qanastek/EMEA-V3 huggingface dataset:
The excretion of Twinrix Paediatric in milk has not been studied in animals.
L- eskrezzjoni ta ’ Twinrix Paediatric ġol- ħalib ma ’ ġietx studjata fl- annimali.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.
Id- deċisjoni fuq jekk wieħed għandux ikompli/ jwaqqaf it- treddigħ jew ikompli/ jwaqqaf it- terapija bi Twinrix Paediatric għandha tiġi bbażata fuq il- benefiċju tat- treddigħ għat- tarbija u l- benefiċju tat- terapija bi Twinrix Paediatric għall- mara.
Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
Twinrix Paediatric m ’ għandu l’ ebda effett jew ftit li xejn effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
4 • Clinical trials
• Provi Kliniċi
The current formulation of Twinrix does not contain thiomersal (an organomercuric compound) or any preservative.
Il- preparazzjoni t’ issa ta ’ Twinrix ma ’ fihiex thiomersal (kompost organomerkurjali) jew preservattivi.
In a clinical study conducted with the current formulation, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation.
F’ studju kliniku bil- preparazzjoni t’ issa, il- frekwenza ta ’ uġigħ, ħmura, nefħiet, għeja, gastro- enterite, uġigħ ta ’ ras u deni kienet komparabbli mal- frekwenza osservata bil- preparazzjoni ta ’ qabel li kien fiha thiomersal u preservattivi.
The following undesirable events have been reported following the widespread use of the former formulation.
L- effetti mhux mixtieqa li ġejjin ġew irrappurtati wara l- użu fuq medda wiesgħa tal- preparazzjoni ta ’ qabel.
The safety profile presented below is based on data from approximately 800 subjects.
Il- profil ta ’ sigurtà ppreżentat hawn taħt huwa bbażat fuq tagħrif miġbur minn bejn wieħed u ieħor 800 suġġett.
Very rare:
Il- frekwenzi ġew rappurtati hekk: ≥ 1/ 10 Komuni ħafna ≥ 1/ 100 sa < 1/ 10 Komuni ≥ 1/ 1, 000 sa < 1/ 100 Mhux komuni ≥ 1/ 10, 000 sa < 1/ 1, 000 Rari Rari ħafna
≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
< 1/ 10, 000
* refers to adverse reactions observed in clinical trials performed with the adult formulation
* jirreferi għal effetti mhux mixtieqa li ġew osservati fi provi kliniċi li saru bil- preparazzjoni għall - adulti
Nervous system disorders Common: drowsiness, headache Rare: hypoaesthesia*, paraesthesia*, dizziness
Disturbi fis- sistema nervuża Komuni: tħeddil, uġigħ ta ’ ras Rari: ipoestesja *, tnemnim *, sturdament
Gastrointestinal disorders Common: gastrointestinal symptoms, nausea Uncommon: diarrhoea, vomiting, abdominal pain
Disturbi gastro- intestinali Komuni: sintomi gastro- intestinali, dardir Mhux komuni: dijarrea, rimettar, uġigħ addominali
Skin and subcutaneous tissue disorders Uncommon: rash Rare: urticaria, pruritus*
Distubi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: raxx Rari: urtikarja, ħakk *
Musculoskeletal and connective tissue disorders Uncommon: myalgia* Rare: arthralgia*
Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni: majalġja * Rari: artralġja *
Metabolism and nutrition disorders Common: appetite lost
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni: telf t’ aptit
Infections and infestations Uncommon: upper respiratory tract infection*
Infezzjonijiet u infestazzjonijiet Mhux komuni: infezzjoni fil- parti ta ’ fuq tas- sistema respiratorja *
Vascular disorders Rare: hypotension*
Disturbi vaskulari Rari: pressjoni baxxa *
General disorders and administration site conditions Very common: pain and redness at the injection site Common: swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C) Rare: influenza like illness*, chills*
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni ħafna: uġigħ u ħmura fis- sit ta ’ l- injezzjoni Komuni: nefħa fis- sit ta ’ l- injezzjoni, reazzjonijiet fis- sit ta ’ l- injezzjoni (bħal tbenġil), għeja, tħossok ma tiflaħx, deni (≥ 37. 5°Ċ) Rari: sintomi bħal tal- influwenza *, tkexkix ta ’ bard *
5 The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
5 Disturbi psikjatriċi Komuni: irritabilità
Investigations Abnormal liver function tests
Investigazzjonijiet Testijiet seroloġiċi tal- fwied abnormali
Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix Paediatric huwa vaċċin kombinat ifformulat billi jinġemaw preparazzjonijiet fuq skala kbira tal - virus tal- epatite A (HA) ippurifikat u inattivat u l- antiġenu ta ’ barra tal- epatite B ippurifikat (HbsAg), separatament adsorbiti fuq aluminium hyroxide u aluminium phosphate.
The HA virus is propagated in MRC5 human diploid cells.
6 Il- virus HA huwa ppropagat f’ ċelluli umani tat- tip diploid MRC5.
Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Twinrix Paediatric tagħti immunita ’ kontra l- infezzjoni ta ’ HAV u HBV billi tinduċi antikorpi speċifiċi kontra HAV u HBs.
Specific
Fi studji kliniċi, l - antikorpi speċifiċi kontra l- epatite A ġew osservati f’ madwar 89% tas- suġġetti xahar wara l- ewwel doża u f’ 100% xahar wara t- tielet doża (i. e. fis- seba xahar).
6 humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Antikorpi speċifiċi kontra l- epatite B ġew osservati f ’ madwar 67% tas- suġġetti wara l- ewwel doża u 100% wara t- tielet doża.
In a long term clinical trial, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 48 months following the initiation of a primary vaccination course of Twinrix Paediatric in the majority of vaccinees (see section 4.2).
F ’ studju kliniku meħud fit- tul, il- peristenza tal- antikorpi anti- HAV u anti- HBs ġiet ippruvata sa 48 xahar mill- bidu tal- kors primarju ta ’ tilqim bi Twinrix Paediatric fil- biċċa l- kbira ta ’ dawk mlaqqma (ara sezzjoni 4. 2).
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Il - kinetika ta ’ kif jonqsu l- livelli tal- antikorpi anti- HAV u anti- HB kienet tixbaħ lil dik tal- vaċċini indipendenti.
These data were generated with the former Twinrix formulation containing thiomersal and a preservative.
Dan it- tagħrif ġie miġbur bil- preparazzjoni ta ’ qabel ta ’ Twinrix li kien fiha thiomersal u preservattiv.
A clinical study conducted with the current formulation of Twinrix in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation.
Studju klinku fl- adulti li sar bil- preparazzjoni t’ issa ta ’ Twinrix wera li l- preparazzjoni t’ issa ġabet l - istess rati ta ’ seroprotezzjoni u serokonversjoni meta mqabbla mal- preparazzjoni ta ’ qabel.
5.3 Preclinical safety data
5. 3 Studju qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina
For adjuvants, see section 2.
6. 2 Inkompatabilitajiet
Store in a refrigerator (2°C - 8°C).
Aħżen fil- friġġ (2°C – 8°C)
0.5 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl).
7 0. 5 ml ta ’ suspensjoni fi fjala (ħġieġ tip I) magħluqha bi planġer (lakstu butyl).
Pack sizes of 1, 3 and 10.
Pakketti ta ’ 1, 3 jew 10.
7 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin għandu jiġi mħallat sewwa biex tinkiseb suspensjoni bajdanija w opaka u għandu jkun mifli sew għal xi partiċelli barranin u / jew xi tibdil fl- aspett fiżiku qabel ma jintuża.
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
GlaxoSmith Kline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixensart, Il- Belġju
10 February 1997 Date of latest renewal:
10 ta ’ Frar 1997 Data ta ’ l- aħħar tiġdid:
10 February 2007
10 ta ’ Frar 2007
Twinrix Paediatric, suspension for injection in prefilled syringe Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine ((adsorbed).
Twinrix Paediatric, suspensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB).
Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4 Adsorbed on aluminium phosphate
0. 025 milligrammi A13+ Adsorbit fuq aluminium hydroxide idratat 3 Manifatturat fuq ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA 4 0. 2 milligrammi A13+ Adsorbit fuq aluminium phosphate Għal lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Suspension for injection in prefilled syringe Turbid white suspension.
Suspensjoni għall- injezzjoni f’ siringa mimlija lesta Is- suspensjoni hija bajda u mdardra.
Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Twinrix Paediatric huwa indikat għall- użu fit- trabi, tfal u adoloxxenti ta ’ eta ’ minn sena sa u jinkludi 15 il- sena li ma jkollhomx l- immunita ’ relevanti u li huma fir- riskju ta ’ infezzjoni mill- epatite A kif ukoll mill- epatite B.
The dose of 0.5 ml (360 ELISA Units HA/ 10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Doża ta ’ 0. 5 ml (360 ELISA Units/ 10μg HbsAg) hija rakkomandata għal trabi, tfal u adoloxxenti t- eta` minn sena sa u jinkludi 15 il- sena.
9 for booster vaccination can therefore be drawn from experience with the monovalent vaccines.
L- antikorpi jonqsu wkoll bl- istess kinetika.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
F’ sitwazzjonijiet fejn doża ta ’ rinforz kemm tal- epatite A u l- epatite B huwa meħtieġ, Twinrix Paediatric tista tingħata.
Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and children or in the anterolateral thigh in infants.
Twinrix Paediatric tingħata b ’ injezzjoni ġol- muskoli, l- aħjar fil- muskolu deltoid fl- adoloxxenti u fit - tfal jew fil- parti anterolaterali tal- koxxa fit- trabi.
It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Jista jkun li fil- ħin tat- tilqima is- suġġett ikun fil- perjodu ta ’ inkubazzjoni tal - marda epatite A jew B. Mhuwiex magħruf jekk Twinrix Paediatric iwaqqafx l- epatite A u B f’ dawn il- każijiet.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Il- vaċċin ma jwaqqafx infezzjonijiet li huma kawżati b’ aġenti oħra bħall- epatite C u l - epatite E kif ukoll patoġeni magħrufa li jinfettaw il- fwied.
Twinrix Paediatric is not recommended for postexposure prophylaxis (e. g. needle stick injury).
Twinrix Paediatric mhux irrakkomandat għal prevenzjoni ta ’ wara l- esposizzjoni għall- virus (eż. tniggi b’ labbra użata).
Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail
F’ pazjenti fuq l- emodijalisi jew pazjenti b ’ immunita ’ baxxa, livelli adekwati tal- antikorpi anti- HAV u anti- HBs jistgħu ma jintlaħqux wara l -
10 to demonstrate an adequate response.
10 ewwel kors primarju ta ’ tilqim u dawn il- pazjenti jista jkollhom bżonn li jingħatalhom dożi addizzjonali oħra ta ’ vaċċin; xorta waħda f’ pazjenti b ’ immunita ’ baxxa jista ma jkunx hemm l- effett meħtieġ.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal kull injezzjoni vaċċinali, għandu jingħata trattament mediku addattat u għandu jkun hemm sorveljanza dejjem lesta f’ każ rari ta ’ problemi anafilattiċi wara l- amministrazzjoni tal- vaċċin.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Peress li l- injezzjoni għal ġol- ġilda jew somministrazzjoni għal ġol- muskolu gluteali tista jikkawża rispons suboptimali għall- vaċċin, dawn il- metodi għandhom jiġu evitati.
However, exceptionally Twinrix Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Madanakollu Twinrix Paediatric jista jingħata taħt il- ġilda lil suġġetti bl- għadd ta ’ pjastrini baxxi jew problemi fejn ma jagħqadx id- demm peress li jista jkun hemm xi telf ta ’ demm wara s- somministrazzjoni għal ġol - muskoli f’ dawn is- suġġetti.
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Għad ma hemmx tagħrif dwar s- somministrazzjoni ta ’ Twinrix Paediatric flimkien ma l - immunoglobulina speċifika tal- epatite A jew B.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titers.
Madanakollu, meta l- vaċċin tal- epatite A jew B ingħataw ma immunoglobina speċifika ma rriżulta l- ebda bidla fis- serokonverżjoni għalkemm jista jirriżulta f’ livelli aktar baxxi ta ’ antikorpi.
11 • Clinical trials
• Provi Kliniċi
Psychiatric disorders Common: irritability
12 Disturbi psikjatriċi Komuni: irritabilità
12 The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
L- effetti mhux mixtieqa li ġejjin ġew irrappurtati wara Twinrix jew wara l- vaċċini separati tal- epatite A jew B ta ’ GlaxoSmithKline:
Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Twinrix Paediatric huwa vaċċin kombinat ifformulat billi jinġemgħu preparazzjonijiet fuq skala kbira tal - virus tal- epatite A (HA) ippurifikat u inattivat u l- antiġenu ta ’ barra tal- epatite B ippurifikat (HbsAg), separatament adsorbiti fuq aluminium hyroxide u aluminium phosphate.
The HA virus is propagated in MRC5 human diploid cells.
13 Il- virus HA huwa ppropagat f’ ċelluli umani tat- tip diploid MRC5.
13 humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Antikorpi speċifiċi kontra l- epatite B ġew osservati f ’ madwar 67% tas- suġġetti wara l- ewwel doża u 100% wara t- tielet doża.
In a long term clinical trial, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 48 months following the initiation of a primary vaccination course of Twinrix Paediatric in the majority of vaccinees (see section 4.2).
F ’ studju kliniku meħud fit- tul, il- peristenza tal- antikorpi anti- HAV u anti- HBs ġiet ippruvata sa 48 xahar mill- bidu tal - kors primarju ta ’ tilqim bi Twinrix Paediatric fil- biċċa l- kbira ta ’ dawk mlaqqma (ara sezzjoni 4. 2).
For adjuvants, see section 2.
Għal sustanzi awżiljari, ara sezzjoni 2.
6.3 Shelf life
6. 3 Żmien kemm idum tajjeb
0.5 ml of suspension in a prefilled syringe (type I glass) with a plunger stopper (rubber butyl).
14 0. 5 ml ta ’ suspensjoni f’ siringa mimlija lesta (ħġieġ tip I) magħluqha bi planġer (lakstu butyl).
Pack sizes of 1, 10 and 50 with or without needles.
Pakketti ta ’ 1, 10 jew 50 bi jew mingħajr labar.
14 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Meta jkun maħżun, depożitu fin u abjad u saff ċara bla kulur fil- wiċċ jistgħu jifformaw.
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin għandu jiġi mħallat sewwa biex tinkiseb suspensjoni bajdanija w opaka u għandu jkun mifli sew għal xi partiċelli barranin u/ jew xi tibdil fl- aspett fiżiku qabel ma jintuża.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Twinrix Paediatric – Suspension for injection Hepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine ((adsorbed).
Twinrix Paediatric, suspensjoni għall- injezzjoni Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB).
Suspension for injection 1 vial 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Fjala Doża 1 (0. 5 ml)
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN GĦANDU JINGĦATA
Read the package leaflet before use Intramuscular use Shake before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu Użu għal ġol- muskoli Ħawwad qabel tuża
Suspension for injection 3 vials 3 x 1 dose 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni 3 Fjali 3 x doża 1 Doża 1 (0. 5 ml)
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIETSPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Suspension for injection 10 vials 10 x 1 dose 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni 10 fjali 10 x doża 1 Doża 1 (0. 5 ml)
Suspension for injection 1 syringe 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Siringa Doża 1 (0. 5 ml)
Suspension for injection 10 syringes 10 x 1 dose 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni 10 siringi 10 x doża 1 Doża 1 (0. 5 ml)
Suspension for injection 50 syringes 50 x 1 dose 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni 50 siringa 50 x doża 1 Doża 1 (0. 5 ml)
Suspension for injection 1 syringe 1 needle 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Siringa Labra Doża 1 (0. 5 ml)
Suspension for injection 10 syringes 10 needles 10 x 1 dose 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni 10 siringi 10 labar 10 x doża 1 Doża 1 (0. 5 ml)
Suspension for injection 1 syringe 2 needles 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Siringa 1 2 labar Doża 1 (0. 5 ml)
Suspension for injection 10 syringes 20 needles 10 x 1 dose 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni 10 siringi 20 labra 10 x doża 1 Doża 1 (0. 5 ml)
Twinrix Paediatric, suspension for injection HAB vaccine I. M.
Twinrix Paediatric, suspensjoni għall- injezzjoni Vaċċin tal- HAB I. M.
1 dose (0.5 ml)
Doża 1 (0. 5 ml)
Twinrix Paediatric, Suspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Twinrix Paediatric, Suspensjoni għall- injezzjoni Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB)
Read all of this leaflet carefully before you start/ your child starts receiving this vaccine.
Aqra dan il- fuljett kollu qabel int jew ibnek/ bintek tibdew titlaqqmu b’ dal- vaċċin
- This vaccine has been prescribed for you/ your child.
- Dan il- vaċċin ġie preskritt għalik / għal ibnek/ bintek.
What Twinrix Paediatric is and what it is used for 2.
X’ inhu Twinrix Paediatric u għal xiex jintuża 2.
Before you receive/ your child receives Twinrix Paediatric 3.
Qabel ma inti / bintek/ ibnek tieħu/ jieħu Twinrix Paediatric 3.
How Twinrix Paediatric is given 4.
Kif Twinrix Paediatric għandu jingħata 4.
How to store Twinrix Paediatric 6.
Kif taħżen Twinrix Paediatric 6.
WHAT TWINRIX PAEDIATRIC IS AND WHAT IT IS USED FOR
X’ INHU TWINRIX PAEDIATRIC U GĦALXIEX JINTUŻA
Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B.
Twinrix Paediatric huwa vaċċin li jintuża fi trabi, tfal u adoloxxenti minn sena l- fuq sa u jinkludi 15 il - sena sabiex jipproteġi minn żewġ mardiet: epatite A u epatite B.
The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Il- vaċċin jaħdem billi jġiegħel lill - ġisem jipproduċi protezzjoni (l- antikorpi) kontra dawn il- mard.
Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
Il- biċċa l - kbira tan- nies jirkupraw kompletament, għalkemm l- marda taf tkun qawwija biżżejjed li żżomm lin- nies ma jifilħux għal madwar xahar.
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinstab fil- fluwidi tal- ġisem bħal demm, semen, tisfija tal- vaġina, jew saliva (bżiq) ta ’ nies infettati.
BEFORE YOU RECEIVE/ YOUR CHILD RECEIVES TWINRIX PAEDIATRIC
QABEL MA INT/ BINTEK/ IBNEK TIEĦU/ JIEĦU TWINRIX PAEDIATRIC
Twinrix Paediatric should not be given:
Twinrix Paediatric m’ għandux jingħata:
• if you have/ your child has previously had any allergic reaction to Twinrix Paediatric, or any ingredient contained in this vaccine.
• jekk int jew ibnek/ bintek kellek xi reazzjonijiet allerġiċi għal Twinrix Paediatric, jew għal xi ingredjent tal- vaċċin.
The active substances and other ingredients in Twinrix Paediatric are listed at the end of the leaflet.
Is- sustanzi attivi u l- ingredjenti l- oħra li jinstabu fi Twinrix Paediatric huma mniżżlin fl- aħħar ta ’ dan il- fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if you have/ your child has previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases. • if you have/ your child has a severe infection with a high temperature (over 38°C).
Is- sinjali ta ’ xi allerġija jistgħu jinkludu, raxx tal- ġilda bil- ħakk, qtugħ ta ’ nifs, u nefħa fil- wiċċ u fl- ilsien. • jekk int jew ibnek/ bintek kellek xi rejazzjonijiet allerġiċi għal xi vaċċin kontra l- marda tal- epatite A u l- epatite B. jekk int jew ibnek/ bintek għandek xi infezzjoni serja b’ deni għoli (l- fuq minn 38°C).
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Xi • infezzjoni ħafifa bħal xi riħ m’ għandiex tkun problema iżda qabel ikkonsulta mat- tabib.
42 Take special care with Twinrix Paediatric:
42 Oqgħod attent ħafna bi Twinrix Paediatric:
• if you have/ your child has experienced any health problems after previous administration of a vaccine. • if you have/ your child has a bleeding problem or bruise/ bruises easily.
• jekk int jew ibnek/ bintek qatt kellek xi problemi relatati mas- saħħa wara xi tilqima. • jekk int jew ibnek/ bintek għandek problemi biex jagħqad id- demm jew titbenġel malajr.
Using other medicines or vaccines Please tell your doctor if you are/ your child is taking or have/ has recently taken any other medicines, including medicines obtained without a prescription or have/ has recently received any other vaccine.
Meta tuża mediċini jew vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk int jew bintek/ ibnek qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk ħadt xi tilqim ieħor dan l- aħħar
Pregnancy and breast-feeding Take special care with Twinrix Paediatric if you are or think you may be pregnant or if you intend to become pregnant.
Tqala u Treddigħ Oqgħod attenta ħafna jekk inti tqila jew jekk taħseb li inti tqila jew qed tippjana li toħroġ tqila.
Your doctor will discuss with you the possible risks and benefits of having Twinrix Paediatric during pregnancy.
It- tabib tiegħek għandu jiddiskuti miegħek ir- riskji u l- benefiċċji ta ’ Twinrix Paediatric waqt it- tqala.
It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
M’ hux magħruf jekk Twinrix Paediatric jgħaddix għal ġol- ħalib, iżda mhux mistenni li l- vaċċin jikkawża problemi fi trabi li qed jitreddgħu.
Important information about some of the ingredients of Twinrix Paediatric Please tell your doctor if you have/ your child has had an allergic reaction to neomycin (antibiotic).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Twinrix Paediatric Jekk jogħġbok għid lit- tabib tiegħek jekk int jew bintek/ ibnek qatt kellek xi reazzjoni allerġika għal neomycin (antibijotiku)
HOW TWINRIX PAEDIATRIC IS GIVEN
KIF GĦANDU JINGĦATA TWINRIX PAEDIATRIC
You/ your child will receive a total of three injections over 6 months.
