qanastek/EMEA-V3 huggingface dataset:
In the case of treatment failure associated with S. aureus, the presence of strains possessing additional virulence factors (such as Panton-Valentine Leukocidin) should be considered.
Fil- każ ta ’ falliment tat- trattament assoċjat ma ’ S. aureus, il - preżenza ta ’ razez li jkollhom fatturi virulenti addizzjonali (bħal Panton- Valentine Leukocidin) għandha tkun ikkunsidrata.
6 Clinical Success Rates at Follow up for SIOW patients with S. aureus
Rati ta ’ Suċċessi Kliniċi wara t- Trattament ta ’ Pazjenti b’ SIOW b ’ S. aureus
Phenotype/ PFGE
Fenotip/ Tip PFGE
Success 95% Exact n/ N
Rata ta ’ suċċess (%)
CI
Exact n/ N CI
Rate (%)
Rata ta ’ suċċess (%)
S. aureus (all) MRSA $MSSA
S. aureus (kollha) MRSA $MSSA
88.9 75.7 90.4
88. 9% 75. 7% 90. 4
(85.3,91.9) (58.8,88.2) (86.7,93.3)
(85. 3, 91. 9) (58. 8, 88. 2) (86. 7, 93. 3)
83.3 80.8 83.6
83. 3 80. 8 83. 6
CI: confidence interval.
CI: confidence interval.
Exact CI is calculated using the F-distribution method. $: the response rate for MRSA due to PVL+ MRSA was 8/ 13 (62%)
CI eżatt huwa kalkolat bl- użu tal- metodu ta ’ distribuzzjoni F. $: ir- rata ta ’ rispons kontra MRSA kkawżata minn PVL+ MRSA kienet ta ’ 8/ 13 (62%)
In a study of healthy adult subjects, 1% retapamulin ointment was applied daily to intact and to abraded skin under occlusion for up to 7 days.
Fi studju fuq suġġetti adulti f’ saħħithom, ingwent b’ 1% retapamulin indilek kuljum fuq ġilda intatta u oħra bi brix f’ okklużjoni sa sebgħat ijiem.
Systemic exposure following topical application of retapamulin through intact skin was very low.
Esponiment sistemiku wara applikazzjoni topika ta ’ retapamulin minn ġilda intatta kien baxx ħafna.
The geometric mean Cmax value in plasma after application to 200 cm2 of abraded skin was 9.75 ng/ ml on day 1 and 8.79 ng/ ml on day 7 and the maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ ml.
Il- valur ġeometriku medju Cmax fi plażma wara applikazzjoni fuq 200 ċm2 ta ’ ġilda mibruxa kien ta ’ 9. 75 ng/ ml fl- ewwel ġurnata u 8. 79 ng/ ml fis- seba ’ ġurnata u l- ogħla esponiment sistemiku (Cmax) individwali rreġistrat kien 22. 1 ng/ ml.
Single plasma samples were obtained from 516 adult and paediatric patients who received topical treatment with retapamulin 1% ointment twice daily for 5 days for the treatment of secondarily infected traumatic lesions.
Kampjuni ta ’ plażma waħedhom ġew miksuba minn 516 adulti u pazjenti pedjatriċi li kienu ħadu trattament topiku b’ ingwent ta ’ 1% retapamulin darbtejn kuljum għal 5 jiem għat- trattament ta ’ feriti trawmatiċi infettati sekondarjament.
Sampling occurred pre-dose for adult subjects on days 3 or 4, and between 0-12 hours after the last application for paediatric subjects on days 3 or 4.
Kampjuni ttieħdu qabel id- doża minn suġġetti adulti f’ jum 3 u 4, u bejn 0- 12- il siegħa wara l- aħħar applikazzjoni minn suġġetti pedjatriċi fit- tielet jew ir- raba ’ jum.
The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ ml).
Il- maġġoranza tal - kampjuni (89%) kienu taħt il- limitu t’ isfel ta ’ kwantitazzjoni (0. 5 ng/ ml).
Of the samples that had measurable concentrations 90% had retapamulin concentrations less than 2.5 ng/ ml.
Mill- kampjuni li kellhom konċentrazzjonijiet li jistgħu jitkejlu 90% kellhom konċentrazzjonijiet ta ’ retapamulin ta ’ inqas minn 2. 5 ng/ ml.
The maximum measured plasma concentration of retapamulin was 10.7 ng/ ml in adults and 18.5 ng/ ml in paediatric patients.
L- ogħla konċentrazzjoni ta ’ plażma mkejla ta ’ retapamulin kienet 10. 7 ng/ ml fl- adulti u 18. 5 ng/ ml f’ pazjenti pedjatriċi.
Distribution
6 Distribuzzjoni
Due to the very low systemic exposures, tissue distribution of retapamulin has not been investigated in humans.
Minħabba l- esponimenti sistemiċi verament baxxi, id- distribuzzjoni f ’ tessuti ta ’ retapamulin ma ġietx investigata fil- bniedem.
In vitro, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor.
In vitro, retapamulin wera li kien substrat u impeditur ta ’ P- glycoprotein (Pgp).
However, the maximum individual systemic exposure in humans following topical application of 1% ointment on 200 cm2 of abraded skin (Cmax= 22 ng/ ml; AUC(0-24) = 238 ng. h/ ml) was 660-fold lower than the retapamulin IC50 for Pgp inhibition.
Madankollu, l- ogħla esponiment sistemiku individwali fil- bniedem wara applikazzjoni topika ta ’ ingwent ta ’ 1% fuq 200 ċm2 ta ’ ġilda mibruxa (Cmax= 22 ng/ ml; AUC( 0- 24) = 238 ng. h/ ml) kien 660 darba inqas mill- IC50 ta ’ retapamulin għal inibizzjoni Pgp.
Retapamulin is approximately 94% bound to human plasma proteins.
Madwar 94% ta ’ retapamulin jeħel ma ’ proteini tal- plażma fil- bniedem.
The in vitro oxidative metabolism of retapamulin in human liver microsomes was primarily mediated by CYP3A4 with minor contributions from CYP2C8 and CYP2D6 (see section 4.5).
Il- metaboliżmu ossidattiv in vitro ta ’ retapamulin f’ mikorosomi tal- fwied fil- bniedem kien primarjament medjat b’ CYP3A4 b’ kontribuzzjonijiet żgħar minn CYP2C8 u CYP2D6 (ara sezzjoni 4. 5).
Retapamulin elimination in humans has not been investigated.
L- eliminazzjoni ta ’ retapamulin mill- bniedem ma ġietx investigata.
7 Special Patient Populations
Popolazzjonijiet ta ’ Pazjenti Speċjali
No pharmacokinetic data are available in children aged less than 2 years, or in patients with renal or hepatic impairment.
Ma hawn ebda tagħrif farmakokinetiku dwar tfal taħt is- sentejn, jew pazjenti b’ indeboliment tal- kliewi jew tal- fwied.
However, due to the low systemic plasma levels that have been observed, no safety problems are foreseen.
Madankollu, minħabba l- livelli baxxi sistemiċi ta ’ plażma li ġew osservati, ebda problemi ta ’ sigurta` m’ huma previsti.
Repeated-dose toxicity
Tossiċita` minn dożi ripetuti
In 14-day (50, 150 or 450 mg/ kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes.
Fi studji mifruxa fuq 14- il ġurnata (50, 150 jew 450 mg/ kg) dwar tossiċita` orali fi ġrieden kien hemm evidenza ta ’ tibdiliet adattivi fil- fwied u fit- tirojde.
Neither of these findings is of clinical relevance.
Ebda waħda minn dawn il- konklużjonijiet ma hi ta ’ rilevanza klinika.
In monkeys dosed orally (50, 150 or 450 mg/ kg) for 14 days there was dose-related emesis.
F’ xadini li ngħataw dożi (50, 150 jew 450 mg/ kg) mill- ħalq għal 14- il ġurnata kien hemm emesi relatata mad- dożi.
Carcinogenesis, mutagenesis, reproductive toxicity
Karċinoġenesi, mutaġenesi, tossiċita` riproduttiva
Long-term studies in animals to evaluate carcinogenic potential have not been conducted with retapamulin.
Ma sarux studji fit- tul b’ retapamulin fuq annimali biex jiġi evalwat il- potenzjal karċinoġeniku.
There was no evidence of genotoxicity when evaluated in vitro for gene mutation and/ or chromosomal effects in the mouse lymphoma cell assay, in cultured human peripheral blood lymphocytes, or when evaluated in vivo for chromosomal effects in a rat micronucleus test.
Ma kienx hemm sinjali ta ’ ġenotossiċita` meta evalwata in vitro għal tibdil ta ’ ġene u/ jew effetti kromosomali fil- lymphoma cell assay fil- ġrieden, f’ limfoċiti kkultivati periferali tad- demm uman, jew meta evalwati in vitro għal effetti kromosomali f’ test mikronukleu fuq ġurdien.
There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 450 mg/ kg/ day, resulting in exposure margins of up to 5-times the highest human estimated exposure (topical application to 200 cm2 abraded skin:
Ma kienx hemm sinjali ta ’ indeboliment ta ’ fertilita` fi ġrieden irġiel jew nisa b’ dożi mill- ħalq ta ’ 50, 150 jew 450 mg/ kg/ kuljum, li irriżulta f’ marġni ta ’ esponiment sa 5 darbiet aktar mill- ogħla esponiment stmat tal- bniedem (applikazzjoni totali fuq 200 ċm2 ta ’ ġilda mibruxa:
In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/ kg/ day (corresponding to ≥ 3 times the human estimated exposure (see above).
Fi studju dwar embrijotossiċita` fil- ġrieden, tossiċita` ta ’ l- iżvilupp (tnaqqis fil- pis tal- fetu u dewmien fl - ossifikazzjoni skeltrali) ġiet osservata b’ dożi orali ta ’ ≥ 150 mg/ kg/ kuljum li jikkorrispondu għal ≥ 3 darbiet aktar mill- ogħla esponiment stmat tal- bniedem (ara hawn fuq).
There were no treatment-related malformations in rats.
Ma kienx hemm deformazzjonijiet relatati mat- trattament fil- grieden.
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 of gestation.
7 Retapamulin ingħata bħala infużjoni kontinwa ġol- vini lil fniek fi tqala mis- 7 sad- 19- il jum ta ’ ġestazzjoni.
Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/ kg/ day corresponding to ≥ 8 times the estimated human exposure (see above).
Tossiċita` materna dehret f’ dożaġġi ta ’ ≥ 7. 2 mg/ kg/ kuljum li jikkorrispondu għal ≥ 8 darbiet aktar mill - ogħla esponiment stmat fil- bniedem (ara hawn fuq).
There was no treatment-related effect on embryo-fetal development.
Ma kien hemm ebda effett relatat mat- trattament fuq l - iżvilupp embrijo- fetali.
No studies to evaluate effects of retapamulin on pre-/ postnatal development were performed.
Ma saru ebda studji biex jiġu evalwati l- effetti ta ’ retapamulin fuq l- iżvilupp ta ’ qabel jew wara t- twelid.
However, there were no systemic effects on juvenile rats with topical application of retapamulin ointment.
Madankollu ma ’ kien hemm l- ebda effett sistemiku f’ ġrieden żgħar wara l- applikazzjoni ta ’ l- ingwent retapamulin fuq il- ġilda.
White soft paraffin.
Paraffin abjad u ħafif
Butylated hydroxytoluene
Butylated hydroxytoluene
In-use:
Waqt l- użu:
7 days.
7 ġranet
Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25°Ċ.
0.5 g aluminium foil sachet.
0. 5 g qartas magħmula minn folja ta ’ l- aluminju.
Carton of 12 sachets.
Pakkett ta ’ 12- il qartas.
5 g, 10 g and 15 g aluminium tubes with a plastic screw cap.
Tubi ta ’ l- aluminju tal- 5g, 10g u 15g b’ tapp tal- plastik bil- kamin.
Carton of 1 tube.
Pakkett ta ’ tubu 1.
Any remaining ointment at the end of treatment should be discarded.
Kull ma jifdal mill- ingwent meta jispiċċa t- trattament għandu jintrema.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN Ir- Renju Unit
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
(trdg as Glaxo Wellcome Operations) Harmire Road Barnard Castle Durham, DL12 8DT United Kingdom
(trdg bħala Glaxo Wellcome Operations) Harmire Road Barnard Castle Durham, DL12 8DT Ir- Renju Unit
The MAH must ensure that the system of pharmacovigilance, as described in version 6.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 6. 2 preżentat fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ postah u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u għat- tul ta ’ żmien kollu li l - prodott jibqa fis- suq.
Risk Management plan
Pjan għal Maniġġjar ta ’ Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jintrabat li jwettaq l- istudji u l- attivitajiet ta ’ Farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 1 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP), preżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u fl- aġġornamenti sussegwenti tal- RMP mifthema mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport Perjodikament Aġġornat dwar Sigurta` (PSUR) li jmiss, skond ir- regolament tas- CHMP dwar Sistemi għal- Maniġġjar ta ’ Riskji għal- prodotti mediċinali għall- użu fil- bniedem.
In addition, an updated RMP should be submitted
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat:
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities.
Meta tasal informazzjoni ġdida li jista ’ jkollha effett fuq l- ispeċifikazzjoni tas- sigurta` kurrenti, fuq il- Pjan ta ’ Farmakoviġilanza kurrenti jew fuq l- attivitajiet għat- tnaqqis tar- riskji.
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
F’ żmien ta ’ 60 ġurnata wara li tkun tlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta 'riskji)
At the request of the EMEA.
Fuq talba ta ’ l- EMEA
CARTON FOR 5 g, 10 g, 15 g TUBE
KARTUNA GĦAL TUBU TA ’ 5 g, 10 g, 15 g.
Altargo 1% ointment Retapamulin
Ingwent 1% Altargo Retapamulin
1 g contains:
1 g fiha:
10 mg retapamulin (1% w/w)
10 mg retapamulin (1% w/ w)
White soft paraffin E321 See package leaflet for further information
Paraffin abjad u ħafif E321 Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
ointment 5 g x 1 tube 10 g x 1 tube 15 g x 1 tube
ingwent 5 g x tubu 1 10 g x tubu 1 15 g x tubu 1
Cutaneous use only Do not swallow Apply to the affected area as directed by your doctor Read the package leaflet before use
Jintuża biss fuq il- ġilda Tibilgħux Idlek fil- post affettwat kif jgħidlek it- tabib Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Do not use in the eyes or on mucous membranes
Tużahx fuq l- għajnejn jew membrani mukużi
Do not store above 25°C.
Taħżinx f’ temperatura’ l fuq minn 25°Ċ.
EU/1/07/390/002 5 g EU/1/07/390/003 10 g EU/1/07/390/004 15 g
EU/ 1/ 07/ 390/ 002 EU/ 1/ 07/ 390/ 003
CARTON FOR 0.5 g SACHET
KARTUNA GĦAL QRATAS TA ’ 0. 5 g
0.5 g x 12 sachets
Ingwent 0. 5 g x 12- il qartas
Cutaneous use only Do not swallow Apply to the affected area as directed by your doctor Read the package leaflet before use
Jintuża biss fuq il- ġilda Tibilgħux Idlek fil- post affettwat skond kif jgħidlek it- tabib Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Do not use in the eyes or on mucous membranes
Tużahx fuq l- għajnejn jew fuq membrani mukużi
5 g, 10 g 15 g TUBE
TUBU TA ’ 5 g, 10 g, 15 g
Altargo 1% ointment Retapamulin Cutaneous use.
Jintuża fuq il- ġilda
Read the package leaflet before use.
Aqra l- fuljett mal- pakkett qabel tużah
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IT- TUBI Ż- ŻGĦAR EWLENIN
0.5 g SACHET
QARTAS ta ’ 0. 5 g
0.5 g
0. 5 g
20 PACKAGE LEAFLET:
20 FULJETT TA ’ TAGĦRIF:
Altargo 1% ointment
Ingwent Altargo 1%
It may harm
Tista ’ tagħmlilhom il- ħsara, anki jekk
them, even if their symptoms seem the same as yours.
ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex
leaflet, please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Altargo is and what it is used for 2.
X’ inhu Altargo u għalxiex jintuża 2.
Before you use Altargo 3.
Qabel ma tuża Altargo 3.
How to use Altargo 4.
Kif għandek tuża Altargo 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu Kif taħżen Altargo 5.
WHAT ALTARGO IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
Altargo is used to treat bacterial infections affecting small areas of skin.
Altargo jintuża fit- trattament ta ’ infezzjonijiet batteriċi li jaffettwaw partijiet żgħar tal- ġilda.
Infections that may be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.
Infezzjonijiet li jistgħu jiġu ttrattati jinkludu impetigo (li tikkawża qoxra niexfa fuq partijiet infettati), qtugħ, brix u feriti meħjuta.
Altargo is for adults and children aged nine months and older.
Altargo qiegħed għal adulti u tfal ta ’ 9 xhur jew akbar.
BEFORE YOU USE ALTARGO
QABEL MA TUŻA ALTARGO
Do not use Altargo:
Tużax Altargo:
If you are allergic (hypersensitive) to retapamulin or any of the other ingredients of Altargo.
Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal retapamulin jew sustanzi oħra ta ’ Altargo
Take special care with Altargo:
Oqgħod attent ħafna b’ Altargo:
If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor.
Jekk tara li l- infezzjoni qed tiħżien jew jekk tiżdiedlek il- ħmura, l- irritazzjoni jew xi sinjali jew sintomi oħra fil- parti fejn tapplikah m’ għandekx tkompli tuża Altargo u għid lit- tabib tiegħek.
See also section 4 of this leaflet.
Ara wkoll is- sezzjoni 4 ta ’ dan il- fuljett.
If there is no improvement in your infection after two to three days of treatment contact your doctor.
Jekk ma tarax titjib fl- infezzjoni tiegħek wara jumejn jew tlieta ta ’ trattament kellem lit- tabib tiegħek.
Do not apply other ointments, creams or lotions to the area being treated with Altargo unless specifically instructed to do so by your doctor.
M’ għandekx tapplika ingwenti, kremi jew xi mediċini likwidi oħra fil- parti trattata b’ Altargo sakemm ma jkunx qallek speċifikament tagħmel hekk it- tabib tiegħek.
21 Pregnancy and breast-feeding:
21 Tużax Altargo jekk int tqila, jew qed tippjana biex toħroġ tqila.
Ask your doctor or pharmacist for advice before using any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek.
Do not use Altargo if you are pregnant, or planning to become pregnant.
Tużax Altargo jekk qed tredda ’ xi tarbija.
Ask your doctor or pharmacist for advice.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek.
HOW TO USE ALTARGO
KIF GĦANDEK TUŻA ALTARGO
Always use Altargo exactly as your doctor has told you.
Dejjem għandek tuża Altargo skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l - ispiżjar tiegħek jekk ikollok xi dubju.
Altargo is for use on the skin only.
Altargo qiegħed għal użu fuq il- ġilda biss.
It must not be put in the eyes, on the mouth or lips, inside the nose or inside the female genital area.
M’ għandux jintuża fuq l- għajnejn, fil- ħalq jew fuq ix- xofftejn, fl - imnieħer jew ġewwa l- parti ġenitali tal- mara.
If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort.
Jekk l- ingwent imiss aċċidentalment ma ’ dawn il- partijiet, aħsel il- parti affettwata bl- ilma u kellem lit- tabib tiegħek jekk tħoss xi uġigħ ħafif.
Wash your hands before and after applying the ointment.
Aħsel idejk qabel u wara li tuża l- ingwent.
How to apply Altargo A thin layer of ointment is usually put on the infected skin twice a day for five days.
Kif tuża Altargo Normalment, saff irqiq ta ’ l- ingwent jitqiegħed fuq il- ġilda nfettata darbtejn kuljum għal ħamest ijiem.
After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.
Wara li tapplika l- ingwent, tista ’ tgħatti l- parti trattata b’ faxxa sterilizzata jew b’ garża, sakemm it- tabib ma jkunx qallek biex tħalliha mikxufa.
Keep using Altargo for as long as your doctor advises.
Ibqa ’ uża Altargo sakemm jgħidlek it- tabib tiegħek.
If you use too much Altargo
Jekk tuża Altargo aktar milli suppost
Carefully wipe off the extra ointment.
Imsaħ b’ attenzjoni l- ingwent żejjed
Problems with overdosage with this medicine are unlikely.
Mhuwiex probabbli li jinqalaw problemi b’ doża eċċessiva b’ din il- mediċina
If you forget to use Altargo
Jekk tinsa tuża Altargo
Apply the ointment as soon as you remember, and apply the next dose at the usual time.
Idlek l- ingwent malli tiftakar, u idlek id- doża li jmiss fil- ħin normali.
If you accidentally swallow Altargo
Jekk aċċidentalment tibla ’ Altargo
Contact your doctor or pharmacist for advice.
Kellem lit- tabib jew spiżjar tiegħek għal parir.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- mediċina, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Altargo can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Altargo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects have occurred on the skin where Altargo has been applied:
Dawn l- effetti sekondarji seħħew fuq il- ġilda fejn Altargo kien applikat:
- skin irritation
- irritazzjoni tal- ġilda
This may affect up to 1 in 10 people.
Din tista ’ taffetwa sa wieħed minn kull 10 persuni.
- pain, itching, redness or rash (contact dermatitis)
- uġigħ, ħakk, ħmura jew raxx (dermatite minn kuntatt)
22 These may affect up to 1 in 100 people.
Dawn jistgħu jaffettwaw sa wieħed minn kull 100 persuna.
Altargo contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Altargo fih butylated hydroxytoluene, li jista jikkawża reazzjonijiet lokali fil- ġilda (per eż. dermatite minn kuntatt) jew irritazzjoni ta ’ l- għajnejn u tal- membrana mukuża.
If you develop signs of a local reaction, such as itching, swelling, redness or pain where you have used Altargo:
22 Jekk joħorġulek sinjali ta ’ reazzjoni lokali, bħal ħakk, nefħa, ħmura jew uġigħ fil- parti fejn użajt Altargo:
Tell your doctor.
Kellem lit- tabib tiegħek.
If you have a severe reaction (e.g. severe itching or severe rash):
Jekk ikollok xi reazzjoni qawwija (ħafna ħakk jew raxx qawwi):
Stop using Altargo, carefully wipe off the ointment, and contact your doctor or pharmacist immediately.
Ieqaf uża Altargo, imsaħ l- ingwent b’ attenzjoni, u kellem lit- tabib jew spiżjar tiegħek mill- ewwel.
If any of the side effects gets serious, or if you notice any side-effects that are not mentioned in this leaflet:
Jekk xi effetti sekondarji jiggravaw, jew jekk tinnota xi effetti sekondarji mhux imsemmijin f’ dan il- fuljett:
Tell your doctor or pharmacist.
Kellem lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ALTARGO
KIF TAĦŻEN ALTARGO
Do not store above 25°C.
Taħżinx f’ temperatura ogħla minn 25° Ċ
Do not use Altargo after the expiry date which is stated on the carton.
Tużax Altargo wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Discard open tubes 7 days after opening.
Armi t- tubi 7 jiem wara li tkun bdejt tużahom.
Return any unused Altargo to your pharmacist.
Ħu lura lill- ispiżjar xi Altargo li ma tkunx użajt.
What Altargo contains
X’ fih Altargo:
- The active substance is retapamulin.
- Is- sustanza attiva hi retapamulin
- The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a
Is- sustanzi l- oħra huma paraffin ħafif u abjad u butylated hydroxytoluene (E321), priservattiv.
preservative.
-
What Altargo looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett:
Altargo is a smooth, off-white ointment.
Altargo hu ingwent lixx u bajdani.
It is supplied in an aluminium tube with a plastic cap, containing either 5, 10 or 15 grams of ointment, or in an aluminium foil sachet containing 0.5 g of ointment.
Jinbiegħ f’ tubu ta ’ l- aluminju b’ tapp tal- plastik, li jkun fih 5 grammi, 10 grammi jew 15- il gramma ingwent, jew f’ qartas ta ’ l- aluminju li jkun fih 0. 5g t’ ingwent.
Marketing authorisation holder
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Manufacturer
l- Manifattur
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
Glaxo Operations UK, Ltd, (trading bħala Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
23 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
23 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
24 Ísland GlaxoSmithKline ehf.
24 Ísland GlaxoSmithKline ehf.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
What is Ambirix?
X' inhu Ambirix?
Ambirix is a vaccine, which is available as a suspension for injection.
Ambirix huwa vaċċin li jinsab bħala sospensjoni għal injezzjoni.
It contains inactivated (killed) hepatitis A virus and parts of the hepatitis B virus as active substances.
Bħala sustanzi attivi huwa fih vajrusis inattivati (maqtulin) ta 'l- epatite A u partijiet mill- vajrus ta' l- epatite B.
What is Ambirix used for?
Għal xiex jintuża Ambirix?
Ambirix is used to protect against hepatitis A and hepatitis B (diseases that affect the liver) in children between one and 15 years of age who are not already immune to these two diseases.
Ambirix jintuża biex jipproteġi kontra infezzjoni b' epatite A u b' epatite B (mard li jaffettwa l- fwied) fi tfal u adolexxenti ta 'etajiet bejn sena u 15- il sena li mhumiex diġà immuni.
Ambirix is used as a two-dose schedule and protection against hepatitis B may not be obtained until after the second dose.
Ambrix jintuża bħala programm ta 'żewġ dożi u protezzjoni kontra l- epatite B tista' ma tinkisibx sa wara t- tieni doża.
Because of this, Ambirix should only be used when there is a low risk of hepatitis B infection during the vaccination course, and when it is certain that the two-dose vaccination course can be completed.
Minħabba dan, Ambrix għandu jintuża biss fejn hemm riskju baxx ta 'infezzjoni bl - epatite B waqt il- kors ta' tilqim, u meta jkun hemm ċertezza li l- kors ta 'tilqim ta' żewġ dożi jista 'jiġi mitmum.
This medicine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss b' riċetta ta' tabib.
How is Ambirix used?
Kif jintuża Ambirix?
The vaccination schedule for Ambirix is two doses given six to 12 months apart.
Il- programm ta 'tilqim irrakkomandat għal Ambirix huwa ta' żewġ dożi mogħtija sitta sa tnax- il xahar 'il bogħod minn xulxin.
The vaccine is given as an injection into the muscle of the upper arm, or into the thigh in very young children.
Il- vaċċin jingħata permezz ta 'injezzjoni fil- muskolu tal- parti ta' fuq tad- driegħ jew fil- koxxa fi tfal żgħar ħafna.
Individuals who receive the first dose should complete the course with Ambirix.
Individwi li jirċievu l- ewwel doża għandhom ikomplu l- kors b' Ambrix.
Where a booster dose of hepatitis A or B is desired, Ambirix, or a separate hepatitis A or B vaccine may be given.
Meta tkun mixtieqa doża booster ta 'l- epatite A jew B jistgħu jingħataw Ambirix jew vaċċin separat ta' l- epatite A jew B.
How does Ambirix work?
Kif jaħdem Ambirix?
Ambirix is a vaccine.
Ambirix huwa vaċċin.
Ambirix contains small amounts of inactivated hepatitis A viruses and the ‘ surface antigen ’ (proteins from the surface) of the hepatitis B virus.
Ambirix fih ammonti żgħar ta 'vajrusis ta' l- epatite A inattivati u l - 'antiġene tas- superfiċje' (proteini mis- superfiċje) tal- vajrus ta 'l- epatite B.
When a child is given the vaccine, the immune system recognises the viruses and surface antigens as ‘ foreign’ and makes antibodies against them.
Meta tifel jew tifla jingħataw il- vaċċin, is- sistema immunitarja tagħraf l- antiġeni tas- superfiċje bħala 'barranin' u tipproduċi antikorpi kontrihom.
If exposed to the viruses in the future, the immune system will be able to make antibodies more quickly.
Fil- futur, is- sistema immunitarja tkun tista 'tagħmel antikorpi aktar malajr meta tkun esposta għall- vajrusis.
The antibodies will help to protect against diseases caused by these viruses.
L- antikorpi se jgħinu biex jipproteġu kontra l - marda kkaġunata minn dawn il- vajrusis.
The vaccine is ‘ adsorbed’.
Il- vaċċin huwa 'adsorbit'.
This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Dan ifisser li l- vajrusis u l- antiġeni tas- superfiċje jitwaħħlu fuq komposti ta 'l- aluminju, biex jistimolaw reazzjoni aħjar.
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
L- antiġeni tas- superfiċje tal- vajrus ta 'l- epatite B jiġu
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. prodotti permezz ta 'metodu magħruf bħala' teknoloġija rikombinanti tad- DNA ': huma jiġu prodotti minn ħmira li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
The active substances in Ambirix have been available in other vaccines authorised in the European Union (EU):
Is- sustanzi attivi f' Ambrix ilhom jinsabu f' vaċċini oħrajn awtorizzati fl- Unjoni Ewropea (UE):
Ambirix contains the same ingredients as Twinrix Adult, which has been authorised since 1996, and as Twinrix Paediatric, which has been authorised since 1997.
Ambrix fih l- istess sustanzi attivi bħal Twinrix Adult, li ilu awtorizzat mill- 1996, u bħal Twinrix Paediatric, li ilu awtorizzat mill- 1997.
The three vaccines are used to protect against the same diseases, but Twinrix Adult and Twinrix Paediatric are given as a three-dose schedule.
It- tliet vaċċini jintużaw biex jipproteġu kontra l- istess mard, iżda Twinrix Adult u Twinrix Paediatric jingħataw bħala skeda ta 'tliet dożi.
How has Ambirix been studied?
Kif ġie studjat Ambirix?
Because Ambirix and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Ambirix.
Minħabba li Ambirix u Twinrix Adult fihom sustanzi identiċi, xi dejta użata biex tappoġġa l- użu ta 'Twinrix Adult intużat biex tappoġġa l- użu ta' Ambrix.
Three main studies of Ambirix were carried out in a total of 615 children from one year of age.
Tliet studji ewlenin ta 'Ambirix saru f' total ta' 615- il tifel u tifla minn età ta 'sena.
All of the children received two doses of Ambirix six months apart.
It- tfal kollha rċevew żewġ dożi ta 'Ambirix sitt xhur' il bogħod minn xulxin.
Two of the studies compared Ambirix with other vaccines against hepatitis A and B.
Tnejn mill- istudji qabblu Ambirix ma 'vaċċini oħrajn kontra l- epatite A u B.
The main measure of effectiveness was the proportion of vaccinated children who developed protective levels of antibodies one month after the last injection.
Il- kejl ewlieni ta 'l- effikaċja kien il- proporzjon ta' tfal imlaqqma li żviluppaw livelli ta 'protezzjoni ta' antikorpi xahar wara l- aħħar injezzjoni.
An additional study in 208 children compared the vaccine’ s effectiveness when a six-month or a 12- month interval was used between the two injections.
Studju addizzjonali f' 208 itfal qabbel l- effikaċja tal- vaċċin meta ntuża intervall ta 'sitt xhur jew intervall ta' 12- il xahar bejn iż- żewġ injezzjonijiet.
What benefit has Ambirix shown during the studies?
X' benefiċċji wera Ambirix waqt l- istudji?
Ambirix led to the development of protective levels of antibodies against hepatitis A and B in between 98 and 100% of the vaccinated children at one month after the last injection.
Ambirix wassal għall- iżvilupp ta 'antikorpi protettivi kontra l- epatite A u B f' madwar 98 u 100% tat - tfal imlaqqma f' xahar wara l- aħħar injezzjoni.
These levels were maintained in over 93% of the children after two years.
Dawn il- livelli nżammu fi 'l fuq minn 93% tat- tfal wara sentejn.
Ambirix was as effective as other vaccines against hepatitis A and B once the full vaccination course had been completed.
Ambirix kien effikaċi daqs vaċċini oħrajn kontra l- epatite A u B ġa ladarba l- kors sħiħ ta 'tilqim kien ġie komplut.
However, full protection against hepatitis B did not develop until the second dose of Ambirix had been given.
Madankollu, protezzjoni sħiħa kontra l- epatite B ma żviluppatx sakemm ingħatat it- tieni doża ta 'Ambrix.
The additional study showed that the levels of protection with Ambirix were similar with a six- and a 12-month gap between injections.
L- istudju addizzjonali wera li livelli ta 'protezzjoni b' Ambirix kienu simili b' perjodu ta' żmien ta 'sitt xhur u ta' tnax- il xahar bejn l- injezzjonijiet.
What is the risk associated with Ambirix?
X' inhu r- riskju assoċjat ma 'Ambirix?
The most common side effects with Ambirix (seen in more than 1 in 10 doses of the vaccine) are headache, loss of appetite, pain at the site of injection, redness, fatigue (tiredness) and irritability or fussiness.
L- aktar effett sekondarju komuni bi Ambirix (deher f' aktar minn 1 f' 10 dożi tal- vaċċin) huma uġigħ ta 'ras, telf ta' aptit, uġigħ fil- punt fejn ingħatat l- injezzjoni, ħmura, għeja kbira u irritabilità u nervużiżmu.
For the full list of all side effects reported with Ambirix, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Ambirix, ara l- Fuljett ta' Tagħrif.
Ambirix should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Ambirix ma għandux jintuża f' nies li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe mis - sustanzi attivi, kwalunkwe mis- sustanzi l- oħra jew għal neomiċina (antibijotiku).
It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.
Ma għandux jintuża ukoll f' nies li kellhom reazzjoni allerġika wara li ngħataw il- vaċċini ta 'l- epatite A jew ta' l- epatite B.
Vaccination with Ambirix should be postponed in patients with a severe sudden fever.
Ambirix għandu jiġi pospost f' pazjenti b' deni qawwi li jitla 'f' daqqa waħda.
The vaccine should never be injected into a vein.
Huwa qatt ma għandu jiġi injettat fil- vina.
Why has Ambirix been approved?
Għalfejn ġiex approvat Ambirix?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ambirix’ s benefits are greater than its risks for use in non-immune persons from one year up to and including 15 years for protection against hepatitis A and hepatitis B infection.
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Ambirix huma akbar mir- riskji tiegħu għal użu f' persuni mhux immuni minn sena sa u inkluża 15- il sena għall- protezzjoni kontra infezzjoni bl- epatite A u l- epatite B.
The Committee recommended that Ambirix be given marketing authorisation.
Il- Kumitat irrakkomanda li Ambirix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Ambirix:
Tagħrif ieħor dwar Ambirix:
The European Commission granted a marketing authorisation valid throughout the EU for Ambirix to GlaxoSmithKline Biologicals s. a. on 30 August 2002.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Ambirix valida fl- Unjoni Ewropea kollha lil GlaxoSmithKline Biologicals s. a. fit- 30 ta' Awissu 2002.
The marketing authorisation was renewed on 30 August 2007.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 30 ta 'Awissu 2007.
The full EPAR for Ambirix can be found here.
L- EPAR sħiħ għal Ambirix jista 'jinsab hawn.
Ambirix, suspension for injection Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine (adsorbed).
Ambirix, suspensjoni għal injezzjoni Tilqima (adsorbita) ta ’ l- epatite A (inattivata) u epatite B (rDNA) (HAB).
1 dose (1 ml) contains:
Doża waħda (1 ml) fiha:
Hepatitis A virus (inactivated)1,2 Hepatitis B surface antigen3,4 1 Produced on human diploid (MRC-5) cells 2
Virus ta 'l- epatite A (inattivat) 1, 2 Antiġen tal- wiċċ ta' l- epatite B3, 4 1 Magħmul fuq ċelluli diplojdi (MRC- 5) umani 2
720 ELISA Units 20 micrograms
720 Unitajiet ELISA 20 mikrogramma
Adsorbed on aluminium hydroxide, hydrated
GĦAMLA FARMAĊEWTIKA
0.05 milligrams Al3+
Suspensjoni għal injezzjoni.
0.4 milligrams Al3+
TAGĦRIF KLINIKU
Ambirix is a turbid white suspension.
4. 1 Indikazzjonijiet terapewtiċi
Ambirix is for use in non-immune persons from 1 year up to and including 15 years for protection against hepatitis A and hepatitis B infection.
Ambirix qiegħed biex jintuża f`persuni mhux immuni mill- eta ’ ta ’ sena sa 15- il sena, ta ’ l- aħħar inkluża, għall- protezzjoni kontra l- infezzjoni ta ’ l- epatite A u l- epatite B.
Therefore:
Il- protezzjoni kontra infezzjonijiet ta ’ l- epatite B għandha mnejn ma tinkisibx qabel tittieħed it- tieni doża (ara sezzjoni 5. 1) Għalhekk:
- Ambirix should be used only when there is a relatively low risk of hepatitis B infection during
- Ambirix għandu jintuża biss meta jkun hemm riskju relattivament żgħir ta 'infezzjoni ta' l -
the vaccination course.
epatite B waqt il- kors tat- tilqim.
- It is recommended that Ambirix should be administered in settings where completion of the
- Huwa rakkomandat li Ambirix jingħata f' sitwazzjonijiet meta jista ’ jkun żgurat li l- kors biż -
two-dose vaccination course can be assured.
żewġ dożi tal- vaċċin ser jitkompla.
- Dosage
- Dożaġġ
A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Doża ta ’ 1. 0 ml hija rakkomandata f`individwi mill- eta 'ta' sena sa 15- il sena, ta 'l- aħħar inkluża.
- Primary vaccination schedule
- Skeda ta 'tilqim primarju
The standard primary course of vaccination with Ambirix consists of two doses, the first administered at the elected date and the second between six and twelve months after the first dose.
Il- kors primarju standard ta ’ tilqim bl- Ambirix jikkonsisti f’ żewġ dożi, l- ewwel waħda tittieħed fid - data magħżula u l- oħra bejn is- sitt u t- tnax- il xahar wara l- ewwel doża.
2 The recommended schedule should be adhered to.
2 L- iskeda rakkomandata trid tiġi segwita.
Once initiated, the primary course of vaccination should be completed with the same vaccine.
La darba jinbeda, il- kors primarju tat- tilqim għandu jispiċċa bl- istess tilqima.
- Booster dose
- Doża ta ’ rinforz
In situations where a booster dose of hepatitis A and/ or hepatitis B is desired, a monovalent or combined vaccine can be given.
F`ċirkostanzi fejn hija mixtieqa doża ta ’ rinforz ta ’ l- epatite A u/ jew l- epatite B, jista ’ jintuża vaċċin monovalenti jew vaċċin kombinat.
The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.
Is- sigurtà u l- immunoġeniċità ta ’ Ambirix mogħti bħala doża ta ’ rinforz, wara kors primarju ta ’ tilqim ta ’ żewġ dożi, għadhom ma ġewx evalwati.
The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
L- antiġen tal- wiċċ ta 'kontra l- epatite B (anti- HBs) u t- titri ta' l- antikorpi tal- virus ta 'kontra l- epatite A (anti- HAV) li kienu osservati wara kors primarju ta ’ tilqim bl- Ambirix huma fil- marġini ta' dak li jidher wara t- tilqim bil- vaċċini ta ’ l- epatite A u B monovalenti.
General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Għalhekk, linji gwida dwar it- tilqim ta ’ rinforz jista ’ jinkiseb mill- esperjenza li għandna bil- vaċċini monovalenti kif ġej.
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established.
Għadu ma ġiex stabbilit jekk hemmx bżonn ta 'doża ta ’ rinforz tat- tilqima għall- epatite B f' individwi b' saħħithom li kienu ħadu kors primarju kollu ta' tilqim.
However some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Madankollu, xi programmi uffiċjali ta 'tilqim bħalissa jinkludu rakkomandazzjoni għal doża ta ’ rinforz tat- tilqima ta ’ l- epatite B u dawn ta ’ min jagħti kashom.
For some categories of subjects at risk of exposure to HBV (e. g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥ 10 mIU/ ml is maintained.
Għal xi kategoriji ta ’ individwi esposti għal riskju ta 'HBV (e. g. pazjenti fuq dijaliżi tad- demm jew pazjenti immunokompromessi) trid tittieħed attitudni ta' prekawzjoni biex ikun żgurat li jinżamm livell ta 'antikorpi protettiv ta' ≥ 10 mUI/ ml.
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Għad mhux stabbilit għal kollox jekk individwi immunokompetenti li fihom tkun ħadmet it- tilqima ta 'l- epatite A jkollhomx bżonn ta' dożi ta ’ rinforz għax meta ma jkunx jidher li hemm antikorpi, il - protezzjoni tista ’ tiġi assigurata permezz ta 'memorja immunoloġika.
Guidelines for boosting are based on the assumption that antibodies are required for protection.
Linji gwida għad- doża ta ’ rinforz huma bbażati fuq is- suppożizzjoni li l- antikorpi huma meħtieġa għall- protezzjoni.
Anti-HAV antibodies have been predicted to persist for at least 10 years.
Huwa previst li antikorpi għal kontra l- HAV jippersistu mill- anqas għal 10 snin.
Ambirix is for intramuscular injection, usually into the deltoid muscle.
Ambirix għandu jingħata bħala injezzjoni ġol- muskolu, normalment fil- muskolu deltojd.
However the anterolateral thigh may be used in very young subjects if preferred.
Madankollu jista ’ jingħata fil- koxxa anterolaterali f`individwi żgħar ħafna jekk mixtieq.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Bħala eċċezzjoni, t- tilqima tista ’ tingħata taħt il- ġilda f' pazjenti li jbatu minn tromboċitopenja jew li għandhom disturbi tal- fsada.
However, this route of administration may result in suboptimal immune response to the vaccine.
Madankollu, meta tingħata hekk jista ’ ma jkunx hemm l- aħjar rispons ta 'immunità għat- tilqima.
(see section 4.4)
(ara sezzjoni 4. 4).
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Sensittività eċċessiva għas- sustanzi attivi jew għal kwalunkwe mis- sustanzi mhux attivi jew għal neomycin.
Hypersensitivity after previous administration of hepatitis A and/ or hepatitis B vaccines.
Sensittività eċċessiva wara li ingħata tilqim ta ’ l- epatite A u/ jew l- epatite B fil- passat.
As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness.
Bħal b’ kull tilqim ieħor, it- tilqima ta 'Ambirix għandha tiġi posposta f' każijiet fejn il- pazjent ikun marid akutament b' deni għoli.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħall b’ kull tilqim ieħor li jiġi injettat, kura medika xierqa u superviżjoni għandom dejjem ikunu disponibbli għal xi każ rari ta ’ reazzjoni anafilattika wara li jkun ingħata l- vaċċin.
3 It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
3 Jista ’ jagħti l- każ li wieħed ikun qiegħed f' perjodu ta ’ inkubazzjoni ta ’ l- infezzjoni ta ’ l- epatite A jew l- epatite B waqt li jkun qed jieħu t- tilqima.
It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases.
Mhux magħruf jekk Ambirix jilqax kontra l- epatite A u l - epatite B f' każijiet bħal dawn.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
It- tilqima ma tipproteġix kontra infezzjonijiet kkaġunati minn aġenti oħra bħall- epatite C u l- epatite E u patoġeni oħra magħrufa li jinfettaw il- fwied.
Ambirix is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Ambirix mhux rakkomandat għal prevenzjoni kontra l- infezzjoni wara l- esposizzjoni għall- virus (eż. tingiża b’ labra użata).
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Jekk ikun hemm ħtieġa ta 'protezzjoni ta' malajr kontra l- epatite B, hi rakkomandata il- kura standard ta 'tliet dożi tat- tilqima kombinata li jkun fiha 360 Unitajiet ELISA tal- virus ta ’ l- epatite A inattivat bil- formalina u 10 mikrogrammi ta' antiġen tal- wiċċ ta 'l- epatite B rikombinanti.
This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix.
Dan hu minħabba li l - akbar proporzjon ta ’ individwi huma protetti fl- intervall ta 'bejn it- tieni u t- tielet doża tat- tilqima kombinata ta' tliet dożi, milli wara doża waħda ta 'Ambirix.
This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
Din id- differenza ma tibqax tidher wara t - teħid tat- tieni doża ta ’ Ambirix (ara sezzjoni 5. 1 dwar r- rati ta 'seroprotezzjoni)
It is recommended that the two-dose regimen of Ambirix be completed prior to start of sexual activity.
Hu rakkomandat li l- kura b' żewġ dożi ta 'Ambirix tintemm qabel ikun hemm xi attività sesswali.
The vaccine has not been tested in patients with an impaired immune system.
It- tilqima ma ġietx ittestjata f' pazjenti li għandhom problemi fis- sistema immuni.
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
F' pazjenti fuq dijaliżi tad- demm u oħrajn li għandhom problemi fis- sistema immuni, titri adegwati ta ’ antikorpi ta ’ kontra l - HAV u l- HBs jistgħu ma jinkisbux wara l- kors primarju ta 'tilqim.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Ladarba injezzjoni għal ġol- ġilda jew tilqima għal ġol- muskolu mogħtija fil- muskolu glutejali jistgħu iwasslu għal riżultat inqas minn dak mistenni, dawn is- siti ta 'injezzjoni għandhom jiġu evitati.
However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Madankollu, b' eċċezzjoni Ambirix jista ’ jingħata minn taħt il- ġilda lill- pazjenti li jbatu minn tromboċitopenja jew disturbi tal- fsada għaliex wara li dawn l- individwi jingħataw it- tilqima, ġol - muskolu jista ’ jkollhom fsada.
AMBIRIX SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
AMBIRIX M' GĦANDU QATT JINGĦATA B’ MOD INTRAVASKULARI
No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Ma ħareġ l- ebda tagħrif dwar it- teħid ta ’ Ambirix flimkien ma 'immunoglobulin speċifiku ta ’ l- epatite A jew immunoglobulin speċifiku ta' l- epatite B.