qanastek/EMEA-V3 huggingface dataset:
Otherwise, insulin will leak out of the needle and the dose will be incorrect • If you have, by mistake, tried to set a dose over 78 units, follow these steps:
230 • Jekk, bi żball, tkun ippruvajt tissettja doża ogħla minn 78 unità, segwi dawn il- passi:
Close your Mixtard 40 NovoLet fully with 0 next to the dosage indicator.
Agħlaq il- Mixtard 40 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Mixtard 40 NovoLet carefully without the needle attached.
Armi l- Mixtard 40 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Mixtard 40 NovoLet is designed to work accurately and safely.
Il- Mixtard 40 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Mixtard 40 NovoLet.
Timliex mill- ġdid Mixtard 40 NovoLet.
You can clean the exterior of your Mixtard 40 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Mixtard 40 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
225 PACKAGE LEAFLET:
231 FULJETT TA 'TAGĦRIF:
Using other medicines
232 Meta tuża mediċini ohra
228 Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C) Do not store them in or too near the freezer section or cooling element.
235 In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
230 Information on how to use Mixtard 50 NovoLet
236 Informazzjoni dwar kif tuża Mixtard 50 NovoLet
Please read the following instructions carefully before using your Mixtard 50 NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Mixtard 50 NovoLet.
Mixtard 50 NovoLet is a simple, compact pre-filled pen.
Mixtard 50 NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Mixtard 50 NovoLet hi maħsuba biex tintuża mal- labar NovoFine Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta 'l - insulina f' każ li l- NovoLet tiegħek tintilef jew ikollha l- ħsara.
Check the label to make sure that your Mixtard 50 NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Mixtard 50 NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Mixtard 50 NovoLet ġdida
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine needle • Screw the needle straight and tightly onto Mixtard 50 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Mixtard 50 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Mixtard 50 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Mixtard 50 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Mixtard 50 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture F) to set the right dose.
238 • Żomm il- Mixtard 50 NovoLet tiegħek b' mod orizzontali.
Otherwise, insulin will leak out of the needle and the dose will be incorrect • If you have, by mistake, tried to set a dose over 78 units, follow these steps:
239 • Jekk, bi żball, tkun ippruvajt tissettja doża ogħla minn 78 unità, segwi dawn il- passi:
Close your Mixtard 50 NovoLet fully with 0 next to the dosage indicator.
Agħlaq il- Mixtard 50 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Mixtard 50 NovoLet carefully without the needle attached.
Armi l- Mixtard 50 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Mixtard 50 NovoLet is designed to work accurately and safely.
Il- Mixtard 50 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Mixtard 50 NovoLet.
Timliex mill- ġdid Mixtard 50 NovoLet.
You can clean the exterior of your Mixtard 50 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Mixtard 50 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
234 PACKAGE LEAFLET:
240 FULJETT TA 'TAGĦRIF:
Using other medicines
241 Meta tuża mediċini ohra
► In insulin infusion pumps ► If InnoLet is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk InnoLet titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Mixtard) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
4.
242 4.
237 Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
The InnoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
244 L- InnoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
It is supplied in packs of 1, 5 or 10 pre-filled pens of 3 ml.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja opaka u bajda Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml.
239 Information on how to use Mixtard 30 InnoLet
245 Informazzjoni dwar kif tuża Mixtard 30 InnoLet
Please read the following instructions carefully before using your Mixtard 30 InnoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Mixtard 30 InnoLet.
Mixtard 30 InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Mixtard 30 InnoLet hi pinna mimlija għal- lest sempliċi u kumpatta li hi kapaċi tforni minn 1 sa 50 unità f' inkrementi ta 'unità 1.
Mixtard 30 InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
Mixtard 30 InnoLet hi maħsuba biex tintuża mal- labar NovoFine S ta '8 mm jew iqsar.
Check the label to make sure that your Mixtard 30 InnoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Mixtard 30 InnoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
If there are less than 12 units left, use a new Mixtard 30 InnoLet • Move the pen up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other (picture 1A) at least 20 times.
Jekk ikun baqa ’ anqas minn 12- il unità, uża Mixtard 30 InnoLet ġdida. • Mexxi l- pinna ’ l fuq u ’ l isfel bejn il- pożizzjonijiet A u B u lura biex b’ hekk il- boċċa tal- ħġieġ tiċċaqlaq minn tarf għall- ieħor ta ’ l- iskartoċċ (stampa 1A) għal mill- anqas 20 darba.
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien
• Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S needle • Screw the needle straight and tightly onto Mixtard 30 InnoLet (picture 1B) • Pull off the big outer needle cap and the inner needle cap.
• Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine S • Invita l- labra bi dritt u b' mod issikkat fuq Mixtard 30 InnoLet (stampa 1B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold Mixtard 30 InnoLet with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (picture 1C). • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin must appear at the needle tip.
Is - selettur tad- doża jirritorna fuq iż- żero • Qatra insulina għandha tidher fil- ponta tal- labra.
Dispose of your used Mixtard 30 InnoLet carefully without the needle attached.
Armi l- Mixtard 30 InnoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Mixtard 30 InnoLet is designed to work accurately and safely.
Il- Mixtard 30 InnoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Mixtard 30 InnoLet.
Timliex mill- ġdid Mixtard 30 InnoLet.
You can clean your Mixtard 30 InnoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Mixtard 30 InnoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
243 PACKAGE LEAFLET:
249 FULJETT TA 'TAGĦRIF:
Many medicines affect the way glucose works in your body and they may influence your insulin dose.
250 Il- mod kif jaħdem glukosju fil- ġisem tiegħek huwa affetwat minn ħafna mediċini, u dawn jistgħu jinfluwenzaw id- doża tiegħek ta ’ l- insulina.
► In insulin infusion pumps ► If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk FlexPen titwaqqa ’, jiġrilha l- ħsara jew titgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Mixtard) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
4.
251 4.
245 If you get any of these signs. eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Jekk ikollok xi wieħed minn dawn is- sinjali, kul pilloli tal- glukosju jew ikla ħafifa li fiha ħafna zokkor (ħelu, gallettini, meraq tal- frott), u mbagħad strieħ.
If you notice your skin pitting or
Li tibdel is- sit ma 'kull injezzjoni jista' jgħin biex jiġi evitat dan il- kambjament fil - ġilda.
246 thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Jekk tinnota li- fis- sit ta ’ l- injezzjoni l- ġilda qiegħda titħaffer jew qiegħda teħxien, għid lit- tabib tiegħek jew lill- infermier/ a għax dawn ir- reazzjonijiet jistgħu jsiru aktar serji, jew jekk l- injezzjoni ssir f’ sit bħal dan jistgħu jbiddlu l- assorbiment ta ’ l- insulina tiegħek.
Do not store them in or too near the freezer section or cooling element.
253 Tagħmilhomx fil- friża.
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
Il- FlexPen li tkun qeda tintuża, li waslet biex tintuża, jew li qeda tinġarr bħala spare, m' għandiex tinżamm fil- friġġ.
It is supplied of 1, 5 or 10 pre-filled pens of 3 ml.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja opaka u bajda Issibu f’ pakketti ta ’ 1, 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml.
248 Introduction
254 Introduzzjoni
Please read the following instructions carefully before using your Mixtard 30 FlexPen.
Jekk jogħġbok aqra sew l- istruzzjonijiet li ġejjin qabel ma tuża l- Mixtard 30 FlexPen tiegħek.
Mixtard 30 FlexPen Pen cap
Mixtard 30 FlexPen Għatu tal- pinna
Preparing your Mixtard FlexPen
Kif tipprepara l- Mixtard FlexPen tiegħek
249 A Let the insulin reach room temperature before you use it.
255 Ħalli l- insulina tilħaq it- temperatura tal- kamra qabel ma tużaha.
D Pull off the big outer needle cap and keep it for later.
256 D Neħħi l- għatu l- kbir ta ’ barra tal- labra u żommu għal wara
J Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
J Agħti d- doża billi tagħfas il- buttuna ta ’ l- injezzjoni kollha 'l ġewwa sakemm l- indikatur jiġi fuq iż - żero.
252 Turning the dose selector will not inject insulin.
Billi ddawwar is- selettur tad- doża ma tkunx qed/ a tagħti l- insulina.
Dispose of it carefully and put the pen cap back on.
259 Oqgħod attent kif tarmiha u erġa ’ poġġi lura l- għatu tal- pinna
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella, il- likwidu jista ’ jnixxi li jista ’ jwassal li tittieħed doża żbaljata. • • Persuni li jieħdu ħsieb il- pazjent għandhom joqogħdu attenti kif jimmaniġġjaw il- labar użati biex ma jiġux imniggża mil- labar.
What is M-M-RVAXPRO?
X' inhu M- M- RVAXPRO?
M-M-RVAXPRO is a vaccine against measles, mumps, and rubella (German measles).
M- M- RVAXPRO huwa vaċċin kontra l- ħosba, l- gattone u r- rubella (ħosba Ġermaniża).
It is a powder and solvent to be made up into a suspension for injection.
Huwa disponibbli bħala trab u solvent biex imbagħad jitħalltu f' sospensjoni għal injezzjoni.
The active substances are attenuated (weakened) viruses for the diseases.
Is- sustanzi attivi huma virusijiet attenwati (imdgħajfin) għall- mard.
What is M-M-RVAXPRO used for?
Għalxiex jintuża M- M- RVAXPRO?
M-M-RVAXPRO is used to vaccinate against measles, mumps, and rubella, individuals 12 months or older.
M- M- RVAXPRO jintuża biex ilaqqam kontra l- ħosba, il- gattone u r- rubella l- individwi f' età ta '12- il xahar jew aktar.
How is M-M-RVAXPRO used?
Kif jintuża M- M- RVAXPRO?
M-M-RVAXPRO is given by a doctor or nurse who will inject the suspension subcutaneously (just under the skin) into the upper arm or thigh.
M- M- RVAXPRO jingħata minn tabib jew infermier li jinjetta s- sospensjoni taħt il- ġilda fil- parti ta 'fuq tad- driegħ jew koxxa.
Individuals 12 months or older should receive one dose.
L- individwi ta '12- il xahar jew aktar għandhom jirċievu doża waħda.
A second dose may be given at least 4 weeks after the first dose.
Tista 'tingħata t- tieni doża għallinqas 4 ġimgħat wara l- ewwel waħda.
The second dose is intended for people who did not respond to the first dose for any reason.
It- tieni doża hija maħsuba għal persuni li ma jkunux irrispondew għall- ewwel doża għal xi raġuni.
There is no information on the safety and effectiveness of M-M-RVAXPRO in infants below 12 months.
Ma hemm ebda informazzjoni dwar is- sigurtà u l- effikaċja ta 'M- M- RVAXPRO fi tfal taħt it- 12- il xahar.
How does M-M-RVAXPRO work?
Kif jaħdem M- M- RVAXPRO?
M-M-RVAXPRO is a vaccine.
M- M- RVAXPRO huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Il- vaċċini jaħdmu billi 'jgħallmu' lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi lilha nfisha kontra marda.
M-M-RVAXPRO contains small amounts of weakened forms of the viruses that cause measles, mumps, and rubella.
M- M- RVAXPRO fih ammonti żgħar ta 'forom imdgħajfin tal- virus li jikkawża l- ħosba, il- gattone u r- rubella.
When a person is given the vaccine, the immune system recognises the weakened viruses as ‘ foreign’ and makes antibodies against them.
Meta persuna jingħata l- vaċċin, is- sistema immunitarja tagħraf il- virusijiet imdgħajfin bħala 'barranin' u tipproduċi antikorpi kontrihom.
In the future, the immune system will be able to produce antibodies quicker when it is again exposed to the viruses.
Fil- futur, is- sistema immunitarja tkun tista 'tipproduċi antikorpi aktar malajr meta tkun esposta mill- ġdid għall- virusijiet.
The antibodies will help to protect against diseases caused by these viruses.
L- antikorpi jgħinu biex jipproteġu kontra mard ikkawżat minn dawn il- virusijiet.
M-M-RVAXPRO is very similar to another presentation of the measles, mumps and rubella vaccine already authorised (M-M-R II) but with a slight difference: where the existing presentation is manufactured with a protein, albumin, that is extracted from human serum (the liquid part of the blood); M-M-RVAXPRO is manufactured with the same protein, but made using ‘ recombinant DNA technology’ (a technique where a yeast is given a gene (DNA) that makes it able to produce human albumin).
M- M- RVAXPRO huwa simili ħafna għal preżentazzjoni oħra tal- vaċċin kontra l- ħosba, il- gattone u r - rubella diġà awtorizzata (M- M- R II) iżda b' differenza żgħira: filwaqt li l- preżentazzjoni eżistenti hija prodotta bi proteina, l- albumina, li tiġi estratta mis- serum (il- parti likwida tad- demm) tal- bniedem; M - M- RVAXPRO huwa prodott mill- istess proteina, iżda miksuba billi tintuża 'teknoloġija tad- DNA rikombinanti' (teknika li fiha ħmira tingħata ġene (DNA) li jagħmilha kapaċi tipproduċi l- albumina umana).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has M-M-RVAXPRO been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat M- M- RVAXPRO?
The study for M-M-RVAXPRO compared its effectiveness to that of the previous presentation of the measles, mumps and rubella vaccine in 1,279 children.
L- istudju għal M- M- RVAXPRO qabbel l- effikaċja tiegħu mal- vaċċin preċedenti kontra l- ħosba, il - gattone u r- rubella f' 1, 279 tifel/ tifla.
The study measured the ability of the vaccine to make the immune system respond to the viruses.
L- istudju kejjel il- kapaċità tal- vaċċin li jagħmel lis- sistema immunitarja tirrispondi għall- virusijiet.
Another study in a further 1,997 children looked more specifically at one of the component of the vaccine (mumps) to show that the level used in M-M-RVAXPRO provides enough protection against the disease.
Studju ieħor f' 1, 997 tifel/ tifla oħrajn studja b' mod aktar speċifiku wieħed mill- komponenti tal- vaċċin (gattone) biex juri li l- livell użat f 'M- M- RVAXPRO jipprovdi protezzjoni biżżejjed kontra l- marda.
What benefit has M-M-RVAXPRO shown during the studies?
Liema benefiċċju wera M- M- RVAXPRO waqt l- istudji mwettqa?
M-M-RVAXPRO provided the same level of immune response as the measles, mumps, and rubella vaccine containing serum albumin.
M- M- RVAXPRO pprovda l- istess livell ta 'rispons immunitarju daqs il- vaċċin kontra l- ħosba, il - gattone u r- rubella li fih l- albumina tas- serum.
The response rates (measuring how the immune system had responded to the viruses) were:
Ir- rati ta 'rispons (li jkejlu kif is- sistema immunitarja wieġbet għall- virusijiet) kienu:
98.3% for measles, 99.4% for mumps and 99.6% for rubella.
98. 3% għall- ħosba, 99. 4% għall- gattone u 99. 6% għar- rubella.
What is the risk associated with M-M-RVAXPRO?
X' inhu r- riskju assoċjat ma 'M- M- RVAXPRO?
The most common side effects in children who were given M-M-RVAXPRO were fever (38.5°C or higher), and injection site reactions (redness, pain, swelling).
L- iktar effetti sekondarji komuni fi tfal li ngħataw M- M- RVAXPRO kienu deni (38. 5°C jew ogħla), u reazzjonijiet fil- punt ta 'l- injezzjoni (ħmura, uġigħ, nefħa).
For the full list of all side effects reported with M-M-VAXPRO, please see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati ma' M- M- VAXPRO, jekk jogħġbok ara l- Fuljett ta 'Tagħrif.
M-M-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps, or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic).
M- M- RVAXPRO ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe tilqima kontra l- ħosba, il- gattone jew r- rubella, jew għal kwalunkwe sustanza oħra, inkluża n- neomiċina (neomycin - antibijotiku).
M-M-RVAXPRO should not be given during pregnancy, an illness with fever (over 38.5°C), active untreated tuberculosis (TB), or when the patient has any disease that affects their immune system.
M- M- RVAXPRO ma għandux jingħata matul tqala, marda bid- deni (aktar minn 38. 5°C), tuberkulożi attiva mhux trattata (TB), jew meta pazjent ikollu xi marda li tolqot is- sistema immunitarja tiegħu.
Why has M-M-RVAXPRO been approved?
Għaliex ġie approvat M- M- RVAXPRO?
The Committee for Medicinal products for Human Use (CHMP) decided that M-M-RVAXPRO’ s benefits are greater than its risks for the combined vaccination against measles, mumps, and rubella in individuals 12 months or older.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'M - M- RVAXPRO huma ikbar mir- riskji tiegħu għall- vaċċinazzjoni kontra l- ħosba, il- gattone u r- rubella f' individwi ta' età ta '12- il xahar jew aktar.
They recommended that M-M-RVAXPRO be given marketing authorisation.
Il- Kumitat irrakkomanda li M- M- RVAXPRO jingħata awtorizzazzjoni għat- tqegħid fis- suq.
What measures are being taken to ensure the safe use of M-M-RVAXPRO?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal M- M- RVAXPRO?
The Company that makes M-M-RVAXPRO will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVAXPRO leads to side effects such as allergic reactions.
Il- Kumpanija li tagħmel M- M- RVAXPRO sejra tkompli timmonitorja l- effetti sekondarji biex tara jekk l- użu ta 'l- albumina rikombinanti fil- proċess tal- manifattura ta' M- M- RVAXPRO jwassalx għal effetti sekondarji bħal reazzjonijiet allerġiċi.
Other information about M-M-RVAXPRO:
Informazzjoni oħra dwar M- M- RVAXPRO:
The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVAXPRO to Sanofi Pasteur MSD SNC on 5 May 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha, għal M- M- RVAXPRO lil Sanofi Pasteur MSD SNC fil- 5 ta 'Mejju 2006.
The full EPAR for M-M-RVAXPRO is available here.
L- EPAR sħiħ għal M- M- RVAXPRO jista 'jiġi kkonsultat hawn.
This summary was last updated in 05-2006.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU Number
Numru tal- proċedura ta ’ l - EMEA / Numru ta ’ l- EU
Content
Kontenut (konċentra zzjoni)
Powder and solvent for suspension for injection
Trab u solvent għal suspensjoni għal injezzjoni
powder: vial (glass); solvent: vial (glass)
trab: kunjett (ħġieġ); solvent: kunjett (ħġieġ)
10 vials + 10 vials
10 kunjetti + 10 kunjetti
Powder and solvent for suspension for injection
Trab u solvent għal suspensjoni għal
powder: vial (glass); solvent: pre-filled syringe (glass)
trab: kunjett (ħġieġ); solvent: siringa mimlija
1 vial + 1 pre-filled syringe with attached needle
1 kunjett + 1 siringa mimlija għal- lest bil- labra mwaħħla
10 vials + 10 pre-filled syringes with attached needle
10 kunjetti + 10 siringi mimlija għal- lest bil- labra
1 vial + 1 pre-filled syringe without needle
1 kunjett + 1 siringa mimlija għal- lest mingħajr labra
M-M-RVAXPRO
RVAXPRO
Powder and solvent for suspension for injection
suspensjoni għal
10 vials + 10 pre-filled syringes without needle
10 kunjetti + 10 siringi mimlija għal- lest mingħajr labra
Powder and solvent for suspension for injection
suspensjoni għal injezzjoni
powder: vial (glass); solvent: pre-filled syringe (glass)
trab: kunjett (ħġieġ); solvent: siringa mimlija għal- lest (ħġieġ)
20 vials + 20 pre-filled syringes without needle
20 kunjett + 20 siringa mimlija għal- lest mingħajr labra
1 vial + 1 pre-filled syringe + 1 needle
1 kunjett + 1 siringa mimlija għal- lest + 1 labra
10 vials + 10 pre-filled syringes + 10 needles
10 kunjetti + 10 siringi mimlija għal- lest + 10 labriet
20 vials + 20 pre-filled syringes + 20 needles
20 kunjett + 20 siringa mimlija għal- lest + 20 labra
1 vial + 1 pre-filled syringe + 2 needles
1 kunjett + 1 siringa mimlija għal- lest + 2 labriet
10 vials + 10 pre-filled syringes + 20 needles
10 kunjetti + 10 siringi mimlija għal- lest + 20 labra
20 vials + 20 pre-filled syringes + 40 needles
20 kunjett + 20 siringa mimlija għal- lest + 40 labra
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Measles, mumps, and rubella vaccine (live).
M- M- RVAXPRO Trab u solvent għal suspensjoni għall- injezzjoni Vaċċin tal- ħosba, gattone, u ħosba Ġermaniża (ħaj).
After reconstitution, one dose (0.5 ml) contains:
Wara rikostituzzjoni, doża waħda (0. 5 ml) fiha:
Measles virus1 Enders’ Edmonston strain (live, attenuated)......... not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated).... not less than 12.5x103 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)............... not less than 1x103 CCID50*
Razza tal- virus1 tal- ħosba Enders ’ Edmonston (tat- tip ħaj, attenwat) ………. mhux inqas minn 1x103 CCID50 * Razza tal- virus1 tal- gattone Jeryl Lynn™ [Livell B] (tat- tip ħaj, attenwat) ……… mhux inqas minn 12. 5x103 CCID50 * Razza tal- virus2 ħosba Ġermaniża Wistar RA 27/ 3 (tat- tip ħaj, attenwat) ……… mhux inqas minn 1x103 CCID50 *
*50% cell culture infectious dose 1 produced in chick embryo cells.
* 50% doża infettuża ta 'kultura taċ- ċelloli 1 prodott f’ ċelloli ta ’ l- embriju tal- flieles.
2 produced in WI-38 human diploid lung fibroblasts.
2 prodott f’ WI- 38 human diploid lung fibroblasts.
For a full list of excipients, see section 6.1.
Għal- lista kompleta sħiħa ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
Powder and solvent for suspension for injection.
Trab u solvent għal suspensjoni għall- injezzjoni
Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless fluid.
Qabel rikostituzzjoni, it- trab huwa kejk kristallin kumpatt ta ’ kulur safrani ċar u s- solvent huwa likwidu ċar bla kulur.
M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older (see section 4.2).
4. 1 Indikazzjonijiet terapewtiċi
For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
Għal użu f’ tifqigħa tal- ħosba, jew għal tilqima wara espożizzjoni, jew, għal użu fi tfal li qatt ma ġew imlaqqma qabel, li għandhom iktar minn 12- il xahar, li huma f’ kuntatt ma ’ nisa tqal suxxettibbli, u persuni b' ċans li jkunu suxxettibbli għall- gattone u għall- ħosba Ġermaniża, (ara sezzjoni 5. 1).
Posology
Pożologija
M-M-RVAXPRO is to be used on the basis of official recommendations.
M- M- RVAXPRO għandu jintuża fuq il- bażi ta ’ rakkomandazzjonijiet uffiċjali.
2 Individuals 12 months or older
Individwi ta ’ 12- il xahar jew akbar
Individuals 12 months or older should receive one dose at an elected date.
Individwi ta ’ 12- il xahar jew akbar għandhom jirċievu doża waħda f’ data partikolari.
A second dose may be administered at least 4 weeks after the first dose in accordance with official recommendation.
It- tieni doża tista ’ tingħata ta ’ l- inqas 4 ġimgħat wara l- ewwel doża skond rakkomandazzjonijiet uffiċjali.
The second dose is intended for individuals who did not respond to the first dose for any reason.
It- tieni doża hija intenzjonata għal dawk l- individwi li ma rrispondewx għall- ewwel doża għal kwalunkwe raġuni.
Infants between 6 months and less than 12 months
2 Trabi bejn 6 xhur u iżgħar minn 12- il xahar
No data on the efficacy and safety of M-M-RVAXPRO for use in children below 12 months are currently available (see section 5.1).
L- ebda tagħrif fuq is- sigurtà u l- effikaċja sabiex M- M- RVAXPRO jintuża fuq it- tfal taħt 12- il xahar m’ huwa disponibbli (ara sezzjoni 5. 1).
Infants between 6 months and less than 12 months vaccinated with a measles-containing vaccine during measles outbreak or vaccinated at that age in accordance with official recommendation may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin.
Fi trabi bejn 6 xhur u iżgħar minn 12- il xahar mlaqqma b’ tilqima li fiha l- ħosba waqt tifqigħa tal - ħosba jew li tlaqqmu f’ dik l- età skond rakkomandazzjonijiet uffiċjali jistgħu ma jirrispondux għall - vaċċin minħabba l- preżenza ta ’ antikorpi ta ’ oriġini materna li jkunu qed jiċċirkolaw f’ dan iż- żmien.
Such infants should be revaccinated at 12 to 15 months followed by an additional dose with a measles-containing vaccine according to the official recommendations.
Dawn it- trabi għandhom jerġgħu jieħdu t- tilqima meta jkollhom bejn 12 u 15- il xahar u mbagħad għandhom jieħdu doża oħra tat- tilqima li fiha l- virus tal- ħosba skond rakkomandazzjonijiet uffiċjali.
Method of administration
Metodu ta ’ kif jingħata
The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
It- tilqima għandha tiġi injettata ġol- muskoli (IM) jew taħt il- ġilda (SC).
The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
Il- postijiet ta ’ injezzjoni ppreferuti huma ż- żona anterolaterali tal- koxxa fi tfal żgħar u ż- żona tad - deltoid fi tfal ikbar, f’ adoloxxenti u f’ adulti.
The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Il- vaċċin għandu jingħata taħt il- ġilda f’ pazjenti bi tromboċitopenja jew b’ xi disturb relatat mal - koagulazzjoni.
See section 6.6 for preparation instructions.
Ara sezzjoni 6. 6 għall- istruzzjonijiet fuq il- preparazzjoni.
DO NOT INJECT INTRAVASCULARLY.
TINJETTAX ĠOL- VINI.
History of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin (see sections 2, 4.4, and 6.1).
Storja ta ’ sensitività eċċessiva għal xi vaċċin tal- ħosba, gattone, jew ħosba Ġermaniża, jew għal xi sustanza mhux attiva, inkluż neomycin (ara sezzjonijiet 2, 4. 4, u 6. 1).
Pregnancy (see also sections 4.4 and 4.6).
Tqala (ara wkoll sezzjonijiet 4. 4 u 4. 6).
Vaccination should be postponed during any illness with fever > 38.5°C.
It- tilqim għandu jiġi pospost waqt mard b’ deni > 38. 5 °C.
Active untreated tuberculosis (see section 4.4).
Tuberkulożi attiva mhux trattata (ara sezzjoni 4. 4).
Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems.
Anormalitajiet fid- demm, lewkimja, limfomi tat- tipi kollha, jew neoplasmi oħra malinni li jaffetwaw is- sistema ematopoetika u limfatika.
Current immunosuppressive therapy (including high doses of corticosteroids).
Terapija immunosuppressiva kurrenti (inklużi dożi għoljin ta ’ corticosteroids).
M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e. g. for asthma prophylaxis or replacement therapy).
M- M- RVAXPRO m’ huwiex kontra indikat f’ individwi li qed jieħdu corticosteroids topikali jew inkella f’ doża baxxa parenterali (e. ż. għal profilassi ta ’ l- ażma jew terapija ta ’ sostituzzjoni).
In severely immunocompromised individuals
Immunodefiċjenza umorali jew ċellolari (primarja jew akkwistata), inkluż ipogammaglobulinemia, u dysgammaglobulinemia u AIDS, jew infezzjoni ta ’ l- HIV sintomatika jew perċentwal li tiddependi fuq l- età ta ’ CD4+ T- limfoċiti < 25% (ara sezzjoni 4. 4).
3 inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
F’ individwi li huma immunokompromessi b’ mod gravi li b’ nuqqas ta ’ attenzjoni ġew imlaqqma b’ vaċċin li fih il- ħosba, ġew rappurtati measles inclusion body encephalitis, pnewmonite u riżultati fatali bħala konsegwenza diretta ta ’ tixrid ta ’ l - infezzjoni tal- virus tal- vaċċin tal- ħosba.
Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Storja fil- familja ta ’ immunodefiċjenza konġenitali jew ereditarja, sakemm il- kompetenza ta 'l - immunità tar- reċipjent ma tkunx intweriet.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Trattament mediku u superviżjoni addattata għandom ikunu disponibbli fil- pront f’ każ ta ’ reazzjoni anafilattika rari wara l- għoti tal- vaċċin.
Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions.
3 Adulti u adoloxxenti bi storja ta ’ allerġiji jistgħu potenzjalment ikunu f’ riskju akbar ta ’ anafilassi jew ta ’ reazzjonijiet anafilaktojde.
Close monitoring is recommended following vaccination for the early signs of such reactions.
Huwa rrakkomandat monitoraġġ mill- qrib wara t- tilqima għas- sinjali bikrin ta ’ reazzjonijiet bħal dawn.
Since live measles vaccine and live mumps vaccine are produced in chick embryo cell culture, persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e. g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.
Minħabba li l- vaċċin tal- ħosba tat- tip ħaj u tal - gattone tat- tip ħaj huma prodotti f’ kultura taċ- ċelloli ta ’ l- embriju tal- flieles, persuni bi storja ta ’ reazzjonijiet anafilattiċi, reazzjonijiet jixbħu lil dawk anafilattiċi, jew reazzjonijiet immedjati oħra (eż., ħorriqija, nefħa fil- ħalq u l- griżmejn, diffikultà fit - teħid tan- nifs, tnaqqis fil- pressjoni jew xokk) wara li jieħdu l- bajd, jistgħu ikunu f’ riskju ikbar ta ’ sensittività eċċessiva ta ’ tip immedjata.
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Il- proporzjon bejn ir- riskju u l- benefiċċju għandu jiġi evalwat bl- ikbar attenzjoni qabel wieħed jikkunsidra tilqim f’ każijiet bħal dawn.
Due caution should be employed in administration of M-M-RVAXPRO to persons with individual or family history of convulsions, or a history of cerebral injury.
Għandha tingħata l- attenzjoni kollha dovuta meta M- M- RVAXPRO jingħata lil persuni bi storja individwali jew familjari ta ’ konvulżjonijiet, jew storja ta ’ korriment ċerebrali.
The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8).
It- tabib għandu jkun attent għal xi żjidiet fit- temperatura li jistgħu jseħħu wara t- tilqima (ara sezzjoni 4. 8).
The vaccine contains 1.9 mg of sucrose as an excipient.
It- tilqima fiha 1. 9 mg ta ’ sucrose bħala sustanza mhux attiva.
This amount is too low to cause adverse events in patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
Dan l- ammont huwa baxx wisq biex jikkawża effetti mhux mixtieqa f’ pazjenti bi problemi ereditarji rari, bħal intolleranza għall - fructose, assorbiment ħażin ta 'glucose- galactose jew insuffiċjenza ta ’ sucrase- isomaltase.
The vaccine contains residual traces of recombinant human albumin (rHA).
It- tilqima fiha traċċi residwi ta ’ albumina umana rikombinanti (rHA).
In a study with children receiving a second dose of M-M-RVAXPRO, sensitisation to rHA was not observed.
Fi studju li fih, tfal ħadu t- tieni doża ta ’ M- M- RVAXPRO ma ġietx osservata sensitizzazzjoni għal rHA.
A theoretical risk of hypersensitivity to rHA at a low frequency cannot be ruled out.
Ir- riskju teoretiku ta ’ sensittività eċċessiva għal rHA fi frekwenza baxxa ma jistax jiġi eliminat.
Therefore caution needs to be exercised when using any product containing rHA in individuals who previously showed signs of hypersensitivity to rHA.
Għalhekk għandha tingħata kull attenzjoni dovuta meta jintuża kwalunkwe prodott li fih rHA f’ individwi li xi darba wrew sensittività eċċessiva għal rHA
Pregnancy The vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.3 and 4.6).
Barra minn hekk, it- tqala għandha tiġi evitata għal 3- xhur wara t- tilqima (ara sezzjonijiet 4. 3 u 4. 6).
Thrombocytopenia This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Tromboċitopenja Dan il- vaċċin għandu jingħata taħt il- ġilda lil individwi bi tromboċitopenja jew b’ xi disturb relatat mal- koagulazzjoni minħabba li tista ’ sseħħ fsada wara għoti ġol- muskoli f’ dawn l- individwi.
Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Individwi li għandhom tromboċitopenja jistgħu jiżviluppaw tromboċitopenja iktar gravi wara t - tilqima.
In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RVAXPRO (or its component vaccines) may develop thrombocytopenia with repeat doses.
Barra minn hekk, individwi li jesperjenzaw tromboċitopenja ma ’ l- ewwel doża ta ’ M- M - RVAXPRO (jew b’ xi waħda mill- komponimenti tat- tilqim) jistgħu jiżviluppaw tromboċitopenja b’ dożi ripetuti.
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
L- istat seroloġiku jista jiġi evalwat biex jiġi stabbilit jekk ikunx hemm bżonn ta ’ dożi addizzjonali.
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8).
Il- proporzjoni bejn ir- riskju u l- benefiċċju għandu jiġi evalwat sew qabel ma tiġi kkunsidrata tilqima f' dawn il- każijiet (ara sezzjoni 4. 8).
4 Other Individuals who are known to be infected with human immunodeficiency viruses and are not immunocompromised may be vaccinated.
Oħrajn Individwi magħrufin li huma nfettati bl- HIV u li m’ humiex immunokompromessi jistgħu jiġu imlaqqma.
However, these vaccinees should be monitored closely for measles, mumps, and rubella because vaccination may be less effective in these patients than in persons not infected with human immunodeficiency viruses (see section 4.3).
Madankollu dawn in- nies għandhom jiġu mmonitorjati mill- qrib għall- ħosba, gattone u ħosba Ġermaniża, għaliex it- tilqima tista 'tkun inqas effettiva f’ dawn il- pazjenti milli f’ nies li m’ humiex infettati bl- HIV (ara sezzjoni 4. 3).
Children under treatment for tuberculosis have not experienced exacerbation of the disease when vaccinated with live measles virus vaccine; no studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis (see section 4.3).
L- ebda studji ma ġew irrapportati s’ issa fuq l- effett tal- vaċċin tal- ħosba fuq it- tfal b’ tuberkulożi mhux trattata (ara sezzjoni 4. 3).
As for any vaccine, vaccination with M-M-RVAXPRO may not result in protection in all vaccinees.
Bħal b' kull tilqima oħra, tilqima b ’ M- M- RVAXPRO tista 'ma tirriżultax fi protezzjoni f’ kull min jitlaqqam.
Transmission Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Trasmissjoni Kien hemm eskrezzjoni ta ’ ammonti żgħar tal- vaċċin tal- ħosba Ġermaniża tat- tip ħaj attenwat mill - imnieħer jew mill- ġriżmejn fil- maġġoranza ta ’ l- individwi suxxettibbli 7 sa 28 ġurnata wara t- tilqima.
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
M’ hemmx evidenza kkonfermata li tindika li virus bħal dan huwa trasmess lil persuni suxxettibbli li
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
B' konsegwenza ta ’ dan, trasmissjoni minħabba kuntatt personali, għalkemm aċċettata bħala possibilità teoretika, m' hijiex meqjusa bħala riskju sinifikanti; madankollu, it- trasmissjoni tal- virus tal- vaċċin tal- ħosba Ġermaniża lil trabi mill- ħalib tas- sider ġiet dokumentata mingħajr evidenza ta ’ mard kliniku (ara sezzjoni 4. 6).
There are no reports of transmission of the more attenuated Enders’ Edmonston strain of measles virus or the Jeryl Lynn ™ strain of mumps virus from vaccinees to susceptible contacts.
M’ hemm l- ebda rapporti ta ’ trasmissjoni tar- razza iktar attenwata tal- virus tal- ħosba bl- isem ta ’ Enders ’ Edmonston, jew ir- razza Jeryl Lynn™ tal- gattone minn min ġie mlaqqam għal kuntatti suxxettibbli.
Immune globulin (IG) is not to be given concomitantly with M-M-RVAXPRO.
Immune globulin (IG) m' għandux jingħata flimkien ma ’ M- M- RVAXPRO.
Administration of immune globulins concomitantly with M-M-RVAXPRO may interfere with the expected immune response.
L- għoti ta ’ immune globulins flimkien ma ’ M- M- RVAXPRO jista 'jinterferixxi mar- rispons t' immunità mistenni.
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.
It- tilqima trid tiġi posposta għal ta ’ l- inqas 3 xhur wara trasfużjoni tad- demm jew plasma, jew għoti ta ’ serum immune globulin uman.
Administration of measles, mumps, or rubella antibody-containing blood products, including immune globulin preparations, should be avoided within 1 month after a dose of M-M-RVAXPRO unless considered to be essential.
Għoti ta ’ prodotti tad- demm, inkluż preparazzjonijiet ta ’ immunoglobulin, li fihom antikorpi għall - ħosba, ħosba Ġermaniża u gattone jridu jiġu evitati sa xahar wara doża ta ’ M- M- RVAXPRO sakemm dan ma jkunx meqjus bħala essenzjali.
It has been reported that live attenuated measles, mumps, and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Ġie rappurtat li l- vaċċini tal- ħosba, gattone jew ħosba Ġermaniża tat- tip ħaj attenwati meta jingħataw individwalment jistgħu jirriżultaw fi tnaqqis temporanju tas- sensittività tal- ġilda għat- tuberkulina.
Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.
Għalhekk, jekk għandu jsir test tat- tuberkulina, dan irid isir f’ xi ħin qabel, jew flimkien ma ’, jew 4 sa 6 ġimgħat wara t- tilqima b ’ M- M- RVAXPRO.
Use with other vaccines Published clinical data support concomitant administration of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. with other childhood vaccinations, including DTaP (or DTwP), IPV (or OPV), HIB (Haemophilus influenzae type b), HIB-HBV (Haemophilus influenzae type b with Hepatitis B vaccine), and VAR (varicella).
Użu ma ’ vaċċini oħra Tagħrif kliniku ippubblikat jagħti appoġġ għal għoti tal- formolazzjoni preċedenti tal- vaċċin tal- ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc. ma ’ vaċċini oħra li jingħataw lit - tfal, inkluż DTaP (jew DTwP), IPV (jew OPV), HIB (Haemophilus influenzae tip b), HIB- HBV (Haemophilus influenzae tip b ma ’ vaċċin ta ’ l- epatite B), u VAR (variċella).
Currently no specific studies have been conducted on the concomitant use of M-M-RVAXPRO and other vaccines.
S’ issa, ma sarux studji speċifiċi fuq l- użu ta ’ M- M- RVAXPRO flimkien ma ’ vaċċini oħra.
5 and rubella vaccine manufactured by Merck & Co., Inc., experience with this vaccine can be considered.
Iżda, minħabba li ntwera li M- M- RVAXPRO għandu profili ta 'sigurtà u ta' immuniġeniċità li huma simili ħafna għall- formolazzjoni preċedenti tal- vaċċin kombinat tal- ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc., esperjenza b’ dan il- vaċċin tista ’ tiġi kkunsidrata.
M-M-RVAXPRO should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines.
M- M - RVAXPRO għandu jingħata flimkien ma ', iżda f’ siti ta ’ injezzjoni differenti, jew xahar qabel jew wara l- għoti ta ’ vaċċini oħra b’ virus tat- tip ħaj attenwat.
Studies have not been conducted with M-M-RVAXPRO in pregnant women.
Ma sarux studji dwar l- effett ta 'M- RVAXPRO fuq nisa tqal.
It is not known whether M-M-RVAXPRO can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
M’ huwiex magħruf jekk M- M - RVAXPRO jikkawżax ħsara fuq il- fetu meta jingħata lil mara tqila jew jekk jaffettwax il- kapaċità riproduttiva.
Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.3 and 4.4).
Għalhekk, il- vaċċin m' għandux jingħata lil nisa tqal; barra minn hekk, tqala għandha tiġi evitata għal 3 xhur wara t- tilqima (ara sezzjonijiet 4. 3 u 4. 4).
(1) In a 10 year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/ 3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome; (2) Mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Biex ikun jista jingħata parir lil nisa li, b’ nuqqas t’ attenzjoni ġew imlaqqma waqt it- tqala jew li ħarġu tqal fi żmien 3 xhur mit- tilqima, it- tabib irid ikun konxju ta ’ li ġej; (1) fi stħarriġ ta ’ 10 snin b’ involviment ta ’ iktar minn 700 mara tqila li rċevew il- vaċċin tal- ħosba Ġermaniża fi żmien 3 xhur qabel jew wara l- konċeviment (minn dawn 189 irċevew ir- razza Wistar RA 27/ 3), l- ebda tarbija ma kellha anormalitajiet kompatibbli mas- sindromu tal- ħosba Ġermaniża konġenitali; (2) Infezzjoni bil - gattone waqt l- ewwel tlett xhur tat- tqala tista ’ żżid ir- rata ta ’ abort spontanju.
Although mumps vaccine virus has been shown to infect the placenta and foetus, there is no evidence that it causes congenital malformations in humans; and (3) Reports have indicated that contracting wild-type measles during pregnancy enhances foetal risk.
Għalkemm il- virus tal - vaċċin tal- gattone ġie muri li jinfetta l- plaċenta u l- fetu, m’ hemm l- ebda evidenza li dan jikkawża malformazzjonijiet konġenitali fl- umani; u (3) Rapporti ndikaw li t- teħid tal- virus tal- ħosba tat- tip selvaġġ waqt it- tqala jżid ir- riskju għall- fetu.
Increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity have been observed subsequent to wild-type measles during pregnancy.
M’ hemm l- ebda studji
There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy.
5 adekwati fuq ir- razza attenwata tal- virus tal- ħosba fi tqala.
However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse foetal effects.
Madankollu, ikun prudenti jekk persuna tassumi li r- razza tal- vaċċin tal- virus tista 'wkoll tikkawża effetti negattivi fuq il- fetu.