Inti / ibnek/ bintek għandek tirċievi tliet injezzjonijiet fi żmien sitt xhur.
The remaining two doses will be given one month, and six months after the first dose.
Iż- żewġ dożi li jkun għad baqa jingħataw fi żmien xahar, u fi żmien sitt xhur wara l- ewwel doża.
Third dose:
T- tieni doża: xahar T- tielet doża:
at an elected date 1 month later 6 months after the first dose
fid- data magħżula wara 6 xhur wara l- ewwel doża.
If you miss/ your child misses a scheduled injection, talk to your doctor and arrange another visit.
Jekk inti tfalli jew ibnek/ bintek ifallu xi injezzjoni skedata, kellem lit- tabib tiegħek u għamel appuntament ieħor.
Make sure you finish/ your child finishes the complete vaccination course of three injections.
Kun żgur li int tispiċċa jew ibnek/ bintek jispiċċaw il- programm kollu tat- tlett vaċċinazzjoniet.
If not, you/ your child may not be fully protected against the diseases.
Jekk le, int tista ma tkunx protett kontra dan il- mard.
The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.
It- tabib jagħti Twinrix Paediatric bħala injezzjoni fil- muskolu tan- naħa ta ’ fuq ta ’ driegħek jew fil - muskolu tal- koxxa ta ’ ibnek/ bintek.
Like all medicines, Twinrix Paediatric can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Twinrix Paediatric jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix include:
Effetti sekondarji li dehru waqt provi kliniċi jew wara l- użu normali tal- vaċċin jew b’ vaċċini tal - epatite A u l- epatite B separati jew bil- preparazzjoni ta ’ Twinrix għall- adulti jinkludu:
Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Sinjali ta ’ reazzjonijiet allergiċi serji jistgħu jkunu tipi ta ’ raxx li jistgħu jkunu b’ ħakk jew bil- blisters, nefħa ta ’ l- għajnejn u tal- wiċċ, diffikultà biex tieħu n - nifs u biex tibla, pressjoni li titbaxxa f’ salt u tintilef minn sensik.
However, if you get any of these symptoms you should contact a doctor urgently. • Abnormal laboratory liver test results • Multiple sclerosis, swelling of the spinal cord (myelitis) • Drooping eyelid and sagging muscles on one side of the face (facial palsy) • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome) • A disease of the nerves of the eye (optic neuritis)
Madankollu jew ikollok xi wieħed minn dawn is- sintomi għandek tkellem tabib b’ urġenza. • Riżultati tat- testijiet tal- laboratorju tal- fwied abnormali • Sklerożi multipla, nefħa fin- nerv li jgħaddi minn ġos- sinsla tad- dahar (majelite) • Tebqet il- għajn nieżla l- isfel u muskoli rotob fuq naħa waħda tal- wiċċ (palsy tal- wiċċ) • Infjammazzjoni temporanja tan- nervituri li tikkawża uġigħ, dgħjufija u paraliżi fid- dirgħajn u s- saqajn u ħafna drabi li tkompli sejra fis- sider u fil- wiċċ (marda ta ’ Guillain- Barré) • Mard tan- nervituri ta ’ l- għajnejn (newrite ottika)
HOW TO STORE TWINRIX PAEDIATRIC
KIF TAĦŻEN TWINRIX PAEDIATRIC
Keep out of the reach and sight of children.
44 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
44 Do not use Twinrix Paediatric after the expiry date which is stated on the carton.
Tużax Twinrix Paediatric wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Store in the original package in order to protect from light.
Żomm fil- kontenitur oriġinali sabiex tilqa mid- dawl.
What Twinrix Paediatric contains
X’ fih Twinrix Paediatric
3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4
0. 025 milligrammi A13+ Adsorbit fuq aluminium hydroxide idratat 3 Manifatturat fuq ċelluli tal- ħmira (Saccharomyces cerevisiae) b’ teknoloġija rikombinanti tad- DNA 4 0. 2 milligrammi A13+ Adsorbit fuq aluminium phosphate
- The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
- L- ingredjenti l- oħra f’ Twinrix Paediatric huma: sodium chloride, ilma għall- injezzjonijiet.
What Twinrix Paediatric looks like and contents of the pack
Id- dehra ta ’ Twinrix Paediatric u l- kontenuti tal- pakkett:
Twinrix Paediatric is a white, slightly milky liquid presented in a glass vial (0.5 ml).
Twinrix Paediatric huwa likwidu abjad qisu ħalib, preżentat ġo fjala tal- ħġieġ (0. 5 ml).
Twinrix Paediatric is available in packs of 1, 3 and 10.
Twinrix Paediatric jinsab f’ pakketti ta ’ 1, 3 jew 10.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
Il- vaċċin għandu jiġi mħawwad sew sabiex tinkiseb suspensjoni bajda w ftit opaka u għandu jkun mifli sew għal xi pariċelli barranin jew xi tibdil fl- apparenza fiżika qabel ma jingħata.
Twinrix Paediatric, Suspension for injection in prefilled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Twinrix Paediatric, Suspensjoni għall- injezzjoni Vaċċin (adsorbit) tal- epatite A (inattivat) u epatite B (rDNA) (HAB)
Before you receive/ your child receives Twinrix Paediatric 3.
Qabel ma inti/ bintek/ ibnek tieħu/ jieħu Twinrix Paediatric 3.
This disease is caused by the hepatitis A virus.
Din il- marda hija kawżata mill- virus tal- epatite A.
None of the components in the vaccine are infectious.
L- ebda komponent tal - vaċċin ma hu infettiv.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if you have/ your child has previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases. • if you have/ your child has a severe infection with a high temperature (over 38°C).
Is- sinjali ta ’ xi allerġija jistgħu jinkludu, raxx tal- ġilda bil- ħakk, qtugħ ta ’ nifs, u nefħa fil- wiċċ u fl- ilsien. • jekk int jew ibnek/ bintek kellek xi reazzjonijiet allerġiċi għal xi vaċċin kontra l- marda tal- epatite A u l- epatite B.
48 Take special care with Twinrix Paediatric:
48 jekk int jew ibnek/ bintek għandek xi infezzjoni serja b’ deni għoli (l- fuq minn 38°C).
Third dose:
It- tieni doża: xahar It- tielet doża:
If you miss/ your child misses a scheduled injection, talk to your doctor and arrange a nother visit.
Jekk inti tfalli jew ibnek/ bintek ifallu xi injezzjoni skedata, kellem lit- tabib tiegħek u għamel appuntament ieħor.
50 Do not use Twinrix Paediatric after the expiry date which is stated on the carton.
Tużax Twinrix Paediatric wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass prefilled syringe (0.5 ml).
Twinrix Paediatric huwa likwidu abjad qisu ħalib, preżentat ġo siringa tal- ħġieġ mimlija għall- lest (0. 5 ml).
Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Twinrix Paediatric jinsab f’ pakketti ta ’ 1, 10 jew 50 bil- labar jew mingħajrhom.
България ГлаксоСмитКлайн ЕООД Тел.: + 359 2 953 10 34
51 България ГлаксоСмитКлайн ЕООД Тел.: + 359 2 953 10 34
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The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
Il- vaċċin għandu jiġi mħawwad sew sabiex tinkiseb suspensjoni bajda w ftit opaka u għandu jkun mifli sew għal xi partiċelli barranin jew xi tibdil fl- apparenza fiżika qabel ma jingħata.
London, 30 May 2008 Doc.
Londra, 30 ta ’ Mejju 2008 Dok.
EMEA/ 245771/ 2008
EMEA/ 402811/ 2008
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for TYGACIL
MISTOQSIJA U TWEĠIBA DWAR L- IRTIRAR TA ’ L- APPLIKAZZJONI GĦAL MODIFIKA FL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ għal TYGACIL
International non-proprietary name (INN): tigecycline
Denominazzjoni Komuni Internazzjonali (DKI): tigecycline
On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.
Fit- 22 ta ’ April 2008, Wyeth Europa Limited għarrfet uffiċjalment lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirtira l- applikazzjoni għal indikazzjoni ġdida għal Tygacil fit- trattament ta ’ pnewmonja akkwiżita fil- komunità.
What is Tygacil?
X' inhu Tygacil?
Tygacil is a powder that is made up into a solution for infusion (drip into a vein).
Tygacil huwa trab li huwa magħmul f’ soluzzjoni għall- infużjoni (drip fil- vina).
It contains the active substance tigecycline.
Fih is- sustanza attiva tigecycline.
Tygacil is an antibiotic that is already used to treat adults with complicated infections of the skin or soft tissue (the tissue below the skin) and complicated infections in the abdomen.
Tygacil huwa antibijotiku li qiegħed diġà jintuża biex jitratta adulti b’ infezzjonijiet kumplikati tal- ġilda jew tat- tessut artab (it- tessut taħt il- ġilda) u infezzjonjiet ikkumplikati fl- addome.
What was Tygacil expected to be used for?
Għal xiex kien mistenni li jintuża Tygacil?
Tygacil was also expected to be used to treat adults with community-acquired pneumonia.
Tygacil kien ukoll mistenni li jintuża sabiex jitratta adulti b’ pnewmonja akkwiżita fil- komunità.
This is a serious type of lung infection that is caught outside of hospital.
Din hija tip ta ’ infezzjoni serja tal- pulmun li tittieħed barra mill- isptar.
Community-acquired pneumonia is usually caused by infection with bacteria.
Il- pnewmonja akkwiżita fil - komunità hija ġeneralment ikkawżata minn infezzjoni bil- batterji.
How is Tygacil expected to work?
Kif kien mistenni li jaħdem Tygacil?
The active substance in Tygacil, tigecycline, belongs to the group of antibiotics called ‘ glycylcyclines’, which are similar to tetracycline.
Is- sustanza attiva fi Tygacil, tigecycline tagħmel parti mill- grupp ta ’ antibijotiċi imsejħa ‘ glycylcylines ’ li huma simili għal tetracycline.
Tigecycline works by blocking the bacteria’ s ribosomes, the parts of the bacterial cells where new proteins are made.
Tigecycline jaħdem billi jimblokka ir- ribosomi tal - batterji, il- partijiet taċ- ċelloli tal- batterji fejn jiġu prodotti proteini ġodda.
By blocking the production of new proteins, the bacteria cannot multiply and they eventually die.
Billi l- produzzjoni ta ’ proteini ġodda tiġi imblukkata, il- batterji ma jkunux jistgħu jimmultiplikaw u eventwalment imutu.
This is expected to help in the treatment of community-acquired pneumonia.
Dan huwa mistenni li jgħin fit- trattament ta ’ pnewmonja akkwiżita fil- komunità.
The effects of Tygacil were first tested in experimental models before being studied in humans.
L- effetti ta ’ Tygacil għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ’ ġew studjati fil - bniedem.
The effectiveness of Tygacil was tested in two main studies involving a total of 846 adults who needed treatment in hospital for community-acquired pneumonia.
L- effikaċja ta ’ Tygacil ġiet ittestjata f’ żewġ studji ewlenin li kienu jinvolvu total ta ’ 846 adult li kellhom bżonn trattament fi sptar għall- pnewmonja akkwiżita fil- komunità.
Both studies compared Tygacil with levofloxacin (another antibiotic).
Iż- żewġ studji ipparagunaw Tygacil ma ’ levofloxacin (antibijotiku ieħor).
Both antibiotics were given for up to two weeks.
Iż- żewġ antibijotiċi ingħataw sa żmien ta ’ gimgħatejn.
The main measure of effectiveness was the number of patients who were cured of their pneumonia within the three weeks after their last dose of antibiotic.
Il- kejl ewlieni ta ’ l- effikaċja kien in- numru ta ’ pazjenti li ġew imfejqa mill- pnewmonja tagħhom fi żmien tliet ġimgħat wara l- aħħar doża tagħhom ta ’ antibijotiċi.
An additional study looked at the effectiveness of Tygacil in patients who had caught pneumonia in hospital.
Studju ieħor ħares lejn l- effikaċja ta ’ Tygacil f’ pazjenti li kienu qabdu pnewmonja fl- isptar.
The application was at day 150 when the company withdrew.
L- applikazzjoni kienet waslet f' jum 150 meta l- kumpanija rtiratha.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Wara li s- CHMP kien evalwa t - tweġibiet mill- kumpanija għal lista ta 'mistoqsijiet, kien għad fadal xi kwistjonijiet pendent li baqgħu ma ġewx solvuti.
The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Is- CHMP normalment idum 90 ġurnata sakemm jadotta opinjoni wara li jkun irċieva applikazzjoni għal modifika fl- awtorizzazzjoni għat- tqegħid fis- suq.
Following the CHMP’ s opinion, it usually takes around six weeks for the European Commission to update the licence.
Wara l- opinjoni tas- CHMP, normalment ikun hemm bżonn ta 'madwar sitt ġimgħat sabiex il- Kummissjoni Ewropea taġġorna l- awtorizzazzjoni.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tygacil could not have been approved for the treatment of community-acquired pneumonia.
Skond l- analiżi tad- dejta u t- tweġiba tal- kumpanija għal- lista ta ’ mistoqsijiet tas- CHMP, fi żmien l - irtirar, is- CHMP kellu xi tħassib u kellu opinjoni proviżorja li Tygacil ma setax jiġi approvat għat - trattament ta ’ pnewmonja akkwiżita fil- komunità.
What were the major concerns that led the CHMP to recommend the refusal of the change to the marketing authorisation?
X’ kien it- tħassib ewlieni li wassal sabiex is- CHMP jirrakkomanda r- rifjut ta ’ modifika fl - awtorizzazzjoni għat- tqegħid fis- suq?
The CHMP was concerned that the patients included in the main studies may not have needed hospital treatment using medicines given intravenously (into a vein), so they did not match the types of patients for whom the medicine was intended.
Is- CHMP wera tħassib dwar il- fatt li l- pazjenti inklużi fl- istudji ewlenin setgħu ma kellhomx bżonn trattament l- isptar bl- użu ta ’ mediċini mogħtija fil- vina, għalhekk ma kienux jaqblu mat- tipi ta ’ pazjenti li għalihom kienet intenzjonata l- mediċina.
The Committee was also concerned over the number of deaths in patients receiving Tygacil with more serious infections, especially in the study of patients who had caught pneumonia in hospital.
Il- Kumitat wera wkoll tħassib dwar in- numru ta ’ mwiet f’ pazjenti b’ infezzjonijiet iktar serji li kienu qed jirċievu Tygacil, speċjalment fl- istudju ta ’ pazjenti li kienu ħadu l- pnewmonja l- isptar.
This raised doubts over whether Tygacil would be sufficiently effective in the treatment of patients with severe community-acquired pneumonia.
Dan qajjem dubji dwar jekk Tygacil huwiex effikaċi biżżejjed fit- trattament ta ’ pazjenti bi pnewmonja serja akkwiżita fil- komunità.
The CHMP also had concerns over the measures that the company intended to put in place to minimise the risks associated with the medicine.
Is- CHMP kellu wkoll tħassib dwar il- miżuri li l- kumpanija kellha l- intenzjoni li tieħu sabiex tnaqqas ir- riskji assoċjati mal - mediċina.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Tygacil had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Għalhekk, fi żmien ta ’ l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta 'Tygacil ma kienx intwera biżżejjed u li kwalunkwe benefiċċju li seta' kellu ma kinux jegħlbu r- riskji identifikati.
What are the consequences of the refusal for patients in clinical trials using Tygacil?
X’ inhuma l- konsegwenzi tar- rifjut għall- pazjenti fil- provi kliniċi li jkunu qed jużaw Tygacil?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Tygacil.
Il- kumpanija għarrfet lill- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li kienu qed jieħdu sehem fi studji kliniċi b' Tygacil.
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 prova klinika u trid iżjed tagħrif dwar it - trattament tiegħek, ikkuntattja lit- tabib li jkun qed jagħtik dan it- trattament.
What is happening for Tygacil for treatment of complicated skin and soft tissue infections and complicated infections in the abdomen?
X’ se jiġri għal Tygacil għat- trattament ta ’ infezzjonijiet ikkumplikati fil- ġilda u fit- tessut artab u għat- trattament ta ’ infezzjonijiet ikkumplikati fl- addome?
There are no consequences on the use of Tygacil in the authorised indications, for which the balance of benefits and risks remains unchanged.
Ma hemm l- ebda konsegwenza fuq l- użu ta ’ Tygacil fl- indikazzjonijiet awtorizzati, fejn il- bilanċ bejn il- benefiċċju u r- riskju jibqa ’ kif kien.
Tygacil 50 mg powder for solution for infusion.
Tygacil 50 mg trab għal soluzzjoni għall- infużjoni
Each 5 ml Tygacil vial contains 50 mg of tigecycline.
Kull kunjett ta ’ 5 ml ta 'Tygacil fih 50 mg ta' tigecycline.
After reconstitution, 1 ml contains 10 mg of tigecycline.
Wara r- rikostituzzjoni, kull ml fih 10 mg ta 'tigecycline.
For a full list of excipients, see section 6.1.
Għal- lista kompleta sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Powder for solution for infusion.
Trab għal soluzzjoni għall- injezzjoni.
Lyophilised orange cake or powder.
Kejk jew trab oranġjo lajofilizzat.
Tygacil is indicated for the treatment of the following infections (see sections 4.4 and 5.1):
Tygacil huwa indikat għat- trattament ta ’ l- infezzjonijiet li ġejjin (ara sezzjonijiet 4. 4 u 5. 1):
• Complicated skin and soft tissue infections • Complicated intra-abdominal infections
• Infezzjonijiet tal- ġilda u tessuti rotob ikkumplikati • Infezzjonijiet intra- addominali kkumplikati
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata konsiderazzjoni għal regoli uffiċjali fuq l- użu xieraq ta ’ mediċini antibatteriċi.
The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Pożologija Id- doża rakomandata għall- adulti hija doża inizjali ta ’ 100 mg segwita b’ 50 mg kull 12- il siegħa għal bejn 5 sa 14- il jum.
The duration of therapy should be guided by the severity, site of the infection, and the patient’ s clinical response.
Id- dewmien tat- terapija għandu jkun iggwidat mis- severità, is- sit ta ’ l- infezzjoni, u r- reazzjoni klinika tal- pazjent.
Hepatic insufficiency No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
Insuffiċjenza epatika L- ebda aġġustament fid- doża ma huwa meħtieġ f’ pazjenti b’ indeboliment epatiku ħafif sa moderat (Child Pugh A u Child Pugh B).
In patients with severe hepatic impairment (Child Pugh C), the dose of Tygacil should be reduced to 25 mg every 12 hours following the 100 mg loading dose.
F’ pazjenti b’ indeboliment epatiku serju (Child Pugh C), id- doża ta ’ Tygacil għandha tiġi mnaqqsa għal 25 mg kull 12- il siegħa wara id- doża ta ’ tagħbija ta ’ 100 mg.
Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2).
Pazjenti b’ indeboliment epatiku serju (Child Pugh C) għandhom jiġu ttrattati bil- kawtela u sorveljati għar- reazzjoni għat- trattament (ara sezzjonijiet 4. 4 u 5. 2).
2 Renal insufficiency No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
2 Insuffiċjenza renali L- ebda aġġustament fid- doża ma huwa meħtieġ f’ indeboliment renali jew f’ pazjenti li tkun qed isirilhom emodijalisi (ara sezzjoni 5. 2).
Elderly patients No dosage adjustment is necessary in elderly patients (see section 5.2).
Pazjenti anzjani L- ebda aġġustament tad- doża mhu meħtieġ għal pazjenti anzjani (ara sezzjoni 5. 2).
Paediatric patients Tygacil is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy (see sections 5.2 and 4.4).
Pazjenti pedjatriċi Tygacil mhuwiex rrakkomandat għal użu fit- tfal u adolexxenti taħt it- 18- il sena minħabba nuqqas ta ’ dejta fuq is- sigurtà u l- effikaċja (ara sezzjonijiet 5. 2 u 4. 4).
Tygacil is administered only by intravenous infusion over 30 to 60 minutes (see section 6.6).
Metodu ta ’ kif jingħata Tygacil huwa mogħti biss permezz ta ’ infużjoni intravenuża fuq perijodu ta '30 sa 60 minuta (ara sezzjoni 6. 6).
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal xi wieħed mis- sustanzi mhux attivi.
Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
Pazjenti li għandhom sensittività eċċessiva għall- klassi ta ’ antibijotiċi tat- tetraċiklini jistgħu jkunu ipersensittivi għal tigecycline.
Anaphylaxis/ anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline (see sections 4.3 and 4.8).
Anafilassi/ reazzjonijiet anafilattojdi, li potenzjalment jistgħu jkunu ta ’ periklu għal ħajja, ġew rapportati b’ tigecycline (ara sezzjonijiet 4. 3 u 4. 8)
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics.
Il- klassi ta ’ antibijotiċi glycylcycline huma struturalment simili għal antibijotiċi tal- klassi tetraċiklini.
Tigecycline may have adverse reactions similar to tetracycline class antibiotics.
Tigecycline jista ’ jkollu reazzjonijiet avversi simili bħal dawk tal- klassi ta ’ antibijotiċi tetraċiklini.
Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.8).
Reazzjonijiet bħal dawn jistgħu jinkludu fotosensittività, psewdotumur ċerebri, pankreatite, u azzjoni anti - anabolika li twassal għal żieda fil- BUN, ażotemija, aċidożi, u iperfosfatemija (ara sezzjoni 4. 8).
The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis.
Marbut mat- trattament b’ tigecycline kien hemm każijiet (frekwenza: mhix komuni) ta ’ pankreatite akuta, li tista ’ tkun serja (ara sezzjoni 4. 8) Id- dijanjosi ta ’ pankreatite akuta għandha tiġi kkonsidrata f’ pazjenti li qed jieħdu tigecycline li jiżviluppaw sintomi kliniċi, sinjali jew ikollhom riżultati mhux normali tal - laboratorju li huma suġġestivi ta ’ pankreatite akuta.