FrancophonIA/ELRC3.0 huggingface dataset:
English: Long term booster immune memory:
Maltese: Memorja immuni fuq perjodu fit-tul tal-booster:
English: One dose of 0.5 ml will be given.
Maltese: Tingħata doża waħda ta' 0.5 mL.
English: Toddlers (6-<36 months)
Maltese: Trabi li telqu jimxu (6 -<36 xahar)
English: Alternative vaccination schedules:
Maltese: Skedi alternattivi ta' vaċċinazzjoni:
English: Zoonotic influenza viruses occasionally infect humans, and can cause disease ranging from mild upper respiratory infection (fever and cough) to rapid progression to severe pneumonia, acute respiratory distress syndrome, shock and even death.
Maltese: Il-viruses tal-influwenza żoonotika xi drabi jinfettaw lill-bnedmin, u jistgħu jikkawżaw mard li jvarja minn infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju (deni u sogħla) għal progressjoni rapida għal pnewmonja severa, sindrome ta' diffikultà respiratorja akut, xokk u anki mewt.
English: * measured by SRH assay seroprotection: SRH area ≥25 mm2, seroconversion: SRH area ≥25 mm2 for subjects with a baseline SRH area ≤4 mm2 or a minimum 50% increase in SRH area for subjects with >4 mm2.
Maltese: * Seroprotezzjoni: żona ta' SRH ≥25 mm2 ** Serokonverżjoni kienet definita bħala żona ta' SRH ta' ≥25 mm2 għal individwi li kienu seronegattivi fil-linja bażi (Jum 1 żona ta' SRH ≤4 mm2) jew żieda sinifikanti (mill-inqas 50%)
English: A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
Maltese: Adulti (18-60 sena) Saret prova klinika ta' fażi II (V87P1) b'AFLUNOV (A/Vietnam/1194/2004) fi 312-il adult b'saħħtu.
English: In these trials, lower levels of antibodies and reduced seroprotection rates against homologous H5N1 A/turkey/Turkey/1/2005 were also measured in healthy elderly subjects, as compared to healthy adults, though previous studies showed induction of sufficiently immunogenic responses against H5N1 strains (see above for information on elderly).
Maltese: F'dawn il-provi, livelli aktar baxxi ta' antikorpi u rati tas-seroprotezzjoni mnaqqsa kontra H5N1 A/turkey/Turkey/1/2005 omologu kienu wkoll mkejla f'individwi anzjani b'saħħithom, meta mqabbla ma' adulti b'saħħithom, għalkemm studji preċedenti wrew induzzjoni ta' risponsi suffiċjentament immunoġeniċi kontra razez ta' H5N1 (ara hawn fuq għal informazzjoni dwar l-anzjani).
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' theddida għall-ħajja) għal xi wieħed mill-kostitwenti jew traċċi residwi (bajd u proteini tat-tiġieġ, ovalbumina, kanamycin, neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide ta' dan il-vaċċin.
English: No data are available in children aged less than 6 months.
Maltese: Ma hemm ebda dejta disponibbli dwar tfal iżgħar minn 6 xhur.
English: * Seroprotection: SRH area ≥ 25 mm2
Maltese: * imkejla mill-assaġġ tas-seroprotezzjoni ta' SRH: Żona ta' SRH ≥25 mm2, serokonverżjoni:
English: GMR (95% CI) Day 43 to Day 1
Maltese: GMR (95% CI) Jum 43 sa Jum 1 % SC (95% CI) Jum 43
English: • Tingling
Maltese: • Tnemnim
English: One dose of 0.5 ml contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hens' eggs from healthy chicken flocks, of strain:
Maltese: Doża waħda ta' 0.5 mL fiha: Antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase), propagata fil-bajd fertilizzat tat-tiġieġ minn qatgħat ta' tiġieġ b'saħħithom, tar-razza:
English: 87% of animals challenged with virus heterologous to the vaccine strain after 2 doses of vaccine were protected, and a single dose of heterologous vaccine protected 56% of the animals.
Maltese: AFLUNOV kienu protetti. 87% tal-annimali esposti għall-virus etorologu għall-razza tal-vaċċin wara 2 dożi tal-vaċċin kienu protetti, u doża waħda tal-vaċċin etorologu pproteġiet 56% tal-annimali.
English: Packs of 1 or 10 pre-filled syringes.
Maltese: Pakketti ta' 1 jew 10 siringi mimlija għal-lest.
English: Tell your doctor if you have a weak immune system or an underlying long term medical problem.
Maltese: Għid lit-tabib tiegħek jekk għandek sistema immunitarja dgħajfa jew problema medika sottostanti li ddum fit-tul.
English: Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Maltese: Il-vaċċin għandu jitħalla jilħaq it-temperatura tal-kamra qabel jintuża.
English: • Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
Maltese: • Vaskulite (infjammazzjoni fil-vini u l-arterji li tista' tikkawża raxxijiet fil-ġilda, uġigħ fil-ġogi u problemi fil-kliewi)
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
Maltese: Din l-indikazzjoni hija bbażata fuq dejta dwar l-immunoġeniċità minn individwi f'saħħithom ta' 18-il sena u aktar wara l-għoti ta' żewġ dożi tal-vaċċin li fih razza li tixbah A/turkey/Turkey/1/2005 (H5N1) (ara sezzjonijiet 4.4 u 5.1).
English: The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly:
Maltese: L-effetti sekondarji elenkati hawn isfel seħħew b'AFLUNOV fi provi kliniċi fuq persuni adulti,
English: AFLUNOV may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3).
Maltese: traċċa kif ġej: bajd u proteini tat-tiġieġ, ovalbumina, formaldehyde, kanamycin u neomycin sulphate (antibijotiċi) jew cetyltrimethylammonium bromide (CTAB).
English: Elderly years)*
Maltese: CI)**
English: ** geometric mean ratios of SRH
Maltese: *** proporzjonijiet ġeometriċi medji (GMRs) ta' SRH
English: a actual age range of population enrolled
Maltese: a il-firxa tal-età attwali tal-popolazzjoni rreġistrata
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c
Maltese: Studju V87P1 A/turkey/Turkey/1/2005 21 jum wara t-tieni doża
English: AFLUNOV is intended also to be given when there is anticipation of a possible pandemic due to the same or a similar strain.
Maltese: AFLUNOV huwa intenzjonat li jingħata meta tiġi antiċipata possibilità ta' pandemija minħabba listess razza jew waħda simili.
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=182
Maltese: Studju V87P1 A/turkey/Turkey/1/2005 21 jum wara t-tieni doża ċ
English: Non-clinical data obtained with AFLUNOV and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Maltese: Informazzjoni mhux klinika miksuba b'AFLUNOV u bil-vaċċin tal-influwenza staġjonali li fih l-adjuvant MF59C.1, magħmula fuq studji konvenzjonali ta' effett tossiku minn dożi ripetuti,
English: A study in rabbits did not indicate reproductive or developmental toxicity of AFLUNOV (see section 5.3).
Maltese: Studju fuq il-fniek ma weriex effett tossiku ta' AFLUNOV fuq is-sistema riproduttiva jew fuq l-iżvilupp (ara sezzjoni 5.3).
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=66
Maltese: Studju V87P13 A/Vietnam/1194/2004 21 jum wara t-tieni doża N=66
English: Anaphylaxis
Maltese: Disturbi respiratorji
English: ** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** geometric mean ratios (GMRs) of SRH
Maltese: ** Serokonverżjoni kienet definita bħala żona ta' SRH ta' ≥25 mm2 għal individwi li kienu seronegattivi fil-linja bażi (Jum 1 żona ta' SRH ≤4 mm2) jew żieda sinifikanti (mill-inqas 50%) fiż-żona ta' SRH għal individwi li kienu seropożittivi fil-linja bażi (Jum 1 żona ta' SRH
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 (A/Vietnam/1194/2004 and to A/ turkey/Turkey/1/2005) in subjects aged 61 years and older (limited number of subjects were above 70 years of age; n=123) measured by SRH assay assessed in three clinical studies were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni** u l-fattur ta' serokonverżjoni*** għall-antikorp anti-HA għall-H5N1 (A/Vietnam/1194/2004 u għall-H5N1 A/turkey/Turkey/1/2005) f'persuni li jkollhom 61 sena u aktar (numru limitat ta' suġġetti kellhom aktar minn 70 sena; N=123),
English: A single vaccination with AFLUNOV (A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as AFLUNOV but using the strain H5N3.
Maltese: Tilqima waħda b'AFLUNOV (A/Vietnam/1194/2004) ikkawżat rispons seroloġiku qawwi u rapidu f'individwi li 6-8 snin qabel kienu ġew primed b'żewġ dożi ta' vaċċin sostitut differenti tal-H5N, li kellu l-istess formulazzjoni bħal AFLUNOV iżda li kien juża r-razza N5N3.
English: The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to AFLUNOV.
Maltese: L-effetti sekondarji elenkati hawn isfel seħħew fil-jiem jew ġimgħat wara tilqima b'vaċċin ieħor imsejjaħ Focetria H1N1v - simili għal AFLUNOV.
English: Study V87P13 A/Vietnam/1194/2004 21 days after 2nd dose N=143
Maltese: Studju V87P13 A/Vietnam/1194/2004 21 jum wara t-tieni doża N=143
English: Study V87P3 21 days after 2nd dose N=30
Maltese: Studju V87P3 21 jum wara t-tieni doża
English: Injection site ecchymosis, Fever, Malaise, Shivering
Maltese: Disturbi newroloġiċi, bħal newralġija, paraestesija, konvulżjonijiet u newrite
English: The following adverse events were reported from post-marketing surveillance with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV, approved for use in children 6 months of age and above, adults and the elderly:
Maltese: L-episodji avversi li ġejjin kienu rrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq b'Focetria (vaċċin kontra l-pandemija ta' H1N1 simili għal AFLUNOV) li fih l-istess ammont ta' adjuvant
English: PHARMACEUTICAL FORM
Maltese: Eritema multiforme
English: However, in a pandemic situation, it may be appropriate for you to be vaccinated with AFLUNOV provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Maltese: bil-kundizzjoni li jkun hemm immedjatament disponibbli trattament mediku xieraq f'każ ta' reazzjoni allerġika.
English: Milky-white liquid.
Maltese: Ħawwad bil-mod qabel tużah.
English: Clinical trials with AFLUNOV have been conducted with either the former A/Vietnam/1194/2004 (H5N1) (clade 1) or the current A/turkey/Turkey/1/2005 (H5NI) vaccine strain (clade 2.2.1).
Maltese: Ġew ittestjati AFLUNOV (A/Vietnam/1194/2004) u vaċċin kontra l-H5N1(li jixbah lil A/turkey/Turkey/2005) li jixbah lil AFLUNOV.
English: L24 9GR
Maltese: TAGĦRIF
English: Geometric Mean Area (95%CI)* Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Maltese: (95%CI)* Rata tasseroprotezzjoni (95%CI)* Rata tas serokonverżjoni
English: • Rash or swelling of the skin and mucous membranes
Maltese: • Raxx jew nefħa fil-ġilda jew fil-membrani mukużi
English: PSUR submission when AFLUNOV is used during an influenza pandemic:
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (PSURs) Sottomissjoni ta' PSUR meta AFLUNOV jintuża matul pandemija tal-influwenza:
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Maltese: għall-antikorp anti-HA għall-H5N1 A/turkey/Turkey/1/2005, wara t-tieni doża fl-adulti ta' 18-60 sena,
English: Study V87P1 Elderly booster after 2nd dose
Maltese: Studju V87P1 Anzjani booster wara t-tieni doża
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
English: Arthralgia
Maltese: Anafilassi
English: However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1).
Maltese: Madankollu, il-grad ta' protezzjoni li jista' jiġi eliċitat għal razez H5N1 ta' gruppi oħra mhuwiex magħruf (ara sezzjoni 5.1).
English: Anti-HA antibody Study V87P12 21 days after 2nd dose N=60
Maltese: Studju V87P12 21 jum wara t-tieni doża
English: AFLUNOV may not fully protect everyone who is vaccinated, especially elderly subjects and those with weakened immune systems, such as HIV patients, or those with underlying long term medical problems, such as diabetes, lung disease or heart problems.
Maltese: AFLUNOV jista' ma jipproteġix b'mod sħiħ lil kull min jiġi mlaqqam, speċjalment individwi anzjani u lil dawk b'sistemi immunitarji dgħajfa, bħal pazjenti ta' HIV, jew dawk li jkollhom problemi mediċi sottostanti li jdumu fit-tul, bħal dijabete, mard tal-pulmun jew problemi tal-qalb.
English: There is limited experience in elderly over 70 years of age (see section 5.1).
Maltese: Teżisti esperjenza limitata dwar persuni anzjani ta' iżjed minn 70 sena (ara sezzjoni 5.1).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with AFLUNOV in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus.
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'AFLUNOV f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika f'immunizzazzjoni attiva kontra s-subtip H5N1 tal-virus tal-Influwenza A.
English: Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows:
Maltese: Iż-żona tal-medja ġeometrika*, ir-rata tas-seroprotezzjoni*, ir-rata tas-serokonverżjoni* u l-fattur tas serokonverżjoni** għall-anitikorp anti-HA għal H5N1 A/turkey/Turkey/1/2005 imkejla mill-assaġġi
English: A second dose of 0.5 ml should be given after an interval of at least 3 weeks.
Maltese: Għandha tingħata doża oħra ta' 0.5 mL wara intervall ta' mill-inqas 3 ġimgħat.
English: - If you get any side effects, talk to your doctor or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew l-infermier tiegħek.
English: Study V87P13 21 days after 2nd dose N=197
Maltese: Studju V87P13 21 jum wara t-tieni doża
English: • Swollen lymph nodes, palpitations (irregular or forceful heart beat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).
Maltese: • Anġjoedema (nefħa anormali tal-ġilda, normalment madwar l-għajnejn, xufftejn, ilsien,
English: Persistence of antibodies after primary vaccination in this population was assessed by hemagglutination inhibition (HI), SRH, and MN assays.
Maltese: Il-persistenza tal-antikorpi wara t-tilqima primarja f'din il-popolazzjoni ġiet imkejla b'assaġġi ta' inibizzjoni tal-emagglutinazzjoni (HI), SRH, u MN.
English: Based on humoral immune responses to the vaccine strain A/turkey/Turkey/1/2005 after two doses of AFLUNOV, a protective immune response may not be elicited in all vaccinees.
Maltese: Abbażi ta' risponsi immuni umorali għar-razza tal-vaċċin A/turkey/Turkey/1/2005 wara żewġ dożi ta' AFLUNOV, rispons immuni protettiv jista' ma jkunx eliċitat fil-vaċċini kollha (ara sezzjoni 5.1).
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Maltese: Disturbi muskolu-skeletriċi, tat-tessuti konnettivi u tal-għadam
English: Seroconversion rates against homologous A/turkey/Turkey/1/2005 ranged from 37.50% to 43.10% in healthy adults, and from 19.18% to 26.47% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 21.43% to 30.65% in healthy elderly subjects, and from 24.49% to 27.86% in elderly subjects with immunosuppressive or underlying medical conditions.
Maltese: 47% f'adulti b'kundizzjonijiet mediċi immunosoppressivi jew sottostanti, rispettivament; ir-rati tas-serokonverżjoni kienu jvarjaw minn 21.43% għal 30.65% f'individwi anzjani b'saħħithom, u minn 24.
English: All animals receiving 2 doses of AFLUNOV were protected, and 94% of animals receiving a single dose of AFLUNOV were protected.
Maltese: L-annimali li rċivew 2 dożi ta' AFLUNOV kienu protetti, u 94% tal-annimali li rċivew doża waħda ta'
English: Injection 2
Maltese: ANNESS II
English: • if you have a severe infection with a high temperature (over 38°C).
Maltese: • jekk int għandek infezzjoni akuta b'temperatura għolja ('il fuq minn 38°C).
English: • Injection site redness
Maltese: • Reazzjonijiet ġeneralizzati fil-ġilda fosthom
English: What AFLUNOV looks like and contents of the pack
Maltese: Kif jidher AFLUNOV u l-kontenut tal-pakkett
English: • Fatigue.
Maltese: • Għeja.
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Maltese: Rari ħafna (<1/10,000).
English: Seroconversion factor (95%CI)°° * Seroprotection: SRH area ≥ 25 mm2
Maltese: SRH Rata ta' seroprotezzjoni (95% CI)* 65% (52-77)
English: HI Seroprotection rate (95%CI)°
Maltese: Rata ta' seroprotezzjoni (95%CI)* Rata ta'
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Maltese: tolleranza lokali, fertilità femminili, u effett tossiku fuq is-sistema riproduttiva u l-iżvilupp
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli attwalment f'suġġetti ta' bejn 6 xhur u 18-il sena hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: There is limited experience in elderly over 70 years of age.
Maltese: aktar minn 70 sena.
English: To be administered intramuscularly into the deltoid muscle.
Maltese: Għandu jingħata b'mod intramuskolari fil-muskolu deltojde.
English: Eye swelling
Maltese: sorbitan trioleate
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Maltese: • jekk int se tagħmel test tad-demm biex tfittex evidenza ta' infezzjoni b'ċerti virusijiet.
English: In a third clinical trial (V87P11) 194 adult subjects were enrolled and received two doses of AFLUNOV (A/turkey/Turkey/1/2005) administered three weeks apart.
Maltese: F'tielet prova klinika (V87P11), ġew reklutati 194 individwu adult u dawn irċivew żewġ dożi ta'
English: Paediatric population The safety and efficacy of AFLUNOV in subjects under 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' AFLUNOV f'suġġetti iżgħar minn 18-il sena ma ġewx determinati s'issa.
English: Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients
Maltese: Effetti mhux mixtieqa f'pazjenti bi problemi mediċi sottostanti li jdumu fit-tul bħal dijabete, mard talpulmun jew problemi tal-qalb u sistemi immunitarji dgħajfa (immunokompromessi) bħal pazjenti ta'
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Maltese: Sitwazzjoni bħal din teħtieġ notifikazzjoni rapida tal-informazzjoni tas-sigurtà li jista' jkollha l-ikbar implikazzjonijiet għal bilanċ bejn ir-riskju u l-benefiċċju f'pandemija.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation 726/2004/EC will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Maltese: F'sitwazzjoni ta' pandemija, il-frekwenza tas-sottomissjoni ta' rapporti perjodiċi ta' aġġornament dwar is-sigurtà speċifikati fl-Artikolu 24 tar-Regolament 726/2004/KE ma tkunx adegwata għall-monitoraġġ tas-sigurtà ta' vaċċin ta' pandemija li għalih ikunu mistennija livelli għoljin ta' espożizzjoni fi ħdan perjodu ta' żmien qasir.
English: 5 April 2016 EMA/108531/2016
Maltese: EMA/108531/2016
English: Castor oil medicines should not be taken in case of obstruction or narrowing of the gut, atony (loss of normal movement in the gut muscle), appendicitis (inflammation of the appendix, a small organ connected to the bowel), inflammatory diseases of the colon (the lower part of the bowel), unexplained abdominal pain and severe dehydration.
Maltese: Il-mediċini li fihom iż-żejt ir-Riġnu m'għandhomx jittieħdu f'każ ta' imblokk jew tidjieq tal-musrana, atonja (telf tal-moviment normali fil-muskolu tal-musrana), appendiċite (infjammazzjoni tal-appendiċi, organu żgħir konness mal-imsaren), mard ta' infjammazzjoni tal-kolon (il-parti l-baxxa tal-imsaren), uġigħ addominali mingħajr spjegazzjoni u deidrazzjoni severa.
English: Side effects have been reported with castor oil.
Maltese: Ġew irrapportati effetti sekondarji biż-żejt ir-Riġnu.
English: Further information on the HMPC assessment of castor oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Other information about castor oil medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom iż-żejt ir-Riġnu
English: In one of the studies the effects of castor oil capsules were similar to those of senna capsules (another herbal preparation commonly used to treat constipation).
Maltese: F'wieħed minn dawn l-istudji, l-effetti tal-kapsuli taż-żejt irRiġnu kienu simili għal dawk tal-kapsuli tas-senna (preparazzjoni tal-ħxejjex oħra użata b'mod komuni sabiex tikkura l-istitikezza).
English: Castor oil is the common name for the oil obtained from the seeds of the plant Ricinus communis L. The HMPC conclusions only cover castor oil preparations which are obtained by ‘cold expression' of the seeds.
Maltese: Meta jinbela', iż-żejt ir-Riġnu jitkisser f'ricinoleic acid li jaħdem billi jnaqqas l-assorbiment tal-fluwidu u l-imluħa fil-musrana ż-żgħira (il-parti ta' fuq tal-musrana).
English: Further information on the risks associated with castor oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom iż-żejt ir-Riġnu, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/498/002 Thymanax
Maltese: Għamla farmaċewtika
English: <Similarity>
Maltese: <Similarità>
English: <Derogation>
Maltese: <Deroga>