qanastek/EMEA-V3 huggingface dataset:
Tell your doctor immediately if you experience shortness of breath, fever, sudden weight gain, water retention, fainting or palpitations (strong heartbeat you can feel in your chest).
Għid lit- tabib tiegħek minnufih jekk tħoss qtugħ ta ’ nifs, deni, żjieda f’ daqqa fil- piż, ikun hemm akkumulazzjoni ta ’ l- ilma, iħossok ħażin jew palpitazzjonijiet (taħbit qawwi tal- qalb li tħoss f’ sidrek).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TRISENOX
KIF TAĦŻEN TRISENOX
Do not use after the expiry date stated on the ampoule label.
Tużahx wara d- data ta ’ skadenza li tidher fuq it- tikketta ta ’ l- ampulla.
After dilution, if not used immediately, in-use storage times and conditions before use are the responsibility of your doctor and would normally not be longer than 24 hours at 2ºC – 8ºC, unless dilution has taken place in a sterile environment.
Wara d- dilwazzjoni, jekk ma tużahx minnufih, il- ħinijiet u l- kondizzjonijiet tal- ħażna tal- mediċini li għadhom qed jintużaw jaqgħu fuq spallejn it- tabib u normalment ma jkunux ta 'aktar minn 24 siegħa f' 2ºC – 8ºC għajr meta tkun saret id- dilwazzjoni f’ ambjent sterili.
Do not use TRISENOX if you notice foreign particulate matter or if discolouration is present.
Tużax TRISENOX jekk tinnota xi frak jew telf fil- kulur.
What TRISENOX contains
X’ fih TRISENOX
- The active substance is arsenic trioxide 1 mg/ml
- Is- sustanza attiva hi arsenic trioxide 1 mg/ ml
- The other ingredients are sodium hydroxide, hydrochloric acid and water for injections
- Is- sustanzi l- oħra huma sodium hydroxide, hydrochloric acid u ilma għal injezzjonijiet
What TRISENOX looks like and contents of the pack
Id- dehra ta ’ TRISENOX u d- daqs tal- pakkett
- TRISENOX is a concentrate for solution for infusion.
- TRISENOX hu konċentrat għal solużjoni għall- infużjoni.
TRISENOX is supplied in glass ampoules
TRISENOX jingħata f’ ampulli tal -
as a concentrated, sterile, clear, colourless, aqueous solution that is prepared and diluted at the hospital
ħġieġ bħala soluzzjoni konċentrata, sterili, ċara, bla kulur, milwima li hi ppreparata u dilwita fl - isptar u tingħata bħala infużjoni fil- vina tad- demm.
Each carton contains 10 single-use glass ampoules.
Kull kartuna fiha 10 ampulli tal- ħġieġ li tużahom darba biss.
Each ampoule contains 10 mg of arsenic trioxide.
Kull ampulla fiha 10 mg ta 'arsenic trioxide.
- Marketing Authorisation Holder:
- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Cephalon Europe, 5 Rue Charles Martigny, 94700 Maisons Alfort, FRANCE
Cephalon Europe, 5 Rue Charles Martigny, 94700 Maisons Alfort, FRANZA
- Manufacturer:
- Manifattur
This medicine has been authorised under “Exceptional Circumstances”.
Din il- mediċina kien awtorizzata taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”.
This means that because of the rarity of this disease, it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja tal- mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser ikun aġġornat, skond il- bżonn.
Detailed information on this medicine is available on the EMEA web site:http://www.emea.europa.eu There are also links to other websites about rare diseases and treatments.
Tagħrif dettaljat dwar din il- mediċina tinsab fuq il- website ta ’ l- EMEA http: // www. emea. europa. eu Hemm ukoll links għall- websites oħra dwar mard rari u kura.
TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5%) injection or sodium chloride 9 mg/ml (0.9%) injection immediately after withdrawal from the ampoule.
TRISENOX irid ikun dilwit ma ’ injezzjoni ta ’ minn 100 sa 250 ml ta 'glukows 50 mg/ ml( 5%) jew injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) hekk kif jinġibed mill- ampulla.
TRISENOX must be administered intravenously over 1-2 hours.
TRISENOX għandu jingħata fil- vina fuq firxa ta ’ 1- 2 sigħat.
The diluted solution must be clear and colourless.
25 Is- soluzzjoni dilwita trid tkun ċara u bla kulur.
All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Is- soluzzjonijiet parenterali kollha jridu jkunu spezzjonati viżwalment għall- frak u telf ta ’ kulur qabel ma jingħata.
After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 hours at 15-30°C and 48 hours at refrigerated (2-8°C) temperatures.
Wara d- dilwazzjoni fis- soluzzjoni fil- vina, TRISENOX hu kemikalment u fiżikament stabbli għal 24 siegħa f’ 15- 30°C u 48 siegħa f’ temperaturi fil- friġġ (2- 8°C).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- ħinijiet u l- kondizzjonijiet tal- ħażna tal- mediċini li għadhom qed jintużaw jaqgħu fuq spallejn min juża l- prodott u normalment m’ għandhomx ikunu ta ’ aktar minn 24 siegħa f’ 2- 8°C, ħlief meta tkun saret id- dilwazzjoni taħt kondizzjonijiet kkontrollati u aseptiċi validati.
25 Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements.
Kull fdal tal- prodott mhux użat, kwalunkwe affarijiet li għamlu kuntatt mal- prodott jew skart li jibqa ’ wara l- użu għandu jintrema kif jitolbu l- liġijiet lokali.
What is Tritanrix HepB?
X’ inhu Tritanrix HepB?
Tritanrix HepB is a vaccine, which is available as a suspension for injection.
Tritanrix HepB huwa vaċċin, li huwa disponibbli bħala sospensjoni għal injezzjoni.
It contains toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough) and parts of the hepatitis B virus as active substances.
Fih tossojdi (tossini kimikament imdgħajjfin) minn difterite u tetnu, Bordetella pertussis inattivat (maqtul) (batterju li jikkaġuna sogħla konvulżiva) u partijiet mill- virus ta ’ l- epatite B bħala sustanzi attivi.
What is Tritanrix HepB used for?
Għalxiex jintuża Tritanrix HepB?
Tritanrix HepB is used to vaccinate infants from six weeks of age against diphtheria, tetanus, pertussis (whooping cough) and hepatitis B.
Tritanrix HepB jintuża għat- tilqim ta ’ trabi li għandhom minn sitt ġimgħat sa sena kontra difterite, tetnu, pertussi (sogħla konvulżiva) u epatite B.
How is Tritanrix HepB used?
Kif jintuża Tritanrix HepB?
Tritanrix HepB is given by deep injection into a muscle, preferably the thigh.
Tritanrix HepB jingħata b’ injezzjoni fil- fond ġo muskolu, preferibbilment fil- koxxa.
The recommended vaccination schedule consists of three doses within the first six months of life, with at least four weeks between each dose.
L- iskeda ta ’ tilqim irrakkomandata tikkonsisti fi tliet dożi fi żmien l- ewwel sitt xhur ħajja, b’ mill- inqas erba ’ ġimgħat bejn kull doża.
If a vaccine against hepatitis B has not been given at birth, Tritanrix HepB can be given as early as eight weeks of age.
Jekk ma tkunx ingħatat tilqima kontra l- epatite B mat- twelid, Tritanrix HepB jista ’ jingħata lil trabi li jkollhom minn tmien ġimgħat ’ il fuq.
In areas where hepatitis B is common, vaccination against hepatitis B at birth should be continued as normal, with Tritanrix HepB started at six weeks of age.
F’ żoni fejn l- epatite B hija komuni, it - tilqima kontra l- epatite B mat- twelid għandha titkompla b’ mod normali, bi Tritanrix HepB jinbeda fl - età ta ’ sitt ġimgħat.
A booster dose is recommended before the end of the second year of life.
Doża buster hija rrakkomandata qabel it- tmeim tat- tieni sena ta ’ ħajja.
How does Tritanrix HepB work?
Kif jaħdem Tritanrix HepB?
Tritanrix HepB is a vaccine.
Tritanrix HepB huwa vaċċin.
Tritanrix HepB contains small amounts of: • toxoids from the bacteria that cause diphtheria and tetanus; • killed whole B. pertussis, the bacterium that causes pertussis; • ‘ surface antigen’ (proteins from the surface) of the hepatitis B virus.
Tritanrix HepB fih ammonti żgħar ta ’: • tossojdi minn batterji li jikkaġunaw difterite u tetnu; • B. pertussis sħiħ maqtul, il- batterju li jikkawża pertussi; • ‘ antiġen tal- wiċċ ’ (proteini mill- wiċċ) tal- virus ta ’ l- epatite B.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses contained in the vaccine as ‘ foreign’ and makes antibodies against them.
Meta tarbija tingħata t- tilqima, is- sistema immunitarja tagħraf il- partijiet tal- batterji u virusijiet li jkunu fit- tilqima bħala ‘ barranin ’ u tagħmel antikorpi kontra tagħhom.
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Dan ifisser li t- tossojdi u l- partijiet tal- virus ta ’ l- epatite B jitwaħħlu fuq taħlititiet ta ’ l- aluminju, biex jistimulaw reazzjoni immunitarja aħjar.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- antiġeni tal- wiċċ tal- virus ta ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. l- epatite B huma prodotti permezz ta ’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: huma magħmulin minn ħmira li rċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
The active substances in Tritanrix HepB have been available in the European Union (EU) for a number of years in other vaccines.
Is- sustanzi attivi fi Tritanrix HepB ilhom disponibbli fl- Unjoni Ewropea (UE) għal bosta snin f’ vaċċini oħrajn.
How has Tritanrix HepB been studied?
Kif ġie studjat Tritanrix HepB?
The effects of Tritanrix HepB were first tested in experimental modes before being studied in humans.
L- effetti ta ’ Tritanrix HepB ġew l- ewwel ittestjati f’ modi sperimentali qabel ma ġew studjati fuq il - bniedem.
Tritanrix HepB has been studied in six studies involving a total of 872 infants aged between seven and 20 weeks, all of whom received the vaccine.
Tritanrix HepB ġie studjat f’ sitt studji li b’ kollox involvew 872 tarbija ta ’ bejn seba ’ u 20 ġimgħa, li kollha kemm huma rċevew it- tilqima.
The main measure of effectiveness was the production of protective antibodies in the infants after the first set of vaccinations.
Il- miżura ewlenija ta ’ l- effettività kienet il- produzzjoni ta ’ antikorpi ta ’ protezzjoni fit- trabi wara l- ewwel sett ta ’ tilqim.
Further studies looked at the effects of the vaccine in younger infants and at the persistence of antibody levels after vaccination.
Studji oħrajn studjaw l- effetti tat- tilqima fi trabi iżgħar u l- persistenza tal- livelli ta ’ antikorpi wara t - tilqima.
What benefit has Tritanrix HepB shown during the studies?
Liema benefiċċju wera Tritanrix HepB waqt l- istudji mwettqa?
The studies showed that the production of protective levels of antibodies against diphtheria, tetanus and hepatitis B occurred in at least 98% of the infants.
L- istudji wrew li l- produzzjoni ta ’ livelli ta ’ protezzjoni ta ’ antikorpi kontra d- difterite, it- tetnu u l - epatite B seħħet f’ għallinqas 98% tat- trabi.
At least 92% developed protective levels of antibodies against pertussis.
Għallinqas 92% żviluppaw livelli ta ’ protezzjoni ta ’ antikorpi kontra l- pertussi.
The additional studies showed that starting vaccination at six weeks was adequate, and that a booster dose is needed in the second year of life in order to maintain protection.
L- istudji addizzjonali wrew li l- għoti ta ’ l- ewwel tilqim wara sitt ġimgħat kien adegwat, u li hemm bżonn ta ’ doża buster fit- tieni sena ta ’ ħajja sabiex tinżamm il- protezzjoni.
What is the risk associated with Tritanrix HepB?
X’ inhu r- riskju assoċjat ma ’ Tritanrix HepB?
The most common side effects with Tritanrix HepB (seen in more than 1 in 10 doses of the vaccine) are drowsiness, feeding problems, fever, redness, swelling, pain, unusual crying and irritability.
L- aktar effetti sekondarji komuni bi Tritanrix HepB (jidhru f’ aktar minn doża 1 minn kull 10 tal - vaċċin) huma sturdament, problemi bit- tmigħ, deni, ħmura, nefħa, uġigħ, biki mhux normali u irritabbiltà.
For the full list of all side effects reported with Tritanrix HepB, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Tritanrix HepB, ara l- Fuljett ta ’ Tagħrif.
Tritanrix HepB should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Tritanrix HepB m’ għandux jintuża fi tfal li huma ipersensittivi (allerġiċi) għal xi sustanza attiva tiegħu jew għal xi sustanza oħra tiegħu.
It should also not be used in infants who have had an allergic reaction after being given diphtheria, tetanus, pertussis or hepatitis B vaccines.
Ma għandux jintuża wkoll fi trabi li kellhom reazzjoni allerġika wara li ngħataw tilqim tad- difterite, it- tetnu, il- pertussi jew l- epatite B.
Tritanrix HepB should be postponed in infants with a severe sudden fever, and it should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Tritanrix HepB għandu jiġi pospost fi trabi li żviluppaw deni sever f’ daqqa, u ma għandux jingħata jekk it- tifel jew tifla kellu/ ha enċefalopatija (marda tal- moħħ) li kaġun tagħha ma jkunx magħruf fi żmien sebat ijiem mit- tilqima ta ’ qabel b’ vaċċin li kien fih pertussi.
As for all vaccines, if Tritanrix HepB is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħal fil- każ tal- vaċċini kollha, jekk Tritanrix HepB jintuża fi trabi prematuri ħafna, hemm ir- riskju li t- trabi jesperjenzaw apneja (waqfiet qosra fit- teħid tan- nifs).
Their breathing should be monitored for up to three days after vaccination.
It- teħid tan- nifs tagħhom għandu jkun sorveljat sa tlett ijiem wara t- tilqima.
Why has Tritanrix HepB been approved?
Għaliex ġie approvat Tritanrix HepB?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tritanrix HepB’ s benefits are greater than its risks for active immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tritanrix HepB huma ikbar mir- riskji tiegħu għal tilqim attiv kontra d- difterite, it- tetnu, il- pertussi u l - epatite B fi trabi minn sitt ġimgħat ’ l fuq.
The Committee recommended that Tritanrix HepB be given marketing authorisation.
Il- Kumitat irrakkomanda li Tritanrix HepB jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tritanrix HepB:
Informazzjoni oħra dwar Tritanrix HepB:
The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s. a. for Tritanrix HepB on 19 July 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida madwar l- Unjoni Ewropea, għal Tritanrix HepB lil GlaxoSmithKline Biologicals s. a fid- 19 ta ’ Lulju 1996.
The marketing authorisation was renewed on 19 July 2001 and on 19 July 2006.
L - awtorizzazzjoni għat- tqegħid fis suq ġiet imġedda fid- 19 ta ’ Lulju 2001 u fid- 19 ta ’ Lulju 2006.
The full EPAR for Tritanrix HepB can be found here.
L- EPAR sħiħ għal Tritanrix HepB jista ’ jiġi konsultat hawnhekk.
EU Number
Numru tal - proċedura ta ’ l- EMEA
vial (glass)
fjala (ħġieġ)
1 1 dose (0.5 ml) contains:
1 Doża 1 (0. 5 ml) fiha:
Diphtheria toxoid* Tetanus toxoid*
Toxoid tad- difterite * Toxoid tat- tetnu * Razza ta ’ Bordetella pertussis inattivat ** Antiġen tas- superfiċje ta ’ l- epatite B rekombinanti ** * adsorbit fuq aluminium oxide idratat ** adsorbit fuq aluminium phosphate
≥ 30 IU ≥ 60 IU
≥ 30 IU ≥ 60 IU ≥ 4 IU (proteina S) *** 10 mikrogrammi Total:
Total:
0. 26 milligrammi Al3+ Total:
0.26 milligrams Al3+ Total:
0. 37 milligrammi Al3+
0.37 milligrams Al3+ cells (Saccharomyces cerevisiae)
cerevisiae) maħdumin ġenetikament
Tritanrix HepB, suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB, suspensjoni għall- injezzjoni Vaċċin (adsorbit) tad- difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV).
