qanastek/EMEA-V3 huggingface dataset:
Keep this card with you for 3 months after the last RoActemra dose, since side effects could occur for some time after your last dose of RoActemra.
Żomm dan il- biljett miegħek għal 3 xhur wara l- aħħar doża ta ’ RoActemra peress li l- effetti sekondarji jistgħu jseħħu wara xi żmien li tkun ħadt l- aħħar doża ta ’ RoActemra.
RoActemra 20 mg/ml concentrate for solution for infusion Tocilizumab
RoActemra, 20 mg/ ml, konċentrat għal soluzzjoni għall- infużjoni Tocilizumab
In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with RoActemra.
Barra minn dan il- fuljett, inti ser tingħata Biljett ta ’ Twissija għall- Pazjent, li fiha informazzjoni importanti dwar is- sigurtà li għandek bżonn tkun taf qabel u waqt il- kura b’ RoActemra.
What RoActemra is and what it is used for 2.
X’ inhu RoActemra u għalxiex jintuża 2.
Before you use RoActemra 3.
Qabel ma tuża RoActemra 3.
How to use RoActemra 4.
Kif għandek tuża RoActemra 4.
How to store RoActemra 6.
Kif taħżen RoActemra 6.
WHAT ROACTEMRA IS AND WHAT IT IS USED FOR
X’ INHU ROACTEMRA U GĦALXIEX JINTUŻA
RoActemra contains the active substance tocilizumab, a monoclonal antibody that blocks the action of a specific protein (cytokine) called interleukin-6.
RoActemra fih is- sustanza attiva tocilizumab, antikorp monoklonali li jimblokka l- azzjoni ta ’ proteina speċifika (ċitokina) msejjħa interleukin- 6.
This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Din il- proteina hija nvoluta f’ proċessi infjammatorji tal - ġisem, u jekk tiġi mblukkata tista ’ titnaqqas l- infjammazzjoni fil- ġisem tiegħek.
RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
RoActemra jintuża biex jikkura adulti b’ artrite rewmatojde (RA), marda awtoimmuni, attiva, moderata sa severa., jekk terapiji ta ’ qabel ma ħadmux tajjeb biżżejjed.
RoActemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks.
RoActemra jgħin biex inaqqas sintomi bħal uġigħ u n- nefħa fil- ġogi tiegħek u jista ’ wkoll ittejjeb il- mod kif tagħmel ix- xogħol tiegħek ta ’ kuljum.
RoActemra is usually given in combination with methotrexate.
RoActemra ġeneralment jingħata flimkien ma ’ methotrexate.
However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
Madankollu, RoActemra jista ’ jingħata waħdu jekk it- tabib tiegħek jiddetermina li methotrexate mhux adattat.
BEFORE YOU USE ROACTEMRA
QABEL MA TUŻA ROACTEMRA
Do not use RoActemra
Tużax RoActemra
- if you are allergic (hypersensitive) to tocilizumab or any of the other ingredients of RoActemra
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal tocilizumab jew sustanzi oħra ta ’
(listed in section 6, ‘What RoActemra contains’).
RoActemra (imniżżla f’ sezzjoni 6. ‘ X’ fih RoActemra ’).
- if you have an active, severe infection.
- jekk għandek infezzjoni attiva severa.
Take special care with RoActemra
Oqgħod attent ħafna b’ RoActemra
- If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-
- Jekk ikollok reazzjonijiet allerġiċi bħal tgħafis f’ sidrek, tħarħir, sturdament qawwi jew ħafif,
headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
nefħa tax- xofftejn jew raxx fil- ġilda waqt jew matul l- infużjoni, għid lit- tabib tiegħek immedjatament.
Tell your
- Jekk għandek kwalunkwe tip ta ’ infezzjoni, dawk li jdumu għal tul qasir ta ’ żmien kif ukoll
doctor immediately if you feel unwell.
dawk fit- tul, jew jekk ikollok infezzjonijiet ta ’ spiss.
RoActemra can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.
RoActemra jista ’ jnaqqas l- abilità tal- ġisem tiegħek li jirreaġixxi għall - infezzjonijiet u jekk ikollok diġà infezzjoni din tista ’ tmur għall- agħar jew jista ’ jżid ir- riskju li jkollok infezzjoni ġdida.
- If you have had tuberculosis, tell your doctor.
- Jekk kellek it- tuberkulosi, għid lit- tabib tiegħek.
Your doctor will check for signs and symptoms
Qabel ma tibda RoActemra, it- tabib se
of tuberculosis before starting RoActemra.
jeżaminak għal sinjali u sintomi ta ’ tuberkulosi.
- If you have had intestinal ulcers or diverticulitis, tell your doctor.
- Jekk kellek ulċeri intestinali jew divertikulite, għid lit- tabib tiegħek.
Symptoms would include
Is- sintomi jinkludu uġigħ
abdominal pain and unexplained changes in bowel habits with a fever.
addominali u tibdil bla spjegazzjoni fil- mod kif jaħdmu l- imsaren, flimkien mad- deni.
- If you have liver disease, tell your doctor.
- Jekk għandek mard fil- fwied, għid lit- tabib tiegħek.
Before you use RoActemra, your doctor may examine
Qabel ma tuża RoActemra, it- tabib tiegħek
your liver function.
jista ’ jeżamina kif qed jaħdem il- fwied.
Certain types of
- Jekk reċentement ħadt xi tilqima jew qed tippjana biex tieħu xi tilqima, għid lit- tabib tiegħek.
vaccines should not be given while receiving RoActemra.
Ċertu tip ta ’ tilqim m’ għandhux jingħata waqt li qed tirċievi RoActemra.
- If you have cancer, tell your doctor.
- Jekk għandek il- marda tal- kanċer, għid lit- tabib tiegħek.
Your doctor will have to decide if you can still be given
It- tabib tiegħek se jiddeċiedi jekk tistax
RoActemra.
tingħata RoActemra.
- If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol
- Jekk għandek fatturi ta ’ riskju kardjovaskulari bħal pressjoni tad- demm għolja u livelli tal -
levels, tell your doctor.
kolesterol għolja, għid lit- tabib tiegħek.
These factors need to be monitored while receiving RoActemra.
Dawn il- fatturi għandhom jiġu sorveljati waqt li qed tirċievi RoActemra.
- If you have moderate to severe kidney function problems, your doctor will monitor you.
- Jekk għandek problemi moderati sa severi fil- funzjoni tal- kliewi, it- tabib tiegħek se jissorveljak.
Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Qabel ma tirċievi RoActemra it- tabib tiegħek se jagħmillek eżami tad- demm biex jara jekk għandekx għadd baxx ta ’ ċelluli bojod fid- demm, għadd baxx ta ’ plejtlits jew livelli għoljin ta ’ enżimi tal- fwied.
RoActemra is not recommended for use in children or adolescents under 18 years of age.
RoActemra mhuwiex irrakkomandat għall- użu fit- tfal jew fl- adoloxxenti taħt it- 18- il sena.
RoActemra can affect the way some medicines work, and the dose of these may require adjustment.
RoActemra jista ’ jaffettwa l- mod kif jaħdmu xi mediċini u d- doża ta ’ dawn għandu mnejn tkun teħtieġ aġġustament.
You should tell your doctor if you are using medicines containing any of the following active substances: • atorvastatin, used to reduce cholesterol levels • calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure • theophylline, used to treat asthma • warfarin, used as a blood thinning agent • phenytoin, used to treat convulsions • ciclosporin, used to suppress your immune system during organ transplants • benzodiazepines (e.g. temazepam), used to relieve anxiety
Għandek tgħid lit- tabib tiegħek jekk qed tuża mediċini li fihom xi wieħed minn dawn is- sustanzi attivi: • atorvastatin, użat biex inaqqas il- livelli tal- kolesterol • imblokkaturi tal- kanali tal- kalċju (e. ż. amlodipine), użati għall- kura ta ’ pressjoni tad- demm għolja • theophylline, użat għall- kura ta ’ l- ażżma • warfarin, użat bħala sustanza li traqqaq id- demm • phenytoin, użat għall- kura ta ’ konvulżjonijiet • ciclosporin, użat biex jissopprimi s- sistema immuni tiegħek waqt trapjanti ta ’ organi • benzodiazepines (e. ż. temazepam), użati biex itaffu l- ansjetà
Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA.
Minħabba nuqqas ta ’ esperjenza klinika, RoActemra mhux irrakkomandat għall- użu flimkien ma ’ mediċini bijoloġiċi oħra għall- kura ta ’ RA.
Pregnancy and breast-feeding Talk to your doctor if you are pregnant, may be pregnant, intend to become pregnant or if you are breast-feeding.
Tqala u treddigħ Tkellem mat- tabib tiegħek jekk inti tqila, tista ’ tkun tqila, għandek l- intenzjoni li toħroġ tqila jew jekk qed tredda ’.
Women of childbearing potential must use effective contraception during and up to 6 months after treatment.
Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt u sa 6 xhur wara l - kura.
RoActemra should not be used during pregnancy unless clearly necessary.
RoActemra m’ għandux jintuża fit- tqala sakemm mhux verament neċessarju.
It is not known whether RoActemra is excreted in breast milk.
Mhux magħruf jekk RoActemra jitneħħiex fil- ħalib tas- sider.
If you are a nursing mother, you should stop breast-feeding if you are to be given RoActemra.
Jekk inti omm li qed tredda ’, għandek twaqqaf it- treddigħ jekk se tingħata RoActemra.
Before starting breast-feeding, your last treatment with RoActemra should be at least 3 months ago.
Qabel tibda tredda ’, l- aħħar kura tiegħek b’ RoActemra għandha tkun ta ’ l- inqas 3 xhur ilu.
Driving and using machines There are no studies on the effects of RoActemra on the ability to drive and use machines.
34 Sewqan u tħaddim ta ’ magni M’ hemmx studji dwar l- effetti ta ’ RoActemra fuq il- ħila biex issuq u tħaddem magni.
However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Madankollu, jekk ikollok esperjenza ta ’ sturdament, effett sekondarju komuni, m’ għandekx issuq jew tħaddem magni.
33 Important information about some of the ingredients of RoActemra This medicinal product contains 26.55 mg sodium per maximum dose of 1200 mg (8.85 mg sodium per 400 mg vial).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ RoActemra Dan il- prodott mediċinali fih 26. 55 mg ta ’ sodium f’ kull doża massima ta ’ 1200 mg (8. 85 mg sodium f’ kull kunjett ta ’ 400 mg).
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jittieħed f’ kunsiderazzjoni minn pazjenti fuq dieta ta ’ sodium kkontrollat.
Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium free’.
Dożi taħt 1025 mg ta ’ dan il- prodott mediċinali fihom inqas minn 1 mmol ta ’ sodium (23 mg), i. e. essenzjalment ‘ bla sodium ’.
HOW TO USE ROACTEMRA
KIF GĦANDEK TUŻA ROACTEMRA
The usual dose of RoActemra is 8 mg per kg of body weight.
Id- doża ta ’ RoActemra li ssoltu tingħata hija 8 mg għal kull kg ta ’ piż tal- ġisem.
Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.
Skond ir- rispons tiegħek, it- tabib tiegħek jista ’ jnaqqas id- doża tiegħek għal 4 mg/ kg u wara jżida lura għal 8 mg/ kg meta jkun xieraq.
You will receive RoActemra once every 4 weeks through a drip in your vein (intravenous infusion) over one hour.
Inti se tirċievi RoActemra darba kull 4 ġimgħat permezz ta ’ dripp ġol- vina tiegħek (infużjoni fil- vini) fuq medda ta ’ siegħa.
After dilution, RoActemra will be given to you by a doctor or nurse, who will also monitor you during and after administration.
Wara d- dilwazzjoni, RoActemra se jingħatalek minn tabib jew infermier, li se jissorveljak waqt u wara l- għoti.
If you use more RoActemra than you should Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much.
Jekk tuża RoActemra aktar milli suppost Peress li RoActemra jingħata minn tabib jew infermier mhux mistenni li inti tiġi mogħti żżejjed.
However, if you are worried, talk to your doctor.
Madankollu jekk inti inkwetat/ a, kellem lit- tabib tiegħek.
If you forget to use RoActemra Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose.
Jekk tinsa tuża RoActemra Peress li RoActemra jingħata minn tabib jew infermier mhux mistenni li taqbeż doża.
If you stop using RoActemra You should not stop using RoActemra without discussing with your doctor first.
Jekk tieqaf tuża RoActemra M’ għandekx tieqaf tuża RoActemra qabel tiddiskuti dan mat- tabib tiegħek.
If you have any further questions on the use of RoActemra, then please ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ RoActemra, jekk jogħġbok staqsi lit- tabib jew lill - ispiżjar tiegħek.
Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, RoActemra jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects could occur at least up to 3 months after your last dose of RoActemra.
Effetti sekondarja jistgħu jseħħu ta ’ l- inqas sa 3 xhur wara l- aħħar doża ta ’ RoActemra.
The most common side effects of RoActemra are upper respiratory tract infections, with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache.
L- aktar effetti sekondarji komuni ta ’ RoActemra huma infezzjonijiet fl- apparat respiratorju ta ’ fuq b’ sintomi tipiċi bħal sogħla, imnieħer imblukkat, imnieħer iqattar, griżmejn juġghaw u uġigħ ta ’ ras.
Possible serious side effects include serious infections and allergic (hypersensitivity) reactions.
Effetti sekondarji serji li jista ’ jkollok jinkludu infezzjonijiet serji u reazzjonijiet allerġiċi (sensittività eċċessiva).
If you notice any of the following signs of:
Jekk tinnota xi wieħed mis- sinjali li ġejjin ta ’:
allergic reactions during or after infusion, tell your doctor immediately:
Reazzjonijiet allerġiċi waqt jew wara l- infużjoni, għid lit- tabib tiegħek immedjatament:
- difficulty with breathing or light-headedness
- diffikultà biex tieħu n- nifs jew sturdament
- rash, itching, hives, swelling of the lips.
- raxx, ħakk, urtikarja, nefħa fix- xufftejn.
infections, tell your doctor as soon as possible:
35 Infezzjonijiet, għid lit- tabib tiegħek kemm jista ’ jkun malajr: -
- fever and chills
- deni u sirdiet
- mouth or skin blisters
- infafet fil- ħalq jew fuq il- ġilda
- stomach ache
- uġigħ ta ’ stonku
- persistent headaches.
- uġigħ ta ’ ras persistenti.
The symptoms described above can be signs of the side effects listed below, all of which have been observed with RoActemra in clinical studies.
Is- sintomi deskritti fuq jistgħu jkunu sinjali tal- effetti sekondarji mniżżla taħt, li fi studji kliniċi ġew kollha kemm huma osservati b’ rabta ma ’ RoActemra.
34 Side effects may occur with certain frequencies, which are defined as follows:
L- effetti sekondarji jistgħu jseħħu b’ ċertu frekwenzi, li huma definiti kif ġej:
- very common: affects more than 1 user in 10
- komuni ħafna: jaffettwaw aktar minn persuna waħda li qed tużah minn kull 10
- common: affects 1 to 10 users in 100
- komuni: jaffettwaw minn persuna waħda sa 10 li qed jużawh minn kull 100
- uncommon: affects 1 to 10 users in 1,000
- mhux komuni: jaffettwaw minn persuna waħda sa 10 li qed jużawh minn kull 1, 000
- rare: affects 1 to 10 users in 10,000
- rari: jaffettwaw minn persuna waħda sa 10 li qed jużawh minn kull 10, 000
- very rare: affects less than 1 user in 10,000
- rari ħafna: jaffettwaw inqas minn persuna waħda li qed jużawh minn kull 10, 000
Very common side effects: upper respiratory tract infections like coughs and colds.
Effetti sekondarji komuni ħafna: infezzjonijiet fl- apparat respiratorju ta ’ fuq bħal sogħla u rjiħat.
Common side effects: lung infection (pneumonia), cold sores (oral herpes simplex), blisters, shingles (herpes zoster), skin infection sometimes with fever and chills, low white blood cell counts shown by blood tests (neutropenia, leucopenia), high cholesterol levels, headache, dizziness, high blood pressure, mouth ulceration, stomach pain, abnormal liver function tests (increased transaminases), rash and itching and eye infection (conjunctivitis).
Effetti sekondarji komuni: infezzjoni fil- pulmun (pnewmonja), ponta tad- deni (herpes simplex orali), infafet, ħruq ta ’ Sant’ Antnin (herpes zoster), infezzjoni fil- ġilda xi kultant bid- deni u tkexkix ta ’ bard, għadd baxx taċ- ċelluli bojod tad- demm kif muri mit- testijiet tad- demm (newtropenija, lewkopenija), livelli għoljin ta ’ kolesterol, uġigħ ta ’ ras, sturdament, pressjoni għolja tad- demm, ulċerazzjoni tal- ħalq, uġigħ fl- istonku, testijiet tal- funzjoni tal- fwied mhux normali (żjieda fit- transaminases), raxx u ħakk u infezzjoni fl- għajnejn (konġuntivite).
Uncommon side effects: diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain), red swollen (inflamed) areas in the mouth, high blood fat (triglycerides) and serious allergic (hypersensitivity) reactions.
Effetti sekondarji mhux komuni: divertikulite (deni, tqalligħ, dijarea, stitikezza, uġigħ fl- istonku), ħmura u nefħa (infjamazzjoni) f’ xi partijiet mill- ħalq, livell għoli ta ’ xaħam fid- demm (trigliċeridi) u reazzjonijiet allerġiċi serji (sensittività eċċessiva).
HOW TO STORE ROACTEMRA
KIF TAĦŻEN ROACTEMRA
Store in a refrigerator (2°C–8°C).
Aħżen fi friġġ (2°C – 8°C).
What RoActemra contains
X’ fih RoActemra:
- The active substance is tocilizumab.
- Is- sustanza attiva hi tocilizumab.
Each 4 ml vial contains 80 mg tocilizumab (20 mg/ml).
Kull kunjett ta ’ 4 ml fih 80 mg tocilizumab (20 mg/ ml).
Each 10 ml vial contains 200 mg tocilizumab (20 mg/ml).
Kull kunjett ta ’ 10 ml fih 200 mg tocilizumab (20 mg/ ml).
Each 20 ml vial contains 400 mg tocilizumab (20 mg/ml).
Kull kunjett ta ’ 20 ml fih 400 mg tocilizumab (20 mg/ ml).
- The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium
- Is- sustanzi l- oħra huma sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium
dihydrogen phosphate dihydrate and water for injections.
dihydrogen phosphate dihydrate u ilma għall- injezzjonijiet.
What RoActemra looks like and contents of the pack RoActemra is a concentrate for solution for infusion.
RoActemra huwa konċentrat għal soluzzjoni għall- infużjoni.
The concentrate is a clear to opalescent, colourless to pale yellow liquid.
Il- konċentrat huwa likwidu ċar jew ikanġi, bla kulur jew isfar ċar.
RoActemra is supplied as vials containing 4 ml, 10 ml and 20 ml concentrate for solution for infusion.
36 RoActemra huwa fornut bħala kunjetti li fihom 4 ml, 10 ml u 20 ml ta ’ konċentrat għall- soluzzjoni għall- infużjoni.
Pack size of 1 and 4 vials.
Daqs tal- pakkett ta ’ kunjett wieħed jew 4 kunjetti.
35 Manufacturer Roche Pharma AG Emil-Barell-Str.
Il- Manifattur Roche Pharma AG Emil- Barell- Str.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
The following information is intended for medical or healthcare professionals only
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/ml (0.9%) solution for injection from a 100 ml infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Taħt kundizzjonijiet asettiċi iġbed volum ta ’ soluzzjoni għall- injezzjoni sterili u mhux piroġenika ta ’ sodium chloride 9 mg/ ml (0. 9%) minn borża għall- infużjoni ta ’ 100 ml, daqs il- volum ta ’ konċentrat ta ’ RoActemra meħtieġ għad- doża tal- pazjent.
The required amount of RoActemra concentrate (0.4 ml/kg) should be withdrawn from the vial and placed in the 100 ml infusion bag.
Dan għandu
This should be a final volume of 100 ml.
38 jkun volum finali ta ’ 100 ml.
What is Rotarix?
X' inhu Rotarix?
Rotarix is an oral vaccine.
Rotarix huwa vaċċin orali (vaċċin li jingħata mill- ħalq).
It contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Jinsab disponibbli f’ żewġ forom: • trab u solvent li jitħalltu flimkien għal sospensjoni orali f’ applikatur orali • sospensjoni orali f’ applikatur orali mimli bil- lest Rotarix fih għamla ħajja attenwata (mdgħajfa) tar- rotavirus uman (razza RIX4414).
What is Rotarix used for?
Għalxiex jintuża Rotarix?
Rotarix is used in babies from six weeks of age as a vaccine to prevent gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Rotarix jingħata bħala vaċċin lit- trabi minn sitt ġimgħat ‘ l fuq għall- prevenzjoni tal- gastroenterite (dijarrea u remettar) ikkawżata minn infezzjonijiet tar- rotavirus.
Rotarix is given according to official recommendations.
Rotarix jingħata skond ir - rakkomandazzjonijiet uffiċjali.
How is Rotarix used?
Kif jintuża Rotarix?
Rotarix is given as two doses, given at least four weeks apart.
Rotarix jingħata f' żewġ dożi, b' mill- anqas erba 'ġimgħat bejn kull doża.
The first dose is given when the baby is older than six weeks.
L- ewwel doża tingħata meta t - tarbija jkollha iktar minn sitt ġimgħat.
It is better if the full course (both doses) is given before the child is aged 16 weeks, and in any case, it should have been given by the time the child is 24 weeks old.
Idelament, iż- żewġ dożi għandhom jingħataw qabel ma t- tarbija jkollha 16- il ġimgħa u għandu jingħata sa ma t- tarbija jkollha 24 ġimgħa.
The powder and solvent are mixed just before administration, and the resulting suspension is given directly into the mouth of the baby using the oral syringe provided.
Jekk jintużaw it- trab u s - solvent, dawn għandhom jitħalltu flimkien eżattament qabel ma jingħata l- vaċċin u s- sospensjoni li tirriżulta tingħata direttament fil- ħalq tat- tarbija permezz ta ’ applikatur orali pprovdut.
Rotarix can be given at the same time as other vaccinations.
Rotarix jista 'jingħata fl- istess ħin ma' vaċċini oħrajn.
How does Rotarix work?
Kif jaħdem Rotarix?
Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Rotarix fih ammonti żgħar ta 'rotavirus, virus li jikkawża l- gastroenterite.
The virus is alive, but it has been weakened so that it does not cause the disease, and this makes it suitable to use in a vaccine.
Il- vajrus huwa ħaj, iżda mdgħajjef sabiex ma jikkawżax il- marda, li jagħmlu adatt għall- użu f' tilqima.
When a child is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘ foreign’ and makes antibodies against it (an antibody is a special protein that can neutralise or destroy an antigen, such as an infectious agent or virus).
Antikorp huwa proteina speċjali li tista 'tikkawża jew teqred antiġene, bħal aġent jew vajrus li jgħaddi infezzjoni.
Between 78 and 95% of babies receiving Rotarix make antibodies against rotavirus after vaccination.
Bejn 78 u 95% tat- trabi li jirċievu Rotarix jipproduċu antikorpi kontra rotavirus wara t- tilqima.
How has Rotarix been studied?
©European Medicines Agency 2008, Reproduction is authorised provided the source is acknowledged Kif ġie studjat Rotarix?
The effects of Rotarix were first tested in experimental models before being studied in humans.
L- effetti ta 'Rotarix ġew ittestjati f' mudelli sperimentali qabel ma ġew ittestjati fuq il- bnedmin.
Overall, the clinical studies of Rotarix in humans involved over 72,000 infants and took place in various countries worldwide.
B' kollox, fl- istudji kliniċi dwar Rotarix ħadu sehem aktar minn 72, 000 tarbija u saru f' bosta pajjiżi madwar id- dinja.
In all studies, the vaccine was compared with a placebo (a dummy vaccine).
Fl- istudji kollha, il- vaċċin tqabbel ma’ plaċebo (vaċċin finta).
The main study looked at the effectiveness and safety of Rotarix, and it involved over 63,000 infants.
L- istudju prinċipali eżamina l- effifaċja u s- sigurtà ta 'Rotarix, u involva aktar minn 63, 000 tarbija.
The study was very large because it was designed to see if the vaccine caused a very rare, serious side effect, intussusception, a condition in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage.
L- istudju kien kbir ħafna minħabba li kien imfassal biex jara jekk il- vaċċin ikkawżax effett sekondarju serju u rari ħafna, imsejjaħ intussuxxezzjoni, kundizzjoni li fiha, parti mill- musrana tidħol f' parti oħra tal- musrana, u dan iwassal għal imblukkar.
Effectiveness was measured by looking at how many 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- effikaċja tal- vaċċin tkejlet b' ħarsa lejn kemm kien hemm trabi u tfal żgħar li żviluppaw gastroenterite kkawżata minn rotaviruses fix- xhur ta 'wara li jkunu ġew imlaqqmin u qabel ma kienu laħqu l- età ta' sena.
(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 children developed severe rotavirus gastroenteritis in the months after they had been vaccinated (and before they reached one year of age).
Ġew imwettqa erba ’ studji oħra f’ iktar minn 3000 tarbija sabiex jikkonfermaw li ż- żewġ forom tal - vaċċin kienu siguri u effikaċi indaqs fl- istimular tal- produzzjoni ta ’ antikorpi kontra r- rotavirus.
What benefit has Rotarix shown during the studies?
Liema benefiċċju wera Rotarix waqt l- istudji mwettqa?
Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus.
Rotarix kien iktar effikaċi mill- plaċebo fil- prevenzjoni ta 'gastroenterite severa dovuta għal rotavirus.
In over 20,000 children in whom effectiveness was assessed, the number of cases of severe rotavirus gastroenteritis decreased following vaccination with Rotarix:
Fl- istudju ewlieni, in- numru ta 'każijiet ta' gastroenterite severa bir- rotavirus kien inqas wara t- tilqima b' Rotarix:
12 infants vaccinated with Rotarix developed severe rotavirus gastroenteritis compared to 77 cases among those who received placebo.
0. 1% mit- trabi/ tfal żgħar imlaqqmin b' Rotarix, li fihom ġiet ittestjata l- effikaċja tal- vaċċin, żviluppaw gastroenterite severa bir- rotavirus (12 minn iktar 9, 000) meta mqabbla ma '0. 9% tat - trabi/ tfal żgħar li rċevew plaċebo (77 minn kważi 9, 000)..
What is the risk associated with Rotarix?
X' inhu r- riskju assoċjat ma 'Rotarix?
In the main study, in which about 31,500 children received Rotarix and 31,500 received placebo, nine children developed intussusception following vaccination with Rotarix, compared to 16 who developed the disease after receiving a placebo vaccine.
Fl- istudju ewlieni, li fih madwar 31, 500 tarbija/ tifel u tifla ngħataw Rotarix u 31, 500 ingħataw il - plaċebo, disa ’ trabi/ tfal żgħar żviluppaw intussuxxezzjoni wara tilqima b' Rotarix, meta mqabbla mas - sittax li żviluppawha wara li ngħataw it- tilqima bil- plaċebo.
This shows that there is no increased risk of intussusception with Rotarix.
Dan juri li ma kien hemm ebda riskju miżjud ta 'intussuxxezzjoni b' Rotarix.
The most common side effects (seen in more than 1 patient in 10) are irritability and loss of appetite.
L- iktar effetti sekondarji komuni b' Rotarix (li dehru f' iktar minn pazjent 1 minn kull 10) huma l- irritabilità u t- telf fl- aptit.
For the full list of all side effects reported with Rotarix, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' Rotarix, ara l- Fuljett ta' Tagħrif.
Rotarix should not be used in children who may be hypersensitive (allergic) to any of the ingredients of the vaccine, or who have shown signs of allergy after having received a previous dose of rotavirus vaccine.
Rotarix ma għandux jintuża fuq trabi li huma ipersensittivi (allerġiċi) għal kwalunkwe sustanza minn tal- vaċċin, jew li jkollhom sinjali ta 'allerġija wara li jkunu rċevew doża preċedenti ta' vaċċin tar - rotavirus.
It should not be given to children who have had intussusception in the past, or who have problems with their bowel that could predispose them to the disease.
Ma għandux jingħata lil tfal żgħar li fl- imgħoddi kellhom intussuxxezzjoni jew f' dawk li jbatu minn problemi fl- imsaren li jippredisponuhom għall- marda.
It should also not be given to children whose immune system is weakened.
Il- vaċċin b’ Rotarix għandu jiġi pospost fi trabi li f’ daqqa waħda jaqbadhom deni għoli, dijarea jew remettar.
For the full list of restrictions, see the Package Leaflet.
Għal- lista sħiħa ta 'restrizzjonijiet, ara l - Fuljett ta' Tagħrif.
As for all vaccines, if Rotarix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Rotarix qatt m’ għandu jiġi injettat, taħt l- ebda ċirkostnaza.
Their breathing should be monitored for up to three days after vaccination.
Bħall- vaċċini l- oħra kollha, jekk Rotarix jintuża fi trabi li jkunu twieldu prematuri ħafna, ikun hemm riskju li jesperjenzaw apnea (waqtiet qosra li fihom ma jiħdux nifs).
Why has Rotarix been approved?
Għaliex ġie approvat Rotarix?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rotarix’ s benefits are greater than its risks for the vaccination of infants from the age of six weeks for the prevention of gastroenteritis due to rotavirus infection.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Rotarix huma akbar mir- riskji tiegħu għat- tilqim ta' tarbi li għandhom sitt ġimgħat u iktar għall - prevenzjoni ta 'gastroenterite dovuta għal infezzjoni bir- rotavirus.
The Committee recommended that Rotarix be given marketing authorisation.
Il- Kumitat irrakkomanda li Rotarix jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rotarix:
Informazzjoni oħra dwar Rotarix:
The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix to GlaxoSmithKline Biologicals s. a. on 21 February 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Rotarix lil GlaxoSmithKline Biologicals s. a. fil- 21 ta 'Frar 2006.
The full EPAR for Rotarix can be found here.
L- EPAR sħiħ għal Rotarix jista 'jiġi kkonsultat hawnhekk.
not less than 106.0 CCID50
mhux inqas minn 106. 0 CCID50
Powder and solvent for oral suspension
Trab u solvent għal suspensjoni orali
powder: glass container; solvent: oral applicator (glass)
trab: kontenitur tal- ħġieġ; solvent: applikatur tal- ħalq (ħġieġ)
1 glass container + 1 oral applicator + 1 transfer adapter
Kontenitur tal- ħġieġ 1 + applikatur tal- ħalq 1 + transfer adapter 1
5 glass containers + 5 oral applicators + 5 transfer adapters
5 kontenituri tal- ħġieġ + 5 applikaturi tal- ħalq + 5 transfer adapters
10 glass containers + 10 oral applicators + 10 transfer adapters
10 kontenituri tal- ħġieġ + 10 applikaturi tal- ħalq + 10 transfer adapters
25 glass containers + 25 oral applicators + 25 transfer adapters
25 kontenitur tal- ħġieġ + 25 applikatur tal- ħalq + 25 transfer adapter
not less than 106.0 CCID50
Rotarix
Oral suspension
mhux inqas minn Suspensjoni orali 106. 0 CCID50
1.5 ml
Applikatur tal- ħalq mimli 1. 5 ml lest (ħġieġ)
1 oral applicator
applikatur tal- ħalq
5 oral applicators
5 applikaturi tal- ħalq
Prefilled oral applicator (glass)
Applikatur tal- ħalq mimli lest (ħġieġ)
10 oral applicators
10 applikaturi tal- ħalq
25 oral applicators
25 applikaturi tal- ħalq
Squeezable tube (polyethylene)
Tubu li jingħafas (polyethylene)
1 squeezable tube
tubu li jingħafas
10 squeezable tubes
10 tubi li jingħafsu
50 squeezable tubes
50 tubu li jingħafas
Rotarix powder and solvent for oral suspension Rotavirus vaccine, live
Rotarix trab u solvent għal suspensjoni orali Vaċċin ta ’ Rotavirus, ħaj
After reconstitution, 1 dose (1ml) contains:
Wara li tiġi rikostitwita, doża waħda (1 ml) ikun fiha:
Human rotavirus RIX4414 strain (live, attenuated)*
Razza ta ’ Rotavirus uman RIX4414( b’ ħajja attenwata) * mhux inqas minn 106. 0 CCID50
not less than 106.0 CCID50
* Prodott fuq ċelluli Vero
This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4)
Dan il- prodott fih 9 mg sukrosju u 13. 5 mg sorbitol (ara sezzjoni 4. 4)
Powder and solvent for oral suspension.
Trab u solvent għal suspensjoni orali.
The powder is white.
It- trab huwa abjad.
The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.
Is- solvent ikun likwidu mdardar b’ depożitu abjad li joqgħod bil- mod, u b’ sustanza bla kulur tgħum fil - wiċċ.
Rotarix is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection (see section 4.2).
Rotarix hu indikat għall- immunizzazzjoni attiva tat- tfal mill- età ta ’ 6 gimgħat għall- prevenzjoni ta ’ gastro- enterite li tkun ġejja minn infezzjoni ta ’ rotavirus (ara sezzjoni 4. 2).
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] (see sections 4.4 and 5.1).
Fi provi kliniċi, ġie stabbilit l- effikaċja kontra l- gastro- enterite li tkun ġejja minn rotavirus tat- tipi GIP[ 8], G2P[ 4], G3P[ 8], G4P[ 8] u G9P[ 8] (ara sezzjonijiet 4. 4 u 5. 1).
The use of Rotarix should be based on official recommendations.
L- użu ta ’ Rotarix għandu jkun bażat fuq rakkomandazzjonijiet uffiċjali
The vaccination course consists of two doses.
Il- kors tal- vaċċinazzjoni jikkonsisti f’ żewġ dożi.
The first dose may be administered from the age of 6 weeks.
L- ewwel doża tingħata mill- eta` ta ’ 6 ġimgħat.
There should be an interval of at least 4 weeks between doses.
Għandu jkun hemm intervall ta ’ mill- inqas 4 ġimgħat bejn id- dożi.
The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
Il- kors tal- vaċċinazzjoni l- aħjar għandu jingħata qabel l- età ta ’ 16- il ġimgħa, iżda għandu jintemm ma ’ l- età ta ’ 24 ġimgħa.
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given.
Fi provi kliniċi, rarament ġie osservat li l- vaċċin inbeżaq jew ġie rigurġitat u, f’ ċirkostanzi bħal dawn, ma terġax tingħata doża oħra minflok.
However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Biss, jekk fis- sitwazzjoni mhux tas- soltu li t- tarbija fl- ewwel snin ta ’ ħajjitha tobżoq jew ittella ’ l- parti l- kbira tad- doża, ħaġa pjuttost rari, tista ’ minflok tingħata doża oħra fl- istess żjara għall- vaċċinazzjoni.
It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix.
Hu rakkomandat li trabi li jieħdu l- ewwel doża ta ’ Rotarix għandhom jingħataw iż- żewġ dożi ta ’ Rotarix.
There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.
Ma hawnx tagħrif dwar sigurtà, immunoġeċità jew effikaċja meta Rotarix jingħata għall - ewwel doża u xi vaċċin ieħor ta ’ rotavirus jingħata bħala t- tieni doża jew bil- maqlub.
2 Method of administration
2 Metodu ta ’ kif jingħata
Rotarix is for oral use only.
Rotarix għandu jitteħed mill- ħalq biss
Rotarix should under no circumstances be injected.
Rotarix m’ għandux jiġi njettat taħt l- ebda ċirkostanzi.
Hypersensitivity after previous administration of rotavirus vaccines.
Sensittività eċċessiva wara li jkunu ngħataw vaċċini ta ’ rotavirus.
Previous history of intussusception.
Storja minn qabel ta ’ intussuxezzjoni.
Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Persuni b’ malformazzjoni konġenitali mhux ikkoreġuta tal- passaġġ gastrointestinali li jkunu predisposti għal intussuxezzjoni.
Infants who have known or suspected immunodeficiency.
Trabi li għandhom jew suspettati li għandhom immunodefiċjenza.
Asymptomatic HIV infection is not expected to affect the safety or efficacy of Rotarix.
Infezzjoni ta ’ HIV asintomatika mhix mistennija li jkollha xi effett fuq is- sigurtà jew l- effikaċja ta ’ Rotarix.
However, in the absence of sufficient data, administration of Rotarix to asymptomatic HIV subjects is not recommended.
Madankollu, fin- nuqqas ta ’ tagħrif biżżejjed, mhuwiex rakkomandat li persuni b’ HIV asintomatika jingħataw Rotarix.
Administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness.
L- għoti ta ’ Rotarix għandu jiġi posponut f’ persuni li jbatu minn mard akut b’ deni severi.
The presence of a minor infection is not a contra-indication for immunisation.
Il- presenza ta ’ infezzjoni minuri mhijiex kontra- indikazzjoni għall- immunizazzjoni.
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
L- għoti ta ’ Rotarix għandu jiġi posponut f’ persuni li jbatu b’ dijareja jew remettar.
It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination.
Hi prattika ta ’ klinika tajba li qabel il- vaċċinazzjoni għandha tiġi riveduta l- istorja medika speċjalment għal dawk li huma kontra- indikazzjonijiet u anke eżami kliniku.
There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation.
Ma hawnx tagħrif dwar is- sigurtà u l- effikaċja ta ’ Rotarix fi trabi b’ mard gastrointestinali jew li jikbru bil- mod wisq.
Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
L- għoti ta ’ Rotarix jista ’ jiġi kkunsidrat b’ kawtela fi trabi bħal dawn meta, fil- fehma tat- tabib, jekk ma jingħatax il- vaċċin ikun ta ’ riskju ikbar.
Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day.
Il- purgar tal- virus tal- vaċċin fi ħmieġ solidu hu magħruf li jseħħ wara l- vaċċinazzjoni u l- iktar li dan jiġri hu madwar is- seba ’ jum.
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose.
Frak antiġen virali skopert b’ ELISA instab f’ 50% ta ’ ħmieġ solidu wara l- ewwel doża u f’ 4% ta ’ ħmieġ solidu wara t- tieni doża.
When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Meta dan il- ħmieġ ġie ttestjat għall- presenza tar- razza tal- vaċċin ħaj, 17% biss tiegħu kien pożittiv.
Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom.
Każi ta ’ trasmissjoni tal- virus ta ’ dan il- vaċċin fil- ħmieġ għal kuntatti seronegattivi ta ’ dawk li ħadu l - vaċċin ġew osservati bla ma kkaġunaw xi sintomi kliniċi.
Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy.
Rotarix għandu jingħata b’ prekawzjoni lil individwi b’ kuntatti mill- qrib immunodefiċjenti, bħal individwi b’ tumuri malinni, jew b’ xi mod ieħor immunokompromessi jew individwi li jkunu fuq terapija immunosoppressiva.
Contacts of recent vaccinees should observe personal hygiene (e. g. wash their hands after changing child’ s nappies).
Persuni li jkunu f’ kuntatt ma ’ min ħa l- vaċċin riċentement għandhom josservaw l- iġjene personali (e. g ħasil ta ’ l- idejn wara bdil ta ’ ħrieqi tat- trabi).
Limited data in 140 premature children indicate that Rotarix can be given to premature children, however a lower immune response may be observed and the level of clinical protection remains unknown.
Tagħrif limitat fi 140 tfal prematuri jindika li Rotarix jista ’ jingħata lil tfal prematuri, biss jista ’ jkun hemm inqas rispons ta ’ immunità u l- livell ta ’ protezzjoni klinika għadu mhux magħruf.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
3 qabel iż- żmien (twieldu ≤ 28 ġimgħa ta ’ tqala) u speċjalment f’ dawk li diġà kellhom immaturità respiratorja.
3 As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Minħabba li l- vaċċinazzjoni f' dan il- grupp ta 'trabi hija ta ’ ġid kbir, t- tilqim m’ għandux jinżamm lura jew jiġi pospost.
A protective immune response may not be elicited in all vaccinees (see section 5.1).
Rispons ta ’ immunità protettiva mhux dejjem mistenni minn dawk li jieħdu l- vaċċin (ara sezzjoni 5. 1).
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
Fi provi kliniċi, irriżultat effikaċja kontra gastroenterite kawżata minn tipi ta ’ rotavirus G1P[ 8], G2P[ 4], G3P[ 8], G4P[ 8] u G9P[ 8].
The extent of protection that Rotarix might provide against other serotypes is unknown.
Mhux magħruf kemm Rotarix jista ’ jkun ta ’ protezzjoni kontra sereotipi oħra.
Clinical studies from which efficacy data were derived were conducted in Europe and Central and South America (see section 5.1).
Studji kliniċi li minnhom ħareġ tagħrif dwar l- effikaċja saru fl- Ewropa u l- Amerika Ċentrali u l- Amerika t’ Isfel (ara sezzjoni 5. 1).
Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
Rotarix ma jagħti ebda protezzjoni kontra gastro- enterite kawżata minn patoġeni għajr rotavirus.
No data are available on the use of Rotarix for post-exposure prophylaxis.
Ma hawnx tagħrif disponibbli dwar l- użu ta ’ Rotarix għal profilassi ta ’ wara l- esponiment.
The vaccine contains sucrose and sorbitol as excipients.
Il- vaċċin fih sukrosju u sorbitol bħala sustanzi mhux attivi.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Pazjenti bi problemi ereditarji rari ta ’ nuqqas ta ’ tolleranza għal fruttosju, malassorbiment ta ’ glukosju- galattosju jew nuqqas ta ’ sucrase - isomaltase m’ għandomx jieħdu dan il- vaċċin.
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/ Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine.
Rotarix jista ’ jingħata flimkien ma ’ kull wieħed minn dawn il- vaċċini monovalenti jew kombinati li ġejjin [inklużi vaċċini eżavalenti (DTPa- HBV- IPV/ Hib)]: vaċċin għad- difterja- tetanu- sogħla konvulsiva b’ ċellula sħiħa (DTPw), vaċċin għad- difterja- tetnu- sogħla konvulsiva bla ċelluli (DTPa), vaċċin tip b Haemophilus influenzae (Hib), vaċċin tal- poljo inattivat (IPV), vaċċin ta ’ l- epatite B (HBV), vaċċin ta ’ pneumococcal conjugate u vaċċin ta ’ meningococcal serogroup C conjugate.
Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Studji kliniċi wrew li r- rispons immunitarju u l- profili tas- sigurtà tal- vaċċini li jkunu ngħataw ma kienx hemm effett fuqhom.
Concominant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens.
L- għoti flimkien ta ’ Rotarix u l- vaċċin tal- poljo mill- ħalq (OPV) m’ għandux effett fuq ir- reazzjoni immuni għall- antiġeni tal- poljo.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4200 subjects who received Rotarix concomitantly with OPV.
Għalkemm meta l- OPV tingħata fl- istess ħin, tista ’ tnaqqas ftit ir - rispons immunitarju għall- vaċċin tar- rotavirus, il- protezzjoni klinika kontra gastro- enterite severi mir - rotavirus tibqa ’ u dan intwera fi prova klinika fejn kienu involuti aktar minn 4200 persuni li rċievew Rotarix flimkien ma ’ OPV.
There are no restrictions on the infant’ s consumption of food or liquid, either before or after vaccination.
M’ hemmx restrizzjonijiet fuq il- konsum ta ’ ikel jew likwidi minn trabi, la qabel u lanqas wara l - vaċċinazzjoni.
Rotarix is not intended for use in adults.
Rotarix mhuwiex maħsub għal użu minn adulti.
Thus human data on use during pregnancy or lactation are not available and animal reproduction studies have not been performed.
Għalhekk m’ hawnx disponibbli tagħrif uman dwar l - użu waqt it- tqala jew meta mara tkun tredda ’ u studji fuq riproduzzjoni fl- annimali għadhom ma sarux.
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
Fuq il- bażi ta ’ evidenza minn provi kliniċi, it- treddigħ ma jnaqqasx mill- protezzjoni kontra l- gastro - enterite minn rotavirus li tingħata minn Rotarix.
Therefore, breast-feeding may be continued during the vaccination schedule.
Għalhekk, mara tista ’ tibqa ’ tredda ’ waqt l- iskeda tal- vaċċinazzjoni.
• Clinical trials
• Provi kliniċi:
4 In a total of eleven placebo-controlled clinical trials, approximately 77800 doses of Rotarix were administered to approximately 40200 infants.
F’ total ta ’ ħdax- il prova klinika kontrollati bi plaċebo, madwar 77800 dożi ta ’ Rotarix ingħataw lil madwar 40200 trabi.
In two clinical trials (Finland), Rotarix was administered alone (administration of routine paediatric vaccines was staggered).
F’ żewġ provi kliniċi (Finlandja), Rotarix ingħata waħdu (l- għoti ta ’ vaċċini pedjatriċi ta ’ rutina kien jitqassam fuq perijodi).
The incidence of diarrhoea, vomiting, loss of appetite, fever and irritability was not different in the group receiving Rotarix when compared to the group receiving placebo.
L- inċidenza ta ’ dijareja, remettar, nuqqas t’ aptit, deni u irritabilità ma kienitx differenti fil- grupp li ħadu Rotarix meta mqabbla mall- grupp li ħadu plaċebo.
No increase in the incidence or severity of these reactions was seen with the second dose.
Ma ġiet osservata ebda żjieda fl- inċidenza jew fis- severità ta ’ dawn ir- reazzjonijiet mat- teħid tat- tieni doża.
In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix was co-administered with routine paediatric vaccines (see section 4.5).
Fid- disa ’ provi li kien baqa ’ (Ewropa, Canada, Stati Uniti ta ’ l- Amerika, Amerika Latina, Singapore, Afrika t’ Isfel), Rotarix ingħata flimkien ma ’ vaċċini pedjatriċi ta ’ rutina (ara sezzjoni 4. 5).
The adverse reaction profile observed in these subjects was similar to the adverse reaction profile observed in subjects receiving the same paediatric vaccines and placebo.
Il- profil ta ’ reazzjonijiet avversi osservat f’ dawn il- persuni kien bħall- profil ta ’ reazzjonijiet avversi f’ persuni li ħadu l- istess vaċċini u plaċebo.
Adverse reactions are listed below per system organ class and frequency.
Reazzjonijiet avversi huma elenkati hawn taħt skond il- klassi ta ’ sistema ta ’ organi u frekwenza.
Frequencies are reported as:
Frekwenzi huma rappurtati bħala:
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100, < 1/ 10) Mhux komuni (≥1/ 1, 000, < 1/ 100) Rari (≥1/ 10, 000, < 1/ 1, 000)
Nervous system disorders Uncommon: somnolence
Disturbi fis- sistema nervuża Mhux komuni: ngħas ta ’ spiss
Respiratory, thoracic and mediastinal disorders Rare: hoarseness, rhinorrhoea
Disturbi respiratorji, toraċiċi u medjastinali Rari: ħanqa, rinoreja
Gastrointestinal disorders Very common: loss of appetite Common: diarrhoea, vomiting, abdominal pain, flatulence, regurgitation of food Uncommon: constipation
Disturbi gastro- intestinali Komuni ħafna: nuqqas t’ aptit Komuni: dijareja, remettar, uġigħ addominali, gass fl- istonku, rigurġitazzjoni ta ’ ikel Mhux komuni: stitikezza
Skin and subcutaneous tissue disorders Rare: dermatitis, rash
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rari: dermatite, raxx
Musculoskeletal and connective tissue disorders Rare: muscle cramp
Disturbi muskolu- skeltrali u tal- connective tissue Rari: bugħawwieġ fil- muskoli