qanastek/EMEA-V3 huggingface dataset:
Ελλάδα Allen Φαρ µακευτική Α .Ε Tηλ: + 30 210 68 82 100 lP
Polska Ελλάδα Pr
Tel.: + 48 (22) 576 9000
Allen Φαρµακευτική Α. Ε Tel.: + 48 (22) 576 9000 Tηλ: + 30 210 68 82 100
Portugal Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
37
es-ci@gsk. com i dic
Farmacêuticos, Lda.
France Laboratoire GlaxoSmithKline Tél: + 33 1 39 17 84 44 Me
at Laboratoire GlaxoSmithKline Tél: + 33 1 39 17 84 44
diam@gsk. com
zz diam@ gsk. com
Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
Ireland
Slovenija GlaxoSmithKline d. o. o.
Slovenija
Tel: + 386 1 280 25 00 gqq41253@glaxowellcome. co. uk
ori GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0) 1 4955000
37 Ísland GlaxoSmithKline ehf.
GlaxoSmithKline d. o. o.
Tel: +354-530 3700
Tel: + 386 1 280 25 00 gqq41253@ glaxowellcome. co. uk
Slovenská republika GlaxoSmithKline Slovakia s. r. o.
t aw Slovenská republika Ísland GlaxoSmithKline Slovakia s. r. o.
Tel: + 39 04 59 21 81 11
ux Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
GlaxoSmithKline Oy Puh/ Tel: + 358 10 30 30 30 Finland. tuoteinfo@gsk. com
ad Puh/ Tel: + 358 10 30 30 30 Tel: + 39 04 59 21 81 11 Finland. tuoteinfo@ gsk. com ’ g ħ Κύπρος GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 89 95 01
ris Κύπρος GlaxoSmithKline Cyprus Ltd
im
United Kingdom
United Kingdom Latvija GlaxoSmithKline UK GlaxoSmithKline Latvia SIA li l
au GlaxoSmithKline Latvia SIA Tel: + 371 7312687 lv-epasts@gsk. com
Tel: + 44 (0) 808 100 9997 Tel: + 371 7312687 customercontactuk@ gsk. com lv- epasts@ gsk. com ina
GlaxoSmithKline UK Tel: + 44 (0)808 100 9997 customercontactuk@gsk. com
Lietuva GlaxoSmithKline Lietuva UAB Tel. +370 264 90 00 info. lt@ gsk. com diċ
r ge Lietuva GlaxoSmithKline Lietuva UAB Tel. +370 264 90 00 info. lt@gsk. com lon This leaflet was last approved on: no
Dan il- fuljett kien approvat l- aħħar f ’ me
The following information is intended for medical or healthcare professionals only: t
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa:
Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component. uc
Meta jinħażen, depożitu abjad u saff likwidu ċar fil- wiċċ jistgħu jiġu osservati għall- komponent ott
This does not constitute a sign of deterioration. rod
Dan ma jfissirx li l- prodott ħżien.
The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Il- komponent DTPw- HBV għandu jitħawwad sewwa biex tinkiseb suspensjoni uniformi, bajda u od
Any unused vaccine or waste material should be disposed of in accordance with local requirements. lP
Pr
The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder.
Il- vaċċin jiġi rikostitwit billi tiġbed il- kontenut tal- fjala li fiha l- komponent DTPw- HBV permezz ta ’ siringa u żżidu mal- fjala li fiha t- trab ta ’ l- HIB.
After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until na
Wara li żżid il- komponent DTPw- HBV mat- trab ta ’ l - HIB, it- taħlita għandha titħawwad sewwa sakemm it- trab jinħall kollu.
The reconstituted vaccine is a homogeneous turbid white suspension. i dic
Il- vaċċin rikostitwit huwa suspensjoni uniformi bajda u mdardra.
Remove and discard the needle used for reconstitution and replace it with a second needle to administer the vaccine.
38 Neħħi u armi l- labra li ntużat għar- rikostituzzjoni u minflokha poġġi l- labra li biha se tagħti l- vaċċin.
After reconstitution, the vaccine should be injected promptly.
Wara r- rikostituzzjoni, il- vaċċin għandu jiġi injettat immedjatament.
Quintanrix should not be given to subjects with hypersensitivity to the active substances or to any of Me
Quintanrix m’ għandux jingħata lil suġġetti li għandhom sensittività eċċessiva għas- sustanzi attivi jew għal xi waħda mis- sustanzi mhux attivi.
the excipients.
at Quintanrix huwa kontra- indikat jekk ibnek/ bintek kellu/ ha enċefalopatija li l- kawża tagħha ma kinetx
Quintanrix is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
zz magħrufa, u li tkun seħħet fi żmien 7 ijiem minn tilqim preċedenti b’ vaċċin li kien fih il- pertussis.
In these circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.
F’ dawn iċ- ċirkustanzi l- kors ta ’ tilqim għandu jitkompla b’ vaċċini tad- difterite, tat- tetnu, ta ’ l- epatite B u tal- HIB.
38 As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering from acute severe febrile illness.
ori Bħal f’ vaċċini oħra, l- amministrazzjoni ta ’ Quintanrix għandha tiġi posposta f’ suġġetti li qed ibatu minn mard b’ deni akut u serju.
The presence of a minor infection, such as a cold, is not a contraindication for vaccination.
Il- preżenza ta ’ infezzjoni ħafifa, bħal riħ, m’ hijiex kontra -
If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give subsequent doses of a vaccine containing the pertussis component should be carefully considered:
aw Jekk kwalunkwe waħda minn dawn il- ġrajjiet li ġejjin tiġri fl- istess żmien meta jittieħed Quintanrix, għandu jiġi kkunsidrat bir- reqqa jekk għandhomx jingħataw id- dożi li jmiss tal- vaċċin li fih il - komponent tal- pertussis:
ed • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. • Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
ux • Temperatura ≥ 40. 0 °C fi żmien 48 siegħa, mhux minħabba kawża oħra magħrufa. • Kollass jew stat bħal f’ xokk (episodju ipotoniku- iporisponsiv) fi żmien 48 siegħa. • Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa mit- tilqima.
ris • Convulsions with or without fever, occurring within 3 days.
ad • Aċċessjonijiet bid- deni jew mingħajr deni li jiġru fi żmien tlett ijiem.
tho 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.
Jista ’ jkun hemm ċirkustanzi, bħal per eżempju inċidenza għolja ta ’ pertussis, meta l- benefiċċji jkunu akbar mir- riskji possibbli. ’ g ħ Bħal fil- każ tal- vaċċini l- oħra kollha li jiġu injettati, kura u sorveljanza medika xierqa għandhom dejjem ikunu disponibbli fil- każ rari ta ’ ġrajja anafilattika li tista ’ tinqala ’ wara l- amministrazzjoni tal - vaċċin. im
au Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
Quintanrix qiegħed għal injezzjoni fil- fond ġol- muskolu, preferibbilment ġol- koxxa anterolaterali. li l
Quintanrix should under no circumstances be administered intravascularly.
Quintanrix m’ għandu qatt jingħata fil- vina. ina diċ me ott od Pr
39 PACKAGE LEAFLET
39 FULJETT TA ’ TAGĦRIF
You may need to
- Żomm dan il- fuljett sakemm ibnek/ bintek jispiċċa/ tispiċċa l- kors kollu ta ’ tilqim.
read it again.
Jista jkollok
- If you have further questions, please ask your doctor or your pharmacist.
bżonn terġa ’ taqrah.
- This medicine has been prescribed for your child and should not be passed on to others.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
In this leaflet:
zz F’ dan il- fuljett:
What Quintanrix is and what it is used for 2.
ori 2.
Before your child receives Quintanrix 3.
Qabel ma ibnek/ bintek jirċievi/ tirċievi Quintanrix 3.
How Quintanrix is given
Kif għandu jingħata Quintanrix 4.
Possible side effects 5.
Kif taħżen Quintanrix
Storing Quintanrix 6.
aw 6.
au Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
ux Vaċċin (adsorbit) tad- difterite, it- tetnu, il- pertussis (ċellula sħiħa), l- epatite B (rDNA) u l - Haemophilus tat- tip B konjugat
r ge
ad
- The active substances contained in 1 doses (0.5 ml) of Quintanrix are:
- Is- sustanzi attivi li fiha doża waħda (0. 5 ml) ta ’ Quintanrix huma:
Diphtheria toxoid1
Toxoid tad- difterite1
not less than 30 International Units lon
mhux anqas minn 30 Unitajiet Internazzjonali ’ g ħ
Tetanus toxoid1 Inactivated Bordetella pertussis 2 Hepatitis B surface antigen (rDNA) 2, 3 Haemophilus influenzae type b polysaccharide no
Toxoid tat- tetnu1 Bordetella pertussis inattivat2
not less than 60 International Units not less than 4 International Units 10 micrograms
10 mikrogrammi
(polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as a carrier 1
konjugat ma ’ toxoid tat- tetnu bħala ġarrier 1
2.5 micrograms 5-10 micrograms
5- 10 mikrogrammi
0.26 milligrams Al3+
0. 26 milligrammi Al3+ li l
adsorbed on aluminium phosphate uc
adsorbit fuq aluminium hydroxide, idratat 2 Total:
Total:
DNA
- The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and
- L- ingredjenti l- oħra tal- vaċċin huma: lattosju, thiomersal (preservattiv), sodium chloride u ilma
water for injections.
għall- injezzjonijiet. diċ
Marketing authorisation holder and Manufacturer: lP
Id- Detentur Ta ’ l- Awtorizzazzjoni għalt- Tqegħid fis- Suq u l- Manifattur:
GlaxoSmithKline Biologicals s. a.
GlaxoSmithKline Biologicals s. a. me
Rue de l’ Institut 89 B-1330 Rixensart Belgium na
Rue de l’ Institut 89 B- 1330 Rixensart Il- Belġju ott
WHAT QUINTANRIX IS AND WHAT IT IS USED FOR i dic
X’ HINU QUINTANRIX U GHALXIEX JINTUZA
Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder.
(DTPw- HBV) tad- difterite (D), it- tetnu (T) iċ- ċellula sħiħa tal- pertussis (Pw) u l- epatite B (HBV), mal- fjala li fiha t- trab ta ’ l - Haemophilus influenzae type b (HIB).
Both components are presented in a glass vial for 2 doses or for 10 doses and must be mixed together before your child receives the Me
Iż- żewġ komponenti jinstabu fi fjala tal- ħġieġ għal 2 dożi jew għal- 10 dożi u jridu jitħalltu flimkien qabel ma ’ ibnek/ bintek Pr
vaccine.
jirċievi/ tirċievi l- vaċċin.
For 2 doses:
Għal 2 dożi:
- pack size of 100 vials of powder plus 100 vials of liquid
- pakkett b’ 100 fjala ta ’ trab flimkien ma ’ 100 fjala ta ’ likwidu
40 For 10 doses:
Għal 10 dożi:
- pack size of 50 vials of powder plus 50 vials of liquid
- pakkett b’ 50 fjala ta ’ trab flimkien ma ’ 50 fjala ta ’ likwidu
Not all pack sizes may be marketed.
at Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- iskop kummerċjali.
ed Quintanrix is a vaccine used in children to prevent five infectious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (a type of bacteria).
zz Quintanrix huwa vaċċin użat fit- tfal biex jilqa ’ kontra ħames mardiet infettivi: difterite, tetnu (lockjaw), pertussis (sogħla konvulsiva), epatite B u Haemophilus influenzae tat- tip b (tip ta ’
ris these infectious diseases.
ori batterju).
• Diphtheria:
t • Id- Difterite:
Generally the airways
Ġeneralment il -
tho become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.
aw passaġġi tan- nifs jiffjammaw (jintefħu) u dan jikkawża diffikultajiet serji fit- teħid tan- nifs u kultant mewt bit- taħniq.
The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
Il- batterji jipproduċu tossin (velenu), li jista ’ jikkawża ħsara fin- nervituri, problemi tal- qalb u anke jikkawża l- mewt.
au • Tetanus (Lockjaw):
ux • It- Tetnu (lockjaw):
The bacteria release a toxin
Ġrieħi li għandhom tendenza speċjali għall- infezzjoni huma l- ħruq tal- ġilda, il- ksur ta ’ l- għadam, ġrieħi fondi jew ġrieħi mniġġsa bil- ħamrija, trab, ħmieġ/ demel taż- żwiemel jew skald ta ’ l- injam.
ge muscle spasms can be strong enough to cause bone fractures of the spine.
ad batterji jerħu tossin (velenu), li jista ’ jikkawża ebusija fil- muskoli, spażmi li jweġġgħu fil- muskoli, aċċessjonijiet u anki mewt.
• Pertussis (Whooping cough):
L- ispażmi tal- muskoli jistgħu jkunu qawwija biżżejjed biex jiksru għadam mix- xewka tad- dahar. ’ g ħ • Il- Pertussis (sogħla konvulsiva):
The disease affects the lon airways causing severe spells of coughing that may interfere with normal breathing.
Il- marda taffetwa l- passaġġi tan- nifs u tikkawża attakki serji ta ’ sogħla li jistgħu jaffettwaw it- teħid normali tan- nifs.
The coughing is often accompanied by a “ whooping” sound, hence the common name “ whooping cough”.
Is- sogħla ħafna drabi ġġib magħha tħarħir (whooping), mnejn ġie l- isem komuni ‘ whooping cough ’ (sogħla im
The cough may last for 1-2 months or longer.
Is- sogħla tista ’ ddum bejn xahar u xaharejn u anke aktar.
Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death. no
Il- pertussis tista ’ wkoll tikkawża infezzjoni fil- widnejn, bronkite li tista ’ tieħu fit- tul, pulmonite, aċċessjonijiet, ħsara fil - moħħ u saħansitra mewt. li l
• Hepatitis B:
• L- Epatite B:
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinsab fil- likwidi tal- ġisem bħad- demm, is- semen, it- tisfija tal- vaġina, jew is- saliva (bżiq) tal - ina
Signs of the disease may not be seen for 6 weeks to 6 months after infection.
Sinjali tal- marda jistgħu ma ’ jkunux jidhru minn 6 ġimgħat sa 6 xhur wara l - infezzjoni.
Others have signs of mild flu, t uc
Huma jistgħu ikunu diċ
They may be extremely tired, and have dark urine, pale faces, yellowish skin and/ or eyes (jaundice), and other signs of the disease possibly requiring hospitalisation. rod
għajjenin ħafna, ikollhom l- awrina skura, wiċċhom bla kulur, ġilda safranija u/ jew sfura fl- abjad ta ’ l- għajnejn (suffejra) u sintomi oħra tal- marda li għalihom jista ’ jkollhom bżonn jittieħdu l- isptar.
But some people, particularly children, who may not have shown signs of the disease can remain infected.
Madankollu xi nies, partikolarment it- tfal, li me
They are called hepatitis B virus carriers.
setgħu ma urewx sinjali ta ’ mard jistgħu jibqgħu infettati.
Hepatitis B carriers can infect others throughout their lives.
Dawn jissejħu carriers tal- virus ta ’ l - epatite B.
Hepatitis B carriers are at risk of lP
Carriers ta ’ l- epatite B jistgħu jinfettaw oħrajn tul ħajjithom.
serious liver disease, such as cirrhosis (liver scarring) and liver cancer.
Carriers ta 'l- epatite B għandhom ir- riskju ta' mard serju tal- fwied, bħal ċirrożi (ċikatriżazzjoni tal- fwied) u kanċer tal - fwied. ott
HIB infection most frequently causes brain inflammation na
Infezzjoni tal- HIB ħafna drabi tikkawża infjammazzjoni (nefħa) fil- moħħ.
HIB infection also causes inflammation of the throat.
L- infezzjoni tal- HIB od
It occasionally causes death by suffocation.
tikkawża wkoll infjammazzjoni fil- gerżuma.
Less commonly, the bacteria can also infect the blood, i
Xi kultant tikkawża mewt bit- taħniq.
Me
Il- vaċċin ma ’ jistax jikkawża infezzjonijiet tad - difterite, tat- tetnu (lockjaw), tal- pertussis (sogħla konvulsiva), ta ’ l- epatite B jew tal- Haemophilus influenzae tat- tip b.
The hepatitis B and Haemophilus influenzae type b components of Quintanrix can only help to protect your child against infections with hepatitis B or Haemophilus influenzae type b viruses.
41 Il- komponenti ta ’ l- epatite B u l- Haemophilus influenzae tat- tip b ta ’ Quintanrix jistgħu jgħinu biss biex f’ ibnek/ f’ bintek jilqgħu kontra infezzjonijiet permezz tal- viruses ta ’ l- epatite B u l - Haemophilus influenzae tat- tip b.
It cannot protect your child against other infections that can affect the liver or against infections due to other bacteria than Haemophilus influenzae type b or against meningitis caused by other organisms.
Ma tistax tipproteġi lil ibnek/ bintek kontra infezzjonijiet oħra li jistgħu jaffettwaw il- fwied jew kontra infezzjonijiet minħabba batterji oħra li m’ humiex Haemophilus influenzae tat- tip b jew kontra meninġite ikkawżata minn organiżmi oħra.
41 2.
at zz 2.
In the following cases, Quintanrix should not be given to your child.
Fil- każijiet li ġejjin, Quintanrix m’ għandiex tingħata lill- ibnek/ bintek.
You must tell your doctor:
ori tiegħek:
• if your child has experienced any health problems after previous administration of a vaccine. • if your child has previously had any allergic reaction to Quintanrix, or any ingredient contained
t • jekk ibnek/ bintek kellu/ kellha xi reazzjoni allerġika għal Quintanrix, jew għal kwalunke
ed in this vaccine.
aw ingredjent li fih dan il- vaċċin.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Is- sinjali ta` reazzjoni allerġika jistgħu jinkludu, raxx fil- ġilda li jġagħlek tħokk, qtugħ ta ’ nifs, u nefħa fil- wiċċ jew fl- ilsien. • jekk ibnek/ bintek kellu/ kellha xi reazzjoni allerġika għal kwalunkwe vaċċin kontra l- mard tad -
ris • if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b diseases. • if your child experienced problems of the nervous system (such as repetitive fits, decrease of
ux difterite, tat- tetnu, tal- pertussis (sogħla konvulżiva), ta ’ l- epatite B jew tal- Haemophilus influenzae tat- tip b. • jekk ibnek/ bintek kellu/ kellha xi problemi fis- sistema nervuża (bħal aċċessjonijiet ripetittivi,
In these cases, the
ad nuqqas ta ’ koxjenza) fi żmien sebat ijiem wara li tlaqqam/ tlaqqmet kontra l- pertussis (sogħla konvulżiva). • jekk ibnek/ bintek għandu/ għandha xi infezzjoni qawwija b`deni għoli (’ l fuq minn 38°C). ’ g ħ F’ dawn il- każijiet il- vaċċinazzjoni tkun posposta sakemm it- tifel/ tifla tirkupra.
A minor infection such as a cold should not be a problem, but talk to your doctor first. • if your child has any known allergies.
Infezzjoni ħafifa bħal riħ, m’ għandiex tkun problema, iżda l- ewwel dejjem ikkonsulta mat- tabib. • jekk ibnek/ bintek ibati/ tbati minn xi allerġiji li taf bihom. im
r In the following cases, your doctor can determine the right time and scheme of vaccination for
Fil- każijiet li ġejjin, it- tabib tiegħek jista ’ jiddetermina l- aħjar żmien u skeda ta ’ tilqim għal - ibnek/ bintek.
Tell your doctor:
Għid lit- tabib tiegħek: li l
• if after previously having Quintanrix or another vaccine against pertussis (whooping cough) lon disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse (floppiness) or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination no
• jekk wara xi tiqim fil- passat bi Quintanrix jew b’ xi vaċċin ieħor kontra l- pertussis (sogħla konvulżiva), ibnek/ bintek kellu/ kellha xi problemi speċjalment: ♦ Deni għoli (‘ l fuq minn 40° C) fi żmien 48 siegħa mit- tilqima ina
♦ Seizures/ fits with or without a high temperature within 3 days of vaccination • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/ fits due to a fever, or if there is a history in the family of this t
♦ Kollass jew stat bħal f’ xokk fi żmien 48 siegħa mit- tilqima ♦ Biki persistenti li jdum tliet sigħat jew aktar fi żmien 48 siegħa mit- tilqima ♦ Aċċessjonijiet b`deni għoli jew mingħajr deni għoli fi żmien 3 ijiem mit- tilqima diċ
Your uc
• jekk ibnek/ bintek għandu/ għandha problema ta ’ fsada jew jekk jitbenġel/ titbenġel malajr. • jekk ibnek/ bintek għandu/ għandha tendenza għall- aċċessjonijiet minħabba deni għoli, jew jekk hemm storja ta ’ dan fil- familja. me
doctor will be able to tell you what to do if Quintanrix is to be given with another vaccine or medicine. rod
It- tabib ikun jista ’ jgħidlek x’ għandek tagħmel jekk Quintanrix jkun se jingħata flimkien ma ’ vaċċin ieħor jew mediċina oħra.
Important information about some of the ingredients of Quintanrix
Informazzjoni importanti dwar xi sustanzi ta ’ Quintanrix ott
Tell you doctor if your child has any known allergies. lP
Għid lit- tabib tiegħek jekk ibnek/ bintek għandu/ għandha xi allerġiji od
HOW QUINTANRIX IS GIVEN na
KIF JINGĦATA QUINTANRIX
Your child will receive a total of three injections with an interval of at least one month between each one.
Ibnek/ bintek se jirċievi/ tirċievi total ta ’ tliet injezzjonijiet b’ intervall ta ’ mill- anqas xahar bejn kull waħda.
The first injection can be given from the age of 6 i dic
L- ewwel injezzjoni tista ’ tingħata mill- età ta ’ 6
weeks onwards.
42 ġimgħat il- quddiem.
You will be informed by the doctor or nurse when you should come back for subsequent injections.
Inti se tkun infurmat/ a mit- tabib jew l- infermier tiegħek meta għandek terġa ’ tmur għall- injezzjonijiet li jkun imiss.
Me
It- tabib jew l- infermier jagħtu Quintanrix bħala injezzjoni fil- muskolu.
Your doctor will advise on the possible need for extra doses.
It- tabib tiegħek jinfurmak jekk ikun hemm bżonn ta ’ dożi żejda.
If your child misses the visit scheduled for the second or third injection, talk to your doctor and arrange another visit as soon as possible.
at Jekk ibnek/ bintek jitlef/ titlef vista skedata għat- tieni jew it- tielet injezzjoni, kellem lit- tabib tiegħek u
Make sure your child finishes the complete vaccination course of three injections.
Jekk le,
If not, your child may not be fully protected against the diseases.
ori ibnek/ bintek jista ’ / tista’ ma ’ jkunx/ tkunx kompletament protett/ a kontra dan il- mard.
42 The vaccine should never be given into a vein.
Il- vaċċin m’ għandu qatt jingħata fil- vina.
4.
t aw 4.
ed Any vaccine can have some side effects.
Kwalunkwe vaċċin jista ’ jkollu xi effetti oħra.
Side effects that occurred during clinical trials with Quintanrix were as follows:
ux Effetti oħra li ġraw waqt provi kliniċi bi Quintanrix kienu kif ġej:
ris ♦ Very common (more than 1 per 10 doses of vaccine): • Pain, redness or swelling at the injection site
ad ♦ Komuni ħafna (aktar minn każ wieħed minn kull 10 dożi ta ’ vaċċin): • Uġigħ, ħmura jew nefħa fis- sit ta ’ l- injezzjoni • Deni (aktar minn 37. 5°C) ’ g ħ • Irritabilità • Nuqqas t’ aptit • Ngħas im
tho • Fever (more than 37.5°C) • Irritability • Loss of appetite
♦ Komuni (anqas minn każ wieħed minn kull 10 dożi iżda aktar minn każ wieħed minn kull 100 doża ta ’ vaċċin): • Boċċa iebsa li l
au • Drowsiness
• Deni (aktar minn 39°C) ina
♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): • Induration (hard lump)
♦ Rari (anqas minn każ wieħed minn kull 1000 doża iżda aktar minn każ wieħed minn kull 10 000 doża ta ’ vaċċin): • Bronkite • Sogħla diċ
♦ ge Rare (less than 1 per 1000 but more than 1 per 10 000 doses of vaccine): • Bronchitis lon • Coughing • Vomiting • Collapse (floppiness) or periods of unconsciousness or lack of awareness • Fits no
• Rimettar • Kollass (telqa) jew perjodi ta ’ telf jew nuqqas ta ’ koxjenza • Aċċessjonijiet me
Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets have been reported very rarely (less than 1 per 10,000 doses of vaccine) with the hepatitis B component of Quintanrix. t uc
Rari ħafna (anqas minn każ wieħed minn kull 10, 000 doża ta ’ vaċċin) kienu rrappurtati fsada jew tbenġil aktar faċilment mis- soltu minħabba tnaqqis fl- ammont ta ’ tip ta ’ ċelluli tad- demm imsejħa plejtlits bil- komponent ta ’ l- epatite B ta ’ Quintanrix. ott
Such reactions rod
Dawn jistgħu jkunu raxx lokali jew mifrux fejn ikun hemm ħakk jew jitilgħu l- bżieżaq, nefħa fl- għajnejn jew fil- wiċċ, diffikultà biex tieħu n- nifs jew tibla ’, pressjoni li taqa ’ f’ daqqa u telf ta ’ koxjenza. od
If these events continue or become severe, tell your doctor. lP
Jekk dawn il- ġrajjiet ikomplu jew isiru serji, għid lit- tabib tiegħek.
This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction. na
Dan il- prodott mediċinali fih thiomersal bħala preservattiv u huwa possibbli li ibnek/ bintek jkollu/ jkollha reazzjoni allerġika.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. i dic
43 Jekk tinnota xi effetti oħra li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib jew lill- ispiżjar tiegħek.
Me
Huwa possibbli li ibnek/ bintek ma ’ jkollux/ jkolliex effetti sekondarji mit- tilqim.
5.
at zz 5.
Store in the original package in order to protect from light.
ori Żommu fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
Keep out of the reach and sight of children.
t Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
43 Do not use after the expiry date stated on the pack.
aw Tużax wara d- data ta ’ skadenza li tidher fuq il- pakkett.
The date for last use corresponds to the last day of the month mentioned.
Id- data sa meta jista ’ intuża l- aħħar hija l- aħħar ġurnata tax- xahar imsemmi.
6.
ux 6.
ris België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
ad Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għatTqegħid fis- Suq. ’ g ħ Luxembourg/ Luxemburg België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
tho Tél/ Tel: + 32 2 656 21 11
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r ge Česká republika GlaxoSmithKline s.r.o.
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KG
KG ott
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---------------------------------------------------------------------------------------------------------------------- t uc
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The following information is intended for medical or healthcare professionals only: rod
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa:
Upon storage, a white deposit and clear supernatant may be observed for the DTPw-HBV component.
Meta jinħażen, depożitu abjad u saff likwidu ċar fil- wiċċ jistgħu jiġu osservati għall- komponent od
The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white lP
Il- komponent DTPw- HBV għandu jitħawwad sewwa biex tinkiseb suspensjoni uniformi, bajda u Pr
suspension and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
imdardra u li għanda tiġi miflija viżwalment għal xi frak u/ jew dehra fiżika mhux normali.
Any unused vaccine or waste material should be disposed of in accordance with local requirements. na
Kull fdal tal- vaċċin li ma jiġix użat jew skart li jibqa ’ wara l- użu għandu jintrema kif jitolbu l- liġijiet lokali.
After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until i dic
Wara li żżid il- komponent DTPw- HBV mat- trab ta ’ l -
the powder is completely dissolved.
45 HIB, it- taħlita għandha titħawwad sewwa sakemm it- trab jinħall kollu.
The reconstituted vaccine is a homogeneous turbid white suspension.
Il- vaċċin rikostitwit huwa suspensjoni uniformi bajda u mdardra.
Remove and discard the needle used for reconstitution and replace it with a second needle to Me
Wara r- rikostituzzjoni, il- vaċċin għandu jiġi injettat immedjatament.
After reconstitution, the vaccine should be injected promptly.
at Quintanrix m’ għandux jingħata lil suġġetti li għandhom sensittività eċċessiva għas- sustanzi attivi jew
Quintanrix should not be given to subjects with hypersensitivity to the active substances or to any of the excipients.
Quintanrix huwa kontra- indikat jekk ibnek/ bintek kellu/ ha enċefalopatija li l- kawża tagħha ma kinetx
In these
ori magħrufa, u li tkun seħħet fi żmien 7 ijiem minn tilqim preċedenti b’ vaċċin li kien fih il- pertussis.
45 circumstances the vaccination course should be continued with diphtheria, tetanus, hepatitis B and HIB vaccines.
F’ dawn iċ- ċirkustanzi l- kors ta ’ tilqim għandu jitkompla b’ vaċċini tad- difterite, tat- tetnu, ta ’ l- epatite B u tal- HIB.
As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering from acute severe febrile illness.
t aw Bħal f’ vaċċini oħra, l- amministrazzjoni ta ’ Quintanrix għandha tiġi posposta f’ suġġetti li qed ibatu minn mard b’ deni akut u serju.
The presence of a minor infection, such as a cold, is not a contraindication for vaccination.
Il- preżenza ta ’ infezzjoni ħafifa, bħal riħ, m’ hijiex kontra - indikazzjoni għat- tilqim.
ed If any of the following events occur in temporal relation to receipt of Quintanrix, the decision to give subsequent doses of a vaccine containing the pertussis component should be carefully considered:
ux Jekk kwalunkwe waħda minn dawn il- ġrajjiet li ġejjin tiġri fl- istess żmien meta jittieħed Quintanrix, għandu jiġi kkunsidrat bir- reqqa jekk għandhomx jingħataw id- dożi li jmiss tal- vaċċin li fih il - komponent tal- pertussis:
ris • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. • Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
ad • Temperatura ≥ 40. 0 °C fi żmien 48 siegħa, mhux minħabba kawża oħra magħrufa. • Kollass jew stat bħal f’ xokk (episodju ipotoniku- iporisponsiv) fi żmien 48 siegħa. • Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa mit- tilqima. ’ g ħ • Aċċessjonijiet bid- deni jew mingħajr deni li jiġru fi żmien tlett ijiem.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Jista ’ jkun hemm ċirkustanzi, bħal per eżempju inċidenza għolja ta ’ pertussis, meta l- benefiċċji jkunu akbar mir- riskji possibbli. im
au As with all injectable vaccines, app ropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal fil- każ tal- vaċċini l- oħra kollha li jiġu injettati, kura u sorveljanza medika xierqa għandhom dejjem ikunu disponibbli fil- każ rari ta ’ ġrajja anafilattika li tista ’ tinqala ’ wara l- amministrazzjoni tal - vaċċin. li l
r Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
Quintanrix qiegħed għal injezzjoni fil- fond ġol- muskolu, preferibbilment ġol- koxxa anterolaterali. ina
ge Quintanrix should under no circumstances be administered intravascularly. lon
Quintanrix m’ għandu qatt jingħata fil- vina. diċ me ott od Pr
QUIXIDAR
t za QUIXIDAR
It explains how
riz to Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
ho the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji
ut If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni
ra information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
x Xjentifika (ukoll parti mill- EPAR).
e What is Quixidar?
X’ inhu Quixidar?
Quixidar is a solution for injection in a prefilled syringe. ng Quixidar contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe). lo What is Quixidar used for?
Quixidar hu soluzzjoni għall- injezzjoni f’ siringa mimlija bil- lest.
Quixidar (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, no
Quixidar fih is- sustanza attiva fondaparinux sodium (1. 5, 2. 5, 5, 7. 5 jew 10 mg f’ kull siringa). ’ g Għal x’ hiex jintuża Quixidar? im
problems caused by blood clots) in patients who are having major surgery to their legs, such as a hip replacement or surgery to repair a knee or hip fracture.
Quixidar (f’ dożi ta ’ 1. 5 u 2. 5 mg) jintuża fil- prevenzjoni ta ’ avvenimenti trombolitiċi venużi (VTEs, problemi kkawżati minn demm magħqud) f’ pazjenti li jkunu sa jagħmlu operazzjoni serja f’ riġlejhom, bħal sostituzzjoni ta ’ l- ingroppa jew operazzjonijiet għat- tiswija ta ’ ksur fl- irkoppa jew fl- ingroppa.
It can also be used in patients at high risk (because of their age or disease) when they have abdominal surgery, especially for cancer, or when ct
Jista ’ jintuża wkoll f’ pazjenti li jkollhom riskju kbir (minħabba l- età jew mard) meta jagħmlu li l
At higher strengths (5, 7.5 and 10 mg), Quixidar is used to treat VTEs such as deep vein thrombosis du
operazzjonijiet addominali maġġuri, speċjalment għall- kanċer, jew meta jkollhom joqogħdu fis- sodda minħabba marda akuta. na
(DVT, a blood clot in the leg) or pulmonary embolism (PE, blood clot in the lung).
F’ qawwiet iktar għolja (5, 7. 5 u 10 mg), Quixidar huwa wżat għall- kura tal- VTEs bħal ma huma trombożi fil- vini l- fondi (DVT, embolu fis- sieq) jew emboliżmu pulmonarju (PE, embolu fil- pulmun).
The 2.5 mg strength is also used to treat patients with unstable angina (a type of chest pain that ro
Il- qawwa ta ’ 2. 5 mg hija wżata wkoll għall- kura ta ’ pazjenti li jbatu minn anġina li mhijiex stabbli (tip iċi
changes in severity) or who are having a myocardial infarction (heart attack): • without ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) in patients who are not going to undergo urgent angioplasty (within two hours): angioplasty or lP
• Mingħajr ‘ l- elevazzjoni tas- segment ST ’ (qari mhux normali fuq l- elettrokardjogramma jew l - ECG) f ’ pazjenti li mhumiex ser jagħmlu anġjoplastija urġenti (urgent angioplasty) (fi żmien sagħtejn): anġjoplastija jew ‘ intervent perkutanju koronarju ’ (PCI) (percutaneous coronary tm
‘ percutaneous coronary intervention’ (PCI) is an operation to unblock the heart’ s blood vessels, • with ‘ ST segment elevation ’ in patients who are receiving thrombolytic medicines (‘ clot busters’) na
intervention) hija operazzjoni li tiżblokka l- arterji u l- vini tal- qalb, • ‘ Bl- elevazzjoni tas- segment ST ’ f’ pazjenti li qed jirċievu mediċini trombolitiċi (‘ dawk li jeqirdu l- emboli ’) jew li mhumiex ser jirċievu xi tip ta ’ kura oħra immedjata biex il- fluss tad- demm ot
or who are not about to receive any other treatment to restore blood flow to the heart.
jerġgħa lura lejn il- qalb.
The medicine can only be obtained with a prescription. ici
Il- mediċina tista ’ tinkiseb biss b’ riċetta tat- tabib. od
How is Quixidar used? ed
Pr
In the prevention of VTEs, the recommended dose of Quixidar is 2.5 mg once a day by subcutaneous injection (under the skin).
Fil- prevenzjoni ta ’ VTEs, id- doża rakkomandata ta ’ Quixidar hija ta ’ 2. 5 mg darba kuljum amministrata permezz ta ’ injezzjoni taħt il- ġilda.
For patients having surgery, the first dose should be given six hours after the end of the operation.
Għal pazjenti li jkunu se jagħmlu operazzjoni, l - ewwel doża għandha tingħata sitt sigħat wara tmiem l- operazzjoni.
Treatment should be continued until the risk of VTE has been reduced, M
It- trattament għandu jitkompla sakemm jitnaqqas ir- riskju tal- VTE, ġeneralment minn ta ’ l- inqas bejn ħames u disat ijiem wara l - kirurġija.
For patients who have kidney problems, Quixidar may not be suitable, or the lower 1.5-mg dose may be used.
Għall- pazjenti li jbatu minn problemi fil- kliewi, Quixidar jista ’ ma jkunx adattat, jew inkella tista ’ tintuża doża iżgħar ta ’ 1. 5- mg.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged started as soon as possible after diagnosis and continued for up to eight days or until the patient is discharged from hospital.
Id- doża tista ’ tiġi aġġustata, skond il- piż tal - ġisem.
Quixidar is not recommended in patients who are about to undergo certain types of PCI.
za f’ pazjenti li ser jgħaddu minn ċertu tipi ta ’ PCI.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar informazzjoni, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
How does Quixidar work?
riz Kif jaħdem Quixidar?
Blood clotting can be a problem when blood flow is disturbed in any way.
Quixidar
Quixidar is an anticoagulant; it prevents the blood from coagulating (clotting).
to hu antikoagulant; jipprevjeni d- demm milli jikkoagula (jagħqad).
The active ingredient in Quixidar, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood,
Is- sustanza attiva f’ Quixidar, fondaparinux sodium, twaqqaf waħda mis- sustanzi (fatturi) li jieħdu sehem fil- koagulazzjoni tad -
d Factor Xa.
aw demm, il- Fattur Xa.
When this is blocked, no thrombin (another factor) can be produced, and no clot can be
Meta dan jiġi imblukkat, ma jkunx jista ’ jiġi prodott thrombin (fattur ieħor), u ma jkunx jista ’ jifforma embolu.
By using Quixidar after surgery, the risk of a blood clot forming is greatly reduced.
Bl- użu ta ’ Quixidar wara operazzjoni, ir- riskju ta ’ formazzjoni ta ’ embolu jitnaqqas drastikament.
By reducing blood clots, Quixidar can also help the flow of blood to the heart to be maintained in patients
Peress illi huwa jnaqqas l- emboli, Quixidar jista ’ wkoll jgħin biex il - fluss tad- demm lejn il- qalb jinżamm f’ pazjenti li jbatu minn anġina jew li qegħdin isofru minn attakk
ris with angina or who are having a heart attack.
x tal- qalb.
ho How has Quixidar been studied?
du Kif ġie studjat Quixidar?
The effectiveness of Quixidar has been studied for the prevention of and in the treatment of VTE.
L- effettività ta ’ Quixidar ġiet studjata fil- prevenzjoni ta ’ u fit- trattament ta ’ VTE.
It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839
Fl- istudji tal - ħa prevenzjoni, Quixidar tqabbel ma ’ antikoagulanti oħra: enoxaparin (fil- kirurġija fl- irkoppa jew fl - ingroppa; iktar minn 8, 000 pazjent) jew dalteparin (fil- kirurġija addominali; 2, 927 pazjent).
ra patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).
Tqabbel ukoll ma ’ plaċebo (trattament finta) użat ma ’ pazjenti b’ marda akuta (839 pazjent) u ma ’ pazjenti ’ g ttrattati għal 24 jum ieħor wara kirurġija għal ksur fl- ingroppa (656 pazjent).
In the treatment of VTE, Quixidar was compared with enoxaparin (DVT:
Fit- trattament ta ’ VTE, Quixidar tqabbel ma ’ enoxaparin (DVT:
2,192 patients) or with unfractionated heparin (PE:
2, 184 im
2,184 patients).
pazjent).
In all studies, the main measure of effectiveness was the
Fl- istudji kollha, il- mezz prinċipali ta ’ effikaċja kien ir- rata globali ta ’ avvenimenti trombotiċi (problemi kkawżati minn emboli).
The main measure of effectiveness no
L- ewwel wieħed ikkumpara l- effetti ta ’ Quixidar ma ’ dawk ta ’ enoxaparin f’ iktar minn 20, 000 – il pazjent li jbatu minn anġina mhux stabbli u infart mijokardjali mingħajr l- elevazzjoni tas- segment ST, u t- tieni wieħed ikkumpara Quixidar mal- kura standard (eparina mhux frazzjonata na
was the proportion of patients who died or had an ‘ ischaemic event’ (restriction of blood supply to an organ, including the heart). ct
f’ pazjenti eliġibbli, jew plaċebo) f’ iktar minn 12, 000 – il pazjent li jbatu minn infart mijokardjali b ’ elevazzjoni tas- segment ST.
What benefit has Quixidar shown during the studies?
X’ inhuma l- benefiċċji ta ’ Quixidar li ntwerew f’ dawn l- istudji?
The overall rate of thrombotic events in patients treated with Quixidar was significantly less than in du
Ir- rata globali ta ’ avvenimenti trombotiċi f’ pazjenti ttrattati b’ Quixidar kienet ferm inqas minn dik f’ pazjenti ttrattati bi plaċebo jew b’ enoxaparin (għal pazjenti li kienu se jiġu operati f’ saqajhom), u tm
patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
kienet simili għal dik b’ enoxaparin (trattament tad- DVT), dalteparin jew eparina mhux frazzjonata.
Quixidar was at least as effective as enoxaparin in preventing death or an ischaemic event in patients ro
Quixidar kien minn ta ’ l- inqas effettiv daqs enoxaparin fil- prevenzjoni tal- mewt jew avveniment iskaemiku f’ pazjenti li jbatu minn anġina mhux stabbli jew infart mijokarkjali mingħajr elevazzjoni ot
with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
tas- segment ST, b’ madwar 5% tal- pazjenti f’ kull grupp li mietu jew li kellhom avveniment iskaemiku wara disat ijiem.
In the study of myocardial lP
Fl- istudju ta ’ l- infarti mijokardjali b’ elevazzjoni tas- segment ST, Quixidar naqqas ir - od
infarction with ST segment elevation, Quixidar reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
riskju ta ’ mewt jew attakk tal- qalb ieħor b’ 14% wara 30 jum, meta imqabbel mal- kura standard.
However, these results were insufficient to show whether Quixidar was more effective than unfractionated heparin or not. na
Pr
What is the risk associated with Quixidar?
X’ inhu r- riskju assoċjat ma ’ Quixidar?
For the ici
Bħall- mediċini antitrombotiċi l- oħra, l- iktar effetti sekondarji komuni ta ’ Quixidar kien il- ħruġ tad - demm.
Quixidar should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or ed
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Quixidar, ara l- Fuljett ta ’ Tagħrif.
The Committee for Medicinal Products for Human Use (CHMP) decided that Quixidar’ s benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Quixidar m’ għandux jintuża minn persuni allerġiċi għal fondaparinux sodium jew għal xi sustanza oħra tiegħu, li jista ’ diġà jkollhom ħruġ ta ’ demm, li għandhom endokartite batterjali akuta (acute
The European Commission granted a marketing authorisation valid throughout the European Union for Quixidar on 21 March 2002.
bacterial endocarditis) (infezzjoni fil- qalb) jew li jkollhom problemi serji fil- kliewi.
The marketing authorisation holder is Glaxo Group Ltd.
Għal- lista sħiħa ta ’ restrizzjonijiet, ara l- Fuljett ta ’ Tagħrif.
The full EPAR for Quixidar can be found here.
Il- Kumitat irrakkomanda li Quixidar jingħata awtorizzazzjoni għat- tqegħid fis- suq.
This summary was last updated in 09-2007.
t za Tagħrif ieħor dwar Quixidar:
ut
Id- detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq huwa Glaxo Group Ltd.
ho
to L- EPAR sħiħ dwar Quixidar jista ’ jinstab hawnhekk.
ris
aw Dan is- sommarju kien aġġornat l- aħħar f’ 09- 2007.
du ro lP na ici ed M
x du ħa ’ g im li l na iċi ed tm ot od Pr
ed EU Number
t a z iz Numru ta ’ l_ EU
Invented name
Isem iventat
ris EU/ 1/ 02/ 207/ 001
r EU/ 1/ 02/ 207/ 001
Subcutaneous or
Użu subkutanju jew intravenuż
pre-filled syringe (glass) 0.5 ml
siringa mimlija lesta (ħġieġ) 0. 5 ml
2 pre-filled syringes
2 siringi mimlijin lesti
7 pre-filled syringes
7 siringi mimlijin lesti
a EU/ 1/ 02/ 207/ 004
w EU/ 1/ 02/ 207/ 004
pre-filled syringe (glass) 0.5 ml
0. 5 ml Soluzzjoni għall- injezzjoni Użu subkutanju jew intravenuż siringa mimlija lesta (ħġieġ) 0. 5 ml
20 pre-filled syringes
20 siringa mimlijin lesti
Subcutaneous use
Użu subkutanju
pre-filled syringe (glass)
siringa mimlija lesta (ħġieġ)
e EU/ 1/ 02/ 207/ 006
a EU/ 1/ 02/ 207/ 006
pre-filled syringe (glass) 0.3 ml
siringa mimlija lesta (ħġieġ) 0. 3 ml
g EU/ 1/ 02/ 207/ 007
x EU/ 1/ 02/ 207/ 007
pre-filled syringe (glass) 0.3 ml
0. 3 ml Soluzzjoni għall- injezzjoni Użu subkutanju siringa mimlija lesta (ħġieġ) 0. 3 ml
lo EU/ 1/ 02/ 207/ 009
u EU/ 1/ 02/ 207/ 009
0.4 ml Solution for injection Subcutaneous use pre-filled syringe (glass) 0.4 ml
siringa mimlija lesta (ħġieġ) 0. 4 ml
EU/ 1/ 02/ 207/ 010
d EU/ 1/ 02/ 207/ 010
o EU/ 1/ 02/ 207/ 012
ħ EU/ 1/ 02/ 207/ 012
0.6 ml
7. 5 mg/ 0. 6 ml
pre-filled syringe (glass) 0.6 ml
0. 6 ml Soluzzjoni għall- injezzjoni Użu subkutanju siringa mimlija lesta (ħġieġ) 0. 6 ml
pre-filled syringe (glass) 0.6 ml
siringa mimlija lesta (ħġieġ) 0. 6 ml
ct EU/ 1/ 02/ 207/ 014
’ g EU/ 1/ 02/ 207/ 014
0.6 ml Solution for injection Subcutaneous use pre-filled syringe (glass) 0.6 ml
0. 6 ml Soluzzjoni għall- injezzjoni Użu subkutanju siringa mimlija lesta (ħġieġ) 0. 6 ml
10 mg/ 0.8 ml
0. 8 ml
0.8 ml Solution for injection Subcutaneous use pre-filled syringe (glass) 0.8 ml
siringa mimlija lesta (ħġieġ) 0. 8 ml
EU/ 1/ 02/ 207/ 016
im EU/ 1/ 02/ 207/ 016
pre-filled syringe (glass) 0.8 ml
0. 8 ml Soluzzjoni għall- injezzjoni Użu subkutanju siringa mimlija lesta (ħġieġ) 0. 8 ml
pre-filled syringe (glass) 0.8 ml
siringa mimlija lesta (ħġieġ) 0. 8 ml
d EU/ 1/ 02/ 207/ 018
l EU/ 1/ 02/ 207/ 018
pre-filled syringe (glass) 0.4 ml
siringa mimlija lesta (ħġieġ) 0. 4 ml
o EU/ 1/ 02/ 207/ 019
li EU/ 1/ 02/ 207/ 019
d i e M
a in ċ i d e tm t o d ro P
SUMMARY OF PRODUCT CHARACTERISTICS lo no ct du ro lP na ici ed M
t za riz to aw x du ħa ANNESS I ’ g SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT im li l na iċi ed tm ot od Pr
Quixidar 1.5 mg/ 0.3 ml solution for injection, pre-filled syringe.
Quixidar 1. 5 mg/ 0. 3 ml soluzzjoni għall- injezzjoni, siringa mimlija lesta.
Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
t Kull siringa mimlija lesta (0. 3 ml) fiha 1. 5 mg fondaparinux sodium.
d Excipient(s):
za Sustanza( i):