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen 2,3 1
Toxoid tad- difterite1 Toxoid tat- tetnu1 Bordetella pertussis (inattivat) 2 Antiġen tal- wiċċ ta ’ l- epatite B 2, 3 1 Adsorbit fuq aluminium hydroxide idratat 2 Adsorbit fuq aluminium phosphate 3
not less than 30 IU not less than 60 IU not less than 4 IU 10 micrograms
mhux anqas minn 30 UI mhux anqas minn 60 UI mhux anqas minn 4 UI 10 mikrogrammi 0. 26 milligrammi Al3+ 0. 37 milligrammi Al3+
Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Manifatturat f’ ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA
Turbid white suspension.
Suspensjoni bajda imdardra.
Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards (see section 4.2).
Tritanrix HepB huwa indikat għal tilqim attiv kontra d- difterite, it- tetnu, il- pertussis u l- epatite B (HBV) fit - trabi minn sitt ġimgħat ’ l quddiem (ara sezzjoni 4. 2).
The recommended dose is 0.5 ml.
Id- doża rakkomandata hija 0. 5ml.
The primary vaccination schedule consists of three doses within the first six months of life.
L- iskeda ta ’ tilqim primarju tikkonsisti fi tliet dożi, mogħtija sa l- età ta ’ sitt xhur.
Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age.
Meta l- vaċċin ta ’ l- HBV ma jingħatax mat- twelid, il- vaċċin kombinat jista ’ jibda jingħata mill- età ta ’ 8 ġimgħat.
Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be continued.
F’ postijiet fejn l - endemiċità ta ’ l- HBV hija għolja, l- pratttika li l- vaċċin ta ’ l- HBV jiġi amministrat mat- twelid, għandha titkompla.
In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.
F’ dawn iċ- ċirkustanzi, it- tilqim bil- vaċċin kombinat għandu jibda mill- età ta ’ 6 ġimgħat.
Three vaccine doses must be administered at intervals of at least 4 weeks.
Tliet dożi tal- vaċċin għandhom jingħataw f’ intervalli ta ’ mill- anqas 4 ġimgħat.
When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.
Meta Tritanrix HepB jingħata skond l- iskeda tas- 6- 10- 14- il ġimgħa, huwa rakkomandat li tamministra doża tal- vaċċin ta ’ l- HBV mat- twelid biex ittejjeb il- protezzjoni.
In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified.
Fil- każ ta ’ trabi mwielda minn ommijiet magħrufa li huma ġarriera ta ’ l- HBV, il- miżuri immunoprofilattiċi għall- epatite B, m’ għandhomx jinbidlu.
This may require separate vaccination with HBV and DTPw vaccines and also include the administration of HBIg at birth.
Dan jista ’ joħloq il- bżonn ta ’ tilqim separat bil- vaċċini ta ’ l- HBV u tad- DTPw u jinkludi wkoll l- amministrazzjoni ta ’ l- HBIg mat- twelid.
2 Booster vaccination:
2 Tilqim ta ’ rinforz:
A booster dose with Tritanrix HepB will give rise to increased reactogenicity as would be expected for a booster during the second year of life.
Id- doża ta ’ rinforz b’ Tritanrix HepB tista ’ toħloq aktar reazzjonijiet, kif ikun mistenni minn tilqim ta ’ rinforz li jingħata bejn l- età ta ’ sena u sentejn.
In consequence, boostering should follow local recommendations.
Minħabba f’ hekk, f’ dożi ta ’ rinforz għandhom jiġu segwiti r - rakkommandazzjonijiet lokali.
The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the second year of life.
Huwa rakkommandat li tingħata doża ta ’ rinforz bil- vaċċin DTP trivalenti qabel mat- tarbija tagħlaq sentejn.
For long-term protection against HBV, a booster dose of HBV vaccine could also be administered after the first year of life.
Għall- protezzjoni fit- tul kontra l- HBV, id- doża ta ’ rinforz tal- vaċċin ta ’ l- HBV tista ’ tingħata wkoll wara li t- tarbija tagħlaq sena.
However, the need for this dose is currently not established.
Madankollu, bħalissa għadu mhux stabbilit jekk hemmx bżonn ta ’ din id- doża.
Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh.
Tritanrix HepB qiegħed għal injezzjoni ġol- muskolu fil- fond, preferibbilment fil- koxxa anterolaterali.
It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered subcutaneously (see section 4.4).
Huwa rakommandat li fil- pazjenti b’ tromboċitopenja jew disturbi tal- fsada, il- vaċċin jingħata taħt il- ġilda (ara sezzjoni 4. 4).
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines.
Sensittività eċċessiva wara amministrazzjoni preċedenti ta ’ vaċċini tad- difterite, tetnu, pertussis jew epatite B.
The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe febrile illness.
L- amministrazzjoni ta ’ Tritanrix HepB għandha tiġi posposta f’ individwi li qed ibatu minn mard b’ deni akut serju.
Tritanrix HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Tritanrix HepB huwa kontra- indikat jekk it- tifel/ tifla kellu/ ha enċefalopatija li l- kawża tagħha ma kinetx magħrufa, u li tkun seħħet fi żmien 7 ijiem minn tilqim preċedenti b’ vaċċin li kien fih il- pertussis.
In these circumstances the vaccination course should be continued with DT and HBV vaccines.
F’ dawn iċ- ċirkustanzi l- kors ta ’ tilqim għandu jitkompla b’ vaċċini tad- DT u l- HBV.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of adverse reactions) and a clinical examination.
Qabel it- tilqim għandu jinġabar tagħrif fuq l- istorja medika tal- familja (b’ mod speċjali dwar it- tilqim preċedenti u l- possibiltà li ġraw effetti mhux mixtieqa) u jsir eżami kliniku.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
Bħal fil- vaċċini kollha li jiġu injettati, trattament mediku xieraq għandu dejjem ikun disponibbli malajr f’ każ ta ’ reazzjonijiet anafilattiċi li jistgħu jinqalgħu wara li tkun ingħatat it- tilqima.
For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.
Għal din ir- raġuni, min qed jiġi mlaqqam għandu jibqa ’ taħt superviżjoni medika għal 30 minuta wara t- tilqim.
If any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.
Jekk kwalunkwe waħda minn dawn l- effetti li ġejjin tiġri fl- istess żmien meta jittieħed Tritanrix HepB, id - deċiżjoni dwar jekk għandhomx jingħataw id- dożi li jkun imiss tal- vaċċin li fih il- komponent tal- pertussis għandha tiġi meqjusa bir- reqqa.
Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Temperatura ta ’ ≥ 40. 0°C fi żmien 48 siegħa, mhux minħabba kawża oħra li tista tiġi identifikata.
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Kollass jew stat li jixbaħ lil xokk (episodju ipotoniku- iporisponsiv) fi żmien 48 siegħa.
Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa.
Convulsions with or without fever, occurring within 3 days.
Aċċessjonijiet, bid- deni jew mingħajru, li jiġru fi żmien tlett ijiem.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Jista ’ jkun hemm ċirkustanzi, bħal inċidenza għolja ta ’ pertussis, fejn il- benefiċċji tat- tilqima jkunu akbar mir- riskji possibbli.
As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
F’ tarbija jew f’ tifel/ tifla li qed tbati minn bidu ta ’ xi disturb newroloġiku sever jew li dan id- distub qed jikber bil- ftit il- ftit, il- benefiċji u r- riskji ta ’ tilqim b’ Tritanrix HepB jew li din titħalla għal darb’ oħra għandha tiġi kkunsidrata sewwa, bħal fil- każ ta ’ kull vaċċinazzjoni.
A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
3 Storja ta ’ aċċessjonijiet bid- deni, storja fil- familja ta ’ aċċessjonijiet, storja fil- familja ta ’ SIDS (Sindrome ta ’ Mewt f’ Daqqa fit- Trabi), u storja medika ta ’ effett avvers wara tilqim b’ Tritanrix HepB, m’ humiex kontra- indikazzjonijiet.
3 HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination.
Infezzjoni ta ’ l- HIV m’ hijiex meqjusa bħala kontra- indikazzjoni għat- tilqim kontra d- difterite, tetnu, pertussis u l- HBV.
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e. g. patients on immunosuppressive therapy.
Ir- rispons immunoloġiku mistenni jista ’ ma jinkisibx wara t- tilqim ta ’ pazjenti immunosoppressi, e. ż.. pazjenti fuq kura immunosoppressiva..
Tritanrix HepB should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Tritanrix HepB għandu jingħata b’ attenzjoni f’ individwi b’ tromboċitopenja jew b’ disturbi tal- fsada minħabba li jista ’ jkun hemm fsada wara l- amministrazzjoni tat- tilqima ġol- muskolu lil dawn l- individwi.
TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY.
TRITANRIX HepB M’ GĦANDU QATT JINGĦATA FIL- VINA.
As the benefit of 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.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott mediċinali u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
It is current practice in paediatric vaccination to co-administer different vaccines during the same session with injectable vaccines being administered at separate injection sites.
Bħalissa, f’ tilqim pedjatriku, hemm id- drawwa li vaċċini differenti jingħataw flimkien waqt l- istess sessjoni b’ tilqim li jiġi injettat f’ postijiet differenti tal- ġisem.
Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with other paediatric vaccines if this fits conveniently in the immunisation scheme.
Tritanrix HepB jista ’ jingħata flimkien ma ’ vaċċini oħra pedjatriċi f’ postijiet differenti tal- ġisem jew fl - istess perjodu ta ’ żmien magħhom jekk dan ikun konvenjenti fl- iskeda tat- tilqim.
In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) and Haemophilus influenzae type b (Hib) vaccine.
Waqt studji kliniċi, Tritanrix HepB ingħata flimkien ma ’ vaċċin orali tal- poljo (OPV) u vaċċin tal - Haemophilus influenzae tat- tip b (Hib).
In some clinical studies, Tritanrix HepB was used to reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response to any of the antigens was observed as compared to the responses observed following administration of the vaccines at separate sites (see section 6.2).
F’ dawn l- istudji, r- rispons immuni għall- vaċċin orali tal- poljo ma ġiex investigat, madankollu, esperjenza preċedenti b’ amministrazzjoni tal- vaċċini DTP, OPV u HBV f’ daqqa, ma wrietx li kien hemm xi interferenza F’ xi studji kliniċi, Tritanrix HepB intuża biex jiġi rikostitwit il- vaċċin lajofilizzat Hib (Hiberix); l- ebda interferenza fir- rispons immuni għall- kwalukwe wieħed mill- antiġeni ma ġie osservat meta mqabbel mar- risponsi li ġew osservati wara li ngħataw vaċċini f’ postijiet differenti tal- ġisem (ara sezzjoni 6. 2).
In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved.
F’ pazjenti li qed jirċievu kura immunosoppressiva jew pazjenti b’ immunodefiċjenza, jista ’ ma jinkisibx rispons adegwat.
As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
Minħabba li Tritanrix HepB mhux intenzjonat għall- użu fl- adulti, informazzjoni dwar is- sigurtà tal- vaċċin meta dan jintuża waqt it- tqala jew treddigħ, m’ hijiex disponibbli.
In clinical studies, the most commonly reported adverse events were reactions at the injection site, including redness, swelling and pain.
Waqt studji kliniċi, l- aktar effetti avversi li kenu rrappurtati b’ mod komuni, kienu reazzjonijiet fis- sit ta ’ l- injezzjoni fosthom ħmura, nefħa u uġigħ.
General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.
4 Reazzjonijiet ġenerali, li jistgħu jiġru fl- istess żmien meta jsir tilqim bil- vaċċin Tritanrix HepB huma elenkati hawn taħt.
Frequencies are defined as follows:
Il- frekwenzi huma definiti kif ġej:
4 Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000) Not known (cannot be estimated from the available data)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 sa < 1/ 10) Mhux komuni (≥1/ 1, 000 sa < 1/ 100) Rari (≥1/ 10, 000 sa < 1/ 1, 000) Rari ħafna (< 1/ 10, 000) Mhux magħruf (ma tistax tittieħed stima mit- tagħrif disponibbli)
Nervous system disorders: very common: drowsiness
Komuni ħafna: tħeddla
Respiratory, thoracic and mediastinal disorders: common: bronchitis uncommon: respiratory disorder
Distubi respiratorji, toraċiċi u medjastinali: komuni: bronkite mhux komuni: disturb respiratorju
Gastro-intestinal disorders: very common: feeding problems common: gastro-intestinal symptoms such as vomiting and diarrhoea
Disturbi gastro- intestinali: komuni ħafna: problemi meta titma ’ lit- tarbija komuni: sintomi gastro- intestinali bħal rimettar u dijarea
Infections and infestations: common: otitis media, pharyngitis uncommon: pneumonia
Infezzjonijijiet u infestazzjonijiet: komuni: otite tal- widna tan- nofs, farinġite mhux komuni: pulmonite
General disorders and administration site conditions: very common: fever, swelling, pain and redness
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata: komuni ħafna: deni, nefħa, wġigħ u ħmura
Immune system disorders: very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness like disease
Disturbi fis- sistema immuni: rari ħafna: reazzjonjiet allerġiċi inkluż reazzjonijiet anafilattiċi u anafilaktojd u marda tixbaħ lil serum sickness
Psychiatric disorders: very common: unusual crying, irritability
Disturbi psikjatriċi: komuni ħafna: biki mhux tas- soltu, irritabilità
5 In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine.
5 Fi studju prospettiv kumparattiv, li qabbel l- amministrazzjoni tal- vaċċin kombinat DTPw HBV ma ’ l - amministrazzjoni separata iżda fl- istess ħin tal- vaċċin DTPw u HBV, ġiet irrappurtata inċidenza ogħla ta ’ uġigħ, ħmura, nefħa u deni fil- grupp li ħadu il- vaċċin kombinat.
The incidences are presented below:
L- inċidenzi huma ppreżentati hawn taħt:
(combined)
(kombinat)
N° of symptom checklists
Listi ta ’ kontroll tan - numru ta ’ sintomi
Local symptoms (%)
Sintomi lokali (%)
Total Severe*
Total Serju *
32.0 0.0
32. 0 0. 0
15.3 0.0
15. 3 0. 0
2.8 0.0
2. 8 0. 0
Redness
Ħmura
Total > 2cm
Total > 2ċm
Swelling
Nefħa
General Symptoms (%)
Sintomi ġenerali (%)
Fever > 38°C Fever > 39.5° C
Deni ≥ 38°C Deni > 39. 5° C
* reported by the parents as adversely affecting the child’ s daily activities
* irrappurtat mill- ġenituri li affettwa b’ mod avvers l- attivitajiet ta ’ kuljum tat- tifel/ tifla.
For both vaccination groups, the majority of the reactions were short lasting.
Għaż- żewġ gruppi ta ’ tilqim, il- maġġoranza tar- reazzjonijiet ma damux ħafna.
• Post marketing surveillance:
• Sorveljanza wara t- tqegħid fis- suq:
Collapse or shock-like state (hypotonic-hyporesponsive episode)
Kollass u stat bħal f’ xokk (episodju ipotoniku- iporisponsiv)
Convulsions
Aċċessjonijiet
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)
Dan il- prodott mediċinali fih Thiomersal (kompost organomerkurjali) bħala preservattiv u għalhekk jista jkun hemm reazzjonijiet ta ’ sensitizzazzjoni (ara sezzjoni 4. 3).
6 Pharmaco-therapeutic group:
Kategorija farmakoteropewtika: vaċċini batterjali u virali kombinati, Kodiċi ATC:
Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and the purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts.
Tritanrix HepB fih toxoids tad- difterite (D), u tat- tetnu (T), batterji inattivati tal- pertussis (Pw) u l- antiġenu prinċipali tal- wiċċ ippurifikat tal- virus ta ’ l- epatite B (HBV), adsorbiti fuq aluminium salts.
The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology.
It- toxoids D u T jiġu ppreparati mit- tossini ta ’ kolturi ta ’ Corynebacterium diphtheriae u Clostridium tetani li jiġu inattivati permezz tal- formalina bl- użu ta ’ teknoloġija stabbilita.
The Pw component is obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria.
Il- komponent Pw jinkiseb b’ inattivazzjoni permezz tas- sħana ta ’ koltura fil- fażi 1 tal- batterji Bordetella pertussis.
The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells (Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV.
L- antiġen tal- wiċċ ta ’ l- HBV (HBsAg) huwa magħmul minn koltura ta ’ ċelluli tal- ħmira ġenetikament mibdula (Saccharomyces cerevisiae) li jġorru l- ġeni bil- kodiċi ta ’ l- antiġeni prinċipali tal- wiċċ ta ’ l- HBV.
This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
L- HBsAg li toħroġ miċ- ċelluli tal- ħmira tiġi ppurifikata b’ diversi stadji fiżiko- kimiċi.
The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.
L- HBsAg jinbidel spontanjament, mingħajr trattament kimiku, f’ partiċelli sferiċi ta ’ dijametru medju ta ’ 20 nm, li fihom polipeptide ta ’ l- HBsAg mhux glikosilat u matriċi lipidu li hu magħmul l- aktar minn fosfolipidi.
Extensive tests have demonstrated that these particles display the characteristic properties of the natural HBsAg.
Testijiet estensivi wrew li dawn il- partiċelli juru l- kwalitajiet karatteristiċi ta ’ l- HBsAg naturali.
Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first six months of life.
Erba ’ skedi differenti ġew studjati (6- 10- 14- il ġimgħa, 2- 4- 6 xhur; 3- 4- 5 xhur u 3- 4½- 6 xhur) skond il - prattiċi ta ’ tilqim ta ’ rutina f’ pajjiżi differenti bi tliet dożi mogħtija fl- ewwel sitt xhur mit- twelid.
For each component of the vaccine, the following immune responses have been documented one month after completion of the primary vaccination schedule.
Għal kull komponent tal- vaċċin, ir- risponsi immuni li ġejjin ġew dokumentati xahar wara li tlestiet l- iskeda ta ’ tilqim primarju.
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Tritanrix HepB:
Persentaġġ ta ’ individwi b’ titri ta ’ antikorpi ≥ mill- punt tal- waqfa ta ’ l- analiżi, xahar wara t- tilqim primarju b’ Tritanrix HepB:
Antibody (cut-off)
– il- ġimgħa
6-10-14 weeks%
2- 4- 6 xhur; 3- 4- 5 xhur u 3 -
2-4-6 months; 3-4-5 months and 3-4½-6 months%
4½- 6 xhur%
Anti-diphtheria (0.1 IU/ ml) †
Kontra d- difterite (0. 1 UI/ ml) †
93.1
93. 1
Anti-tetanus (0.1 IU/ ml) †
Kontra t- tetnu (0. 1 UI/ ml) †
Pertussis (vaccine response) ††
Kontra l- B. pertussis (rispons tal- vaċċin) ††
97.2
97. 2
97.7
97. 7
Anti-HBs (10 mIU/ ml) †
Kontra l- HBs (10 mUI/ ml) †
97.7*
97. 7 *
* in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres ≥ 10 mIU/ ml † cut-off accepted as indicative of protection †† vaccine response:% of subjects considered to have responded to the Bordetella pertussis antigen
* f’ sottogrupp ta ’ trabi li ma ngħatalhomx il- vaċċin ta ’ l- epatite B mat- twelid, 89. 9% ta ’ l- individwi kellhom titri ≥10 mUI/ ml kontra l- HBs. † il- punt tal- waqfa aċċettat bħala wieħed li juri protezzjoni †† rispons tal- vaċċin:% ta ’ l- individwi kkunsidrati li rrispondew għall- antiġen tal- Bordetella pertussis
Non-clinical data reveal no special hazard for humans based on general safety studies.
Informazzjoni li m’ hijiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, ma turi l - ebda periklu speċjali għall- bnedmin.
7 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
Thiomersal Sodium chloride Water for injections
Thiomersal Sodium chloride Ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra, ħlief dawk imsemmija f ’ sezzjoni 6. 6.
Store in the original package, in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
0.5 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl) – pack size of 1.
0. 5 ml ta ’ suspensjoni fi fjala (ħġieġ tat- tip I) magħluqa bi planġer (lastku butyl) - pakkett bi fjala waħda.
Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).
Tritanrix HepB jista ’ jitħallat mal- vaċċin lajofilizzat Hib (Hiberix).
Upon storage, a white deposit and clear supernatant can be observed.
Meta jinħażen, jista ’ jiġi osservat depożitu abjad b’ saff likwidu ċar bla kulur fil- wiċċ.
The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin għandu jitħawwad sewwa biex tinkiseb suspensjoni uniformi, bajda u imdardra u għandu jiġi mifli viżwalment għal xi frak u/ jew dehra fiżika mhux normali qabel ma jiġi amministrat.
In the event of either being observed, discard the vaccine.
F’ każ li xi waħda minn dawn tiġi osservata, armi l- vaċċin.
Any unused product of waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 B- 1330 Rixensart, Il- Belġju
19 July 1996.
19 ta ’ Lulju 1996.
8 Date of latest renewal:
Data ta ’ l- aħħar tiġdid:
19 July 2006.
19 ta ’ Lulju 2006.
Tritanrix HepB, suspension for injection, multidose Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB, suspensjoni għall- injezzjoni, ħafna dożi Vaċċin (adsorbit) tad- difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV).
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen2,3 1
Toxoid tad- difterite1 Toxoid tat- tetnu1 Bordetella pertussis (inattivat) 2 Antiġen tal- wiċċ ta ’ l- epatite B 2, 3 1 Adsorbit fuq aluminium hydroxide idratat 2 Adsorbit fuq aluminium phosphate 3
This is a multidose container.
Dan huwa kontenitur b’ ħafna dożi.
See section 6.5 for the number of doses per vial.
Ara sezzjoni 6. 5 għan- numru ta ’ dożi li fiha kull fjala.
10 In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified.
10 Fil- każ ta ’ trabi mwielda minn ommijiet magħrufa li huma ġarriera ta ’ l- HBV, il- miżuri immunoprofilattiċi għall- epatite B, m’ għandhomx jinbidlu.
Booster vaccination:
Tilqim ta ’ rinforz:
It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered subcutaneously (see section 4.4.).
Huwa rakommandat li fil- pazjenti b’ tromboċitopenja jew disturbi tal- fsada, il- vaċċin jingħata taħt il- ġilda (ara sezzjoni 4. 4).
