qanastek/EMEA-V3 huggingface dataset:
25 pre-filled oral applicators 25 x 1 dose (1.5 ml)
25 applikaturi tal- ħalq mimlijin lesti 25 x doża waħda (1. 5 ml)
41 Ready to use No reconstitution required
44 Lest għall- użu M’ hemmx bżonn ta ’ rikostituzzjoni
EU/0/00/000/000 – pack of 1 pre-filled oral applicator EU/0/00/000/000 – pack of 5 pre-filled oral applicators EU/0/00/000/000 – pack of 10 pre-filled oral applicators EU/0/00/000/000 – pack of 25 pre-filled oral applicators
EU/ 0/ 00/ 000/ 000 – pakkett ta ’ applikatur tal- ħalq 1 mimli lest EU/ 0/ 00/ 000/ 000 – pakkett ta ’ 5 applikaturi tal- ħalq mimlijin lesti EU/ 0/ 00/ 000/ 000 – pakkett ta ’ 10 applikaturi tal- ħalq mimlijin lesti EU/ 0/ 00/ 000/ 000 – pakkett ta ’ 25 applikaturi tal- ħalq mimlijin lesti
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING TUBE, PACK SIZES OF 1, 10 OR 50
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA TUBU, PAKKETTI TA ’ 1, 10 JEW 50
Oral suspension 1 tube 1 dose (1.5 ml)
Suspensjoni orali tubu 1 doża waħda (1. 5 ml)
10 tubes 10 x 1 dose (1.5 ml)
10 tubi 10 x doża waħda (1. 5 ml)
50 tubes 50 x 1 dose (1.5 ml)
50 tubu 50 x doża waħda (1. 5 ml)
43 FOR ORAL USE ONLY
47 GĦALL- UŻU ORALI BISS
EU/0/00/000/000 – pack of 1 tube EU/0/00/000/000 – pack of 10 tubes EU/0/00/000/000 – pack of 50 tubes
EU/ 0/ 00/ 000/ 000 – pakkett ta ’ tubu 1 EU/ 0/ 00/ 000/ 000 – pakkett ta ’ 10 tubi EU/ 0/ 00/ 000/ 000 – pakkett ta ’ 50 tubu
44 16.
48 16.
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS PRE-FILLED ORAL APPLICATOR
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI APPLIKATUR TAL- ĦALQ MIMLI LEST
46 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED ORAL APPLICATOR
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN APPLIKATUR GĦALL- ĦALQ MIMLI LEST
Rotarix Oral suspension Rotavirus vaccine, live Oral use
Rotarix Suspensjoni orali Vaċċin ta ’ Rotavirus, ħaj Użu orali
1 dose (1.5 ml)
Doża waħda (1ml)
47 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE
51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TUBU
49 PACKAGE LEAFLET:
53 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before your child receives this vaccine.
Aqra sew dan il- fuljett kollu qabel tibda tagħti l- vaċċina lit- tarbija tiegħek. • Żomm dan il- fuljett.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Jista jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Dan il- vaċċin ingħata għat- tarbija tiegħek.
please tell your doctor or pharmacist.
TAGĦTIHX lil persuni oħra. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Rotarix is and what it is used for 2.
X’ inhu Rotarix u għalxiex jintuża 2.
Before your child receives Rotarix 3.
Qabel ma t- tarbija tiegħek tieħu Rotarix 3.
How Rotarix is given 4.
Kif għandek tagħti Rotarix 4.
How to store Rotarix 6.
Kif taħżen Rotarix 6.
WHAT ROTARIX IS AND WHAT IT IS USED FOR
X’ INHU ROTARIX U GĦALXIEX JINTUŻA
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.
Rotarix hu vaċċin virali, li fih rotavirus uman attenwat, li jgħin billi jipproteġi t- tarbija tiegħek, mill - età ta ’ sitt ġimgħat, kontra l- gastro- enterite (dijareja u remettar) kawżata minn infezzjoni ta ’ rotavirus.
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children.
Infezzjoni ta ’ rotavirus hi l- aktar kawża komuni għal dijareja severi fi trabi u tfal żgħar.
Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person.
Ir- rotavirus jittieħed faċilment mill- idejn għall- ħalq minħabba kuntatt ma ’ ħmieġ solidu minn persuna infettata.
Most children with rotavirus diarrhoea recover on their own.
Il - biċċa l- kbira tat- tfal b’ dijareja minn rotavirus ifiequ waħedhom.
However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.
Biss, xi whud mit- tfal jimirdu serjament b’ remettar u dijareja severi u nuqqas kbir ta ’ likwidi fil- ġisem li jipperikolaw il- ħajja u li jkollhom bżonn ta ’ kura fi sptar.
When a person is given the vaccine, the immune system (the body’s natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja (ir- reżistenza naturali tal- ġisem) toħloq anti- korpi kontra l- aktar tipi komuni ta ’ rotavirus.
These antibodies protect against disease caused by these types of rotavirus.
Dawn l- anti- korpi jħarsu kontra l- mard kaġunat minn dawn it- tipi ta ’ rotavirus.
As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.
Bħal kull każ ta ’ vaċċini oħra, Rotarix jista ’ ma jipproteġix kompletament lil kull min jieħu l- vaċċin kontra l- infezzjonijiet ta ’ rotavirus li hu maħsub li jagħmel.
BEFORE YOUR CHILD RECEIVES ROTARIX
QABEL MA T- TARBIJA TIEGĦEK TINGĦATA L- VAĊĊIN
Rotarix should not be given: • if your child has previously had any allergic reaction to rotavirus vaccines or any component contained in Rotarix.
Rotarix m’ għandux jingħata: • Jekk it- tarbija tiegħek qatt kellha xi reazzjoni allerġika għal vaċċini ta ’ rotavirus jew għal xi komponent li jinstab f’ Rotarix.
The active substances and other ingredients in Rotarix are listed at the end of the leaflet.
Is- sustanzi attivi u l- ingredjenti oħra li jinsabu f’ Rotarix huma elenkati fl- aħħar tal- fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment). • if your child was born with a malformation of the gut that could lead to intussusception. • if your child has any disease which reduces his/her resistance to infection. • if your child has a severe infection with a high temperature.
Sinjali ta ’ reazzjoni allerġika jistgħu jinkludu raxx fil- ġilda bil - ħakk, qtugħ ta ’ nifs u nefħa fil- wiċċ jew fl- ilsien. • Jekk it- tarbija tiegħek fl- imgħoddi kellha intussuxezzjoni (ostaklu fl- imsaren li bih parti mill - musrana titkebbeb ma ’ parti oħra). • Jekk it- tarbija tiegħek kienet twieldet b’ xi malformazzjoni fl- imsaren li tista ’ twassal għal intussuxezzjoni. • Jekk it- tarbija tiegħek għandha xi mard li jdgħajfilha r- reżistenza tagħha għall- infezzjonijiet. • Jekk it- tarbija tiegħek għandha xi infezzjoni severi b’ deni għoli.
It might be necessary to postpone the vaccination until recovery.
Jista ’ jkun il- każ li l- vaċċin jiġi postponut sakemm tfieq.
A minor infection such as a cold should not be a problem, but talk to your doctor first. • if your child has diarrhoea or is vomiting.
Infezzjoni żgħira bħal riħ komuni m’ għandhiex tkun problema, biss dejjem għandek tkellem lit- tabib qabel xejn.
It might be necessary to postpone the vaccination until recovery.
54 • Jekk it- tarbija tiegħek għandha d- dijareja jew tirremetti.
50 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
Oqgħod attent ħafna b’ Rotarix • Għarraf lit- tabib / professjonist fil- qasam tas- saħħa tiegħek jekk it- tarbija tiegħek: għandha kuntatt ma ’ persuna fil qrib tagħha bħal persuna li tgħix magħha li għandha sistema immunitarja mdgħajjfa, eż., persuna bil- kanċer jew li qed tieħu mediċini li jistgħu jwasslu għal sistema immunitarja mdgħajjfa. • għandha xi disturb fis- sistema gastro- intestinali. • mhux qed iżżid fil- piż u tikber kif suppost. • twieldet qabel iż- żmien, għaliex il- livell ta ’ protezzjoni mill- vaċċin mhux mgħaruf f’ dan il- każ.
As always, please take care to wash your hands thoroughly after changing soiled nappies.
Bħal dejjem, jekk jogħġbok ara li taħsel idejk sewwa wara li tbiddel ħrieqi maħmuġin.
Using other vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Meta tieħu vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk it- tarbija tiegħek qed tieħu jew ħadet dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta tat- tabib jew jekk ħadet dan l- aħħar xi vaċċin ieħor.
Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Rotarix jista jingħata fl- istess ħin li t- tarbija tiegħek tkun qed tieħu xi vaċċini rakkomandati oħra, bħal difterite, tetanu, pertussis (sogħla konvulsiva), Haemophilus influenzae tip b, poljo orali jew inattivat, vaċċini ta ’ l- epatite B kif ukoll vaċċini pneumococcal u meningococcal serogroup C conjugate.
Using Rotarix with food and drink There are no restrictions on your child’s consumption of food or liquids, either before or after vaccination.
Meta tieħu Rotarix ma ’ l- ikel u max- xorb Ma hemm ebda restrizzjonijiet dwar il- konsum mit- tarbija tiegħek ta ’ ikel jew likwidi, kemm qabel u kemm wara l- vaċċinazzjoni.
Breast-feeding Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
Treddigħ Fuq il- bażi ta ’ evidenza disponibbli minn provi kliniċi, treddigħ ma jnaqqasx mill- protezzjoni kontra gastro- enterite bir- rotavirus li jagħti Rotarix.
Therefore, breast-feeding may be continued during the vaccination schedule.
Għalhekk, it- treddigħ jista ’ jitkompla matul l- iskeda tal - vaċċinazzjoni.
Important information about some of the ingredients of Rotarix If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before using this vaccine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Rotarix Jekk it- tabib ikun qallek li t- tarbija li tkun ser tieħu l- vaċċinazzjoni ma jaqbilx magħha z- zokkor, kellem lit- tabib tiegħek qabel tuża dan il- vaċċin.
HOW ROTARIX IS GIVEN
KIF GĦANDEK TAGĦTI ROTARIX
The doctor or nurse will administer the recommended dose of Rotarix to your child.
It- tabib jew l- infermier/ a għandhom jagħtu d- doża rakkomandata ta ’ Rotarix lit- tarbija tiegħek.
The vaccine (1 ml liquid) will be given orally.
Il- vaċċin (1ml likwidu) jingħata mill- ħalq.
Under no circumstance should this vaccine be administered by injection.
Dan il- vaċċin fl- ebda ċirkostanza m’ għandu jingħata b’ injezzjoni.
Your child will receive two doses of the vaccine.
It- tarbija tiegħek ħa tingħata żewġ dożi tal- vaċċin.
Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses.
Kull doża tingħata f’ ġurnata għaliha b’ intervall ta ’ mill- anqas 4 ġimgħat bejn iż- żewġ dożi.
The first dose may be given from the age of 6 weeks.
L- ewwel doża tista ’ tingħata mill- età`ta ’ 6 ġimgħat.
The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.
Iż- żewġ dożi tal- vaċċin għandhom ikunu ngħataw ma ’ l- età ta ’ 24 ġimgħa, għalkemm preferibbilment għandhom jingħataw qabel l- età ta ’ 16- il ġimgħa.
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Fil- każ li t- tarbija tobżoq jew ittella ’ l- parti l- kbira tal- vaċċin, tista minflok terġa ’ tingħata doża waħda fl- istess żjara għall- vaċċinazzjoni.
When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.
Meta t- tarbija tiegħek tingħata Rotarix għall- ewwel doża, hu rakkomandat li t- tarbija tieħu Rotarix (u mhux xi vaċċin ieħor tar- rotavirus) ukoll għat- tieni doża.
It is important that you follow the instructions of your doctor or nurse regarding return visits.
Hu importanti li timxi fuq l- istruzzjonijiet li jagħtuk it- tabib jew infermier/ a tiegħek dwar żjarat ta ’ ritorn.
If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Jekk tinsa tmur lura għand it- tabib meta jmissek, saqsi għall- parir tat- tabib.
51 Like all medicines, Rotarix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Rotarix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects that occurred during clinical trials with Rotarix were as follows:
Effetti sekondarji li seħħew waqt provi kliniċi b’ Rotarix kienu kif ġej:
♦ Very common (These may occur with 1 in 10 doses or more of the vaccine): • loss of appetite • irritability
♦ Komuni ħafna (Dawn jistgħu jseħħu b’ doża waħda minn kull 10 dożi jew aktar tal- vaċċin): • Nuqqas t’ aptit • Irritabilità
♦ Common (These may occur with up to 1 in 10 doses of the vaccine): • fever, tiredness • diarrhoea, vomiting, regurgitation of food, flatulence, abdominal pain
♦ Komuni (Dawn jistgħu iseħħu f’ sa doża waħda minn kull 10 dożi tal- vaċċin. • Deni, għeja • Dijareja, remettar, rigurġitazzjoni ta ’ ikel, gass fl- istonku, uġigħ addominali
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): • crying • sleep disorder, sleepiness • constipation
♦ Mhux komuni (Dawn jistgħu jseħħu f’ sa doża waħda minn kull 100 doża tal- vaċċin): • biki • Irqad ħażin, ngħas ta ’ spiss • stitikezza
♦ Rare (These may occur with up to 1 in 1,000 doses of the vaccine): • infection of the upper respiratory system, hoarseness, runny nose • inflammation of the skin, rash • muscle cramp
♦ Rari (Dawn jistgħu jseħħu f’ sa doża waħda minn kull 1, 000 doża tal- vaċċin): • infezzjoni fin- naħa ta ’ fuq tas- sistema respiratorja, ħanqa, mnieħer inixxi l- imħat • infjammazzjoni tal- ġilda, raxx • bugħawwieġ
HOW TO STORE ROTARIX
KIF TAĦŻEN ROTARIX
Do not use Rotarix after the expiry date which is stated on the carton.
Tużax Rotarix wara d- data ta ’ skadenza li tidher fuq il- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall - aħħar ġurnata ta ’ dak ix- xahar..
Store in the original package in order to protect from light.
Żommu fil- pakkett oriġinali biex tipproteġih mid- dawl.
After reconstitution, the vaccine contained in the oral applicator should be administered promptly.
Wara rikostituzzjoni, il- vaċċin li jkun fl- applikatur tal- ħalq għandu jingħata mill- ewwel.
If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Jekk il - vaċċin rikostitwit ma jintużax fi żmien 24 siegħa, għandu jintrema.
What Rotarix contains
X’ fih Rotarix
Human rotavirus RIX4414 strain (live, attenuated)*
Ir- razza ta ’ rotavirus uman RIX4414 (b’ ħajja attenwata) * mhux inqas minn 106. 0 CCID50
*Produced on Vero cells
56
- The other ingredients in Rotarix are:
- Is- sustanzi l- oħra f’ Rotarix huma:
Powder: sucrose, dextran, sorbitol, amino acids, Dulbecco’s Modified Eagle Medium (DMEM)
Trab: sukrosju, dextran, sorbitol, amino aċidi, Dulbecco’ s Modified Eagle Medium (DMEM) Solvent: karbonat tal- kalċju, gomma xanthan, ilma sterili
What Rotarix looks like and contents of the pack
Id- dehra tal- prodott u l- kontenuti tal- pakkett
Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant.
Rotarix jinbiegħ bħala trab bajdani f’ kontenitur tal- ħġieġ ta ’ doża waħda u applikatur separat tal- ħalq li jkun fih depożitu abjad li joqgħod bil- mod u sustanza bla kulur tgħum fil- wiċċ.
There is also a transfer adapter which allows easy transfer of the solvent into the glass container containing the powder for mixing the different components of the vaccine.
Ikun hemm ukoll transfer adapter li jippermetti t- trasferiment faċli tas- solvent għal ġol- kontenitur tal- ħġieġ li jkun fih it- trab għat- taħlit tal- komponenti differenti tal- vaċċin.
Both components must be mixed together before your child receives the vaccine.
Iż- żewġ komponenti għandhom jitħalltu flimkien qabel it- tarbija tingħata l- vaċċin.
The mixed vaccine will appear more turbid than the solvent alone.
Il- vaċċin imħallat ikun jidher aktar imdardar mis- solvent waħdu.
Rotarix is available in a pack of 1, 5, 10 or 25.
Rotarix jista ’ jiġi f’ pakketti ta ’ 1, 5, 10 jew 25.
Not all pack sizes may be marketed.
Mhux id- daqsijiet tal- pakketti kollha jistgħu jitqiegħdu fis- suq.
Tel: + 43 1 970 75-0 at .info@gsk.com
57 GlaxoSmithKline Pharma GmbH.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu. -------------------------------------------------------------------------------------------------------------------------
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the solvent.
Depożitu abjad u sustanza ċara tgħum fil- wiċċ jiġu osservati mal- ħażna ta ’ l- applikatur tal- ħalq li jkun fih is- solvent.
The solvent should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution.
Is- solvent għandu jiġi spezzjonat viżwalment kemm qabel u wara li jitħawwad għal xi partiċelli barranin u/ jew xi dehra fiżika mhux normali qabel ir- rikostituzzjoni.
54 The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance.
Il- vaċċin rikostitwit ikun ftit aktar imdardar mis- solvent u jkun abjad ħalib fid- dehra tiegħu.
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Il- vaċċin rikostitwit għandu wkoll jiġi spezzjonat viżwalment għal xi partiċelli barranin u/ jew għal xi dehra fiżika mhux normali qabel ma jingħata.
In the event of either being observed, discard the vaccine.
Jekk dawn jiġu osservati, armi l- vaċċin.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Kull vaċċin mhux użat jew xi materjal żejjed ieħor għandu jintrema kif jitolbu l- liġijiet lokali.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit.
Is- suspensjoni li tkun tħawwdet tidher bħal likwidu mdardar b’ depożitu abjad li jibda joqgħod bil- mod il mod.
Connect the oral applicator into the transfer adapter by pushing it firmly on this device.
Waħħal l- applikatur tal- ħalq mat- transfer adapter billi timbuttah sew fuq dan.
55 Transfer adapter
59 Transfer adapter
The shaken suspension will appear as a turbid liquid with a slow settling white deposit
suspensjoni li tkun tħawwdet tidher bħal likwidu mdardar b’ depożitu abjad li jibda joqgħod bil- mod.
The reconstituted vaccine will appear more turbid than the solvent alone.
Il- vaċċin rikostitwit ikun jidher iktar imdardar mis - solvent waħdu.
This appearance is normal
Din id- dehra hi normali
Withdraw the entire mixture back into the oral applicator
Erga ’ iġbed it- taħlita kollha għal ġo l- applikatur tal- ħalq
Remove the oral applicator from the transfer adapter
Aqla ’ l- applikatur tal- ħalq mit - transfer adapter
56 PACKAGE LEAFLET:
60 FULJETT TA ’ TAGĦRIF:
Rotarix oral suspension in pre-filled oral applicator Rotavirus vaccine, live
Rotarix suspensjoni orali f’ applikatur tal- ħalq mimli lest Vaċċin ta ’ rotavirus, ħaj
It might be necessary to postpone the vaccination until recovery.
61 • Jekk it- tarbija tiegħek għandha d- dijareja jew tirremetti.
57 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
Oqgħod attent ħafna b’ Rotarix • Għarraf lit- tabib / professjonist fil- qasam tas- saħħa tiegħek jekk it- tarbija tiegħek: għandha kuntatt ma ’ persuna fil qrib tagħha bħal persuna li tgħix magħha li għandha sistema immunitarja mdgħajjfa, eż., persuna bil- kanċer jew li qed tieħu mediċini li jistgħu jwasslu għal sistema immunitarja mdgħajjfa. • għandha xi disturb fis- sistema gastro- intestinali. • mhux qed iżżid fil- piż u tikber kif suppost. • twieldet qabel iż- żmien, għaliex il- livell ta ’ protezzjoni mill- vaċċin mhux mgħaruf f’ dan il- każ.
The vaccine (1.5 ml liquid) will be given orally.
Il- vaċċin (1ml likwidu) jingħata mill- ħalq.
58 4.
62 4.
Like all medicines, Rotarix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Rotarix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The vaccine should be used immediately after opening.
Il- vaċċin għandu jintuża immedjatament kif jinfetaħ.
*Produced on Vero cells
63
- The other ingredients in Rotarix are: sucrose, Di-sodium Adipate, Dulbecco’s Modified Eagle
- Is- sustanzi l- oħra f’ Rotarix huma: sukrosju, Di- sodium Adipate, Dulbecco’ s Modified Eagle
59 Medium (DMEM), sterile water
Medium (DMEM), ilma sterili
Oral suspension in pre-filled oral applicator.
Suspensjoni orali f’ applikatur tal- ħalq mimli lest
Rotarix is supplied as clear and colourless liquid in a single dose pre-filled oral applicator (1.5 ml).
Rotarix jinbiegħ bħala likwidu ċar u bla kulur f’ applikatur tal- ħalq mimli lest b’ doża waħda (1. 5ml).
Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
64 Portugal España Smith Kline & French Portuguesa, Produtos GlaxoSmithKline, S. A.
France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
România France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@ gsk. com
România GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208 www.gsk.ro
GlaxoSmithKline (GSK) SRL Tel: +40 (0) 21 3028 208 www. gsk. ro
Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0) 1 4955000
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu. ------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
65 Kull fdal tal- vaċċin li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
61 Instructions for administration of the vaccine:
Struzzjonijiet għall- għoti tal- vaċċin:
Oral applicator Tip-Cap
Applikatur tal - ħalq Tip- Cap
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral
Agħti mill- ħalq (jiġifieri ġo ħalq it- tarbija, fuq il - ġewwieni ta ’ ħaddejha) il - kontenut kollu ta ’ l- applikatur tal - ħalq
62 PACKAGE LEAFLET:
66 FULJETT TA ’ TAGĦRIF:
Rotarix oral suspension Rotavirus vaccine, live
Rotarix suspensjoni orali Vaċċin ta ’ rotavirus, ħaj
It might be necessary to postpone the vaccination until recovery.
67 • Jekk it- tarbija tiegħek għandha d- dijareja jew tirremetti.
63 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
Oqgħod attent ħafna b’ Rotarix • Għarraf lit- tabib / professjonist fil- qasam tas- saħħa tiegħek jekk it- tarbija tiegħek: għandha kuntatt ma ’ persuna fil qrib tagħha bħal persuna li tgħix magħha li għandha sistema immunitarja mdgħajjfa, eż., persuna bil- kanċer jew li qed tieħu mediċini li jistgħu jwasslu għal sistema immunitarja mdgħajjfa. • għandha xi disturb fis- sistema gastro- intestinali. • mhux qed iżżid fil- piż u tikber kif suppost. • twieldet qabel iż- żmien, għaliex il- livell ta ’ protezzjoni mill- vaċċin mhux mgħaruf f’ dan il- każ.
64 4.
68 4.
*Produced on Vero cells
69
65 Medium (DMEM), sterile water
Medium (DMEM), ilma sterili
Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml).
Rotarix jinbiegħ bħala likwidu ċar u bla kulur f’ tubu li jingħafas b’ doża waħda (1. 5ml).
Rotarix is available in a pack of 1, 10 or 50.
Rotarix jista ’ jiġi f’ pakketti ta ’ 1, 10 jew 50.
Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
70 Portugal España Smith Kline & French Portuguesa, Produtos GlaxoSmithKline, S. A.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
71 Kull fdal tal- vaċċin li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
67 Instructions for administration of the vaccine:
Struzzjonijiet għall- għoti tal- vaċċin:
Tube Cap
Għatu tat - tubu
Tube tip
Parti ta ’ fuq tat - tubu
What is RotaTeq?
X' inhu RotaTeq?
RotaTeq is an oral vaccine, presented as a solution in a single dose tube.
RotaTeq huwa vaċċin orali, li jiġi bħala soluzzjoni f' tubu għal doża waħda.
It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
Fih ħames razez ta 'rotavirus ħaj, li kollha jkollhom antiġene differenti (G1, G2, G3, G4 u P1[ 8]).
What is RotaTeq used for?
Għalxiex jintuża RotaTeq?
RotaTeq is a vaccine given to babies from six weeks of age to prevent gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
RotaTeq huwa vaċċin li jingħata lil trabi li għandhom iktar minn sitt ġimgħat għall- prevenzjoni tal - gastroenterite (dijarrea u remettar) ikkawżata minn infezzjonijiet tar- rotavirus.
RotaTeq is given according to official recommendations.
RotaTeq jingħata skond ir- rakkomandazzjonijiet uffiċjali.
How is RotaTeq used?
Kif jintuża RotaTeq?
RotaTeq is given as three doses, with at least four weeks between each dose.
RotaTeq jingħata fi tliet dożi, b' mill- anqas erba 'ġimgħat bejn kull doża.
The content of the tube of RotaTeq is given directly into the mouth of the baby.
Il- kontenut tat- tubu ta 'RotaTeq jingħata direttament f' ħalq it- tarbija.
The first dose is given when the baby is between six and 12 weeks of age.
L- ewwel doża tingħata meta t- tarbija jkollha bejn sitta u 12- il ġimgħa.
It is better if the last dose is given before the child is aged 20 to 22 weeks, and in any case, all three doses should have been given by the time the child is 26 weeks (six months) old.
Aħjar jekk l- aħħar doża tingħata qabel ma t- tarbija jkollha bejn 20 u 22 ġimgħa, u irrispettivament minn dan, it- tliet dożi għandhom ikunu ngħataw kollha sa ma t- tarbija jkollha 26 ġimgħa (sitt xhur).
RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between administration of the two vaccines).
RotaTeq jista 'jingħata fl- istess ħin ma' tilqimiet oħra (ħlief mat- tilqima tal- poljo, li bejnha u bejn RotaTeq iridu jgħaddu ġimagħtejn).
RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
RotaTeq jista 'jingħata lil trabi prematuri, sakemm it- tqala tkun damet ta' mill- inqas 25 ġimgħa.
The first dose should be given six weeks after birth.
L - ewwel doża għandha tingħata sitt ġimgħat wara t- twelid.
How does RotaTeq work?
Kif jaħdem RotaTeq?
There are various types of rotaviruses that cause gastroenteritis.
Hemm diversi tipi ta 'rotaviruses li jikkawżaw gastroenterite.
They vary in that they may carry different antigens.
Dawn ivarjaw fis- sens li jista 'jkollhom antiġeni differenti.
An antigen is a specific structure that the body can recognise as ‘ foreign’ and against which it can make an antibody, a special protein that can neutralise or destroy the antigen.
Antikorp huwa proteina speċjali li tista 'tinnewtralizza jew teqred l - antiġene.
RotaTeq contains viruses that carry the antigens for some of the most commonly occurring types of rotaviruses.
RotaTeq fih vajrusis li jkollhom antiġeni għal uħud mill- iktar tipi komuni ta 'rotaviruses.
When a child is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally that carry the same or very similar antigens.
Meta tifel jew tifla jingħata l- vaċċin, is- sistema immunitarja (is- sistema li tiġġieled il- mard) tipproduċi antikorpi kontra dawn l- antiġeni, li jgħinu fil- prevenzjoni ta 'infezzjonijiet ikkawżati minn rotaviruses li jeżistu b' mod naturali u li jkollhom antiġeni simili jew simili ħafna.
How has RotaTeq been studied?
Kif ġie studjat RotaTeq?
The effects of RotaTeq were first tested in experimental models before being studied in humans.
L- effetti ta 'RotaTeq ġew ittestjati f' mudelli sperimentali qabel ma ġew ittestjati fil- bnedmin.
Overall, the studies of RotaTeq involved over 72,000 infants, including about 2,000 premature babies.
B' kollox, fl- istudji dwar RotaTeq ħadu sehem 72, 000 tifel u tifla, foshom madwar 2, 000 tarbija prematura.
About half of the babies received the medicine, and the others received placebo (a dummy vaccine).
Madwar nofs it- trabi ngħataw il- mediċina, u l- oħrajn ingħataw plaċebo (vaċċin finta).
The main study was 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged very large (over 70,000 infants) because it was designed to see if the vaccine caused a very rare, serious side effect called intussusception, a condition in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage.
L- istudju ewlieni kien kbir ħafna (b' iktar minn 70, 000 tifel u tifla) billi kien maħsub biex ikun magħruf jekk il- vaċċin ikkawżax effett sekondarju serju magħruf bħala intussuxxezzjoni, kundizzjoni li fiha, parti mill- musrana tidħol f' parti oħra tal- musrana, u dan iwassal għal imblukkar.
The effectiveness of the vaccine was measured by looking at how many children developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
L- effikaċja tal- vaċċin tkejlet b' ħarsa lejn kemm kien hemm tfal li żviluppaw gastroenterite kkawżata minn rotaviruses li huma magħrufa li jiċċirkulaw u jikkawżaw infezzjoni, ġeneralment waqt ix- xhur kesħin tax- xitwa u tal- bidu tar- rebbiegħa).
What benefit has RotaTeq shown during the studies?
Liema benefiċċju wera RotaTeq waqt l- istudji mwettqa?
In the almost 6,000 infants in whom effectiveness was studied, the number of cases of rotavirus gastroenteritis due to viruses with the same antigens as in the vaccine decreased following vaccination with RotaTeq:
Fil- kważi 6, 000 tifel u tifla li fihom ġiet studjata l- effikaċja, l- għadd ta 'każijiet tal- gastroenterite kkawżata mir- rotavirus minħabba vajrusis bl- istess antiġeni bħal dawk fil- vaċċin naqas wara t- tilqima b' RotaTeq:
82 infants vaccinated with RotaTeq developed rotavirus gastroenteritis (one with severe gastroenteritis) compared to 315 cases among those who received placebo (51 severe cases).
82 tifel u tifla mlaqqma b' RotaTeq żviluppaw gastroenterite (wieħed minnhom b' gastroenterite severa) meta mqabbla ma '315- il każ f' dawk li kienu ngħataw plaċebo (51 każ minnhom severi).
The study also showed that, when the children had been vaccinated with RotaTeq, there were fewer hospital admissions or visits to emergency clinics for rotavirus gastroenteritis in vaccinated infants.
L- istudju wera wkoll li, meta t- tfal tlaqqmu b' RotaTeq, kien hemm inqas persuni li kellhom bżonn jiddaħħlu l- isptar u kien hemm inqas visti kliniċi ta 'emerġenza minħabba gastroenterite mir- rotavirus fi tfal imlaqqma.
What is the risk associated with RotaTeq?
X' inhu r- riskju assoċjat ma 'RotaTeq?
During the main study, in which about 35,000 infants received RotaTeq and 35,000 received placebo, six infants developed intussusception in the 42 days following a dose of RotaTeq, compared to five who developed the disease after receiving a placebo vaccine.
Waqt l- istudju ewlieni, li fih madwar 35, 000 tifel u tifla ngħataw plaċebo, sitt itfal żviluppaw intussuxxezzjoni fit- 42 jum ta 'wara d- doża ta' RotaTeq, meta mqabbla ma 'ħamsa li żviluppaw il - marda wara li ngħataw it- tilqima bil- plaċebo.
The most common side effects (seen in more than 1 patient in 10) were pyrexia (fever), diarrhoea and vomiting.
L- iktar effetti sekondarji komuni b' RotaTeq (li dehru f' iktar minn pazjent 1 minn kull 10) huma piressija (deni), dijarrea u remettar.
For the full list of all side effects reported with RotaTeq, see the Package Leaflet.
Għal- lista sħiħa ta 'l - effetti sekondarji kollha rrappurtati b' RotaTeq, ara l- Fuljett ta' Tagħrif.
RotaTeq should not be given to infants who have had intussusception in the past or who have problems with their bowel that could predispose them to the disease, or in infants whose immune system is weakened.
RotaTeq m' għandux jintuża f' nies li huma ipersensittivi (allerġiċi) għas- sustanza attiva jew għal xi sustanza oħra tiegħu, m' għandux jingħata lil tfal żgħar li fl- imgħoddi kellhom intussuxxezzjoni jew f' dawk li jkollhom problemi fl- imsaren li jippredisponuhom għall- marda, jew fi tfal żgħar li s- sistema immunitarja tagħhom tkun imdgħajfa.
As for all vaccines, if RotaTeq is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħall- vaċċini l- oħra kollha, jekk RotaTeq jintuża fi trabi prematuri ħafna, ikun hemm riskju li t- trabi jesperjenzaw apnea (waqtiet qosra li fihom ma jiħdux nifs).
Their breathing should be monitored for up to three days after vaccination.
In- nifs tagħhom għandu jiġi sorveljat għal massimu ta 'tlitt ijiem wara t- tilqima.
Why has RotaTeq been approved?
Għaliex ġie approvat RotaTeq?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the studies carried out had shown that RotaTeq protects against rotavirus gastroenteritis due to specific types of the virus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- istudji li saru wrew li RotaTeq jipproteġi kontra l- gastroenterite kkawżata minn tipi speċifiċi ta 'rotavirus.
The possibility of a low risk of intussusception following vaccination, which cannot be ruled out, will be closely monitored after the vaccine is introduced onto the market.
Il - possibilità ta 'riskju baxx ta' intussuxxezzjoni wara t- tilqima, li ma tistax tiġi eliminata għal kollox, se tiġi ssorveljata mill- qrib wara li l- vaċċin jiġi introdott fis- suq.
The Committee decided that RotaTeq’ s benefits are greater than its risks when used in infants from the age of six weeks for the prevention of gastroenteritis due to rotavirus infection.
Il- Kumitat iddeċieda li l- benefiċċji ta 'RotaTeq huma ikbar mir- riskji meta jintuża fit- tfal żgħar mill - età ta' sitt ġimgħat għall- prevenzjoni tal- gastroenterite minħabba infezzjoni mir- rotavirus.
The Committee recommended that RotaTeq be given marketing authorisation.
Il- Kumitat irrakkomanda li RotaTeq jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of RotaTeq?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal RotaTeq?
The company that makes RotaTeq will monitor some of the side effects of RotaTeq once it is on the market, particularly the side effects that affect the digestive system.
Il- kumpanija li tagħmel RotaTeq se tissorvelja xi effetti sekondarji ta 'RotaTeq hekk kif jitqiegħed fis - suq, b' mod partikolari l- effetti sekondarji li jaffettwaw is- sistema diġestiva.
Other information about RotaTeq:
Informazzjoni oħra dwar RotaTeq:
The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq to Sanofi Pasteur MSD, SNC, on 27 June 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal RotaTeq lil Sanofi Pasteur MSD, SNC, fis- 27 ta 'Ġunju 2006.
The full EPAR for RotaTeq can be found here.
L- EPAR sħiħ għal RotaTeq jista 'jinstab hawn.
EU Number
Daqs tal- pakkett Numru ta ’ l- EU
EU/ 1/ 06/ 348/ 001
EU/ 1/ 06/ 348/ 001 EU/ 1/ 06/ 348/ 002
RotaTeq
RotaTeq RotaTeq
_*_
_ * _ _ * _
Oral solution
tubu (LTPE) tubu (LTPE)
Oral use
2 ml 2 ml
tube (LDPE)
1 10
2 ml
_ * _ Doża waħda ta ’ 2 ml fiha:
EU/ 1/ 06/ 348/ 002
rotavirus serotip * G1 rotavirus serotip * G2 rotavirus serotip * G3 rotavirus serotip * G4
RotaTeq
mhux inqas minn 2. 2 x 10 IU 6 mhux inqas minn 2. 8 x 10 IU 6 mhux inqas minn 2. 2 x 10 IU 6 mhux inqas minn 2. 0 x 10 IU 6
Oral solution
1, 2 1, 2 1, 2 1, 2
tube (LDPE)
rotavirus serotip * P1[ 8]
10
mhux inqas minn 2. 3 x 10 IU
* human-bovine rotavirus reassortants (live), produced in Vero cells.
* reassortanti ta ’ rotavirus uman- bovin (ħaj), prodotti f’ ċelloli Vero.
1 Infectious Units 2 As lower confidence limit (p = 0.95)
1 Unitajiet infettużi 2 Bħala limitu ta ’ kunfidenza l- baxx (p = 0. 95)
RotaTeq, oral solution
RotaTeq, soluzzjoni orali
Rotavirus vaccine (live, oral)
Vaċċin tar- rotavirus (ћaj, orali)
not less than 2.2 x 106 IU1, 2 not less than 2.8 x 106 IU1, 2 not less than 2.2 x 106 IU1, 2 not less than 2.0 x 106 IU1, 2 not less than 2.3 x 106 IU1, 2
Doża waћda ta ’ 2- ml fiha: mhux inqas minn 2. 2 x 106 IU1, 2 rotavirus serotip * G1 mhux inqas minn 2. 8 x 106 IU1, 2 rotavirus serotip * G2 mhux inqas minn 2. 2 x 106 IU1, 2 rotavirus serotip * G3 mhux inqas minn 2. 0 x 106 IU1, 2 rotavirus serotip * G4 mhux inqas minn 2. 3 x 106 IU1, 2 rotavirus serotip * P1[ 8]
* human-bovine rotavirus reassortants (live), produced in Vero cells.
* human- bovine rotavirus reassortants (ћaj), prodott f’ ċelloli Vero.
1 Infectious Units 2 As lower confidence limit (p = 0.95)
1 Units infettivi 2 Bћala limiti baxxi ta 'kunfidenza (p = 0. 95)
This product contains sucrose 1080 mg (see section 4.4).
Dan il- prodott fih 1080 mg sucrose (ara sezzjoni 4. 4).
PHARMACEUTICAL FORM
GHAMLA FARMAĊEWTIKA
Pale yellow clear liquid that may have a pink tint
Likwidu trasparenti isfar ċar li jista jkollu sfumatura roża
RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastroenteritis due to rotavirus infection (see section 4.2).
RotaTeq huwa indikat gћall- immunizzazzjoni attiva ta ’ trabi minn età ta ’ 6 ġimgћat gћall- prevenzzjoni ta ’ gastroenterite minћabba infezzjoni b' rotavirus (ara sezzjoni 4. 2).
In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of serotypes G1P1[8], G2P[4], G3P1[8], G4P1[8], and G9P1[8].
Fi provi kliniċi, l- effikaċja ġiet dimostrata kontra l- gastroenterite minћabba rotavirus ta 'serotipi G1P1[ 8], G2P[ 4], G3P1[ 8], G4P1[ 8], u G9P1[ 8].
The use of RotaTeq should be in accordance with official recommendations.
L- użu ta ’ RotaTeq irid jaqbel ma ’ rakkomandazzjonijiet uffiċjali.
Posology Three doses of RotaTeq should be administered.
Pożoloġija Għandhom jingħataw tlett dożi ta ’ RotaTeq.
The first dose may be administered from the age of six weeks and no later than the age of 12 weeks.
L- ewwel doża tista tingħata mill- età ta ’ 6 ġimgћat u mhux iktar tard mill- eta ’ ta ’ 12- il ġimgћa.
RotaTeq may be given to infants who were born prematurely provided that the period of gestation was at least 25 weeks.
RotaTeq jista ’ jingħata lil trabi li twieldu prematuri diment li l- perjodu ta ’ ġestazzjoni tagħhom kien ta ’ mill- inqas 25 ġimgħa.
These infants should receive the first dose of RotaTeq at least six weeks after birth.
Dawn it- trabi għandhom jirċievu l- ewwel doża ta ’ RotaTeq għallinqas sitt ġimgħat wara t- twelid.
2 There should be intervals of at least 4 weeks between doses.
2 Għandu jkun hemm intervalli ta ’ mill- inqas 4 ġimgћat bejn id- dożi.
It is preferable that all three doses should be administered before the age of 20-22 weeks.
Huwa preferibbli li t- tlett dożi kollha jingħataw qabel l- età ta ’ 20- 22 ġimgћa.
All three doses should be given by the age of 26 weeks.
It- tlett dożi gћandhom jingћataw sa l- età ta ’ 26 ġimgћa.
As no data exist regarding the interchangeability of RotaTeq with another rotavirus vaccine, it is recommended that infants who receive RotaTeq for the first immunisation against rotavirus should receive this same vaccine for the subsequent doses.
Minћabba li m’ hemm l- ebda dejta eżistenti dwar jekk tistax tibdel RotaTeq ma ’ xi vaċċin ieћor ta 'rotavirus, huwa rrakkomandat li trabi li ћadu RotaTeq gћall- ewwel immunizzazzjoni kontra rotavirus jirċievu l- istess vaċċin għad- dożi sussegwenti.
If it is observed or strongly suspected that an incomplete dose has been swallowed (e. g., infant spits or regurgitates the vaccine), a single replacement dose may be given at the same vaccination visit, however, this has not been studied in clinical trials.
Jekk jiġi osservat jew ikun hemm suspett qawwi li d- doża li nbelgћet ma kinitx waħda sħiħa (eż., it- tarbija tobżoq jew ittella 'l- vaċċin), doża waћda ta ’ sostituzzjoni trid tinbelgћa fl- istess ġurnata tal- vaċċinazzjoni, madankollu dan ma ġiex studjat fi provi kliniċi.
If the problem recurs, additional replacement doses should not be given.
Jekk il- problema terġa 'tiġri, m' għandomx jingћataw dożi oћra ta ’ sostituzzjoni.
No further doses are recommended after completion of the 3-dose series (see sections 4.4 and 5.1 regarding available information on persistence of protection).
M’ huwiex rakkomandat li jittieћdu iktar dożi wara li titlesta s- serje ta ’ 3 dożi (ara sezzjonijiet 4. 4 u 5. 1 dwar informazzjoni disponibbli fuq il- persistenza tal- protezzjoni).
Method of administration For oral administration only.
Metodu ta ’ amministrazzjoni Gћal użu orali biss.
RotaTeq SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
RotaTeq TAĦT L- EBDA ĊIRKOSTANZA M’ GĦANDU JIĠI INJETTAT.
RotaTeq may be given without regard to food, liquid, or breast milk.
RotaTeq jista ’ jingћata mingħajr rigward gћall- ikel, likwidi jew ћalib tas- sider.
See section 6.6 for administration instructions.
Ara sezzjoni 6. 6 gћall- istruzzjonijiet dwar kif għandu jingħata.
Hypersensitivity after previous administration of rotavirus vaccines.
Sensitività eċċessiva wara għoti preċedenti ta ’ vaċċin ta 'rotavirus.
Previous history of intussusception.
Storja ta ’ intussussezzjoni.
Subjects with congenital malformation of the gastrointestinal tract that could predispose to intussusception.
Suġġetti b’ malformazzjoni konġenitali tal- pajp gastrointestinali li jista 'jagħmilhom suxxettibbli gћal intussusezzjoni.
Infants who have known or suspected immunodeficiency.
Trabi li gћandhom, jew li hemm suspett li gћandhom immunodefiċenza.
Asymptomatic HIV infection is not expected to affect the safety or efficacy of RotaTeq.
Infezzjoni ta ’ l- HIV mingħajr sintomi mhux suppost li taffetwa s- sigurtà u l- effikaċja ta ’ RotaTeq.
However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV subjects is not recommended.
Madankollu, fin- nuqqas ta 'tagħrif suffiċjenti, l- għoti ta ’ RotaTeq lil trabi b’ HIV mingħajr sintomi m’ huwiex rakkommandat.
Administration of RotaTeq should be postponed in infants suffering from acute severe febrile illness.
L- għoti ta ’ RotaTeq irrid jiġi pospost fi trabi li qed ibatu minn mard akut b’ deni qawwi.
The presence of a minor infection is not a contraindication for immunisation.
Il- preżenza ta ’ infezzjoni minuri m’ hijiex kontra- indikazzjoni gћal immunizzazzjoni.
The administration of RotaTeq should be postponed in subjects suffering from acute diarrhoea or vomiting.
L- għoti ta ’ RotaTeq irrid jiġi pospost fi trabi li qed ibatu minn dijarea akuta jew rimettar akut.
No safety or efficacy data are available regarding administration of RotaTeq to immunocompromised infants, infants infected with HIV or infants who have received a blood transfusion or immunoglobulins within 42 days of dosing.
M’ hemm l- ebda dejta disponibbli dwar is- sigurtà u l- effikaċja rigward l- għoti ta ’ RotaTeq lil trabi immunokompromessi, trabi infettati bl- HIV jew trabi li rċevew trasfużjoni tad- demm jew immunoglobulini fi żmien 42 ġurnata mid- doża.
In trials, RotaTeq was shed in the stools of 8.9% of vaccine recipients almost exclusively in the week after dose 1 and in only one vaccine recipient (0.3%) after dose 3.
Fi provi kliniċi, RotaTeq ġie merħi fl- ippurgar ta ’ 8. 9% tar- riċevituri tal- vaċċin kważi kollha f’ dik il- ġimgћa ta ’ wara l- ewwel doża u f’ riċevitur wieћed biss (0. 3%) wara t- tielet doża.
Peak excretion occured within 7 days of dosing.
L- eskrezzjoni massima saret fi żmien 7 t’ ijiem wara d- doża.
It is theoretically possible that transmission of vaccine virus may occur to
Huwa tejoratikament possibbli li t- trasmissjoni tal- virus
3 seronegative contacts.
3 tal- vaċċin jista 'jsir lil kuntatti seronegattivi.
RotaTeq should be administered with caution to individuals with close contacts who are immunodeficient (e. g., individuals with malignancies or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy).
RotaTeq għandu jingħata b’ kawtela lil individwi li għandhom kuntatti mil- viċin li huma immunodefiċjenti (eż. individwi b’ tumuri malinni jew li b’ xi mod ieħor huma immunokompromessi jew individwi li qed jieħdu terapija immunosoppressiva).
Also, those caring for recent vaccinees should observe careful hygiene especially when handling excreta.
Barraminhekk, dawk li qed jieħdu ħsieb persuni li ġew vaċċinati riċentament għandhom josservaw l- iġjene b’ attenzjoni speċjalment meta jiġu f’ kuntatt ma 'eskrezzjonijiet.
In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Fi studji kliniċi, RotaTeq ingħata lil madwar 1, 000 tarbija li twieldu f’ età ta ’ ġestazzjoni ta ’ 25 sa 36 ġimgħa.
The first dose was administered from 6 weeks after birth.
L- ewwel doża ingħatat minn 6 ġimgħat wara t- twelid.
The safety and efficacy of RotaTeq were comparable between this subset of infants and infants born at term.
Is- sigurtà u l- effikaċja ta ’ RotaTeq kienu komparabbli bejn dan is- subsett ta ’ trabi u trabi li twieldu f’ ġestazzjoni normali.
However, 19 of the approximately 1,000 infants were born at a gestational age of 25 to 28 weeks, 55 were born at a gestational age of 29 to 31 weeks and the remainder was born at a gestational age of between 32 and 36 weeks.
Madankollu, 19 minn madwar 1, 000 tarbija twieldu f’ età ta ’ ġestazzjoni ta ’ 25 sa 28 ġimgħa, 55 twieldu f’ età ta ’ ġestazzjoni ta ’ 29 sa 31 ġimgħa u l- bqija twieldu f’ età ta ’ ġestazzjoni ta ’ bejn 32 u 36 ġimgħa.
See sections 4.2 and 5.1.
Ara sezzjonijiet 4. 2 u 5. 1.