qanastek/EMEA-V3 huggingface dataset:
After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ ml) within 1.5 hours after dosing.
Wara li tqattret qatra waħda ta ’ 0. 03% bimatoprost kuljum fiż- żewġ għajnejn għal ħmistax, il - konċentrazzjonijiet fid- demm laħqu l- massimu f’ 10 minuti wara l- għotja tad- doża u naqsu sa taħt l - inqas limitu ta ’ osservazzjoni (0. 025 ng/ ml) f’ 1. 5 sigħat wara l- għotja tad- doża.
Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ ml and 0.09 ng• hr/ ml respectively, indicating that a steady drug concentration was reached during the first week of ocular dosing.
Il- medja tal- valuri ta ’ Cmax u AUC 0- 24siegħa kienu simili fis- 7 u l- 14- il ġurnata f’ ammonti ta ’ madwar 0. 08 ng/ ml u 0. 09 ng• siegħa/ ml rispettivament, u dan jindika li konċentrazzjoni fissa tal- prodott mediċinali ntlaħaqet matul l- ewwel ġimgħa ta ’ l- għotja fl- għajn.
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 1/ kg.
Bimatoprost jitqassam b’ mod moderat fit- tessuti tal- ġisem u l- volum ta ’ distribuzzjoni sistemika fiss fin- nies hu ta ’ 0. 67 l/ kg.
In human blood, bimatoprost resides mainly in the plasma.
Fid- demm uman, bimatoprost ikun l- aktar fil- plażma.
The plasma protein binding of bimatoprost is approximately 88%.
88% ta ’ bimatoprost jeħel mal- proteini tad- demm fil- plażma.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing.
Bimatoprost hu l- iktar sustanza li tiċċirkola fid- demm hekk kif jilħaq iċ- ċirkolazzjoni sistemika wara l- għotja fl- għajn.
Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Bimatoprost imbagħad jgħaddi minn ossidazzjoni, N- deethylation u glukoronidazzjoni biex jifforma varjetà differenti ta ’ metaboliti.
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
Bimatoprost jiġi eliminat primarjament mill- kliewi, sa 67% mid- doża mogħtija mill- vina lil voluntiera f’ saħħithom kienet imneħħija fl- awrina, 25% tad- doża tneħħiet fl- ippurgar.
The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 1/ hr/ kg.
Il- half- life ta ’ l - eliminazzjoni, wara l- għoti ġol- vina, kienet ta ’ madwar 45 minuta; it- tneħħija totali mid- demm kienet ta ’ 1. 5 l/ siegħa/ kg.
Characteristics in elderly patients:
Karatteristiċi f’ pazjenti anzjani:
After twice daily dosing, the mean AUC 0-24hrs value of 0.0634 ng• hr/ ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng• hr/ ml in young healthy adults.
Wara li d- doża ngħatat darbtejn kuljum, il- valur medju ta ’ AUC0- 24siegha ta ’ 0. 0634 ng• siegħa/ ml ta ’ bimatoprost fl- anzjani (individwi ta ’ 65 sena jew aktar) kien, b’ mod sinifikanti, aktar għoli minn 0. 0218 ng• siegħa/ ml f’ adulti żgħażagħ f’ saħħithom.
However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing.
Madankollu, dan ir- riżultat mhux klinikament relevanti għaliex l- espożizzjoni sistemika kemm għall- individwi anzjani kif ukoll għaż- żgħażagħ baqgħet baxxa ħafna wara l- għoti tad- doża fl- għajn.
There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.
Ma kienx hemm akkumulazzjoni ta ’ bimatoprost fid- demm matul il- ħin u l- profil ta ’ sigurtà kien simili f’ pazjenti anzjani u fiż- żgħażagħ.
After ocular administration of a 0.5% eye drops solution in humans undergoing cataract surgery, peak timolol concentration was 898 ng/ ml in the aqueous humour at one hour post-dose.
Wara li jitqattar qtar ta ’ 0. 5% fl- għajn f’ persuni li għaddew minn kirurġija tal- kataratti, l- ogħla konċentrazzjoni ta ’ timolol kien ta ’ 898 ng/ ml fl- aqueous humour siegħa wara d- doża.
Part of the dose is absorbed systemically where it is extensively metabolised in the liver.
Parti mid- doża tkun assorbita sistemikament fejn tiġi metabolizzata mill- fwied b’ mod estensiv.
The half-life of timolol in plasma is about 4 to 6 hours.
Il- half- life ta ’ timolol fil- plażma hija ta ’ madwar 4 sigħat sa 6 sigħat.
Timolol is partially metabolised by the liver with timolol and its metabolites excreted by the kidney.
Timolol jiġi metabolizzat parzjalment mill- fwied u timolol u l- metaboliti tiegħu jiġu mneħħija mill- kliewi.
Timolol is not extensively bound to plasma.
Timolol ma jintrabatx b’ mod estensiv mal - plażma.
Repeated dose ocular toxicity studies on GANFORT showed no special hazard for humans.
Studji dwar t- tossiċità ta ’ l- għoti ripetut fl- għajn ta ’ GANFORT ma urew ebda periklu speċjali għall - bnedmin.
The ocular and systemic safety profile of the individual components is well established.
Il- profil tas- sigurtà sistemika u ta ’ l- għajnejn, tal- komponenti individwali huwa stabbilit tajjeb.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential.
Tagħrif mhux kliniku ma juri ebda periklu speċjali għall- bnedmin bbażat fuq studji konvenzjonali dwar is- sigurtà farmakoloġika, il- ġenotossiċità, il- potenzjal karċinoġeniku.
Studies in rodents produced species-specific abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular administration.
Studji f’ annimali gerriema pproduċew assorbiment speċifiku għall- ispeċi f' livelli ta ’ 33 sa 97 darba aktar minn dak li ntlaħaq fil - bnedmin wara li ingħata fl- għajnejn.
Monkeys administered ocular bimatoprost concentrations of ≥ 0.03% daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/ or lower sulcus and widening of the palpebral fissure.
Meta konċentrazzjoni ta ’ ≥0. 03% ta ’ bimatoprost ngħatat kuljum fl- għajn tax- xadini, irriżultat f’ żjieda fil- pigmentazzjoni tal- ħabba tal- għajn u effetti periokulari marbuta mad- doża li huma riversibbli u karaterizzati minn sulcus promininenti fuq u/ jew isfel u twessiegħ tal- fissura palpebrali..
The increased iris pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and not by an increase in 7 melanocyte number.
Iż- żjieda fil - pigmentazzjoni tal- ħabba ta ’ l- għajn jidher li hi kkaġunata minn żjieda fl- istimulazzjoni tal - produzzjoni ta ’ melanin fil- melanoċiti u mhux minn żjieda fin- numru ta ’ melanoċiti.
No functional or microscopic changes related to the periocular effects have been observed, and the mechanism of action for the periocular changes is unknown.
L- ebda bidliet funzjonali jew mikroskopiċi marbuta ma ’ l- effetti periokulari ma kienu osservati, u l- mekkaniżmu ta ’ azzjoni għall- bidliet perjokulari mhux magħruf.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Tagħrif mhux kliniku ma juri ebda periklu speċjali għall- bnedmin bbażat fuq studji konvenzjonali dwar s- sigurtà farmakoloġika, t- tossiċità ta ’ dożi ripetuti, il- ġenotossiċità, il- potenzjal karċinoġeniku, t- tossiċità għar- riproduzzjoni.
Benzalkonium chloride Sodium chloride Sodium phosphate dibasic heptahydrate Citric acid monohydrate Hydrochloric acid or sodium hydroxide (to adjust pH) Purified water
Benzalkonium chloride Sodium chloride Sodium phosphate dibasic heptahydrate Citric acid monohydrate Hydrochloric acid jew sodium hydroxide (biex ikun aġġustat il- livell ta ’ pH) Ilma purifikat
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Kienet murija stabilità kimika u fiżika waqt l- użu għal 28 ġurnata f’ temperatura ta ’ 25°C.
From a microbiological point of view, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 28 days at 25°C.
Minn aspett mikrobioloġiku, il- perjodu u l- kundizzjonijiet tal- ħażna waqt l- użu huma responsabbilità ta ’ min qed jużah u ġeneralment ma jkunux ta ’ aktar minn 28 ġurnata f’ temperatura ta ’ 25°C.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jinħtieġ ebda kundizzjonijiet speċjali għall- ħażna.
White opaque low-density polyethylene bottles with polystyrene screw cap.
Fliexken bojod u opaki ta ’ polyethylene ta’ densità baxxa b’ għatu ta ’ polystyrene tal- kamin.
Each bottle has a fill volume of 3 ml.
Kull flixkun għandu volum mimli ta ’ 3 ml.
The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml.
Jeżistu dawn il- pakketti differenti: kaxxa ta ’ 1 jew 3 fliexken ta ’ 3 ml.
CARTON FOR SINGLE BOTTLE
KAXXA GĦAL FLIXKUN WIEĦED
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution bimatoprost/ timolol
GANFORT 300 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni bimatoprost/ timolol
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZI ATTIVI
One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)
Ml wieħed tas- soluzzjoni fih 0. 3 mg bimatoprost u 5 mg timolol (bħala 6. 8 mg ta ’ timolol maleate)
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Benzalkonium chloride, sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid jew sodium hydroxide (biex tadatta l- pH) u ilma purifikat.
Eye drops, solution, 3 ml
Qtar għall- għajnejn, soluzzjoni, 3 ml
Remove contact lenses before use.
Neħħi l- lentijiet tal- kuntatt qabel l- użu.
Opened:
JIS Armih erba ’ ġimgħat wara li tiftħu l- ewwel darba Infetaħ:
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDINĊINALI, JEKK HEMM BŻONN.
CARTON CONTAINING THREE BOTTLES
KAXXA BI TLETT IFLIEXKEN
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution bimatoprost/ timolol
GANFORT 300 mikrogrammi/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni bimatoprost/ timolol
Eye drops, solution, 3 x 3 ml
Qtar għall- għajnejn, soluzzjoni, 3 x 3 ml
Opened (1):
JIS Armi erba ’ ġimgħat wara li tiftħu l- ewwel darba Infetaħ (1):
Opened (2):
Infetaħ (2):
Opened (3):
Infetaħ (3):
BOTTLE
FLIXKUN
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution bimatoprost/ timolol Ocular Use
GANFORT 300 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni. bimatoprost/ timolol Użu għall- għajnejn
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel ma tużah.
EXP:
Jis:
INFORMATION FOR THE USER
INFORMAZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution bimatoprost and timolol maleate
GANFORT 300 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni bimatoprost u timolol maleate
- If you have any further questions, please ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even
Tista ’ tagħmililhom il -
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispżjar tiegħek.
What GANFORT is and what it is used for 2.
X’ inhu GANFORT u għalxiex jintuża 2.
Before you use GANFORT 3.
Qabel ma tuża GANFORT 3.
How to use GANFORT 4.
Kif għandek tuża GANFORT 4.
Possible side effects 5 How to store GANFORT 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħzen GANFORT 6.
WHAT GANFORT IS AND WHAT IT IS USED FOR
X’ INHU GANFORT U GĦALXIEX JINTUŻA
GANFORT is an eye drop that is used to control glaucoma.
GANFORT huwa qtar għall- għajnejn li jintuża għall- kontroll tal- glawkoma.
It contains two different active substances (bimatoprost and timolol) that both reduce high pressure in the eye.
Fih żewġ sustanzi attivi differenti (bimatoprost u timolol) u t- tnejn li huma jnaqqsu l- pressjoni għolja fil- għajn.
Bimatoprost belongs to a group of medicines called prostamides.
Bimatoprost jifforma parti minn grupp ta ’ mediċini magħrufa bħala prostamides.
Timolol belongs to a group of medicines called beta-blockers.
Timolol jifforma parti minn grupp ta ’ mediċini magħrufa bħala mblokkaturi tar- riċetturi beta.
GANFORT is prescribed to reduce high pressure in the eye.
GANFORT jingħata fuq riċetta tat- tabib biex tnaqqas il- pressjoni għolja fl- għajn.
Your eye contains a clear, watery liquid that feeds the inside of the eye.
Għajnejk fiha likwidu ċar li jsostni l- parti ta ’ ġewwa ta ’ l- għajn.
Liquid is constantly being drained out of the eye and new liquid is made to replace this.
Il- likwidu joħroġ kontinwament mill - għajn u likwidu ġdid jiġi magħmul biex jeħodlu postu.
If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight.
Jekk il- likwidu ma joħroġx malajr biżżejjed, tiżdied il- pressjoni fuq il- parti ta ’ ġewwa ta 'l- għajn u tista' eventwalment tkun ta ’ dannu għall- vista tiegħek.
GANFORT works by reducing the production of liquid and also increasing the amount of liquid that is drained.
GANFORT jaħdem billi jnaqqas il- produzzjoni ta ’ likwidu kif ukoll billi jżid l- ammont ta ’ likwidu li jitneħħa.
This reduces the pressure inside the eye.
Dan inaqqas il- pressjoni fil- parti ta ’ ġewwa ta ’ l- għajn.
BEFORE YOU USE GANFORT
QABEL MA TUŻA GANFORT
Do not use GANFORT:
Tużax GANFORT:
- if you are allergic (hypersensitive) to bimatoprost, timolol or any of the other ingredients of
- jekk int allerġiku/ a (tbagħti minn sensittività eċċessiva) għal bimatoprost, timolol jew sustanzi
GANFORT
oħra ta ’ GANFORT.
- if you have any breathing illnesses such as asthma or a history of asthma, or severe chronic
- jekk għandek xi problemi biex tieħu n- nifs bħall- ażma jew jekk fil- passat kont tbati bl- ażma,
obstructive lung disease
jew b’ marda kronika ostruttiva tal- pulmun
- if you have heart problems such as heart weakness or heart beat disorders
- jekk għandek problemi tal- qalb bħal debolezza tal- qalb jew disturbi fit- taħbit tal- qalb
Take special care with GANFORT:
Oqgħod attent ħafna b’ GANFORT:
Before you use this medicine, tell your doctor
Qabel ma tuża din il- mediċina, għid lit- tabib tiegħek
- if you have now or have had in the past
- jekk għandek issa jew jekk kellek fil- passat
• heart, blood pressure or breathing problems • overactivity of the thyroid • diabetes or low blood sugar levels (hypoglycaemia) • severe allergic reactions • liver or kidney problems • known risk factors for macular oedema (swelling of the retina within the eye leading to worsening vision), for example, cataract surgery
• problemi tal- qalb, fil- pressjoni jew tan- nifs • attività żejda tat- tirojde • dijabete jew livelli baxxi taz- zokkor fid- demm (ipogliċemija) • reazzjonijiet allerġiċi severi • problemi fil- fwied jew fil- kliewi • riskju ta ’ ‘ macular oedema ’ (bħall tintefaħ ir- retina u tmur lura il- vista) per eżempju operazzjoni biex tneħħi il- katarretti.
20 GANFORT may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too.
20 GANFORT jista ’ jikkawża skurament u żjieda fit- tul tax- xagħar ta ’ xfar il- għajn, u jikkawża ukoll skurament tal- ġilda tal- kappell ta ’ l- għajn.
The colour of your iris may also go darker over time.
Il- kulur tal- ħabba ta ’ l- għajn tista ’ tiskura wkoll fuq perijodu ta ’ żmien.
These changes may be permanent.
Dawn il- bidliet jistgħu jkunu permanenti.
The change may be more noticeable if you are only treating one eye.
Il- bidla tista ’ tkun aktar evidenti meta l - kura ssir fuq għajn waħda biss.
GANFORT should not be used in people under 18 unless your doctor still recommends it.
Persuni taħt it- 18- il sena m' għandhomx jużaw GANFORT sakemm ma jkunx rrakkomandat mit- tabib tiegħek.
If you use GANFORT with another eye medicine, leave at least 5 minutes between putting in GANFORT and the other medicine.
Jekk tuża GANFORT flimkien ma ’ mediċina oħra ta ’ l- għajnejn, ħalli mill- anqas 5 minuti bejn l- użu ta 'GANFORT u l- mediċina l- oħra.
Use any eye ointment or eye gel last.
Ħalli xi dlik jew ġel ta ’ l- għajnejn għall- aħħar.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u Treddigħ Itlob għall- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel ma tieħu xi mediċina.
Tell your doctor if you are pregnant or planning to become pregnant.
Għid lit- tabib jekk inti tqila jew qiegħda tippjana li tinqabad tqila.
GANFORT should not be used during pregnancy unless your doctor still recommends it.
GANFORT ma għandux jintuża waqt it- tqala ħlief f’ kazijiet fejn it- tabib tiegħek xorta waħda jirrakkomandalek l- użu tiegħu.
GANFORT should not be used if you are breast-feeding.
GANFORT ma għandux jintuża jekk qed tredda ’.
Driving and using machines GANFORT may cause blurred vision in some patients.
Sewqan u tħaddim ta ’ magni Il- vista tiegħek tista ’ ssir ftit imċajpra għal ftit ħin hekk kif tuża GANFORT.
Do not drive or use machinery until the symptoms have cleared.
M’ għandekx issuq jew tħaddem xi magni qabel ma terġa ’ tiċċaralek il- vista.
Important information about some of the ingredients of GANFORT Do not use the drops while your contact lenses are in your eyes.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ GANFORT Tużax il- qtar waqt li tkun liebes il- lentijiet tal- kuntatt.
Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes.
Stenna mqar 15- il minuta wara li tkun użajt qtar ta ’ l- għajnejn, qabel ma terġa tqiegħed il- lentijiet tal- kuntatt lura f’ għajnejk.
A preservative in GANFORT (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.
Preservattiv f’ GANFORT (benzalkonium chloride) jista ’ jikkawża iritazzjoni fl- għajn u huwa magħruf ukoll li jibdel il- kulur ta ’ lentijiet tal- kuntatt rotob.
HOW TO USE GANFORT
KIF GĦANDEK TUŻA GANFORT
Always use GANFORT exactly as your doctor has told you.
Dejjem għandek tuża GANFORT skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew l- ispiżjar tiegħek jekk ikollok xi dubju.
The usual dose is one drop in the morning in each eye that needs treatment.
Id- doża li ssoltu tingħata hija qatra waħda f’ kull għajn li teħtieġ il- kura, filgħodu.
However, your doctor may recommend you apply the drop in the evening instead.
Madanakollu, t- tabib tiegħek jista ’ jirrakkomandalek li tapplika il- qatra filgħaxija minflokk.
Instructions for use You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
Istruzzjonijiet għall- użu M’ għandekx tuża l- flixkun jekk is- siġill ta ’ sigurtà fl- għonq tal- flixkun ikun miksur qabel ma tkun bdejt tużah għall- ewwel darba.
Tilt your head back and look at the ceiling.
Mejjel rasek lura u ħares lejn is- saqaf.
Gently pull down the lower eyelid until there is a small pocket.
Bil- mod niżżel l- isfel tebqet il- għajn t’ isfel sakemm ikun hemm spazju żgħir.
Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
Aqleb il- flixkun rasu l- isfel u agħfsu sakemm toħroġ qatra waħda f’ kull għajn li teħtieġ il- kura.
Let go of the lower lid, and close your eye for 30 seconds.
Itlaq tebqet il- għajn t’ isfel u agħlaq għajnejk għal 30 sekonda.
If a drop misses your eye, try again.
21 Jekk xi qatra ma tidħolx f’ għajnejk, erġa ’ pprova.
To avoid contamination, do not let the tip of the bottle touch your eye or anything else.
Biex tevita kontaminazzjoni, tħallix il- parti ta ’ fuq tal- flixkun tmiss m’ għajnejk jew ma ’ x’ imkien ieħor.
Put the cap back on and close the bottle straight after you have used it.
Poġġi l- għatu f’ postu u agħlaq il- flixkun mill- ewwel wara li tkun użajtu.
21 If you use more GANFORT than you should If you use more GANFORT than you should, it is unlikely to cause you any serious harm.
Jekk tuża GANFORT aktar milli suppost, mhux suppost li għandu jikkaġunalek xi danni serji.
Put your next dose in at the usual time.
Qattar id- doża li jmiss fil- ħin tas- soltu.
If you are worried, talk to your doctor or pharmacist.
Jekk int inkwetat, kellem lit- tabib jew lill- ispiżjar tiegħek.
If you forget to use GANFORT If you forget to use GANFORT, use a single drop as soon as you remember, and then go back to your regular routine.
Jekk tinsa tuża GANFORT Jekk tinsa tuża GANFORT, qattar qatra waħda hekk kif tiftakar, imbagħad erġa ’ dur għar- rutina regolari tiegħek.
Do not use a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using GANFORT GANFORT should be used every day to work properly.
Jekk tieqaf tuża GANFORT GANFORT għandu jintuża kuljum biex jaħdem kif suppost.
Like all medicines, GANFORT can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, GANFORT jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The chance of having a side effect is described by the following categories:
Il- possibilità li jkollu effetti sekondarji huwa deskritt mill- kategoriji segwenti:
Very common Common Uncommon Not known
Komuni ħafna Komuni Mhux komuni Mhux magħruf
May occur in more than one person in every 10 people Occurs in up to nine people in every 100 people Occurs in up to nine people in every 1000 people Cannot be estimated from the available data
Jista jseħħ f’ iżjed minn pazjent wieħed minn kull 10 pazjenti Iseħħ sa f’ disgħa pazjenti minn kull 100 pazjent Iseħħ sa f’ disgħa pazjenti minn kull 1000 pazjent Ma tistax tittieħed stima mid- data disponibbli
The following eye side effects may be seen with GANFORT:
fil- għajn, li ġejjin, jistgħu jidhru b’ GANFORT:
eye redness, longer eyelashes
ħmura fl- għajn, żjieda fit- tul tax- xagħar ta ’ xfar il- għajn
burning, itching, stinging, sensitivity to light, eye pain, sticky eyes, dry eyes, a feeling of something in the eye, small breaks in the surface of the eye with or without inflammation, difficulty in seeing clearly, redness and itching of the eyelids, darkening of the eyelids
ħruq, ħakk, tingiż, sensittività għad- dawl, uġigħ fl- għajn, għajnejn iwaħħlu, għajnejn nexfin, sensazzjoni li hemm xi ħaġa f’ għajnejk, qasmiet żgħar fil- wiċċ ta ’ l- għajn b’ infjammazzjoni jew mingħajrha, diffikultajiet fil- vista, ħmura u ħakk fil - kappell ta ’ l- għajn, skurament tal- kappell ta ’ l- għajn
watery eyes, swollen or painful eyelids, tired eyes, in-growing eyelashes, headache, runny nose, hair growing around the eye
għajnejn idemmgħu, uġigħ jew nefħa fil- kappell ta ’ l- għajn, għajnejn għajjenin, xagħar ta ’ xfar il- għajn li jikbru ‘ l ġewwa, uġigħ ta ’ ras, imnieħer inixxi, jikber xagħar madwar il- għajn
cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
edema makulari fiċ- ċistojde (bħall tintefaħ ir- retina u tmur lura il- vista)
The following side effects have been seen with bimatoprost or timolol and so may possibly be seen with GANFORT:
L- effetti sekondarji li ġejjin dehru b’ bimatoprost jew b’ timolol u għalhekk jistgħu jidhru b’ GANFORT:
Allergic reaction in the eye, cataract, darkening of the eyelashes, darkening of the iris colour, dizziness, high blood pressure, an increase in blood test results that show how your liver is working, cold, effects on the heart beat, heart failure, increased heart rate, low blood pressure, skin rash, cough, dry mouth, hair loss, nightmares, reduced sexual urge, memory loss, tiredness, ringing in the ears and a worsening of myasthenia gravis (increased muscle weakness).
Reazzjoni allerġika fl- għajn, katarretti, skurament tax- xagħar ta ’ xfar il- għajn, skurament tal- kulur tal- ħabba ta ’ l- għajn, sturdament, pressjoni għolja tad- demm, żjieda fir- riżultati tat- testijiet tad- demm li juru kif qiegħed jaħdem il- fwied, riħ, effetti fuq it- tħabbit tal- qalb, insuffiċjenza tal- qalb, tħabbit tal- qalb aktar mgħaġġel, pressjoni baxxa tad- demm, raxx tal- ġilda, sogħla, nixfa fil- ħalq, telf ta ’ xagħar, inkubi, xewqa sesswali mnaqqsa, telf ta ’ memorja, għejja, tisfir fil- widnejn u myasthenia gravis li tmur għall- agħar (żjieda fid- dgħjufija tal- muskoli).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE GANFORT
KIF TAĦŻEN GANFORT
Do not use GANFORT after the expiry date which is stated on the bottle label and the carton after EXP:.
Tużax GANFORT wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- flixkun u fuq il- kaxxa wara JIS:.
The expiry date refers to the last day of that month.
Id- Data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jinħtieġx kundizzjonijiet speċjali għall- ħażna.
Once opened, solutions may become contaminated, which can cause eye infections.
La darba jinfetħu, is- soluzzjonijiet jistgħu jiġu kkontaminati, u dan jista ’ jikkawża infezzjonijiet fl - għajn.
Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left.
Għalhekk, għandek tarmi l- flixkun 4 ġimgħat wara li tkun ftaħtu l- ewwel darba, anke jekk ikun għad fadal xi soluzzjoni.
To help you remember, write down the date that you opened it in the space on the carton.
Biex ma tinsiex, ikteb id- data ta 'meta ftaħtu fl- ispazju li hemm provdut fuq il- kaxxa.
What GANFORT contains
X’ fih GANFORT
• The active substances are bimatoprost 0.3 mg/ ml and timolol 5 mg/ ml corresponding to timolol maleate 6.8 mg/ ml.
• Is- sustanzi attivi huma bimatoprost 0. 3 mg/ ml u timolol 5 mg/ ml li jikkorrispondi għal timolol maleate 6. 8 mg/ ml.
• The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
• Is- sustanzi l- oħra huma benzalkonium chloride (preservattiv), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate u ilma purifikat.
Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH level.
Ammonti żgħar ta ’ hydrochloric acid jew sodium hydroxide jistgħu jkunu miżjuda biex iġibu s- soluzzjoni fil - livell korrett ta ’ pH.
What GANFORT looks like and contents of the pack GANFORT is a colourless, clear eye drop solution in a plastic bottle.
GANFORT hu soluzzjoni ta ’ qtar għall- għajnejn, ċara, mingħajr kulur li jinsab fi flixkun tal- plastik.
Each pack contains either 1 or 3 plastic bottles each with a screw-cap.
Kull pakkett ikun fih jew flixkun 1 jew 3 fliexken tal- plastik, kull wieħed b’ għatu tal- kamin.
Each bottle is about half full and contains 3 millilitres of solution.
Kull flixkun ikun mimli sa madwar nofsu u fih 3 millilitri ta ’ soluzzjoni.
This is enough for 4 weeks’ usage.
Dan hu biżżejjed għall- użu fuq perijodu ta ’ 4 ġimgħat.
Mayo Ireland
Allergan Pharmaceuticals Ireland Castlebar Road Westport Co Mayo Irlanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Suspension for injection
Sospensjoni għal injezzjoni
Intramuscular use
Għal użu ġol- muskoli
1 pre-filled syringe + 1 needle
1 siringa mimlija għal- lest + 1 labra
10 pre-filled syringes + 10 needles
10 siringi mimlijin għal- lest + 10 labriet
1 pre-filled syringe + 2 needles
1 siringa mimlija għal- lest + 2 labriet
10 pre-filled syringes + 20 needles
10 siringi mimlijin għal- lest + 20 labra
1 pre-filled syringe with needle guard
1 siringa mimlija għal- lest b’ għant tal- labra
10 pre-filled syringes with needle guard
10 siringi mimlijin għal- lest b’ għant tal- labra
20 pre-filled syringes with needle guard
20 siringa mimlija għal- lest b’ għant tal- labra
1 pre-filled syringe with needle guard + 1 needle
1 siringa mimlija għal- lest b’ għant tal- labra + 1 labra
10 pre-filled syringes with needle guard + 10 needles
10 siringi mimlijin għal- lest b’ għant tal- labra + 10 labriet
20 pre-filled syringes with needle guard + 20 needles
20 siringa mimlija għal- lest b’ għant tal- labra + 20 labra
1 pre-filled syringe with needle guard + 2 needles
1 siringa mimlija għal- lest b’ għant tal- labra + 2 labriet
10 pre-filled syringes with needle guard + 20 needles
10 siringi mimlijin għal- lest b’ għant tal- labra + 20 labra
20 pre-filled syringes with needle guard + 40 needles
20 siringa mimlija għal- lest b’ għant tal- labra + 40 labra
20 pre-filled syringes
20 siringa mimlija għal- lest
20 pre-filled syringes + 20 needles
20 siringa mimlija għal- lest + 20 labra
20 pre-filled syringe + 40 needles
20 siringa mimlija għal- lest + 40 labra
1 dose (0.5 ml) contains
doża 1 (0. 5 ml) fiha bejn
approximately:
wieħed u ieħor:
Human Papillomavirus¹ Type 6 L1 protein², ³ Human Papillomavirus¹ Type 11 L1 protein², ³ Human Papillomavirus¹ Type 16 L1 protein², ³ Human Papillomavirus¹ Type 18 L1 protein², ³
Papillomavirus Uman1 Proteina tip 6 L12, 3 Papillomavirus Uman1 Proteina tip 11 L12, 3 Papillomavirus Uman1 Proteina tip 16 L12, 3 Papillomavirus Uman1 Proteina tip 18 L12, 3
20 micrograms 40 micrograms 40 micrograms 20 micrograms
20 mikrogramma 40 mikrogramma 40 mikrogramma 20 mikrogramma
² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
¹ Papillomavirus Uman = HPV ² L1 proteina fis- sura ta 'partikuli qishom virus prodotti fiċ- ċelluli tal- moffa (Saccharomyces cerevisiae CANADE 3C- 5 (Speċi 1895)) minn teknoloġija DNA rikombinanti ³ adsorbit fuq amorphous aluminium hydroxyphosphate sulphate adjuvant (225 mikrogramma Al)
What is Gardasil?
X’ inhu Gardasil?
Gardasil is a vaccine.
Gardasil huwa vaċċin.
It is a suspension for injection that contains purified proteins from four types of the human papillomavirus (types 6, 11, 16 and 18).
Huwa sospensjoni għall- injezzjoni li fiha proteini ppurifikati minn erba ’ tipi ta ’ papillomavirusis tal- bniedem (tipi 6, 11, 16 u 18).
What is Gardasil used for?
Għalxiex jintuża Gardasil?
Gardasil is used to vaccinate against precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina), cancer of the cervix and genital warts that are caused by infection with the human papillomavirus (HPV) types 6, 11, 16 or 18.
Gardasil jintuża biex ilaqqam kontra leżjonijiet ta ’ qabel il- kanċer (żvilupp anormali ta ’ ċelloli) fiż - żona ġenitali (ċerviċi, vulva jew vaġina), kanċer taċ- ċerviċi u felul ġenitali li huma kkaġunati b’ infezzjoni minn papillomavajrus tal- bniedem (HPV) tipi 6, 11, 16 jew 18.
The effectiveness of Gardasil has been studied in women aged 16 to 26 years, and its immunogenicity (its ability to make the immune system respond to the viruses) has been studied in children and adolescents aged nine to 15 years.
L- effikaċja ta ’ Gardasil ġiet studjata f’ nisa b’ età ta ’ bejn 16 u 26 sena, u l- immunoġeniċità tiegħu (l- abbilità tiegħu li jġiegħel lis- sistema immunitarja tirrispondi għal vajrusijiet) ġiet studjata fi tfal u adoloxxenti b’ età ta ’ bejn disa ’ u 15- il sena.
Its protective effectiveness has not been studied in males.
L- effikaċja protettiva tiegħu ma ġietx studjata fl- irġiel.
Gardasil is given according to official recommendations.
Gardasil jingħata skond rakkomandazzjonijiet uffiċjali.
How is Gardasil used?
Kif jintuża Gardasil?
Gardasil is given to individuals aged nine years or older, as three doses, with two months between the first and second doses, and four months between the second and third doses.
Gardasil jingħata lill- individwi li għandhom disa ’ snin u iktar, bħala tliet dożi, b’ xahrejn bejn l- ewwel u t- tieni dożi, u erba ’ xhur bejn it- tieni u t- tielet doża.
If a different schedule is needed, there should be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Jekk tkun meħtieġa skeda differenti, għandu jkun hemm ta ’ l- inqas xahar bejn l- ewwel u t- tieni doża, jew ta ’ l- inqas tliet xhur bejn it- tieni u t- tielet doża, u d- dożi kollha għandhom jingħataw fi żmien sena.
It is recommended that individuals who receive the first dose of Gardasil should complete all three doses with Gardasil.
Huwa rrakkomandat li individwi li jirċievu l- ewwel doża ta ’ Gardasil għandhom ikomplu t- tliet dożi kollha b’ Gardasil.
The vaccine is given as an injection into a muscle, preferably in the upper arm or the thigh.
Il- vaċċin jingħata bħala injezzjoni ġewwa muskolu, preferibbilment fin- naħa ta ’ fuq tad- driegħ jew fil- koxxa.
How does Gardasil work?
Kif jaħdem Gardasil?
Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Papillomavirusis huma vajrusijiet li jikkaġunaw felul u żvilupp mhux normali tat- tessuti.
There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Hemm iktar minn 100 tip ta ’ papillomavirus, xi wħud mil- liema huma assoċjati ma ’ kanċers ġenitali.
HPV types 16 and 18 cause approximately 70% of cervical cancers and HPV types 6 and 11 cause approximately 90% of genital warts.
HPV tipi 16 u 18 jikkaġunaw 70% ta ’ kanċers ċervikali u HPV tipi 6 u 11 jikkaġunaw madwar 90% ta ’ felul ġenitali.
All papillomaviruses have a shell, or ‘ capsid’, that is made up of proteins called ‘ L1 proteins’.
Il- papillomavirusis kollha għandhom qoxra, jew ‘ kapsid ’, li hija magħmula minn proteini msejħin ‘ proteini L1 ’.
Gardasil contains the purified L1 proteins for four of the types of human papillomavirus: types 6, 11, 16, and 18.
Gardasil fih proteini L1 ippurifikati ta ’ erba ’ tipi ta ’ papillomavirus tal- bniedem: tipi 6, 11, 16, u 18.
The proteins in Gardasil are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the L1 proteins.
Huma magħmulin minn ħmira li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini L1.
Reproduction is authorised provided the source is acknowledged. that the body can recognise them easily).
Reproduction is authorised provided the source is acknowledged. ġisem ikun jista ’ jagħrafhom faċilment).
The vaccine also contains an ‘ adjuvant ’ (a compound containing aluminium) to stimulate a better response.
Il- vaċċin fih ukoll ‘ aġġuvant ’ (taħlita li fiha l- aluminju) biex jistimola rispons aħjar.
When a patient is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these proteins.
Meta pazjent jingħata l- vaċċin, is- sistema immunitarja (is- sistema li tiġġieled il- mard) tagħmel antikorpi kontra dawn il- proteini.
The antibodies help to block the virus from infecting cells in the body.
L- antikorpi jgħinu biex jimblokkaw il- vajrus milli jinfetta ċ- ċelloli fil- ġisem.
After vaccination, the immune system is able to produce antibodies quickly when it is exposed to the real viruses.
Wara t- tilqima, is- sistema immunitarja tkun kapaċi tipproduci antikorpi malajr meta tkun esposta għall- vajrusijiet ta ’ vera.
This will help to protect against the diseases caused by these viruses.
Dan jgħin biex jipproteġi kontra l- mard ikkaġunat minn dawn il - vajrusijiet.
How has Gardasil been studied?
Kif ġie studjat Gardasil?
The effects of Gardasil were first tested in experimental models before being studied in humans.
L- effetti ta ’ Gardasil għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The four main studies in humans involved almost 21,000 women aged between 16 and 26 years.
L- erba ’ studji ewlenin fil- bnedmin involvew kważi 21, 000 mara b’ età ta ’ bejn 16 u 26 sena.
Gardasil was compared with placebo (a dummy vaccine).
Gardasil tqabbel ma ’ plaċebo (vaċċin finta).
The studies looked at how many women developed genital lesions or warts that were due to HPV infection.
L- istudji ħarsu lejn kemm nisa żviluppaw leżjonijiet ġenitali jew felul minħabba infezzjoni b’ HPV.
The women were followed up for around three years after the third dose of the vaccine.
In- nisa kienu segwiti għal madwar tliet snin wara t - tielet doża tal- vaċċin.
What benefit has Gardasil shown during the studies?
Liema benefiċċju wera Gardasil waqt l- istudji mwettqa?
Gardasil was effective against precancerous genital lesions of the cervix, vulva and vagina, cervical cancer, and warts related to HPV types 6, 11, 16 and 18.
Gardasil kien effettiv kontra leżjonijiet ġenitali ta ’ qabel il- kanċer taċ- ċerviċi, vulva u vaġina, kanċer taċ- ċerviċi, u felul relatat ma ’ HPV tipi 6, 11, 16 u18.
Looking at the results of all four studies together, in women who had never been infected by HPV types 6, 11, 16 or 18 before, and who received the full course of vaccination, one woman out of over 8,000 vaccinated with Gardasil developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Meta wieħed iħares lejn ir- riżultati ta ’ l- erba ’ studji flimkien, f’ nisa li qatt qabel ma kienu infettati b’ HPV tipi 6, 11, 16 jew18, u li rċievew il- kors sħiħ tat- tilqim, mara waħda minn aktar minn 8, 000 imlaqqma b’ Gardasil żviluppat leżjoni ta ’ qabel il- kanċer fiċ- ċerviċi li setgħet seħħet minħabba HPV tip 16 jew 18.
In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
F’ kuntrast, 85 minn iktar min 8, 000 mara li rċievew vaċċin plaċebo żviluppaw leżjonijiet li kienu minħabba dawn iż- żewġ tipi ta ’ HPV.
A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Effett simili ta ’ Gardasil deher meta l- analiżi inkludew ukoll leżjonijiet taċ- ċerviċi minħabba ż- żewġ tipi l- oħra ta ’ HPV (tipi 6 u 11).
For external genital lesions due to HPV types 6, 11, 16 or 18 (including warts and precancerous lesions of the vulva or the vagina), the results of three of the studies were looked at together.
Għal leżjonijiet ġenitali esterni minħabba HPV tipi 6, 11, 16 jew 18 (inkluż felul u leżjonijet ta ’ qabel il- kanċer tal- vulva jew il- vaġina), ir- riżultati ta ’ tlieta mill- istudji ġew analizzati f’ daqqa.
Two women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Fil- grupp ta ’ Gardasil żewġ nisa minn kważi 8, 000 żviluppaw felul ġenitali, u ma kien hemm l- ebda każ ta ’ leżjonijiet ta ’ qabel il- kanċer tal- vulva u l- vaġina.
In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
B’ kuntrast, kien hemm total ta ’ 189 każ ta ’ leżjonijiet ġenitali esterni minn kważi 8, 000 mara fil- grupp tal- plaċebo.
What is the risk associated with Gardasil?
X’ inhu r- riskju assoċjat ma ’ Gardasil?
In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were pyrexia (fever) and reactions at the site of the injection (redness, pain and swelling).
Fl- istudji, l- iktar effetti sekondarji komuni b’ Gardasil (li dehru f' iktar minn pazjent 1 minn kull 10) kienu deni u reazzjonijiet fis- sit ta ’ l- injezzjoni (ħmura, uġigħ u nefħa).
For the full list of all side effects reported with Gardasil, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtati b’ Gardasil, ara l- Fuljett ta ’ Tagħrif.
Gardasil should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Gardasil m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għas- sustanza attiva jew għal xi sustanza oħra tiegħu.
If a patient shows signs of an allergy after a dose of Gardasil, she should not receive further doses of the vaccine.
Jekk pazjenta turi sinjali ta ’ allerġija wara doża ta ’ Gardasil, m’ għandhiex tingħata iktar dożi tal- vaċċin.
Vaccination should be postponed in patients who are ill with a high fever.
It- tilqima għandha tiġi posposta f’ pazjenti li jkunu ma jifilħux b’ deni għoli.
Why has Gardasil been approved?
Għaliex ġie approvat Gardasil?
The Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil’ s benefits are greater than its risks as a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to HPV types 6, 11, 16 and 18.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Gardasil huma ikbar mir- riskji tiegħu għall- prevenzjoni ta ’ leżjonijiet ġenitali premalinni (ċervikali, vulvari u vaġinali), kanċer taċ- ċerviċi u felul ġenitali estern (kondiloma akuminata) kawżalment relatati ma ’ HPV tipi 6, 11, 16 u 18.
The Committee recommended that Gardasil be given marketing authorisation.
Il- Kumitat irrakkomanda li Gardasil jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Gardasil:
Informazzjoni oħra dwar Gardasil:
The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil to Sanofi Pasteur MSD SNC on 20 September 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Gardasil lill- kumpanija Sanofi Pasteur MSD SNC fl- 20 ta ’ Settembru 2006.
The full EPAR for Gardasil can be found here.
L- EPAR sħiħ għal Gardasil jista ’ jinstab hawn.
Gardasil, suspension for injection.
Gardasil, sospensjoni għall- injezzjoni.
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit).
1 dose (0.5 ml) contains approximately:
Doża waħda (0. 5 ml) fiha madwar:
Human Papillomavirus1 Type 6 L1 protein2,3 Human Papillomavirus1 Type 11 L1 protein2,3 Human Papillomavirus1 Type 16 L1 protein2,3 Human Papillomavirus1 Type 18 L1 protein2,3 1 Human Papillomavirus = HPV.
2
2
20 mikrogramma 40 mikrogramma 40 mikrogramma 20 mikrogramma
L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
L1 proteina fis- sura ta 'partikuli qishom virus prodotti fiċ- ċelluli tal- moffa (Saccharomyces cerevisiae CANADE 3C- 5 (Speċi 1895)) minn teknoloġija DNA rikombinanti.
3 adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al).
3 adsorbit fuq amorphous aluminium hydroxyphosphate sulphate adjuvant (225 mikrogramma Al).
Suspension for injection.
Sospensjoni għall- injezzjoni.
Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate.
Qabel ma jitħawwad, Gardasil jista 'jidher bħala likwidu ċar bi preċipitat abjad.
After thorough agitation, it is a white, cloudy liquid.
Wara li jitħawwad sewwa, isir likwidu abjad u mċajpar.
Gardasil is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).
Gardasil hu vaċċin għall- prevenzjoni ta ’ leżjonijiet ġenitali malinni minn qabel (ċervikali, vulvari u vaġinali), kanċer ċervikali u felul ġenitali esterni (condyloma acuminata) li l- kawża tiegħu hi marbuta mal- Papillomavirus Uman (HPV) tat- tipi 6, 11, 16 u 18 (ara sezzjoni 5, 1).
The indication is based on the demonstration of efficacy of Gardasil in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents.
L- indikazzjoni hi bbażata fuq it- turija ta ’ l- effikaċja ta ’ Gardasil f’ nisa adulti ta ’ età ta ’ bejn is- 16 u s - 26 sena u fuq it- turija ta ’ l- immunoġeniċità ta ’ Gardasil fi tfal u adolexxenti ta ’ bejn id- 9 u l- 15- il sena.
Protective efficacy has not been evaluated in males (see section 5.1).
L- effikaċja protettiva ma kienitx evalwata fl- irġiel (ara sezzjoni 5. 1).
The use of Gardasil should be in accordance with official recommendations.
Gardasil għandu jintuża skond ir- rakkomandazzjonijiet uffiċjali.
The primary vaccination series consists of 3 separate 0.5 ml doses administered according to the following schedule:
Is- serje tat- tilqim primarju tikkonsisti fi 3 dożi separati ta ’ 0. 5 ml mogħtija skond l- iskeda li ġejja:
0, 2, 6 months.
0, 2, u 6 xhur.
If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Jekk skeda alternattiva tat- tilqim tkun meħtieġa, it- tieni doża għandha tingħata mill- inqas xahar wara l- ewwel doża u t- tielet doża għandha tingħata mill- inqas 3 xhur wara t- tieni doża.
All three doses should be given within a 1-year period.
It- tliet dożi għandhom jingħataw fi żmien sena.
The need for a booster dose has not been established.
Il- ħtieġa għal doża booster ma kienitx stabblita.
2 Paediatric population:
2 Popolazzjoni pedjatrika:
Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy (see section 5.1).
Gardasil mhux rakkomandat għall- użu fit- tfal taħt il- 9 sena għax m’ hemmx biżżejjed informazzjoni dwar l- immunoġeniċità, is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
The vaccine should be administered by intramuscular injection.
Il- vaċċin għandu jingħata permezz ta ’ injezzjoni ġol- muskoli.
The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Is- sit preferit huwa ż- żona tad- deltojd fin- naħa ta ’ fuq tad- driegħ jew fiż- żona anterolaterali ogħla tal- koxxa.
Gardasil must not be injected intravascularly.
Gardasil m’ għandux jiġi injettat intravaskularment.
Neither subcutaneous nor intradermal administration has been studied.
La amministrazzjoni taħt il- ġilda u lanqas amministrazzjoni fil- ġilda ma ġiet studjata.
These methods of administration are not recommended (see section 6.6).
Dawn il- metodi ta ’ amministrazzjoni mhumiex rakkomandati (ara sezzjoni 6. 6).
It is recommended that subjects who receive a first dose of Gardasil complete the 3-dose vaccination course with Gardasil (see section 4.4).
Huwa rrakomandat li suġġetti li jirċievu l- ewwel doża ta ’ Gardasil jtemmu l- kors ta ’ tilqim ta ’ 3 dożi b’ Gardasil (ara sezzjoni 4. 4).
Hypersensitivity to the active substances or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.
Individwi li jiżviluppaw sintomi ta ’ sensittività eċċessiva wara li jirċievu doża ta ’ Gardasil m’ għandhomx jirċievu dożi addizzjonali ta ’ Gardasil.
Administration of Gardasil should be postponed in subjects suffering from an acute severe febrile illness.
L- għoti ta ’ Gardasil għandu jkun pospost f’ pazjenti li jbatu minn mard b’ deni serju u akut.
However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.
Madankollu, il- preżenza ta ’ infezzjoni minuri, bħal infezzjoni ħafifa fl- apparat respiratorju ta ’ fuq jew deni mhux qawwi, mhix kontra- indikazzjoni għall- immunizzazzjoni.