qanastek/EMEA-V3 huggingface dataset:
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Cerepro had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tal- CHMP kienet li l- benefiċċju ta 'Cerepro ma kienx intwera biżżejjed u li kwalunkwe benefiċċji li seta' kellu, dawn ma kinux jegħlbu r- riskji identifikati.
What were the reasons given by the company to withdraw the application?
X' kienu r- raġunijiet mogħtija mill- kumpanija għall- irtirar ta 'l- applikazzjoni?
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA dwar l- irtirar ta 'l- applikazzjoni tinsab hawn.
What are the consequences of the withdrawal for patients in clinical trials with Cerepro?
X' inhuma l- konsegwenzi ta 'l- irtirar għall- pazjenti li kienu qed jieħdu sehem fi studji kliniċi b' Cerepro?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Cerepro.
Il- kumpanija għarrfet lill- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li kienu qed jieħdu sehem fi studji kliniċi b' Cerepro.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi studju kliniku u trid iżjed tagħrif dwar it - trattament tiegħek, ikkuntattja lit- tabib li qed jagħtihulek.
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.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR). Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom 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 teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek. Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Cerezyme?
X’ inhu Cerezyme?
Cerezyme is a powder to be made up into a solution for infusion (a drip into a vein).
Cerezyme huwa trab li jsir f’ soluzzjoni għal infużjoni (drip fil- vina).
Cerezyme contains the active substance imiglucerase.
Cerezyme fih is- sustanza attiva imiglucerase.
What is Cerezyme used for?
Għalxiex jintuża Cerezyme?
Cerezyme is used as long-term enzyme replacement therapy in patients with Gaucher disease.
Cerezyme jintuża f’ terapija ta ’ sostituzzjoni ta ’ enzimi fuq perjodu ta ’ żmien twil f’ pazjenti bil- marda ta ’ Gaucher.
Gaucher disease is a rare inherited disorder.
Il- marda ta ’ Gaucher hija disturb ereditarju rari.
People with the disease do not have enough of an enzyme, glucocerebrosidase.
Nies bil- marda ma jkollhomx biżżejjed minn enzim, imsejjaħ glucocerebroside.
This enzyme normally breaks down a fatty waste product called glucocerebroside.
Dan l- enzim normalment ikisser il- prodott skartat xaħmi imsejjaħ glucocerebroside.
Without the enzyme, glucocerebroside builds up in the body, typically in the liver, spleen and bone marrow, and this produces the symptoms of the disease: anaemia (low blood count), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and fractures.
Mingħajr l- enzim, glucocerebroside jinġema ’ fil- ġisem, b’ mod partikolari fil- fwied, milsa u mudullun, u dan jipproduċi s- sintomi tal- marda: anemija (għadd baxx tad- demm), għejja, tbenġil malajr u tendenza ta ’ fsada, milsa u fwied akbar u uġigħ u ksur fl- għadam.
Cerezyme is used in patients who have type 1 (non-neuronopathic) or type 3 (chronic neuronopathic) Gaucher disease and who have one or more of the following conditions caused by the disease: • anaemia (low red blood cell counts), • thrombocytopenia (a decrease in the number of platelets in the blood), • bone disease, • hepatomegaly (enlarged liver) or splenomegaly (enlarged spleen).
Cerezyme jintuża f’ pazjenti li għandhom il- marda ta ’ Gaucher ta ’ tip 1 (mhux- newronopatika) jew ta ’ tip 3 (newronopatika kronika) u li kellhom kundizzjoni waħda jew aktar minn dawn li ġejjin ikkawżati mill- marda: • anemija (għadd ta ’ ċelloli tad- demm ħomor baxx), • tromboċitopenja (tnaqqis fin- numru ta ’ plejtlits fid- demm), • marda fl- għadam, • epatomegalija (fwied imkabbar) jew splenomegalija (milsa mkabbra).
The medicine can only be obtained with a prescription.
Din il- mediċina tista ’ tinkiseb biss b’ riċetta.
How is Cerezyme used?
Kif jintuża Cerezyme?
Cerezyme should be given by doctors experienced in the management of patients with Gaucher disease.
Cerezyme għandu jingħata minn tobba b’ esperjenza fil- ġestjoni ta ’ pazjenti bil- marda ta ’ Gaucher.
It is given by infusion over one to two hours every two weeks with higher doses at first.
Jingħata b’ infużjoni tul siegħa jew sagħtejn kull ġimagħtejn b’ dożi ogħla għall- ewwel.
The doses are then adjusted according to how the patient responds to the treatment.
Imbagħad id - dożi jiġu aġġustati skond kif jirrispondi l- pazjent għat- trattament.
Cerezyme is designed for long-term use.
Cerezyme huwa mfassal għal użu fit- tul.
How does Cerezyme work?
Kif jaħdem Cerezyme?
Gaucher disease has previously been treated using an enzyme, alglucerase, prepared from human placentae.
Il- marda ta ’ Gaucher kienet tiġi ttrattata permezz ta ’ enzim, alglucerase, imħejji minn plaċenti umani.
Imiglucerase, the active substance in Cerezyme, is a copy of this enzyme, produced by a method known as ‘ recombinant DNA technology’: the enzyme is made by a cell which has received a gene (DNA) that makes it able to produce the enzyme.
Imiglucerase, is- sustanza attiva f’ Cerezyme, hija kopja ta ’ dan l- enzim, prodott b’ metodu msejjaħ ‘ teknoloġija rekombinanti tad- DNA ’: l- enzim huwa magħmul minn ċellola li rċeviet ġene (DNA) li jagħmilha possibbli li tipproduċi enzim.
Imiglucerase helps (catalyses) the break down of glucocerebroside and stops it building up in the body.
Imiglucerase tgħin fit- tkissir (tikkatalizza) ta ’ glucocerebroside u twaqqaf il- bini tiegħu fil- ġisem.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Cerezyme been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Cerezyme?
