qanastek/EMEA-V3 huggingface dataset:
- Breathing difficulty, chest pain, fluid accumulation in the lungs
- Pressjoni tad- demm baxxa, infjammazzjoni ta 'vina (li tista' tkun assoċjata mal- ħolqien ta 'embolu)
- Low blood sugar, low blood potassium
- Diffikulta 'biex tieħu nifs, uġigħ tas- sider, akkumulazzjoni ta' fluwidu fil- pulmuni
- Jaundice, redness of the skin
- Suffejra, ħmura tal- ġilda
- Swelling of the lips or face
- Nefħa tax- xufftejn jew tal- wiċċ
- Allergic reactions (sometimes severe), including widespread blistering rash and skin
- Reazzjonijiet allerġiċi (kultant severi), fosthom raxx mifrux bl- infafet u tqaxxir tal- ġilda,
peeling, severe skin reaction following exposure to light or sun
reazzjoni severa tal- ġilda wara esponiment għad- dawl jew għax- xemx
- Itchiness
- Ħakk
- Hair loss
- Twaqqigħ tax- xagħar
- Back pain
- Uġigħ tad- dahar
- Kidney failure, blood in the urine, changes in blood tests of kidney function
- Insuffiċjenza tal- kliewi, demm fl- awrina, bidliet fit- testijiet tad- demm tal- funzjoni tal- kliewi
- Changes in blood tests of liver function
- Bidliet fit- testijiet tad- demm tal- funzjoni tal- fwied
Uncommon side effects (occurring in at least 1 in 1,000 patients) are:
118 Effetti sekondarji mhux komuni (iseħħu f' mill- anqas 1 f' 1, 000 pazjent) huma:
- Enlarged lymph glands (sometimes painful)
- Tkabbir tal- glandola limfatika (kultant bl- uġigħ)
- Increase in a type of white blood cell which may be associated with allergic reaction, disorder
- Żieda f' tip ta 'ċellola bajda tad- demm li tista' tkun assoċjata ma 'reazzjoni allerġika, mard tas -
of blood clotting system -Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting -Depressed function of the adrenal gland
sistema tat- tagħqid tad- demm,
- Problem with coordination
- Problema bil- koordinazzjoni
- Swelling of the brain
- Nefħa tal- moħħ
- Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the
- Vista doppja, uġigħ u infjammazzjoni ta 'l- għajnejn u tal- kpiepel ta' l- għajnejn, moviment
eye
involontarju ta 'l- għajn
- Decreased sensitivity to touch
- Sensittività mnaqqsa għall- mess
- Constipation, inflammation of upper small intestine, dyspepsia, pancreatitis, peritonitis
- Stitikezza, infjammazzjoni tal- parti ta 'fuq tal- musrana ż- żgħira, dispepsja, pankreatite, peritonite
- Gingivitis,
- Ġenġivite
- Swelling and inflammation of the tongue
- Nefħa u infjammazzjoni ta 'l- ilsien
- Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones
- Fwied akbar, epatite, insuffiċjenza tal- fwied, mard tal- bużżieqa tal- marrara, ġebel fil- marrara
- Inflammation of the kidney, proteins in the urine
- Infjammazzjoni tal- kliewi, proteini fl- awrina
- Abnormal electrocardiogram (ECG)
- Elettrokardjogramm (ECG) anormali
- Blood chemistry changes
- Bidliet fil- kimika tad- demm
113 Rare side effects (occurring in at least 1 in 10,000 patients) are:
Effetti sekondarji rari (iseħħu f' mill- anqas 1 f' 10, 000 pazjent) huma:
- Inability to sleep
- Inkapaċità biex torqod
- Hearing difficulties, ringing in the ears
- Diffikultajiet tas- smigħ, żarżir fil- widnejn
- Abnormal sense of taste
- Sens anormali tat- togħma
- Increase in muscle tone, muscle weakness caused by an abnormal immune system
- Żieda fit- ton tal- muskoli, indeboliment tal- muskoli kkawżat minn rispons anormali tas- sistema
response
immunitarja
- Abnormal brain function, Parkinson-like symptoms, convulsion
- Funzjoni anormali tal- moħħ, sintomi bħall- Parkinson, konvulżjoni
As VFEND has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests.
Billi huwa magħruf li VFEND jaffettwa l- fwied u l- kliewi, it- tabib tiegħek għandu jimmonitorja l - funzjoni tal- fwied u l- kliewi tiegħek billi jagħmillek testijiet tad- demm.
Please advise your doctor if you have any stomach pains or if your stools have a different consistency.
Jekk jogħġbok avża lit- tabib tiegħek jekk ikollok xi wġigħ fl- istonku jew jekk il- purgar tiegħek ikollu konsistenza differenza.
If any of these side effects persist or are troublesome, please tell your doctor.
Jekk xi wieħed minn dawn l- effetti sekondarji jippersisti jew idejqek, jekk jogħġbok għid lit- tabib tiegħek.
HOW TO STORE VFEND
KIF TAĦŻEN VFEND
Do not use VFEND after the expiry date which is stated on the label.
Tużax VFEND wara d- data ta 'skadenza li tidher fuq it- tikketta.
The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għall - aħħar ġurnata ta ’ dak ix- xahar.
There are no special storage instructions.
M' hemm ebda struzzjonijiet speċjali għall- ħażna.
Medicines should not be disposed of via wastewater or houshold waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- drenaġġ jew ma' l- iskart domestiku.
What VFEND contains  The active substance is voriconazole.
X' fih VFEND
What VFEND looks like and contents of the pack VFEND 50 mg film-coated tablets is supplied as white round film-coated tablets with Pfizer marked on one side and VOR50 on the reverse.
Kull pillola fiha 50 mg (għal VFEND 50mg pilloli miksija
VFEND 200 mg film-coated tablets is supplied as white capsule shaped film-coated tablets with Pfizer marked on one side and VOR200 on the reverse.
b’ rita) jew 200mg (għal VFEND 200mg pilloli miksija b’ rita) ta 'voriconazole.
VFEND 50 mg film-coated tablets and 200 mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100.
Il- pilloli VFEND 50 mg miksijin b' rita u l- pilloli VFEND 200mg miksijin b' rita huma disponibbli bħala pakketti ta '2, 10, 14, 20, 28, 30, 50, 56 u 100.
The information in this leaflet is about VFEND 50 mg tablets and VFEND 200 mg tablets only.
It- tagħrif f' dan il- fuljett huwa dwar il- pilloli VFEND 50 mg biss u il- pilloli VFEND 200 mg.
For further information on VFEND 200 mg powder for solution for infusion or VFEND 40 mg/ ml powder for oral suspension, please see the User Package Leaflets for these products.
Għal aktar tagħrif dwar il- pilloli VFEND 200 mg trab għal soluzzjoni għal infużjoni, jew VFEND 40 mg/ ml trab għal suspensjoni orali, jekk jogħġbok ara l- Fuljetti ta 'Tagħrif għal dawn il- prodotti.
114 Marketing Authorisation Holder Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, United Kingdom.
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, Renju Unit
Manufacturer Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Str.
Manifattur Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Str.
35 D-89257 Illertissen Germany
35 D- 89257 Illertissen Ġermanja
Danmark Pfizer ApS Tlf: +45 44 20 11 00
Danmark Pfizer ApS Tél: +45 (44) 20 11 00 11
España Pfizer S. A.
120 España Pfizer S. A.
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar fi
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Tagħrif dettaljat dwar din il- mediċina huwa disponibbli fuq il- website ta 'l- Aġenzija Ewropea għall - Mediċini (EMEA): http: // www. emea. europea. eu
116 PACKAGE LEAFLET:
121 FULJETT TA ’ TAGĦRIF:
VFEND 200 mg powder for solution for infusion Voriconazole
VFEND 200 mg trab għal soluzzjoni għal infużjoni Voriconazole
Read all of this leaflet carefully before you start taking this medicine.  Keep this leaflet.
Jista jkollok bżonn terġa ’ taqrah.
You may need to read it again.  If you have any questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
Din il- mediċina ġiet preskritta lilek.
It may harm them, even if their symptoms are the same as yours.  If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
Jekk xi wieħed mill- effetti kollaterali jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
In this leaflet:
F' dan il- fuljett:..
What VFEND is and what it is used for 2.
X' inhu VFEND u għalxiex jintuża 2.
Before you take VFEND 3.
Qabel tieħu VFEND 3.
How to use VFEND 4.
Kif għandek tieħu VFEND 4.
How to store VFEND 6.
Kif taħżen VFEND 6.
WHAT VFEND IS AND WHAT IT IS USED FOR
X' INHU VFEND U GĦALXIEX JINTUŻA
VFEND belongs to a group of medicines called triazole antifungal agents.
VFEND jappartjeni għal grupp ta 'mediċini msejħa aġenti antifungali triazole.
These medicines are used to treat a wide variety of fungal infections.
Dawn il- mediċini jintużaw sabiex jikkuraw varjetà wiesgħa ta 'infezzjonijiet fungali.
VFEND works by killing or stopping the growth of the fungi that cause infections.
VFEND jaħdem billi joqtol jew iwaqqaf it- tkabbir tal- fungi li jikkawżaw l- infezzjonijiet.
What fungal infections are treated with VFEND?
Liema infezzjonijiet fungali huma kkurati b' VFEND?
VFEND is used to treat serious fungal infections caused by Aspergillus, Scedosporium, Fusarium, fluconazole-resistant Candida, and candidaemia in patients with normal white blood cell counts.
VFEND jintuża sabiex jiġu kkurati infezzjonijiet fungali serji kkawżati minn Aspergillus, Scedosporium, Fusarium, Cadida reżistenti għal fluconazole, u candidaemia f' pazjenti b' għadd ta 'ċelloli bojod tad- demm normali.
This product should only be used under the supervision of a doctor.
Dan il- prodott għandu jittieħed biss taħt is- superviżjoni ta 'tabib.
VFEND is mainly for use in seriously ill patients.
VFEND huwa maħsub prinċipalment għal pazjenti morda serjament.
BEFORE YOU TAKE VFEND
QABEL MA TIEĦU VFEND
Do not take VFEND:
Tiħux b' VFEND:
- If you are allergic to the active ingredient voriconazole, or to sulphobutylether beta cyclodextrin
- jekk int allerġiku( a) għas- sustanza attiva voriconazole, jew għal sulphobutylether beta
sodium.
cyclodextrin sodium.
It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription.
Huwa importanti ħafna li tinforma lit- tabib jew spiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l - aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Some medicines affect the way VFEND works, or VFEND may affect the way they work.
Ċerti mediċini jaffettwaw il- mod kif jaħdem VFEND, jew VFEND jista 'jaffettwa l- mod kif jaħdmu huma.
A list of the medicines that may affect VFEND is shown in the section ‘ Taking other medicines with VFEND’.
Lista tal- mediċini li jistgħu jaffettwaw lil VFEND tidher fis- sezzjoni ‘ Teħid ta 'mediċini oħra ma' VFEND ’.
However, the medicines in the following list must not be taken during your VFEND treatment:
Madankollu, il- mediċini fil- lista segwenti m' għandhomx jintużaw waqt il- kura tiegħek b' VFEND:
 Terfenadine (used for allergy)  Astemizole (used for allergy)  Cisapride (used for stomach problems)  Pimozide (used for treating mental illness)  Quinidine (used for irregular heart beat)  Rifampicin (used for treating tuberculosis)  Carbamazepine (used to treat seizures) 117  Phenobarbital (used for severe insomnia and seizures)  Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine)  Sirolimus (used in transplant patients)  Ritonavir (used for treating HIV) in doses of 400mg and more twice daily  St John’ s Wort (herbal supplement)
John’ s Wort (fexfiex) (suppliment erbali)
Take special care with VFEND:  If you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘ long QT syndrome’.
mod jew anormalità ta 'l- elettrokardjogramm (ECG) imsejħa ‘ sindrome tal- QT twil ’.
Tell your doctor if you are taking any of the following medicines, as VFEND must not be taken if you are already taking any of these medicines (See also Section 2 above ‘ Do not take VFEND):
Għid lit- tabib tiegħek jekk qed tieħu xi waħda mill- mediċini li ġejjin, billi VFEND m' għandux jittieħed jekk diġa 'qed tieħu xi waħda minn dawn il - mediċini (Ara wkoll Sezzjoni 2 fuq ‘ Tiħux VFEND):
 Terfenadine (used for allergy)  Astemizole (used for allergy)  Carbamazepine (used to treat seizures)  Cisapride (used for stomach problems)  Pimozide (used for treating mental illness)  Quinidine (used for irregular heart beat)  Rifampicin (used for treating tuberculosis)  Phenobarbital (used for severe insomnia and seizures)  Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine)  Sirolimus (used in transplant patients)  Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily  St John’ s Wort (herbal supplement)
John’ s Wort (fexfiex) (suppliment erbali)
Tell your doctor if you are taking the following medicine, as treatment with VFEND at the same time should be avoided if possible:  Ritonavir (used for treating HIV) in doses of 100 mg twice daily
Għid lit- tabib tiegħek jekk qed tieħu l- mediċina li ġejja, billi jekk ikun possibbli għandha tiġi evitata kura b' VFEND fl- istess ħin:  Ritonavir (użat għall- kura ta 'l- HIV) f' dożi ta' 100 mg u aktar darbtejn kuljum
Tell your doctor if you are taking either of the following medicines, as treatment with VFEND at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:  Rifabutin (used for treating tuberculosis)  Phenytoin (used to treat epilepsy)
Għid lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn iż- żewġ mediċini li ġejjin, billi jekk jista 'jkun għandha tiġi evitata kura b' VFEND fl- istess ħin, u jista' jkun meħtieġ aġġustament fid- doża ta 'voriconazole.  Rifampicin (użat għall- kura tat- tuberkulosi)  Phenytoin (użat għall- kura ta' l- epilessija)
Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:  Warfarin and other anticoagulants (e. g. phenprocoumon, acenocoumarol; used to slow down clotting of the blood)  Ciclosporin (used in transplant patients)  Tacrolimus (used in transplant patients)  Sulphonylureas (e. g. tolbutamide, glipizide, and glyburide) (used for diabetes)  Statins (e. g. atorvastatin, simvastatin) (used for lowering cholesterol)  Benzodiazepines (e. g midazolam, triazolam) (used for severe insomnia and stress)  Omeprazole (used for treating ulcers)  Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)  Vinca alkaloids (e. g. vincristine and vinblastine) (used in treating cancer)  Indinavir and other HIV protease inhibitors (used for treating HIV)
Għid lit- tabib tiegħek jekk qed tieħu xi waħda mill- mediċini li ġejjin, billi jista 'jkun meħtieġ aġġustament fid- doża jew monitoraġġ sabiex jiġi aċċertat li l- mediċini u / jew VFEND ikunu għadhom qed ikollhom l- effett mixtieq:  Warfarin u sustanzi oħra kontra l- koagulazzjoni tad- demm (p. e. phenprocoumon, acenocoumarol; użati biex jirritardjaw it- tagħqid tad- demm)  Ciclosporin (użat f' pazjenti tat- trapjanti)  Tacrolimus (użat f' pazjenti tat- trapjanti)  Sulphonylureas (p. e. tolbutamide, glipizide, u glyburide) (użati għad- dijabete)  Statins (p. e. atorvastatin, simvastatin) (użati biex ibaxxu l- kolesterol)  Benzodiazepines (p. e. midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)  Omeprazole (użat għall- kura ta 'l- ulċeri)
118  Non-nucleoside reverse transcriptase inhibitors (e. g. efavirenz, delavirdine, nevirapine) (used for treating HIV)  Methadone (used to treat heroin addiction)  Efavirenz (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as VFEND)  Alfentanil and other short acting opiates such as fentanyl and sufentanil (painkillers used for surgical procedures)  Non-steroidal anti-inflammatory drugs (e. g. ibuprofen, diclofenac) (used for treating pain and inflammation)
123  Kontraċettivi orali (jekk tieħu VFEND waqt li tkun qed tuża kontraċettivi orali, jista 'jkollok effetti mhux mixtieqa bħal dardir u disturbi mestrwali)  Alkalojdi vinka (p. e. vincristine u vinblastine) (użati fil- kura tal- kanċer)  Indinavir u inibituri oħra tal- protease ta' l- HIV (użati għall- kura ta 'l- HIV)  Non- nucleoside reverse transcriptase inhibitors (p. e. efavirenz, delavirdine, nevirapine) (użati għall- kura ta' l- HIV)  Methadone (użat għat- trattament tal- vizzju tat- teħid ta 'l- eroina)  Efavirenz (użat għat- trattament ta ’ l- HIV) (ċerti dożi ta ’ efavirenz MHUX suppost jittieħdu fl - istess ħin ma voriconazole)  Alfentanil u opiates oħra li jaħdmu fuq qasir żmien bħal fentanyl u sulfentanil (mediċini kontra l - uġiegħ li jintużaw għal proċeduri kirurġiċi)  Mediċini anti- infjammatorji non- sterojdali (e. ż. ibuprofen, diclofenac) (użati kontra l- uġigħ u infjammazzjoni)
Before being treated with VFEND, tell your doctor if:  you have had an allergic reaction to other azoles.  you are suffering from, or have ever suffered from kidney disease.
Qabel ma tiġi kkurat b' VFEND, għid lit- tabib tiegħek jekk:
Dependent upon the degree of kidney disease the doctor may decide to give you VFEND tablets.
jista 'jiddeċiedi li jagħtik il- pilloli VFEND.
Your doctor should monitor your renal function while you are being treated with VFEND by doing blood tests.  you are suffering from, or have ever suffered from liver disease.
It- tabib tiegħek għandu jimmonitorja l- funzjoni tal - kliewi tiegħek waqt li tkun qed tiġi kkurat/ a b' VFEND billi jagħmillek testijiet tad- demm.
Your doctor may stop the infusion of VFEND if this occurs.
l- effetti sekondarji għal rifabutin iridu jiġu mmonitorjati.
Pregnancy and breast-feeding:
Waqt li tkun qed tingħata kura b' VFEND:
VFEND must not be used during pregnancy, unless indicated by your doctor.
Tqala u treddigħ VFEND m' għandux jittieħed waqt it- tqala, sakemm ma jkunx indikat mit- tabib tiegħek.
Contact your doctor immediately if you become pregnant while being treated with VFEND.
Ikkuntattja lit- tabib tiegħek immedjatament jekk tinqabad tqila waqt li tkun qed tieħu VFEND.
VFEND must not be used during breast-feeding.
VFEND m' għandux jittieħed waqt li tkun qed tredda '.
Driving and using machines:
124 Sewqan u tħaddim ta 'magni:
Tell your doctor if you experience this.
Ikkuntattja lit- tabib tiegħek jekk tesperjenza dan.
Important information about some of the ingredients of VFEND Each vial of VFEND contains 217.6 mg of sodium per vial.
Kull kunjett ta 'VFEND fih 217. 6 mg ta' sodju.
This should be taken into consideration if you are on a strictly controlled sodium diet.
Inti għandek tieħu dan in konsiderazzjoni jekk qiegħed fuq dieta ta 'sodju kkontrollat.
HOW TO USE VFEND Always take VFEND exactly as your doctor has told you.
Dejjem għandek tieħu VFEND eżatt kif qallek it- tabib tiegħek.
You should check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma 'l- ispiżjar tiegħek jekk ikollok xi dubju/ a.
Your doctor will determine your dose depending on your weight and the type of infection you have.
It- tabib tiegħek jista 'jibdel id- doża tiegħek skond il- kondizzjoni tiegħek.
Your doctor may change your dose depending on your condition.
 Id- doża normali għall- adulti (inkluż pazjenti anzjani) hija kif ġej:
119 The usual dose for adults (including elderly patients) is as follows:
Doża għall- ewwel 24 siegħa (Loading Dose)
Intravenous 6 mg/ kg every 12 hours for Dose for the first 24 hours the (Loading Dose)
6 mg/ kg kull 12- il siegħa għall - ewwel 24 siegħa.
first 24 hours
Doża wara l- ewwel 24 siegħa (Doża ta 'Manteniment)
Dose after the first 24 hours 4 mg/ kg twice a day (Maintenance Dose)
4 mg darbtejn kuljum
Depending on your response to treatment, your doctor may decrease the dose to 3 mg/ kg twice daily.
Jiddependi fuq ir- rispons tiegħek għall- kura, it- tabib tiegħek jista 'jnaqqas id- doża għal 3 mg/ kg darbtejn kuljum.
 The usual dose for children aged 2 to less than 12 years is 7 mg/ kg twice daily.
 Id- doża normali għal tfal minn 2 sa anqas minn 12- il sena hija 7 mg darbtejn kuljum.  Id- doża normali għal żgħażagħ bejn 12 u 16- il sena hija l- istess bħal dik ta 'l- adulti.
VFEND powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
VFEND trab għal soluzzjoni għal infużjoni jiġi rikostitwit u dilwit għall- konċentrazzjoni korretta mill- ispiżjar jew infermier ta 'l- isptar tiegħek.
(Please refer to the end of this leaflet for further information)
(Jekk jogħġbok irreferi għall- aħħar ta 'dan il- fuljett għal aktar tagħrif)
This will be given to you by intravenous infusion (into a vein) at a maximum rate of 3 mg/ kg per hour over 1 to 2 hours.
Dan se jingħatalek b' infużjoni fil- vini (ġo vina) b' rata massima ta '3 mg/ kg fis- siegħa mifruxa fuq siegħa sa sagħtejn.
VFEND treatment will continue for as long as your doctor advises, however duration of treatment with VFEND powder for solution for infusion should be no more than 6 months.
Il- kura b' VFEND għandha tkompli sakemm jagħti parir it- tabib tiegħek, madankollu t- tul tal- kura b' VFEND trab għal soluzzjoni għal infużjoni m' għandux ikun ta 'aktar minn 6 xhur.
You may be switched from the intravenous infusion to tablets once your condition improves.
Inti tista 'tinqaleb mill- infużjoni fil- vini għall- pilloli meta l- kondizzjoni tiegħek titjieb.
If a dose of VFEND has been forgotten:
125 Jekk ma titteħidx doża ta 'VFEND:
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Billi inti se tingħata din il- mediċina taħt sorveljanza medika mill- qrib, mhux probabbli li tfalli doża.
However tell your doctor or pharmacist if you think that a dose has been forgotten.
Madankollu għid lit- tabib jew spiżjar tiegħek jekk taħseb li tkun intesiet xi doża.
If you have any further questions on the use of this product, ask your doctor.
Jekk ikollok xi mistoqsijiet oħra dwar l- użu ta 'dan il- prodott, staqsi lit- tabib tiegħek.
POSSIBLE SIDE EFFECTS Like all medicines, VFEND can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, VFEND jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
120 Very common side effects (occurring in at least 1 in 10 patients) are:
Effetti sekondarji komuni ħafna (iseħħu f' mill- anqas 1 f' 10 pazjenti) huma:
-Visual disturbances (change in vision) -Fever -Rash -Nausea, vomiting, diarrhoea -Headache -Swelling of the extremities -Stomach pains.
- Disturbi viżwali (tibdil fil- vista)
-Flu-like symptoms, sinusitis, chills, weakness -Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells or of all types of blood cells, red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes -Low blood sugar, low blood potassium -Anxiety, depression, tingling, confusion, dizziness, agitation, trembling, hallucinations and other nervous symptoms -Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot) -Breathing difficulty, chest pain, fluid accumulation in the lungs -Jaundice, redness of the skin -Swelling of the lips or face -Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reaction following exposure to light or sun -Itchiness -Hair loss -Back pain -Kidney failure, blood in the urine, changes in blood tests of kidney function -Inflammation at injection sites -Changes in blood tests of liver function
- Bidliet fit- testijiet tad- demm tal- funzjoni tal- fwied
Uncommon side effects (occurring in at least 1 in 1,000 patients) are:
Effetti sekondarji mhux komuni (iseħħu f' mill- anqas 1 f' 1, 000 pazjent) huma:
-Enlarged lymph glands (sometimes painful) -Increase in a type of white blood cell which may be associated with allergic reaction, disorder of blood clotting system -Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting -Depressed function of the adrenal gland -Problem with coordination -Swelling of the brain -Double vision pain and inflammation of the eyes and eyelids, involuntary movement of the eye -Decreased sensitivity to touch -Constipation, inflammation of upper small intestine, dyspepsia, pancreatitis, peritonitis -Gingivitis, -Swelling and inflammation of the tongue -Enlarged liver, hepatitis, liver failure, gallbladder disease, gallstones -Joint pain -Inflammation of the kidney, proteins in the urine -Abnormal electrocardiogram (ECG) -Blood chemistry changes
- Bidliet fil- kimika tad- demm
Rare side effects (occurring in at least 1 in 10,000 patients) are:
Effetti sekondarji rari (iseħħu f' mill- anqas 1 f' 10, 000 pazjent) huma:
-Hearing difficulties, ringing in the ears -Abnormal sense of taste
- Diffikultajiet tas- smigħ, żarżir fil- widnejn
121 -Increase in muscle tone, muscle weakness caused by an abnormal immune system response -Abnormal brain function, Parkinson-like symptoms, convulsion -Sleepiness during infusion
- Funzjoni anormali tal- moħħ, sintomi bħall- Parkinson, konvulżjoni
Reactions during the infusion have occurred uncommonly with VFEND (including flushing, fever, sweating, increased heart rate and shortness of breath).
Kultant kien hemm reazzjonijiet waqt l- infużjoni b' VFEND (fosthom fwawar, deni, tagħriq, taħbit tal - qalb mgħaġġel u qtugħ ta 'nifs).
Your doctor may stop the infusion if this occurs.
It- tabib tiegħek jista 'jwaqqaf l- infużjoni jekk dan iseħħ.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji mhux imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Keep VFEND out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Once reconstituted, VFEND should be used immediately, but if necessary may be stored for up to 24 hours at 2°C - 8°C (in a refrigerator).
Ladarba jiġi rikostitwit, VFEND għandu jintuża immedjatament, iżda jekk ikun hemm bżonn jista 'jinħażen sa 24 siegħa f' temperatura ta' 2C - 8C (fi friġġ).
Reconstituted VFEND needs to be diluted with a compatible infusion solution first before it is infused.
VFEND rikostitwit irid jiġi dilwit b' soluzzjoni kompatibbli għal infużjoni qabel ma jiġi infuż.
(Please refer to the end of this leaflet for further information).
(Jekk jogħġbok irreferi għall- aħħar ta 'dan il- fuljett għal aktar tagħrif).
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- drenaġġ jew ma' l- iskart domestiku.
What VFEND contains
X' fih VFEND
-The active substance is voriconazole. -The other ingredient is sulphobutylether beta cyclodextrin sodium.
- Is- sustanza l- oħra hi sulphobutylether beta cyclodextrin sodium.
Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ ml solution when reconstituted as directed by your hospital pharmacist or nurse (see the information at the end of this leaflet).
127 Kull kunjett fih 200 mg voriconazole, ekwivalenti għal soluzzjoni ta '10 mg/ ml meta rikostitwita kif qallek it- tabib jew infermier ta' l- isptar tiegħek (ara t- tagħrif fl- aħħar ta 'dan il- fuljett).
What VFEND looks like and contents of the pack
Id- dehra ta 'VFEND u l- kontenut tal- pakkett VFEND hu ppreżentat f' kunjetti tal- ħġieġ li jintużaw darba biss bħala trab għal soluzzjoni għal infużjoni.
The information in this leaflet is about VFEND 200 mg powder for solution for infusion only.
It- tagħrif f' dan il- fuljett huwa dwar VFEND 200 mg trab għal soluzzjoni għal infużjoni biss.
For further information on VFEND 50 mg and 200 mg film-coated tablets or VFEND 40 mg/ ml powder for oral suspension, please see the User Package Leaflet for these products.
Għal aktar tagħrif dwar il- pilloli VFEND 50 mg u 200 mg miksijin b' rita jew VFEND 40 mg/ ml trab għal suspensjoni orali, jekk jogħġbok ara l- Fuljett ta 'Tagħrif għal dawn il- prodotti.
Manufacturer
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, Renju Unit.
Pfizer PGM, Zone Industrielle, 29 Route des Industries, 37530 Pocé-sur-Cisse, France.
Manifattur Pfizer PGM, Zone Industrielle, 29 route des Industries, 37530 Pocé- sur- Cisse, Franza.
For any information about this medicinal product, please contact the local representative of the 122 Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq.
Ireland Pfizer Healthcare Ireland Tel:
128 Ireland Pfizer Healthcare Ireland
< ----------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
< -------------------------------------------------------------------------------------------------------------------------- L- informazzjoni li ġejja hija maħsuba għal professjonisti mediċi jew tal- kura tas- saħħa biss:
Reconstitution and Dilution information  VFEND powder for solution for infusion needs to first be reconstituted with 19 ml of Water for Injections to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ ml voriconazole.  Discard the VFEND vial if the vacuum does not pull the diluent into the vial.  It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of Water for Injections is dispensed.  The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final VFEND solution containing 0.5 to 5 mg/ ml of voriconazole.  This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.  Not for administration as a bolus injection.  For storage information, please refer to Section 5 ‘ How to store VFEND’.
Tagħrif dwar ir- Rikostituzzjoni u t- Taħlit bl- Ilma  VFEND trab għal soluzzjoni għall- infużjoni l- ewwel irid jiġi rikostitwit bi 19- il ml Ilma għall - Injezzjonijiet sabiex jinkiseb volum li jista 'jinġibed ta' 20 ml ta 'konċentrat ċar li fih 10 mg/ ml ta' voriconazole.  Armi l- kunjett ta 'VFEND jekk il- vakum ma jiġbidx id- dilwent għal ġol- kunjett.  Huwa rakkomandat li tintuża siringa standard ta' 20 ml (mhux awtomatika) sabiex jiġi żgurat li jingħata l- ammont eżatt (19. 0 ml) ta 'Ilma għall- Injezzjonijiet.  Il- volum meħtieġ tal- konċentrat rikostitwit imbagħad jiġi miżjud ma' infużjoni kompatibbli rakkomandata għal infużjoni msemmija hawn isfel biex tinkiseb soluzzjoni finali ta 'VFEND li jkun fiha 0. 5 sa 5 mg/ ml ta' voriconazole.  Dan il- prodott mediċinali għandu jintuża darba biss u kwalunkwe soluzzjoni mhux użata trid tintrema u għandhom jintużaw biss soluzzjonijiet ċari mingħajr partikoli.  M' għandux jingħata bħala injezzjoni bolus.  Għal tagħrif dwar kif jinħażen, jekk jogħġbok irreferi għal Sezzjoni 5 ‘ Kif taħżen VFEND ’.
124 Required Volumes of 10 mg/ ml VFEND Concentrate
129 Volumi Meħtieġa ta '10 mg/ ml ta' Konċentrat VFEND
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma tintużax minnufih, il- ħinijiet u l- kundizzjonijiet ta 'ħżin waqt l- użu huma r- responsabbiltà ta' l- utent u normalment ma għandhomx ikunu iktar minn 24 siegħa f' 2 sa 8C, sakemm ir- rikostituzzjoni ma tkunx seħħet f' kundizzjonijiet ikkontrollati u asettiċi.
Compatible Infusion Solutions:
Soluzzjonijiet Kompatibbli għal Infużjoni:
The reconstituted solution can be diluted with:
Is- soluzzjoni rikostitwita tista 'tiġi dilwita ma':
The compatibility of VFEND with diluents other than listed above (or listed below under ‘ Incompatibilities’) is unknown.
Il- kompatibilità ta 'VFEND ma' dilwenti mhux dawk deskritti fuq (jew elenkati taħt f ''Inkompatibilitajiet ') m' hiex magħrufa.
VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e. g., Aminofusin 10% Plus).
VFEND ma għandux jiġi infuż fl- istess linja jew kannula fl- istess ħin ma 'infużjonjiet ta' prodotti mediċinali oħra, inkluż nutriment parenterali (eż Aminofusin 10% Plus).
Infusions of blood products must not occur simultaneously with VFEND.
Infużjonijet ta 'prodotti tad- demm ma għandhomx iseħħu simultanjament ma' VFEND.
Infusion of total parenteral nutrition can occur simultaneously with VFEND but not in the same line or cannula.
130 Infużjoni ta 'nutrizzjoni parenterali totoali tista' sseġġ simultanjament ma 'VFEND iżda mhux fl- istess linja jew kannula.
125 PACKAGE LEAFLET:
131 FULJETT TA ’ TAGĦRIF:
VFEND 40 mg/ ml powder for oral suspension.
VFEND 40 mg/ ml trab għal suspensjoni orali Voriconazole
Voriconazole
- - -
Before you take VFEND 3.
Qabel ma tieħu VFEND 3.
How to take VFEND 4.
Kif għandek tieħu VFEND 4.
How to store VFEND 6 Further information
Aktar tagħrif
This product should only be taken under the supervision of a doctor.
Dan il- prodott għandu jittieħed biss taħt is- superviżjoni ta 'tabib.
BEFORE YOU TAKE VFEND
Tiħux VFEND:
Do not take VFEND:  if you are allergic to voriconazole or any of the other ingredients of VFEND
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal voriconazole jew sustanzi oħra ta '
However, the medicines in the following list must not be taken during your course of VFEND treatment:
Madankollu, il- mediċini fil- lista segwenti m' għandhomx jintużaw waqt il- kura tiegħek b' VFEND:
 Terfenadine (used for allergy)  Astemizole (used for allergy)  Cisapride (used for stomach problems)  Pimozide (used for treating mental illness)  Quinidine (used for irregular heart beat)  Rifampicin (used for treating tuberculosis)  Carbamazepine (used to treat seizures)  Phenobarbital (used for severe insomnia and seizures)
 Terfenadine (użat għal allerġija)  Astemizole (użat għal allerġija)  Cisapride (użat għal problemi ta 'l- istonku)  Pimozide (użat għall- kura ta' mard mentali)
126  Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine)  Sirolimus (used in transplant patients)  Ritonavir (used for treating HIV) in doses of 400mg and more twice daily  St John’ s Wort (herbal supplement)
John’ s Wort (fexfiex) (suppliment erbali)
Tell your doctor if you are taking any of the following medicines, as VFEND must not be taken if you are already taking any of these medicines (See also Section 2 above ‘ Do not take VFEND’):  Terfenadine (used for allergy)  Astemizole (used for allergy)  Carbamazepine (used to treat seizures)  Cisapride (used for stomach problems)  Pimozide (used for treating mental illness)  Quinidine (used for irregular heart beat)  Rifampicin (used for treating tuberculosis)  Phenobarbital (used for severe insomnia and seizures)  Ergot alkaloids (e. g. ergotamine, dihydroergotamine; used for migraine)  Sirolimus (used in transplant patients)  Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily  St John’ s Wort (herbal supplement)
John’ s Wort (fexfiex) (suppliment erbali)
Tell your doctor if you are taking the following medicine, as treatment with VFEND at the same time should be avoided if possible:  Ritonavir (used for treating HIV) in doses of 100 mg twice daily
Għid lit- tabib tiegħek jekk qed tieħu l- mediċina li ġejja, billi jekk ikun possibbli għandha tkun evitata kura b' VFEND fl- istess ħin:  Ritonavir (użat għall- kura ta 'l- HIV) f' dożi ta' 100 mg u aktar darbtejn kuljum Għid lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn iż- żewġ mediċini li ġejjin, billi jekk jista 'jkun għandha tiġi evitata kura b' VFEND fl- istess ħin, u jista' jkun meħtieġ aġġustament fid- doża ta 'voriconazole.  Rifampicin (użat għall- kura tat- tuberkulosi)  Phenytoin (użat għall- kura ta' l- epilessija)
Tell your doctor if you are taking either of the following medicines, as treatment with VFEND at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:  Rifabutin (used for treating tuberculosis)  Phenytoin (used to treat epilepsy)
Għid lit- tabib tiegħek jekk qed tieħu xi waħda mill- mediċini li ġejjin, billi jista 'jkun meħtieġ aġġustament fid- doża jew monitoraġġ sabiex jiġi aċċertat li l- mediċini u / jew VFEND ikunu għadhom qed ikollhom l- effett mixtieq:  Warfarin u sustanzi oħra kontra l- koagulazzjoni tad- demm (p. e. phenprocoumon, acenocoumarol; użati biex jirritardjaw it- tagħqid tad- demm)  Ciclosporin (użat f' pazjenti tat- trapjanti)  Tacrolimus (użat f' pazjenti tat- trapjanti)  Sulphonylureas (p. e. tolbutamide, glipizide, u glyburide) (użati għad- dijabete)  Statins (p. e. atorvastatin, simvastatin) (użati biex ibaxxu l- kolesterol)  Benzodiazepines (p. e. midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)  Omeprazole (użat għall- kura ta 'l- ulċeri)
Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:  Warfarin and other anticoagulants (e. g. phenprocoumon, acenocoumarol; used to slow down clotting of the blood)  Ciclosporin (used in transplant patients)  Tacrolimus (used in transplant patients)  Sulphonylureas (e. g. tolbutamide, glipizide, and glyburide) (used for diabetes)  Statins (e. g. atorvastatin, simvastatin) (used for lowering cholesterol)  Benzodiazepines (e. g midazolam, triazolam) (used for severe insomnia and stress)  Omeprazole (used for treating ulcers)  Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)  Vinca alkaloids (e. g. vincristine and vinblastine) (used in treating cancer)  Indinavir and other HIV protease inhibitors (used for treating HIV)  Non-nucleoside reverse transcriptase inhibitors (e. g. efavirenz, delavirdine, nevirapine) (used for treating HIV)
133  Kontraċettivi orali (jekk tieħu VFEND waqt li tkun qed tuża kontraċettivi orali, jista 'jkollok effetti mhux mixtieqa bħal dardir u disturbi mestrwali)  Alkalojdi vinka (p. e. vincristine u vinblastine) (użati fil- kura tal- kanċer)  Indinavir u inibituri oħra tal- protease ta' l- HIV (użati għall- kura ta 'l- HIV)  Non- nucleoside reverse transcriptase inhibitors (p. e. efavirenz, delavirdine, nevirapine) (użati għall- kura ta' l- HIV)  Methadone (użat għat- trattament tal- vizzju tat- teħid ta 'l- eroina)  Efavirenz (użat għat- trattament ta ’ l- HIV) (ċerti dożi ta ’ efavirenz MHUX suppost jittieħdu fl - istess ħin ma voriconazole)  Alfentanil u opiates oħra li jaħdmu fuq qasir żmien bħal fentanyl u sulfentanil (mediċini kontra l - uġiegħ li jintużaw għal proċeduri kirurġiċi)  Mediċini anti- infjammatorji non- sterojdali (e. ż. ibuprofen, diclofenac) (użati kontra l- uġigħ u infjammazzjoni)
127  Methadone (used to treat heroin addiction)  Efavirenz (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as VFEND)  Alfentanil and other short acting opiates such as fentanyl and sufentanil (painkillers used for surgical procedures)  Non-steroidal anti-inflammatory drugs (e. g. ibuprofen, diclofenac) (used for treating pain and inflammation)
- jekk kellek reazzjoni allerġika għal azoli oħrajn.
Before being treated with VFEND, tell your doctor if:  you have had an allergic reaction to other azoles.  you are suffering from, or have ever suffered from liver disease.
Jekk għandek mard tal- fwied, it- tabib tiegħek
While being treated with VFEND:  tell your doctor immediately if you develop a severe skin rash or blisters.  avoid sunlight while being treated with VFEND, as an increased sensitivity of skin to the sun’ s UV rays can occur.  your doctor should monitor the function of your liver and kidney by doing blood tests.
u l- effetti sekondarji għal rifabutin iridu jiġu mmonitorjati.
VFEND suspension must be taken at least one hour before or two hours after a meal.
- għid lit- tabib tiegħek immedjatament jekk tiżviluppa raxx sever tal- ġilda jew infafet.
Important information about some of the ingredients of VFEND:
134 Tagħrif importanti dwar xi wħud mis- sustanzi ta 'VFEND:
VFEND suspension contains 0.54g sucrose per ml of suspension.
Is- suspensjoni VFEND fiha 0. 54g sucrose għal kull ml ta 'suspensjoni.
HOW TO TAKE VFEND Always take VFEND exactly as your doctor has told you.
Dejjem għandek tieħu VFEND eżatt kif qallek it- tabib tiegħek.
128 The usual dose for adults (including elderly patients) is as follows:
 Id- doża normali għall- adulti (inkluż pazjenti anzjani) hija kif ġej:
Oral suspension Patients 40 kg and above Patients less than 40 kg
Pazjenti li jiżnu anqas minn 40 kg
Dose for the first 24 hours (Loading Dose)
Doża għall- ewwel 24 siegħa (Loading Dose)
400 mg (10 ml) every 12 hours for the first 24 hours
400 mg (10 ml) kull 12- il siegħa għall- ewwel 24 siegħa
200 mg (5 ml) every 12 hours for the first 24 hours
200 mg (5 ml) kull 12- il siegħa għall- ewwel 24 siegħa
200 mg (5 ml) twice a day
(5 ml) darbtejn kuljum
100 mg (2.5 ml) twice a day
100 mg (2. 5 ml) darbtejn kuljum
The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.  The usual dose for children aged 2 to less than 12 years is 200 mg twice daily.  VFEND should not be given to children younger than 2 years of age.  Teenagers (aged 12 to 16 years) should be dosed as for adults.
 Id- doża normali għal tfal minn 2 sa anqas minn 12- il sena hija 200 mg darbtejn kuljum.
Take your suspension at least one hour before, or two hours after a meal.
Ħu s- suspensjoni tiegħek mill- inqas siegħa qabel, jew sagħtejn wara ikla.
Patients with a weakened immune system or those with difficult infections may require long-term treatment to prevent the infection from returning.
Il- pazjenti li għandhom sistema immunitarja mdgħajfa jew dawk b' infezzjonijiet diffiċli jistgħu jkollhom bżonn kura fit- tul biex jiġi evitat li l- infezzjoni terġa 'titfaċċa.
VFEND suspension should not be mixed with any other medication.
Is- suspensjoni VFEND m' għandhiex tiġi mħallta ma 'xi medikazzjoni oħra.
The suspension should not be further diluted with water or any other liquids.
Is- suspensjoni m' għandhiex tiġi dilwita aktar bl- ilma jew xi likwidi oħra.
If you take more suspension than prescribed (or if someone else takes your suspension) you must seek medical advice or go to the nearest hospital casualty department immediately.
Jekk tieħu aktar suspensjoni milli ordnat (jew jekk xi ħadd ieħor jieħu s- suspensjoni tiegħek) inti għandek tfittex parir mediku jew tmur fid- dipartiment ta 'l- emerġenz ta' l- eqreb sptar immedjatament.
Take your bottle of VFEND suspension with you.
Ħu l- flixkun tas- suspensjoni VFEND miegħek.
If you forget to take VFEND:
135 Jekk tinsa tieħu VFEND:
It is important to take your VFEND suspension regularly at the same time each day.
Huwa importanti li tieħu s- suspensjoni VFEND tiegħek regolarment fl- istess ħin kuljum.
Do not take a double dose to make up for the forgotten dose.
Tiħux doża doppja biex tpatti għad- doża li nsejt.
However if you were taking medicines containing cyclosporin or tacrolimus you must mention this to your doctor, as the dose will need to be adjusted.
Madankollu, jekk kont qiegħed/ qiegħda tieħu mediċini li fihom cyclosporin jew tacrolimus inti għandek tgħid b' dan lit- tabib tiegħek, billi d- doża tkun trid tiġi aġġustata.
Instructions to constitute the suspension:
Struzzjonijiet dwar kif tikkostitwixxi s- suspensjoni:
It is recommended that your pharmacist constitutes VFEND suspension before giving it to you.
Huwa rakkomandat li l- ispiżjar tiegħek jikkostitwixxi s- suspensjoni VFEND qabel jagħtihielek.
VFEND suspension is constituted if it is in a liquid form.
Is - suspensjoni VFEND tkun kostitwita jekk tkun f' għamla likwida.
If it appears to be a dry powder you should constitute the oral suspension by following the instructions below.
Jekk jidher li hu trab xott inti għandek tikkostitwixxi s- suspensjoni orali billi ssegwi l- istruzzjonijiet ta 'hawn isfel.
Remove the cap.
Neħħi t- tapp.
Measure 23 ml of water by filling the measuring cup (included in the carton) to the top of the
Kejjel bil- kikkra 23 ml ieħor ta 'ilma u żid dan mal- flixkun.
Using the cup measure another 23 ml water and add this to the bottle. You should always add a total of 46 ml (2 x 23 ml) of water irrespective of the dose you are taking.
Dejjem għandek iżżid total ta '46 ml (2 x 23 ml) ilma irrispettivament mid- doża li tkun qed tieħu.
Press the bottle adaptor into the neck of the bottle (as shown on figure below).
Agħfas l- adapter tal- flixkun fil- għonq tal- flixkun (kif muri fl- istampa ta 'hawn isfel).
The adaptor is provided so that you can fill the oral syringe with medicine from the bottle.
L- adapter huwa pprovdut biex tkun tista 'timla s- siringa orali bil- mediċina mill- flixkun.
Replace the cap on the bottle.
Erġa 'poġġi t- tapp fuq il- flixkun.
Write the date of expiry of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Ikteb id- data ta 'skadenza tas- suspensjoni kostitwita fuq it- tikketta tal- flixkun (iż- żmien kemm iddum tajba s- suspensjoni kostitwita huwa 14- il jum).
Any unused suspension should be discarded after this date.
Kwalunkwe suspensjoni mhux użata għandha tintrema wara din id- data.
Instructions for use:
English Oral syringe Bottle Adaptor Bottle Cap Bottle
Your pharmacist should advise you how to measure the medicine using the multi-dosing oral syringe provided in the pack.
Struzzjonijiet dwar l- użu L- ispiżjar tiegħek għandu jgħidlek kif tkejjel il- mediċina billi tuża s- siringa orali multi- dosing ipprovduta fil- pakkett.
Please see instructions below before using VFEND suspension.
Jekk jogħġbok ara l- istruzzjonijiet ta 'hawn isfel qabel tuża s- suspensjoni VFEND.
1.
136 1.
Shake the closed bottle of constituted suspension for approximately 10 seconds before use.
Ħawwad il- flixkun magħluq tas- suspensjoni kostitwita għal madwar 10 sekondi qabel l- użu.
While the bottle is upright, on a flat surface, insert the tip of the oral syringe into the adaptor.
Waqt li l- flixkun ikun wieqaf, fuq wiċċ ċatt, daħħal il- ponta tas- siringa orali fl- adapter.
Turn the bottle upside down while holding the oral syringe in place.
Dawwar il- flixkun rasu 'l isfel waqt li żżomm is- siringa orali fil- post.
Slowly pull back the plunger of the oral syringe to the graduation mark that marks the dose for you.
Iġbed bil- mod il- planġer tas - siringa orali sal- marka tal- gradazzjoni li timmarka d- doża għalik.
To measure the dose accurately, the top edge of the black ring should be lined up with the graduated mark on the oral syringe.
Biex tkejjel id- doża b' mod eżatt, ix- xifer ta 'fuq taċ- ċirku iswed għandu jkun f' linja mal- marka gradata fuq is- siringa orali.
If large bubbles can be seen, slowly push the plunger back into the syringe.
Jekk tara bżieżaq kbar, imbotta bil- mod il- planġer mill- ġdid fis- siringa.
This will force the medicine back into the bottle.
Dan jimbotta l- mediċina mill- ġdid fil- flixkun.
Repeat step 3 again.
Irrepeti pass 3 mill- ġdid.
Turn the bottle back upright with the oral syringe still in place.
Erġa 'dawwar il- flixkun rasu' l fuq bis- siringa orali għadha fil- post.
Remove the oral syringe from the bottle.
Neħħi s- siringa orali mill - flixkun.
Put the tip of the oral syringe into the mouth.
Poġġi l- ponta tas- siringa orali fil- ħalq.
Point the tip of the oral syringe towards the inside of the cheek.
Immira l- ponta tas- siringa orali lejn il- naħa ta 'ġewwa tal - ħadd.
SLOWLY push down the plunger of the oral syringe.
Imbotta BIL- MOD il- planġer tas- siringa orali.
Do not squirt the medicine out quickly.
Tferrax il- mediċina 'l barra malajr.
If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine.
Jekk il - mediċina trid tingħata lil tifel/ tifla, kun żgur li t- tifel/ tifla jkunu bil- qiegħda, jew jinżammu weqfin qabel ma jingħataw il- mediċina.
Replace the cap on the bottle, leaving the bottle adaptor in place.
Erġa 'poġġi t- tapp fuq il- flixkun, u ħalli l- adapter tal- flixkun fil- post.
Wash the oral syringe as instructed below.
Aħsel is- siringa orali skond l- istruzzjonijiet ta 'hawn isfel.
Cleaning and storing the syringe:
Kif tnaddaf u taħżen is- siringa: