUCTIONS ON USE To be completed nationally 16.
Maltese: ISTRUZZJONIJIET DWAR L-UŻU Trid timtela mill-pajjiż konċernat 16.
English: • Priorix must not be administered to pregnant women.
Maltese: • Priorix m'għandux jingħata lil nisa tqal.
English: Clinical trial data
Maltese: Dejta mill-provi kliniċi
English: MMR-associated thrombocytopenia is rare and generally selflimited.
Maltese: It-tromboċitopenija assoċjata mal-MMR hija rari u ġeneralment awtolimitata.
English: Very common: redness at the injection site, fever 38°C (rectal) or 37.5°C (axillary/oral) Common: pain and swelling at the injection site, fever >39.5°C (rectal) or >39°C (axillary/oral)
Maltese: Komuni ħafna: ħmura fil-post tal-injezzjoni, deni 38°C (rektum) jew 37.5°C (abt/orali) Komuni: uġigħ u nefħa fil-post tal-injezzjoni, deni >39.5°C (rektum) jew >39°C (abt/orali)
English: If this is not possible, it must be stored at 2°C - 8°C and used within 8 hours of reconstitution.
Maltese: Jekk dan ma jkunx possibbli, huwa għandu jinħażen f'temperatura ta' 2°C - 8°C u jintuża fi żmien 8 sigħat mir-rikostituzzjoni.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1 jew neomycin.
English: PRIORIX is indicated for the active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella.
Maltese: PRIORIX hu indikat għall-immunizzazzjoni attiva ta' tfal minn età ta' 9 xhur 'il fuq, ta' adoloxxenti u ta' adulti kontra l-ħosba, il-gattone u r-rubella.
English: • Kawasaki syndrome (major signs of the illness are for instance: fever, skin rash, swollen lymph glands, inflammation and rash of the mucous membranes of the mouth and throat)
Maltese: • sindrome ta' Kawasaki (sinjali prinċipali tal-marda huma pereżempju: deni, raxx tal-ġilda, glandoli limfatiċi minfuħin, infjammazzjoni u raxx tal-membrani mukużi tal-ħalq u lgerżuma)
English: Uncommon: conjunctivitis
Maltese: Mhux komuni: konġuntivite
English: Uncommon: lymphadenopathy
Maltese: Mhux komuni: limfadenopatija
English: Uncommon: nervousness, abnormal crying, insomnia Nervous system disorders:
Maltese: Mhux komuni: nervożiżmu, biki mhux normali, nuqqas ta' rqad Disturbi fis-sistema nervuża:
English: In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period.
Maltese: Fl-istudji kliniċi kkontrollati, is-sinjali u s-sintomi ġew immonitorjati b'mod attiv matul perjodu ta' segwitu ta' 42 jum.
English: Two years after primary vaccination seroconversion rates were 93.4% for measles, 94.4% for mumps and 100% for rubella.
Maltese: Sentejn wara l-vaċċinazzjoni primarja, ir-rati ta' serokonverżjoni kienu 93.4% għall-ħosba, 94.4% għall-gattone u 100% għar-rubella.
English: PRIORIX is contraindicated during pregnancy (see section 4.3).
Maltese: PRIORIX huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: • swollen parotid glands (glands in the cheek)
Maltese: • glandoli parotidi minfuħin (glandoli fil-ħaddejn)
English: Very common: redness at the injection site, fever 38°C (rectal) or 37.5°C (axillary/oral) Common: pain and swelling at the injection site, fever >39.5°C (rectal) or >39°C (axillary/oral) In general, the frequency category for adverse reactions was similar for the first and second vaccine doses.
Maltese: Komuni ħafna: ħmura fil-post tal-injezzjoni, deni 38°C (rektum) jew 37.5°C (abt/orali) Komuni: uġigħ u nefħa fil-post tal-injezzjoni, deni >39.5°C (rektum) jew >39°C (abt/orali) B'mod ġenerali, il-kategorija tal-frekwenzi għar-reazzjonijiet avversi kienet simili għall-ewwel u ttieni doża tal-vaċċin.
English: BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT
English: For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1.
Maltese: Għall-użu fi tfal bejn 9 sa 12-il xahar, ara sezzjonijiet 4.2, 4.4 u 5
English: A limited number of subjects received PRIORIX intramuscularly in clinical trials.
Maltese: Numru limitat ta' individwi rċevew PRIORIX ġol-muskoli fi provi kliniċi.
English: A history of contact dermatitis to neomycin is not a contraindication.
Maltese: Storja ta' dermatite ta' kuntatt għan-neomycin mhijiex kontraindikazzjoni.
English: Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles.
Maltese: Tista' tinkiseb protezzjoni limitata kontra l-ħosba b'vaċċinazzjoni sa 72 siegħa wara esponiment għallħosba naturali.
English: Infants between 9 and 12 months of age
Maltese: Trabi bejn 9 u 12-il xahar
English: Priorix is intended for children from 9 months up, adolescents and adults.
Maltese: Priorix huwa maħsub għat-tfal minn 9 xhur 'il fuq, l-adoloxxenti u l-adulti.
English: To be completed nationally For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: After the marketing of Priorix, the following additional side effects have been reported on a few occasions:
Maltese: Wara t-tqegħid fis-suq ta' Priorix, fi ftit okkażjonijiet ġew irrapportati l-effetti sekondarji addizzjonali li ġejjin:
English: Other medicines and Priorix
Maltese: Mediċini oħra u Priorix
English:  Rare (these may occur with up to 1 in 1,000 doses of the vaccine):
Maltese:  Rari (dawn jistgħu jseħħu b'sa 1 f'kull 1,000 doża tal-vaċċin):
English: Priorix may be given at the same time you or your child receives other recommended vaccinations such as diphtheria, tetanus, pertussis, Haemophilus influenzae type b, oral or inactivated polio, hepatitis A and B, meningococcal serogroup C conjugate vaccines, varicella as well as 10-valent pneumococcal conjugate vaccine.
Maltese: Priorix jista' jingħata fl-istess ħin li int jew it-tifel/tifla tiegħek tirċievu vaċċinazzjonijiet rakkomandati oħra bħad-difterite, tetnu, sogħla konvulsiva, Haemophilus influenzae tat-tip b, poljo orali jew inattivat, epatite A u B, vaċċini konjugati kontra l-meninġokokku tas-serogrupp C, ġidri r-riħ kif ukoll vaċċin konjugat 10-valenti kontra l-pnewmokokku.
English: Of these 147 subjects received PRIORIX and VARILRIX concomitantly.
Maltese: Minn dawn, 147 individwu rċevew PRIORIX u VARILRIX fl-istess ħin.
English: Pharmaco-therapeutic group: Viral vaccine, ATC code J07BD52
Maltese: Vaċċin virali, Kodiċi ATC:
English: Blood and lymphatic system disorders: Uncommon: lymphadenopathy
Maltese: Disturbi fis-sistema immuni: Rari: reazzjonijiet allerġiċi
English: Dispose of in accordance with local regulations
Maltese: Armi skont ir-regolamenti lokali
English: Priorix is a vaccine for use in children from 9 months up, adolescents and adults to protect them against illnesses caused by measles, mumps and rubella viruses.
Maltese: Priorix huwa vaċċin għall-użu fi tfal minn 9 xhur 'il fuq, adoloxxenti u adulti sabiex jipproteġihom kontra mard ikkawżat mill-virus tal-ħosba, gattone u rubella.
English: • swollen lymph glands (glands in the neck, armpit or groin)
Maltese: • glandoli limfatiċi minfuħin (glandoli fil-għonq, fil-abt jew fil-groin)
English: The safety profile presented below is based on a total of approximately 12,000 subjects administered PRIORIX in clinical trials.
Maltese: Il-profil tas-sigurtà ppreżentat hawn taħt huwa bbażat fuq total ta' madwar 12,000 individwu mogħtija PRIORIX fi provi kliniċi.
English: • upper respiratory tract infection
Maltese: • infezzjoni fil-parti ta' fuq tal-apparat respiratorju
English: Due caution should be employed in administration of PRIORIX to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions.
Maltese: Għandha tingħata l-attenzjoni dovuta fl-għoti ta' PRIORIX lil individwi b'disturb fis-Sistema Nervuża Ċentrali (CNS), suxxettibbiltà għall-konvulżjonijiet bid-deni jew storja ta' konvulżjonijiet fil-familja.
English: The most common adverse reactions following PRIORIX administration were injection site redness and fever 38°C (rectal) or 37.5°C (axillary/oral).
Maltese: L-iżjed reazzjonijiet avversi komuni wara l-għoti ta' PRIORIX kienu ħmura fil-post tal-injezzjoni u deni 38°C (rektum) jew 37.5°C (abt/ħalq).
English: Meningitis, orchitis, epididymitis, atypical mild or attenuated measles, mumps-like syndrome Blood and lymphatic system disorders:
Maltese: Meninġite, orkite, epididimite, ħosba atipika ħafifa jew mdgħajfa, sintomi jixbħu l-gattone Disturbi tad-demm u tas-sistema limfatika:
English: Rare: febrile convulsions
Maltese: Rari: konvulżjonijiet bid-deni
English: Pharyngeal excretion of the rubella and measles virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day.
Maltese: L-eskrezzjoni tal-virus tar-rubella u tal-ħosba mill-farinġi hija magħrufa li sseħħ madwar 7 sa 28 jum wara l-vaċċinazzjoni bl-akbar eskrezzjoni sseħħ madwar il-11-il ġurnata.
English: • abnormal crying
Maltese: • biki abnormali
English: Uncommon: parotid gland enlargement, diarrhoea, vomiting Skin and subcutaneous tissue disorders:
Maltese: Mhux komuni: tkabbir tal-glandoli parotidi, dijarea, rimettar Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: • reduced measles
Maltese: GĦAMLA KWALITATTIVA
English: An evaluation of pharmacokinetics in vaccines is not necessary.
Maltese: Mhix meħtieġa evalwazzjoni tal-farmakokinetiċi fil-vaċċini.
English: 1%, against mumps in 94.4% and against rubella in 100% of previously seronegative vaccinees.
Maltese: Il-vaċċinazzjoni b'doża waħda ta' PRIORIX ipproduċiet antikorpi kontra l-ħosba fi 98.1%, kontra lgattone f'94.4% u kontra r-rubella f'100% tal-persuni mlaqqma li qabel kienu seronegattivi.
English: Priorix is injected under the skinor into the muscle.
Maltese: Priorix jiġi injettat taħt il-ġilda jew fil-muskolu.
English: Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jiġu vaċċinati bi PRIORIX billi dan fih is-sorbitol.
English: When a person is vaccinated with Priorix, the immune system (the body's natural defence system) will make antibodies to protect the person from being infected by measles, mumps and rubella viruses.
Maltese: Meta persuna tiġi vaċċinata bi Priorix, is-sistema immuni (is-sistema ta' difiża naturali tal-ġisem) tagħmel antikorpi biex tipproteġi lill-persuna milli tiġi infettata bil-virus tal-ħosba, tal-gattone u tarrubella.
English: List of adverse reactions Adverse reactions reported are listed according to the following frequency:
Maltese: Ir-reazzjonijiet avversi li ġew irrapportati huma elenkati skont il-frekwenza li ġejja:
English:  Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Maltese:  Mhux komuni (dawn jistgħu jseħħu b'sa 1 f'kull 100 doża tal-vaċċin):
English: The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein.
Maltese: Il-komponenti tal-ħosba u tal-gattone fil-vaċċin huma prodotti f'kultura ta' ċelloli tal-embrijuni talflieles u għalhekk jista' jkollhom traċċi ta' proteini tal-bajd.
English: The seroconversion rates reported following the second dose given 3 months after the first dose were 100% for measles and 99.2% for mumps.
Maltese: Ir-rati ta' serokonverżjoni rrapportati wara t-tieni doża mogħtija 3 xhur wara l-ewwel doża kienu 100% għall-ħosba u 99.2% għall-gattone.
English: These patients should be monitored carefully for signs of measles, parotitis and rubella.
Maltese: Dawn il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni għal sinjali ta' ħosba, parotite u rubella.
English: For instructions on reconstitution of the medicinal product before administration see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: • if you or your child has disorders of the central nervous system, a history of convulsion accompanying high fever or family history of convulsions.
Maltese: • jekk int jew it-tifel/tifla tiegħek għandkom disturbi tas-sistema nervuża ċentrali, storja ta' konvulżjonijiet li jakkumpanjaw deni għoli jew storja ta' konvulżjonijiet fil-familja.
English: EXP
Maltese: Anness
English: The injections should be given at separate injection sites.
Maltese: L-injezzjonijiet għandhom jingħataw f'siti tal-injezzjoni separati.
English: In patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination the risk-benefit of administering PRIORIX should be carefully evaluated.
Maltese: F'pazjenti bi tromboċitopenija eżistenti jew storja ta' tromboċitopenija wara vaċċinazzjoni kontra lħosba, gattone jew rubella, ir-riskju u l-benefiċċju tal-għoti ta' PRIORIX għandhom jiġu evalwati b'attenzjoni.
English: • inability to sleep (insomnia)
Maltese: • inkapaċità li torqod (nuqqas ta' rqad)
English: Cases of worsening of thrombocytopenia and cases of recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines.
Maltese: Jekk ikun irid isir ittestjar tat-tuberkulina, dan għandu jitwettaq qabel jew fl-istess ħin malvaċċinazzjoni billi ġie rrapportat li l-vaċċini kombinati tal-ħosba, gattone u rubella jistgħu jikkawżaw dipressjoni temporanja tas-sensittività tal-ġilda għat-tuberkulina.
English: Gastrointestinal disorders: Uncommon: parotid gland enlargement, diarrhoea, vomiting
Maltese: Mhux komuni: tkabbir tal-glandoli parotidi, dijarea, rimettar
English: The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder (see section 4.4).
Maltese: Għandhom jiġu evitati kuntatti mad-diżinfettanti (ara sezzjoni 4.4).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml) To be completed nationally
Maltese: INDIVIDWALI 1 doża (0.5 ml) Trid timtela mill-pajjiż konċernat
English: Infants in their first year of life may not respond sufficiently to the components of the vaccine, due to the possible interference with maternal antibodies (see sections 4.2 and 5.1).
Maltese: It-trabi fl-ewwel sena tal-ħajja tagħhom jistgħu ma jirrispondux b'mod suffiċjenti għall-komponenti tal-vaċċin, minħabba l-interferenza possibbli mal-antikorpi tal-omm (ara sezzjonijiet 4.2 u 5.1).
English: As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
Maltese: Billi dan in-nuqqas ta' immunità jista' jdum sa massimu ta' 6 ġimgħat, m'għandux isir ittestjar tat-tuberkulina f'dak il-perjodu wara lvaċċinazzjoni sabiex jiġu evitati riżultati negattivi foloz.
English: Infections and infestations: Meningitis, orchitis, epididymitis, atypical mild or attenuated measles, mumps-like syndrome
Maltese: Meninġite, orkite, epididimite, ħosba atipika ħafifa jew mdgħajfa, sintomi jixbħu l-gattone
English: Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. generalised urticaria, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after vaccination, although these types of reactions have been shown to be very rare.
Maltese: Persuni bi storja ta' reazzjonijiet anafilattiċi, anafilaktojdi, jew reazzjonijiet immedjati oħra (eż. urtikarja ġeneralizzata, nefħa fil-ħalq u fil-gerżuma, diffikultà fit-teħid tan-nifs, pressjoni baxxa, jew xokk) wara inġestjoni tal-bajd jistgħu jkunu f'riskju akbar ta' reazzjonijiet ta' sensittività eċċessiva tat-tip immedjat wara l-vaċċinazzjoni, għalkemm dawn it-tipi ta' reazzjonijiet intwerew li huma rari ħafna.
English: Under no circumstances should the interval between doses be less than four weeks (see sections 4.4 and 5.1).
Maltese: L-intervall bejn id-dożi ma għandu taħt l-ebda ċirkostanza jkun ta' inqas minn erba' ġimgħat (ara sezzjonijiet 4.4 u 5.1).
English: PRIORIX may be used in individuals who have previously been vaccinated with another monovalent or combined measles, mumps and rubella vaccine.
Maltese: PRIORIX jista' jintuża f'individwi li jkunu ġew vaċċinati qabel b'vaċċin monovalenti jew kombinat ieħor kontra l-ħosba, il-gattone u r-rubella.
English: 4 (4 x 1) vials (multipack)
Maltese: kunjett (ħġieġ) 4 (4 x 1) kunjetti (pakkett b'ħafna)
English: 1 vial
Maltese: Mnejn għandu jingħata
English: EU/2/14/167/001 EU/2/14/167/002 EU/2/14/167/003 EU/2/14/167/004 EU/2/14/167/005 EU/2/14/167/006 EU/2/14/167/007
Maltese: EU/2/14/167/001 EU/2/14/167/002 EU/2/14/167/003 EU/2/14/167/004
English: * RP - relative potency (ELISA).
Maltese: * RP, qawwa relattiva (ELISA)
English: 10 doses
Maltese: 10 dożi
English: LABORATORIOS HIPRA, S.A. Avda.
Maltese: LABORATORIOS HIPRA, S.A.
English: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran
Maltese: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminju) DEAE-Dextran
English: Disodium phosphate dodecahydrate Ginseng
Maltese: Disodium phosphate dodecahydrate Ġinseng
English: * IE50% - Inhibition ELISA 50%.
Maltese: ** IE50 % inibizzjoni ELISA - 50%
English: 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Maltese: 10 dożi (20 ml) 25 doża (50 ml) 50 doża (100 ml) 125 doża (250 ml)
English: Aluminium hydroxide .............................................................................. 5.29 mg (aluminium) DEAE-Dextran
Maltese: Aluminium hydroxide ……………………. ............................................... 5.29 mg (aluminju) DEAE-Dextran
English: 25 doses
Maltese: 25 doża
English: 50 doses
Maltese: 50 doża
English: + 10 doses (20 ml)
Maltese: + 10 dożi (20 ml)
English: Date of first authorisation: 08/07/2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizazzjoni: 08/07/2014
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: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a) matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Polyethylene (PET) bottles of 20, 50, 100 and 250 ml.
Maltese: Fliexken tal-Polyethylene (PET) ta' 20, 50, 100 u 250 ml.
English: Sodium hydroxide Water for injections
Maltese: Sodium hydroxide
English: + 50 doses (100 ml)
Maltese: + 50 doża (100 ml)
English: Suspension for injection Whitish suspension
Maltese: Suspensjoni għal injezzjoni Suspensjoni bajdanija
English: The second injection should be administered 3-4 weeks before mating.
Maltese: It-tieni injezzjoni għandha tingħata 3-4 ġimgħat qabel ittgħammir.
English: Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Maltese: Reazzjonijiet avversi rari ħafna: - Reazzjonijiet tat-tip anaflattiku ġew rappurtati f'rapporti spontanji u kura sintomatika xierqa hija rakkomandata.
English: + 25 doses (50 ml)
Maltese: + 25 doża (50 ml)
English: For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Maltese: erisipelas tal-majjali kkawżata minn Erysipelothrix rhusiopathiae, serotip 1 and serotip 2.
English: Pack sizes:
Maltese: Tilqim mill-ġdid:
English: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP* > 1.15, Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .............. ELISA > 3.34 log2 IE50%**
Maltese: Parvovirus tal-majjali inattivat, razza NADL-2 ....................................................... RP > 1.15* Erysipelothrix rhusiopathiae inattivat, razza R32E11 ................. ELISA > 3.34 log2 IE50 % **
English: E. rhusiopathiae: three weeks after completion of the basic vaccination scheme.
Maltese: E. rhusiopathiae: tliet ġimgħat wara t-tmiem tal-iskema ta' tilqim bażiku.
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), refer to section “Dosage for each species, route(s) and method of administration”.
Maltese: E. rhusiopathiae: tilqima li tipproteġi kontra l-erisipelas tal-majjali saż-żmien tat-tilqima mill-ġdid rakkomandata (bejn wieħed u ieħor sitt xhur wara l-iskema tat-tilqima bażika), irreferi għas-sezzjoni “Doża għal kull speċi, mod(i) u metodu ta' amministrazzjoni”.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il pussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Allow the vaccine to reach room temperature (15-25 ºC) before administration.
Maltese: Ħalli l-vaċċin jilħaq it-temperatura ambjentali (15-25ºC) qabel tagħtih.
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) Bottles (100 ml, 250 ml) and vials (100 ml)
Maltese: KAXXA TAL-KARTUN, (20 ml, 50 ml, 100ml u 250ml)
English: ERYSENG PARVO suspension for injection for pigs
Maltese: ERYSENG PARVO suspensjoni għal injezzjoni għall-majjali
English: Porcine parvovirus: from the beginning of the gestation period.
Maltese: Parvovirus tal-majjali: mill-bidu tal-perjodu ta' ġestazzjoni.
English: For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.
Maltese: Għat-tilqim attiv ta' majjali nisa għall-protezzjoni ta' proġeni kontra infezzjoni transplaċentali kkawżata mill-parvovirus tal-majjali.
English: Whitish suspension for injection.
Maltese: Suspensjoni għal injezzjoni
English: Inactivated porcine parvovirus, strain NADL-2, ....................................................... RP > 1.15, inactivated Erysipelothrix rhusiopathiae, strain R32E11, ................. ELISA > 3.34 log2 IE50%.
Maltese: Parvovirus tal-majjali inattivat, razza NADL-2 ......................................................... RP > 1.15 Erysipelothrix rhusiopathiae inattivat, razza R32E11 ...................
English: Cardboard box with 1 PET bottle of 125 doses (250 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 125 doża (250 ml).