For type 1 Gaucher disease, Cerezyme has been studied in three studies, and in a total of 40 patients (this is an acceptable number because the disease is very rare).
Għall- marda ta ’ Gaucher ta ’ tip 1, Cerezyme ġie studjat fi tliet studji u fuq total ta ’ 40 pazjent (dan huwa numru aċċettabbli minħabba li l- marda hija waħda rari).
The studies examined Cerezyme’ s effectiveness in controlling the symptoms of Gaucher disease, such as normalising (increasing) the number of red blood cells and platelets in the blood, and normalising (decreasing) the size of the liver and spleen.
L- istudji eżaminaw l- effikaċja ta ’ Cerezyme fil- kontroll tas- sintomi tal- marda ta ’ Gaucher, bħan- normalizzazzjoni (żieda) fin- numru ta ’ ċelloli tad- demm ħomor u plejtlits fid- demm, u normalizzazzjoni (tnaqqis) tad- daqs tal- fwied u tal - milsa.
Cerezyme was compared to alglucerase.
Cerezyme tqabbel ma ’ alglucerase.
For type 3 Gaucher disease (which is an extremely rare form of the disease), data from published articles and from the special register of Gaucher’ s patients were used.
Għall- marda ta ’ Gaucher ta ’ tip 3 (li hija forma rari ħafna tal- marda), intużat dejta minn artikli ppubblikati u mir- reġistru speċjali tal- pazjenti ta ’ Gaucher.
What benefit has Cerezyme shown during the studies?
X’ inhu l- benefiċċju ta ’ Cerezyme li ntwera f’ dawn l- istudji?
The studies have shown that Cerezyme is as safe and effective as alglucerase in controlling the symptoms of Gaucher disease.
L- istudji urew li Cerezyme huwa sikur u effettiv bħala alglucerase fil- kontroll tas- sintomi tal- marda ta ’ Gaucher.
It has also been shown that patients may safely switch from alglucerase to imiglucerase treatment.
Intwera li l- pazjenti jistgħu jaqilbu mingħajr riskju minn trattament b’ alglucerase għal trattament b’ imiglucerase.
What is the risk associated with Cerezyme?
X’ inhu r- riskju assoċjat ma ’ Cerezyme?
The most common side effects with Cerezyme (seen in between 1 and 10 patients in 100) are respiratory symptoms, urticaria or angioedema (hives), pruritus (itching) and rash.
L- aktar effetti sekondarji komuni b’ Cerezyme (li jidhru f’ pazjent 1 u 10 minn kull 100) huma sintomi respiratorji, urtikarja jew anġjoedema (ħorriqija), prurite (ħakk) u raxx.
Patients can develop antibodies (proteins that are produced in response to Cerezyme and can affect treatment) and they should be monitored for any allergic reaction to Cerezyme during the first year of treatment.
Il- pazjenti jistgħu jiżviluppaw antikorpi (proteini li huma prodotti b’ risposta għal Cerezyme u jistgħu jaffettwaw it- trattament) u dawn għandhom jiġu ssorveljati għal kwalunkwe reazzjoni allerġika għal Cerezyme matul l- ewwel sena tat- trattament.
Cerezyme should be used carefully in people who may be hypersensitive (allergic) to imiglucerase or any of the other ingredients.
Cerezyme għandu jintuża b’ attenzjoni minn nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal imiglucerase jew għal xi ingredjenti oħra tiegħu.
Why has Cerezyme been approved?
Għaliex ġie approvat Cerezyme?
The Committee for Medicinal products for Human Use (CHMP) decided that Cerezyme gives effective control of the symptoms of types 1 and 3 Gaucher disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Cerezyme jagħti kontroll effettiv tas- sintomi tal- marda Gaucher tat- tip 1 u 3.
The Committee decided that Cerezyme’ s benefits are greater than its risks and recommended that Cerezyme be given marketing authorisation.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Cerezyme huma akbar mir- riskji tiegħu u rrakkomanda li Cerezyme jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Cerezyme:
Tagħrif ieħor dwar Cerezyme:
The European Commission granted a marketing authorisation valid throughout the European Union for Cerezyme to Genzyme Europe B. V. on 17 November 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Cerezyme lil Genzyme Europe B. V. fis- 17 ta ’ Novembru 1997.
The marketing authorisation was renewed on 17 November 2002 and on 17 November 2007.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 17 ta ’ Novembru 2002 u fis- 17 ta ’ Novembru 2007.
The full EPAR for Cerezyme can be found here.
L- EPAR sħiħ għal Cerezyme jista ’ jinstab hawnhekk.
This summary was last updated in 11-2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ 11- 2007.
EU-number
Numru ta ’ l- EU
Trade name
Isem inventat
Packaging size
Daqs tal - pakkett
Powder for concentrate for solution for infusion
Trab għall- konċentrat għal taħlita likwida għall- infużjoni
Vial (glass)
Kunjett (ħġieġ) Kunjett
1 vial
kunjett x 1
Vial (glass)
(ħġieġ) Kunjett
25 vials
25 kunjett
Vial (glass)
(ħġieġ)
5 vials
5 kunjett
1 1.
ANNESS 1
Cerezyme 200 U Powder for concentrate for solution for infusion
Cerezyme 200 U trab għal konċentrat għal soluzzjoni għall- infużjoni
Each vial contains 200 units* of imiglucerase**.
Kull kunjett fih 200 unità * ta ’ imiglucerase **.
After reconstitution, the solution contains 40 units of imiglucerase per ml (200 U/ 5 ml).
Wara r- rikonstituzzjoni, is- soluzzjoni fiha 40 unità ta ’ imiglucerase kull ml, (200 U/ 5 ml).
