qanastek/EMEA-V3 huggingface dataset:
PRE-FILLED SYRINGE OF SOLVENT
SIRINGA MIMLIJA GĦAL- LEST B' SOLVENT
47 PACKAGE LEAFLET:
40 FULJETT TA 'TAGĦRIF:
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
M- M- RVAXPRO Trab u solvent għal suspensjoni għal injezzjoni Vaċċin tal- ħosba, gattone u ħosba Ġermaniża (ħaj)
Read all of this leaflet before you or your child is vaccinated.
Aqra dan il- fuljett kollu qabel it- tifel/ tifla tiegħek jitlaqqam/ titlaqqam.
- This vaccine has been prescribed for you or your child.
- Din il- mediċina ġiet mogħtija lit- tifel/ tifla tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex
leaflet, please tell your doctor or pharmacist.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What M-M-RVAXPRO is and what it is used for 2.
X' inhu M- M- RVAXPRO u għalxiex jintuża 2.
Before you use M-M-RVAXPRO 3.
Qabel ma tuża M- M- RVAXPRO 3.
How to use M-M-RVAXPRO 4.
Kif għandek tuża M- M- RVAXPRO 4.
How to store M-M-RVAXPRO 6.
Kif taħżen M- M- RVAXPRO 6.
WHAT M-M-RVAXPRO IS AND WHAT IT IS USED FOR
X' INHU M- M- RVAXPRO U GĦALXIEX JINTUŻA
M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened.
M- M- RVAXPRO hija tilqima li fiha l- virus tal- ħosba, tal- gattone u tal- ħosba Ġermaniża li ġew imdgħajjfa.
When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, and rubella viruses.
Meta persuna tingħata t- tilqima, is- sistema ta 'l- immunità (id- difiża naturali tal- ġisem) tagħmel antikorpi kontra l- virus tal- ħosba, tal- gattone u tal- ħosba Ġermaniża.
The antibodies help protect against infections caused by these viruses.
L- antikorpi jgħinu fil - protezzjoni kontra infezzjonijiet ikkawżati minn dawn il- virusijiet.
M-M-RVAXPRO is given to help protect you or your child against measles, mumps, and rubella.
M- M- RVAXPRO qiegħed jingħata lilek sabiex jgħin jipproteġi lilek jew lit- tifel/ tifla tiegħek kontra l - ħosba, gattone u l- ħosba Ġermaniża.
The vaccine may be administered to persons 12 months or older.
Il- vaċċin jista 'jingħata lil persuni minn 12- il xahar' il fuq.
M-M-RVAXPRO can also be used 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.
M- M- RVAXPRO jista 'jintuża wkoll 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.
Although M-M-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people.
Għalkemm M- M- RVAXPRO fih virusijiet ħajjin, huma dgħajjfa wisq biex jikkawżaw il- ħosba, il - gattone jew ħosba Ġermaniża f' nies b' saħħithom.
BEFORE YOU USE M-M-RVAXPRO
QABEL MA TUŻA M- M- RVAXPRO
Do not use M-M-RVAXPRO
Tużax M- M- RVAXPRO:
- If you or your child are allergic (hypersensitive) to any of the components of
- Jekk inti jew it- tifel/ tifla tiegħek intom allerġiċi (tbatu minn sensittività eċċessiva) għal xi
M-M-RVAXPRO (including neomycin or any of the ingredients listed under “ other ingredients”.
sustanza ta 'M- M- RVAXPRO (inkluż neomycin jew xi ingredjent elenkat taħt “ ingredjenti oħra ”.
See section 6.
Ara sezzjoni 6.
Further information)
Aktar tagħrif)
- If you or your child are pregnant (in addition, pregnancy should be avoided for 3 months
- Jekk inti jew it- tifla tiegħek intom tqal (barra minn hekk, it- tqala għandha tiġi evitata għal 3
after vaccination, see Pregnancy)
xhur wara t- tilqima, ara Tqala)
- If you or your child have active untreated tuberculosis
- Jekk inti jew it- tifel/ tifla tiegħek għandkom tuberkolożi attiva mhux ittrattata
- If you or your child are receiving treatment or taking medicines that may weaken the
- Jekk inti jew it- tifel/ tifla tiegħek qed tirċievu trattament jew qed tieħdu mediċini li jistgħu
immune system (except low-dose corticosteroid therapy for asthma or replacement therapy)
jdgħajjfu s- sistema ta 'l- immunità (għajr terapija ta' doża baxxa ta 'corticosteroid għall- ażżma jew terapija ta' sostituzzjoni)
- If you or your child have a weakened immune system because of a disease (including
- Jekk inti jew it- tifel/ tifla tiegħek għandkom sistema ta 'immunità mdgħajjfa minħabba marda
AIDS)
(inkluż AIDS)
- If you or your child have a blood disorder or any type of cancer that affects the immune
- Jekk inti jew it- tifel/ tifla tiegħek tbatu minn xi mard tad- demm jew minn xi tip ta 'kanċer li
system
41
- If you or your child have a family history of congenital or hereditary immunodeficiency,
- Jekk inti jew it- tifel/ tifla tiegħek għandkom storja familjari ta 'immunodefiċjenza konġenitali
unless the immune competence of you or your child is demonstrated.
jew ereditarja, sakemm ma tintweriex il- kompetenza ta 'l- immunità tiegħek jew tat- tifel/ tifla tiegħek.
- If you or your child have any illness with fever higher than 38.5°C; however, low-grade
- Jekk inti jew it- tifel/ tifla tiegħek għandkom xi marda b' deni ogħla minn 38. 5 °C; madankollu,
fever itself is not a reason to delay vaccination
deni baxx m' huwiex raġuni l- għala t- tilqima għandha ddum biex tingħata.
Take special care with M-M-RVAXPRO If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before M-M-RVAXPRO is given:
Jekk il- persuna li għandha tieħu t- tilqima esperjenzat xi waħda minn dawn li ġejjin, kellem lit- tabib jew lill- ispiżjar tiegħek qabel ma jingħata M- M- RVAXPRO:
- If you or your child have an allergic reaction to eggs or anything that contained egg
- Jekk inti jew it- tifel/ tifla tiegħek għandkom reazzjoni għall- bajd jew għal xi ħaġa li fiha l- bajd
- If you or your child have a history or family history of allergies or of convulsions (fits)
- Jekk inti jew it- tifel/ tifla tiegħek għandkom storja jew storja familjari ta 'allerġiji jew ta'
- If you or your child have a side effect after vaccination with measles, mumps, or rubella
- Jekk inti jew it- tifel/ tifla tiegħek għandkom xi effett sekondarju wara t- tilqima bil- ħosba,
vaccine (in a single component vaccine or a combination vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.) that involved easy bruising or bleeding for longer than usual
gattone, jew ħosba Ġermaniża (f' tilqima singola jew f' tilqima kombinata, bħat- tilqima kontra l - ħosba, il- gattone u l- ħosba Ġermaniża immanifatturata minn Merck & Co., Inc.) li jinvolvi tbenġil malajr jew fsad itwal min- normal
- If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not
- Jekk inti jew it- tifel/ tifla tiegħek intom infettati bl- HIV iżda ma turux sintomi tal- marda tal -
show symptoms of HIV disease.
HIV.
You or your child should be monitored closely for measles, mumps, and rubella because vaccination may be less effective than for uninfected persons (see section Do not use M-M-RVAXPRO).
Inti jew it- tifel/ tifla tiegħek għandkom tiġu mmonitorjati mill- qrib għall- ħosba, gattone, jew ħosba Ġermaniża minħabba li t- tilqima tista 'tkun inqas effettiva milli fuq nies mhux infettati (ara sezzjoni Tużax M- M- RVAXPRO).
As with other vaccines, M-M-RVAXPRO may not completely protect all persons who are vaccinated.
Bħal ħafna tilqim ieħor, M- M- RVAXPRO mhux bilfors jagħti protezzjoni totali lill- persuni kollha li jieħdu t- tilqima.
Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, M-M-RVAXPRO may not be able to prevent the illness from appearing.
Barra minn hekk, jekk il- persuna li se tiġi mlaqqma diġà ġiet esposta għall- virus tal - ħosba, gattone jew ħosba Ġermaniża iżda għadha mhux marida, M- M- RVAXPRO jista 'ma jkunx kapaċi jimpedixxi milli tfeġġ il- marda.
M-M-RVAXPRO can be given to persons who have been in recent (within 3 days) contact with a case of measles and may be incubating the disease.
M- M- RVAXPRO jista 'jingħata lil persuni li kienu f' kuntatt riċenti (fi żmien 3 ijiem) ma' każ ta 'ħosba u jistgħu jkunu qegħdin jinkubaw il- marda.
However, M-M-RVAXPRO may not always be able to prevent measles developing in these cases.
Madankollu, M- M- RVAXPRO mhux dejjem ikun jista 'jimpedixxi l- ħosba milli tiżviluppa f' dawn il- każijiet.
Using other medicines and other vaccines The doctor may delay your or your child’ s vaccination for at least 3 months following blood or plasma transfusions, or immune globulin (known as IG).
It- tabib jista 'jdewwem it- tilqima tiegħek jew tat- tifel/ tifla tiegħek għal mill- inqas 3 xhur wara t - trasfużjonijiet tad- demm jew tal- plażma, jew ta' globulina immuni (magħruf bħala IG).
After vaccination with M-M-RVAXPRO, IG should not be given for 1 month, unless your doctor tells you otherwise.
Wara tilqim bi M- M- RVAXPRO, IG ma għandux jingħata għal xahar, sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.
Jekk għandu jsir test tat- tuberculin, dan għandu jsir jew f' xi ħin qabel, fl- istess ħin ta ', jew 4 sa 6 ġimgħat wara t- tilqima bi M- M- RVAXPRO.
M-M-RVAXPRO may be given with some routine childhood vaccines that may be due to be given at the same time.
M- M- RVAXPRO jista 'jingħata ma' tilqim ieħor ta 'rutina li jingħata waqt it- tfulija li jista' jkun wasal iż- żmien biex jingħata.
For vaccines that cannot be given at the same time, M-M-RVAXPRO should be given 1 month before or after administration of those vaccines.
Għal tilqim li ma jistax jingħata fl- istess ħin, M- M- RVAXPRO għandu jingħata xahar qabel u wara l- għoti ta 'dan it- tilqim.
Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines), including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk inti jew it- tifel/ tifla tiegħek qegħdin tieħdu jew ħadtu dan l- aħħar xi mediċini oħra (jew tilqim ieħor), anki dawk mingħajr riċetta.
49 Pregnancy and breast-feeding M-M-RVAXPRO must not be given to pregnant females.
Tqala u Treddigħ M- M- RVAXPRO ma għandux jingħata lil nisa tqal.
Females of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months, or according to doctor’ s recommendation, after they have been given the vaccine.
Nisa li huma f' età li jwelldu għandhom jieħdu l - prekawzjonijiet meħtieġa sabiex jevitaw tqala għal 3 xhur, jew skond ir- rakkomandazzjonijiet tat - tabib, wara li jkunu ngħataw it- tilqima.
Persons who are breast-feeding or intend to breast-feed should tell the doctor.
Persuni li qegħdin ireddgħu jew li għandhom l- intenzjoni li jreddgħu għandhom javżaw lit- tabib.
The doctor will decide if M-M-RVAXPRO should be given.
It - tabib tiegħek jiddeċiedi jekk M- M- RVAXPRO għandux jingħata.
Driving and using machines There is no information to suggest that M-M-RVAXPRO affects the ability to drive or operate machinery.
M' hemmx informazzjoni li tissuġġerixxi li M- M- RVAXPRO jaffettwa l- abbiltà biex issuq jew tħaddem magni.
HOW TO USE M-M-RVAXPRO
KIF GĦANDEK TUŻA M- M- RVAXPRO
M-M-RVAXPRO should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm.
M- M- RVAXPRO għandu jiġi injettat fil- muskolu jew taħt il- ġilda jew fil- parti ta 'fuq tad- dirgħajn jew fil- parti ta' barra tal- koxxa.
Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site.
Normalment, fi tfal żgħar, il- post preferut fejn jingħataw injezzjonijiet fil - muskoli huwa ż- żona tal- koxxa filwaqt li f’ individwi ikbar, il- post preferut fejn jingħataw injezzjonijiet huwa ż- żona tal- parti ta ’ fuq tad- driegħ.
M-M-RVAXPRO is not to be injected directly into any blood vessel.
M- M- RVAXPRO ma għandux jiġi injettat direttament f' xi vina.
M-M-RVAXPRO is given as follows:
M- M- RVAXPRO jingħata kif ġej:
- To persons 12 months or older.
- Lil persuni minn 12- il xahar 'il fuq.
One dose is given at an elected date.
Tingħata doża waħda f' data partikolari.
- For persons vaccinated at 12 months or older, an additional dose is usually recommended
- Għal persuni imlaqqma meta jkollhom 12- il xahar 'il fuq, normalment tkun rakkomandata doża
at least 4 weeks after the first dose according to your doctor’ s recommendation.
addizzjonali għallinqas 4 ġimgħat wara l- ewwel doża skond ir- rakkomandazzjoni tat- tabib tiegħek.
- Children first vaccinated between 6 months and less than 12 months should be revaccinated
- Tfal imlaqqmin għall- ewwel darba meta jkollhom bejn 6 xhur u inqas minn 12- il xahar
at 12 to 15 months followed by an additional dose according to your doctor’ s recommendation.
għandhom jitlaqqmu mill- ġdid meta jkollhom 12 sa 15- il xahar segwita b' doża addizzjonali skond ir- rakkomandazzjoni tat- tabib tiegħek.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet.
L- istruzzjonijiet dwar ir- rikonstituzzjoni maħsubin għall- professjonisti fil- qasam mediku huma nklużi fil- parti ta 'l- aħħar tal- fuljett
Like all medicines, M-M-RVAXPRO can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, M- M- RVAXPRO jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Approximately 1 out of 10 patients reported the following side effects with the use of M-M-RVAXPRO: fever (38.5°C or higher), injection site redness, and injection site pain and swelling.
Bejn wieħed u ieħor 1 minn kull 10 pazjenti rrapportaw l- effetti sekondarji li ġejjin bl- użu ta 'M- M - RVAXPRO: deni (38. 5 °C jew ogħla), ħmurija tas- sit ta' l- injezzjoni, u uġigħ u nefħa fis- sit ta 'l - injezzjoni.
Injection site bruising was reported in approximately 1 out of 100 patients.
Tbenġil fis- sit ta 'l- injezzjoni ġie rrapportat f' madwar 1 minn kull 100 pazjent.
Other side effects have been reported with the use of either the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or of its monovalent (single) components: burning and/ or stinging of short duration at the injection site, joint pain and/ or swelling (which could be transient or chronic), rash, unusual bleeding or bruising under the skin, and swelling of the testicles.
Effetti sekondarji oħra ġew irrapportati jew bl- użu tal- vaċċin tal- ħosba, gattone, u ħosba Ġermaniża mmanifatturar minn Merck & Co., Inc. jew blużu tal- komponenti monovalenti tiegħu (singoli): ħruq u/ jew tingiż fuq perjodu ta 'żmien qasir fis- sit ta' l- injezzjoni, uġigħ u/ jew nefħa fil- ġogi (li jistgħu jkunu temporanji jew kroniċi), raxx, fsada mhux normali jew tbenġil taħt il- ġilda, u nefħa tat- testikoli.
Other less common side effects have been reported and some of these were serious.
Effetti sekondarji oħra inqas komuni ġew irrapportati u xi wħud minn dawn kienu serji.
These included: allergic reactions, seizures (fits), and inflammation of the brain (encephalitis).
Dawn kienu jinkludu: reazzjonijiet allerġiċi, puplesija (attakki), u infjammazzjoni tal- moħħ (enċefalite).
50 The doctor has a more complete list of side effects for M-M-RVAXPRO.
It- tabib għandu lista aktar dettaljata ta 'effetti sekondarji għal M- M- RVAXPRO.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Jekk xi wieħed mill - effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
If the condition persists or worsens, seek medical attention.
Jekk il- kondizzjoni tippersisti jew tiggrava, fittex attenzjoni medika.
HOW TO STORE M-M-RVAXPRO
KIF TAĦŻEN M- M- RVAXPRO
Store and transport refrigerated (2°C- 8°C).
Żomm kiesaħ waqt il- ħażna u l- ġarr (2 °C – 8 °C).
Keep the vial of powder in the outer carton in order to protect from light.
Żomm il- kunjett bit- trab fil- kartuna ta 'barra biex tilqa' mid- dawl.
Do not freeze the vaccine.
Tagħmilx it- tilqima fi friża.
Do not use M-M-RVAXPRO after the expiry date which is stated on the outer carton after EXP.
Tużax M- M- RVAXPRO wara d- data ta ’ skadenza li tidher fuq il- kartuna ta 'barra wara JIS.
Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within eight hours.
43 Ladarba l- vaċċin ikun ġie mħallat mas- solvent fornut, għandu jintuża minnufih jew inkella għandu jinħażen fi friġġ u wżat fi żmien tminn sigħat.
What M-M-RVAXPRO contains
X' fih M- M- RVAXPRO
The active substances are:
Is- sostanzi attivi huma:
* 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.
Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Trab: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 b' Hanks ’ salts, MEM, monosodium L- glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (biex jaġġusta l- pH), u sodium hydroxide (biex jaġġusta l- pH)
51 What M-M-RVAXPRO looks like and contents of the pack
Id- Dehra ta 'M- M- RVAXPRO u l- d- daqs tal- pakkett
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided.
It- tilqima hija f' għamla ta 'trab għal suspensjoni għall- injezzjoni f' kunjett ta' doża waħda, li għandha tiġi mħallta mas- solvent mogħti.
The solvent is a clear and colourless liquid.
Is- solvent huwa likwidu ċar u bla kulur.
The powder is a light yellow compact crystalline cake.
It- trab huwa kejk kristallin kumpatt isfar ċar.
M-M-RVAXPRO is available in packs of 1 and 10.
M- M- RVAXPRO huwa disponibbli f' pakkett ta '1 u f' pakkett ta' 10.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għal skop kummerċjali.
Marketing Authorisation Holder:
Detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq:
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F - 69007 Lyon, Franza
Manufacturer Responsible for Batch Release:
Isem u Indirizz tal- Manifattur( i) Responsabbli għall- Ħruġ tal- Lott:
Merck Sharp and Dohme, B. V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Merck Sharp and Dohme, B. V., Waarderweg 39, 2031 BN Haarlem, L- Olanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
44 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq.
52 This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f '{XX/ SSSS}:
Reconstitution instructions The solvent is a clear colourless liquid.
Struzzjonijiet għar- rikostituzzjoni Dan is- solvent huwa likwidu ċar u bla kulur.
Withdraw the entire volume of solvent into a syringe.
Iġbed il- volum kollu f' siringa ta 'solvent f' siringa.
Gently agitate to dissolve completely.
Ħawwad bil- mod sabiex iddewwbu għal kollox.
It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency.
Huwa rrikmandat li l- vaċċin jingħata minnufih wara rikostituzzjoni jew jinħażen fi friġġ u wżat fi żmien 8 sigħat sabiex jitnaqqas kemm jista 'jkun it- telf tas- saħħa tiegħu.
Discard if reconstituted vaccine is not used within 8 hours.
Armi l- vaċċin rikonstitwit jekk ma jintużax fi żmien 8 sigħat.
Do not freeze the reconstituted vaccine.
Tagħmilx il- vaċċin rikostitwit fi friża.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Tużax il- vaċċin rikonstitwit jekk tinnota xi materja ta 'partikulati jew jekk id- dehra tas- solvent jew trab jew tal- vaċċin rikonstitwit tkun differenti minn dik deskritta fuq.
Any unused product or waste material should be disposed of in accordance with local requirements.
45 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
See also section 3 HOW TO USE M-M-RVAXPRO.
Ara wkoll sezzjoni 3 KIF GĦANDEK TUŻA M- M- RVAXPRO.
53 PACKAGE LEAFLET:
46 FULJETT TA 'TAGĦRIF:
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live)
Vaċċin tal- ħosba, gattone u ħosba Ġermaniża (ħaj)
system
47
unless the immune competence of your or your child is demonstrated.
jew ereditarja, sakemm ma tintweriex il- kompetenza ta 'l- immunità tiegħek jew tat- tifel/ tifla tiegħek.
fever itself is not a reason to delay vaccination
deni baxx m' huwiex raġuni l- għala t- tilqima għandha ddum biex tingħata
55 Pregnancy and breast-feeding M-M-RVAXPRO must not be given to pregnant females.
Tqala u Treddigħ M- M- RVAXPRO ma għandux jingħata lil nisa tqal.
M-M-RVAXPRO should be injected into the muscle under the skin either in the area of the outer thigh or of the upper arm.
M- M- RVAXPRO għandu jiġi injettat fil- muskoli taħt il- ġilda jew fiż- żona tal- parti ta 'fuq tad- dirgħajn jew fil- parti ta' barra tal- koxxa.
Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site.
Normalment, fi tfal żgħar, il- post preferut fejn jingħataw injezzjonijiet fil- muskoli huwa ż- żona tal- koxxa filwaqt li f’ individwi ikbar, il- post preferut fejn jingħataw injezzjonijiet huwa ż- żona tal- parti ta ’ fuq tad- driegħ.
M- M-RVAXPRO is not to be injected directly into any blood vessel.
M- M- RVAXPRO ma għandux jiġi injettat direttament f' xi vina.
56 The doctor has a more complete list of side effects for M-M-RVAXPRO.
It- tabib għandu lista aktar dettaljata ta 'effetti sekondarji għal M- M- RVAXPRO.
Keep the vial of powder in the outer carton in order to protect from light.
Żomm kiesaħ waqt il- ħażna u l- ġarr (2 °C – 8 °C) Żomm il- kunjett bit- trab fil- kartuna ta 'barra biex tilqa' mid- dawl.
Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within eight hours.
49 Ladarba l- vaċċin ikun ġie mħallat mas- solvent fornut, għandu jintuża minnufih jew inkella għandu jinħażen fi friġġ u wżat fi żmien tminn sigħat.
57 What M-M-RVAXPRO looks like and contents of the pack
Id- Dehra ta 'M- M- RVAXPRO u l- d- daqs tal- pakkett
M-M-RVAXPRO is available in packs of 1, 10 and 20, with or without needles.
M- M- RVAXPRO huwa disponibbli f' pakketti ta '1, 10 u 20 bi jew mingħajr labar.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
50 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq.
This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f '{XX/ SSSS}:
Inject the entire content of the pre-filled syringe into the vial containing the powder.
Injetta l- kontenut kollu tas- siringa f' kunjett li fih it- trab.
Any unused product or waste material should be disposed of in accordance with local requirements.
51 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below i. e. the details of a prescription checklist are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha deskritti hawn isfel fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali, jiġifieri dettalji ta ’ lista ta ’ verifiki gћal riċetti, jiġu implimentati:
• Mycamine is contra-indicated if the patient has a history of hypersensitivity to micafungin or excipients. • Mycamine should not be used during pregnancy unless clearly necessary. • Caution must be demonstrated if the patient:
• Mycamine huwa kontra- indikat jekk il- pazjent ikollu storja ta ’ sensittività eċċessiva għal micafungin jew xi sustanza mhux attiva. • Mycamine ma jintużax waqt it- tqala sakemm ma jkunx hekk meħtieġ b’ mod ċar. • Kawtela għandha tintwera jekk il- pazjent:
- has severe liver function impairment
- għandu indeboliment sever fil- funzjoni tal- fwied
- has chronic liver diseases known to represent preneoplastic conditions (e. g. advanced liver
- għandu mard tal- fwied kroniku li hu magħruf li jirrapreżenta kundizzjonijiet
fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects)
preneoplastiċi (eż. fibrosi tal- fwied avvanzata, ċirrosi, epatite virali, mard tal- fwied fit- tarbija li għada titwieled jew difett f’ enzimi konġenitali)
- is receiving a concomitant therapy including hepatotoxic and/ or genotoxic properties
- qed jirċievi xi terapija konkomitanti li tinkludi karatteristiċi epatotossiċi u/ jew ġenotossiċi
- has history of haemolysis, haemolytic anaemia or renal impairment.
- għandu storja ta ’ emolisi, anemija emolitika jew indeboliment renali.
• Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary. • Patients should be carefully monitored for liver damage and for worsening of renal function. • To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/ AST is recommended.
• Pazjenti li qed jirċievu sirolimus, nifedipine jew itraconazole flimkien ma ’ Mycamine għandhom jiġu monitorati għat- tossiċità ta ’ sirolimus, nifedipine jew itraconazole u d- doża ta ’ sirolimus, nifedipine jew itraconazole għandha tiġi mnaqqsa jekk meħtieġ. • Il- pazjenti għandhom jiġu sorveljati mill- qrib għal ħsara fil- fwied u kemm- il darba il- funzjoni renali tmur għall- agħar. • Sabiex jitnaqqas ir- riskju għal riġenerazzjoni adattiva u sussegwentement il- possibilità ta ’ formazzjoni ta ’ tumur fil- fwied, it- twaqqif bikri minħabba preżenza sinifikanti u persistenti għolja ta ’ ALT/ AST hi rakkomandata.
What is Mycamine?
X' inhu Mycamine?
Mycamine is a powder that is dissolved to make a solution for infusion (drip into a vein).
Mycamine huwa trab li jdub sabiex isir soluzzjoni għal infużjoni (dripp fil- vina).
It contains the active substance micafungin.
Fih is- sustanza attiva micafungin.
What is Mycamine used for?
Għalxiex jintuża Mycamine?
Mycamine is used in babies, children and adults in the following situations: • to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called Candida). ‘ Invasive ’ means that the fungus has spread into tissue and blood vessels; • to prevent infection with Candida in patients who are having a bone marrow transplant (to treat bone marrow or blood problems, or certain types of cancer) or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.
'Invażiva' tfisser li l- fungus infirex fit- tessut u fil- vażi tad- demm; • biex jimpedixxi infezzjoni b' Candida f' pazjenti li jkunu se jagħmlu/ qegħdin jagħmlu trapjant tal - mudullun (għat- trattament tal- mudullun jew ta 'problemi bid- demm, jew ċerti tipi ta' kanċer) jew li huma mistennija li jkollhom newtropenija (livelli baxxi ta 'newtrofili, tip ta' ċelluli tad- demm bojod) għal 10 ijiem jew aktar.
Mycamine is also used to treat candidiasis in the oesophagus (gullet) in patients over 16 years of age for whom intravenous treatment is suitable.
Mycamine jintuża wkoll biex jittratta kandidjażi fl- esofagu f' pazjenti li għandhom aktar minn 16- il sena li għalihom, trattament intravenuż huwa adatt.
Doctors should only use Mycamine when using other antifungal medicines is not appropriate.
It- tobba għandhom jużaw Mycamine biss meta l- użu ta 'mediċini antifungali oħrajn ma jkunx adatti.
This is because micafungin has been shown to increase the risk of liver tumours developing in rats.
Dan minħabba li ntwera li micafungin iżid ir- riskju ta 'żvilupp ta' tumuri tal- fwied fil- firien.
How is Mycamine used?
Kif jintuża Mycamine?
Treatment with Mycamine should be initiated by a doctor who has experience in the management of fungal infections, and after considering official or national guidance on the use of antifungal medicines.
It- trattament b' Mycamine għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta 'infezzjonijiet fungali, u wara li jkun ikkunsidra gwida ufiiċjali jew nazzjonali dwar l- użu ta' mediċini antifungali.
Mycamine is given once a day as an infusion lasting around one hour.
Mycamine jingħata darba kuljum bħala infużjoni li ddum madwar siegħa.
The dose depends on what it is being used for, the patient’ s weight, and the response to treatment.
Id- doża tiddependi fuq ir - raġuni għal liema jkun qiegħed jintuża, fuq il- piż tal- pazjent, u fuq ir- rispons għat- trattament.
Patients being treated for invasive candidiasis should receive Mycamine for at least two weeks, and for a week after symptoms have resolved and there are no signs of fungus in the blood.
Pazjenti li jkunu qegħdin jiġu ttrattati għal kandidjażi invażiva jirċievu Mycamine għal mill- inqas ġimagħtejn, u għal ġimgħa wara li jkunu għaddew is- sintomi u ma jkun hemm ebda sinjal tal- fungus fid- demm.
Patients being treated for oesophageal candidiasis should continue to receive Mycamine for at least one week after symptoms have resolved.
Il- pazjenti li jkunu qegħdin jiġu ttrattati għal kandidjażi ta 'l- esofagu għandhom ikomplu jirċievu Mycamine għal mill- inqas ġimgħa wara li jkunu għaddew is- sintomi.
When Mycamine is used to prevent Candida infection, treatment should continue for one week after white blood cell counts have recovered.
Meta Mycamine jintuża biex jipprevjeni infezzjoni Candida, it- trattament għandu jibqa 'għaddej għal ġimgħa wara li l- għadd taċ- ċelluli bojod tad- demm ikunu ġew irkuprati.
How does Mycamine work?
Kif jaħdem Mycamine?
The active substance in Mycamine, micafungin, is an antifungal medicine, which belongs to the group ‘ echinocandins’.
Is- sustanza attiva f' Mycamine, micafungin, hija mediċina antifungali, li tappartjeni għall- grupp 'ekinokandini'.
It works by interfering with the production of a component of the fungal cell wall called 1,3-β -D-glucan, which is necessary if the fungus is to continue living and growing.
Taħdem billi tinterferixxi mal- produzzjoni ta 'komponent tal- ħajt taċ- ċelluli fungali msejjaħ 1, 3- β- D- glucan, li huwa neċessarju jekk il- fungus irid ikompli jikber u jgħix.
Fungal cells treated with Mycamine have incomplete or defective cell walls, making them fragile and unable to grow.
Iċ- ċelluli fungali ttrattati b' Mycamine għandhom ħitan taċ- ċelluli inkompluti jew difettużi, u dan jagħmilhom fraġli u inkapaċi li jikbru.
The list of fungi against which Mycamine is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Il- lista ta 'fungi kontra liema Mycamine huwa attiv tista' tiġi kkonsultata fis - Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
How has Mycamine been studied?
Kif ġie studjat Mycamine?
The effects of Mycamine were first tested in experimental models before being studied in humans.
L- effetti ta 'Myacamine ġew l- ewwel ittestjati f' mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The effectiveness of Mycamine has been studied in four main studies, in which it was compared with other antifungal medicines.
L- effikaċja ta 'Mycamine ġiet studjata f' erba' studji prinċipali, li fihom tqabbel ma 'mediċini antifungali oħrajn.
There were three treatment studies and one prevention study.
Kien hemm tliet studji tat- trattament u studju wieħed dwar il- prevenzjoni.
For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in one study involving 531 adults and 106 children, including newborns and premature babies.
Għat- trattament ta 'kandidjażi invażiva, Mycamine tqabbel ma' amphotericin B fi studju wieħed li kien jinvolvi 531 adult u 106 tifel/ tifla, inkluż trabi tat- twelid u trabi prematuri.
For the treatment of oesophageal candidiasis, Mycamine was compared with fluconazole in one study involving 518 adults, and with caspofungin in another study involving 452 adults.
Mycamine tqabbel ma 'fluconazole fi studju wieħed li involva 518- il adult, u ma' caspofungin fi studju ieħor li involva 452 adult.
Most of the patients in these two studies were infected with human immunodeficiency virus (HIV).
Ħafna mill- pazjenti f' dawn iż- żewġ studji kienu infettati bil- virus ta 'l- immunodefiċjenza umana (HIV).
In all three studies, the main measure of effectiveness was the number of patients in whom treatment was successful, based on an improvement in symptoms and eradication of the fungus at the end of treatment.
Fit- tliet studji kollha, il - kejl ewlieni ta 'l- effikaċja kienet in- numru ta' pazjenti li fihom it- trattament kien ta 'suċċess, abbażi ta' titjib fis- sintomi u l- qerda tal- fungus fit- tmiem tat- trattament.
For the prevention of candidiasis, Mycamine was compared with fluconazole in 889 adults and children undergoing a bone marrow transplant.
Għall- prevenzjoni ta 'kandidjażi, Mycamine tqabbel ma' fluconazole fi 889 adult u tfal li jkunu se jagħmlu trapjant tal- mudullun.
The main measure of effectiveness was the number of patients who did not develop a fungal infection during treatment or the following four weeks.
Il- kejl ewlieni ta 'l- effikaċja kien in- numru ta' pazjenti li ma żviluppawx infezzjoni fungali matul it- trattament jew matul l- erba 'ġimgħat suċċessivi.
What benefit has Mycamine shown during the studies?
Liema benefiċċju wera Mycamine waqt l- istudji mwettqa?
Mycamine was as effective as the comparator medicines in the treatment of candidiasis.
Mycamine kien effikaċi daqs il- mediċini tat- tqabbil fit- trattament tal- kandidjażi.
In the study of invasive candidiasis, around 90% of the adults receiving either Mycamine or amphotericin B were successfully treated.
Fl- istudju tal - kandidjażi invażiva, madwar 90% ta 'l- adulti li rċevew jew Mycamine jew amphotericin B ġew ittrattati b' suċċess.
Similar results were seen in children.
Riżultati simili ntwerew fit- tfal.
In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
Fiż- żewġ studji ta 'kandidjażi ta' l- esofogu, madwar 90% tal- pazjenti ġew ittrattati b' suċċess b' Mycamine, fluconazole jew caspofungin.
Mycamine was more effective than fluconazole in preventing fungal infection in patients undergoing a bone marrow transplant:
Mycamine kien aktar effikaċi minn fluconazole fil- prevenzjoni ta 'infezzjoni fungali f' pazjenti li kienu sejrin jagħmlu trapjant tal- mudullun:
80% of the patients (340 out of 425) receiving Mycamine did not develop a fungal infection, compared with 74% of the patients (336 out of 457) receiving fluconazole.
80% tal- pazjenti (340 minn 425) li rċevew Mycamine ma żviluppawx infezzjoni fungali, meta mqabbla ma '74% tal- pazjenti (336 minn 457) li rċevew fluconazole.
What is the risk associated with Mycamine?
X' inhu r- riskju assoċjat ma 'Mycamine?
The most common side effects with Mycamine (seen in between 1 and 10 patients in 100) are leucopenia (low levels of leucocytes, a type of white blood cell), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels), hypocalcaemia (low blood calcium levels), headache, phlebitis (inflammation of a vein), nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, signs of liver problems in the blood (increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase or bilirubin), rash, pyrexia (fever) and rigors (shaking chills).
L- aktar effetti sekondarji komuni assoċjati ma 'Mycamine (li deher f' bejn 1 u 10 pazjenti minn kull 100) kienu lewkopenija (livelli baxxi ta' lewkoċiti, tip ta 'ċelloli tad- demm bojod), newtropenija (livelli baxxi ta' newtrofili, tip ta 'ċelloli tad- demm bojod), anemija (għadd baxxi ta' ċelluli tad- demm ħomor), ipokaljemija (livelli baxxi ta 'potassju fid- demm), ipomanjeżjemija (livelli baxxi ta' manjeżju fid- demm), ipokalċemija (livelli baxxi ta 'kalċju fid- demm), uġigħ ta' ras, flebite (infjammazzjoni ta 'vina), nawżea (dardir), remettar, dijarrea, uġigħ addominali (ta' żaqq), sinjali ta 'problemi tal- fwied fid- demm (żieda fil- livelli ta' fosfatażi alkalina, aspartat aminotransferażi, alanina aminotransferażi jew bilirubina), raxx, piressija (deni) u rogħda (tertir).
Additional common side effects in children (seen in between 1 and 10 children in 100) are thrombocytopenia (low blood platelet counts), tachycardia (rapid heart rate), hypertension (high blood pressure), hypotension (low blood pressure), hepatomegaly (enlarged liver), acute renal failure (sudden kidney failure) and increased blood urea levels.
Effetti sekondarji komuni addizzjonali fit- tfal (li dehru f' bejn 1 u 10 itfal minn kull 100) huma tromboċitopenija (għadd baxxi ta 'platelets fid- demm), takikardija (rata ta' taħbit tal- qalb mgħaġġla), ipertensjoni (pressjoni tad- demm għolja), ipotensjoni (pressjoni tad- demm baxxa), epatomegalija (tkabbir tal- fwied), insuffiċjenza renali (tal- fwied) akuta (f' daqqa) u żieda ta 'l- urea fid- demm.
For the full list of all side effects reported with Mycamine, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Mycamine, ara l- Fuljett ta' Tagħrif.
Mycamine should not be used in people who may be hypersensitive (allergic) to micafungin or any of the other ingredients.
Mycamine ma għandux jintuża f' nies li jistgħu jkunu ipersensittivi (allerġiċi) għal micafungin jew għal kwalunkwe sustanza oħra tiegħu.
Because liver damage and tumours have been seen in rats receiving Mycamine for long periods, patients should be monitored for liver problems during Mycamine treatment using blood tests.
Minħabba li dehru kemm ħsara fil- fwied kif ukoll rogħda f' firien li rċevew Mycamine għal perjodi twal, il- pazjenti għandhom jiġu mmonitorjati għal problemi fil- fwied matul trattamenti b' Mycamine permezz ta 'testijiet tad- demm.
Treatment should be stopped if there are persistent increases in liver enzymes.
It- trattament għandha tieqaf jekk ikun hemm żidiet persistenti fl- enzimi tal- fwied.
Mycamine is not recommended for use in patients who have severe problems with their liver, who have long-term liver disease or who are taking other medicines that could harm the liver or the DNA.
Mycamine għandu jintuża biss wara valutazzjoni attenta tar- riskji u l- benefiċċji tiegħu, b' mod partikolari f' pazjenti li għandhom problemi eżistenti bil- fwied tagħhom, li għandhom mard għal perjodu twil ta 'żmien fil- fwied tagħhom jew li jkunu qegħdin jieħdu mediċini oħrajn li jistgħu jagħmlu ħsara lill- fwied jew lid- DNA.
2/ 3 Why has Mycamine been approved?
2/ 3 Għaliex ġie approvat Mycamine?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mycamine’ s benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days, but that it should only be used if other antifungals are not appropriate.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Mycamine huma ikbar mir- riskji tiegħu għat- trattament ta' kandidjażi invażiva u ta 'kandidjażi ta' l - esofogu, u għall- profilassi ta 'infezzjoni b' Candida f' pazjenti li jkunu sejrin jagħmlu trapjant alloġeniku ta' ċelluli staminali ematopojetiċi jew li huma mistennija li jkollhom newtropenija għal 10 ijiem jew aktar, iżda għandu jintuża biss jekk antifungali oħrajn ma jkunux xierqa.
The Committee recommended that Mycamine be given marketing authorisation.
Il- Kumitat irrakkomanda li Mycamine jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Mycamine?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Mycamine?
The company that makes Mycamine will ensure that prescribers in all Member States receive a checklist before the launch of the medicine.
Il- kumpanija li tipproduċi Mycamine sejra tiżgura li dawk kollha li jagħtu riċetti fl- Istati Membri kollha jirċievu lista ta 'kontroll qabel il- mediċina titqiegħed fis- suq.
This checklist will remind prescribers how to use the medicine safely.
Din il- lista ta 'kontroll se tfakkar lil dawk kollha li jagħtu r- riċetta fuq kif jużaw il- mediċina b' mod sikur.
Other information about Mycamine:
Informazzjoni oħra dwar Mycamine:
The European Commission granted a marketing authorisation valid throughout the European Union for Mycamine to Astellas Pharma GmbH on 25 April 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha, għal Mycamine lil Astellas Pharma GmbH fil- 25 ta 'April 2008.
The full EPAR for Mycamine can be found here.
L- EPAR sħiħ għal Mycamine jista 'jiġi kkonsultat hawn.
This summary was last updated in 03-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
(concentration)
Kontenut (konċentrazzjoni)
Powder for solution for infusion
Trab għal soluzzjoni għall- infużjoni
Mycamine 50 mg powder for solution for infusion
Mycamine 50 mg trab għal soluzzjoni għall- infużjoni
Each vial contains 50 mg micafungin (as sodium).
Kull kunjett fih 50 mg micafungin (bħala sodium).
After reconstitution each ml contains 10 mg micafungin (as sodium).
Wara r- rikostituzzjoni kull ml fih 10 mg micafungin (bħala sodium).
For a full list of excipients, see section 6.1.
Kull kunjett ta ’ 50 mg fih 200 mg ta ’ lactose Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
White compact powder.
Trab abjad kompatt.
Mycamine is indicated for:
Mycamine hu indikat għal:
Adults, adolescents ≥ 16 years of age and elderly:
Adulti, adoloxxenti ≥ 16- il sena jew aktar u anzjani:
- Treatment of invasive candidiasis.
- Trattament ta ’ kandidjasi invażiva.
- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
- Trattament ta ’ kandidjasi esofagali f’ pazjenti li għalihom hija xierqa terapija intravenuża.
- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell
- Profilassi ta ’ infezzjoni Candida f’ pazjenti li jkunu ser jagħmlu trapjant ta ’ ċelluli stem
transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days.
alloġeniċi ematopojetiċi jew f’ pazjenti li jkunu mistennija li jkollhom newtropenja (għadd assolut ta ’ newtrofili < 500 ċellola / µl) għal 10 ijiem jew aktar.
Children (including neonates) and adolescents < 16 years of age:
Tfal (li jinkludu trabi għadhom jitwieldu) u adoloxxenti < 16- il sena:
transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days.
alloġeniċi ematopojetiċi jew pazjenti li jkunu mistennija li jkollhom newtropenja (għadd assolut ta ’ newtrofili < 500 ċellola / µl) għal 10 ijiem jew aktar.
The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4).
Id- deċiżjoni jekk jintużax Mycamine għandha titqies fuq riskju potenzjali li jiżviluppaw tumuri fil - fwied (ara sezzjoni 4. 4).
Mycamine should therefore only be used if other antifungals are not appropriate.
Għalhekk, Mycamine għandu jintuża biss jekk antifungali oħrajn ma jkunux adattati.
Consideration should be given to official/ national guidance on the appropriate use of antifungal agents.
Għandha tingħata konsiderazzjoni għal gwida uffiċjali/ nazzjonali dwar l- użu xieraq ta ’ mediċini antifungali.
Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.
It- trattament b’ Mycamine għandu jinbeda minn tabib li għandu esperjenza fil- ġestjoni ta ’ infezzjonijiet fungali.
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s).
Għandhom jinkisbu kampjuni għal kultura fungali u studji rilevanti oħra tal- laboratorju (fosthom istopatoloġija) qabel it- terapija sabiex jiġu iżolati u identifikati l- organiżmi kawżattivi.
Therapy may be instituted before the results of the cultures and other laboratory studies are known.
It- terapija tista ’ tinbeda qabel ma jkunu magħrufa r- riżultati tal- kulturi u ta ’ studji oħra tal- laboratorju.
However, once these results become available, antifungal therapy should be adjusted accordingly.
Madankollu, ladarba dawn ir- riżultati jkunu disponibbli, it- terapija antifungali għandha tiġi aġġustata kif meħtieġ.
2 The dose regimen of Mycamine depends on the body weight of the patient as given in the following tables:
2 Ir- reġimen tad- doża ta ’ Mycamine jiddependi fuq il- piż tal- ġisem tal- pazjent kif mogħti fit- tabelli li ġejjin:
Use in adults, adolescents ≥ 16 years of age and elderly
L- użu f’ adulti, adoloxxenti ≥ 16- il sena t’ età u anzjani
Body weight > 40 kg
Piż tal- ġisem > 40 kg
Body weight ≤ 40 kg
Piż tal- ġisem ≤ 40 kg
Treatment of invasive candidiasis Treatment of oesophageal candidiasis Prophylaxis of Candida infection
Trattament ta ’ kandidjasi invażiva Trattament ta ’ kandidjasi esofagali Profilassi ta ’ infezzjoni Candida * Kemm- il darba r- rispons tal- pazjent ma jkunx adegwat, eż.
100 mg/ day* 150 mg/ day 50 mg/ day
100 mg/ kuljum * 150 mg/ kuljum 50 mg/ kuljum persistenza ta- kulturi jew jekk
2 mg/ kg/ day* 3 mg/ kg/ day 1 mg/ kg/ day
2 mg/ kg/ kuljum * 3 mg/ kg/ kuljum 1 mg/ kg/ kuljum il- kundizzjoni
*If the patient’ s response is inadequate, e. g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/ day in patients weighing > 40 kg or 4 mg/ kg/ day in patients ≤ 40 kg.
klinika ma titjibx, id- doża tista ’ tiżdied għal 200 mg/ kuljum f’ pazjenti li jiżnu > 40 kg jew 4 mg/ kuljum f’ pazjenti li jiżnu ≤ 40 kg.
Treatment duration Invasive candidiasis:
Tul tat- trattament Kandidjasi invażiva:
The treatment duration of Candida infection should be a minimum of 14 days.
It- tul tat- trattament ta ’ infezzjoni b’ Candida għandu jkun ta ’ mill- anqas 14- il jum.
The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
It- trattament antifungali għandu jissokta għal mill- anqas ġimgħa wara li jkunu nkisbu żewġ kulturi tad- demm negattivi wara xulxin u wara l- għibien tas- sinjali kliniċi u s- sintomi ta ’ l- infezzjoni.
Oesophageal candidiasis:
Kandidjasi esofagali:
For the treatment of oesophageal candidiasis, Mycamine should be administered for at least one week after resolution of clinical signs and symptoms.
Għat- trattament ta ’ kandidjasi esofagali, Mycamine għandu jingħata għal ta ’ lanqas ġimgħa wara l- għibien tas- sinjali kliniċi u s- sintomi.
Prophylaxis of Candida infections:
Profilassi ta ’ infezzjonijiet Candida:
For prophylaxis of Candida infection, Mycamine should be administered for at least one week after neutrophil recovery.
Għall- profilassi ta ’ infezzjoni b’ Candida, Mycamine għandu jingħata għal ta ’ lanqas ġimgħa wara l- irkupru tan- newtrofili.