qanastek/EMEA-V3 huggingface dataset:
Safety was evaluated in either the entire study population (4 studies) or in a
Is- sigurtà kienet evalwata jew fil- popolazzjoni studjata kollha (4 studji) jew f’ sett speċifiku definit minn qabel (studju wieħed) tal- popolazzjoni studjata bl- użu ta sorveljanza megħjuna b' kard ta ’ rappurtaġġ tat- tilqima (VRC) għal 14- il jum wara kull injezzjoni ta ’ Silgard jew tal- plaċebo
The subjects who were monitored using VRC-aided surveillance included 6,160 subjects (5,088 females 9 to 26 years of age and 1,072 males 9 to 15 years of age at enrolment) who received Silgard and 4,064 subjects who received placebo.
16 Il- pazjenti li kienu mmonitorjati bl- użu ta ’ sorveljanza megħjuna bil- VRC inkludew 6, 160 pazjent (5, 088 mara, ta ’ età bejn 9 u 26 sena, u 1, 072 raġel ta ’ età bejn 9 u 15- il sena fiż- żmien tar - reġistrazzjoni) li rċivew Silgard u 4, 064 pazjent li rċevew il- plaċebo.
Gastrointestinal disorders: nausea, vomiting.
Disturbi gastro- intestinali: nawsea, rimettar.
17 4.9 Overdose
17 4. 9 Doża eċċessiva
In general, the adverse event profile reported with overdose was comparable to recommended single doses of Silgard.
B’ mod ġenerali, il- profil ta ’ l- avvenimenti avversi rrapputati b’ doża eċċessiva kien komparabbli ma 'dak tad- doża waħidha rakkomandata ta ’ Silgard.
The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/ 3), high-grade vulvar intraepithelial neoplasia (VIN 2/ 3) and high- grade vaginal intraepithelial neoplasia (VaIN 2/ 3).
It- terminu "leżjonijiet ġenitali premalinni" f’ sezzjoni 4. 1. jikkorrespondi għal neoplasja intraepiteljali ċervikali ta ’ grad għoli (CIN 2/ 3), neoplasja intraepiteljali vulvari ta ’ grad għoli (VIN 2/ 3) u neoplasja intraepiteljali vaġinali ta ’ grad għoli (VaIN 2/ 3).
At end of study, subjects enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Fl- aħħar tal- istudju, is - suġġetti rreġistrati fiż- żewġ studji ta ’ Fażi III (Protokoll 013 u Protokoll 15) ġew segwiti għal perjodu sa 4 snin (medjan 3. 7 snin).
Cervical Intraepithelial Neoplasia (CIN) Grade 2/ 3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
18 In- Neoplasja Intraepiteljali Ċervikali (CIN) ta ’ Grad 2/ 3 (displasja moderata sa grad għoli) u adenokarċinoma in situ (AIS) intużaw fi provi kliniċi bħala indikazzjoni sostituttiva għall- kanċer ċervikali.
18 Prophylactic Efficacy against Vaccine HPV Types (HPV 6, 11, 16, or 18)
Effikaċja profilattika kontra Tipi ta ’ Vaċċini HPV (HPV 6, 11, 16 jew 18)
of of
każijiet
(95% CI) of
każijiet
of of (95% CI) of of
f’ sena 2
(95% CI)
istudju
subjects* subjects*
(95% CI)
subjects* subjects*
Numru Numru Numru Numru ta ’ ta ’ ta ’ ta ’
0 53
suġġetti * suġġetti * 0
100.0
suġġetti * 100. 0
(93.5, 99.8)
2 **
HPV 16/ 18-related CIN 3
(88. 4, 99. 6)
0 8487
100. 0)
91.4, 98.4)
91. 4, 98. 4) fil- protokolli kkombinati wara 3 snin.
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related VIN2/ 3 and VaIN 2/ 3 was 100% (95% CI:
19 l- effikaċja ta ’ Silgard kontra VIN2/ 3 u VaIN 2/ 3 relatata ma ’ HPV 6 -, 11 -, 16 -, 18 kienet 100% (95% CI:
19 follow-up of up to 4 years (mean of 3.6 years).
93. 2, 100. 0) għal HPV 18 rispettivament, wara follow- up ta ’ massimu ta ’ 4 snin (medja ta ’ 3. 6 sena).
Placebo Silgard
Placebo Silgard
%
Numru
Number
Numru ta ’ Numru ta ’
Efficacy**
%
Efficacy** of cases
Effikaċja **
Number of Number at 2 years Number Number
fl- aħħar
study
Numru ta ’
of
f’ sena 2
subjects* subjects*
Numru ta ’
HPV 16- or HPV
Numru ta ’
54.3
(< 0, 87. 6)
37.6, 98.4), and against HPV 6-, 11-, 16-, 18- related genital warts was 80.3% (95% CI:
20 ġenitali relatat ma ’ HPV 6 -, 11 -, 16 -, 18 li kienet 80. 3% (95% CI:
23.7, 57.3) and of genital 20 warts by 82.8% (95% CI:
Fil- popolazzjoni ITT, it- tnaqqis korrespondenti kien 23. 9% (95% CI:
The efficacy of Silgard against CIN (any grade) and CIN 2/ 3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Effikaċja kross- protettiva L- effikaċja ta ’ Silgard kontra CIN (kull grad) u CIN 2/ 3 jew AIS ikkawżati minn 10 tipi ta ’ HPV mhux vaċċin (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strutturalment relatati ma ’ HPV 16 jew ma ’ HPV 18, ġiet evalwata fid- database kombinata ta ’ l- effikaċja ta ’ Fażi III (N = 17, 599) wara medjan ta ’ 3. 7 snin (fl- aħħar ta ’ l- istudju).
Table 3:
21 Tabella 3:
Results for CIN 2/ 3 or AIS in Type-Specific HPV-Naïve Subjects† (end of study results) Naïve to ≥ 1 HPV Type
Riżultati għal CIN 2/ 3 jew AIS f’ Suġġetti naïve għall- HPV Speċifiku għat- Tip † (riżultati ta ’ tmiem l- istudju) Naïve għal ≥ Tip ta ’ HPV 1
(HPV 31/ 33/ 45/ 52/ 58) § 10 non-vaccine HPV Types║
(HPV 31/ 33/ 45/ 52/ 58) § 10 tipi ta ’ HPV mhux vaċċin║
Placebo
< 0, 32. 5 †
Composite Endpoint A6 species (HPV 56) †
Speċi A6 (HPV 56) †
Efficacy -13.7%
- 13. 7%
Bridging the Efficacy of Silgard from Young Adult Women to Young Adolescents
22 Ħolqien ta ’ Pont fl- Effikaċja ta ’ Silgard minn Nisa Żgħażagħ Adulti sa Adolexxenti Żgħar
Anti-HPV responses at Month 7 among 9- to 15-year-old girls and boys were non-inferior to anti-HPV 22 responses in 16- to 26-year-old young women for whom efficacy was established in the phase III studies.
Ir- risponsi anti- HPV f' Xahar 7 fost bniet ta 'bejn 9 u 15- il sena kienu mhux inferjuri għar- risponsi anti - HPV f' nisa żgħażagħ ta' bejn 16 u 26 sena li għalihom l- effikaċja kienet stabbilita fl- istudji ta 'fażi III.
On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old girls is inferred.
Fuq bażi ta ’ l- ħolqien ta ’ pont ta ’ l- immunoġeniċità, l- effikaċja ta 'Silgard fi bniet ta ’ bejn 9 u 15- il sena hija inferita.
The GMTs declined through Month 24 and then stabilized until at least Month 60.
Suġġetti li kienu seronegattivi għal anti- HPV 6, 11, 16, 18 fil- cLIA fi tmiem l- istudju kienu għadhom protetti kontra mard kliniku
Silgard induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
23 Silgard ikkawża risponsi speċifiċi ta ’ l- anti- korpi kontra t- tipi HPV 6, 11, 16, u 18 f’ firien tqal, wara injezzjoni waħda jew aktar fil- muskoli.
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’ s size and weight. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
• Silgard huwa disponibbli f’ siringa mimlija għal- lest biex tintuża għal injezzjoni ġol- muskoli (IM), preferibbilment fiż- żona tad- deltojd tan- naħa ta ’ fuq tad- driegħ. • Jekk fil- pakkett ikun hemm 2 labriet ta ’ tulijiet differenti, agħżel il- labra adattata sabiex tiżgura amministrazzjoni IM skond id- daqs u l- piż tal- pazjent tiegħek. • Il- prodotti ta ’ mediċini parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal - kulur qabel ma jingħataw.
Using the pre-filled syringe with needle guard (safety) device
24 Kif għandek tuża s- siringa mimlija b’ apparat ta ’ protezzjoni (sigurtà) tal- labra
24 Shake well before use.
Ħawwad sewwa qabel l- użu.
Inject the full dose by slowly pushing the plunger forward until it cannot be pushed further.
Injetta d- doża sħiħa billi tagħfas bil- mod il- planġer sakemm ma jkunx jista ’ jiġi imbottat aktar.
Do not release the pressure on the plunger.
Terħix il- pressjoni fuq il- planġer
To remove the detachable labels, rotate the plunger until the coloured tab becomes visible.
25 Biex tneħħi t- tikketti li jinqalgħu, dawwar il- planġer sakemm it- tab bil- kulur jiġi jidher.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
Merck & Co., INC Sumneytown Pike P. O. Box 4 West Point PA 19486 USA
Merck & Co., INC Sumneytown Pike P. O. Box 4 West Point PA 19486 Stati Uniti ta ’ l- Amerika
The MAH must ensure that the system of pharmacovigilance, as described in version 1 (dated April 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Il- MAH irid jiżgura li s- sistema ta 'farmakoviġilanza kif deskritta fil- verżjoni 1 (datata April 2006) ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq tkun fis- seħħ u li din tkun qed taħdem qabel u waqt li l- prodott ikun fis- suq.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Skond Artikolu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il- ħruġ uffiċjali tal - lott ser ikun ir- responsabbiltà ta 'laboratorju ta' l- Istat jew ta 'laboratorju magħżul għal dak il- għan.
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – single dose vial, pack of 1, 10, 20
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – kunjett għal doża waħda, pakkett ta' 1, 10, 20
1 dose vial, 0.5 ml.
Kunjett b' doża waħda, 0. 5 ml.
10 single dose vials, 0.5 ml each.
10 kunjetti b' doża waħda, 0. 5 ml kull wieħed.
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Renju Unit
EU/ 1/ 06/ 358/ 001 – pack of 1 EU/ 1/ 06/ 358/ 002– pack of 10 EU/ 1/ 06/ 358/ 018– pack of 20
EU/ 1/ 06/ 358/ 001 - pakkett ta '1 EU/ 1/ 06/ 358/ 002 - pakkett ta' 10 EU/ 1/ 06/ 358/ 018 - pakkett ta ’ 20
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe without needle, pack of 1, 10, 20
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – siringa mimlija lesta mingħajr labra, pakkett ta' 1, 10, 20
Suspension for injection in a pre-filled syringe.
Doża waħda, siringa mimlija lesta ta '0. 5 ml mingħajr labra.
1 dose, 0.5 ml pre-filled syringe without needle.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml mingħajr labar.
10 single doses, 0.5 ml pre-filled syringes without needles.
20 doża singola, siringi mimlijin lesti ta '0. 5 ml mingħajr labar.
EU/ 1/ 06/ 358/ 003 – pack of 1 EU/ 1/ 06/ 358/ 004 – pack of 10 EU/ 1/ 06/ 358/ 019 – pack of 20
EU/ 1/ 06/ 358/ 003 – pakkett ta '1 EU/ 1/ 06/ 358/ 004 – pakkett ta' 10 EU/ 1/ 06/ 358/ 019 – pakkett ta ’ 20
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with 1 needle, pack of 1, 10, 20
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – siringa mimlija lesta b' labra waħda, pakkett ta' 1, 10, 20
Suspension for injection in a pre-filled syringe.