* An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β -D-glucopyranoside (pNP-Glc) per minute at 37°C. ** modified form of glucocerebrosidase produced in Chinese Hamster Ovary cells by recombinant DNA technology.
* Unità (U) ta ’ enzima hi definita bħala l- ammont ta ’ enzima li tikkatalizza l- idrolisi ta ’ mikromol wieħed tas- substrat sintetiku para- nitrophenyl β- D glucopyranoside (pNP- Glc) kull minuta f’ temperatura ta ’ 37° Ċ. ** għamla modifikata ta ’ glucocerebrosidase prodotta miċ- ċelloli ta ’ l- ovarju tal- Ħamster Ċiniż b’ teknoloġija rikombinanti tad- DNA.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Dan il- prodott mediċnali fih is- sodju u jiġi mogħti f’ soluzzjoni ta ’ 0. 9% ta ’ sodium chloride ġol- vina (ara sezzjoni 6. 6).
After reconstitution, the solution contains 0.62 mmol sodium (200 U/ 5 mL).
Wara r- rikostituzzjoni, is- soluzzjoni jkun fiha 0. 62 mmol sodju (200 U/ 5 mL).
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jitqies minn pazjenti li qegħdin fuq dieta kkontrollata tas- sodju.
Cerezyme is a white to off-white powder.
Cerezyme hu trab ta ’ kulur bejn bajdani u off- white.
Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease and who exhibit clinically significant non-neurological manifestations of the disease.
Cerezyme (imiglucerase) hu indikat għall- użu tat- terapija fit- tul li tinvolvi s- sostituzzjoni enzimatika f’ pażjenti li għandhom dijanjosi konfermata tal- marda Gaucher li mhix newropatika (Tip 1) jew newropatika kronika (Tip 3) u li juru sinjali tal- marda li huma klinikament sinifikanti u li mhux newroloġiċi.
The non-neurological manifestations of Gaucher disease include one or more of the following conditions: • anaemia after exclusion of other causes, such as iron deficiency • thrombocytopenia • bone disease after exclusion of other causes such as Vitamin D deficiency • hepatomegaly or splenomegaly
Is- sinjali li mhux newroloġiċi tal- marda Gaucher jinkludu wieħed jew aktar mill- kondizzjonijiet li jidhru hawn taħt: • anemija wara l- esklużjoni ta ’ kawżi oħra, bħal defiċjenza tal- ħadid • tromboċitopenija • mard ta ’ l- għadam wara l- esklużjoni ta ’ kawżi oħra bħal defiċjenza tal- Vitamina D • epatomegalija jew splenomegalija
Therapy should be directed by physicians knowledgeable in the management of Gaucher disease.
It- terapija ser tkun immaniġġjata minn speċjalisti tal- marda Gaucher.
Posology for Adults, Children and Elderly Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of the clinical manifestations of the disease.
Minħabba l- eteroġeneità u n- natura multi- sistematika tal- marda Gaucher, id- doża għandha tkun individwalizata għal kull pazjent skond evalwazzjoni komprensiva tas- sinjali kliniċi tal- marda.
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
2 Firxa ta ’ reġimi ta ’ doża wrew li huma effettivi għal xi wħud jew is- sinjali kollha tal- marda li mhumiex newroloġiċi.
Initial doses of 60 U/ kg of body weight once every 2 weeks have shown
Dożi inizjali ta ’ 60 U/ kg tal- piż tal- ġisem darba kull ġimagħtejn urew titjib fil- parametri ematoloġiċi u vixxerali fi żmien 6 xhur ta ’ terapija u l- użu kontinwu waqqaf il- progressjoni jew tejjeb il- mard ta ’ l- għadam.
Administration of doses as low as 2.5 U/ kg of body weight three times a week or 15 U/ kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters.
L- għoti ta ’ dożi baxxi daqs 2. 5 U/ kg tal- piż tal- ġisem tliet darbiet fil- ġimgħa jew 15 U/ kg tal- piż tal- ġisem darba kull ġimagħtejn urew titjib fil- parametri ematoloġiċi u organomegali, imma mhux fil- parametri ta ’ l- għadam.
The usual, and for the patient, most convenient frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
Il- frekwenza ta ’ l- infużjoni normali u l- aktar konvenjenti għall- pazjent hu ta ’ darba kull ġimagħtejn; din hi l- frekwenza ta ’ l- infużjoni li hemm l- aktar informazzjoni dwarha.
Patient responses must be routinely evaluated and dosages should only be adjusted (up or down) based on a comprehensive evaluation of patient response relating to all clinical manifestations of the disease.
Ir- reazzjonijiet tal- pazjenti jridu jkunu evalwati regolarment u d- dożi għandhom ikunu aġġustati (’ l fuq jew ’ l isfel) biss wara evalwazzjoni komprensiva tar- reazzjoni tal- pazjent li għandha x’ taqsam mas- sinjali kliniċi tal- marda.
Once individual patient response for all relevant clinical manifestations is well-established and stabilised, dosages may be adjusted for continued effective therapy, while continuing to closely monitor response parameters and patient well-being.
Hekk kif ir- reazzjoni individwali tal- pazjent għas- sinjali kliniċi rilevanti kollha tkun stabbilita sew u stabilizzat ruħha, id- doża tista ’ tkun aġġustata għat- terapija effettiva kontinwa, waqt li jibqgħu sorveljati bir- reqqa l- parametri tar- reazzjoni u l- ġid ta ’ saħħet il- pazjent.
Usual monitoring intervals range from 6 to 12 months.
L- intervalli regolari biex tagħmel osservazzjoni ivarjaw bejn 6 sa 12- il xahar.
The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
L- effikaċja ta ’ Cerezyme fuq is- sintomi newroloġikali ta ’ pazjenti li jbatu bil- marda kronika u newronopatika tal- Gaucher ma ġietx stabbilita u ma jista ’ jiġi rrakkomandat l- ebda reġimen speċjali ta ’ dożaġġ għal dawn il- manifestazzjonijiet (ara sezzjoni 5. 1).
After reconstitution and dilution (see section 6.6) the preparation is administered by intravenous infusion over 1 to 2 hours.
Wara r- rikonstituzzjoni u d- dilwazzjoni (ara sezzjoni 6. 6) il- preparazzjoni tingħata permezz ta ’ infużjoni ġol- vina fuq medda ta ’ minn siegħa sa sagħtejn.
Alternatively, the appropriate dose of Cerezyme may be administered at a rate not exceeding 1 unit per kg body weight per minute.
Inkella, id- doża xierqa ta ’ Cerezyme għandha mnejn tingħata f’ rata li ma taqbiżx unità 1 għal kull kg tal- piż tal- ġisem kull minuta.
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ ICGG Gaucher Registry” (see section 5.1).
Il- professjonisti mediċi u tal- kura tas- saħħa huma mħeġġa li jirreġistraw il- pazjenti bil- marda Gaucher, inklużi dawk li għandhom sinjali kroniċi u newropatiċi tal- marda, fir- reġistru ta ’ l- ICGG Gaucher (ara sezzjoni 5. 1).
Hypersensitivity to the active substance or to any of the excipients (see section 4.4).
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 4. 4).
Hypersensitivity Current data suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients.
Sensittività eċċessiva L- informazzjoni attwali tissuġġerixxi li, matul l- ewwel sena ta ’ terapija, anti- korpi ta ’ l- IgG għal imiglucerase ffurmaw f’ bejn wieħed u ieħor 15% tal- pazjenti li ngħataw il- kura.
It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy.
Jidher li l- pazjenti li jkunu ser jiżviluppaw l- anti- korpi IgG wisq probabbli jagħmlu dan fi żmien 6 xhur u jkunu qed jingħataw kura u rarament jiżviluppaw anti- korpi għal Cerezyme wara 12- il xahar ta ’ terapija.
It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Huwa rakkomandat li pazjenti suspettati li għandhom rispons mnaqqas għat- trattament jiġu ssorveljati perjodikament għal formazzjoni ta ’ antikorpi ta ’ l- IgG għal imiglucerase.
Patients with antibody to Cerezyme (imiglucerase) have a higher risk of hypersensitivity reactions (see section 4.8).
Pazjenti b’ anti- korpi għal Cerezyme (imiglucerase) għandhom riskju ogħla ta ’ reazzjonijiet ta ’ sensittività eċċessiva (ara sezzjoni 4. 8).
If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised.
Jekk il- pazjent jesperjenza reazzjoni suġġestiva ta ’ sensittività eċċessiva, hu rakkomandat li jkun hemm testijiet sussegwenti għal anti- korpi ta ’ l- imiglucerase.
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible.
Bħal f’ prodott ta ’ proteina li tingħata ġol- vina, reazzjonijiet ta ’ sensittività eċċessiva dovuti għal allerġiji severi huma possibbli.
The current medical standards for emergency treatment are to be observed.
Jekk dawn ir- reazzjonijiet iseħħu, huwa rakkomandat li l- infużjoni ta ’ Cerezyme tieqaf minnufih u trattament mediku xieraq għandu jinbeda, L- istandards mediċi attwali għal trattament ta ’ emerġenza għandhom jiġu osservati.
Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme (imiglucerase).
Pazjenti li żviluppaw anti- korpi jew sintomi ta ’ sensittività eċċessiva għal Ceradese (alglucerase) għandhom ikunu ikkurati b’ attenzjoni meta jingħataw Cerezyme (imiglucerase).
Pulmonary hypertension Pulmonary hypertension is a known complication of Gaucher disease.
3 Ipertensjoni pulmonari Ipertensjoni pulmonari hi komplikazzjoni magħrufa tal- marda Gaucher.
It has been observed both in patients receiving and not receiving enzyme replacement therapy.
Din kienet osservata kemm fil- pazjenti li kienu qegħdin jirċievu t- terapija li tinvolvi s- sostituzzjoni enzimatika u kemm dawk li ma kinux qed jirċevuha.
No causal relationship with enzyme replacement therapy has been established.
Ma kienet stabilita l- ebda relazzjoni każwali mat- terapija li tinvolvi s- sostituzzjoni enzimatika.
Patients with respiratory symptoms should be evaluated for the presence of pulmonary hypertension.
Pazjenti li għandhom sintomi respiratorji għandhom ikunu evalwati għall- preżenza ta ’ ipertensjoni pulmonari.
3 Excipients This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Sustanzi mhux attivi Dan il- prodott mediċinali fih is- sodium u jingħata f’ soluzzjoni ta ’ 0. 9% sodium chloride li tingħata ġol- vina (ara sezzjoni 6. 6).
To be taken into consideration by patients on a controlled sodium diet.
Pazjenti li qegħdin fuq dieta ta 'sodium ikkontrollat għandhom iqiesu dan.
No interaction studies have been performed.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
4.6 Pregnancy and lactation
Tqala u treddigħ 4. 6.
Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying Gaucher disease in pregnancy.
Esperjenza limitata minn 150 każ ta ’ tqala (ibbażati prinċipalment minn rapporti spontanji u reviżjoni tal- letteratura medika) hi disponibbli li tissuġerixxi li l- użu ta ’ Cerezyme hu ta ’ siwi biex jikkontrolla l- marda ta ’ Gaucher fl- isfond fit- tqala.
Furthermore, these data indicate no malformative toxicity for the foetus by Cerezyme, although the statistical evidence is low.
Barra minn hekk dan it- tagħrif jindika li m’ hemmx tossiċità għal formazzjoni ħażina għal fetu, għalkemm l- evidenza statistika hija baxxa.
Foetal demise has been reported rarely, although it is not clear whether this related to the use of Cerezyme or to the underlying Gaucher disease.
Il- mewt ta ’ feti ġiet rapportata b’ mod rari, għalkemm mhux ċar jekk din kinetx tirrelata mal- użu ta ’ Cerezyme jew mal- marda ta ’ Gaucher fl- isfond.
No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/ foetal development, parturition and postnatal development.
Ma sarux studji fuq l- annimali sabiex jiġu assessjati l- effetti ta ’ Corezyme fit- tqala, l- iżvilupp embrijonali/ fetali, it- twelid u l- iżvilupp ta ’ wara t- twelid.
It is not known whether Cerezyme passes via the placenta to the developing foetus.
Mhux magħruf jekk Cerezyme jgħaddiex mis- sekonda għal fetu li qed jiżviluppa.
In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy.
Għal pazjenti tqal bil- marda ta ’ Gaucher, u għal dawk maħsuba biex jinqabdu tqal, hu meħtieġ li ssir stima tat- trattament tar- riskju- siwi għal kull tqala.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Pazjenti li għandhom il- marda ta ’ Gaucher u jinqabdu tqal jistgħu jesperjenzaw perijodu ta ’ attività ogħla tal- marda waqt it- tqala u fil- pwerperjum.
This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion.
Dan jinkludi riskju ogħla ta ’ manifestazzjonijiet skeletriċi, tħarrix ta ’ ċitopenija, emorraġija u ħtieġa akbar ta ’ trasfużjoni.
Both pregnancy and lactation are known to stress maternal calcium homeostasis and to accelerate bone turnover.
Kemm it- tqala u it- treddigħ huma magħrufin li jistressjaw l- omeostasi tal- kalċju matern u li jħaffef ir- rendiment tal- għadam.
This may contribute to skeletal disease burden in Gaucher disease.
Dan jista ’ jikkontribwixxi għal mard skeletali agħar fil- marda ta ’ Gaucher.
Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health.
Nisa inkonsapevoli mit- trattament għandhom jingħataw parir sabiex jibdew it- terapija qabel il- konċepiment sabiex jilħqu l- aħjar saħħa.
In women receiving Cerezyme treatment continuation throughout pregnancy should be considered.
Il- kontinwazzjoni waqt it- tqala għandu jiġi kkonsidrat f’ nisa li qed jirċievu t- trattament b’ Cerezyme.
Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose according to the patient ’ s needs and therapeutic response.
Monitoraġġ mill- qrib tal- manifestazzjonijiet waqt it- tqala u dawk kliniċi tal- marda Gaucher huwa meħtieġ sabiex tingħata doża individwali skond il- ħtiġijiet tal- pazjent u r- rispons terapewtiku.
It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child ’ s gastrointestinal tract
Mhux magħruf jekk is- sustanza attiva tiġix eliminata fil- ħalib tal- bniedem, madankollu, l- enżima x’ aktarx tiġi diġerita fl- apparat gastrointestinali tat- tarbija.
Cerezyme has no or negligible influence on the ability to drive and use machines.
Cerezyme m’ għandu l- ebda effett jew ftit li xejn għandu fuq il- ħila ta ’ sewqan u l- użu tal- magni.
4.8 Undesirable effects
4 4. 8 Effetti mhux mixtieqa
Adverse drug reactions are listed by system organ class and frequency (common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100)) in the table below.
Ir- reazzjonijiet avversi tal- mediċina huma elenkati skond il- klassi organika u sistematika u frekwenza (komuni (≥1/ 100 sa < 1/ 10) u mhux komuni (≥1/ 1, 000 sa 1/ 100) fil- lista hawn taħt..
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl - aktar serji jitniżżlu l- ewwel.
Tachycardia, cyanosis Vascular disorders
Disturbi tas- sistema nervuża Mhux komuni Sturdamenti, uġigħ ta ’ ras, paraestesija Disturbi fil- qalb Mhux komuni Takikardja, ċijanożi, Disturbi vaskulari
Uncommon:
Mhux komuni
Flushing, hypotension
Fwawar, pressjoni baxxa
Common:
Komuni
Respiratory symptoms
Sintomi respiratorji
Vomiting, nausea, abdominal cramping, diarrhoea
Remettar, dardir, brim addominali, dijarea,
Musculoskeletal and connective tissue disorders
Disturbi fil- ġilda u t- tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeletriċi u tat- tessut konnettiv
Urticaria/ angioedema, pruritus, rash
Urtikarja/ anġjodema, prurite, raxx
Arthralgia
Artralġja
Infusion site discomfort, infusion site burning, infusion site swelling, injection site sterile abscess, chest discomfort, fever, rigors, fatigue
Skumdità fis- sit ta ’ l- injezzjoni, ħruq fis- sit ta ’ l- injezzjoni, tinfiħ fis- sit ta ’ mnejn jingħata, axxess sterili tas- sit mnejn jingħata, Skumdità fis- sider, deni, tertir, għeja
In a small number of patients undesirable effects have been reported which are related to the route of administration: discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture.
Kienu rapportati f’ numru żgħir ta ’ pazjenti effetti mhux mixtieqa li għandhom x’ jaqsmu ma ’ mnejn jingħata: skumdità, ħakk tal- ġilda, ħruq, nefħa, jew axxess sterili fis- sit tad- dħul fil- vina.
Symptoms suggestive of hypersensitivity have been noted in approximately 3% of the patients.
Kienu osservati sintomi li jissuġġerixxu sensittività eċċessiva f’ madwar 3% tal- pazjenti.
Onset of such symptoms has occurred during or shortly after infusions; these have included pruritus, flushing, urticaria/ angioedema, chest discomfort, tachycardia, cyanosis, respiratory symptoms, and paraesthesia.
Dawn is- sintomi bdew matul jew ftit wara l- infużjoni; dawn kienu jinkludu ħakk tal- ġilda, fawra, urtikarja/ anġjoedema, uġigħ fis- sider, takikardija, ċjanożi, sintomi respiratorji, u paraestesja.
Hypotension associated with hypersensitivity has also been reported rarely.
Kienet irraportata rarament wkoll pressjoni baxxa assoċjata ma ’ sensittività eċċessiva.
These symptoms generally respond to treatment with antihistamines and/ or corticosteroids.
Dawn is- sintomi ġeneralment jirrispondu għat- trattament b’ antiħistamini u/ jew kortikosterojdi.
Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Il- pazjenti għandhom jingħataw parir biex ma jkomplux l- infużjoni tal- prodott u jikkuntattjaw lit- tabib tagħhom jekk ikun hemm dawn is- sintomi.
Enzymes-Imiglucerase (recombinant macrophage targeted β - glucocerebrosidase), ATC code:
Enżimi- Imiglucerase (β- glukocerebrosidase rikombinanta u mmirata lejn il- makrofagi), Kodiċi ATC:
Imiglucerase (recombinant macrophage targeted β -glucocerebrosidase) catalyses the hydrolysis of the glycolipid, glucocerebroside, to glucose and ceramide following the normal degradation pathway for membrane lipids.
Imiglucerase (β- glukocerebrosidase rikombinanta u mmirata lejn il- makrofagi) jikkatilizza l- idrolosi tal- glikolipidu, glukocerebroside, għall- glukows u ċeramidi wara l- kors ta’ degradazzjoni normali għall- membrani lipidi.
Glucocerebroside is primarily derived from haematopoietic cell turnover.
5 Glukocerebroside hu principalment miksub waqt li jkunu qed isiru ċ- ċelluli ematopoietiċi.
Gaucher disease is characterised by a functional deficiency in β -glucocerebrosidase enzymatic activity and the resultant accumulation of lipid glucocerebroside in tissue macrophages, which become engorged and are termed Gaucher cells.
Il- marda Gaucher hi karaterizzata minn defiċjenza funzjonali fl- attività enzimatika ta ’ β- glukocerebrosidase u l- akkumulazzjoni li tirrużulta ta ’ lipidu glukocerebroside fil- makrofagi tat- tessuti, li jinstaddu u jgħidulhom ċelluli Gaucher.
Gaucher cells are typically found in liver, spleen and bone marrow and occasionally, as well, in lung, kidney and intestine.
Normalment iċ- ċelluli Gaucher jinstabu fil- fwied, milsa, mudulun ta ’ l- għadam, u anki kultant, fil- pulmun, il- kliewi u l- imsaren.
Secondary haematologic sequelae include severe anaemia and thrombocytopenia
Is- sintomi ematoloġiċi sekondarji jinkludu anemija severa u tromboċitopenija barra l- epatosplenomegalija progressiva u karatteristika.
The skeletal complications are a common, and frequently the most debilitating and disabling feature of Gaucher disease.
Il- komplikazzjonijiet skeletali huma komuni u huma spiss l- aktar fattur li jdgħajjef u jidiżabilita fil- marda Gaucher.
Possible skeletal complications are: osteonecrosis, osteopenia with secondary pathological fractures, remodeling failure, osteosclerosis and bone crises.
Komplikazzjonijiet possibbli skeletali huma: ostejonekrosi, osteopenja bi qsim patoloġiku u sekondarju, falliment fl- imodellar mill- ġdid, ostjosklerosi u kriżi ta ’ l- għadam.
No controlled clinical studies have been conducted on the efficacy of Cerezyme on neurological manifestations of the disease.
Ma saru l- ebda studji kontrollati u kliniċi fuq l- efikaċja ta ’ Cerezyme fuq is- sinjali newroloġiċi tal- marda.
Therefore no conclusions on the effect of enzyme replacement therapy on the neurological manifestations of the disease can be drawn.
Għalhekk ma wasalna għall- ebda konklużjoni fuq l- effett tat- terapija tas- sostituzzjoni ta ’ l- enżima fuq is- sinjali newroloġiċi tal- marda.
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ ICGG Gaucher Registry”.
Professjonisti mediċi u tal- kura tas- saħħa huma mħeġġa jirreġistraw il- pazjenti Gaucher, inklużi dawk li għandhom sinjali kroniċi u newropatiċi tal- marda fir- reġistru ta ’ l- ICGG Gaucher.
Patient data will be anonymously collected in this Registry.
L- informazzjoni dwar il- pazjent ser jinġabru b’ mod anonimu fir- Reġistru ta ’ l- ICGG Gaucher.
The objectives of the “ ICGG Gaucher Registry” are to enhance the understanding of Gaucher disease and to evaluate the effectiveness of enzyme replacement therapy, ultimately leading to improvement in the safe and efficacious use of Cerezyme.
L- objettivi tar- reġistru ta ’ l- ICGG Gaucher huwa li jsaħħaħ l- għarfien tal- marda Gaucher u biex jiġi evalwat l- effettività tat- terapija tas- sostituzzjoni ta ’ l- enzima, u dan għandu jwassal fl- aħħarnett fit- titjib fl- użu mingħajr periklu u effikaċi ta’ Cerezyme.
During 1 hour intravenous infusions of 4 doses (7.5, 15, 30, 60 U/ kg) of imiglucerase, steady-state enzymatic activity was achieved by 30 minutes.
Matul is- siegħa ta ’ l- infużjoni għal ġol- vina ta ’ erbgħa dożi (7. 5, 15, 30, 60 U/ kg) ta ’ imiglucerase, intlaħqet attività enzimatika ta ’ stat stabbli fi 30 minuta.
Following infusion, plasma enzymatic activity declined rapidly with a half-life ranging from 3.6 to 10.4 minutes.
Wara l- infużjoni, l- attività enzimatika tal- plażma naqset malajr b’ half- life ta ’ bejn 3. 6 sa 10. 4 minuti.
Plasma clearance ranged from 9.8 to 20.3 ml/ min/ kg, (mean ± S. D, 14.5 ± 4.0 ml/ min/ kg).
Ir- rata tat- tneħħija mill- plażma kienet ta ’ bejn 9. 8 sa 20. 3 ml/ min/ kg, (medja ± S. D, 14. 5 ± 4. 0 ml/ min/ kg).
The volume of distribution corrected for weight ranged from 0.09 to 0.15 l/ kg (mean ± S. D 0.12 ± 0.02 l/ kg).
Il- volum tad- distribuzzjoni aġġustata għall- piż tvarja minn 0. 09 sa 0. 15 1/ kg (medju ± S. D 0. 12 ± 0. 02 1/ kg).
These variables do not appear to be influenced by dose or duration of infusion, however, only 1 or 2 patients were studied at each dose level and infusion rate.
Dawn il- varjabbli ma jidhrux li huma influwenzati mid- doża jew minn kemm damet l- infużjoni, imma, pazjent wieħed jew tnejn biss kienu studjati f’ kull livell tad- doża u r- rata ta ’ l- infużjoni.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, and genotoxicicty.
Informazzjoni mhux ta ’ l- użu kliniku ma turi l- ebda periklu speċjali għall- bnedmin skond it- tagħrif konvenzjonali fuq is- sigurtà farmakoloġika, l- effett tossiku ta ’ doża waħda u l- effett tossiku ta ’ dożi ripetuti, u ġenotossiċità.
Mannitol Sodium citrate (to adjust pH) Citric acid monohydrate (to adjust pH) Polysorbate 80
Mannitol Sodium Citrate (biex ikun aġġustat il- pH) Citric acid monohydrate (biex ikun aġġustat il- pH) Polysorbate 80.
6.2 Incompatibilities
6. 2 Inkompatibilatijiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li jaqblu miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
6.3 Shelf life
6 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Unopened vials:
Kunjetti mhux miftuħa:
2 years
Sentejn.
Diluted solution:
Soluzzjonijiet dilwiti:
From a microbiological safety point of view, the product should be used immediately.
Mil- lat tas- sigurtà mikrobijoloġika, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C under protection from light.
Jekk ma jintużax immedjatament, il- ħżin fl- użu u l- kondizzjonijiet ta ’ qabel l- użu huma r- responsabilità ta ’ min juża l- prodott u m’ għandux ikun għal aktar minn 24 siegħa f’ temperatura ta ’ bejn 2°Ċ - 8°Ċ.
6 6.4 Special precautions for storage
6. 4 Prekawzjonjiet speċjali għall- ħażna
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°Ċ - 8°Ċ).
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm go fih
Cerezyme is supplied in type I borosilicate (clear) glass 20 ml vials.
Cerezyme jista ’ jinkiseb f’ kunjetti tal- ħġieġ tal- borosilicate tip I (ċar) ta ’ 20 ml.
The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Dan il- kunjett jingħalaq permezz ta ’ tapp ta ’ butyl silikonizzat u għandu għatu li ttajru b’ daqqa ta ’ saba ’ li juri jekk dan ikun infetaħ qabel.
To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.3 ml.
Biex nipprovdu volum biżżejjed ħalli jkun jista ’ jingħata l- ammont eżatt, kull kunjett hu fformulat biex ikun jista ’ jesgħa ammont żejjed ta ’ 0. 3 ml.
Package sizes:
Daqsijiet tal- pakkett:
1 or 25 vials per carton.
Kunjett 1 jew 25 kunjett kull kartuna.
Not all package sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijet kollha jkunu għall- skop kummerċjali.
6.6 Special precautions for disposal and other handling
Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġjar 6. 6 ieħor
Each vial of Cerezyme is for single use only.
Kull kunjett ta ’ Cerezyme hu intiż li jintuża darba biss.
The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
It- trab għall- konċentrat għas- soluzzjoni għall- infużjoni irid ikun rikostitwit bl- ilma għall- injezzjonijiet, dilwit b’ soluzzjoni waħda ta ’ 0. 9% ta ’ sodium chloride u li tingħata permezz ta ’ infużjoni ġol- vina.
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Iddeċiedi kemm kunjetti jridu jkunu rikostitwiti skond ir- reġim tad- doża individwali tal- pazjent u neħhi l- kunjetti mill- friġg.
Occasionally, small dosage adjustments may be made to avoid discarding partially used vials.
Kultant, għandhom mnejn isiru aġġustamenti żgħar tad- doża biex tkun evitata r- rimi ta ’ kunjetti li għad fadlilhom xi ftit.
Dosages may be rounded to the nearest full vial, as long as the monthly administered dosage remains substantially unaltered.
Id- dożi jistgħu jiżdiedu sa l- eqreb kunjett mimli, basta d- doża li tingħata kull xahar tibqa ’ essenzjalment l- istess.
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.
Użu ta ’ Teknika Asettika Rikostituzzjoni Irrikostitwixxi kull kunjett b’ 5. 1 ml ilma għall- injezzjonijiet, evita impatt qawwi ta ’ l- ilma għall- injezzjonijiet fuq it- trab u, ħalltu bil- mod sabiex tevita li s- soluzzjoni tagħmel ir- ragħwa.
The reconstituted volume is 5.3 ml.
Il- volum rikostitwit hu ta ’ 5. 3 ml.
The pH of the reconstituted solution is approximately 6.1.
Il- pH tas- soluzzjoni rikostitwita hu bejn wieħed u ieħor 6. 1.
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Wara r- rikostituzzjoni s- soluzzjoni hija likwidu ċar, mingħajr kulur u ħielsa mill- materja barranija.
The reconstituted solution must be further diluted.
Is- soluzzjoni rikostitwita għandha tiġi dilwita aktar.
Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration.
Qabel ma tiddilwija aktar, ivverifika viżwalment is- soluzzjoni rikostitwita f’ kull kunjett għal xi frak u telf ta ’ kulur.
Do not use vials exhibiting foreign particles or discoloration.
Tużax kunjetti li fihom frak jew li tilfu l- kulur.
After reconstitution, promptly dilute vials and do not store for subsequent use.
Wara r- rikostituzzjoni, iddilwa immedjatament il- kunjett u taħżnux għall- użu aktar tard.
Dilution The reconstituted solution contains 40 units imiglucerase per ml.
7 Dilwazzjoni Is- soluzzjoni rikostitwita fiha 40 unità ta ’ imigluċerase kull ml.
The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Il- volum rikostitwit jippermeti l- ġbid eżatt ta ’ 5. 0 ml (daqs 200 unità) 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 flimkien il- volumi li kont ġbidt.
Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
Imbagħad iddilwa l- volumi mħallta b ’ soluzzjoni ta ’ 0. 9% ta ’ sodium chloride li tingħata ġol- vina għal volum totali ta ’ 100 sa 200 ml.
Mix the infusion solution gently.
Ħallat is- soluzzjoni ta ’ l- infużjoni bil- mod.
It is recommended that the diluted solution be administered within 3 hours.
Hu rakomandat li 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 ta ’ 0. 9% ta ’ sodium chloride li tingħata ġol- vina ser iżomm l- istabbilità 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.
Cerezyme contains no preservatives.
Cerezyme ma fih 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 wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Genzyme Europe, B. V., Gooimeer 10, NL- 1411 DD Naarden, l- Olanda.
MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIŻŻAZZJONI
17 September 2007
17 ta ’ Novembru 1997 Data ta ’ l- aħħar tiġdid: 17/ 09/ 2007
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 /
Cerezyme 400 U Powder for concentrate for solution for infusion
Cerezyme 400 U trab għal konċentrat għal soluzzjoni għall- infużjoni
Each vial contains 400 units* of imiglucerase**.
Kull kunjett fih 400 unità * ta ’ imiglucerase **.
After reconstitution, the solution contains 40 units of imiglucerase per ml (400 U/ 10 ml).
Wara r- rikonstituzzjoni, is- soluzzjoni fiha 40 unità ta ’ imiglucerase kull ml, (400 U/ 10 ml).
Excipients:
Sustanzi mhux attivi:.
After reconstitution, the solution contains 1.24 mmol sodium (400 U/ 10 mL).
Wara r- rikostituzzjoni, is- soluzzjoni jkun fiha 0. 62 mmol sodju (200 U/ 5 mL).
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
9 Firxa ta ’ reġimi ta ’ doża wrew li huma effettivi għal xi wħud jew is- sinjali kollha tal- marda li mhuxiex newroloġiċi.
Hypersensitivity Current data suggest that, during the first year of therapy, IgG antibodies to imigluceraseare formed in approximately 15% of the treated patients.
Sensittività eċċessiva L- informazzjoni attwali tissuġġerixxi li, matul l- ewwel sena ta ’ terapija, anti- korpi ta ’ l- IgG għal imiglucerase ffurmaw f’ bejn wieħed u ieħor 15% tal- pazjenti li ngħataw il- kura.
Pulmonary hypertension Pulmonary hypertension is a known complication of Gaucher disease.
10 Ipertensjoni pulmonari Ipertensjoni pulmonari hi komplikazzjoni magħrufa tal- marda Gaucher.
10 Excipients This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Sustanzi mhux attivi Dan il- prodott mediċinali fih is- sodium u jingħata f’ soluzzjoni ta ’ 0. 9% sodium chloride li tingħata ġol- vina (ara sezzjoni 6. 6).
4.8 Undesirable effects
11 4. 8 Effetti mhux mixtieqa
Adverse drug reactions are listed by system organ class and frequency (common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100)) in the table below.
Ir- reazzjonijiet avversi tal- mediċina huma elenkati skond il- klassi organika u sistematika u frekwenza (komuni (≥1/ 100 sa < 1/ 10) u mhux komuni (≥1/ 1, 000 sa 1/ 100) fil- lista hawn taħt.
Glucocerebroside is primarily derived from haematopoietic cell turnover.
12 Glukocerebroside hu principalment miksub waqt li jkunu qed isiru ċ- ċelluli ematopoietiċi.
13 6.4 Special precautions for storage
6. 4 Prekawzjonjiet speċjali għall- ħażna
Store in a refrigerator (2°C – 8°C).
Aħżen fi- friġġ (2°Ċ - 8°Ċ).
To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.6 ml.
Biex nipprovdu volum biżżejjed ħalli jkun jista ’ jingħata l- ammont eżatt, kull kunjett hu fformulat biex ikun jista ’ jesgħa ammont żejjed ta ’ 0. 6 ml.
1, 5 or 25 vials per carton.
Kunjett 1, 5 jew 25 kunjett kull kartuna.
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.
Użu ta ’ Teknika Asettika Rikostituzzjoni Irrikostitwixxi kull kunjett b’ 10. 2 ml ilma għall- injezzjonijiet, evita impatt qawwi ta ’ l- ilma għall- injezzjonijiet fuq it- trab u, ħalltu bil- mod sabiex tevita li s- soluzzjoni tagħmel ir- ragħwa.
The reconstituted volume is 10.6 ml.
Il- volum rikostitwit hu ta ’ 10. 6 ml.
Dilution The reconstituted solution contains 40 units imiglucerase per ml.
14 Dilwazzjoni Is- soluzzjoni rikostitwita fiha 40 unità ta ’ imigluċerase kull ml.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Il- volum rikostitwit jippermeti l- ġbid eżatt ta ’ 10. 0 ml (daqs 400 unità) 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 flimkien il- volumi li kont ġbidt.