qanastek/EMEA-V3 huggingface dataset:
► The risk of having certain side effects may be increased in the following circumstances:
► Ir- riskju li jkollok ċerti effetti sekondarji jista ’ jiżdied fiċ- ċirkustanzi li ġejjin:
you are overweight, you are elderly, you have diabetes, you have been bedridden for a longer time, you have or have already had problems with your blood vessels (vascular diseases or blockage of a vessel),
jekk għandek piż żejjed, jekk inti anzjan, jekk għandek id- dijabete, jekk tkun ilek fis- sodda minħabba l- mard għal żmien twil, jekk għandek jew diġà kellek problemi bil- vini/ arterji tad- demm (mard vaskulari jew imblukkar ta ’ xi vina/ arterja),
you have or have already had kidney problems, you have a high blood pressure, you blood volume is too low (hypovolaemia), you suffer from a disease which causes your blood to thicken, you suffer from an increased tendency for blood clotting (thrombophilia),
jekk għandek jew diġà kellek problemi fil- kliewi, jekk għandek pressjoni tad- demm għolja, jekk il- volum tad- demm tiegħek hu baxx wisq (ipovolemija), jekk tbati minn marda li tikkawża li d- demm tiegħek jeħxien, jekk tbati minn żieda fit- tendenza għal emboli fid- demm (trombofilja), 22
you suffer from a condition that causes low antibody levels in your blood (hypogammaglobulinaemia or agammaglobulinaemia),
jekk tbati minn kundizzjoni li tikkawża livelli baxxi ta ’ antikorpi fid- demm tiegħek (ipogammaglobulinemija jew agammaglobulinemija),
you suffer from a kidney disease, you are taking medicines that can damage your kidneys (nephrotoxic medicines), you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
jekk tbati minn mard tal- kliewi, jekk qed tieħu mediċini li jistgħu jagħmlu ħsara lill- kliewi (mediċini nefrotossiċi), qed tirċievi Privigen għall- ewwel darba jew wara intervall twil fil- kura (eż. diversi xhur).
Please tell your doctor or health care professional prior to treatment if at least one of these circumstances applies to you.
Jekk jogħġbok għid lit- tabib tiegħek jew lill- professjonist fil- qasam tal- kura tas- saħħa qabel il- kura jekk mill- inqas waħda minn dawn iċ- ċirkustanzi tapplika għalik.
Your doctor will then choose the right intravenous immunoglobulin for you and will take special precautions.
It- tabib tiegħek imbagħad ser jagħżel l- immunoglobulina li tingħata ġol- vini li tkun adattata għalik, u ser jieħu prekawzjonijiet speċjali.
► You may be allergic (hypersensitive) to immunoglobulins (antibodies) without knowing it.
► Tista ’ tkun allerġiku/ a (tbati minn sensittività eċċessiva) għal immunoglobulini (antikorpi) mingħajr ma tkun taf.
This may occur even if you have previously received human immunoglobulins and had tolerated them well.
Dan jista ’ jseħħ anki jekk fil- passat tkun irċevejt immunoglobulini umani u kont ittollerajthom tajjeb.
It may happen particularly if you do not have enough immunoglobulins of the type IgA in your blood.
Jista ’ jseħħ partikularment jekk ma jkollokx biżżejjed immunoglobulini tat- tip IgA fid - demm.
In these rare cases allergic reactions such as a sudden fall in blood pressure or shock may occur.
F’ dawn il- każijiet rari, reazzjonijiet allerġiċi bħal tnaqqis għal għarrieda fil- pressjoni tad- demm jew xokk, jistgħu jseħħu.
If you notice such reactions during the infusion of Privigen, please tell your doctor immediately.
Jekk tinnota reazzjonijiet bħal dawn matul l- infużjoni ta ’ Privigen, jekk jogħġbok għid lit- tabib tiegħek immedjatament.
He will decide whether to slow down the infusion rate or whether to abort the infusion completely.
Hu ser jiddeċiedi jekk ibaxxix ir- rata ta ’ l - infużjoni, jew jekk iwaqqafx l- infużjoni kompletament.
For your personal safety the treatment with Privigen will take place under the supervision of your doctor or health care professional.
Għas- sigurtà personali tiegħek, il- kura bi Privigen ser issir taħt is- superviżjoni tat- tabib tiegħek jew ta ’ professjonist fil- qasam tal- kura tas- saħħa.
You will usually be observed during the whole infusion and for at least 20 minutes thereafter.
Normalment, int ser tkun osservat mill- qrib matul l - infużjoni kollha u għal mill- inqas 20 minuta wara.
In certain circumstances, special precautions may be necessary.
F’ ċerti ċirkustanzi, jista ’ jkun hemm bżonn ta ’ prekawzjonijiet speċjali.
Examples of such circumstances are: ● you are receiving Privigen at a high infusion rate or ● you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
Eżempji ta ’ ċirkustanzi bħal dawn huma: ● jekk qed tirċievi Privigen b’ rata għolja ta ’ infużjoni jew ● qed tirċievi Privigen għall- ewwel darba jew wara intervall twil fil- kura (eż. diversi xhur).
In these cases you will be closely observed during the whole infusion and for at least 1 hour thereafter.
F’ dawn il- każijiet, inti ser tkun osservat mill- qrib matul l- infużjoni kollha u għal mill- inqas siegħa wara dak il- perijodu.
Information on the starting material of Privigen Privigen is made from human blood plasma (this is the liquid part of the blood).
Informazzjoni dwar il- materjal tal- bidu ta ’ Privigen Privigen hu magħmul minn plażma tad- demm uman (din hi l- parti likwida tad- demm).
These include ● careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and ● the testing of each donation and pools of plasma for signs of virus/infections.
Dawn jinkludu ● l- għażla bir- reqqa ta ’ donaturi tad- demm u tal- plażma, biex ikun żgurat li dawk li qegħdin f’ riskju li jkollhom infezzjonijiet ikunu esklużi, u ● l- ittestjar ta ’ kull għotja u taħlita ta ’ plażma minn donaturi differenti għal sinjali ta ’ virus/ infezzjonijiet.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Il- manifatturi ta ’ dawn il- prodotti jinkludu wkoll miżuri fl- ipproċessar tad- demm jew tal- plażma, li jistgħu jgħaxxu jew ineħħu l- viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Minkejja dawn il- miżuri, meta l- mediċini ppreparati minn demm jew plażma umana jingħataw, il- possibbiltà li tgħaddi xi infezzjoni ma tistax tiġi eskluża għal kollox.
This also applies to any unknown or emerging viruses and other types of infections.
Dan japplika wkoll għal kwalunkwe viruses mhux magħrufa jew ġodda, u għal tipi oħrajn ta ’ infezzjonijiet.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and B19 viruses.
Il- miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses enveloped bħall- virus ta ’ l - immunodefiċjenza umana, il- virus ta ’ l- epatite B u l- virus ta ’ l- epatite Ċ u għall- viruses non- enveloped ta ’ l- epatite A u l- viruses B19.
Immunoglobulins like Privigen have not been associated with hepatitis A or B19 infections.
Immunoglobulini bħal Privigen ma kinux assoċjati ma ’ infezzjonijiet ta ’ epatite A jew B19.
These antibodies may help prevent hepatitis A or B19 infections.
Dan hu possibbilment minħabba li l- antikorpi kontra dawn l- infezzjonijiet huma preżenti wkoll fl - immunoglobulini.
► It is strongly recommended that every time you receive a dose of Privigen the name and batch number of the product are recorded in order to maintain a record of the batches used.
Dawn l- antikorpi jistgħu jgħinu fil- prevenzjoni ta ’ infezzjonijiet ta ’ epatite A jew B19. ► Hu rrakkomandat bil- qawwa li kull darba li tingħata doża ta ’ Privigen, l- isem u n- numru tal - lott tal- prodott ikunu rreġistrati, sabiex jinżamm rekord tal- lottijiet li jintużaw.
Taking Privigen with other medicines
Meta tieħu Privigen ma ’ mediċini oħra
Please tell your doctor or health care professional prior to treatment
23 Jekk jogħġbok għid lit- tabib tiegħek jew lill- professjonist fil- qasam tal- kura tas- saħħa qabel il - kura
if you are currently taking any other medicines or if you have recently taken any other medicines.
jekk inti bħalissa qed tieħu xi mediċini oħra jew jekk dan l- aħħar ħadt xi mediċini oħrajn.
This also includes non-prescription medicines.
Dan jinkludi wkoll mediċini li jinkisbu mingħajr riċetta.
22 Vaccinations After receiving Privigen, the efficacy of certain vaccinations may be impaired.
Tilqim Wara li tirċievi Privigen, l- effikaċja ta ’ ċertu tilqim tista ’ tonqos.
Affected are vaccinations with live attenuated virus vaccines such as vaccinations against measles, mumps, rubella and varicella.
It- tilqim affettwat hu tilqim b’ virus ħaj attenwat, bħal tilqim kontra l- ħosba, il- gattone, il- ħosba Ġermaniża u l- ġidri r- riħ.
Such vaccinations should be postponed for at least 3 months after the last infusion of Privigen.
Dan it- tilqim għandu jkun pospost għal mill- inqas 3 xhur wara l- aħħar infużjoni ta ’ Privigen.
In the case of measles vaccinations the impairment may persist for up to one year.
Fil- każ tat- tilqim kontra l- ħosba, dan in- nuqqas ta ’ effikaċja jista ’ jippersisti sa sena.
Therefore your vaccinating doctor should check the efficacy of the measles vaccination.
Għalhekk it- tabib li ser jagħtik it - tilqima għandu jiċċekkja l- effikaċja tat- tilqima tal- ħosba.
Please tell your vaccinating doctor prior to a vaccination about your treatment with Privigen.
Jekk jogħġbok għid lit- tabib li ser jagħtik it- tilqima dwar il- kura tiegħek bi Privigen.
Blood tests After receiving Privigen, the results of certain blood tests (serological tests) may be impaired for a certain time.
Testijiet tad- demm Wara li tirċievi Privigen, ir- riżultati ta ’ ċerti testijiet tad- demm (testijiet serologiċi) jistgħu ma jkunux tajbin għal ċertu żmien.
Please tell your doctor about your treatment with Privigen prior to any blood test.
Jekk jogħġbok għid lit- tabib tiegħek dwar il- kura tiegħek bi Privigen qabel xi test tad- demm.
Please tell your doctor or health care professional if you are pregnant or breast-feeding.
Jekk jogħġbok għid lit- tabib tiegħek jew lill- professjonist fil- qasam tal- kura tas- saħħa jekk inti tqila jew qed tredda ’.
Your doctor will decide whether you can receive Privigen during your pregnancy or while you are breast-feeding.
It- tabib tiegħek ser jiddeċiedi jekk inti tistax tirċievi Privigen matul it - tqala jew waqt li tkun qed tredda ’.
The use of Privigen in pregnant or breast-feeding women has not been studied separately.
L- użu ta ’ Privigen f’ nisa tqal jew li qed ireddgħu ma kienx studjat separatament.
Nevertheless, medicines containing antibodies have been used in pregnant or breast-feeding women.
Madankollu, mediċini li fihom l- antikorpi, intużaw f’ nisa tqal jew li kienu qed ireddgħu.
The long-time experience showed that no harmful effects on the course of the pregnancy or the newborn are to be expected.
L- esperjenza fuq tul ta ’ żmien uriet li mhuma mistennija l- ebda effetti li jagħmlu ħsara matul it- tqala jew lit- tarbija tat- twelid.
If you receive Privigen while you are breast-feeding the antibodies in th is medicine will also be found in the breast milk.
Jekk tirċievi Privigen waqt li tkun qed tredda ’, l- antikorpi f’ din il- mediċina ser jgħaddu fil- ħalib tas - sider.
Thus also your baby can receive the protecting antibodies.
Għaldaqstant, it- tarbija tiegħek tista ’ tirċievi wkoll dawn l- antikorpi li jipproteġu.
No effects of Privigen on the ability to drive and use machines are expected.
L- ebda effetti ta ’ Privigen fuq il- ħila biex issuq u tuża l- magni mhuma mistennija.
HOW TO USE PRIVIGEN
KIF TUŻA PRIVIGEN
► Privigen is usually administered by your doctor or health care professional. ► Privigen is intended solely for the infusion into a vein (intravenous infusion). ► Your doctor decides how much Privigen you will receive.
► Privigen normalment jingħata mit- tabib tiegħek jew minn professjonist fil- qasam tal- kura tas - saħħa. ► Privigen hu intenzjonat biss għall- infużjoni ġo vina (infużjoni intravenuża). ► It- tabib tiegħek ser jiddeċiedi kemm jagħtik Privigen.
The amount depends on your illness, your present condition and your body weight. ► At the beginning of the infusion you will receive Privigen at a slow infusion rate.
L- ammont jiddependi fuq il- marda tiegħek, il- kundizzjoni preżenti tiegħek u fuq il- piż ta ’ ġismek. ► Fil- bidu ta ’ l- infużjoni, inti ser tirċievi Privigen b’ rata baxxa ta ’ infużjoni.
If you tolerate this well your doctor can gradually increase the infusion rate.
Jekk inti tittolleraha tajjeb, it- tabib tiegħek jista ’ jżid bil- mod ir- rata ta ’ l- infużjoni.
If you receive more Privigen than you should
Jekk tieħu Privigen aktar milli suppost
Privigen is usually administered under medical supervision only.
Privigen normalment jingħata taħt superviżjoni medika biss.
Overdose is therefore very unlikely to occur.
Għalhekk, hemm possibbiltà remota ħafna li doża eċċessiva tista ’ sseħħ.
If, in spite of this, you receive more Privigen than you should, your blood may become too thick (hyperviscous).
Jekk, minkejja dan, int tirċievi iktar Privigen milli suppost, id - demm tiegħek jista ’ jsir aktar magħqud (isir iperviskuż).
This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a kidney disease.
Dan jista ’ jseħħ partikularment jekk inti pazjent li qiegħed f’ riskju, per eżempju jekk inti anzjan jew jekk tbati minn mard tal- kliewi.
Like all medicines, Privigen can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Privigen jista ’ jkollu effetti sekondarji, għalkemm mhux fuq kulħadd.
► You may be allergic (hypersensitive) to immunoglobulins (antibodies) and allergic reactions such as a sudden fall in blood pressure or shock may occur.
24 ► Inti tista ’ tkun allerġiku/ a (tbati minn sensittività eċċessiva) għal immunoglobulini (antikorpi) u reazzjonijiet allerġiċi bħal tnaqqis għal għarrieda fil- pressjoni tad- demm jew xokk jistgħu jseħħu.
23 Please see also section 2 of this leaflet about the risk of allergic reactions.
Jekk jogħġbok ara wkoll sezzjoni 2 ta ’ dan il- fuljett dwar ir- riskju ta ’ reazzjonijiet allerġiċi.
► Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
► Effetti sekondarji possibbli jistgħu jitnaqqsu jew anki jkunu evitati jekk l- infużjoni ta ’ Privigen tingħata b’ rata baxxa.
The general experience with immunoglobulin preparations showed that the following side effects may occur: ● headache, ● chills, ● fever, ● vomiting, ● mild hypersensitivity reactions (allergic reactions), ● nausea, ● pain in the joints (arthralgia), ● low blood pressure, ● moderate low back pain.
L- esperjenza ġenerali bi preparazzjonijiet ta ’ l- immunoglobulina wrew li jista ’ jkun hemm l- effetti sekondarji li ġejjin: ● uġigħ ta ’ ras, ● rogħda, ● deni, ● rimettar, ● reazzjonijiet ħfief ta ’ sensittività eċċessiva (reazzjonijiet allerġiċi), ● dardir, ● uġigħ fil- ġogi (artralġja), ● pressjoni tad- demm baxxa, ● uġigħ moderat fin- naħa t’ isfel tad- dahar.
In rare and isolated cases, the following side effects have also been reported with immunoglobulin preparations: ● temporary non-infectious meningitis (reversible aseptic meningitis), ● transient skin reactions, ● increase in blood creatinine level, ● acute renal failure, ● sudden fall in blood pressure, ● severe hypersensitivity reactions (anaphylactic shock), even when you have shown no hypersensitivity on previous infusions, ● formation of blood clots which may be carried off in the blood circulation (thromboembolic reactions) and which may result e.g. in:
F’ każijiet rari u iżolati, l- effetti sekondarji li ġejjin kienu rrappurtati wkoll bi preparazzjonijiet ta ’ l - immunoglobulina: ● każijiet ta ’ meninġite temporanja mhux infettiva (meninġite asettika riversibbli), ● reazzjonijiet lokali tal- ġilda li jgħaddu malajr, ● żieda fil- livell tal- krejatinina fid- demm, ● insuffiċjenza renali akuta, ● tnaqqis għal għarrieda fil- pressjoni tad- demm, ● reazzjonijiet severi ta ’ sensittività eċċessiva (xokk anafilattiku), anki jekk ma kienx hemm l - ebda sensittività eċċessiva meta ngħatajt infużjonijiet fil- passat, ● formazzjoni ta ’ emboli tad- demm li jistgħu jinġarru fiċ- ċirkolazzjoni tad- demm (reazzjonijiet tromboemboliċi), u li jistgħu jirriżultaw f ’:
myocardial infarction, stroke, lung vein blockage (pulmonary embolism), deep vein thrombosis,
infart mijokardjali, puplesija, imblukkar f’ xi vina tal- pulmun (emboliżmu pulmonari), trombożi tal- vini li ma jidhrux,
● transient decrease of red blood cells (reversible haemolytic anaemia/haemolysis).
temporanju ta ’ ċelluli ħomor tad- demm (anemija/ emolisi emolitika riversibbli).
Such side effects may occur even when you have previously received human immunoglobulins (antibodies) and had tolerated them well.
Jista ’ jkun hemm effetti sekondarji bħal dawn anki jekk fil- passat tkun irċevejt immunoglobulini umani (antikorpi) u kont ittollerajthom tajjeb.
Please tell your doctor or health care professional
Jekk jogħġbok għid lit- tabib tiegħek jew lil professjonist fil- qasam tal- kura tas- saħħa
if any of the side effects gets serious or if you notice any side effects not listed in this leaflet.
jekk kwalunkwe mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett.
HOW TO STORE PRIVIGEN
KIF TAĦŻEN PRIVIGEN
► Keep out of the reach and sight of children.
► Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Privigen after the expiry date which is stated on the outer carton and the vial label after EXP.
Tużax Privigen wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ barra u fuq it- tikketta tal- kunjett wara JIS.
► Do not store above 25 °C. ► Do not freeze. ► Keep the vial in the outer carton in order to protect from light.
25 ► Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Do not use Privigen if you notice that the solution is cloudy or has particles.
Tużax Privigen jekk tinnota li s- soluzzjoni hi mċajpra jew ikollha xi partikuli.
What Privigen contains
X’ fih Privigen
● The active substance is human normal immunoglobulin (antibodies of the type IgG).
● Is- sustanza attiva hi immunoglobulina normali umana (antikorpi tat- tip IgG).
Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG. ● The other ingredients are the amino acid L-proline and water for injections.
Privigen fih 100 mg/ ml (10%) ta ’ proteina umana, li minnha, mill- inqas 98% hi IgG. ● Is- sustanzi l- oħra huma l- amino acid L- proline u ilma għall- injezzjonijiet.
What Privigen looks like and contents of the pack
Id- dehra ta ’ Privigen u l- kontenuti tal- pakkett
Privigen is presented as a solution for infusion.
Privigen hu ppreżentat bħala soluzzjoni għall- infużjoni.
The solution is clear or slightly opalescent and colourless to pale-yellow.
Is- soluzzjoni hi ċara jew ftit opalexxenti u bla kulur sa isfar ċar.
Pack size of 1 vial (5 g/50 ml, 10 g/100 ml or 20 g/200 ml).
Daqs tal- pakkett ta ’ 1 kunjett (5 g/ 50 ml, 10 g/ 100 ml jew 20 g/ 200 ml).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Luxembourg/Luxemburg CSL Behring NV Technologielaan 13 B-3001 Leuven Tél/Tel: +32 16 38 80 80
Luxembourg/ Luxemburg CSL Behring NV Technologielaan 13 B- 3001 Leuven België Tél/ Tel: +32 16 38 80 80
Mangion Buildings New Street in Valletta Road MT-LQA 6000 Luqa Tel: +356 2397 6000
Mangion Buildings New Street in Valletta Road MT - LQA 06 Luqa, LQA 6000 – MT Tel: +356 2397 6000
Danmark CSL Behring ApS Lyngby Hovedgade 70B, 1.tv DK-2800 Kgs.
Lyngby
Lyngby Tlf: +45 4520 1420
Danmark Tlf: +45 4520 1420
Nederland CSL Behring NV Claudius Prinsenlaan 128 NL-4818 CP Breda Tel: + 31 76 523 6045
Nederland Tel: + 31 76 523 6045
Norge CSL Behring AB P.O.Box 712 S-182 17 Danderyd
Norge CSL Behring AB P. O. Box 712 S- 182 17 Danderyd Sverige Tlf: +46 8 544 966 70
Eesti CSL Behring AB P.O.Box 712 S-182 17 Danderyd Tel: +46 8 544 966 70
Eesti Österreich CSL Behring AB P. O. Box 712 S- 182 17 Danderyd Rootsi Tel: +46 8 544 966 70
România Prisum International Trading srl Strada Agatha Bârsescu 15B Sector 3 Bucureşti 031481 – RO Tel: +40 21 322 0174
România Prisum International Trading srl Strada Agatha Bârsescu 15B Sector 3 Bucureşti 031481 – RO Tel:. +40 21 322 0174
Ireland CSL Behring Hayworth House, Market Place Haywards Heath RH16 1DB – UK Tel: +44 1444 447400
Ireland CSL Behring Hayworth House, Market Place Haywards Heath RH16 1DB – UK United Kingdom Tel: +44 1444 447400
Ísland CSL Behring AB P.O.Box 712 S-182 17 Danderyd Sími: +46 8 544 966 70
Ísland CSL Behring AB P. O. Box 712 S- 182 17 Danderyd Svíþjóð Sími: +46 8 544 966 70
Trnavská cesta 112 SK-821 01 Bratislava Tel: +421 2 4820 95 11
Trnavská cesta 112 SK- 821 01 Bratislava Tel.: +421 2 4820 95 11
P.le Stefano Türr, 5 I-20149 Milano Tel: +39 02 34964 200
P. le Stefano Türr, 5 IT- 20149 Milano Tel: +39 02 34964 200
Suomi/Finland CSL Behring AB P.O.Box 712 S-182 17 Danderyd Puh/Tel: +46 8 544 966 70
Suomi/ Finland CSL Behring AB P. O. Box 712 S- 182 17 Danderyd Ruotsi Puh/ Tel: +46 8 544 966 70
Latvija CSL Behring AB P.O.Box 712 S-182 17 Danderyd Tel: +46 8 544 966 70
Latvija CSL Behring AB P. O. Box 712 S- 182 17 Danderyd Zviedrija Tel: +46 8 544 966 70
Lietuva CSL Behring AB P.O.Box 712 S-182 17 Danderyd Tel: +46 8 544 966 70
Lietuva CSL Behring AB P. O. Box 712 S- 182 17 Danderyd Švedija Tel: +46 8 544 966 70
This leaflet was last approved in 04/2008.
Dan il- fuljett kien approvat l- aħħar fi 04/ 2008.
--------------------------------------------------------------------------------------------------------------------------- ------- The following information is intended for medical or healthcare professionals only:
--------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
What is PROCOMVAX?
X’ inhu PROCOMVAX?
PROCOMVAX is a vaccine, which is available as a suspension for injection.
PROCOMVAX huwa vaċċin, li jiġi bħala sospensjoni għall- inezzjoni.
It contains proteins from Haemophilus influenzae type b (‘ Hib’, a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances.
Fih proteini mill- Haemophilus influenzae tip b (‘ Hib ’, batterju li jista ’ jikkawża l- meninġite) u partijiet mill- virus ta ’ l- epatite B bħala sustanzi attivi.
What is PROCOMVAX used for?
Għalxiex jintuża PROCOMVAX?
PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘ invasive’ disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus.
PROCOMVAX jintuża fit- tlaqqim ta ’ tfal żgħar li jkollhom bejn sitt ġimgħat u 15- il xahar kontra l - mard ‘ invażiv ’ ikkawżat mill- Hib (bħall- meninġite batterika) u l- infezzjoni bil- virus ta ’ l- epatite B.
How is PROCOMVAX used?
Kif jintuża PROCOMVAX?
The vaccination schedule is three doses of PROCOMVAX, ideally at two, four, and 12 to 15 months of age.
L- iskeda ta ’ tilqim hija ta ’ tliet dożi ta ’ PROCOMVAX, idealment meta t- tfal ikollhom xahrejn, erba ’ xhur, u bejn 12 u 15- il xahar.
Children who receive one dose of a hepatitis B vaccine at or shortly after birth can be given PROCOMVAX.
It- tfal li jingħataw doża waħda tat- tilqima ta ’ l- epatite B mat- twelid jew ftit wara jistgħu jingħataw PROCOMVAX.
The vaccine must only be given by injection into a muscle.
It- tilqima tista ’ tingħata biss b’ injezzjoni fil- muskolu.
How does PROCOMVAX work?
Kif jaħdem PROCOMVAX?
PROCOMVAX is a vaccine.
PROCOMVAX huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tipproteġi ruħha kontra l- mard.
PROCOMVAX contains small amounts of: • a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of the bacterium Neisseria meningitidis); • surface antigen (proteins from the surface) of the hepatitis B virus.
PROCOMVAX fih ammonti żgħar ta ’: • proteina ppurifikata mill- Hib, imwaħħla ma ’ carrier (proteina ppurifikata mill- membrana ta ’ barra tal- batterju Neisseria meningitidis); • antiġenu tas- superfiċje (proteini mill- wiċċ) tal- virus ta ’ l- epatite B.
These 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.
Dawn jiġu prodotti b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: isir minn batterju li jkun irċieva ġene (DNA), li jagħmilha kapaċi tipproduċi t- tossin.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Meta tifel żgħir jingħata t- tilqima, is- sistema immunitarja tagħraf il- partijiet tal- batterji u l- vajrusis bħala ‘ barranin ’ u tagħmel antikorpi kontrihom.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Is- sistema immunitarja mbagħad tkun tista ’ tipproduċi antikorpi iktar malajr meta l- persuna tiġi naturalment esposta għall- batterji u l- vajrusis.
This helps to protect against the diseases that these bacteria and viruses cause.
Dan jgħin fil - protezzjoni kontra l- mardiet li jikkawżaw dawn il- batterji u l- vajrusis.
The active substances are ‘ adsorbed’, meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘ adjuvant’ (a compound containing aluminium) to stimulate a better response.
Is- sustanzi attivi huma ‘ adsorbiti ’, jiġifieri jeħlu ma ’ komposti ta ’ l- aluminju, u l- vaċċin ikun fih ‘ adjuvant ’ (kompost li jkun fih l- aluminju) biex jistimula rispons aħjar.
PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years.
PROCOMVAX huwa kombinazzjoni ta ’ komponenti li ilhom disponibbli fl- Unjoni Ewropea (UE) f’ vaċċini oħra għal ħafna snin.
How has PROCOMVAX been studied?
Kif ġie studjat PROCOMVAX?
PROCOMVAX has been studied in one main study involving 882 infants.
PROCOMVAX ġie studjat fi studju wieħed ewlieni li fih ħadu sehem 882 tifel u tifla żgħar.
The study compared the effects of PROCOMVAX with those of separate vaccines containing the same active substances.
L- istudju qabbel l- effetti ta ’ PROCOMVAX ma ’ dawk ta ’ vaċċini separati li fihom l- istess sustanzi attivi.
In both groups, the infants were vaccinated at two, four, and 12 to 15 months of age.
Fiż - żewġ gruppi, it- tfal tlaqqmu fl- età ta ’ xahrejn, erba ’ xhur, u bejn 12 u 15- il xahar.
The main measure of effectiveness whether protective levels of antibodies to Hib and hepatitis B virus had developed at one and two months after vaccination.
Il- mezz ewlieni tal - kejl ta ’ l- effettività kien jekk il- livelli ta ’ protezzjoni ta ’ l- antikorpi għall- Hib u virus ta ’ l- epatite B kinux żviluppati xahar u xahrejn wara t- tilqima.
The results of further studies were used to support the use of PROCOMVAX, both in infants who had and who had not received hepatitis B vaccination in the past.
Ir- riżultati ta ’ studji oħra ntużaw b’ appoġġ għall- użu ta ’ PROCOMVAX, kemm fit- tfal żgħar li kienu ngħataw it- tilqima ta ’ l- epatite B fl- imgħoddi kif ukoll f’ dawk li ma kinux.
What benefit has PROCOMVAX shown during the studies?
Liema benefiċċju wera PROCOMVAX waqt l- istudji mwettqa?
In the main study, the responses both to PROCOMVAX and to the separate vaccines were low in terms of levels of antibodies against Hib.
Fl- istudju ewlieni, ir- rispons kemm għal PROCOMVAX kif ukoll għall- vaċċini separati kienu baxxi f’ termini ta ’ antikorpi kontra l- Hib.
However, the company provided further information from other studies to show that three doses of PROCOMVAX produced adequate levels of protection.
Madankollu, il- kumpanija pprovdiet iktar tagħrif minn studji oħra biex turi li tliet dożi ta ’ PROCOMVAX ipproduċew livelli adegwati ta ’ protezzjoni.
The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus.
L- istudju ewlieni wera wkoll li PROCOMVAX ipproduċa livelli adegwati ta ’ protezzjoni kontra l - virus ta ’ l- epatite B.
This conclusion was confirmed with the results from seven additional studies supplied by the company.
Din il- konklużjoni ġiet ikkonfermata mar- riżultati minn seba ’ studji addizzjonali fornuti mill- kumpanija.
The additional studies showed that protection against hepatitis B from PROCOMVAX was adequate in infants who had and who had not received hepatitis B vaccination in the past.
L- istudji addizzjonali wrew li l- protezzjoni kontra l- epatite B minn PROCOMVAX kienet adegwata fit- tfal żgħar li kienu jew ma kinux ingħataw it- tilqima ta ’ l- epatite B fl- imgħoddi.
What is the risk associated with PROCOMVAX?
X’ inhu r- riskju assoċjat ma ’ PROCOMVAX?
The most common side effects seen with PROCOMVAX are reactions at the injection site, including pain, soreness, erythema (redness) and swelling.
L- iktar effetti sekondarji komuni li dehru bi PROCOMVAX huma reazzjonijiet fis- sit ta ’ l- injezzjoni, inkluż uġigħ, sliħ, ħmura u nefħa.
Other common side effects are fever, anorexia (loss of appetite), vomiting, diarrhoea, irritability, somnolence (sleepiness), crying (including unusual high- pitched crying and prolonged crying) and otitis media (infection of the middle ear).
Effetti sekondarji oħra huma d- deni, l- anoressija (nuqqas ta ’ aptit), remettar, dijarea, irritabilità, somnolenza (ħafna ngħas), biki (inkluż biki werżieqi u fit- tul), u infezzjonijiet fil- parti nofsanija tal- widna.
For the full list of all side effects reported with PROCOMVAX, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati ma ’ PROCOMVAX, ara l- Fuljett ta ’ Tagħrif.
PROCOMVAX should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
PROCOMVAX m’ għandux jintuża fi tfal li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal xi sustanzi attivi jew ingredjenti oħra tiegħu.
Infants who show signs of hypersensitivity (allergic reaction) after an injection should not receive further injections of the vaccine.
Tfal żgħar li juru sinjali ta ’ sensittività eċċessiva (reazzjoni allerġika) wara injezzjoni ma għandhomx jingħataw iktar injezzjonijiet tat- tilqima.
PROCOMVAX is not recommended for infants younger than six weeks of age, because of a risk of a reduced protective response to Hib.
PROCOMVAX mhux rakkomandat għal tfal ta ’ inqas minn sitt ġimgħat, minħabba riskju ta ’ rispons protettiv imnaqqas għall- Hib.
Vaccination with PROCOMVAX should be postponed in infants with moderate or severe sudden fever until they have recovered.
It- tilqim b’ PROCOMVAX għandu jiġi pospost fit- tfal żgħar b’ deni moderat jew sever sakemm jirkupraw.
As for all vaccines, if PROCOMVAX is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħal fil- każ tat- tilqimiet kollha, jekk PROCOMVAX jintuża fit- trabi prematuri, ikun hemm riskju li t - trabi ma jeħdux nifs għal waqtiet żgħar).
Their breathing should be monitored for up to three days after vaccination.
In- nifs tagħhom għandu jiġi sorveljat għal massimu ta ’ tlett ijiem wara t- tilqima.
Why has PROCOMVAX been approved?
Għaliex ġie approvat PROCOMVAX?
The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX’ s benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ PROCOMVAX huma ikbar mir- riskji tiegħu għat- tilqim kontra mard invażiv ikkawżat mill- Hib u kontra infezzjonijiet ikkawżati mis- subtipi kollha magħrufin tal- virus ta ’ l- epatite B fit- tfal li jkollhom bejn sitt ġimgħat u 15- il xahar.
The Committee recommended that PROCOMVAX be given marketing authorisation.
Il- Kumitat irrakkomanda li PROCOMVAX jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about PROCOMVAX:
Informazzjoni oħra dwar PROCOMVAX:
The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S. N. C. for PROCOMVAX on 7 May 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal PROCOMVAX lil Sanofi Pasteur MSD S. N. C. fis- 7 ta ’ Mejju 1999.
The marketing authorisation was renewed on 7 May 2004.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 7 ta ’ Mejju 2004.
The full EPAR for PROCOMVAX can be found here.
L- EPAR sħiħ għal PROCOMVAX jista ’ jinstab hawnhekk.
PROCOMVAX suspension for injection Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
PROCOMVAX sospensjoni għall- injezzjoni Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis B (Recombinant) Vaccine
Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC
Polyribosylribitol phosphate (PRP) minn Haemophilus influenzae tat- tip b bħala PRP- OMPC
7.5 µg
7. 5 µg
Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B)
Neisseria meningitidis OMPC (complex tal- proteina tal- membrana ta 'barra tar- razza B11 ta ’ Neisseria meningitidis sottogrupp B)
Adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)
Antiġen tal- wiċċ assorbit ta ’ l- epatite B prodott f’ ċelloli rikombinanti tal- ħmira (Saccharomyces cerevisiae)
5.0 µg
5. 0 µg
in 0.5 ml.
f’ 0. 5 ml.
For excipent, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Suspension for injection in vial.
Sospensjoni għal injezzjoni f’ kunjett.
PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.
PROCOMVAX huwa indikat għal tilqim kontra mard invażiv ikkawżat minn Haemophilus influenzae tat- tip b u kontra infezzjoni kkawżata mis- sottotipi magħrufa kollha tal- virus ta ’ l- epitite B fi trabi minn 6 ġimgħat sa 15- il xahar.
Posology Infants born of HBsAg negative mothers should be vaccinated with three 0.5ml doses of PROCOMVAX, ideally at 2, 4, and 12-15 months of age.
Pożoloġija Trabi mwielda minn ommijiet HBsAg negattivi għandhom jiġu mlaqqma bi tliet dożi ta ’ 0. 5 ml ta ’ PROCOMVAX, idealment ta ’ 2, 4, u 12 - 15– il xahar.
If the recommended schedule cannot be followed exactly, the interval between the first two doses should be approximately two months and the interval between the second and third dose should be as close as possible to eight to eleven months.
Jekk l- iskeda rakkomandata ma tkunx tista ’ tiġi segwita eżatt, l- intervall bejn l- ewwel żewġ dożi għandu jkun ta ’ madwar xahrejn u l- intervall bejn it - tieni u t- tielet doża għandu jkun kemm jista ’ jkun qrib għat- tmienja sa ħdax- il xahar.
All three doses must be administered to complete the vaccination regimen.
Iridu jingħataw it- tliet dożi biex tkun kompletata l- iskeda tat- tilqim.
Children who receive one dose of hepatitis B vaccine at or shortly after birth may be administered PROCOMVAX on the schedule of 2, 4, and 12 -15 months of age.
Tfal li jirċievu doża waħda ta ’ vaċċin kontra l- epatite B malli jitwieldu jew ftit wara t- twelid jistgħu jingħataw PROCOMVAX fuq l- iskeda ta ’ 2, 4, u 12- 15– il xahar.
Children not vaccinated according to recommended schedule Vaccination schedules for children not vaccinated according to the recommended schedule should be considered on an individual basis.
Tfal mhux imlaqqma skond l- iskeda rakkomandata L- iskedi tat- tilqim għal tfal mhux imlaqqma skond l- iskeda rakkomandata għandhom jiġu kkunsidrati fuq bażi individwali.
Method of administration FOR INTRAMUSCULAR ADMINISTRATION Do not inject intravenously, intradermally, or subcutaneously
2 Metodu ta ’ kif għandu jingħata GĦAL GĦOTI GĦAL ĠOL- MUSKOLI Tinjettax fil- vini, minn ġol- ġilda jew taħt il- ġilda
Hypersensitivity to the active substances or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi.
Individuals who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.
Individwi li jiżviluppaw sintomi li jissuġġerixxu sensittività eċċessiva wara injezzjoni m’ għandhomx jirċievu aktar injezzjonijiet tal- vaċċin.
Because of the potential for immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen) PROCOMVAX is not recommended for use in infants younger than 6 weeks of age.
Minħabba l- potenzjal ta ’ tolleranza immuni (kapaċità indebolita li individwu jirrispondi għal espożizzjoni suċċessiva għall- antiġen PRP), PROCOMVAX mhux rakkomandat sabiex jintuża fi trabi ta ’ inqas minn 6 ġimgħat.
It has been recommended that immunisation should be delayed during the course of an acute febrile illness.
Kien rakkomandat li t- tilqim jiġi pospost waqt mard akut bid- deni.
All vaccines can be administered to infants with minor illnesses such as diarrhoea or mild upper-respiratory infection.
Il- vaċċini kollha jistgħu jingħataw lil trabi li jkollhom mard minuri bħal dijarea jew infezzjoni ħafifa tal- pajp tan- nifs.
Infants with moderate or severe febrile illness should only be vaccinated as soon as they have recovered from the acute phase of the illness.
Trabi morda b' deni moderat jew sever għandhom jiġu mlaqqma biss malli jkunu rkupraw mill- fażi akuta tal- marda.
As for any vaccine, adequate treatment provisions, including adrenaline, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Bħal fil- każ ta ’ kull vaċċin ieħor, għandu jkun hemm disponibbli proviżjonijiet adegwati ta ’ kura, inkluż adrenalina, għal użu immedjat f’ każ li sseħħ reazzjoni anafilattika jew anaphylactoid.
PROCOMVAX must not be mixed with other vaccines in the same syringe.
PROCOMVAX m’ għandux jitħallat ma ’ vaċċini oħra fl- istess siringa.
Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Trabi mwielda minn ommijiet HBsAg- pożittivi għandhom jirċievu Globulina Immunitarja ta ’ Epatita B u Vaċċin kontra l- Epatite B (Rikombinanti) meta jitwieldu u għandhom ikomplu s- sensiela tat - tilqimiet kontra l- epatite B.
The subsequent administration of PROCOMVAX for completion of the hepatitis B vaccination series in infants who were born of HBsAg positive mothers and received HBIG or infants born of mothers of unknown status has not been studied.
L- għoti suċċessiv ta ’ PROCOMVAX għall- kompletar tas- sensiela ta ’ tilqimiet kontra l- epatite B fi trabi li twieldu minn ommijiet HBsAg- pożittivi u rċevew HBIG jew trabi mwielda minn ommijiet ta ’ status mhux magħruf, għadu ma ġiex studjat.
In infants with bleeding disorders such as haemophilia or thrombocytopenia, special precautions should be taken against the risk of haematoma following the injection.
Fi trabi b’ mard bi fsad bħall- emofilja jew tromboċitopenja, għandhom jittieħdu prekawzjonijiet speċjali kontra r- riskju ta ’ ematoma wara l- injezzjoni.
Since PROCOMVAX has not been studied in persons who have malignancies or are otherwise immunocompromised, the extent of the immune response in such persons is unknown.
Billi PROCOMVAX ma ġiex studjat f’ pazjenti li għandhom tumuri malinni jew li huma immunokompromessi b’ xi mod ieħor, mhix magħrufa l- miżura tar- risposta immunitarja f’ tali persuni.
PROCOMVAX will not protect against invasive disease caused by Haemophilus influenzae other than type b or against invasive disease (such as meningitis or sepsis) caused by other microorganisms.
PROCOMVAX ma jipproteġix kontra mard invażiv ikkawżat minn Haemophilus influenzae ħlief ta 'tip b jew kontra mard invażiv (bħal meninġite jew sepsis) ikkawżat minn mikro- organiżmi oħra.
PROCOMVAX will not prevent hepatitis caused by other viruses known to infect the liver.
PROCOMVAX ma jimpedixxix epatite kkawżata minn virusijiet oħra magħrufa li jinfettaw il- fwied.
Because of a long incubation period for Hepatitis B, it is possible for unrecognised infection to be present at the time the vaccine is given.
Minħabba perjodu ta ’ inkubazzjoni twil għall- Epatite B, huwa possibbli li infezzjoni mhux rikonoxxuta tkun preżenti fil- ħin meta jingħata l- vaċċin.
The vaccine may not prevent hepatitis B in such patients.
Il- vaċċin jista ’ ma jwaqqafx l- epatite B f’ tali pazjenti.
PROCOMVAX may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.
PROCOMVAX jista ’ ma jipproduċix livelli ta 'protezzjoni ta ’ anti- korpi immedjatament wara t - tilqima u jista ’ ma jirriżultax f’ risposta protettiva ta ’ anti- korpi f’ kull persuna li tingħata l- vaċċin.
As reported with Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate Vaccine, cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.
Kif irrapportat bil- Vaċċin Haemophilus b Polysaccharide u b' vaċċin ieħor Haemophilus b Conjugate, jistgħu jirriżultaw każijiet tal- marda Haemophilus b fil- ġimgħa wara t- tilqima, qabel ma jibdew l - effetti ta 'protezzjoni tal- vaċċini.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Għandu jitqies ir- riskju potenzjali ta ’ apneja kif ukoll il- ħtieġa għal monitoraġġ respiratorju għal 48- 72h meta s- serje ta ’ immunizzazzjoni primarja tingħata lil trabi prematuri ħafna (li jitwieldu ≤ 28 ġimgħa ta ’ ġestazzjoni) u b’ mod partikolari għal dawk bi storja preċedenti ta ’ immaturità
3 and Rubella Virus Vaccine Live) using separate sites and syringes for injectable vaccines.
Minħabba li l- benefiċċju ta ’ tilqima huwa wieħed kbir f’ dan il- grupp ta ’ trabi, it - tilqima ma għandhiex tinżamm jew tiddewwem.
Additionally, limited immunogenicity results from an open-labeled, controlled study indicate that PROCOMVAX may be administered concomitantly with DTaP (Diphtheria, Tetanus, and acellular Pertussis vaccine), using separate sites and syringes for injectable vaccines.
Barra minn hekk, riżultati limitati ta ’ l- immunoġeniċità minn studju kkontrollat, ta ’ tikketta mikxufa, jindikaw li PROCOMVAX jista ’ jingħata ma ’ DTaP (Difterite, Tetnu u vaċċin bla ċelloli kontra Pertussis [sogħla konvulsiva]), bl- użu ta ’ siti għall - injezzjoni u siringi separati għal vaċċini li jistgħu jiġu injettati.
Efficacy of whole cell or acellular pertussis vaccines when given concomitantly with PROCOMVAX has not been established in field trials.
L- effikaċja tal- vaċċini ta 'ċellola sħiħa jew bla ċelloli kontra s- sogħla konvulsiva meta jingħataw flimkien ma ’ PROCOMVAX ma ġietx stabbilita fi provi tal- prodott f’ sitwazzjonijiet attwali.
Not applicable.
Mhux relevanti.
For paediatric use only.
Għal użu pedjatriku biss.
In clinical trials involving the administration of 7,350 doses of PROCOMVAX to 2,993 healthy infants 6 weeks to 15 months of age, PROCOMVAX was generally well tolerated.
Fi provi kliniċi li kienu jinvolvu l- għoti ta ’ 7, 350 doża ta ’ PROCOMVAX lil 2, 993 tarbija b’ saħħitha ta ’ bejn 6 ġimgħat u 15- il xahar, PROCOMVAX ġeneralment kien ittollerat tajjeb.
Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines.
Minn dawn it- trabi, 1, 177 kienu involuti fi provi kliniċi li fihom, il- maġġoranza ngħataw PROCOMVAX flimkien ma ’ vaċċini pedjatriċi oħra lliċenzjati.
Of these, 1,110 were monitored for both serious and non-serious adverse experiences.
Minn dawn, 1, 110 kienu mmonitorjati kemm għal esperjenzi avversi serji kif ukoll mhux serji.
The remaining 1,816 infants were involved in trials where PROCOMVAX was administered concomitantly with either an investigational pneumococcal polysaccharide protein conjugate vaccine or an investigational preparation of diphtheria, tetanus, pertussis, and inactivated poliovirus vaccine and were under surveillance for serious adverse experiences.
L- 1, 816- il tarbija l- oħra kienu involuti f’ testijiet fejn PROCOMVAX ingħata flimkien ma ’ pneumococcal polysaccharide protein conjugate vaccine mhux ippruvat jew ma ’ preparazzjoni mhux ippruvata ta ’ vaċċin mhux attivat kontra d- difterite, it- tetnu, is- sogħla konvulsiva u l- virus tal- poljo u kienu taħt sorveljanza għal esperjenzi avversi serji.
Among the 2,993 children given PROCOMVAX, 33 had serious adverse experiences within 14 days of vaccination.
Fost l- 2, 993 tifel u tifla mogħtija PROCOMVAX, 33 kellhom esperjenzi avversi serji fi żmien 14 - il ġurnata mit- tilqima.
None of the serious adverse experiences was judged by the study investigator to be related to this vaccine.
L- ebda waħda mill- esperjenzi avversi serji ma ġiet ikkunsidrata mill - investigatur ta ’ l- istudju bħala relatata ma ’ dan il- vaċċin.
In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12-15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic complaints.
F’ wieħed minn dawn it- testijiet, studju b’ għażla każwali f’ aktar minn ċentru mediku wieħed, 882 tarbija ġew assenjati fi proporzjon ta ’ 3: 1 biex jirċievu jew PROCOMVAX jew Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP- OMPC Vaccine) u Merck Hepatitis B (Recombinant) Vaccine ta ’ 2, 4, u 12 - 15- il xahar, bit- tfal jiġu mmonitorjati kuljum għal ħamest ijiem wara kull injezzjoni għal reazzjonijiet lokali u disturbi sistemiċi.
Most children received DTP and OPV concomitantly with the first two doses of PROCOMVAX or Merck PRP-OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine.
Il- biċċa l- kbira tat- tfal irċevew DTP u OPV flimkien ma ’ l- ewwel żewġ dożi ta ’ PROCOMVAX jew Merck PRP- OMPC Vaccine jew Merck Hepatitis B (Recombinant) Vaccine.
Across all three doses of PROCOMVAX, there were no significant differences in the frequency of adverse experiences between PROCOMVAX and the monovalent vaccines Merck PRP- OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
Bejn it- tliet dożi ta ’ PROCOMVAX, ma kienx hemm differenzi sinifikanti fil- frekwenza ta ’ l- esperjenzi avversi bejn PROCOMVAX u l - vaċċini monovalenti Merck PRP- OMPC Vaccine u Merck Hepatitis B (Recombinant) Vaccine.
However, the frequency of irritability was statistically higher after all three injections of PROCOMVAX combined and after the first injection of PROCOMVAX compared to the monovalent vaccines.
Madankollu, il- frekwenza ta ’ l- irritabilità kienet statistikament ogħla wara t- tliet injezzjonijiet ta ’ PROCOMVAX magħqudin u wara l- ewwel injezzjoni ta ’ PROCOMVAX meta mqabbel mal- vaċċini monovalenti.
The following local reactions and systemic complaints were reported in ≥ 1.0% of children within five days after any injection of PROCOMVAX: pain/ soreness, erythema, swelling/ induration at the injection site; fever (> 38.3 °C, rectal equivalent); anorexia, vomiting, diarrhoea; irritability, somnolence, crying including unusual high-pitched crying, prolonged crying (> 4hrs), and crying not otherwise specified; otitis media.
4 Ir- reazzjonijiet lokali u d- disturbi sistemiċi li ġejjin kienu rrapportati f’ ≥ 1. 0% tat- tfal fi żmien ħamest ijiem minn kwalunkwe injezzjoni ta ’ PROCOMVAX: uġigħ, eritema, nefħa/ ebusija fil- post ta ’ l - injezzjoni; deni (> 38. 3°C, ekwivalenti tar- rektum); anoreksja, rimettar, dijarea; irritabilità, ħedla tan - ngħas, biki fosthom biki jgħajjat mhux tas- soltu, biki fit- tul (> 4 sigħat), u biki mhux speċifikat mod ieħor; otite tal- widna tan- nofs.