qanastek/EMEA-V3 huggingface dataset:
The most frequent side effects reported have been tiredness, pain and local reactions at the site of injection.
L- aktar effetti mhux mixtieqa li kienu rrapurtati kienu l- għeja, uġigħ u reazzjonijiet lokali fis- sit ta ’ l- injezzjoni.
Ovarian hyperstimulation syndrome has been observed in approximately 4% of the patients in clinical studies; most of these cases were mild or moderate in nature.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji kien osservat f’ madwar 4% tal- pazjenti f’ testijiet kliniċi; il- parti l- kbira ta ’ dawn il- każi kienu ta ’ natura ħafifa jew moderata.
Blood in the peritoneal cavity, respiratory difficulties are possible complications of ovarian hyperstimulation syndrome.
Demm fil- kavita ’ peritonali, diffikultajiet fin- nifs huma kumplikazzjonijiet possibli tas- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji.
This syndrome is characterized by large ovarian cysts.
Dan is- sindromu huwa karaterizzat minn ċisti ovarian kbar.
First symptoms of ovarian hyperstimulation are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain.
L- ewwel simptomi ta ’ stimulazzjoni eċċessiva huma wġigħ fil- parti t ’ isfel ta ’ l- addome, possibilment ma ’ nawsea, remettar u zieda fil- piz.
Should the above mentioned symptoms occur, a careful medical examination is indicated as soon as possible.
Jekk jiġru dawn is- sintomi, ezami medika accurata huwa indikat mil- iktar possili.
Common side effects reported include abdominal pain, nausea and vomiting, headache, injection site inflammation and reaction, dizziness.
Effetti komuni rappurtati huma wġigħ addominali, nawżea u remettar, uġigħ ta ’ ras, infjamazzjoni u reazzjoni fis- sit ta ’ l- injezzjoni.
Diarrhoea, depression, irritability, restlessness and breast pain have also been reported in some cases and are considered uncommon.
Sturdament, dijarea, depressjoni, irritabilità, nuqqas ta ’ mistrieħ u wgigħ tas- sider kienu rrapurtati wkoll f’ xi każi u huma kkunsidrati mhux komuni.
Extrauterine pregnancy, ovarian torsion (a condition affecting the ovaries) and other complications may arise from the assisted conception techniques your doctor may use.
Tqala barra mill- utru, torsjoni ta ’ l- ovarji u kumplikazzjonijiet oħra jistgħu jirriżultaw mit - teknika ta ’ konċezzjoni assistita li jista ’ juża t- tabib tiegħek.
Isolated cases of mild allergic reactions to Ovitrelle (rash) have been reported.
Kazi isolati ta ’ reazzjonijiet allerġiċi għal Ovitrelle (raxx) ġew irrapurtati.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinduna b’ xi effetti oħrajn li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek.
HOW TO STORE OVITRELLE
KIF TAĦŻEN OVITRELLE
Once the medicine is reconstituted (made up with the solvent), it should be used immediately.
Wara li tkun tħalltet il- mediċina (permezz tas- solvent), din għandha tintuża immedjatament.
Do not use Ovitrelle if you notice any visible signs of deterioration.
Tużax Ovitrelle jekk tara xi sinjali ċari ta ’ deterjorazzjoni.
The reconstituted solution should not be administered if it contains particles or is not clear.
M’ għandekx tuża t- taħlita likwida jekk tara xi frak jew mhijiex ċara.
Any unused solution should be discarded.
Kull taħlita likwida mhux użata għandha tintrema.
What Ovitrelle contains
X’ fih Ovitrelle
The active substance is choriogonadotropin alfa, each vial contains 285 micrograms.
Is- sustanza attiva hija choriogonadotropin alfa, kull fjala fiha 285 mikrogrammi.
After reconstitution 250 micrograms, which is the equivalent of 6500 IU, is delivered because some choriogonadotropin alfa will be left in the vial, in the syringe and in the needle.
Wara li jitħallat 250 mikrogrammi, li huwa ekwivalenti ta’ 6500 IU, jingħata peress illi xi ftit choriogonadotropin alfa jibqa fil- fjala, fis- siringa u fil- labra.
The other ingredients are sucrose, phosphoric acid, and sodium hydroxide.
L- ingredienti l- oħra huma sukrozju, phosphoric acid, u sodium hydroxide.
The solvent is water for injections.
Is- solvent huwa ilma għall- injezzjonijiet.
What Ovitrelle looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Ovitrelle is provided as a powder and solvent for solution for injection.
Ovitrelle huwa provdut bħala trab u solvent għal soluzzjoni għall- injezzjoni.
It is available in packs containing 1, 2, or 10 vials of powder containing the active substance which are accompanied by the corresponding number of solvent containers.
Huwa disponibbli f’ paketti ta ’ 1, 2 jew 10 fjali ta ’ trab li fih is- sustanza attiva bl- istess numru ta ’ ampulli ta ’ solvent.
Each vial of powder contains 285 micrograms of choriogonadotropin alfa and each container of solvent contains 1 ml of water for injections.
Kull fjala ta ’ trab fiha 285 mikrogrammi ta ’ choriogonadotropin alfa u kull kontenitur ta ’ solvent fiha 1 miliimetru ta ’ ilma għall- injezzjoni.
When one vial is reconstituted with 1 ml of solvent you will receive a dose of 250 micrograms.
Meta fjala hija mħallta ma ’ 1ml ta ’ solvent, jkollok doza ta ’ 250 mikrogrammi.
Merck Serono S. p. A., Via delle Magnolie 15, I-70026 Modugno (Bari), Italy
Merck Serono S. p. A., Via delle Magnolie 15, I- 70026 Modugno (Bari), Italy
For any information about this medicine e, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar fil -
Vial)
Fjala)
please tell you doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar
How to use Ovitrelle 4.
Kif għandek tuża l- Ovitrelle 4.
How to store Ovitrelle 6.
Kif taħżen l- Ovitrelle 6.
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Dan jagħmel parti mill- familja ta ’ ormoni magħrufa bħala gonadotrofini, li huma involuti fil- kontroll normali tar- riproduzzjoni.
Ovitrelle is used in women undergoing assisted reproductive techniques such as in vitro fertilisation (IVF).
Ovitrelle jintuża fuq nisa li fuqhom qed tintuża teknika ta ’ riproduzzjoni assistita bħal fertilizzazzjoni in vitro (IVF).
Ovitrelle is then used to ripen (mature) these follicles.
Ovitrelle jintuża wara biex jimmatura dawn il- follikuli.
BEFORE YOU USE OVITRELLE
QABEL MA ’ TUZA OVITRELLE
Do not take Ovitrelle:
Tieħux Ovitrelle jekk twieġeb ‘ IVA ’ għal imqar waħda minn dawn:
- If you are pregnant or breast-feeding
- inti tqila jew qed tredda ’?
- If you have ovarian enlargement or one or more large ovarian cysts
- għandek tkabbir ta ’ l- ovarji jew waħda jew iżjed ta ’ ċisti kbar fl- ovarji?
- if you have unexplained vaginal bleeding
- għandek demm vaġinali mingħajr spjegazzjoni?
- if you have been diagnosed as having ovarian, uterine or breast cancer
- kien djanjostikat fuqek kanċer fl- ovarji, utru jew fis- sider?
- if you had a tumour of the hypothalamus or pituitary gland
- kellek tumur fl- ipotalamu jew fil- glandola pitwitarja?
- If you suffer from severe inflammation of the veins or blood clotting in the veins (active
- tbati minn infjamazzjoni severa fil- vini jew għandek ċappep ta ’ demm fil- vini (disturbi trombo -
thrombo-embolic disorders)
emboliċi attivi)?
- if you are allergic (hypersensitive) to choriogonadotropin, or any of the ingredients of Ovitrelle.
- għandek xi allerġija magħrufa għal din il- mediċina jew għal xi waħda simili għaliha, jew għal xi
- if you have any condition which would make a normal pregnancy impossible (e. g. absent uterus,
ingredjenti minnha?
ovaries which have not developed properly, fibroids) or you have been through menopause
- għandek xi kundizzjoni li minħabba fiha tqala normali mhix possibbli (eż. nuqqas ta ’ utru,
- if you had an extrauterine pregnancy within the last 3 months
ovarji li mhumiex żviluppati sew, fibrojdi) jew diġà għaddejt mill- menopawża
Treatment with Ovitrelle may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also ‘ Possible side effects’).
Dan it- trattament b’ Ovitrelle jista ’ jżidlek ir- riskju li tiżviluppa kundizzjoni magħrufa bħala sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) (ara wkoll ‘ X’ effetti oħra jista ’ jkollu ’).
You should not have intercourse for at least 4 days, or otherwise you should use a barrier method for contraception.
M’ għandux ikollok rapport sesswali għal mill- anqas erbat ijiem, jew inkella għandek tuża metodi protettivi għall- kontraċezzjoni.
In assisted conception techniques, the number of babies is related to the number of embryos replaced.
Meta tintuża teknika ta ’ konċezzjoni assistita, in- numru ta ’ trabi hu marbut man- numru ta ’ embrijuni mibdula.
Your risk of OHSS or multiple pregnancy is reduced if the usual dose of Ovitrelle is used, and you are monitored closely throughout your treatment cycle (e. g. blood tests for estradiol levels and ultrasound).
Ir- riskju ta ’ OHSS jew tqala multipla jonqos jekk tittieħed id- doża normali ta ’ Ovitrelle, u jekk inti tkun ikontrollat tajjeb matul iċ- ċiklu kollu tat- trattament tiegħek (eż. eżamijiet tad- demm għal- livelli ta ’ estradiol u ultrasawnd).
Using other medicines:
L- użu ta ’ mediċini oħra:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar mediċini oħra, anki dawk mhux bir- riċetta.
You should not take Ovitrelle if you are pregnant or breast-feeding.
M’ għandekx tieħu Ovitrelle jekk int tqila jew qed tredda ’.
Please note that alcohol, swabs, syringes and needles are not contained in the package.
Jekk jogħġbok innota li ċ- ċraret bl- alkoħol, is- siringi u l- labar mhumiex inklużi fil- pakkett.
two alcohol swabs, one solvent vial, one vial containing the medicinal product one syringe, one big needle for reconstitution, a fine-bore needle for subcutaneous injection.
żewġ ċraret bl- alkoħol fjala waħda bis- solvent fjala waħda li fiha l- prodott mediċinali siringa labra waħda kbira għal taħlita likwida labra fina għat- titqib għall- injezzjoni minn taħt il- ġilda
Drawing up the solvent:
Iġbed is- solvent:
Remove the protective cap from the solvent vial.
Neħħi t- tapp protettiv mil- fjala tas- solvent.
Attach the needle for reconstitution (the bigger needle) to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Waħħal il- labra għat- taħlita (il- labra l- kbira) mas- siringa, u iġbed ftit arja fis- siringa billi tiġbed il- planġer sa madwar il- marka ta ’ 1 millilitru.
Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent.
Wara, daħħal il- labra fil- fjala, ibbota l- planġer biex tkeċċi l- arja, eqleb il- fjala rasha ‘ l isfel u bil- mod iġbed is- solvent kollu.
Set the syringe down carefully on the work-surface taking care not to touch the needle.
Poġġi s- siringa b’ attenzjoni fuq il- post fejn qed taħdem u oqgħod attent li ma tmissx mal- labra..
Preparing the injection solution:
Preparazzjoni tat- taħlita likwida għall- injezzjoni:
Remove the protective cap from the Ovitrelle powder vial, pick up your syringe and slowly inject the solvent into the vial of Ovitrelle.
Neħħi l- għatu protettiv mill- fjala tat- trab ta ’ Ovitrelle, aqbad is - siringa tiegħek u bil- mod injetta s- solvent fil- fjala ta ’ Ovitrelle.
Immediately inject the solution:
Injetta t- taħlita likwida mill- ewwel:
Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi mill- ewwel il- labbar u il- kontenituri vojta tal - ħġieġ kollha f’ kontenitur apposta għar- rimi ta ’ dawn l- oġġetti.
Any unused solution must be discarded.
It- taħlita likwida li ma tintużax għandha tintrema.
37 If you take more Ovitrelle than you should:
37 Jekk tuża Ovitrelle aktar milli suppost għandek?
If too much Ovitrelle is used, there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described under ‘ Take special care with Ovitrelle’ and ‘ Possible side effects'.
Jekk jittieħed ammont żejjed ta ’ Ovitrelle, hemm il- possibilità li jseħħ is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji, li hu deskritt f’ aktar dettal fis- sezzjoni ‘ Oqgħod attent ħafna bl- Ovitrelle ’ u ‘ X’ effetti oħra jista ’ jkollu ’.
If you forget to take Ovitrelle:
Jekk tinsa tieħu Ovitrelle?
Like all medicines, Ovitrelle can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Ovitrelle jista ’ jkollu effetti mhux mixtieqa.
The majority of side effects seen to date have been mild or moderate.
Il- parti kbira ta ’ l- effetti li mhux mixtieqa dehru s’ issa kienu ħfief jew moderati.
Extrauterine pregnancy, ovarian torsion (a condition affecting the ovaries) and other complications may arise from the assisted conception techniques your doctor may use.
Tqala barra mill- utru, torsjoni ta ’ l- ovarji u kumplikazzjonijiet oħra jistgħu jirriżultaw mill- użu ta ’ teknika ta ’ konċezzjoni assistita li jista ’ juża t- tabib tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinduna b’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek.
Do not use after the expiry date which is stated on the label after EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta wara JISS.
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 għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
41 PACKAGE LEAFLET:
41 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA (Kontenitur tas- solvent:
Choriogonadotropin alfa
Ovitrelle 250 mikrograami/ 0. 5ml soluzzjoni għall- injezzjoni f’ siringa mimlija lesta Choriogonadotropin alfa.
It may harm them, even
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lill- persuni
if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħall tiegħek.
Ovitrelle is a medicinal product containing choriogonadotropin alfa, which is very similar to chorionic gonadotrophin found naturally in humans, but it is made in laboratories by special recombinant DNA techniques.
Ovitrelle hu prodott mediċinali li fiħ Choriogonadotropin alfa, li hi simili ħafna għal chorionic gonadotrophin li tinstab b’ mod naturali fil- persuni, iżda li ssir fil- laboratorji bl- użu ta ’ teknika speċjali ta ’ DNA rikombinat.
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Jagħmel parti mill- familja ta ’ ormoni magħrufa bħala gonadotrophins, li huma involuti fil- kontroll normali tar- riproduzzjoni.
Ovitrelle is also used in women who do not produce eggs (a condition called anovulation), or who produce too few eggs (oligo-ovulation).
Ovitrelle jintuża wkoll f’ nisa li ma jipproduċux bajd (kundizzjoni fin- nisa li ma jovulawx) jew li jipproduċu ftit bajd (l- ovarji jagħmlu anqas bajd min- normal).
It is given to bring about the release of eggs (ovulation), after other medicines have been used to develop the follicles.
Dan jingħata biex iwassal għall- ħelsien tal- bajd (ovulazzjoni), wara li mediċini oħra jkunu ntużaw biex jiġu żviluppati l- follikuli.
Do not take Ovitrelle:
Tiħux Ovitrelle:
- If you have had an extrauterine pregnancy within the last 3 months
• Jekk inti tqila jew qed tredda ’ • Jekk għandek tkabbir ta ’ l- ovarji jew waħda jew iżjed ta’ ċisti ovarji kbar • Jekk għandek demm vaġinali mingħajr spjegazzjoni • Jekk kien djanjostikat fuqek kanċer fl- ovarji, utru jew fis- sider • Jekk kellek tumur fl- ipotalamu jew fil- glandola pitwitarja • Jekk tbati minn infjamazzjoni severa fil- vini jew għandek ċappep ta ’ demm fil- vini (disturbi trombo- emboliċi attivi) • Jekk għandek xi allerġija magħrufa għal din jew mediċina simili jew għal xi ingredjenti minnha • Jekk għandek xi kundizzjoni li minħabba fiha tqala normali mhix possibbli (eż. nuqqas ta ’ utru, ovarji li mhumiex żviluppati sew, fibrojdi) jew diġà għaddejt mill- menopawża • Jekk kellek tqala barra mill- utru f’ dawn l- aħħar 3 xhur
42 Take special care with Ovitrelle:
42 Oqgħod attent ħafna b’ Ovitrelle:
Treatment with Ovitrelle may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also ‘ Possible side effects’).
Dan it- trattament b’ Ovitrelle jista ’ jżidlek ir- riskju li tiżviluppa kundizzjoni magħrufa bħala sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) (ara wkoll ‘ X’ effetti oħra jista jkollu ’).
The most common symptom is abdominal pain.
L- aktar sintomu komuni hu wġigħ addominali.
If you have significant abdominal pain or discomfort, do not give yourself the injection, and speak to your doctor or nurse as soon as possible.