Doża waħda, siringa mimlija lesta ta '0. 5 ml b' labra waħda.
1 dose, 0.5 ml pre-filled syringe with 1 needle.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml b' labra waħda kull waħda.
10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
20 doża singola, siringi mimlijin lesti ta '0. 5 ml b' labra waħda kull waħda.
EU/ 1/ 06/ 358/ 005 – pack of 1 EU/ 1/ 06/ 358/ 006 – pack of 10 EU/ 1/ 06/ 358/ 020 – pack of 20
EU/ 1/ 06/ 358/ 005 – pakkett ta '1 EU/ 1/ 06/ 358/ 006 – pakkett ta' 10 EU/ 1/ 06/ 358/ 020 – pakkett ta ’ 20
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with 2 needles, pack of 1, 10, 20
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – siringa mimlija lesta b' 2 labriet, pakkett ta' 1, 10, 20
EU/ 1/ 06/ 358/ 007– pack of 1 EU/ 1/ 06/ 358/ 008 – pack of 10 EU/ 1/ 06/ 358/ 021 – pack of 20
EU/ 1/ 06/ 358/ 007 – pakkett ta '1 EU/ 1/ 06/ 358/ 008 – pakkett ta' 10 EU/ 1/ 06/ 358/ 021 – pakkett ta ’ 20
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with a needle guard and no needles, pack of 1, 10, 20
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – siringa mimlija lesta bi protezzjoni tal- labra u bla labar, pakkett ta' 1, 10, 20
Suspension for injection in a pre-filled syringe.
Doża waħda, siringa mimlija lesta ta '0. 5 ml bi protezzjoni tal- labra u mingħajr labar.
1 dose, 0.5 ml pre-filled syringe with a needle guard and no needles.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u u mingħajr labar.
10 single doses, 0.5 ml pre-filled syringes with needle guards and no needles.
20 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u u mingħajr labar.
EU/ 1/ 06/ 358/ 009– pack of 1 EU/ 1/ 06/ 358/ 010 – pack of 10 EU/ 1/ 06/ 358/ 011 – pack of 20
EU/ 1/ 06/ 358/ 009 – pakkett ta '1 EU/ 1/ 06/ 358/ 010 – pakkett ta' 10 EU/ 1/ 06/ 358/ 011 – pakkett ta '20
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with a needle guard and 1 needle, pack of 1, 10, 20
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – siringa mimlija lesta bi protezzjoni tal- labra u labra waħda, pakkett ta' 1, 10, 20
Suspension for injection in a pre-filled syringe.
Doża waħda, siringa mimlija lesta ta '0. 5 ml bi protezzjoni tal- labra u b' labra waħda.
1 dose, 0.5 ml pre-filled syringe with a needle guard and 1 needle.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u b' labra waħda kull waħda.
10 single doses, 0.5 ml pre-filled syringes with needle guards and 1 needle each.
20 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u b' labra waħda kull waħda.
EU/ 1/ 06/ 358/ 012– pack of 1 EU/ 1/ 06/ 358/ 013 – pack of 10 EU/ 1/ 06/ 358/ 014 – pack of 20
EU/ 1/ 06/ 358/ 012 – pakkett ta '1 EU/ 1/ 06/ 358/ 013 – pakkett ta' 10 EU/ 1/ 06/ 358/ 014 – pakkett ta '20
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with a needle guard and 2 needles, pack of 1, 10, 20
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Silgard, sospensjoni għall- injezzjoni – siringa mimlija lesta bi protezzjoni tal- labra u b' 2 labriet, pakkett ta' 1, 10, 20
Silgard, suspension for injection in a pre-filled syringe.
Silgard, sospensjoni għall- injezzjoni f’ siringa mimlija lesta.
1 dose, 0.5 ml pre-filled syringe with a needle guard and 2 needles.
Doża waħda, siringa mimlija lesta ta '0. 5 ml bi protezzjoni tal- labra u b' 2 labriet.
EU/ 1/ 06/ 358/ 015– pack of 1 EU/ 1/ 06/ 358/ 016 – pack of 10 EU/ 1/ 06/ 358/ 017 – pack of 20
EU/ 1/ 06/ 358/ 015 – pakkett ta '1 EU/ 1/ 06/ 358/ 016 – pakkett ta' 10 EU/ 1/ 06/ 358/ 017 – pakkett ta '20
Silgard, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
What Silgard is and what it is used for 2.
X’ inhu Silgard u għalxiex jintuża 2.
Before you use Silgard 3.
Qabel ma tuża Silgard 3.
How to use Silgard 4.
Kif għandek tuża Silgard 4.
How to store Silgard 6.
Kif taħżen Silgard 6.
WHAT SILGARD IS AND WHAT IT IS USED FOR
X’ INHU SILGARD U GĦALXIEX JINTUŻA
Silgard is a vaccine.
Silgard hu vaċċin.
Vaccination with Silgard is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
It- tilqima b’ Silgard hi maħsuba biex tipproteġi kontra l- mard ikkawżat mill - Papillomavirus Uman (HPV) tat- tipi 6, 11, 16 u 18.
Silgard cannot cause the diseases it protects against.
Silgard ma jistax jikkawża l- mard li jagħti protezzjoni kontrihom.
Silgard produces type-specific antibodies and has been shown in clinical trials to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-26 years of age.
Silgard jipproduċi anti- korpi speċifiċi għat- tip u fil- provi kliniċi ntwera li jippreveni dan il- mard marbut ma ’ HPV 6, 11, 16, u 18 f’ nisa adulti ta ’ età ta ’ bejn 16 u 26 sena.
Silgard should be used in accordance with official guidelines.
Silgard għandu jintuża skond il- linji gwida uffiċjali.
The most benefit from Silgard is expected before infection with any of the Human Papillomavirus types covered by the vaccine.
L- ikbar benefiċċju minn Silgard hu mistenni qabel l- infezzjoni b’ xi wieħed mit- tipi ta ’ Papillomavirus Umani koperti mill- vaċċin.
However, in individuals who are already infected by one or more of the vaccine HPV types, the vaccine will protect against the remaining vaccine related HPV types.
Madankollu, f’ individwi li huma diġà infettati b’ wieħed jew iktar mill - vaċċini tat- tipi HPV, il- vaċċin se jipproteġi kontra l- bqija tat- tipi ta ’ HPV marbuta mal- vaċċin.
BEFORE YOU USE SILGARD
QABEL MA TUŻA SILGARD
Do not use Silgard if:
Tużax Silgard jekk:
• is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “ other ingredients”– see section 6). • has developed an allergic reaction after receiving a dose of Silgard. • suffers from an illness with high fever.
il- persuna li ser titlaqqam • hi allerġika (għandha sensittività eċċessiva) għal xi waħda mis- sustanza attivi li jinsabu f’ Silgard (elenkati taħt “ sustanzi oħra ” – ara sezzjoni 6). • żviluppat reazzjoni allerġika wara li rċeviet doża ta ’ Silgard.
49 Take special care with Silgard:
49 • issofri minn mard b’ deni qawwi.
You should tell your doctor if the person to be vaccinated:
Oqgħod attent ħafna b’ Silgard:
As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.
Bħal kull vaċċin, Silgard jista ’ ma jipproteġix kompletament 100% lil dawk li jingħataw il- vaċċin.
Silgard will not protect against every type of Human Papillomavirus.
Silgard mhux ser jipproteġi kontra kull tip ta ’ Papillomavirus Uman.
Silgard will not protect against other diseases that are not caused by Human Papillomavirus.
Silgard mhux ser jipproteġi kontra mard ieħor li mhux ikkawżat mill- Papillomavirus Uman.
You should continue to follow your doctor’ s advice on cervical smear/ Pap tests and preventative and protective measures.
Inti għandek tkompli ssegwi l- parir tat- tabib tiegħek dwar is- smear ċervikali/ testijiet Pap u l- miżuri preventivi u protettivi.
What other important information should I know about Silgard?
X’ informazzjoni importanti oħra għandi nkun naf dwar Silgard?
Silgard can be given with Hepatitis B vaccine at a separate injection site (another part of your body, e. g. the other arm or leg) at the same visit.
Silgard jista ’ jingħata mal- vaċċin ta ’ l- Epatite B f’ sit differenti ta ’ l- injezzjoni (parti oħra minn ġismek, eż. id- driegħ l- ieħor jew ir- riġel l- ieħor) waqt l- istess żjara.
• used with medicines that suppress the immune system.
Silgard jista ’ ma jkollux l- aħjar effett jekk: • jintuża ma ’ mediċini li jrażżnu s- sistema immuni.
In clinical trials, oral or other contraceptives (e. g. the pill) did not reduce the protection obtained by Silgard.
Fi provi kliniċi, kontraċettivi orali jew kontraċettivi oħrajn (eż. pilloli) ma naqqsux il- protezzjoni miksuba minn Silgard.
Silgard may be given to women who are breast-feeding or intend to breast-feed.
Silgard jista ’ jingħata lil nisa li qed ireddgħu jew li beħsiebhom ireddgħu.
There is no information to suggest that Silgard affects your ability to drive or use machinery.
M’ hemm l- ebda informazzjoni li tissuġġerixxi li Silgard jaffettwa l- ħila tiegħek waqt li tkun qed issuq jew waqt li tkun qed tħaddem il- magni.
HOW TO USE SILGARD
KIF GĦANDEK TUŻA SILGARD
Silgard is given as an injection by your doctor.
Silgard jingħata bħala injezzjoni mit- tabib tiegħek.
The person to be vaccinated will receive three doses of the vaccine.
Il- persuna li ser titlaqqam ser tirċievi tliet dożi tal - vaċċin.
First injection: at chosen date Second injection: ideally 2 months after first injection
L- ewwel injezzjoni: fid- data magħżula It- tieni injezzjoni: idealment xahrejn wara l- ewwel injezzjoni It- tielet injezzjoni: idealment 6 xhur wara l- ewwel injezzjoni
50 Third injection: ideally 6 months after first injection
L- iskeda tad- dożaġġ tista ’ tkun aktar flessibbli.
Silgard will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).
Silgard ser jingħata bħala injezzjoni minn ġol- ġilda fil- muskolu (preferibbilment il- muskolu tan- naħa ta ’ fuq tad- driegħ jew fil- koxxa).
If you forget to take Silgard:
Jekk tinsa tieħu Silgard:
Like all vaccines and medicines, Silgard can cause side effects, although not everybody gets them.
Bħal mediċini u l- vaċċini l- oħrajn kollha, Silgard jista ’ jikkawża effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects can be seen after the use of Silgard:
L- effetti sekondarji li ġejjin jistgħu jidhru wara l- użu ta ’ Silgard:
Fainting, sometimes accompanied by shaking or stiffening, has been reported.
Ħass ħażin jista ’ jseħħ wara tilqima, l- aktar fost l- adoloxxenti u ż- żgħażagħ.
Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Għalkemm episodji ta ’ ħass ħażin m’ humiex komuni, il- pazjenti għandhom jiġu osservati għal 15- il minuta wara li huma jirċievu tilqima tal- HPV.
Some of these reactions have been severe.
Uħud minn dawn ir- reazzjonijiet kienu serji.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell.
51 Bħal b’ vaċċini oħra, l- effetti sekondarji li ġew irrapportati matul l- użu ġenerali jinkludu: glandoli minfuħin (għonq, l- abt, jew l- irqiq tal- koxxa), is- sindromu ta ’ Guillain- Barré (dgħjufija tal- muskolu, sensazzjonijiet anormali, tagħrix fl- idejn, saqajn u fil- parti ta ’ fuq tal- ġisem), sturdament u uġigħ ta ’ ras, nawsea u rimettar, uġigħ fil- ġogi, uġigħ fil- muskoli, għejja mhux tas- soltu jew dgħjufija u li wieħed iħossu mhux tajjeb b’ mod ġenerali.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE SILGARD
KIF TAĦŻEN SILGARD
If you have any further questions on Silgard after reading this leaflet, please ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar Silgard wara li taqra dan il- fuljett, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Silgard contains
X’ fih Silgard
Human Papillomavirus1 Type 6 L1 protein2,3 Human Papillomavirus1 Type 11 L1 protein2,3 Human Papillomavirus1 Type 16 L1 protein2,3 Human Papillomavirus1 Type 18 L1 protein2,3 1 Human Papillomavirus = HPV 2
Papillomavirus Uman1 Proteina tip 6 L12, 3 20 mikrogramma Papillomavirus Uman1 Proteina tip 11 L12, 3 40 mikrogramma Papillomavirus Uman1 Proteina tip 16 L12, 3 40 mikrogramma Papillomavirus Uman1 Proteina tip 18 L12, 3 20 mikrogramma 1 Papillomavirus Uman = HPV.
L1 protein in the form of virus like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
2 L1 proteina fis- sura ta 'partikuli qishom virus prodotti fiċ- ċelluli tal- moffa (Saccharomyces cerevisiae CANADE 3C- 5 (Speċi 1895)) minn teknoloġija DNA rikombinanti.
What Silgard looks like and contents of the pack
Id- dehra ta 'Silgard u d- daqs tal- pakkett
1 dose of Silgard suspension for injection contains 0.5 ml.
Doża waħda ta 'Silgard sospensjoni għall- injezzjoni fiha 0. 5 ml.
Silgard is available in packs of 1, 10 or 20 vials.
52 Silgard hu disponibbli f' pakketti ta '1, 10 jew 20 kunjett.
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Renju Unit
For any information about this medicinal product, please contact the local representative of the
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
52 Marketing Authorisation Holder.
België/ Belgique/ Belgien Merck Sharp & Dohme B. V.
België/ Belgique/ Belgien Merck Sharp & Dohme B. V., Tél/ Tel: +32 (0) 2 373 42 11 MSDBelgium_info@merck. com
Tél/ Tel: +32 (0) 2 373 42 11 MSDBelgium_ info@ merck. com
Luxembourg/ Luxemburg Merck Sharp & Dohme B. V., Tél/ Tel: +32 (0) 2 373 42 11 MSDBelgium_info@merck. com
Tél/ Tel: +32 (0) 2 373 42 11 MSDBelgium_ info@ merck. com
Magyarország MSD Magyarország Kft Tel.: + 36.1.888.5300 hungary_msd@merck. com
Tel.: + 36. 1. 888. 5300 hungary_ msd@ merck. com
Tel.: +420.233.010.111 msd_cr@merck. com
Česká republika Merck Sharp & Dohme, IDEA, Inc., org. sl Tel.: +420. 233. 010. 111 msd_ cr@ merck. com
Danmark Merck Sharp & Dohme, Tlf: +45 43 28 77 66 dkmail@merck. com
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@ merck. com
Deutschland MSD SHARP & DOHME GmbH, Tel: +49 (0) 89 4561 2612 Infocenter@msd. de
Deutschland MSD SHARP & DOHME GmBH Tel +49 (0) 89 4561 2612 Infocenter@ msd. de
Norge MSD (Norge) AS, Tlf: +47 32 20 73 00 msdnorge@msd. no
Norge MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@ msd. no
Österreich Merck Sharp & Dohme GmbH, Tel: +43 (0) 1 26 044 msd-medizin@merck. com
Österreich Merck Sharp & Dohme GmbH Tel: +43 (0) 1 26 044 msd- medizin@ merck. com
España Merck Sharp & Dohme de España, S. A., Tel: +34 91 321 06 00 Silgard@msd. es
Tel: +34 91 321 06 00 Silgard@ msd. es
Portugal Merck Sharp & Dohme, Lda, Tel: +351 21 4465700 informacao_doente@merck. com
Portugal Merck Sharp & Dohme, Lda Tel: +351 7364 4465700 informacao_ doente@ merck. com
Slovenija Merck Sharp & Dohme, d. o. o.
Slovenija Ireland Merck Sharp & Dohme, d. o. o.
Tel: +386.1.520.4201 msd_slovenia@merck. com
Merck Sharp and Dohme Ireland (Human Tel: +386. 1. 520. 4201 Health) Limited msd_ slovenia@ merck. com Tel: +353 0 1 2998771 medinfo_ ireland@ merck. com
53 Ísland Icepharma hf.
Ísland Merck Sharp & Dohme Ísland ehf.
Sími: +354 540 8000 ISmail@merck. com
Sími: +354 520 8600 ISmail@ merck. com
Slovenská republika Merck Sharp & Dohme IDEA, Inc.
Slovenska republika Merck Sharp & Dohme IDEA, Inc.
Sverige Merck Sharp & Dohme (Sweden) AB, Tel: +46 (0) 8 626 1400 medicinskinfo@merck. com
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400 medicinskinfo@ merck. com
United Kingdom Merck Sharp and Dohme Limited, Tel: +44 (0) 1992 467272 medinfo_uk@merck. com
United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 0 1992 467272 medinfo_ uk@ merck. com
Silgard, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Silgard, sospensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
56 Take special care with Silgard:
56 • issofri minn mard b’ deni qawwi.
57 Third injection: ideally 6 months after first injection
L- iskeda tad- dożaġġ tista ’ tkun aktar flessibbli.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell.
58 Bħal b’ vaċċini oħra, l- effetti sekondarji li ġew irrapportati matul l- użu ġenerali jinkludu: glandoli minfuħin (għonq, l- abt, jew l- irqiq tal- koxxa), is- sindromu ta ’ Guillain- Barré (dgħjufija tal- muskolu, sensazzjonijiet anormali, tagħrix fl- idejn, saqajn u fil- parti ta ’ fuq tal- ġisem), sturdament u uġigħ ta ’ ras, nawsea u rimettar, uġigħ fil- ġogi, uġigħ fil- muskoli, għejja mhux tas- soltu jew dgħjufija u li wieħed iħossu mhux tajjeb b’ mod ġenerali.
Silgard is available in packs of 1, 10, or 20 pre-filled syringes with a needle guard (safety) device.
Silgard jiġi f' pakketti ta '1, 10, jew 20 siringi mimlijin lesti b’ apparat tal- protezzjoni tal- labra (sigurtà).
Not all pack sizes are marketed.
59 Mhux il- pakketti tad- daqsijiet kollha jinsabu għall- bejgħ.
Magyarország MSD Magyarország Kft Tel.: + 36.1.888.5300 hungary_msd@merck. com
Magyarorszag MSD Magyarország Kft.
Tel.: +420.233.010.111 msd_cr@merck. com
Tel.: + 36. 1. 888. 5300 hungary_ msd@ merck. com
Malta A. M. Mangion Ltd.
Malta Česká republika MSD Interpharma Merck Sharp & Dohme, IDEA, Inc., org. sl.
Deutschland MSD SHARP & DOHME GmbH, Tel: +49 (0) 89 4561 2612 Infocenter@msd. de
Deutschland MSD SHARP & DOHME GmbH Tel +49 (0) 89 4561 2612 Infocenter@ msd. de
Τηλ: +30.210.8009111 Mailbox@vianex. gr
Τηλ: +3 0210 80091 11 Mailbox@ vianex. gr
Portugal Merck Sharp & Dohme, Lda, Tel: +351 21 4465700 informacao_doente@merck. com
Portugal Merck Sharp & Dohme, Lda Tel: +351 21 44 65 700 informacao_ doente@ merck. com
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited, Tel: +353 (0)1 2998771 medinfo_ireland@merck. com
60 Slovenija Ireland Merck Sharp & Dohme d. o. o Merck Sharp and Dohme Ireland (Human Tel: +386. 1. 520. 4201 Health) Limited msd_ slovenia@ merck. com Tel: +353 0 1 2998771 medinfo_ ireland@ merck. com
Tel: +386.1.520.4201 msd_slovenia@merck. com
Slovenská republika Ísland Merck Sharp & Dohme, IDEA, Inc.
60 Ísland Icepharma hf.
Merck Sharp & Dohme Ísland ehf.
Sími: +354 540 8000 ISmail@merck. com
Tel: +421. 2. 58282010 Sími: +354 520 8600 msd_ sk@ merck. com ISmail@ merck. com
Sverige Merck Sharp & Dohme (Sweden) AB, Tel: +46 (0) 8 626 1400 medicinskinfo@merck. com
Sverige Merck Sharp & Dohme (Sweden) AB, Tel: +46 0 8, 626 1400 medicinskinfo@ merck. com
United Kingdom Merck Sharp and Dohme Limited, Tel: +44 (0) 1992 467272 medinfo_uk@merck. com
United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 1992 467272 medinfo_ uk@ merck. com
This leaflet was last approved in: ------------------------------------------------------------------------------------------------------------------------ The following information is intended for medical or healthcare professionals only:
Dan il- fuljett kien approvat l- aħħar fi: ------------------------------------------------------------------------------------------------------------------------ It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
• Silgard is available in a pre-filled syringe, with needle guard (safety device) ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’ s size and weight. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
• Silgard jiġi f’ siringa mimlija għal- lest, bi protezzjoni tal- labra (apparat ta ’ sigurtà) biex tintuża għal injezzjoni ġol- muskoli (IM), preferibbilment fiż- żona tad- deltojd tan- naħa ta ’ fuq tad - driegħ. • Jekk fil- pakkett ikun hemm 2 labriet ta ’ tulijiet differenti, agħżel il- labra adattata sabiex tiżgura amministrazzjoni IM skond id- daqs u l- piż tal- pazjent tiegħek. • Il- prodotti ta ’ mediċini parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal - kulur qabel ma jingħataw.
The labels can only be removed after vaccine injection and when the needle guard covers the needle.
Qabel ma tkun lesta l- injezzjoni, evita kuntatt mal- klips ta ’ l- attivazzjoni (kif indikat bl - asterisks * fl- ewwel stampa) fuq l- apparat biex tevita li l- labra tiġi mgħottija kmieni wisq bl - apparat ta ’ protezzjoni tal- labra.
61 Shake well before use.
61 Nota:
Remove the syringe tip cap and the needle cap.
Kun żgur li kwalunkwe bżieżaq ta ’ l- arja jitneħħew mis- siringa qabel l- injezzjoni.
Screw the needle onto the syringe barrel in a clockwise direction while pressing in the 2 plastic beads to lock the needle securely onto the syringe.
It- tikketti jistgħu jitneħħew biss wara l- injezzjoni tal- vaċċin u meta l- għant tal- labra tgħatti l- labra.
To remove the detachable labels, rotate the plunger until the coloured tab becomes visible.
Biex tneħħi t- tikketti li jinqalgħu, dawwar il- planġer sakemm it- tab bil- kulur jiġi jidher.
These diseases include cervical cancer; pre-cancerous lesions of the female genitals (cervix, vulva and vagina); and genital warts.
Dan il- mard jinkludi l- kanċer ċervikali, feriti pre- kanċeroġeni tal- partijiet ġenitali femminili (s- cervix u l- vulva), u l- felul ġenitali.
HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
It- tipi HPV 16 u 18 huma responsabbli għal ~70% tal- każijiet ta ’ kanċer ċervikali u t- tipi HPV 6, 11 għal madwar 90% tal- każijiet ta ’ felul ġenitali.
• is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “ other ingredients”– see section 6). • has developed an allergic reaction after receiving a dose of Silgard. • suffers from an illness with high fever.
il- persuna li ser titlaqqam • hi allerġika (għandha sensittività eċċessiva) għal xi waħda mis- sustanza attivi li jinsabu f’ Silgard (elenkati taħt “ sustanzi oħra ” – ara sezzjoni 6). • żviluppat reazzjoni allerġika wara li rċeviet doża ta ’ Silgard. • issofri minn mard b’ deni qawwi.
64 Take special care with Silgard:
64 Oqgħod attent ħafna b’ Silgard:
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin), Guillain-Barré Syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body), dizziness and headache, nausea and vomiting, joint pain, aching muscles, unusual tiredness or weakness, and generally feeling unwell.
66 Bħal b’ vaċċini oħra, l- effetti sekondarji li ġew irrapportati matul l- użu ġenerali jinkludu: glandoli minfuħin (għonq, l- abt, jew l- irqiq tal- koxxa), is- sindromu ta ’ Guillain- Barré (dgħjufija tal- muskolu, sensazzjonijiet anormali, tagħrix fl- idejn, saqajn u fil- parti ta ’ fuq tal- ġisem), sturdament u uġigħ ta ’ ras, nawsea u rimettar, uġigħ fil- ġogi, uġigħ fil- muskoli, għejja mhux tas- soltu jew dgħjufija u li wieħed iħossu mhux tajjeb b’ mod ġenerali.
Silgard is available in packs of 1, 10 or 20 pre-filled syringes.
Silgard jiġi f' pakketti ta '1, 10 jew 20 siringa waħda mimlija għal- lest.
Not all pack sizes are marketed.
67 Mhux il- pakketti tad- daqsijiet kollha jinsabu għall- bejgħ.
67 Manufacturer:
Manifattur:
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited, Tel: +353 (0)1 2998771 medinfo_ireland@merck. com
68 Slovenija Ireland Merck Sharp & Dohme, d. o. o Merck Sharp and Dohme Ireland (Human Tel: +386. 1. 520. 4201 Health) Limited, msd_ slovenia@ merck. com Tel: +353 (0) 1 2998771 medinfo_ ireland@ merck. com
Slovenská republika Merck Sharp & Dohme IDEA, Inc.
Slovenská republika Ísland Merck Sharp & Dohme, IDEA, Inc.
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. • If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’ s size and weight. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
• Silgard jiġi f’ siringa mimlija għal- lest, biex tintuża għal injezzjoni ġol- muskoli (IM), preferibbilment fiż- żona tad- deltojd tan- naħa ta ’ fuq tad- driegħ. • Jekk fil- pakkett ikun hemm 2 labriet ta ’ tulijiet differenti, agħżel il- labra adattata sabiex tiżgura amministrazzjoni IM skond id- daqs u l- piż tal- pazjent tiegħek. • Il- prodotti ta ’ mediċini parenterali għandhom jiġu eżaminati viżwalment għal frak u tidnis tal - kulur qabel ma jingħataw.
What is Simulect?
X’ inhu Simulect?
Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein).
Simulect huwa trab u solvent li jitħalltu f’ soluzzjoni għall- injezzjoni jew infużjoni (dripp fil- vina).
It contains the active substance basiliximab.
Fih is- sustanza attiva basiliximab.
What is Simulect used for?
Għal xiex jintuża Simulect?
Simulect is used in adults and children aged over one year, to prevent the body from rejecting a newly transplanted kidney.
Simulect jintuża fl- adulti u fit- tfal li jkollhom iktar minn sena sabiex jipprevjeni l- ġisem milli jirriġetta kilwa li tkun għadha kemm ġiet trapjantata.
Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil.
Simulect jintuża flimkien ma ’ mediċini oħra għall - prevenzjoni tar- riġettar tal- organi, bħas- ciclosporin, kortikosterojdi, azathioprine u mycophenolate mofetil.
How is Simulect used?
Kif jintuża Simulect?
Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant.
Simulect għandu jiġi preskritt u mogħti biss minn tabib bl- esperjenza fl- użu tat- trattament immunosuppressiv wara trapjant tal- organi.
It should be given under qualified medical supervision.
Jingħata taħt superviżjoni medika kwalifikata.
Simulect should not be given unless it is absolutely certain that the patient will receive the transplant and other medicines to prevent rejection.
Simulect m’ għandux jingħata sakemm ma jkunx hemm ċertezza assoluta li l- pazjent se jirċievi t- trapjant u mediċini oħrajn li jipprevjenu r- riġettar tal- organi.
Simulect is given as two injections.
Simulect jingħata f’ żewġ injezzjonijiet.
The first injection should be given a maximum of two hours before transplantation surgery, and the second four days after the transplant, unless the patient has had a severe hypersensitivity (allergic) reaction or has complications after the operation, such as loss of the new kidney.
L- ewwel injezzjoni għandha tingħata mhux iktar minn sagħtejn qabel l- operazzjoni tat- trapjant, u t- tieni waħda erbat ijiem wara t- trapjant, sakemm il- pazjent ma jkunx esperjenza reazzjoni allerġika jew ma jkollux kumplikazzjonijiet wara l- operazzjoni, bħat - telf tal- kilwa l- ġdida.
In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses.
Fl- adulti u fit- tfal li jiżnu iktar minn 35 kg, id- doża totali rakkomandata hija ta ’ 40 mg, mogħtija f’ żewġ dożi ta ’ 20 mg.
In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses.
Fit- tfal li jiżnu inqas minn 35 kg, id- doża hija ta ’ 20 mg, mogħtija f’ żewġ dożi ta ’ 10 mg.
Simulect is given into a vein, either as a ‘ bolus’ injection (given all at once) or as an infusion over 20 to 30 minutes.
Simulect jingħata fil- vina, jew bħala injezzjoni ‘ bolus ’ (mogħtija kollha f’ daqqa) jew bħala infużjoni li ddum bejn 20 u 30 minuta.
How does Simulect work?
Kif jaħdem Simulect?
The active substance in Simulect, basiliximab, is a monoclonal antibody.
Is- sustanza attiva f’ Simulect, basiliximab, hija antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Antikorp monoklonali jfisser antikorp (tip ta ’ proteina) imfassal biex jagħraf u jeħel ma ’ struttura speċifika (magħrufa bħala antiġen) li tinstab fuq ċerti ċelloli fil- ġisem.
Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants).
Basiliximab ġie mfassal biex jaħdem fuq antiġen magħruf bħala CD25, li jinstab fuq il- wiċċ tal- limfoċiti- T (tip ta ’ ċelloli tad- demm bojod li għandhom x’ jaqsmu mar- riġettar tat- trapjant tal- organi).
CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide.
CD25 huwa riċettur għall- messaġġier interleukin- 2, li jistimula l- limfoċiti- T biex jinqasmu.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Billi jeħel ma ’ CD25, basiliximab jimblokka l- attività ta ’ interleukin- 2, inaqqas ir- rata li biha l- limfoċiti 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. lymphocytes multiply.
Reproduction is authorised provided the source is acknowledged. jimmultiplikaw.
This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.
Dan inaqqas l- għadd ta ’ limfoċiti- T attivati, u jnaqqas ir- riskju li l- organi trapjantati jiġu riġettati.
How has Simulect been studied?
Kif ġie studjat Simulect?
Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant.
Simulect ġie vvalutat fi tliet studji ewlenin li fihom b’ kollox ħadu sehem 1, 067 adult li kienu ngħataw trapjant tal- kilwa.
All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment).
It- tliet studji qabblu l- effikaċja ta ’ Simulect ma ’ dik ta ’ plaċebo (trattament finta).
In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘ dual therapy’), with some patients also taking azathioprine or mycophenolate mofetil.
Fl- ewwel żewġ studji, il- biċċa l- kbira tas- 722 pazjent kienu qed jieħdu wkoll ciclosporin u kortikosterojdi (‘ terapija doppja ’), b’ xi pazjenti jieħdu wkoll azathioprine jew mycophenolate mofetil.
In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘ triple therapy’).
Fit- tielet studju, it- 345 adult kollha kienu qed jieħdu ciclosporin, sterojdi u azathioprine (‘ terapija tripla ’).
The main measure of effectiveness was the number of treatment failures (death, loss of the new kidney or signs of rejection) over the first year after the transplant.
Il- mezz ewlieni tal- kejl tal- effikaċja kien l- għadd ta ’ fallimenti tat- trattament (mewt, telf tal - kilwa l- ġdida jew sinjali ta ’ riġettar) matul l- ewwel sena wara t- trapjant.
Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents.
Żewġ studji oħra ħarsu lejn xi jsir minn Simulect fil- ġisem meta jingħata lil tfal li jkollhom iktar minn sena jew lill- adoloxxenti.
What benefit has Simulect shown during the studies?
X’ benefiċċju wera Simulect waqt l- istudji mwettqa?
Simulect was more effective than placebo.
Simulect kien iktar effikaċi mill- plaċebo.
Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
Ħarsa lejn ir- riżultati tal- ewwel żewġ studji meħudin flimkien turi li 40% tal- pazjent li ngħataw Simulect flimkien ma ’ terapija doppja fallew it- trattament fis- sitt xhur ta ’ wara (145 minn 363) meta mqabbla ma’ 56% tal- pazjenti li ngħataw il- plaċebo (201 minn 359).
Similar results were seen after a year.
Riżultati simili dehru wara sena.
In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
Fit- tielet studju, kien hemm inqas pazjenti (26%) li fallew it- trattament meta ngħataw Simulect flimkien ma ’ terapija trippla meta mqabbla ma ’ dawk li ngħataw plaċebo (40%).
The studies in children and adolescents showed that the lower dose of Simulect was appropriate for children, and that adolescents could use the adult dose.
L- istudju fit- tfal u l- adolexxenti wrew li d- doża baxxa ta ’ Simulect kienet xierqa għat- tfal, u li l - adolexxenti setgħu jużaw id- doża adulta.
What is the risk associated with Simulect?
X’ inhu r- riskju assoċjat ma ’ Simulect?
In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines.
Fl- istudji, kien hemm effetti sekondarji simili f’ pazjenti li kienu qed jieħdu Simulect u f’ dawk li ngħataw plaċebo flimkien ma ’ mediċini oħra.
In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Fl- adulti, l- iktar effetti sekondarji komuni (li dehru f’ iktar minn 20% tal- pazjenti) kienu l- istitikezza, infezzjonijiet fil- pajp tal- awrina (fl- istrutturi li tgħaddi minnhom l- awrina), uġigħ, nawżea (dardir), edema periferali (nefħa), pressjoni għolja, anemija (livelli baxxi ta ’ ċelloli tad- demm ħomor), uġigħ ta ’ ras, iperkalemija (livelli għoljin ta ’ potassju fid- demm), iperkolesterolemija (livelli għolja ta ’ kolesterol fid- demm), kumplikazzjonijiet fil - feriti tal- operazzjoni, żieda fil- piż, żieda fil- livell tal- kreatinina (markatur tal- problemi tal- kliewi), ipofosfatemija (livelli baxxi ta ’ fosfat fid- demm), dijarrea u infezzjonijiet fil- pajpijiet tan- nifs ta ’ fuq (irjiħat).
In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Fit- tfal, l- effetti sekondarji li dehru f’ iktar minn 20% tal- pazjenti kienu l- infezzjonijiet fil - pajp tal- awrina, ipertrikożi (xagħar tal- ġisem żejjed), rinite (imnieħer irritat u bil- flissjoni), piressija (deni), pressjoni għolja, infezzjonijiet fil- pajpijiet ta ’ fuq tan- nifs, infezzjonijiet virali, sepsis (infezzjoni fid- demm) u stitikezza.
For the full list of all side effects reported with Simulect, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma ’ Simulect, ara l- Fuljett ta ’ Tagħrif.
Simulect should not be used in people who may be hypersensitive to basiliximab or any of the other ingredients.
Simulect m’ għandux jingħata lil persuni allerġiċi għal basiliximab jew għal xi sustanza oħra tiegħu.
Simulect must not be used during pregnancy or breast-feeding.
Simulect m’ għandux jingħata waqt it- tqala jew waqt it- treddigħ.
Why has Simulect been approved?
Għaliex ġie approvat Simulect?
The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect’ s benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) iddeċieda li l- benefiċċji ta ’ Simulect huma ikbar mir- riskji tiegħu għall- profilassi ta ’ riġettar akut tal- organi trapjantati f’ pazjenti adulti u tfal li jkunu għadhom kemm ħadu trapjant alloġeniku ta ’ kilwa.
The Committee recommended that Simulect be given marketing authorisation.
Il- Kumitat irrakkomanda li Simulect jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Simulect:
Aktar tagħrif dwar Simulect: