qanastek/EMEA-V3 huggingface dataset:
No increase in the frequency or severity of adverse events was seen with subsequent doses.
Ma dehret ebda żieda fil- frekwenza jew severità ta ’ l- episodji avversi b’ dożi suċċessivi.
Post marketing Experience
Esperjenza wara t- tqegħid fis- suq
PROCOMVAX Hypersensitivity Rarely: anaphylaxis, angioedema, urticaria, erythema multiforme.
PROCOMVAX Sensittività eċċessiva Rari: anafilassi, anġioedema, urtikarja, eritema multiformi
Nervous System Seizure, febrile seizure
Sistema nervuża Aċċessjoni, aċċessjonijiet bid- deni
4 Respiratory, thoracic and mediastinal disorders Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Disturbi respiratorji, toraċiċi u medjastinali Apneja fi trabi prematuri ħafna (≤ 28 ġimgħa ta ’ ġestazzjoni) (ara sezzjoni 4. 4).
Potential Adverse Effects
Ġilda Għoqda fil- post ta ’ l- injezzjoni
In addition, a variety of adverse effects have been reported with marketed use of either Merck PRP- OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine in infants and children through 71 months of age.
Effetti Avversi Potenzjali Barra minn hekk, kienu rrapportati varjetà ta ’ effetti avversi bl- użu kummerċjalizzat ta ’ Merck PRP - OMPC Vaccine jew Merck Hepatitis B (Recombinant) Vaccine fi trabi u tfal li kellhom sa 71 xahar.
These adverse effects are listed below.
Dawn l- effetti avversi huma elenkati hawn isfel.
Liquid Merck PRP-OMPC Vaccine
Merck PRP- OMPC Vaccine likwidu Ematoloġiċi/ Limfatiċi Linfadenopatija
Skin Pain at the injection site
Ġilda Uġigħ fil- post ta ’ l- injezzjoni
Merck Hepatitis B (Recombinant) Vaccine Common reactions
Merck Hepatitis B (Recombinant) Vaccine Reazzjonijiet komuni
Local reactions at injection site: transient soreness, erythema, induration
Reazzjonijiet lokali fil- post ta ’ l- injezzjoni: uġigħ għaddien, eritema, ebusija
- elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like
- żieda fl- enżimi tal- fwied, għeja, deni, telqa, sintomi bħal ta ’ l- influwenza, sintomi jixbħu
symptoms, serum sickness, thrombocytopenia
spażmu tal- bronki, mard mis- serum, tromboċitopenja
- dizziness, headache, paresthesia
- sturdament, uġigħ ta ’ ras, paresthesia
- nausea, vomiting, diarrhea, abdominal pain
- nawsja, rimettar, dijarea, uġigħ addominali
- arthralgia, myalgia
- altralġja, uġigħ fil- muskoli
- rash, pruritus,
- raxx, ħakk
- hypotension, syncope
- pressjoni baxxa ħafna, sinkope
- paralysis (Bell’ s palsy), neuropathy, neuritis (including Guillain Barre Syndrome, myelitis
- paralisi (Bell’ s palsy), newropatija, nevrite (inkluż is- Sindrome ta ’ Guillain Barre), mjelite
including transverse myelitis), encephalitis, optical neuritis.
(inkluża l- mjelite trasversali), enċefalite, nevrite ottika
- lymphadenopathy.
- linfadenopatija.
There are no data with regard to overdose.
M’ hemmx informazzjoni rigward dożi eċċessivi.
Pharmacotherapeutic group: anti infectious, ATC code:
Kategorija farmakoterapewtika: kontra l- infezzjonijiet, Kodiċi ATC:
J07CA PROCOMVAX is a sterile bivalent vaccine made of the antigenic components used in producing Merck PRP-OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
J07CA PROCOMVAX huwa vaċċin sterili bivalenti magħmul mill- komponenti antiġeniċi wżati fil - produzzjoni ta ’ Merck PRP- OMPC Vaccine u Merck Hepatitis B (Recombinant) Vaccine.
These components are the Haemophilus influenzae type b capsular polysaccharide (PRP) that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.
Dawn il - komponenti huma l- polisakkarid kapsulari (PRP) ta 'Haemophilus influenzae tat- tip b li huwa marbut b’ mod kovalenti ma ’ kumpless ta ’ proteini tal- membrana esterna (OMPC – outer membrane protein complex) tan- Neisseria meningitides u antiġen tal- wiċċ ta ’ l- epatite B (HBsAg) minn kulturi rikombinanti tal- ħmira.
The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines.
L- effikaċja protettiva tal- komponenti ta ’ PROCOMVAX ġiet stabbilita fi provi tal- prodott f’ sitwazzjonijiet attwali mwettqa bil- vaċċini monovalenti.
5 Anti-HBs Responses to PROCOMVAX in Infants Not Previously Vaccinated with Hepatitis B Vaccine
Reazzjonijiet anti- HBs għal PROCOMVAX fi Trabi Mhux Imlaqqma Qabel kontra l- Vaċċin ta ’ l - Epatite B
In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 1809 infants, approximately 2 months of age, who had not previously received any hepatitis B vaccine.
F’ 4 studji kliniċi li saru bejn l- 1992 u l- 2000, PROCOMVAX ġie mogħti lil 1809 tarbija, ta ’ madwar xahrejn, li ma kienu ngħataw l- ebda vaċċin kontra l- epatite B qabel.
These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Dawn it- trabi rċevew b’ mod nominali PROCOMVAX ta ’ 2, 4 u 12- 15 – il xahar.
In these studies, 1503 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 1309 had anti-HBs results available following the third dose of PROCOMVAX.
F’ dawn l- istudji, 1503 trabi kellhom riżultati kontra HBs disponibbli wara l- ewwel 2 dożi ta ’ PROCOMVAX u 1309 kellhom riżultati kontra Hbs disponibbli wara t- tielet doża ta ’ PROCOMVAX.
Post-dose 2, 77% to 96% of infants developed a protective level of anti-HBs (≥ 10 mIU/ ml) and the GMTs ranged from 30 mIU/ ml to 190 mIU/ ml.
Wara t- 2 doża, 77% sa 96% tat- trabi żviluppaw livell protettiv ta ’ anti- HBs (≥ 10 mIU/ ml) u l- GMTs varjaw minn 30mIU/ ml sa 190mIU/ ml.
Post-dose 3, 96% to 100% of infants developed a protective level of anti-HBs and the GMTs ranged from 897 mIU/ ml to 4467 mIU/ ml.
Wara t- 3 doża, 96% sa 100% tat- trabi żviluppaw livelli protettiv ta ’ anti- HBs u l- GMTs varjaw minn 897 mIU/ ml sa 4467 mIU/ ml.
Anti-HBs Responses to PROCOMVAX in Infants Previously Vaccinated with Hepatitis B Vaccine
Reazzjonijiet anti- HBs għal PROCOMVAX fi Trabi Mlaqqma Qabel b’ Vaċċin kontra l- Epatite B
In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 722 infants, approximately 2 months of age, who had previously received a single dose of hepatitis B vaccine at birth.
F’ 4 studji kliniċi li saru bejn l- 1992 u l- 2000, PROCOMVAX ġie mogħti lil 722 tarbija, ta ’ madwar xahrejn, li kienu ngħataw doża waħda tal- vaċċin kontra l- epatite B malli twieldu.
These infants nominally received PROCOMVAX at 2-3, 4-5, and 12-15 months of age
Dawn it- trabi rċevew b’ mod nominali PROCOMVAX ta ’ 2- 3, 4- 5, u 12- 15 – il xahar.
In these studies, 618 infants had anti-HBs results available following the first 2 doses of PROCOMVAX and 461 had anti-HBs results available following the third dose of PROCOMVAX.
F’ dawn l- istudji, 618- il tarbija kellhom riżultati anti- HBs disponibbli wara l- ewwel 2 dożi ta ’ PROCOMVAX u 461 kellhom riżultati anti- HBs disponibbli wara t- tielet doża ta ’ PROCOMVAX.
Post-dose 2, 93% to 100% of infants developed a protective level of anti-HBs (≥ 10 mIU/ ml) and the GMTs ranged from 125 mIU/ ml to 417 mIU/ ml.
Wara t- tieni doża, 93% sa 100% tat- trabi żviluppaw livell protettiv ta ’ anti- HBs (≥ 10 mIU/ ml) u l - GMTs varjaw minn 125 mIU/ ml sa 417 mIU/ ml.
Post-dose 3, 98% to 100% of infants developed a protective level of anti-HBs and the GMTs ranged from 1509 mIU/ ml to 3913 mIU/ ml.
Wara t- tielet doża, 98% sa 100% tat- trabi żviluppaw livell protettiv ta ’ anti- HBs u l- GMTs varjaw minn 1509 mIU/ ml sa 3913 mIU/ ml.
The duration of the protective effect for hepatitis B in healthy vaccinees is unknown at present and the need for a routine booster dose with hepatitis B-containing vaccines is not yet defined.
It- tul ta ’ żmien kemm idum l- effett protettiv għall- epatite B fi trabi b’ saħħithom li ġew imlaqqma mhuwiex magħruf fil- preżent u l- bżonn ta ’ doża booster ta ’ rutina b’ vaċċini li fihom l- epatite B għadha mhux definita.
Anti-PRP Responses to PROCOMVAX in Infants
Reazzjonijiet anti- PRP għal PROCOMVAX fit- Trabi
In 6 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 2528 infants, approximately 2 months of age, who had not previously received any Hib vaccine.
F’ 6 studji kliniċi li saru bejn l- 1992 u l- 2000, PROCOMVAX ġie mogħti lil 2528 tarbija, ta ’ madwar xahrejn, li ma kienu ngħataw l- ebda vaċċin kontra l- Hib qabel.
These infants nominally received PROCOMVAX at 2, 4, and 12-15 months of age.
Dawn it- trabi rċevew b’ mod nominali PROCOMVAX ta ’ 2, 4, u 12- 15 – il xahar.
In these studies, 2121 infants had anti-PRP results available following the first 2 doses of PROCOMVAX and 1768 had anti-PRP results available following the third dose of PROCOMVAX.
F’ dawn l- istudji, 2121 tarbija kellhom riżultati anti- PRP disponibbli wara l- ewwel żewġ dożi ta ’ PROCOMVAX u 1768 kellhom riżultati anti- PRP disponibbli wara t- tielet doża ta ’ PROCOMVAX.
Post-dose 2, 95% to 99% of infants developed > 0.15 µg/ ml of anti-PRP, a level associated with short-term protection against invasive Hib disease, and the GMTs ranged from 2.5 µg/ ml to 4.3 µg/ ml.
Wara t- tieni doża, 95% sa 99% tat- trabi żviluppaw > 0. 15 µg/ ml ta ’ anti- PRP, livell assoċjat ma ’ protezzjoni fuq perjodu qasir kontra mard invażiv ta ’ l- Hib, u l- GMTs varjaw minn 2. 5 µg/ ml sa
Post-dose 3, 92% to 99% of infants developed > 1.0 µg/ ml of anti-PRP, a level associated with long- term protection against invasive Hib disease, and the GMTs ranged from 7.7 µg/ ml to 14.0 µg/ ml.
Wara t- tielet doża, 92% sa 99% tat- trabi żviluppaw > 1. 0 µg/ ml ta ’ anti- PRP, livell assoċjat ma ’ protezzjoni fuq perjodu fit- tul kontra mard invażiv ta ’ l- Hib, u l- GMTs varjaw minn 7. 7 µg/ ml sa 14. 0 µg/ ml.
6 Formulation contains amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride.
Il- formula fiha amorphous aluminium hydroxyphosphate sulphate u sodium borate f’ 0. 9% ta ’ sodium chloride.
In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or other medicinal products in the same syringe.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- vaċċin m’ għandux jitħallat ma ’ vaċċini jew prodotti mediċinali oħra fl- istess siringa.
Store in a refrigerator (2 °C - 8 °C).
Aħżen fi friġġ (2°C – 8°C).
0.5 ml suspension in vial (type I flint glass).
0. 5 ml sospensjoni f' kunjett (ħġieġ żniedi ta 'tip I).
6.6 Instructions for use and handling
6. 6 Struzzjonijiet għall- użu u maniġġar u għar- rimi
The vaccine should be used as supplied; no reconstitution is necessary.
Il- vaċċin għandu jintuża kif fornut; m' hemm bżonn ta 'ebda rikonstituzzjoni.
After thorough agitation, PROCOMVAX is a slightly opaque, white suspension.
Wara aġitazzjoni tajba, PROCOMVAX huwa soluzzjoni kemmxejn opaka, bajdanija.
Parenteral medicinal products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.
Prodotti mediċinali parenterali għandhom jiġu spezzjonati viżwalment għal partikuli barranin u għal telf fil - lewn qabel l- għoti, kull meta s- soluzzjoni u r- reċipjent jippermettu li dan isir.
Shake well before withdrawal and use.
Ħawwad sew qabel tiġbed u tuża.
Thorough agitation is necessary to achieve suspension of the vaccine.
Aġitazzjoni tajba hija meħtieġa sabiex issir sospensjoni tal- vaċċin.
8, rue Jonas Salk F - 69007 LYON
8, rue Jonas Salk F - 69007 LYON Franza
EU/ 1/ 99/ 104/ 001
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 7 EU/ 1/ 99/ 104/ 001
07/ 05/ 1999 Date of latest renewal:
07/ 05/ 1999 Data ta ’ l- aħħar tiġdid:
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE AND MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES
A MANIFATTUR TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer of the biological active substances
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
For Haemophilus B conjugate and Hepatitis B surface antigen:
Għal antiġen tal- wiċċ ta 'Haemophilis B conjugated u ta' Epatite B:
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott
Box 581, 2003 PC Haarlem The Netherlands
Box 581, 2003 PC Haarlem L- Olanda
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Il- fuljett ta ’ tagħrif stampat tal- prodott mediċinali jrid jindika l- isem, l- indirizz tal- manifattur responsabbli għall- ħruġ tal- lott konċernat.
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT TQEGĦID FIS- SUQ
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq irid jinforma lill- Kummissjoni Ewropea dwar il- pjanijiet għat- tqegħid fis- suq tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EEC, the official batch release will be undertaken by a state laboratory or a laboratory disignated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 Direttiva 2001/ 83/ KEE, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
TIKKETTA
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) Vaccine.
PROCOMVAX sospensjoni għall- injezzjoni Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis B (Recombinant) Vaccine
1 dose (0.5 ml) contains:
doża waħda (0. 5 ml) fiha:
7.5 µg of PRP from Haemophilus influenzae type b as PRP-OMPC 125 µg of Neisseria meningitidis OMPC 5.0 µg of hepatitis B surface antigen produced in recombinant yeast cells
7. 5 µg ta 'PRP minn Haemophilus influenzae tip b bħala PRP- OMPC 125 µg ta' Neisseria meningitidis OMPC 5. 0 µg ta 'antiġen tal- wiċċ ta ’ l- epatite B prodott f’ ċelloli tal- ħmira rikombinanti
Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Amorphous aluminium hydroxyphosphate sulphate u sodium borate f' 0. 9% ta 'sodium chloride
1 single dose 0.5 ml in vial.
Doża waħda ta ’ 0. 5 ml f’ kunjett.
Suspension for injection in vial.
Suspensjoni għal injezzjoni f’ kunjett.
METHOD AND,, ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
Intramuscular use.
Ħawwad sew qabel l- użu Użu għal ġol- muskoli
Store in a refrigerator Do not freeze
Tagħmlux fil- friża
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon
8, rue Jonas Salk F - 69007 LYON Franza
Shake well before use
Ħawwad sew qabel l- użu
1 dose = 0.5 ml
kunjett ta 'doża waħda = 0. 5 ml
14 B.
15 B.
15 PACKAGE LEAFLET
16 FULJETT TA ’ TAGĦRIF
Read all of this leaflet carefully before your child is vaccinated.
Aqra sewwa dan il- fuljett kollu qabel tibda tieħu dim il- mediċina.
- This vaccine has been prescribed for your child and you should not pass it on to others.
Tagħtihx lil persuni oħra.
What PROCOMVAX is and what it is used for 2.
X’ inhu PROCOMVAX u għalxiex jintuża 2.
Before you use PROCOMVAX 3.
Qabel ma tuża PROCOMVAX 3.
How to use PROCOMVAX 4.
Kif għandek tuża PROCOMVAX 4.
Storing PROCOMVAX 6.
Kif taħżen PROCOMVAX 6.
PROCOMVAX suspension for injection in vial.
PROCOMVAX suspensjoni għal injezzjoni f’ kunjett.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine.
Haemophilus b Conjugate (Meningococcal Protein Conjugate) u Hepatitis B (Recombinant) Vaccine.
The active substances are:
Is- sustanzi attivi huma:
Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B)
Neisseria meningitidis OMPC (kumpless tal- proteina tal- membrana ta ’ barra tar- razza B11 ta ’ Neisseria meningitidis sottogrupp B)
The other ingredients are: amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Is- sustanzi l- oħra huma: amorphous aluminium hydroxyphosphate sulphate u sodium borate f’ 0. 9% ta ’ sodium chloride
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F - 69007 Lyon
Manufactured by:
Manifatturat minn:
Merck Sharp & Dohme B. V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Haarlem, L- Olanda
1 WHAT PROCOMVAX IS AND WHAT IT IS USED FOR
X’ INHU PROCOMVAX U GĦALXIEX JINTUŻA
PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial.
PROCOMVAX huwa vaċċin injettabbli f’ kunjett ta ’ doża waħda ta ’ 0. 5ml.
PROCOMVAX is indicated to help protect your child against invasive disease caused by Haemophilus influenzae type b (infection of brain and spinal cord tissues, infection of the blood, etc.) and against infection of the liver caused by all known subtypes of hepatitis B virus.
PROCOMVAX huwa indikat biex jipproteġi aħjar lit- tifel/ tifla tiegħek kontra mard invażiv ikkawżat minn Haemophilus influenzae tat- tip b (infezzjoni tat- tessuti tal- moħħ u tan- nerv li jgħaddi minn ġos - sinsla, infezzjoni tad- demm, eċċ.) u kontra infezzjoni tad- demm ikkawżata mis- sottotipi magħrufa kollha tal- virus ta ’ l- epatite B.
The vaccine can be administered in most infants 6 weeks to 15 months of age.
Il- vaċċin jista ’ jingħata fil- maġġoranza tat- trabi ta ’ bejn 6 ġimgħat u 15- il xahar.
BEFORE YOU USE PROCOMVAX
QABEL MA TUŻA PROCOMVAX
Do not use PROCOMVAX:
Tużax PROCOMVAX:
- if your child is allergic to any component of the vaccine.
- jekk it- tifel/ tifla tiegħek hu/ hi allerġiku/ a għal xi component tal- vaċċin.
- in infants younger than 6 weeks of age
- fi trabi li jkollhom anqas minn 6 ġimgħat
- if your child has fever (vaccination should be delayed).
- jekk it- tifel/ tifla tiegħek ikollu/ ikollha d- deni (it- tilqim għandu jiġi pospost).
- in infants born to HBsAg positive mothers.
- fi trabi mwielda minn ommijiet HBsAg- pożittivi.
16 Take special care with PROCOMVAX:
17 Oqgħod attent ħafna bi PROCOMVAX:
- if your child has bleeding disorders such as haemophilia or thrombocytopenia, special
- jekk it- tifel/ tifla tiegħek ikollhom problemi bi fsad bħall- emofilja jew tromboċitopenja,
precautions should be taken against the risk of haematoma following injection.
għandhom jittieħdu prekawzjonijiet speċjali kontra r- riskju ta ’ ematoma wara l- injezzjoni.
- if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should
- jekk inti omm pożittiva għall- antiġen tal- wiċċ tal- virus ta ’ l- epatite B (HBsAg), it- tarbija
receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
tiegħek għandha tirċievi Globulina Immunitarja ta ’ l- Epatite B (HBIG) u vaċċin kontra l- epatite B (rikombinanti) meta jitwieldu u għandhom ikomplu s- sensiela tat- tilqimiet kontra l- epatite B.
The subsequent administration of PROCOMVAX for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and received HBIG or infants born of mothers of unknown status has not been studied.
L- għoti suċċessiv ta ’ PROCOMVAX għall- kompletar tas- sensiela ta ’ tilqimiet kontra l- epatite B fi trabi li twieldu minn ommijiet HBsAg- pożittivi u rċevew HBIG jew trabi mwielda minn ommijiet ta ’ status mhux magħruf, għadu ma ġiex studjat.
- as with other similar vaccines, cases of Haemophilus b disease may occur in the week after
- l- istess bħal vaċċini oħra simili, jistgħu jseħħu każijiet ta ’ mard bil- Haemophilus b fil- ġimgħa
vaccination prior to the onset of the protective effects of the vaccine.
ta ’ wara t- tilqima qabel ma jibdew l- effetti protettivi tal- vaċċin.
- because hepatitis B infection can go undetected for a long period of time, it is possible that an
- minħabba li infezzjoni bl- epatite B tista ’ tibqa ’ mhux rilevata għal perjodu twil ta ’ żmien, huwa
individual may already be infected at the time the vaccine is given.
possibbli li individwu diġà jkun infettat fil- ħin li jingħata l- vaċċin.
The vaccine may not prevent hepatitis B in these individuals.
Il- vaċċin jista ’ ma jwaqqafx l- epatite B f’ tali individwi.
Using other vaccines
Meta tuża vaċċini oħra
PROCOMVAX can be administered simultaneously with the primary series of diphtheria, tetanus, pertussis vaccine (DTP) and oral polio vaccine (OPV).
PROCOMVAX jista ’ jingħata simultanjament mas- serje primarja tal- vaċċin kontra d- difterite, it- tetnu u s- sogħla konvulsiva (DTP) u l- vaċċin orali kontra l- poljo (OPV).
At 12 to 15 months of age, PROCOMVAX may be given simultaneously with Merck MMR (Measles, Mumps, and Rubella Virus Vaccine Live), or OPV or with a booster dose of diphtheria, tetanus, acellular pertussis vaccine (DTaP) at 15 months of age in children who received the primary series of DTP.
Ta ’ 12 sa 15- il xahar, PROCOMVAX jista ’ jingħata simultanjament ma ’ Merck MMR (Vaċċin kontra l- Virus tal- Ħożba, Gattone u Rubella Ħaj), jew OPV jew ma ’ doża booster tal- vaċċin kontra d- difterite, tetnu u sogħla konvulsiva (DTaP) fi tfal li jkunu rċevew is- serje primarja ta ’ DTP.
PROCOMVAX has been administered simultaneously with the primary series of DTaP and enhanced inactivated poliovirus vaccine (IPV) to a limited number of infants.
PROCOMVAX ingħata simultanjament mas- serje primarja ta ’ DTaP u ma ’ vaċċin mhux attivat aktar b’ saħħtu kontra l- poljo (IPV) lil numru limitat ta ’ trabi.
No serious vaccine-related side effects were reported.
Ma kienu rrapportati l- ebda effetti sekondarji serji marbuta mal- vaċċin.
Immune response data are satisfactory for PROCOMVAX but are currently unavailable for DTaP.
L- informazzjoni dwar ir- rispons immunitarju hija sodisfaċenti għal PROCOMVAX iżda attwalment mhix disponibbli għal DTaP.
HOW TO USE PROCOMVAX
KIF GĦANDEK TUŻA PROCOMVAX
Infants born of HBsAg negative mothers should be vaccinated with three 0.5 ml doses of PROCOMVAX, ideally at 2, 4, and 12-15 months of age.
Trabi mwielda minn ommijiet HBsAg negattivi għandhom jiġu mlaqqma bi tliet dożi ta ’ 0. 5 ml ta ’ PROCOMVAX, idealment ta ’ 2, 4, u 12 - 15– il xahar.
PROCOMVAX must be injected into the muscle of the thigh.
PROCOMVAX irid jiġi injettat fil- muskolu tal- koxxa.
Do not inject intravenously, intradermally, or subcutaneously
Tinjettax fil- vini, minn ġol- ġilda jew taħt il- ġilda
If you forget to take PROCOMVAX:
Jekk tinsa tieħu PROCOMVAX:
Your doctor will decide when to give the missed dose.
It- tabib tiegħek jiddeċiedi meta tingħata d- doża mitlufa.
Like all medicines, PROCOMVAX can have side effects.
Bħal kull mediċina oħra, PROCOMVAX jista ’ jkollu effetti sekondarji.
PROCOMVAX has been generally well tolerated in clinical trials.
Ġeneralment PROCOMVAX kien ittollerat sewwa fil- provi kliniċi.
Side effects include injection-site reactions such as pain, soreness, redness, and swelling.
18 bħal uġigħ, ħmura, u tinfiħ.
Other side effects include irritability, sleepiness, fever, diarrhoea, vomiting, loss of appetite, middle ear infection, and unusual high-pitched crying.
Effetti sekondarji oħra jinkludu l- irritabilità, ħedla ta ’ ngħas, deni, dijarea, rimettar, telf ta ’ l- aptit, infezzjoni tal- widna tan- nofs, u biki jgħajjat mhux tas- soltu.
Other side effects that may occur rarely and be serious include seizure, febrile seizure, allergic reactions, allergic swelling (angioedema) and certain severe types of rash, injection site nodule.
Effetti sekondarji oħra li jistgħu jseħħu b’ mod rari u jkunu serji jinkludu aċċessjonijiet, aċċessjonijiet bid- deni, reazzjonijiet allerġiċi, tinfiħ allerġiku (anġjoedema) u ċerti tipi akuti ta ’ raxxijiet, għoqda fil- post ta ’ l - injezzjoni.
Tell your doctor promptly about these or any other unusual symptoms.
Għid lit- tabib tiegħek minnufih dwar dawn is- sintomi jew oħrajn mhux tas- soltu.
If the condition persists or worsens, seek medical attention.
Jekk il- kondizzjoni tippersisti jew teħżien, fittex attenzjoni medika.
In addition, tell your doctor if your child experienced any symptoms that suggest an allergic reaction after any dose in the vaccination series.
Barra minn hekk, avża lit- tabib tiegħek jekk it- tifel/ tifla tiegħek esperjenzaw sintomi li jissuġġerixxu reazzjoni allerġika wara xi doża fiċ- ċiklu tat- tilqim.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib jew lill- ispiżjar tiegħek.
STORING PROCOMVAX
KIF TAĦŻEN PROCOMVAX
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
AKTAR TAGĦRIF Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Portugal Sanofi Pasteur MSD, SA Tel: +351 21 470 45 50
Sanofi Pasteur MSD, SA Tel: +351 21 470 45 50
Ireland SANOFI PASTEUR MSD Ltd Tel: +3531.468.5600
468. 5600
EU number EU/ 1/ 05/ 316/ 001 EU/ 1/ 05/ 316/ 002 EU/ 1/ 05/ 316/ 003 EU/ 1/ 05/ 316/ 004 EU/ 1/ 05/ 316/ 005 EU/ 1/ 05/ 316/ 006 EU/ 1/ 05/ 316/ 007 EU/ 1/ 05/ 316/ 008 EU/ 1/ 05/ 316/ 009 EU/ 1/ 05/ 316/ 010 EU/ 1/ 05/ 316/ 011 EU/ 1/ 05/ 316/ 012 EU/ 1/ 05/ 316/ 013 EU/ 1/ 05/ 316/ 014
Numru ta ’ l- EU EMEA/ H/ C/ 597/ 001 EMEA/ H/ C/ 597/ 002 EMEA/ H/ C/ 597/ 003 EMEA/ H/ C/ 597/ 004 EMEA/ H/ C/ 597/ 005 EMEA/ H/ C/ 597/ 006 EMEA/ H/ C/ 597/ 007 EMEA/ H/ C/ 597/ 008 EMEA/ H/ C/ 597/ 009
Invented name Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan
Isem inventat Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan
Procoralan 5 mg film-coated tablets
Procoralan 5 mg pilloli miksija b’ rita.
The tablet can be divided into equal halves.
Kulur is- salamun, oblunga, pillola miksija b’ rita b’ sinjal imnaqqax fuq żewġ naħat, fuq naħa waħda. imnaqqax b ’ “ 5 ” u fuq in- naħa l- oħra Il- pillola tista tinqasam f’ nofsijiet ugwali.
Children and adolescents Procoralan is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Tfal u adoloxxenti Procoralan mhux irrakkomandat għall- użu fit- tfal u l- adoloxxenti peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
There are no adequate data concerning the use of ivabradine in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ ivabradine waqt it- tqala.
Procoralan has been studied in clinical trials involving nearly 5,000 participants.
Procoralan ġie studjat f’ provi kliniċi li involvew 5000 partiċipant.
The antianginal and anti-ischaemic efficacy of Procoralan was studied in four double-blind randomised trials (two versus placebo, and one each versus atenolol and amlodipine).
L- effikaċja kontra l- anġina u kontra l- iskemija ta ’ Procoralan ġiet studjata f’ erba ’ provi randomised għamja doppji (tnejn versus placebo, wieħed versus atenolol u wieħed versus amlodipine).
8 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (> 10 mg/ ml).
F’ kundizzjonijiet fiżjoloġiċi, ivabradine jiġi merħi malajr mill- pilloli u jinħall mill- ewwel fl- ilma (> 10 mg/ ml).
Pharmacokinetic/ pharmacodynamic (PK/ PD) relationship PK/ PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
9 Analiżi ta ’ relazzjoni PK/ PD wriet li r- rata tat- taħbit tal- qalb tonqos b’ mod kważi lineari meta tizdied l- konċentrazzjonijiet fil- plażma, ta ’ ivabradine u ta ’ S18982 għal dożi sa 15- 20 mg darbtejn kuljum.
At higher doses, the decrease in heart rate is no longer proportional to ivabradine plasma concentrations and
F’ dożi ogħla t- tnaqqis fir- rata tat- taħbit tal- qalb mhux iktar proporzjonali għal konċentrazzjonijiet fil - plażma ta ’ ivabridine u hemm tendenza li jilħaq livell ta ’ plateau.
High exposures to ivabradine that may occur when ivabradine is given in combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Esponiment qawwi fil- bniedem għal ivabradine li jista ’ jiġri meta ivabradine jingħata flimkien ma ’ impedituri qawwija ta ’ CYP3A4 jista ’ jwassal għal tnaqqis eċċessiv fir- rata tat- taħbit tal- qalb għalkemm ir- riskju jonqos b’ impedituri moderati ta ’ CYP3A4 (ara sezzjonijiet 4. 3, 4. 4 u 4. 5).
10 6.5 Nature and contents of container
10 Folji ta ’ Aluminium/ PVC ippakkjati f’ kaxxi tal- kartun.
Procoralan 7.5 mg film-coated tablets
Procoralan 7. 5 mg pilloli miksija b’ rita.
Salmon-coloured, triangular, film-coated tablet engraved with “ 7.5” on one face and face.
Kulur is- salamun, triangulari, pillola miksija b’ rita b’ sinjal fuq naħa waħda imnaqqax “ 7. 5 ” u fuq in -. naħa l- oħra
CYP3A4 inducers (e. g. rifampicin, barbiturates, phenytoin, Hypericum
Mediċini li jġiegħlu CYP3A4 jaħdem iżjed (eż.
perforatum [St John’ s Wort]) may decrease ivabradine exposure and activity.
John’ s Wort] jistgħu jnaqqsu l - esponiment u l- attivita` ta ’ ivabradine.
16 17 Uncommon:
Mhux komuni
18 Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Ivabradine jista ’ jkollu interazzjoni ma ’ current IH retinali li jixbaħ ħafna lil If kardijaku.
19 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
22 ANNEX II
21 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT B.
23 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Annopol 6B – 03-236 Warszawa, Poland Akmon farmacevtske industrije d. o. o., Industrijska cesta 1J - 1290 Grosuplje – Slovenia
Annopol 6B – 03- 236 Warszawa, Poland Akmon farmacevtske industrije d. o. o., Industrijska cesta 1J - 1290 Grosuplje – Slovenja
Not applicable.
23 ANNESS III
LABELLING
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
{CARTON}
{Kartuna}
Procoralan 5 mg film-coated tablets ivabradine
Procoralan 5 mg pilloli miksija b’ rita ivabradine
EU/ 1/ 05/ 316/ 001 [EU/ 1/ 05/ 316/ 002] [EU/ 1/ 05/ 316/ 003] [EU/ 1/ 05/ 316/ 004] [EU/ 1/ 05/ 316/ 005] [EU/ 1/ 05/ 316/ 006] [EU/ 1/ 05/ 316/ 007]
EU1/ 05/ 316/ 001 [EU1/ 05/ 316/ 002] [EU1/ 05/ 316/ 003] [EU1/ 05/ 316/ 004] [EU1/ 05/ 316/ 005] [EU1/ 05/ 316/ 006] [EU1/ 05/ 316/ 007]
28 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Procoralan 7.5 mg film-coated tablets ivabradine
Procoralan 7. 5 mg pilloli miksija b’ rita ivabradine
EU/ 1/ 05/ 316/ 008 [EU/ 1/ 05/ 316/ 009] [EU/ 1/ 05/ 316/ 010] [EU/ 1/ 05/ 316/ 011] [EU/ 1/ 05/ 316/ 012] [EU/ 1/ 05/ 316/ 013] [EU/ 1/ 05/ 316/ 014]
EU1/ 05/ 316/ 008 [EU1/ 05/ 316/ 009] [EU1/ 05/ 316/ 010] [EU1/ 05/ 316/ 011] [EU1/ 05/ 316/ 012] [EU1/ 05/ 316/ 013] [EU1/ 05/ 316/ 014]
PROCORALAN 7.5 mg
PROCORALAN 7. 5 mg
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
MON TUE WED THU FRI SAT SUN
FULJETT TA ’ TAGĦRIF
PACKAGE LEAFLET
32 FULJETT TA ’ TAGĦRIF:
Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Procoralan 5 mg pilloli miksija b’ rita Procoralan 7. 5 mg pilloli miksija b’ rita ivabradine
What Procoralan is and what it is used for 2.
X’ inhu Procoralan u għalxiex jintuża 2.
Before you take Procoralan 3.
Qabel ma tieħu Procoralan 3.
How to take Procoralan 4.
Kif għandek tieħu Procoralan 4.
Possible side effects 5 How to store Procoralan 6.
Effetti sekondarji li jista ’ jkollu 5.
WHAT PROCORALAN IS AND WHAT IT IS USED FOR
X’ INHU PROCORALAN U GĦALXIEX JINTUŻA
Procoralan is a heart medicine used to treat stable angina pectoris which causes chest pain, when beta- blockers (like atenolol, propranolol, metoprolol, etc, for high blood pressure, heart rhythm disorders, or angina pectoris) are not suitable.
Procoralan huwa mediċina għall- mard tal- qalb li jintuża f’ każ ta ’ anġina pectoris stabbli li tikkaġuna uġigħ fis- sider, meta beta- blockers (bħal atenolol, propranolol, metoprolol, eċċ., għal pressjoni għolja, problemi fir- ritmu tat- taħbit tal- qalb, jew anġina pectoris) m’ humiex adattati.
How does Procoralan work?
Kif jaħdem Procoralan?
Procoralan mainly works by reducing the heart rate by a few beats per minute.
Procoralan jaħdem billi jnaqqas ir- rata tat- taħbit tal- qalb bi ftit taħbit fil- minuta.
In this way Procoralan helps to control and reduce the number of angina attacks.
B’ hekk Procoralan igħin biex jikkontrolla u jnaqqas l- attakki ta ’ anġina.
BEFORE YOU TAKE PROCORALAN
QABEL MA TIEĦU PROCORALAN
Do not take Procoralan:
Tieħux Procoralan
- if you are allergic (hypersensitive) to ivabradine or any of the other ingredients of Procoralan;
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal ivabradine jew sustanzi oħra ta ’
- if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
- jekk qed tieħu mediċini għall- kura ta ’ infezzjoni fungali (bħal ketoconazole, itraconazole),
itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) (see “ Taking other medicines”);
antibijotiċi ta ’ tip macrolide (bħal josamycin, clarithromycin, telithromycin jew erythtromycin meħuda mill- ħalq), mediċini għall- kura ta ’ infezzjonijiet b’ HIV (bħal nelfinavir, ritonavir) jew nefazodone (mediċina għall- kura tad- dipressjoni) (ara taħt “ Meta tieħu mediċini oħra ”);
Take special care with Procoralan:
Oqgħod attent ħafna b’ Procoralan
If any of the above applies to you, talk to your doctor before or while taking Procoralan.
Jekk xi ħaġa msemmija hawn fuq tolqot lilek, kellem lit- tabib tiegħek qabel jew waqt li tkun qed tieħu Procoralan.
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan or monitoring should be required:
Kun ċert li tgħarraf lit- tabib tiegħek jekk qed tieħu xi mediċini hawn taħt imsemmija, għax ikun hemm bżonn ta ’ aġġustar fid- doża ta ’ Procoralan jew għandek bżonn tkun taħt osservazzjoni:
Limit your consumption of grapefruit juice during treatment with Procoralan.
Meta tieħu Procoralan ma ’ l- ikel u max- xorb Naqqas milli tieħu il- ġjus tal- grejpfrut meta tkun qed tieħu Procoralan.
Do not take Procoralan if you are pregnant or planning a pregnancy (see “ Do not take Procoralan”).
34 Tieħux Procoralan jekk qed tredda ’ jew qed tippjana biex toħroġ tqila (ara taħt “ Tieħux Procoralan ”).
If you are pregnant and have taken Procoralan, talk to your doctor.
Jekk int tqila u ħadt Procoralan, għid lit- tabib tegħek.
Do not take Procoralan if you are breast-feeding (see “ Do not take Procoralan”).
Tieħux Procoralan jekk qed tredda (ara taħt “ Tieħux Procoralan ”).
Possible side effects”).
Sewqan u tħaddim ta ’ magni Procoralan jista ’ jikkaġunalek fenomeni viżivi mudwali temporanji (ara taħt “ Effetti Sekondarji li jista ’ jkollu ”).
Procoralan contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Procoralan Procoralan fih il- lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib kien qallek li għandek intolleranza għal xi ħlewwiet għid lit - tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE PROCORALAN
KIF GĦANDEK TIEĦU PROCORALAN
Always take Procoralan exactly as your doctor has told you.
Dejjem għandek tieħu Procoralan skond il- parir tat- tabib.
The usual recommended starting dose is 1 tablet of Procoralan 5 mg twice daily increasing if necessary to 1 tablet of Procoralan 7.5 mg twice daily.
Id- doża li ssoltu tingħata fil- bidu hija ta ’ pillola waħda ta ’ Procoralan 5 mg darbtejn kuljum u tiżdied jekk ikun hemm bżonn għall - 1 pillola ta ’ Procoralan 7. 5 mg darbtejn kuljum.
In some cases (e. g. if you are elderly), your doctor may prescribe half the dose i. e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
F’ xi każijiet (eż. jekk int anzjan/ a) it- tabib tiegħek jista ’ jagħtik nofs id- doża i. e. nofs pinnola Procoralan 5 mg (li hija 2. 5 mg ivabradine) fil- għodu u nofs pillola 5 mg fil- għaxija.
Procoralan should be taken during meals.
Procoralan irid jittieħed ma ’ l- ikel.
If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
Jekk taħseb li l- effett ta ’ Procoralan hu qawwi ħafna jew ħafif wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
Procoralan is not intended for use in children and adolescents younger than 18 years.
Procoralan mhux qiegħed għall- użu tat- tfal u żagħżagħ taħt it- 18 – il sena.
A large dose of Procoralan could make you feel breathless or tired because your heart slows down too much.
Jekk tieħu Procoralan aktar milli suppost B’ doża kbira ta ’ Procoralan tista ’ tħossok b’ nifsek maqtugħ jew għajjien għax il- qalb tħabbat iktar bil - mod.
If you forget to take a dose of Procoralan, take the next dose at the usual time.
Jekk tinsa tieħu Procoralan Jekk tinsa tieħu d- doża ta ’ Procoralan, ħu d- doża normali meta jkun jerġa ’ jmissek.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan.
Il- ġranet stampati fuq il- folja li fiha l- pilloli jistgħu jgħinuk biex tiftakar meta ħadt l- aħħar pillola ta ’ Procoralan.
As the treatment for angina is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Jekk tieqaf tieħu Procoralan Minħabba li din il- kura għall- anġina hija normalment għal- għomrok, int għandek titkellem mat- tabib tiegħek qabel ma twaqqaf dan il- prodott mediċinali.
Like all medicines, Procoralan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Procoralan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (more than 1 in 10 patients) reported with Procoralan are luminous visual phenomena (brief moments of increased brightness, most often caused by sudden changes in light intensity).
Effetti sekondarji komuni ħafna ta ’ Procoralan (iktar minn 1 f ’ kull 10 pazjenti) huma fenomeni mudwali viżivi (perjodi qosra ta ’ dija qawwija ħafna drabi minħabba tibdil f’ daqqa fil- qawwa tad - dawl).
Other common side effects (more than 1 in 100 patients but less than 1 in 10 patients) include affecting the way the heart works (the symptoms are a slowing down of the heart rate), headache, dizziness, blurred vision and palpitations and cardiac extra beats which are uncommon (more than 1 in 1000 patients but less than 1 in 100 patients).
35 uġigħ ta ’ ras, sturdament, vista imċajpra u taħbit mgħaġġel tal- qalb u meta l- qalb tagħmel taħbit żejjed li m’ humiex komuni (iktar minn 1 f’ kull 1000 pazjent iżda inqas minn 1 f’ kull 100 pazjent).
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE PROCORALAN
KIF TAĦŻEN PROCORALAN
Do not use Procoralan after the expiry date which is stated on the carton and blister.
Tużax Procoralan wara d- data ta ’ skadenza li tidher fuq il- kaxxa u il- folja.
What Procoralan contains:
X’ fih Procoralan:
Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride).
Procoralan 5 mg: pillola waħda miksija b’ rita fiha 5 mg ivabradine (ekwivalenti għal 5. 390 mg ivabradine hydrochloride) Procoralan 7. 5 mg: pillola waħda miksija b’ rita fiha 7. 5 mg ivabradine (ekwivalenti għal 8. 085 mg ivabradine hydrochloride)
What Procoralan looks like and contents of the pack:
Id- dehra ta ’ Procoralan u l- kontenut tal- pakkett:
Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “ 7.5” on one face and
Procoralan 5 mg pilloli huma kulur is- salamun, pilloli miksija b’ rita, oblungi, b’ sinjal imnaqqax fuq. iż- żewġ naħat, fuq naħa waħda imnaqax b “ 5 ” u fuq in- naħa l- oħra Procoralan 7. 5 mg pilloli huma kulur is- salamun, triangulari, pilloli miksija b’ rita b’ sinjal fuq naħa waħda imnaqqax “ 7. 5 ” u fuq in- naħa l- oħra
The tablets are available in calendar packs (blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.
Il- pilloli jinsabu f’ pakketti (folji) ta ’ 14, 28, 56, 84, 98, 100 jew 112- il pillola immarkat bil- ġranet.
Not all pack sizes may be available.
Mhux il- pakketti kollha jistgħu jinsabu fis- suq.
Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy – France
36 Manifattur Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy – France
Industrijska cesta 1J 1290 Grosuplje – Slovenia
Industrijska cesta 1J 1290 Grosuplje – Slovenja
España Laboratorios Servier S. L.
37 España Laboratorios Servier S. L.
What is Prometax?
X' inhu Prometax?
Prometax is a medicine containing the active substance rivastigmine.
Prometax huwa mediċina li fiha s- sustanza attiva rivastigmina (rivastigmine).
6 mg), as an oral solution (2 mg/ ml), and as transdermal patches, which release either 4.6 mg or 9.5 mg rivastigmine across the skin over 24 hours.
6 mg), bħala soluzzjoni orali (2 mg/ ml), u bħala stikk transdermiku, li jerħi 4. 6 mg jew 9. 5 mg rivastigmina mill - ġilda fi żmien 24 siegħa.
What is Prometax used for?
Għal xiex jintuża Prometax?
Prometax capsules, oral solution and transdermal patches are used for the treatment of patients with mild to moderately severe Alzheimer’ s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Dan it- tip ta 'demenza huwa disturb tal- moħħ progressiv li jolqot gradwalment il- memorja, l- abilità intellettiva u l- imġiba.
How is Prometax used?
Kif jintuża Prometax?
Treatment with Prometax should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’ s disease or dementia in patients with Parkinson’ s disease.
It- trattament bi Prometax għandu jibda u jiġi mmonitorjat minn tabib li għandu l- esperjenza fid - dijanjożi u fit- trattament tal- marda ta 'Alzheimer jew fid- demenza f' pazjenti bil- marda ta' Parkinson.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Prometax by the patient.
It- trattament għandu jinbeda biss jekk hija disponibbli persuna li tieħu ħsieb il- pazjent, li tista 'tikkontrolla regolarment l- użu ta' Prometax mill- pazjent.
Prometax capsules or oral solution should be given twice a day, with morning and evening meals.
Prometax kapsuli jew soluzzjoni orali għandhom jingħataw darbtejn kuljum, ma 'l- ikla ta' filgħodu jew ma 'dik ta' filgħaxija.
In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Jekk din id- doża tirriżulta tollerata sew, tista 'tiżdied b' 1. 5 mg kull doża waħda, iżda mhux iktar frekwenti minn ġimagħtejn bejn żieda u oħra, sakemm tintlaħaq doża regolari ta' 3- 6 mg darbtejn kuljum.
The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Id- doża massima rakkomandata hija 6 mg darbtejn kuljum.
If the transdermal patches are used, the 4.6 mg per 24 hours patch should be used first, with the dose increased to the 9.5 mg/ 24 h patch after at least four weeks if the lower dose is well tolerated.
Fil- każ ta 'stikk transdermiku, għall- ewwel għandu jitwaħħal l- istikk ta' 4. 6 mg għal 24 siegħa.
The patches are stuck onto clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Sussegwentement, wara talanqas erba 'ġimgħat ta' trattament jekk id- doża l- aktar baxxa tkun ġiet tollerata sew, jista 'jintuża l- istikk ta' 9. 5 mg/ 24 siegħa.
The patches can be worn during bathing and hot weather.
L- istikk jitwaħħal fuq il- ġilda nadifa, xotta, mingħajr xagħar u intatta tad- dahar, tal- parti ta 'fuq tad- driegħ jew tas- sider, u għandu jitbiddel kull 24 siegħa.
See the Summary of Product Characteristics (also part of the EPAR) for detailed information.
L- istikk ma għandux jitwaħħal fuq il- ġilda bi ħmura jew irritata, fuq il- koxxa jew fuq iż- żaqq jew f' pożizzjoni fejn jista 'jitherra meta jħokk ma' ħwejjeġ issikkati.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- istikk ma jinqalax f' każ li 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. joħroġ l- għaraq minħabba s- sħana jew waqt l- għum.
How does Prometax work?
Kif jaħdem Prometax?
The active substance in Prometax, rivastigmine, is an antidementia medicine.
Is- sustanza attiva fi Prometax, rivastigmina, hija mediċina kontra d- demenza.
In patients with Alzheimer’ s dementia or dementia due to Parkinson’ s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Fil- pazjenti b' demenza tat- tip Alzheimer jew b' demenza dovuta għall- marda ta 'Parkinson, ċerti ċelluli nervużi tal- moħħ imutu, b' hekk dan jirriżulta f' livelli baxxi tan- newrotrasmettitur aċetilkolina (acetylcholine - sustanza kimika li tħalli ċ- ċelluli nervużi jikkomunikaw ma' xulxin).
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Rivastigmina taħdem billi timblokka l - enzimi li jkissru l- aċetilkolina: aċetilkolinesterażi (acetylcholinesterase) u butirilkolinesterażi (butyrylcholinesterase).
By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’ s dementia and dementia due to Parkinson’ s disease.
Billi jimblokka dawn l- enzimi, Prometax jippermetti żieda fil- livelli ta 'aċetilkolina fil- moħħ u b' dan il- mod jgħin biex inaqqas is- sintomi tad- demenza tat- tip Alzheimer u tad- demenza dovuta għall- marda ta' Parkinson.
How has Prometax been studied?
Kif ġie studjat Prometax?
Prometax has been studied in mild to moderately severe Alzheimer’ s disease.
Prometax ġie studjat fil- marda ta 'Alzheimer minn ħafifa għal moderatament gravi.
Prometax capsules have also been studied in 541 patients with dementia due to Parkinson’ s disease.
Prometax kapsuli ġew studjati fuq 541 pazjent b' demenza dovuta għall- marda ta 'Parkinson.
All of the studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment).
L- istudji kollha damu sitt xhur u qabblu l- effetti ta 'Prometax ma' dawk tal - plaċebo (trattament finta).
The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Il- kejl ewlieni ta 'l- effikaċja kien il- bidla tas- sintomi fi tliet oqsma prinċipali: konjittiv (kapaċità li dak li jkun jaħseb, jitgħallem u jiftakar) u globali (tagħqid ta' bosta oqsma fosthom il- funzjonament ġenerali, is- sintomi konjittivi, l- imġiba u l- kapaċità li dak li jkun jagħmel l- attivitajiet ta 'kuljum).
An additional study in 27 patients was used to show that Prometax capsules and oral solution produced similar levels of the active substance in the blood.
Intuża studju ieħor fuq 27 pazjent biex juri li Prometax kapsuli u soluzzjoni orali pproduċew livelli simili tas- sustanza attiva fid- demm.
What benefit has Prometax shown during the studies?
X' benefiċċji wera Prometax f' dawn l- istudji?