Jekk għandek uġigħ jew skumdità addominali sinifikanti, tagħtix l- injezzjoni lilek innifsek, u kellem lit- tabib jew lill- infirmiera tiegħek kemm jista ’ jkun malajr.
In assisted conception techniques, the number of babies is related to the number of embryos replaced.
Meta tintuża teknika ta ’ konċezzjoni assistita, in- numru ta ’ trabi hu marbut man- numru ta ’ embrijoni mibdula.
Your risk of OHSS or multiple pregnancy is reduced if the usual dose of Ovitrelle is used, and you are monitored closely throughout your treatment cycle (e. g. blood tests for estradiol levels and ultrasound).
Ir- riskju ta ’ OHSS jew tqala multipla jonqos jekk tittieħed id- doża normali ta ’ Ovitrelle, u jekk int kont ikkontrollata tajjeb matul iċ- ċiklu kollu tat- trattament tiegħek (eż. eżamijiet tad- demm għal- livelli ta ’ estradiol u ultrasawnd).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċċetta.
You should check with your doctor or pharmacist if you are not sure The usual dose of Ovitrelle is 1 pre-filled syringe (250 micrograms/ 0.5 ml) given as a single injection.
Id- doża ta ’ Ovitrelle hi ta ’ 1 siringa mimlija lesta (250 mikrogrammi/ 0. 5 millitru) mogħtija bħala injezzjoni waħda.
Your doctor will have explained exactly when to give the injection.
Jekk tħoss li l- effett ta ’ Ovitrelle hu qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
Ovitrelle is intended for subcutaneous use, that means given by injection under the skin.
Ovitrelle tingħata permezz ta ’ injezzjoni taħt il- ġilda.
Each pre- filled syringe is for single use only, only clear solution without particles should be used.
Kull siringa mimlija lesta għandha tintuża darba biss, u t- taħlita likwida għandha tintuża biss meta hi ċara u ma fihix frak.
Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injection at home.
Xi kultant l- injezzjoni se tingħatalek minn tabib jew infirmiera, jew int jew is- sieħeb tiegħek tkunu tħarriġtu biex tagħti l- injezzjoni d- dar.
If you administer Ovitrelle to yourself, please carefully read the following instructions:
Jekk se tagħti Ovitrelle lilek innifsek, jekk jogħġbok aqra b’ attenzjoni l- istruzzjonijiet segwenti:
It is important that your hands and the items you use are as clean as possible.
Hu importanti li idejk u l- oġġetti li tuża jkunu nodfa kemm jista ’ jkun.
Please note that alcohol swabs are not contained in the package.
Jekk jogħġbok innota li ċraret bl- alkoħol mhumiex inklużi fil - pakkett.
two alcohol swabs, one pre-filled syringe containing the medicinal product
żewġ ċraret bl- alkoħol siringa mimlija lesta li tinkludi il- prodott mediċinali
Immediately inject the solution:
Injetta t- taħlita likwida immedjatament:
Your doctor or nurse will have already advised you where to inject (e. g. tummy, front of thigh).
It- tabib jew l- infirmiera tiegħek se jkunu diġà spjegawlek fejn għandek tinjetta (eż. fiż- żaqq jew fil- parti ta ’ quddiem tal- koxxa).
Firmly pinch the skin together and insert the needle for injection at a 45° to 90° angle using a dart-like motion.
Oqros b’ fermezza l- ġilda u daħħal il- labra għall - injezzjoni f’ anglu minn 45° sa 90° b’ moviment simili għal dak ta ’ dart.
Inject the solution by pushing gently on the plunger.
Injetta s- soluzzjoni billi tagħfas bil- mod il - planġer.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Oħroġ il- labra mill- ewwel u naddaf il- ġilda b’ ċaruta bl - alkoħol f’ moviment ċirkolari.
Once you have finished your injection, immediately discard the empty syringe in a sharps container.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi mill- ewwel is- siringa vojta f’ kontenitur apposta għar- rimi ta siringi.
If you use more Ovitrelle than you should
Jekk tuża Ovitrelle aktar milli suppost għandek
If too much Ovitrelle is used, there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described under ‘ Take special care with Ovitrelle’ and ‘ Possible side effects'.
Jekk jittieħed ammont żejjed ta ’ Ovitrelle, hemm il- possibilità li jseħħ is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji, li hu deskritt f’ aktar dettall fis- sezzjoni ‘ Oqgħod attent ħafna b’ Ovitrelle u ‘ X’ effetti oħra jista ’ jkollu ’.
If you forget to take Ovitrelle
Jekk tinsa tieħu Ovitrelle
Like all medicines, Ovitrelle can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Ovitrelle jista ’ jkollu effetti mhux mixtieqa.
The majority of side effects seen to date have been mild or moderate.
Il- parti kbira ta ’ l- effetti mhux mixtieqa s’ issa kienu kollha ħfief jew moderati.
Ovarian hyperstimulation syndrome has been observed in approximately 4% of the patients in clinical trials; most of these cases were mild or moderate in nature.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji kien osservat f’ madwar 4% tal- pazjenti f’ testijiet kliniċi; il- parti l- kbira ta ’ dawn il- każi kienu ta ’ natura ħafifa jew moderata.
Blood in the peritoneal cavity, respiratory difficulties are possible complications of ovarian hyperstimulation syndrome.
Dan is- sindromu hu karatteriżżat minn ċisti kbar fl- ovarji.
Common side effects reported include abdominal pain, nausea and vomiting, headache, injection site inflammation and reaction, dizziness.
Effetti komuni rappurtati huma huma wġigħ addominali, nawżea u remettar, uġigħ ta ’ ras, infjamazzjoni u reazzjoni fis- sit ta ’ l- injezzjoni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinnota xi effetti oħra li mhumiex imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib jew spiżjar tiegħek.
44 Do not use after the expiry date which is stated on the label after EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta wara JISS.
Store in a refrigerator (2°C-8°C).
Aħżen fi friġġ (2°C u 8°C).
Ovitrelle 250 micrograms solution for injection may be stored at room temperature (at or below +25° C) for up to 30 days without being refrigerated again during this period, and must be discarded if not used during these 30 days.
Ovitrelle 250 mikrogrammi soluzzjoni għall - injezzjoni jista ’ jinħażen f’ temperatura ta’ kamra (25°C jew anqas) sa 30 ġurnata mingħajr ma jerġa ’ jiddaħħal fil- friġġ matul dan il- perjodu u għandu jintrema jekk ma jintużax matul dawn it- 30 ġurnata.
What Ovitrelle contains
X’ fih Ovitrelle:
The active substance is choriogonadotropin alfa.
Is- sustanza attiva hi choriogonadotropin alfa.
Each pre-filled syringe contains 250 micrograms / 0.5 ml (equivalent to 6500 IU).
Kull siringa mimlija lesta fiha 250 mikrogrammi / 0. 5 millitru (ekwivalenti 6500 IU).
The other ingredients are mannitol, methionine, poloxamer 188, diluted phosphoric acid, sodium hydroxide, water for injections.
Is- sustanzi l- oħra jinkludu mannitol, methionine, poloxamer 188, diluted phosphoric acid, sodium hydroxide, ilma għall- injezzjonijiet.
Ovitrelle is provided as solution for injection.
Ovitrelle hu provdut bħala soluzzjoni għall- injezzjoni.
It is available as a single pre-filled syringe (pack of 1).
Huwa disponibli bħala siringa mimlija lesta għal l- uzu (pakkett ta ’ 1).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull taghrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
What is Pandemrix?
X’ inhu Pandemrix?
Pandemrix is a vaccine that is given by injection.
Pandemrix huwa vaċċin li jingħata b’ injezzjoni.
Pandemrix contains a flu strain called ‘ A/ VietNam/ 1194/ 2005 NIBRG-14’ (H5N1).
Pandemrix fiha r- razza ta ’ l- influwenza msejjħa ‘ A/ Viet Nam/ 1194/ 2005 NIBRG- 14 ’ (H5N1).
What is Pandemrix used for?
Għal xiex jintuża Pandemrix?
Pandemrix is a vaccine for use in adults aged between 18 and 60 years to prevent ‘ pandemic’ flu.
Pandemrix huwa vaċċin għall- użu f’ adulti ta ’ bejn it- 18 u s- 60 sena għal prevenzjoni ta ’ l- influwenza ‘ pandemika ’.
It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Pandemrix hija vaċċin li tista ’ tintuża biss ladarba tkun ġiet iddikjarata uffiċjalment influwenza ‘ pandemika ’ mill- Għaqda Dinjija tas- Saħħa (WHO) jew mill- Unjoni Ewropea (EU).
A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Influwenza pandemika sseħħ meta joħroġ tip ta ’ vajrus ġdid (razza) tal- vajrus ta ’ l- influwenza li jista ’ jinfirex faċilment minn persuna għal oħra peress li n- nies ma jkollom l- ebda immunità (protezzjoni) kontra tiegħu.
A pandemic can affect most countries and regions around the world.
Pandemija tista ’ taffettwa l- parti l- kbira tal- pajjiżi u r- reġjuni madwar id- dinja.
Pandemrix would be given according to official recommendations.
Pandemrix tingħata skond ir- rakkomandazzjonijiet uffiċjali.
How is Pandemrix used?
Kif jintuża Pandemrix?
Pandemrix is given by injection into the upper arm muscle in two doses, at least three weeks apart.
Pandemrix jingħata b’ injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ f’ żewġ dożi b’ mill- inqas tliet ġimgħat bejn kull doża ’.
How does Pandemrix work?
Kif jaħdem Pandemrix?
Pandemrix is a ‘ mock-up’ vaccine.
Pandemrix huwa vaċċin tat- tip “ finta ”.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Qabel tibda pandemija, ħadd ma jkun jaf liema razza ta ’ vajrus ta ’ l- influwenza se jkun involut, għalhekk il- kumpaniji ma jistgħux jippreparaw il- vaċċin korrett minn qabel.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Minflok, huma jistgħu jippreparaw vaċċin li fih ir- razza ta ’ vajrus ta ’ l- influwenza magħżul speċifikament peress li ħadd ma kien espost għalih, u għal liema ħadd ma jkun immuni.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Huma jistgħu jittestjaw dan il- vaċċin biex jaraw kif in- nies jistgħu jirreaġġixxu għalih, li tħallihom ibassru kif in- nies se jirreaġġixxu meta r - razza ta ’ l- influwenza li tikkaġuna l- pandemija tkun inkluża.
Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Pandemrix fih ammonti żgħar ta ’ emoaglutinini (proteini mill- wiċċ) ta ’ vajrus imsemmi H5N1.
The virus has first been inactivated (killed) so that it does not cause any disease.
Il- vajrus l- ewwel ġie inattivat (maqtul) sabiex ma jikkaġuna l- ebda mard.
If a pandemic starts, the virus strain in Pandemrix will be replaced by the strain causing the pandemic before the vaccine can be used.
Jekk
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tibda pandemija, ir- razza ta ’ vajrus f’ Pandemrix tinbidel bir- razza li tikkaġuna l- pandemija qabel ma ’ l- vaċċin ikun jista ’ jintuża.
When a person is given the vaccine, the immune system recognises the virus as ‘ foreign’ and makes antibodies against it.
Meta persuna tingħata l- vaċċin, is- sistema immunitarja tagħraf lill- vajrus bħala “ barrani ” u tagħmel antikorpi kontrih.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Is- sistema immunitarja imbagħad tkun tista ’ tagħmel antikorpi aktar malajr meta terġa ’ tkun esposta għal vajrus darb’ oħra.
This will help to protect against the disease caused by the virus.
Dan jgħin fil- protezzjoni kontra l- marda kkawwżata minn vajrus.
Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with an emulsion.
Qabel l- użu, il- vaċċin isir minn taħlita ta ’ sospensjoni li jkun fiha l- partiċelli tal- vajrus flimkien ma ’ emulsjoni.
The resulting ‘ emulsion’ will then be injected.
L - ‘ emulsjoni ’ riżultanti imbagħad tiġi injettata.
How has Pandemrix been studied?
Kif ġie studjat Pandemrix?
The effects of Pandemrix were first tested in experimental models before being studied in humans.
L- effetti ta’ Pandemrix għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The main study of Pandemrix included 400 healthy adults and compared the ability of different doses of Pandemrix, with or without the adjuvant, to trigger the production of antibodies (‘ immunogenicity’).
L- istudju prinċipali ta ’ Pandemrix inkluda 400 adult b’ saħħithom u pparaguna mal- kapaċità ta ’ dożi differenti ta ’ Pandemrix, b’ adjuvant jew mingħajru, jqanqal il- produzzjoni ta ’ antikorpi (‘ immunoġeniċiti ’).
The participants received two injections of Pandemrix containing one of four different doses of haemagglutinin.
Il- parteċipanti rċevew żewġ injezzjonijiet ta ’ Pandemrix li fihom doża waħda minn erba ’ differenti ta ’ emoaglutinini.
What benefit has Pandemrix shown during the studies?
X' benefiċċju wera Pandemrix matul l- istudji mwettqa?
The study showed that Pandemrix containing 3.75 micrograms of haemagglutinin and the adjuvant produced an antibody response that met these criteria.
The study showed that Pandemrix containing 3. 75 micrograms of haemagglutinin and the adjuvant produced an antibody response that met these criteria. » L- istudju wera li Pandemrix fih 3. 75 mikrogramma ta ’ emoaglutinini u l- adjuvant ipproduċa rispons b’ antikorp li qabel ma ’ dawn il- kriterji.
At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
What is the risk associated with Pandemrix?
X’ inhu r- riskju assoċjat ma ’ Pandemrix?
The most common side effects with Pandemrix (occurred with 1 in 10 doses or more of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
L- aktar effetti sekondarji ta ’ Pandemrix (ġraw f’ doża waħda minn għaxra jew aktar tal- vaċċin) huma uġiegħ ta ’ ras, artralġja (uġiegħ fil- ġogi), majalġja (uġiegħ fil- ġogi), reazzjonijiet fis- sit ta ’ l- injezzjoni (ebusija, nefħa, uġiegħ u ħmura), deni u għejja (ħeddla).
For the full list of all side effects reported with Pandemrix, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Pandemrix, ara l- Fuljett ta ’ Tagħrif.
Pandemrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Pandemrix m’ għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill- komponenti tal- vaċċin, jew għal kwalunkwe sustanza li tinsab f’ livelli ta ’ traċċi, bħal bajd, proteina tat- tiġieġ, ovalbumin (proteina fl- abjad tal- bajd), formaldehyde, gentamicin sulphate (antibijotiku) u sodium deoxycholate..
Why has Pandemrix been approved?
Għaliex ġie approvat Pandemrix?
The CHMP decided that Pandemrix’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.
Is- CHMP iddeċieda li l- benefiċċji ta ’ Pandemrix huma akbar mir- riskji tiegħu għal profilassi ta ’ influwenza f’ sitwazzjoni pandemika dikjarata uffiċjalment.
The Committee recommended that Pandemrix be given marketing authorisation.
Il- Kumitat irrakkomanda li Pandemrix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Pandemrix has been authorised under ‘ Exceptional Circumstances’.
Pandemrix ġie awtorizzat taħt ‘ Ċirkostanzi Eċċezzjonali ’.
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
Dan ifisser li minħabba li r- razza tal- vajrus ta ’ l- influwenza li jista ’ jikkaġuna pandemija mhijiex magħrufa, ma kienx possibbli li jinkiseb tagħrif sħiħ dwar il- vaċċin ta ’ pandemija futura.
Which measures are being taken to ensure the safe use of Pandemrix?
Liema informazzjoni għadha mistennija għal Pandemrix?
If Pandemrix is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
Jekk tiġi ddikjarata pandemija, il- kumpanija li tagħmel Pandemrix għandha tinkludi fil- vaċċin ir- razza ta ’ l- influwenza li tkun responsabbli.
This will include information on its side effects and its safety in the elderly, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Imbagħad, hija tiġbor it- tagħrif dwar is- sigurtà u l- effettività tal - vaċċin pandemiku finali, u tisottomettih lis- CHMP għal evalwazzjoni.
The European Commission granted a marketing authorisation valid throughout the EU for Pandemrix to GlaxoSmithKline Biologicals s. a. on 20 May 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Pandemrix, valida fl- Unjoni Ewropea kollha, lil GlaxoSmithKline Biologicals s. a. fil - 20 Mejju 2008.
The full EPAR for Pandemrix can be found here.
L- EPAR sħiħ għal Pandemrix jista ’ jinstab hawnhekk.
This summary was last updated in 03-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
Suspension and Emulsion for
Suspensjoni u Emulsjoni għal emulsjoni għall - injezzjoni
Intramuscular use
Jingħata fil - muskolu
suspension (H5N1): vial (glass)
suspensjoni (H5N1): kunjett (ħġieġ) emulsjoni (suppliment): kunjett (ħġieġ)
2.5 ml (suspension)
2. 5 ml (suspensjoni) 2. 5 ml (emulsjoni)
2 x 25 vials (emulsion)
50 kunjett (suspensjoni) 2 x 25 kunjett (emulsjoni)
Pandemrix suspension and emulsion for emulsion for injection.
Pandemrix suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni.
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Vaċċin għal influwenza pandemika (H5N1) (virion maqsum, mhux attivat, supplimentat)
Split influenza virus, inactivated, containing antigen* equivalent to:
Virus maqsum, mhux attivat ta ’ l- influwenza li jkun fih antiġen * ekwivalenti għal:
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * propagated in eggs ** haemagglutinin
3. 75 mikrogramma ** Razza tixbaħ A/ VietNam/ 1194/ 2004 (H5N1) użat (NIBRG- 14) * imnissla fil- bajd ** emagglutinina
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Dan il- vaċċin hu konformi mar- rakkomandazzjonijiet tal- WHO u d- deċiżjoni ta ’ l- UE dwar l - influwenza pandemika.
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
AS03 supplimentat magħmul minn squalene (10. 68 milligramma), DL- α- tocopherol (11. 86 milligramma) u polysorbate 80 (4. 85 milligramma)
The emulsion is a whitish homogeneous liquid.
L- emulsjoni hija likwidu omoġenu bajdani.
Prophylaxis of influenza in an officially declared pandemic situation.
Profilassi ta ’ influwenza f’ sitwazzjoni ta ’ influwenza pandemika ddikjarata uffiċjalment.
Pandemic influenza vaccine should be used in accordance with official guidance (see sections 4.2 and 5.1).
Il- vaċċin ta ’ l- influwenza pandemika għandu jintuża skond gwidi uffiċjali (ara sezzjonijiet 4. 2 u 5. 1).
1 dose of 0.5 ml at an elected date.
Adulti mill- età ta ’ 18 sa 60 sena: doża 1 ta ’ 0. 5ml f’ data magħżula.
A second dose of vaccine should be given after an interval of at least three weeks.
It- tieni doża għandha tingħata wara intervall ta ’ mill- anqas tlett ġimgħat.
For further information, see section 5.1.
Għal aktar tagħrif, ara sezzjoni 5. 1.
Method of administration 2 Immunisation should be carried out by intramuscular injection.
2 Metodu ta ’ kif għandu jingħata
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Storja ta ’ reazzjoni anafilattika (i. e. li tista ’ twassal għall- mewt) għal xi wieħed mill- kostitwenti jew traċċi ta ’ residwi (proteini tal- bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate) ta ’ dan il- vaċċin.
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Madankollu, f’ sitwazzjoni ta ’ influwenza pandemika, jista ’ jkun jaqbel li l- vaċċin jingħata, basta li jkun hemm disponibbli immedjatament faċilitajiet għal qawmien mit- telfa tas- sensi jekk ikun hemm bżonn.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Għandha tingħata attenzjoni meta l- vaċċin jingħata lil persuni b’ sensittivita` eċċessiva magħrufa (għajr reazzjoni anafilattika) għas- sustanzi attivi, għal xi wieħed mis- sustanzi mhux attivi, għal thiomersal u għal residwi (proteina tal- bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal fil każ tal- vaċċini injettabbli kollha, għandu jkun hemm dejjem disponibbli kura u sorveljanza medika xierqa għal xi każ rari anafilattiku wara li jingħata l- vaċċin.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Jekk is- sitwazzjoni pandemika tippermetti, it- tilqim għandu jiġi pospost f’ pazjenti b’ mard ta ’ deni serju jew infezzjoni akuta.
Pandemrix should under no circumstances be administered intravascularly.
Pandemrix m’ għandu qatt jingħata b’ mod intravaskulari.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Rispons ta ’ antikorpi f’ pazjenti b’ immunosoppressjoni endoġena jew jatroġenika jista ’ ma jkunx biżżejjed.
A protective immune response may not be elicited in all vaccinees (see section 5.1).
Rispons immuni ta ’ protezzjoni jista ’ ma jirriżultax f’ kull minn jieħu l- vaċċin (ara sezzjoni 5. 1).
Pandemrix should not be given at the same time as other vaccines.
Pandemrix m’ għandux jingħata fl- istess ħin li jkunu qed jingħataw xi vaċċini oħra.
However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Madankollu, jekk tkun tidher il- ħtieġa li jingħata flimkien ma ’ xi vaċċin ieħor, it- tilqim għandu jsir fi driegħ jew sieq differenti.
It should be noted that the adverse reactions may be intensified.
Għandu jkun innotat li r- reazzjonijiet avversi jistgħu jkunu aktar qawwija.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Ir- rispons immunoloġiku jista ’ jonqos jekk il- pazjent ikun qed jingħata xi kura immunosoppressiva.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Wara tilqim għall- influwenza, jistgħu jinkisbu riżultati pożittivi foloz f’ testijiet seroloġiċi bl- użu tal - metodu ELISA għal antikorpi għall- virus- 1 ta ’ l- immunodefiċjenza umana (HIV- 1), ta ’ l- epatite ċ u speċjalment ta ’ l- HTLV- 1.
These transitory false-positive results may be due to IgM production in response to the vaccine.
Dawn ir - riżultati pożittivi foloz li jgħaddu malajr jistgħu jkunu minħabba l- produzzjoni ta ’ l- IgM bħala rispons għall- vaċċin.
No data have been generated in pregnant women with Pandemrix or with any other vaccine that contains the AS03 adjuvant
Ma ħarġet l- ebda dejta f’ nisa tqal dwar Pandemrix jew dwar kwalunkwe vaċċin ieħor li fih l- AS03 supplimentat.
Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
3 Dawk li jieħdu ħsieb il- kura tas- saħħa jkollhom bżonn jevalwaw il- benefiċċji u r- riskji involuti meta jagħtu l- vaċċin lil nisa tqal waqt li jikkunsidraw ir- rakkomandazzjonijiet uffiċjali.
Pandemrix may be used during lactation.
Pandemrix jista ’ jintuża waqt it- treddigħ.
3 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Some of the effects mentioned under section 4.8 “ Undesirable Effects” may affect the ability to drive or operate machinery.
Xi wħud mill- effetti msemmija taħt sezzjoni 4. 8 “ Effetti mhux mixtieqa ” jistgħu jaffettwaw il- ħila biex issuq u tħaddem magni.
Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).
Reazzjonijiet avversi minn provi kliniċi b’ vaċċin sperimentali huma elenkati hawn taħt (ara sezzjoni 5. 1 għal aktar tagħrif dwar vaċċini sperimentali).
The incidence of adverse reactions has been evaluated in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/ AS03.
L- inċidenza ta ’ reazzjonijiet avversi ġiet evalwata f’ bejn wieħed u ieħor 5, 000 individwu ta ’ 18- il sena jew aktar li rċievew formulazzjonijiet li kien fihom mill- anqas 3. 75 mikrogramma HA/ AS03.
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)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 to < 1/ 10) Mhux komuni (≥1/ 1, 000 to < 1/ 100) Rari (≥1/ 10, 000 to < 1/ 1, 000) Rari ħafna (< 1/ 10, 000)
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Disturbi gastro- intestinali Mhux komuni: sintomi gastro- intestinali (bħal dijarea, rimettar, uġigħ fl- addome, dardir)
General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni ħafna: ħmura, nefħa, uġigħ u ħmura fis- sit ta ’ l- injezzjoni, deni, għejja Komuni: tregħid, mard bħal ta ’ l- influwenza, reazzjonijiet fis- sit ta ’ l- injezzjoni (bħal sħana, ħakk) Mhux komuni: telqa
No post-marketing surveillance data are available following Pandemrix administration.
L- ebda dejta ta ’ sorveljanza ta ’ wara t- tqegħid fis- suq m’ hija disponibbli wara li jingħata Pandemrix.
4 From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Minn sorveljanza ta ’ wara t- tqegħid fis- suq fuq vaċċini trivalenti interpandemiċi, ir- reazzjonijiet avversi li ġejjin kienu rappurtati:
Neuralgia, convulsions, transient thrombocytopenia.
Newralġja, aċċessjonijiet, tromboċitopenija li tgħaddi.
Allergic reactions, in rare cases leading to shock, have been reported.
Reazzjonijiet allerġiċi, f’ każi rari jwasslu għal xokk, kienu rappurtati.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Mard newroloġiku, bħal enċefalomelite, newrite u s- sindrome ta ’ Guillain Barré.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Dan il- prodott mediċinali fih thiomersal (kompost organomerkuriku) bħala preservattiv u għalhekk hemm il- possibilta` ta ’ reazzjonijiet ta ’ sensittivita` (ara sezzjoni 4. 4).
Influenza vaccines, ATC Code J07BB02.
Vaċċini ta ’ l- influwenza, Kodiċi ATC J07BB02
This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
Din is- sezzjoni tiddeskrivi l- esperjenza klinika bil- vaċċini sperimentali wara teħid ta ’ żewġ dożi.
Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Vaċċini sperimentali fihom antiġeni ta ’ l- influwenza differenti minn dawk fil- virus ta ’ l- influwenza li jkun qed jixtered fil- mument.
These antigens can be considered as “ novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Dawn l- antiġeni jistgħu jitqiesu bħala antiġeni “ novelli ” u jissimulaw sitwazzjoni fejn il- popolazzjoni fil- mira għal vaċċinazzjoni tkun immunoloġikament inġenwa.
Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Dejta miksuba bil- vaċċin sperimentali tiffavorixxi strateġija ta ’ vaċċinazzjoni li x’ aktarx tintuża f’ vaċċin pandemiku: dejta dwar immunoġeniċita` klinika, sigurta` u ġeneċita` reattiva miksuba minn vaċċini sperimentali hi rilevanti għall- vaċċini pandemiċi.
Immune response against vaccine strain contained in Pandemrix (A/ Vietnam/ 1194/ 2004 (H5N1)):
Rispons immuni kontra r- razza tal- vaċċin li fih Pandemrix (A/ Vietnam/ 1194/ 2004 (H5N1):
In a consistency study, more than 900 subjects aged 18-60 years received Pandemrix following a 0, 21 days schedule.
Fi studju ta ’ konsistenza, aktar minn 900 individwu li għandhom età bejn it- 18- 60 sena rċievew Pandemrix fejn segwew skeda ta ’ 0, 21 ġurnata.
Twenty-one days after the first and second dose of the vaccine, the seroprotection rates, seroconversion rates and seroconversion factors for anti-haemagglutinin (anti-HA) antibody were as follows:
Wieħed u għoxrin ġurnata wara l- ewwel u t- tieni doża tal- vaċċin, ir- rata ta ’ seroprotezzjoni, ir- rata ta ’ serokonverżjoni, u l- fattur ta ’ serokonverżjoni, għall- antikorp kontra l- emagglutinina (anti- HA) kienu kif ġej:
anti-HA antibody Seroprotection rate* † Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
5 Antikorp anti- HA Rata ta ’ seroprotezzjoni * † Rata ta ’ serokonverżjoni † Fattur ta ’ serokonverżjoni † * anti- HA ≥1: 40
after 1st dose 44.5% 42.5% 4.1
21 ġurnata wara l- ewwel doża 44. 5% 42. 5% 4. 1
after 2nd dose 94.3% 93.7% 39.8
21 ġurnata wara t- tieni doża 94. 3% 93. 7% 39. 8