qanastek/EMEA-V3 huggingface dataset:
The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Il- prodott dilwit f’ soluzzjoni ta ’ 0. 9% ta ’ sodium chloride li tingħata ġol- vina ser iżomm l- istabilità kemikali jekk tinħażen sa 24 siegħa f’ temperatura ta ’ bejn 2° Ċ u 8° Ċ u f’ post li ma jarax id- dawl; imma s- sigurtà mikrobijoliġikali ser tiddependi minn jekk ir- rikostituzzjoni u dilwazzjoni sarux b’ mod asettiku.
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
ID- DETENTUR TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ Genzyme Europe, B. V., Gooimeer 10, NL- 1411 DD Naarden, l- Olanda.
17 November 1997 Date of latest renewal:
17 ta ’ Novembru 1997 Data ta ’ l- aħħar tiġdid:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott jinstab fuq il- websajt ta ’ l- Aġenzija Ewropea tal- Mediċini (EMEA) http: // www. emea. europa. eu /
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIĊA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIĊIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manufattur tas- sustanza bijoloġika attiva
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott.
37 Hollands Road – Haverhill, Suffolk CB9 8PU - UK
37 Hollands Road – Haverhill, Suffolk CB9 8PU – Ir- Renju Unit
Summary of Product Characteristics, section 4.2)
Sommarju tal- Prodott fil- Qosor, sezzjoni 4. 2)
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L– UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON/ VIAL
KARTUNA TA ’ BARRA/ KUNJETT
Cerezyme 200 U Powder for concentrate for solution for infusion imiglucerase
Cerezyme 200 U Trab għal konċentrat għal soluzzjoni għall- infużjoni imiglucerase
STATEMENT OF ACTIVE SUBSTANCE
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
Each vial contains 200 units of imiglucerase.
Kull kunjett ta ’ trab fih 200 unità ta ’ imiglucerase.
Mannitol, Sodium Citrate, Citric acid monohydrate and Polysorbate 80.
Mannitol, Sodium citrate, Citric acid monohydrate u Polysorbate 80.
1 vial of powder for concentrate for solution for infusion.
1 Kunjett wieħed ta ’ trab għal konċentrat għal soluzzjoni għall- infużjoni.
25 vials of powder for concentrate for solution for infusion.
25 kunjett ta 'trab għall- konċentrat għal soluzzjoni għall- infużjoni.
For intravenous infusion.
Għal infużjoni ġol- vini.
For single use only.
Għandu jintuża darba waħda biss.
EXP:
JIS:
Store in a refrigerator
Aħzen fi friġġ.
Any unused solution should be discarded.
Kwalunkwe soluzzjoni mhux użata għandha tintrema.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
Marketing Authorisation Holder:
Sid l- Awtoriżżazzjoni għall- Kummerċ:
Gooimeer 10 1411 DD Naarden-NL
Gooimeer 10 NL- 1411 DD Naarden l- Olanda
MARKETING AUTHORIZATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Batch:
Lott:
LABEL/ VIAL
TIKKETTA/ KUNJETT
For intravenous infusion.
Għal infużjoni ġol- vina.
Each vial contains 200 units of imiglucerase.
Kull kunjett fih 200 unità ta ’ imiglucerase.
Store in a refrigerator
Aħżen fi friġġ
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETTI TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Cerezyme 400 U Powder for concentrate for solution for infusion imiglucerase
Cerezyme 400 U Trab għal konċentrat għal soluzzjoni għall- infużjoni imiglucerase
Each vial contains 400 units of imiglucerase.
Kull kunjett ta ’ trab fih 400 unità ta ’ imiglucerase.
1 vial of powder for concentrate for solution for infusion.
Kunjett wieħed ta ’ trab għal konċentrat għal soluzzjoni għall- infużjoni.
5 vials of powder for concentrate for solution for infusion.
5 kunjetti ta 'trab għal konċentrat għal soluzzjoni għall- infużjoni.
25 vials of powder for concentrate for solution for infusion.
25 kunjett ta 'trab għal konċentrat għal soluzzjoni għall- infużjoni.
For single use only.
Użah darba waħda biss
EXP:
JIS [XX/ SSSS]
Store in a refrigerator.
Aħzen fi friġġ.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TAL- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
Batch:
Lott [numru]:
Cerezyme 400 U
Cerezyme 400U
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Cerezyme 400 U Powder for concentrate for solution for infusion imiglucerase
Cerezyme 400 U Trab għal konċentrat għal soluzzjoni għall- infużjoni Imiglucerase
Batch:
Lott {numru}:
Each vial contains 400 units of imiglucerase
Kull kunjett fih 400 unità ta ’ imiglucerase
PACKAGE LEAFLET
25 B. FULJETT TA ’ TAGĦRIF
26 PACKAGE LEAFLET:
26 FULJETT TA ’ TAGĦRIF:
Cerezyme 200 U powder for concentrate for solution for infusion Imiglucerase
Cerezyme 200 U trab għal konċentrat għal soluzzjoni għall- infużjoni Imiglucerase
It may harm them, even
Tista ’
if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
please tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Cerezyme is and what it is used for.
X’ inhu Cerezyme u għalxiex jintuża.
Before you use Cerezyme.
Qabel ma tieħu Cerezyme.
How to use Cerezyme.
Kif għandek tieħu Cerezyme.
Possible side effects.
X’ effetti oħra jista ’ jkollu.
How to store Cerezyme.
Kif taħżen Cerezyme.
Further Information
Aktar tagħrif
WHAT CEREZYME IS AND WHAT IT IS USED FOR
X’ INHU CEREZYME U GĦALXIEX JINTUŻA
Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, and who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of platelets - a type of blood cell), spleen or liver enlargement or bone disease.
Cerezyme għandu jintuża fil- każ ta ’ pazjenti li fid- dijanjosi ġew ikkonfermati li kellhom it- Tip 1 jew it- Tip 3 tal- marda Gaucher u li juru sinjali tal- marda bħal: anemija (numru baxx ta ’ ċelluli ħomor tad- demm), tendenza li jkollhom emorraġiji (minħabba n- numru baxx ta ’ plejtlets - tip ta ’ ċellula tad- demm), tkabbir tal- milsa jew tal- fwied jew mard ta ’ l- għadam.
People with Gaucher disease have low levels of an enzyme called β -glucocerebrosidase.
Persuni li jbatu mill- marda ta ’ Gaucher għandhom livelli baxxi ta ’ enżima magħrufa bħala β- glukocerebrosidase.
This enzyme helps the body control levels of glucocerebroside.
Din l- enżima tgħin lill- ġisem jikkontrolla l- livelli tal- glukocerebroside.
Glucocerebroside is a natural substance in the body, made of sugar and fat.
Glukocerebroside hi sustanza naturali fil- ġisem, magħmula minn zokkor u xaħam.
In Gaucher disease glucocerebroside levels can get too high.
Fil- każ tal- marda Gaucher il- livelli tal- glukocerebroside jistgħu jkunu għoljin aktar milli suppost.
Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme β - glucocerebrosidase which is lacking or not active enough in patients with Gaucher disease.
Cerezyme hi enżima artifiċjali magħrufa bħala imiglucerase – din tista ’ tissostitwixxi l- enżima naturali β- glukocerebrosidase li tkun nieqsa jew mhux attiva biżżejjed f' pazjenti li jbatu bil- marda Gaucher.
The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Dan it- tagħrif f’ dan il- fuljett japplika għall- gruppi kollha tal- pazjenti li inkludu tfal, adoloxxenti, adulti u persuni anzjani.
BEFORE YOU USE CEREZYME
QABEL MA TUŻA CEREZYME
Do not use Cerezyme
Tużax Cerezyme:
- If you are allergic (hypersensitive) to imiglucerase, or
- jekk inti allerġik/ a (tbati minn sensittività eċċessiva) għal imiglucerase jew
- if you are allergic to any of the other ingredients of Cerezyme.
- jekk inti allerġiku/ a għal xi wieħed mis- sustanzi ta ’ Cerezyme
Take special care with Cerezyme
Oqgħod attent ħafna b’ Cerezyme:
- If you are treated with Cerezyme, you may experience an allergic reaction while you are being
- Jekk qed tiġi trattat b’ Cerezyme, jista ’ jkollok reazzjoni allerġika waqt li qed tingħata
given the medicine or shortly after.
l- mediċina jew ftit wara.
If you experience a reaction like this, you should tell your doctor immediately.
Jekk ikollok reazzjoni bħal din, inti għandek tgħid lit- tabib tiegħek minnufih.
Your doctor may test if you have an allergic reaction to imiglucerase.
It- tabib tiegħek ser jittestja jekk għandekx reazzjoni allerġika għal imiglucerase.
- Some patients with Gaucher disease have high blood pressure in the lungs (pulmonary
- Xi pazjenti li jbatu mill- marda Gaucher għandhom pressjoni għolja tad- demm fil- pulmuni
hypertension).
(ipertensjoni pulmonari).
It can occur whether the patient is treated with Cerezyme or not.
Il- kawża tista 'ma tkunx magħrufa, jew tista' tkun kaġun ta 'problemi tal- qalb, tal- pulmuni jew tal- fwied, Tista' tiġri kemm jekk il- pazjent ikun ikkurat b‘ Cerezyme jew le.
But, if you suffer with any shortness of breath you should tell your doctor.
Imma, jekk tbati minn kwalunkwe qtugħ ta 'nifs, int għandek tgħarraf lit- tabib tiegħek.
27 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki dawk mingħajr riċetta.
Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Cerezyme m’ għandux jingħata bħala taħlita ma ’ prodotti mediċinali oħra fl- istess infużjoni (dripp).
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or think you may be pregnant.
Tqala u treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tuża din il- mediċina jekk int tqila jew jekk taħseb li int għandek mnejn tkun tqila.
Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.
L- użu b’ mod kawt ta ’ Cerezyme waqt it- tqala u t- treddigħ huwa rakkomandat.
HOW TO USE CEREZYME
KIF JINTUŻA CEREZYME
Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion).
Struzzjonijiet għall- użu kif suppost Cerezyme jingħata permezz ta ’ dripp għal ġo vina (permezz ta 'infuzjoni ġol- vina).
It is supplied as a powder which will be mixed with sterile water before it is given.
Hu fornut bħala trab li jista ’ jkun imħallat ma ’ ilma sterili qabel ma jingħata.
Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Cerezyme jintuża biss taħt is- supervizjoni tat- tabib li jifhem fit- trattament tal- marda Gaucher.
Your dose will be specific to you.
Id- doża tiegħek ser tkun għalik biss.
Your doctor will work out your dose based on how severe your symptoms are, and other factors.
It- tabib tiegħek ser jikkalkula d- doża tiegħek skond kemm ikunu severi s- sintomi tiegħek, u fatturi oħra.
The recommended dose of Cerezyme is 60 units/ kg body weight given once every 2 weeks.
Id- doża rrakkomandata ta 'Cerezyme hi ta ’ 60 unità/ kg tal- piż tal- ġisem li tingħata darba kull gimagħtejn.
Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/ she finds the best dose to control your symptoms.
It- tabib tiegħek ser jiċċekkja bir- reqqa r- rispons tiegħek għat- trattament tiegħek u għandu mnejn jibdel id- doża tiegħek (’ l fuq jew ’ l isfel) sakemm hu/ hi ssib l- aħjar doża biex jikkontrolla s- sintomi tiegħek.
Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose.
Hekk kif tinsab din id- doża t- tabib tiegħek ser jibqa ’ jiccekkja r- rispons tiegħek biex ikun żgur li int qed tużau d- doża xierqa.
This might be every 6 to 12 months.
Dan għandu mnejn isir bejn kull 6 xhur sa 12- il xahar.
There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease.
M’ hemm l- ebda tagħrif dwar l- effett ta ’ Cerezyme fuq sintomi li huma bbażati fuq il- moħħ ta ’ pazjenti li jbatu mill- marda kronika newronopatika ta 'Gaucher.
Therefore no special dosage regimen can be recommended.
Mela ma jista 'jkun rrakkomandat l- ebda reġimen speċjali ta ’ dożaġġ.
The ICGG Gaucher Registry You can ask your doctor to register your patient information into the “ ICGG Gaucher Registry”.
Ir- Reġistru ta 'l- ICGG Gaucher Int tista ’ tistaqsi lit- tabib tiegħek biex jirreġistra t- tagħrif tiegħek fir - “ Reġistru ta ’ l- ICGG Gaucher ”.
The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works.
L- għanijiet ta ’ dan ir- Reġistru huma sabiex jitkabbar il- fehim tal- marda Gaucher u biex jiċċekkja kemm qed taħdem tajjeb it- terapija tas- sostituzzjoni ta ’ l- enżimi bħal Cerezyme.
This should lead to an improvement in the safe and effective use of Cerezyme.
Dan għandu jwassal għal titjib fl- użu sigur u effettiv ta 'Cerezyme.
Your patient data will be registered anonymously – nobody will know it is information about you.
Il- pazjent tiegħek ser ikun irreġistrat b' mod anonimu – ħadd mhu ser ikun jaf li hu tagħrif dwarek.
If you use more Cerezyme than you should There are no cases of overdose of Cerezyme reported.
Jekk tieħu Cerezyme aktar milli suppost L- ebda każ ta ’ doża eċċessiva ta ’ Cerezyme ma ġie rraportat.
If you forget to use Cerezyme If you have missed an infusion, please contact your doctor.
Jekk tinsa tieħu Cerezyme Jekk immissjajt infużjoni, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew l- ispiżjar tiegħek.
Like all medicines, Cerezyme can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Cerezyme jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.
Jekk tħoss xi effetti sekondarji serji oħra jew xi effetti sekondarji li mhumiex imsemmijin hawn taħt jekk jogħġbok għid lit- tabib tiegħek minnufih.
28 Common side effects (occurring in more than 1 in 100 patients) are:
Effetti sekondarji komuni (li jseħħu f’ aktar minn 1 f’ 100 pazjent)
- breathlessness
- nuqqas ta ’ nifs
- hives/ localised swelling of the skin or lining of the mouth or throat
- ħorriqiqa, tinfiħ lokalizzat tal- ġilda jew fir- riti tal- ħalq jew tal- griżmejn
- itching
- ħakk
Uncommon side effects (occurring in more than 1 in 1000 patients) are:
Effetti sekondarji mhux komuni (li jseħħu f’ aktar minn 1 f’ 1000 pazjent)
- dizziness
- stordament
- a sensation of tingling, pricking, burning or numbness of the skin
- sensazzjoni ta ’ tnemin, qris, ħruq jew tirżiħ tal- ġilda
- increased heart rate
- żieda fit- taħbit tal- qalb
- bluish skin
- ġilda blu
- flushing
- fwawar
- fall in blood pressure
taqa ’ il- pressjoni tad- demm
- vomiting
- remettar
- nausea
- dardir
- abdominal cramping
- bugħawwieġ addominali
- pain in the joints
- uġigħ fil- ġogi
- infusion site discomfort
- skumdità fis- sit ta ’ l- infużjoni
- infusion site burning
- ħruq fis- sit ta ’ l- infużjoni
- infusion site swelling
- nefħa fis- sit ta ’ l- infużjoni
- injection site sterile abcess
- axxess sterili fis- sit ta ’ l- injezzjoni
- chest discomfort
- skumdità fis- sider
- fever
- deni
- rigors
- tertir
Some side effects were seen primarily while patients were being given the medicine or shortly after.
Effetti oħra dehru prinċipalment waqt li pazjenti kienu qed jieħdu l- mediċina jew ftit wara.
These have included itching, flushing, hives/ localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin and fall in blood pressure.
Dawn kienu jinkludu ħakk, fwawar, ħorriqija, tinfiħ lokalizzat tal- ġilda jew fir- riti tal- ħalq jew tal - griżmejn, skumdità fis- sider, żieda fit- taħbit tal- qalb, ġilda blu, nuqqas ta ’ nifs, sensazzjoni ta ’ tnemin, qris, ħruq jew tirżiħ tal- ġilda u l- pressjoni tad- demm tinżel.
If you experience any of these symptoms, please tell your doctor immediately.
Jekk tħoss xi wieħd minn dawn is- sintomi, jekk jogħġbok għarraf lit- tabib minnufih.
You may need to be given additional medicines to prevent an allergic reaction (e. g. antihistamines and/ or corticosteroids).
Jista ’ jkun li tingħata mediċini oħra sabiex tipprevjeni reazzjoni allerġika (eż. anti- ħistamini u/ jew kortikosterojdi).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jaggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CEREZYME
KIF TAĦŻEN CEREZYME
Store in a refrigerator (2°C – 8°C) Do not use Cerezyme after the expiry date printed on the labelling after the letters “ EXP”.
Aħżen fi friġġ (2°Ċ - 8°Ċ).
The expiry date refers to the last date of that month.
Id- data ta ’ meta jiskadi tirreferi għall- aħħar data ta ’ dak ix- xahar.
It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.
Hu rrakkomandat li Cerezyme jintuża minnufih wara li jitħallat ma 'l- ilma sterili.
The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.
Is- soluzzjoni mħallta fil- kunjett ma tistax tinħażen u għandha tkun dilwita minnufih f' borża ta 'l- infużjoni; is- soluzzjoni dilwita biss tista' tinżamm sa 24 siegħa f' post frisk (2°Ċ - 8°Ċ) u f’ post mudlam.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- drenaġġ jew ma l- iskart domesiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi l- mediċini li m' għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta 'l- ambjent.
What Cerezyme contains
X’ fih Cerezyme
- The active substance is imiglucerase.
- Is- sustanza attiva hi imiglucerase.
Imiglucerase is a modified form of the human enzyme β -
Imiglucerase hi forma modifikata ta ’ enżima umana
glucocerebrosidase produced by recombinant DNA technology.
β- glukocerebrosidase prodott mit- teknoloġija rikombinanti tad- DNA.
One vial contains 200 units of imiglucerase.
Kunjett wieħed fih 200 unità ta ’ imiglucerase.
After reconstitution, the solution contains 40 units of imiglucerase per ml.
Wara r- rikonstituzzjoni, is- soluzzjoni fiha 40 unità ta ’ imiglucerase kull ml.
- Other ingredients are:
- Ingredjenti oħra huma:
Mannitol Sodium citrate Citric acid monohydrate Polysorbate 80
Mannitol Sodium citrate Citric acid monohydrate Polysorbate 80
Important information about some of the ingredients of Cerezyme This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution.
Tagħrif importanti dwar xi ingredjenti ta ’ Cerezyme Dan il- prodott mediċinali fih sodium u jingħata bħala soluzzjoni ġol- vina ta ’ 0. 9% sodium chloride.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jittieħed inkonsiderazzjoni minn pazjenti fuq dieta ta 'sodium ikkontrollat.
What Cerezyme looks like and contents of the pack Cerezyme, 200 U, is presented as a powder for concentrate for solution for infusion (in a vial- pack size of 1 or 25).
Id- Dehra ta ’ Cerezyme u l- kontenuti tal- pakkett Cerezyme, 200 U, hu ppreżentat bħala trab għal konċentrat għal soluzzjoni għall- infużjoni (f’ pakkett ta ’ kunjett ta ’ 1, jew 25).
Cerezyme is supplied as a white to off-white powder.
Cerezyme hu fornut bħala trab ta ’ lewn bejn abjad u off- white.
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Wara r- rikonstituzzjoni, ikun likwidu ċar, trasparenti mingħajr l- ebda frak barrani.
The reconstituted solution must be further diluted.
Is- soluzzjoni rikonstitwita trid tkun dilwita aktar.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizazzjoni għat- tqegћid fis- suq u l- Manifattur
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, 1411 DD, Naarden, The Netherlands
Id- Detentur ta ’ l- Awtorizazzjoni għat- tqegћid fis- suq Genzyme Europe B. V, Gooimeer 10, 1411 DD, Naarden, l- Olanda
Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Manifattur Genzyme Ltd, 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, Renju Unit
30 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
30 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq:
Č eská Republika/ Slovenská Republika/ Slovenija Genzyme Europe B. V. organizač ní slož ka (Č eská Republika, Republika Č eš ka) Tel: +420 227 133 665
Česká Republika/ Slovenská Republika/ Slovenija Genzyme Europe B. V. organizační složka (Česká Republika) Tel: +420 227 133 665
España Genzyme, S. L., Tel: +34 91 6591670 France Genzyme S. A. S, Tél: + 33 (0) 825 825 863 Italia/ Malta Genzyme Srl (Italia/ Italja), Tel: +39 059 349811
España Genzyme, S. L., Tel: +34 91 6591670 France Genzyme S. A. S, Tél: + 33 (0) 825 825 863 Italja/ Malta Genzyme Srl (Italia/ Italja) Tel: +39 059 349811
This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links ghall- websites oħra dwar mard rari u kura.
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħha:
Instructions for use – reconstitution, dilution and administration Each vial of Cerezyme is for single use only.
Istruzzjonijiet dwar l- użu – rikonstituzzjoni, dilwazzjoni u għoti Kull kunjett ta ’ Cerezyme għandu jintuża darba biss.
After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Wara r- rikostituzzjoni, kull kunjett ta ’ Cerezyme fih 200 unitajiet ta ’ imugluċerasi f’ 5. 0 ml (40 unità kull ml).
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
31 Iddeċiedi kemm- il kunjett trid tirrikostitwixxi skond ir- reġim tad- doża tal- pazjent individwali u neħħi l- kunjetti mill- friġġ.
31 Use Aseptic Technique Reconstitution Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
L- Użu ta ’ Teknika Asettika Rikostituzzjoni Irrikkostitwixxi kull kunjett b’ 5. 1 ml ta ’ ilma għall- injezzjonijiet; evita l- impatt qawwi ta ’ l- ilma għall- injezzjonijiet fuq it- trab, u ħawwad bil- mod, sabiex tevita ’ li s- soluzzjoni tagħmel r- ragħwa.
The reconstituted volume is 5.3 ml.
Il- volum rikostitwit hu 5. 3 ml.
The pH of the reconstituted solution is approximately 6.1.
Il- pH tas- soluzzjoni rikostitwita hu madwar 6. 1.
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Wara r- rikostituzzjoni huwa likwidu ċar, mingħajr kulur u ħieles mill- materja barranija.
Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration.
Qabel ma ssir aktar dilwazzjoni, spezzjona viżwalment is- soluzzjoni rikostitwita f’ kull kunjett għal xi frak u għal xi telf ta’ kulur.
Do not use vials exhibiting foreign particles or discoloration.
Tużax kunjetti li fihom trab jew tilfu l- kulur.
After reconstitution, promptly dilute vials and do not store for subsequent use.
Wara r- rikostituzzjoni, iddilwa immedjatament il- kunjetti u taħżinhomx għall- użu aktar tard.
Dilution The reconstituted solution contains 40 units imiglucerase per ml.
Dilwazzjoni Is- soluzzjoni rikostitwita fiha 40 unità imigluċerasi kull ml.
The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Il- volum rikostitwit jippermetti l- ġbid eżatt ta ’ 5. 0 ml (daqs 200 unitajiet) minn kull kunjett.
Withdraw 5.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Iġbed 5. 0 ml soluzzjoni rikostitwita minn kull kunjett u ħallat il- volumi miġbuda.
Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
Imbagħad ddilwa l- volumi imħallta b’ soluzzjoni li tingħata ghal ġol- vina ta ’ 0. 9% klorur tas- sodju għal volum totali ta ’ minn 100 sa 200 ml.
Administration It is recommended that the diluted solution be administered within 3 hours.
L- Għoti Hu rrakkomandat li s- soluzzjoni dilwita tingħata fi żmien tliet sigħat.
The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Il- prodott dilwit f’ soluzzjoni li tingħata għal ġol- vina ta ’ 0. 9% klorur tas- sodju iżżomm l- istabilità kimika jekk tinħażen sa 24 siegħa f’ temperatura ta ’ 2°Ċ u 8°Ċ u f’ post speċjali li ma jarax id- dawl; imma s- sigurtà mikrobijoloġika ser tiddependi minn jekk ir- rikostituzzjoni u dilwazzjoni sarux b’ mod assettiku.
Cerezyme contains no preservatives.
Cerezyme ma fihx l- ebda preservattivi.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
32 PACKAGE LEAFLET:
32 FULJETT TA ’ TAGĦRIF:
Cerezyme 400 U powder for concentrate for solution for infusion Imiglucerase
Cerezyme 400 U trab għal konċentrat għal soluzzjoni għall- infużjoni Imiglucerase
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il - mediċina.
It may harm them, even
M’ għandekx tgħaddiha lil persuni oħra. Tista ’
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
please tell your doctor or pharmacist
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Cerezyme is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, and who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleeding easily (due to low numbers of platelets– a type of blood cell), spleen or liver enlargement or bone disease.
Cerezyme għandu jintuża fil- każ ta ’ pazjenti li fid- dijanjosi ġew ikkonfermati li kellhom it- Tip 1 jew it- Tip 3 tal- marda Gaucher u li juru sinjali tal- marda bħal: anemija (numru baxx ta ’ ċelluli ħomor tad- demm), tendenza li jkollhom emorraġiji (minħabba n- numru baxx ta ’ plejtlets - tip ta ’ ċellula tad- demm), tkabbir tal- milsa jew tal- fwied jew mard ta ’ l- għadam.
Cerezyme is an artificial enzyme called imiglucerase -this can replace the natural enzyme β - glucocerebrosidase which is lacking or not active enough in patients with Gaucher disease.
Cerezyme hi enżima artifiċjali magħrufa bħala imiglucerase – din tista ’ tissostitwixxi l- enżima naturali β- glukocerebrosidase li tkun nieqsa jew mhux attiva biżżejjed f' pazjenti li jbatu bil- marda Gaucher.
Take special care with Cerezyme
33 Oqgħod attent ħafna b’ Cerezyme:
33 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki dawk mingħajr riċetta.
Cerezyme should not be given as a mixture with other medicinal products in the same infusion (drip).
Cereżyme m’ għandux jingħata bħala taħlita ma ’ prodotti mediċinali oħra fl- istess infużjoni (dripp).
Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.
Tqala u treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tuża din il- mediċina jekk int tqila jew jekk taħseb li int għandek mnejn tkun tqila. L- użu b’ mod kawt ta ’ Cerezyme waqt it- tqala u t- treddigħ huwa rakkomandat..
This should lead to improvement in the safe and effective use of Cerezyme.
Dan għandu jwassal għal titjib fl- użu sigur u effettiv ta 'Cerezyme.
Your patient data will be registered anonymously– nobody will know it is information about you.
Il- pazjent tiegħek ser ikun irreġistrat b' mod anonimu – ħadd mhu ser ikun jaf li hu tagħrif dwarek.
If you forget to use Cerezyme If you have missed an infusion, please contact your doctor.
34 Jekk tinsa tieħu Cerezyme Jekk immissjajt infużjoni, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Like all medicines, Cerezyme can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Cerezyme jista ’ jkollu effetti sekondarji għalkemm ma jidhrux fuq kulħadd.
34 If you experience any serious side effects or side effects not listed below, please tell your doctor immediately.
Jekk tħoss xi effetti sekondarji serji oħra jew xi effetti sekondarji li mhumiex imsemmijin hawn taħt jekk jogħġbok għid lit- tabib tiegħek minnufih.
Common side effects (occurring in more than 1 in 100 patients) are:
Effetti sekondarji komuni (li jseħħ f’ aktar minn 1 f’ 100 pazjent)
- fall in blood pressure
- taqa ’ il- pressjoni tad- demm
These have included itching, flushing, hives/ localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin and fall in blood pressure.
Dawn kienu jinkludu ħakk, fwawar, ħorriqija, tinfiħ lokalizzat tal- ġilda jew fir- riti tal- ħalq jew tal- griżmejn, skumdità fis- sider, żieda fit- taħbit tal- qalb, ġilda blu, nuqqas ta ’ nifs, sensazzjoni ta ’ tnemin, qris, ħruq jew tirżiħ tal- ġilda u l- pressjoni tad- demm tinżel.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jaggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, għid lit- tabib jew lill- ispiżjar tiegħek.
Store in a refrigerator (2°C – 8°C) Do not use Cerezyme after the expiry date printed on the labelling after the letters “ EXP”.
M’ għandekx tuża Cerezyme wara d- data li tiskadi li tidher fuq it- tikketta wara l- ittri “ JIS ”.
35 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- drenaġġ jew ma l- iskart domesiku.
6 FURTHER INFORMATION
AKTAR TAGĦRIF
One vial contains 400 units of imiglucerase.
Kunjett wieħed fih 400 unità ta ’ imiglucerase.
What Cerezyme looks like and contents of the pack Cerezyme, 400 U, is presented as a powder for concentrate for solution for infusion (in a vial- pack size of 1, 5 or 25).
Id- Dehra ta ’ Cerezyme u l- kontenuti tal- pakkett Cerezyme, 400 U, hu ppreżentat bħala trab għall- konċentrat għal soluzzjoni għal- infużjoni (f’ pakkett ta ’ kunjett ta ’ 1, 5 jew 25).
Marketing Authorisation Holder and Manufacturer
Id- Detentur tal- Awtorizazzjoni għat- tqegћid fis- suq u l- Manifattur
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, 1411 DD, Naarden, The Netherlands
Id- Detentur tal- Awtorizazzjoni għat- tqegћid fis- suq Genzyme Europe B. V, Gooimeer 10, 1411 DD, Naarden, l- Olanda
36 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
36 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq:
After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Wara r- rikostituzzjoni, kull kunjett ta ’ Cerezyme fih 200 unitajiet ta ’ imugluċerasi f’ 5. 0 ml (40 unità kull ml).
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
37 Iddeċiedi kemm- il kunjett trid tirrikostitwixxi skond ir- reġim tad- doża tal- pazjent individwali u neħħi l- kunjetti mill- friġġ.
37 Use Aseptic Technique Reconstitution Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
L- Użu ta ’ Teknika Asettika Rikostituzzjoni Irrikkostitwixxi kull kunjett b’ 10. 2 ml ta ’ ilma għall- injezzjonijiet; evita l- impatt qawwi ta ’ l- ilma għall- injezzjonijiet fuq it- trab, u ħawwad bil- mod, sabiex tevita ’ li s- soluzzjoni tagħmel r- ragħwa.
The reconstituted volume is 10.6 ml.
Il- volum rikostitwit hu 10. 6 ml.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Il- volum rikostitwit jippermetti l- ġbid eżatt ta ’ 10. 0 ml (daqs 400 unitajiet) minn kull kunjett.
Withdraw 10.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Iġbed 10. 0 ml soluzzjoni rikostitwita minn kull kunjett u ħallat il- volumi miġbuda.
Cerezyme contains no preservatives.
Cerezyme ma fixh l- ebda preservattivi.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Cervarix?
X’ inhu Cervarix?
Cervarix is a vaccine.
Cervarix huwa vaċċin.
It is a suspension for injection that contains purified ‘ L1 proteins ’ for two types of the human papillomavirus (types 16 and 18).
Dan huwa sospensjoni għal injezzjoni li fiha ‘ proteini L1 ’ purifikati għal żewġ tipi ta ’ papillomavirus uman (tipi 16 u 18).
It is available in a vial or in a prefilled syringe.
Huwa disponibbli f’ kunjett jew f’ siringa mimlija minn qabel.
What is Cervarix used for?
Għal xiex jintuża Cervarix?
Cervarix is used to protect against precancerous lesions (abnormal cell growth) in the cervix and cancer of the cervix that are caused by infection with human papillomavirus (HPV) types 16 or 18.
Cervarix jintuża għall- protezzjoni kontra leżjonijiet prekanċerużi (tkabbir anomalu taċ- ċelloli) fiċ - ċerviċi u kanċer tal- għonq tal- utru kkawżati minn infezzjoni mill- papillomavirus uman (HPM), tipi 16 jew 18.
This use is based on demonstration of the effectiveness of Cervarix in women aged 15 to 25 years, and of its immunogenicity (its ability to make the immune system respond to the vaccine) in girls and women aged 10 to 25 years.
L- effikaċja ta ’ Cervarix intweriet f’ nisa f’ età bejn 15 u 25 sena filwaqt li l- immunoġeniċità tiegħu (jiġifieri l- kapaċità tiegħu li jġiegħel lis- sistema immunitarja tirrispondi għall- vaċċin) ġiet studjata fi bniet u nisa f’ età minn 10 sa 25 sena.
Cervarix is given according to official recommendations.
Cervarix jingħata skont ir- rakkomandazzjonijiet uffiċjali.
How is Cervarix used?
Kif jintuża Cervarix?
Cervarix is given to individuals aged 10 years or older, as three doses, with one month between the first and second doses, and five months between the second and third doses.
Cervarix jingħata lil individwi f’ età ta ’ 10 snin jew aktar, fi tliet dożi u jitħalla intervall ta ’ xahar bejn l- ewwel u t- tieni doża, u ħames xhur bejn it- tieni u t- tielet doża.
It is recommended that individuals who receive the first dose of Cervarix should complete all three doses with Cervarix.
Ladarba tingħata l- ewwel doża, huwa rakkomandat li l- individwu jtemm iċ- ċiklu komplut tat- tliet dożi b’ Cervarix.
The vaccine is given as an injection into the muscle of the upper arm.
Il- vaċċin jingħata b’ injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ.
Cervarix is not recommended for use in girls aged below 10 years, due to a lack of information on safety and immunogenicity in this group.
Cervarix mhuwiex rakkomandat għall- użu fi bniet f’ età taħt l- 10 snin, minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- immunoġeniċità f’ dan il- grupp.
How does Cervarix work?
Kif jaħdem Cervarix?
Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Il- papillomavirus huma virus li jikkawżaw felul u tkabbir anomalu tat- tessuti.
There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Jeżistu ‘ l fuq minn 100 tip ta ’ papillomavirus, uħud minnhom huma assoċjati ma ’ kanċers ġenitali.
HPV types 16 and 18 cause approximately 70% of cervical cancers.
It- tipi 16 u 18 tal- HPV jikkawżaw madwar 70% tal- kanċers tal- għonq tal- utru.
All papillomaviruses have a shell or ‘ capsid’, which is made up of proteins called ‘ L1 proteins’.
Il- papillomavirus kollha għandhom qoxra jew ‘ kapside ’, magħmula minn proteini msejħin ‘ proteini L1 ’.
Cervarix contains purified L1 proteins for two of the types of HPV: types 16 and 18.
Cervarix fih il- proteini L1 purifikati għal żewġ tipi ta ’ HPV: tipi 16 u 18.
The proteins in Cervarix are produced by a method known as ‘ recombinant DNA technology’: they are made by a cell that has received a gene (DNA) that makes it able to produce the L1 proteins.
Il- proteini f’ Cervarix huma prodotti b’ metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: dawn jinkisbu minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi proteini L1.
The proteins are assembled in ‘ virus-like particles’ (structures that look like HPV, so that the body can recognise them
Il- proteini jinġemgħu f ’ ‘ partiċelli qishom virus ’ (strutturi li jixbhu l- HPV, sabiex il- ġisem ikun jista ’ jagħrafhom faċilment).
The vaccine is made using an ‘ adjuvant system ’ that contains MPL, a purified lipid (a fat-like substance) extracted from bacteria, which acts as an immunostimulant: it enhances the response of the immune system (the system that fights diseases) to the vaccine.
Il- vaċċin jinkiseb permezz ta ’ ‘ sistema adjuvanti ’ li fiha MPL li huwa lipidu purifikat (sustanza li tixbah ix- xaħam) estratt mill- batterji, li jaġixxi bħala immunostimulanti; jiġifieri jqanqal ir- risposta tas- sistema immunitarja (is- sistema li tiġġieled il- mard) lill- vaċċin.
The vaccine is ‘ adsorbed’, which means that the L1 protein virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.
Il- vaċċin jgħaddi minn ‘ adsorbiment ’, li jfisser li l- partiċelli qishom virus tal- proteini L1 u l- MPL jitwaħħlu fuq kompost tal - aluminju, biex tiġi stimulata risposta immunitarja aħjar.
When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Meta pazjent jingħata l- vaċċin, is- sistema immunitarja tipproduċi antikorpi kontra l- proteini L1.
The antibodies help to destroy the virus.
L - antikorpi jgħinu biex jinqered il- virus.
After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the viruses.
Wara l- vaċċinazzjoni, is- sistema immunitarja tkun kapaċi tipproduċi antikorpi b’ ritmu iktar mgħaġġel f’ każ ta ’ espożizzjoni għall- virus.
This will help to protect against the diseases caused by these viruses.
Dan se jgħin fil - protezzjoni mill- mard ikkawżat minn dawn il- virus.
How has Cervarix been studied?
Kif ġie studjat Cervarix?
The effects of Cervarix were first tested in experimental models before being studied in humans.
L- effetti ta ’ Cervarix għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bniedem.
The main study involved almost 19,000 women aged between 15 and 25 years.
L- istudju prinċipali involva kważi 19, 000 mara f’ età bejn 15 u 25 sena.
Cervarix was compared to another vaccine, which is not active against HPV (in this case, a vaccine against hepatitis A virus).
Cervarix tqabbel ma ’ vaċċin ieħor, li mhuwiex attiv kontra l- HPV (f’ dan il- każ, vaċċin kontra l- virus tal- epatite A).
The study looked at how many women who were originally uninfected with HPV types 16 and 18 went on to develop precancerous lesions in the cervix linked to infection with these types of HPV.
L- istudju eżamina l- għadd ta ’ nisa li oriġinarjament ma kinux infettati mill- HPV tat- tipi 16 u 18 li sussegwentement żviluppaw leżjonijiet prekanċerużi fiċ- ċerviċi marbuta mal- infezzjoni ma ’ dawn it - tipi ta ’ HPV.
The study was still ongoing at the time of the assessment and will continue for up to four years.
L- istudju kien għadu għaddej waqt li kienet qiegħda ssir il- valutazzjoni u se jkompli sa massimu ta ’ erba ’ snin.
An additional two studies also looked at the development of antibodies to HPV types 16 and 18 in 2,225 girls aged between 10 and 14 years.
Żewġ studji addizzjonali eżaminaw ukoll l- iżvilupp ta ’ antikorpi kontra l- HPV tat- tipi 16 u18 f’ 2, 225 tifla f’ età bejn 10 u 14- il sena.
The studies compared the levels of antibodies between before vaccination and after the third dose (at month seven).
L- istudji qabblu l- livelli ta ’ antikorpi qabel il- vaċċinazzjoni u wara t- tielet doża (fis- seba ’ xahar).
What benefit has Cervarix shown during the studies?
X' benefiċċji wera Cervarix matul l- istudji mwettqa?
Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix.
Cervarix irriżulta aktar effikaċi mill- vaċċin tat- tqabbil fil- prevenzjoni ta ’ tkabbir anomalu taċ- ċelloli fiċ- ċerviċi.
This compared with 21 of the almost 8,000 women receiving the other vaccine.
Fl- istudju prinċipali, wara medja ta ’ 15- il xahar, tnejn fost it- 8, 000 mara li rċevew tal - lanqas doża waħda ta ’ Cervarix u li fl- imgħoddi ma ġewx infettati minn HPV tat- tip 16 jew 18, żviluppaw leżjonijiet prekanċerużi fl- għonq tal- utru marbuta ma ’ dawn it- tipi ta ’ HPV, meta mqabbel mal- 21 mara fost kważi 8, 000 li rċevew vaċċin ieħor.
The additional studies showed that all of the girls aged 10 to 14 years who were given Cervarix developed protective levels of antibodies against HPV types 16 and 18.
L- istudji addizzjonali wrew li l- bniet kollha f’ età bejn 10 u 14- il sena vaċċinati b’ Cervarix żviluppaw livelli protettivi ta ’ antikorpi kontra l- HPV tat- tipi 16 u 18.
This indicated that the vaccine is likely to be effective in preventing HPV infection in girls from the age of 10 years.
Dan indika li l- vaċċin aktarx huwa effikaċi fil- prevenzjoni tal- infezzjoni mill- HPV fil- bniet mill- età ta ’ 10 snin.
What is the risk associated with Cervarix?
X’ inhu r- riskju assoċjat ma ’ Cervarix?
The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
L- effetti sekondarji l- aktar komuni b’ Cervarix (li dehru f' aktar minn pazjent 1 minn 10) huma wġigħ ta 'ras, mijalġija (uġigħ fil- muskoli), reazzjonijiet fil- punt tal- injezzjoni fosthom uġigħ, ħmura u nefħa, u għeja.
For the full list of all side effects reported with Cervarix, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rappurtati ma ’ Cervarix, ara l- Fuljett ta ’ Tagħrif.
Cervarix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Cervarix ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għas- sustanza attiva jew għal kwalunkwe sustanza oħra tiegħu.
Vaccination should be postponed in patients who are ill with a high fever.
Il- vaċċinazzjoni għandha tkun posposta f’ pazjenti morda b’ deni għoli.
Why has Cervarix been approved?
Għaliex ġie approvat Cervarix?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cervarix’ s benefits are greater than its risks for the prevention of premalignant cervical lesions and cervical cancer causally related to HPV types 16 and 18.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Cervarix huma ogħla mir- riskji tiegħu fil- prevenzjoni ta ’ leżjonijiet ċervikali premalinji u kanċer tal - għonq tal- utru kkawżati minn HPV tat- tipi 16 u 18.
The Committee recommended that Cervarix be given marketing authorisation.
Il- Kumitat irrakkomanda li Cervarix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Cervarix:
Aktar tagħrif dwar Cervarix:
The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix to GlaxoSmithKline Biologicals s. a. on 20 September 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Cervarix lil GlaxoSmithKline Biologicals s. a. fl- 20 ta 'Settembru 2007.
The full EPAR for Cervarix can be found here.
L- EPAR sħiħ għal Cervarix jista ’ jiġi konsultat hawn.
This summary was last updated in 10-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
Strength
Qawwa -- 1
1 vial
-- 1
EU/ 1/ 07/ 419/ 002
Suspensjoni għall - injezzjoni
Cervarix
Użu fil- muskolu
--1
kunjett (ħġieġ)
Suspension for injection
0. 5 ml
Intramuscular use
Kunjett wieħed
vial (glass)
Cervarix
EU/ 1/ 07/ 419/ 003
EU/ 1/ 07/ 419/ 002
Suspension for injection
Suspensjoni għall - injezzjoni
Intramuscular use
Użu fil- muskolu
100 vials
100 kunjett
pre-filled syringe (glass)
siringa mimlija minn qabel (ħġieġ)
1 pre-filled syringe + 1 needle
siringa mimlija minn qabel + 1 labra
1 pre-filled syringe + 2 needles
10 siringi mimlija minn
Intramuscular use
injezzjoni
pre-filled syringe (glass)
minn qabel (ħġieġ)
10 pre-filled syringes + 10 needles
10 siringi mimlija minn
10 pre-filled syringes + 20 needles
siringa mimlija minn
Suspension for injection
Suspensjoni għall -
0.5 ml
qabel
10 pre-filled syringes
minn qabel (ħġieġ)
1 vial (multidose)
-- 1
Cervarix
injezzjoni
Intramuscular use
(b’ ħafna dożi)
10 vials (multidose)
10 kunjetti (b’ ħafna
EU/ 1/ 07/ 419/ 012
EU/ 1/ 07/ 419/ 011
100 vials (multidose)
100 kunjett (b’ ħafna
1
EU/ 1/ 07/ 419/ 012