11 A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
11 Storja ta ’ aċċessjonijiet bid- deni, storja fil- familja ta ’ aċċessjonijiet, storja fil- familja ta ’ SIDS (Sindrome ta ’ Mewt f’ Daqqa fit- Trabi), u storja medika ta ’ effett avvers wara tilqim b’ Tritanrix HepB, m’ humiex kontra- indikazzjonijiet.
HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination.
Infezzjoni ta ’ l- HIV m’ hijiex meqjusa bħala kontra- indikazzjoni għat- tilqim kontra d- difterite, tetnu, pertussis u l- HBV.
4.5 Interaction with other medicinal products and other forms of interaction
Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott mediċinali u affarjiet oħra li 4. 5 jistgħu jibdlu l- effett farmaċewtiku tal- prodott
(see section 6.2.).
F’ dawn l- istudji, r- rispons immuni għall- vaċċin orali tal- poljo ma ġiex investigat, madankollu, esperjenza preċedenti b’ amministrazzjoni tal- vaċċini DTP, OPV u HBV f’ daqqa, ma wrietx li kien hemm xi interferenza F’ xi studji kliniċi, Tritanrix HepB intuża biex jiġi rikostitwit il- vaċċin lajofilizzat Hib (Hiberix); l- ebda interferenza fir- rispons immuni għall- kwalukwe wieħed mill- antiġeni ma ġie osservat meta mqabbel mar- risponsi li ġew osservati wara li ngħataw vaċċini f’ postijiet differenti tal- ġisem (ara sezzjoni 6. 2).
12 General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed below.
12 Reazzjonijiet ġenerali, li jistgħu jiġru fl- istess żmien meta jsir tilqim bil- vaċċin Tritanrix HepB huma elenkati hawn taħt.
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000) Not known (cannot be estimated from the available data)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 sa < 1/ 10) Mhux komuni (≥1/ 1, 000 sa < 1/ 100) Rari (≥1/ 10, 000 sa < 1/ 1, 000) Rari ħafna (< 1/ 10, 000) Mhux magħruf (ma tistax tittieħed stima mit- tagħrif disponibbli)
Nervous system disorders: very common: drowsiness
Disurbi fis- sistema nervuża: komuni ħafna: ħeddla
Respiratory, thoracic and mediastinal disorders: common: bronchitis uncommon: respiratory disorder
Disturbi respiratorji, toraċiċi u medjastinali: komuni: bronkite mhux komuni: disturb respiratorju
13 In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine.
13 Fi studju prospettiv kumparattiv, li qabbel l- amministrazzjoni tal- vaċċin kombinat DTPw HBV ma ’ l - amministrazzjoni separata iżda fl- istess ħin tal- vaċċin DTPw u HBV, ġiet irrappurtata inċidenza ogħla ta ’ uġigħ, ħmura, nefħa u deni fil- grupp li ħadu il- vaċċin kombinat.
Redness Total > 2cm Swelling Total > 2cm
Total > 2ċm
38.9 9.1 30.9 10.9
Total > 2ċm
27.1 3.4 21.5 3.4
30. 9 10. 9
5.1 0.6 4.5 0.6
21. 5 3. 4
Collapse or shock-like state (hypotonic-hyporesponsive episode).
Kollass u stat bħal f’ xokk (episodju ipotoniku- iporisponsiv)
14 Pharmaco-therapeutic group:
Kategorija farmakoteropewtika: vaċċini batterjali u virali kombinati, Kodiċi ATC:
15 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
1 ml of suspension in a vial (type I glass) for 2 doses with a plunger stopper (rubber butyl) – pack size of 1.
1 ml ta ’ suspensjoni fi fjala (ħġieġ tat- tip I) għal 2 dożi magħluqa bi planġer (lastku butyl) - pakkett bi fjala waħda.
5 ml of suspension in a vial (type I glass) for 10 doses with a plunger stopper (rubber butyl) – pack size of 1.
5 ml ta ’ suspensjoni fi fjala (ħġieġ tat- tip I) għal 10 dożi magħluqa bi planġer (lastku butyl) - pakkett bi fjala waħda.
Not all pack-sizes may be marketed
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
When using a multidose vial, each dose should be taken with a sterile needle and syringe.
Meta tkun qed tuża fjala b’ ħafna dożi, kull doża għandha tinġibed b’ labra u siringa sterili.
As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
Bħal f’ kull vaċċin ieħor, id- doża tal- vaċċin għandha tinġibed f’ kundizzjonijiet mhux settiċi u għandhom jittieħdu prekawzjonijiet biex jiġi evitat l- ikkontaminar tal- kontenut.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
18 A MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
The Marketing Authorisation Holder will continue to submit Periodic Safety Update Reports on a 2 years basis.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq se jkompli jissottometti Rapporti Perjodiċi Aġġornati ta ’ Sigurtà kull sentejn.
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA FJALA B’ DOŻA WAĦDA
Tritanrix HepB – Suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB - Suspensjoni għall- injezzjoni, Vaċċin (adsorbit) tad- difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV)
1 dose (0.5 ml):
Doża waħda (0. 5 ml):
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen2,3 1
Toxoid tad- difterite1 Toxoid tat- tetnu1 Bordetella pertussis (inattivat) 2 Antiġen tal- wiċċ ta ’ l- epatite B2, 3 1
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
0. 26 mgAl3+ adsorbit fuq aluminium hydroxide, idratat 2 0. 37 mg Al3+ adsorbit fuq aluminium phosphate 3 manifatturat f’ ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA
1 vial 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Fjala waħda Doża waħda (0. 5 ml)
Read the package leaflet before use intramuscular use Shake before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu. użu għal ġol- muskoli Ħawwad sew qabel l- użu
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN