qanastek/EMEA-V3 huggingface dataset:
265 If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”). • Always keep a spare pen and cartridges of Liprolog Mix50, in case you lose your KwikPen or it gets damaged. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu). • Dejjem żomm pinna u stoċċijiet żejda ta 'Liprolog Mix50, fil- każ li titlef il- KwikPen jew jew jiġrilha xi ħsara. • Dejjem żomm xi ħaġa fuqek biex turi li inti dijabetiku. • Dejjem żomm iz- zokkor fuqek.
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.
283 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Illness If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change.
284 Jekk int ma tiflaħx, speċjalment jekk qed tħossok imdardar jew jekk inti mdardar, l- ammont ta 'insulina li għandek bżonn tista' tinbidel.
HOW TO STORE LIPROLOG MIX50 KWIKPEN
KIF TAĦŻEN LIPROLOG MIX50 KWIKPEN
Before the first use store your Liprolog Mix50 KwikPen in a refrigerator (2°C – 8°C).
Qabel ma tużaha l- ewwel darba żomm il- Liprolog Mix50 KwikPen fi friġġ (2°C- 8°C).
Keep your Liprolog Mix50 KwikPen in use at room temperature (below 30°C) for up to 28 days.
Żomm il- Liprolog Mix50 KwikPen li ħa tuża f' temperatura ambjentali ta 'ġewwa (taħt 30°C) għal użu sa 28 ġurnata.
Do not use Liprolog Mix50 KwikPen after the expiry date which is stated on the label and the carton.
Tużax il- Liprolog Mix50 KwikPen wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
Do not use Liprolog Mix50 KwikPen, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.
Tużax il- Liprolog Mix50 KwikPen jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb ta ’ l- istoċċ, u jidher qiesu ġelu.
What Liprolog Mix50 100 U/ml KwikPen, suspension for injection contains
X’ fiha Liprolog Mix50 100 U/ ml KwikPen suspensjoni għal injezzjoni:
50% of the
Id- Dehra ta ’ Liprolog Mix50 100 U/ ml KwikPen, suspensjoni għal injezzjoni u l- kontenuti tal - pakkett:
267 insulin lispro in Liprolog Mix50 is dissolved in water.
Liprolog Mix50 100 U/ ml KwikPen, suspensjoni għall- injezzjoni, hu suspensjoni abjad u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) suspensjoni għal injezzjoni.
Each Liprolog Mix50 KwikPen contains 300 units (3 millilitres).
Kull Liprolog Mix50 KwikPen fiha 300 unità (3 millilitri).
The Liprolog Mix50 KwikPen comes in a pack of 5 pre -filled pens or a multipack of 2 x 5 pre-filled pens.
Il- Liprolog Mix50 KwikPen tiġi f’ pakketti ta ’ 5 pinen mimlijin għal- lest jew f’ pakkett multiplu ta ’ 2 x 5 pinen mimlijin għal- lest.
The Liprolog Mix50 in your pre -filled pen is the same as the Liprolog Mix50, which comes in separate Liprolog Mix50 cartridges.
Il- Liprolog Mix50 fil- pinna mimlija għal- lest tiegħek hi l- istess bħall- Liprolog Mix50 li jiġi fl- istoċċijiet separati ta ’ Liprolog Mix50.
Marketing Authorisation Holder and Manufacturer Liprolog Mix50 100 U/ml KwikPen, suspension for injection is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Lilly Pharma Fertigung und Distribution GmbH & Co.
285 • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Lilly Pharma Fertigung und Distribution GmbH & Co.
Italia Eli Lilly Italia S.p.A.
286 Eli Lilly Italia S. p. A.
Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Oy Eli Lilly Finland Ab Puh/ Tel: + 358 - (0) 9 85 45 250
269 PACKAGE LEAFLET:
287 FULJETT TA ’ TAGĦRIF:
Liprolog Basal 100 U/ml KwikPen, suspension for injection (insulin lispro)
Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni (insulina lispro)
What Liprolog Basal KwikPen is and what it is used for 2.
X’ inhi Liprolog Basal KwikPen u għalxiex tintuża 2.
Before you use Liprolog Basal KwikPen 3.
Qabel ma tuża Liprolog Basal KwikPen 3.
How to use Liprolog Basal KwikPen 4.
Kif għandek tuża Liprolog Basal KwikPen 4.
How to store Liprolog Basal KwikPen 6.
Kif taħżen Liprolog Basal KwikPen 6.
WHAT LIPROLOG Basal KWIKPEN IS AND WHAT IT IS USED FOR
X’ INHI LIPROLOG BASAL KWIKPEN U GĦALXIEX TINTUŻA
Liprolog Basal KwikPen is used to treat diabetes.
Liprolog Basal KwikPen hija użata biex id- dijabete tiġi trattata.
The insulin lispro in Liprolog Basal KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.
L- insulina lispro f’ Liprolog Basal KwikPen hija suspensjoni flimkien ma 'protamine sulphate, ħalli l - azzjoni tagħha tkun mtawwla.
Liprolog Basal is a substitute for your own insulin and is used to control glucose in the long term.
Liprolog Basal huwa sostitwent għall- insulina tiegħek u huwa użat biex jikkontrolla l- glukożju fuq medda twila ta ’ żmien.
Liprolog Basal has a prolonged mode of action compared to soluble insulin
Liprolog Basal għandu mod ta ’ azzjoni mtawwal meta mqabbel ma ’ insulina solubbli.
Your doctor may tell you to use Liprolog Basal as well as a fast-acting insulin.
It- tabib tiegħek jista 'jgħidlek biex tuża Liprolog Basal, kif ukoll insulina li taħdem b’ mod malajr.
BEFORE YOU USE LIPROLOG Basal KWIKPEN
QABEL MA TUŻA LIPROLOG BASAL KWIKPEN
Do not use Liprolog Basal KwikPen
Tużax Liprolog Basal KwikPen
Basal KwikPen.
Liprolog Basal KwikPen
Take special care with Liprolog Basal KwikPen • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
Oqgħod attent ħafna b ’ Liprolog Basal KwikPen • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid- demm.
Warning signs are listed later in this leaflet.
288 Sinjali ta 'twissija huma mniżżla aktar tard f' dan il- fuljett.
HOW TO USE LIPROLOG Basal KWIKPEN
KIF GĦANDEK TUŻA LIPROLOG BASAL KWIKPEN
Make sure you get the Liprolog Basal KwikPen that your doctor has told you to use.
Kun żgur li ġġib il- Liprolog Basal KwikPen li t- tabib tiegħek qallek biex tuża.
Always use Liprolog Basal KwikPen exactly as your doctor has told you.
Dejjem għandek tuża l- Liprolog Basal KwikPen skond il- parir tat- tabib.
Dosage • You should normally inject Liprolog Basal as your basal insulin.
• Normalment għandek tinjetta l- Pinna Liprolog Basal bħala l- insulina bażika tiegħek.
But your doctor will have told you exactly how much to use, when to use it, and how often.
It- tabib tiegħek ikun qallek eżatt kemm għandek tuża, meta għandek tużha, u kemm- il darba.
This might just be for the first injection or it may be a gradual change over several weeks or months. • Inject Liprolog Basal under the skin.
Dan jista 'jkun biss għal l- ewwel injezzjoni jew tista' tkun bidla gradwali tul ħafna ġimgħat jew xhur. • Injetta Liprolog Basal taħt il- ġilda.
Under no circumstances should Liprolog Basal be given intravenously.
Taħt l- ebda ċirkostanza Liprolog Basal m' għandha tingħata ġol- vina.
271 Preparing Liprolog Basal KwikPen • The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky.
Il- KwikPen għandha tkun imdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar • darbiet eżatt qabel l- użu biex tirrisospendi l- insulina sakemm tidher kollha mċajpra jew qiesa ħalib.
If you take more Liprolog Basal than you need If you take more Liprolog Basal than you need, a low blood sugar may occur.
Jekk tuża Liprolog Basal aktar milli suppost Jekk tuża Liprolog Basal aktar milli suppost, jista ’ jkollok livell baxx ta ’ zokkor fid- demm.
Check your blood sugar.
Iċċekkja l - livell taz- zokkor fid- demm tiegħek.
If your blood sugar is low, eat glucose tablets, sugar or drink a sugary drink.
Jekk iz- zokkor fid- demm tiegħek huwa baxx, kul il- pilloli tal - glukożju, zokkor jew ixrob xarba ħelwa.
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest.
Imbagħad kul il- frott, gallettini, jew sandwiċċ, kif qallek it - tabib tiegħek u strieħ ftit.
If you forget to use Liprolog Basal If you take less Liprolog Basal than you need, a high blood sugar may occur.
Jekk tinsa tuża Liprolog Basal Jekk tieħu inqas Liprolog milli għandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
272 • Always keep spare syringes and a spare vial of Liprolog Basal, or a spare pen and cartridges, in case you lose your KwikPen or it gets damaged. • Always carry something to show you are diabetic. • Always carry sugar with you.
• Dejjem żomm siringi żejda u kunjett żejjed ta 'Liprolog Basal, jew xi pinna u skrataċ żejda fil - każ li titlef il- KwikPen tiegħek jew jiġrilha xi ħsara. • Dejjem żomm xi ħaġa fuqek biex turi li inti dijabetiku. • Dejjem żomm iz- zokkor fuqek.
If you stop using Liprolog Basal.
Jekk tieqaf tuża Liprolog Basal
If you take less Liprolog Basal than you need, a high blood sugar may occur.
Jekk tieħu inqas Liprolog Basal milli għandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
Like all medicines, Liprolog Basal can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Liprolog Basal jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you think you are having this sort of insulin allergy with Liprolog Basal, tell your doctor at once.
Jekk taħseb li qed ikollok din it- tip t' allerġija għall- insulina bi Liprolog għid lit- tabib tiegħek minnufih.
If you notice your skin thickening or pitting at the injection site, tell your doctor.
291 Lipodistrofija (li teħxien jew titħaffer il- ġilda) m’ hijiex komuni (> 1/ 1, 000 sa < 1/ 100). Jekk tinnota li l- ġilda qed teħxien jew titħaffer fis- sit ta 'l- injezzjoni, għid lit- tabib tiegħek.
This can be caused if: • you take too much Liprolog Basal or other insulin; • you miss or delay meals or change your diet; • you exercise or work too hard just before or after a meal; • you have an infection or illness (especially diarrhoea or vomiting); • there is a change in your need for insulin; or • you have trouble with your kidneys or liver which gets worse.
• Tieħu wisq Liprolog Basal jew insulina oħra; • Ma tiekolx jew tiekol tard jew jekk tbiddel id- dieta tiegħek; • Tagħmel wisq eżerċizzju jew taħdem iż- żejjed eżatt qabel jew wara ikla; • Għandek infezzjoni jew mard (speċjalment dijarrea jew remettar); • Hemm bidla fil- bżonn tiegħek ta 'l- insulina; jew • Għandek problemi bil- kliewi jew bil- fwied li qed isiru agħar
Severe symptoms are heavy breathing and a rapid pulse.
292 Sintomi qawwija huma nifs qawwi u polz mgħaġġel.
HOW TO STORE LIPROLOG Basal KWIKPEN
KIF TAĦŻEN LIPROLOG BASAL KWIKPEN
Before the first use store your Liprolog Basal KwikPen in a refrigerator (2°C – 8°C).
Qabel ma tuzaha l- ewwel darba żomm Liprolog Basal KwikPen fi friġġ (2°C- 8°C).
Keep your Liprolog Basal KwikPen in use at room temperature (below 30°C) for up to 21 days.
Żomm il- Liprolog Basal KwikPen tiegħek li ħa tuża f' temperatura ambjentali ta 'ġewwa (taħt 30°C) għal użu sa 28 ġurnata.
Do not use Liprolog Basal KwikPen after the expiry date which is stated on the label and the carton.
Tużax Liprolog Basal KwikPen wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
Do not use Liprolog Basal KwikPen, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.
Tużax Liprolog Basal KwikPen jekk jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb ta ’ l- iskartoċċ, u jidher qiesu ġelu.
What Liprolog Basal 100 U/ml KwikPen, suspension for injection contains
X’ fiha Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni
What Liprolog Basal 100 U/ml KwikPen, suspension for injection looks like and contents of the pack Liprolog Basal 100 U/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 U/ml) suspension for injection.
Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni, hu suspensjoni abjad u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) suspensjoni għal injezzjoni.
The insulin lispro in Liprolog Basal is available in a suspension together with protamine sulphate.
L- insulin lispro f’ Liprolog Basal huwa f’ suspensjoni flimkien ma ’ protamine sulphate.
Each Liprolog Basal KwikPen contains 300 units (3 millilitres).
Kull Liprolog Basal KwikPen fiha 300 unità (3 millilitri).
The Liprolog Basal KwikPen comes in a pack of 5 pre-filled pens or a multipack of 2 x 5 pre-filled pens.
Il- Liprolog Basal KwikPen tiġi f’ pakketti ta ’ 5 pinen mimlijin għal- lest jew f’ pakkett multiplu ta ’ 2 x 5 pinen mimlijin għal- lest.
The Liprolog Basal in your KwikPen is the same as the Liprolog Basal, which comes in separate Liprolog
Il- Liprolog Basal fil- KwikPen tiegħek hi l- istess bħall- Liprolog Basal li jiġi fl- iskrataċ separati ta ’ Liprolog Basal.
Marketing Authorisation Holder and Manufacturer Liprolog Basal 100 U/ml KwikPen, suspension for injection is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France • Lilly Pharma Fertigung und Distribution GmbH & Co.
293 Il- Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni huwa manifatturat minn: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Lilly Pharma Fertigung und Distribution GmbH & Co.
275 Eli Lilly Danmark A/S, Útibú á Íslandi Tel: + 354 520 34 00
Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi Tel: + 354 520 34 00
Κύπρος Phadisco Ltd Τηλ: +357 22 715000
294 Κύπρος Phadisco Ltd Τηλ: +357 22 715000
276 USER MANUAL
295 MANWAL GĦAL MIN QED JAGĦMEL UŻU MINNU
KwikPen INSULIN DELIVERY DEVICE
KwikPen APPARAT TA 'L- GĦOTI TA' L- INSULINA
It is a disposable insulin delivery device (“insulin Pen”) containing 3 mL (300 units) of U-100 insulin.
Hija apparat ta 'l- għoti ta' l- insulina li tintrema wara li tinħela ("Pinna ta 'l- insulina") li fiha 3 mL (300 unità) ta' U- 100 ta 'insulina.
If you dial too many units, you can correct the dose without wasting any insulin.
Jekk tikkalibra aktar unitajiet milli suppost, tista 'tikkoreġi d - doża mingħajr ħela ta' insulina.
If you do not follow these directions completely, you may get too much or too little insulin.
Jekk ma ssegwix dawn l- istruzzjonijiet kollha, tista 'ttella' wisq jew ftit wisq insulina.
This Pen is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the product.
Din il- Pinna mhijiex irrakkomandata għall- użu minn persuni għomja jew b' vista batuta mingħajr l- assistenza ta 'persuna mħarrġa fl- użu tajjeb ta' dan il- prodott.
• Read and follow the directions provided in. the package leaflet for the insulin. • Check the label on your Pen before each injection for the expiration date and to make sure you are using the correct type of insulin. • Your healthcare professional has prescribed the most appropriate type of insulin for you.
• Aqra u segwi l- istruzzjonijiet fil- fuljett ta 'tagħrif li ssib ma' l- insulina. • Ikkontrolla t- tabella fuq il- Pinna qabel kull injezzjoni għad- data ta 'skadenza u sabiex tkun żgur li qed tuża t- tip tajjeb ta' insulina. • Il- Professjonist tal- Kura tas- Saħħa tiegħek ordnalek it- tip ta 'insulina l- aktar adattat għalik.
Any changes in insulin therapy should be made only under medical supervision. • The KwikPen is suitable for use with Becton, Dickinson and Company (BD) pen needles. • Be sure the needle is completely attached to the Pen before use. • Do not share your Pen or needles. • Keep these directions for future reference.
Kull tibdil fil- kura bl- insulina għandu jsir taħt superviżjoni medika biss. • Il- KwikPen tista 'tintuża ma' labar tal- pinen Becton, Dickinson and Company (BD). • Qabel l- użu kun ċert li l- labra tkun imwaħħla sew mal- Pinna. • Tagħtix il- Pinna jew labar tiegħek lil xi ħadd ieħor. • Żomm dawn l- istruzzjonijiet biex tirreferi għalihom 'il quddiem.
• Why should I use a new needle for each injection?
296 • Għaliex għandi nuża labra ġdida għal kull injezzjoni?
If needles are reused, you may get the wrong amount of insulin, a clogged needle, a jammed Pen, or an infection.
Jekk terġa 'tuża l- labar jista' jkollok ammont ħażin ta 'insulina, labra misduda, Pinna ġġammjata, jew infezzjoni.
277 Priming the KwikPen
L- Ikkargar tal- Pinna
The Pen must be primed to a stream of insulin before each injection to make sure the Pen is ready to dose. • If you do not prime, you may get too much or too little insulin.
Il- Pinna trid tiġi kkargata għal nixxiegħa ta 'insulina qabel kull injezzjoni biex tiżgura li l- Pinna tkun lesta għad- doża • Jekk ma tikkargax, tista' ttella 'wisq jew ftit wisq insulina.
Confirms that a stream of insulin comes out of the tip of the needle when you push the Dose Knob in.
Tikkonferma li nixxiegħa ta 'insulina toħroġ mill- ponta tal- labra meta tagħfas il- Buttuna tad- Doża.
• What should I do if I cannot completely push in the Dose Knob when priming the Pen?
• X' għandi nagħmel jekk ma nkunx nista 'nagħfas il- Buttuna tad- Doża s' isfel waqt li qed nikkarga l- Pinna?
Important Notes • Follow the instructions for sanitary injection technique recommended by your healthcare professional. • Do not attempt to inject your insulin by turning the Dose Knob.
Noti Importanti • Segwi l- istruzzjonijiet li jirrakkomandalek il- professjonist tal- kura tas- saħħa tiegħek dwar it - teknika ta 'l- injezzjoni iġjenika. • Tippruvax tinjetta l- insulina billi ddawwar il- Buttuna tad- Doża.
You will NOT receive your insulin by turning the Dose Knob.
MHUX ser tieħu l- insulina billi ddawwar il- Buttuna tad- Doża.
You must PUSH the Dose Knob straight in for the dose to be delivered. • Do not attempt to change the dose while injecting. • The directions regarding needle handling are not intended to replace local, healthcare professional and/or institutional policies. • Remove the needle after completing each injection.
Trid TAGĦFAS il- Buttuna tad- Doża s' isfel biex tieħu d- doża. • Tippruvax tbiddel id- doża waqt li tkun qed tagħmel l- injezzjoni. • L- istruzzjonijiet dwar l- użu tal- labar mhumiex maħsuba li jieħdu post il- politiki lokali, tal - professjoni tal- kura tas- saħħa u/ jew istituzzjonali. • Neħħi l- labra wara li ttemm kull injezzjoni.
• Why is it difficult to push the Dose Knob when I try to inject?
• Għaliex qed tkun iebsa li nagħfas il- Buttuna tad- Doża meta nipprova nagħmel injezzjoni?
Pressing the Dose Knob quickly may make the Dose Knob harder to push.
Tista 'tħoss il- Buttuna tad- Doża iebsa biex tagħfas jekk tagħfasha f' daqqa.
Pressing the Dose Knob more slowly may make it easier.
Tista 'tiffaċilita dan billi tagħfas il- Buttuna tad- Doża bil- mod.
Using a larger diameter needle will make it easier to push the Dose Knob during your injection.
Jekk tuża labra b' dijametru akbar ikun aktar faċli li tagħfas il- Buttuna tad- Doża waqt l - injezzjoni.
See your healthcare professional to determine which needle size is best for you.
Kellem lill- professjonist tal- kura tas- saħħa tiegħek biex tara liema daqs ta 'labra tgħodd għalik.
If the Dose Knob continues to be difficult to push after following the steps above, you may need a new Pen.
Jekk il- Buttuna tad- Doża tibqa 'iebsa biex tagħfasha wara li tkun segwejt dawn il- passi, jista' jkollok bżonn Pinna ġdida.
Your Pen is jammed if it is difficult to inject a dose or dial a dose.
Il- pinna tkun iġġammjata jekk tkun iebsa biex tinjetta doża jew tikkalibra doża.
To clear the jam:
Biex terġa 'tħollha:
Attach a new needle.
Wahħal labra ġdida.
Dial your dose and inject.
Ikkalibra d- doża u injettaha.
278 • Why is insulin leaking from the needle after I finished my dose?
• Għaliex wara li nispiċċa d- doża tnixxi l- insulina mil- labra?
Make sure you see a 0 in the Dose Window.
Kun żgur li tara 0 fit- Tieqa tad- Doża.
For the next dose, push and hold the Dose Knob in and count slowly for 5 seconds before removing the needle.
Għad- doża li jmiss, agħfas u żomm il- Buttuna tad- Doża u għodd bil- mod għal 5 sekondi qabel ma tneħħi l- labra.
• What should I do if my dose is dialed and the Dose Knob is accidentally pushed in without a needle attached?
• X' għandi nagħmel jekk id- doża tkun ikkalibrata u l- Buttuna tad- Doża tingħafas bi żball mingħajr ma jkun hemm labra mwaħħla?
• What should I do if I dial a wrong dose (too high or too low)?
• X' għandi nagħmel jekk nikkalibra doża ħażina (għolja wisq jew baxxa wisq)?
Turn the Dose Knob backward or forward to correct the dose.
Dawwar il - Buttuna tad- Doża 'l quddiem jew lura biex tikkoreġi d- doża.
• What should I do if I see insulin leaking from the Pen needle while dialing the dose or correcting the dose?
• X' għandi nagħmel jekk nara li qed tnixxi l- insulina mil- labra tal- Pinna waqt li nkun qed nikkalibra jew nikkoreġi d- doża?
Dial the Pen down to zero and prime the Pen again (see “Priming the Pen” steps 2 A-D).
Ikkalibra l- Pinna fuq iż- żero u erġa 'kkargaha (ara "L- Ikkargar tal- Pinna" passi 2 A- D).
• What should I do if my full dose cannot be dialed?
• X' għandi nagħmel jekk ma nistax nikkalibra d- doża kollha?
The Pen will not allow you to dial a dose greater than the number of insulin units remaining in the cartridge.
Il- Pinna ma tħallikx tikkalibra doża akbar minn- numru ta 'unitajiet ta' l- insulina li fadal fl- iskartoċċ.
For example, if you need 31 units and only 25 units remain in the cartridge you will not be able to dial past 25.
Eżempju, jekk għandek bżonn 31 unità u fl- iskartoċċ fadal 25 unità biss ma tkunx tista 'tikkalibra aktar mill- 25.
Do not attempt to dial past this point.
Tippruvax tikkalibra aktar minn dan il- punt.
1.
Jekk fil- Pinna tibqa 'doża parzjali tista' jew 1.
• Why can I not dial the dose to use the small amount of insulin that remains in my cartridge?
• Għaliex ma nistax nikkalibra d- doża biex nuża l- ammont żgħir ta 'insulina li fadal fl - iskartoċċ?
Storage and Disposal
Il- Ħażna u r- Rimi
Do not use a Pen if it has been frozen. • Keep your Pen in use at room temperature and away from heat and light. • Do not store the Pen with the needle attached.
Tużax Pinna li kienet ġiet iffriżata. • Żomm il- Pinna li tkun qed tuża f' temperatura tal- kamra u 'l bogħod mis- sħana u d- dawl. • Taħżinx il- Pinna bil- labra mwaħħla.
If the needle is left on, insulin may leak from the Pen, insulin may dry inside the needle causing the needle to clog, or air bubbles may form in the cartridge. • Refer to the Information for the package leaflet for complete insulin storage instructions. • After first use the pen should not be used beyond the time specified in the insulin package leaflet Dispose of used needles in a puncture-resistant container or as directed by your healthcare professional. • Dispose of used Pens as instructed by your healthcare professional and without the needle attached. • Keep the Pen out of the reach of children.
298 • Wara l- ewwel użu l- pinna m' għandiex tibqa 'tintuża wara ż- żmien speċifikat fil- fuljett ta' tagħrif ta 'l- insulina. • Armi l- Pinen użati skond l- istruzzjonijiet tal- professjonist tal- kura tas- saħħa tiegħek u mingħajr il - labra. • Żomm il- Pinna fejn ma tintlaħaqx mit- tfal.
If you have any questions or problems with your KwikPen, contact your healthcare professional for assistance.
Jekk ikollok xi mistoqsijiet jew problemi bil- KwikPen, kellem lill- professjonist tal- kura tas - saħħa tiegħek għall- għajnuna.
279 Getting Ready Make sure you have the following items:
Kun żgur li għandek dawn l - oġġetti li ġejjien:
Alcohol Swab
Tajjara mxarrba bl - alkoħol
Pen Needle Parts
Partijiet tal- Labra tal- Pinna (Labar m’ humiex inklużi) Siġill protettiv
Paper Tab
Tikketta Parti
KwikPen Parts
Ġħatu
Label
Għatu
Needle
ta ’
Pen cap Rubber seal
tal- gomma
Pen Body
tal- Pinna
Dose Window
tal - Labra
Preparing the KwikPen A.
Preparazzjoni tal- KwikPen A.
Pull Pen Cap to remove.
Irrombla bil- mod il- Pinna
Gently roll the Pen ten times
Pinna.
Remove paper tab from Outer Needle Shield.
għat -:
Push capped needle straight onto the Pen.
darbiet. u
your insulin for: • Type • Expiration date • Appearance
• Tip • Data ta ’
and invert the Pen ten times.
aqleb il -
The insulin should look evenly mixed.
bl- alkoħol sabiex timsaħ is- siġill tal -
Use an alcohol swab to wipe the rubber seal on the end of the Cartridge Holder.
Invita l- labra sakemm tkun
Screw needle on until secure.
pinna ta ’
280 2.
taħt fuq
Priming the KwikPen Caution:
Iskartoċċ. er.
If you do not prime before each injection, you may get too much or too little insulin.
Jekk ma tikkargax qabel kull injezzjoni, tista ’ tieħu wisq jew ftit wisq ta ’ insulina..
D. • With needle pointed up, push Dose Knob in until it stops and 0 is seen in the Dose
u għandu jidher 0 fit - tieqa tad -
Pull off Outer Needle Shield.
Buttuna ta ’
Dial 2 Units by
Taptap il -
Point Pen up.
dożaġġ.
Window. • Hold Dose
Neħħi l- Għatu ta ’ Dożaġġ.
Do not throw away.
Kontenitur ta ’ l -
Holder to collect air at top.
• Żomm il -
Knob in and count slowly for 5 seconds.
Ġewwa tal- Labra u armih..
Needle Shield and throw away.
Iskartoċċ sabiex l - arja tinġabar ’ il fuq.
• Priming is complete when a stream of insulin appears from the needle tip. • If a stream of insulin does not appear, repeat priming steps 2B thru 2D.
Buttuna ta ’ Dożaġġ ’ il ġewwa u għodd bil - mod għal 5 sekondi • L- ikkargar ikun lest meta mill- ponta tal- labra tidher nixxiegħa ta ’ insulina. • Jekk in - nixxiegħa ta ’ insulina ma tidhirx, irrepeti l - proċeduri ta ’ kkargar minn 2B sa 2D.
281 3.
301 3.
Injecting Your Dose A.
L- Injettar tad- Doża Tiegħek A.
Turn Dose Knob to the number of units you need to inject.
Sabiex tieħu d- doża Dawwar il -
If you dial too many units, you can correct the dose by dialing
kollha, żomm il -
Insert needle into skin using injection technique recommended by your healthcare professional.
fil- ġilda billi
To deliver the full dose, hold Dose Knob in and count slowly for 5 seconds.
injezzjoni
Remove needle from skin.
Neħħi l -
Carefully replace the Outer Needle Shield.
professjonist/ a
Unscrew the capped needle and throw away as directed by your healthcare professional.
labra minn ġol- ġilda.
backwards.
tiegħek..
The odd numbers are shown as full lines between the even numbers.
isselezzjonajt numru żejjed ta ’ unitajiet tista ’
Place your thumb on the Dose Knob and push firmly until the Dose Knob stops moving.
tal- kura tas - saħħa tiegħek.
Check to make sure you see 0 in the Dose Window to confirm you received the complete dose.
li tara 0 fit- Tieqa tad -
Note:
Buttuna ta ’
Remove the needle after each injection to keep air out of the cartridge.
ma tħallix l- arja
Do not store the Pen with the needle attached.
sew sakemm il - Buttuna ta ’ Dożaġġ ma
Replace Pen Cap.
Kappa tal- Pinna.
10 units shown.
Jidhru 10 unitajiet Eżempju:
units left in the Pen, you may either take the amount remaining in your current Pen and then use a new Pen to complete your dose OR take the full dose with a new Pen.
Jekk id- doża tiegħek hija akbar minn numru ta ’ unitajiet li fadal fil- Pinna, tista ’ jew tieħu dak l- ammont li fadal u tuża Pinna ġdida biex tkompli d- doża JEW tieħu d- doża kollha permezz ta ’ Pinna ġdida..
282
302
What is LITAK?
X’ inhu LITAK?
LITAK is a solution for injection that contains the active substance cladribine (2 mg/ ml).
LITAK huwa soluzzjoni għall- injezzjoni li fiha s- sustanza attiva cladribine (2 mg/ ml).
What is LITAK used for?
Għal x’ hiex jintuża LITAK?
LITAK is used to treat patients over 16 years of age who have hairy cell leukaemia.
LITAK jintuża fit- trattament ta ’ pazjenti ta ’ iktar minn 16- il sena li jkollhom lewċemija fiċ- ċelloli tax - xagħar.
This is a cancer of blood in which too many B-lymphocytes (a type of white blood cell) are produced.
Dan huwa kanċer tad- demm li fih jiġu prodotti ħafna limfoċiti- B (tip ta ’ ċelloli tad- demm bojod).
The term ‘ hairy cell’ refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.
It- terminu ‘ ċelloli tax- xagħar ’ jirreferi għal projezzjonijiet qishom xagħar li jidhru fuq l- uċuh tal- limfoċiti meta dawn jiġu eżaminati taħt mikroskopju.
Because the number of patients with hairy cell leukaemia is low, the disease is considered ‘ rare’, and LITAK was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 18 September 2001.
Billi l- għadd ta ’ pazjenti bil- lewċemija fiċ- ċelloli tax- xagħar huwa wieħed żgħir, il- marda hija kkunsidrata ‘ rari ’, u LITAK ġie kklassifikat bħala ‘ mediċina orfni ’ (mediċina għal mardiet rari) fit- 18 ta ’ Settembru 2001.
How is LITAK used?
Kif jintuża LITAK?
LITAK treatment should be initiated by a qualified doctor who has experience in the use of cancer treatments.
It- trattament b’ LITAK għandu jinbeda minn tabib kwalifikat b’ esperjenza fl- użu ta ’ trattamenti tal - kanċer.
LITAK is given as an injection under the skin.
LITAK jingħata b’ injezzjoni taħt il- ġilda.
The recommended dose is 0.14 mg per kilogram body weight, once a day for five days.
Id- doża rakkomandata hija ta ’ 0. 14 mg għal kull kilogramma li jiżen il- pazjent, darba kuljum għal ħamest ijiem.
Patients can inject themselves once they have been trained appropriately.
Il- pazjenti jistgħu jinjettaw lilhom infushom ladarba jkunu tħarrġu bix- xieraq.
LITAK cannot be given to patients with moderate to severe liver or kidney disease.
LITAK ma jistax jingħata lil pazjenti b’ mard moderat jew sever tal- fwied jew tal- kliewi.
How does LITAK work?
Kif jaħdem LITAK?
The active substance in LITAK, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Is- sustanza attiva f’ LITAK, cladribine, hija ċitotossika, mediċina li toqtol iċ- ċelloli li jkunu qed jinqasmu, bħaċ- ċelloli tal- kanċer.
It belongs to the group of anti-cancer medicines called ‘ antimetabolites’.
Tifforma parti mill- grupp ta ’ mediċini ta ’ kontra l- kanċer magħrufa bħala ‘ antimetabolites ’.
Cladribine is an analogue of purine, one of the fundamental chemicals that make up DNA.
Cladribine huwa analogu ta ’ purine, wieħed mill- kimiċi fundamentali li jiffurmaw id- DNA.
In the body, it is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA.
Fil- ġisem, fil- limfoċiti jinbidel f’ kimika magħrufa bħala CdATP, li jinterferixxi mal- produzzjoni ta ’ DNA ġdid.
This prevents the cells from dividing, slowing down the progression of leukaemia.
Dan ma jħallix liċ- ċelloli jinqasmu, u b’ hekk inaqqas il- progressjoni tal- lewċemija.
CdATP can also affect other cells, particularly other types of blood cell, which can cause side effects.
Is- CdATP jista ’ jaffettwa wkoll liċ- ċelloli l- oħra, partikolarment lit- tipi l- oħra ta ’ ċelloli tad- demm, u dan jikkawża effetti sekondarji.
Cladribine has been in use in anticancer medicines since the 1980s and it has been available as an intravenous infusion (drip into a vein) in some European Union (EU) Member States since 1993.
Cladribine ilu jintuża bħala mediċina ta ’ kontra l- kanċer mis- snin tmenin u ilu disponibbli bħala infużjoni intravenuża (dripp fil- vina) f’ xi Stati Membri ta ’ l- Unjoni Ewropea (UE) mill- 1993.
How has LITAK been studied?
Kif ġie studjat LITAK?
Because cladribine has been used for a number of years, the company presented data from the published literature.
Billi cladribine ilu jintuża għal numru ta ’ snin, il- kumpanija ppreżetat dejta mil- letteratura pubblikata.
LITAK has been examined in one main study involving 63 patients with hairy cell leukaemia.
LITAK ġie eżaminat fi studju wieħed ewlieni bis- sehem ta ’ 63 pazjent bil- lewċemija taċ- ċelloli tax - xagħar.
LITAK was not compared to any other treatment in this study.
LITAK ma tqabbilx ma ’ xi trattament ieħor f’ dan l- istudju.
The main measures of effectiveness were the proportions of patients who had complete and partial remission following treatment.
Il- mezz ewlieni tal- kejl ta ’ l - effettività kienu l- proporzjonijiet ta ’ pazjenti li kellhom remissjoni kompleta jew parzjali wara t - trattament.
Complete remission was the disappearance of all evidence of disease, whereas partial remission was improved blood counts and the reduction in the number of cancerous cells.
Remissjoni kompleta kienet l- għajbien ta ’ kull evidenza ta ’ mard, waqt li remissjoni parzjali kienet it- titjib fl- għadd ta ’ ċelloli tad- demm u t- tnaqqis fil- għadd ta ’ ċelloli kanċerużi.
What benefit has LITAK shown during the studies?
X’ inhuma l- benefiċċji ta ’ LITAK li ntwerew f’ dawn l- istudji?
In the main study, 60 (97%) of 62 patients had either complete or partial remission, and 47 (76%) had complete remission.
Fl- istudju ewlieni, 60 (97%) tat- 62 pazjent kellhom remissjoni kompleta jew parzjali, u 47 (76%) kellhom remissjoni kompleta.
These results were similar to those seen in other published studies using intravenous cladribine and were better than results seen with alternative treatments such as interferon alfa and pentostatin.
Dawn ir- riżultati kienu jixbħu lil dawk li dehru fi studji oħra ppubblikati bl- użu ta ’ cladribine fil- vina u kienu aħjar mir- riżultati ta ’ trattamenti alternattivi bħall- inerferon alfa u pentostatin.
What is the risk associated with LITAK?
X’ inhu r- riskju assoċjat ma ’ LITAK?
The most common side effects with LITAK (seen in more than 1 patient in 10) are infections, pancytopenia or myelosuppression (low blood cell counts), purpura (bruising), immunosuppression (a weakened immune system), decreased appetite, headache, dizziness, abnormal breath and chest sounds, cough, nausea (feeling sick), vomiting, constipation, diarrhoea, rash, diaphoresis (excessive sweating), injection site reactions (pain and inflammation at the site of injection), fever, fatigue (tiredness), chills and asthenia (weakness).
L- iktar effetti sekondarji komuni ta ’ LITAK (li dehru f’ bejn pazjent wieħed u għaxra minn kull mija) huma l- infezzjonijiet, pancytopenia jew myelosuppression (għadd baxx ta ’ ċelloli tad- demm), tbenġil, immunosuppressjoni (sistema immunitarja mdgħajfa, tnaqqis fl- aptit, uġigħ ta ’ ras, sturdament, nifs u ħsejjes tan- nifs anormali, sogħla, dardir, remettar, konstipazzjoni, dijarea, raxx, għaraq eċċessiv, reazzjonijiet fis- sit ta ’ l- injezzjoni (uġigħ u infjammazzjoni fis- sit ta ’ l- injezzjoni), deni, għeja kbira, u astenja (dgħufija).
For the full list of all side effects reported with LITAK, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati ma ’ LITAK, ara l- Fuljett ta ’ Tagħrif.
LITAK should not be used in people who may be hypersensitive (allergic) to cladribine or any of the other ingredients.
LITAK m’ għandux jintuża minn persuni allerġiċi għal cladribine jew għal xi sustanzi oħra tiegħu.
LITAK should also not be used during pregnancy or breast-feeding, in patients less than 16 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.
LITAK m’ għandux jintuża waqt it- tqala jew waqt it- treddigħ, f’ pazjenti ta ’ inqas minn 16- il sena, f’ pazjenti b’ mard moderat jew sever tal- kliewi jew tal- fwied jew flimkien ma ’ mediċini oħra li jnaqqsu l- produzzjoni ta ’ ċelloli tad- demm.
Why has LITAK been approved?
Għaliex ġie approvat LITAK?
The Committee for Medicinal Products for Human Use (CHMP) decided that LITAK’ s benefits are greater than its risks for the treatment of hairy cell leukaemia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) iddeċieda li l- benefiċċji ta ’ LITAK huma ikbar mir- riskji tiegħu għat- trattament tal- lewċemija taċ- ċelloli tax- xagħar.
The Committee recommended that LITAK be given marketing authorisation.
Il- Kumitat irrakkomanda li LITAK jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about LITAK:
Tagħrif ieħor dwar LITAK:
The European Commission granted a marketing authorisation valid throughout the EU for LITAK to Lipomed GmbH on 14 April 2004.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal LITAK valida fl- Unjoni Ewropea kollha lil Lipomed GmbH fl- 14 ta ’ April 2004.
The summary of opinion of the Committee for Orphan Medicinal Products for LITAK is available here.
Is- sommarju ta ’ l- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal LITAK huwa disponibbli minn hawnhekk.
The full EPAR for LITAK can be found here.
L- EPAR sħiħ għal LITAK jista ’ jinstab hawnhekk.
EU numbers
Għamla
Strength
Numri tal- EU
Pharmaceutical Form
Isem ivvintat
Route of administration
farmaċewtika
Subcutaneous use
Użu għal taħt il- ġilda Kunjett tal- ħġieġ
What is Livensa?
X’ inhu Livensa?
Livensa is a transdermal patch (a patch that delivers a medicine across the skin).
Livensa huwa roqgħa transdermali (roqgħa li tagħti mediċina minn ġol- ġilda).
What is Livensa used for?
Għalxiex jintuża Livensa?
Livensa is used to treat women who have had their uterus (womb) and both ovaries removed, when they have a lack of sexual thoughts and sexual desire that is causing them distress.
Livensa jintuża fit- trattament ta ’ nisa li jkun tneħħielhom kemm l- utru (il- ġuf) kif ukoll iż- żewġ ovarji, u jkunu qegħdin jesperjenzaw nuqqas ta ’ ħsibijiet u xewqat sesswali, ħaġa li tkun qegħda toħolqilhom inkwiet.
How is Livensa used?
Kif jintuża Livensa?
Livensa is used as a continuous treatment, as one patch twice a week.
Livensa jintuża bħala trattament kontinwu, bħala roqgħa waħda darbtejn fil- ġimgħa.
How does Livensa work?
Kif jaħdem Livensa?
The active substance in Livensa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Is- sustanza attiva f’ Livensa, it- testosteronu, huwa ormon sesswali naturali prodott mill- irġiel u, sa ċertu punt fin- nisa.
Livensa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the uterus and ovaries.
Livensa jirrilaxxa t- testosteronu minn ġol - ġilda għal ġod- demm u jipproduċi livelli ta ’ testosteronu li jaqblu mal- livelli li kienu preżenti qabel it - tneħħija ta ’ l- utru u l- ovajri.
How has Livensa been studied?
Kif ġie studjat Livensa?
Because testosterone is a well-known active substance that is already used in other medicines, the company used data from the published literature as well as carrying out studies itself.
Billi t- testosteronu huwa sustanza magħrufa tajjeb li diġà tintuża f’ mediċini oħrajn, il- kumpanija użat tagħrif mil- letteratura ppubblikata kif ukoll għamlet studji hija stess.
The two main studies involved 1,095 women with an average age of 49 years who received Livensa for up to a year.
Fiż- żewġ studji ewlenin ħadu sehem 1, 095 mara b’ età medja ta ’ 49 sena li ngħataw Livensa għal perjodu ta ’ mhux iktar minn sena.
Livensa was compared with placebo (a patch containing no active substance).
Livensa tqabbel ma ’ plaċebo (roqgħa li ma fiha l- ebda sustanza attiva).
Reproduction is authorised provided the source is acknowledged. satisfying sexual episodes in a four-week period.
Reproduction is authorised provided the source is acknowledged. sesswali sodisfaċenti f’ perjodu ta ’ erba ’ ġimgħat.
What benefit has Livensa shown during the studies?
X’ benefiċċji wera Livensa matul dawn l- istudji?
Livensa was more effective than placebo.
Livensa kien iktar effettiv minn plaċebo.
When the results of the two studies were looked at together, the women who used Livensa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Meta r- riżultati taż- żewġ studji ġew analizzati flimkien, in - nisa li użaw Livensa kellhom medja ta ’ 1. 07 episodji sesswali sodisfaċenti iktar min- nisa li ngħataw il - plaċebo matul perjodu ta ’ erba ’ ġimgħat.
On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Livensa for six months.
Bħala medja, in- nisa li kellhom tliet episodji sesswali sodisfaċenti matul perjodu ta ’ erba ’ ġimgħat qabel it- trattament kellhom madwar ħames episodji matul l- erba ’ ġimgħat ta ’ wara l- użu ta ’ Livensa għal sitt xhur.
In contrast, women who used placebo had around four episodes in a four- week period after six months.
B’ kuntrast, in- nisa li użaw il- plaċebo kellhom madwar erba ’ episodji f’ perjodu ta ’ erba ’ ġimgħat wara s- sitt xhur ta ’ trattament.
What is the risk associated with Livensa?
X’ inhu r- riskju assoċjat ma ’ Livensa?
The most common side effects with Livensa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip), and reactions at the site of application of the patch (redness and itching).
L- iktar effetti sekondarji komuni ma ’ Livensa (li dehru f’ iktar minn pazjent 1 minn kull 10) huma żieda fix- xagħar (speċjalment fuq il- geddum u fix- xoffa ta ’ fuq), u reazzjonijiet fis- sit ta ’ l - applikazzjoni tar- roqgħa (ħmura u ħakk).
For the full list of all side effects reported with Livensa, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurati ma ’ Livensa, ara l- Fuljett ta ’ Tagħrif.
Because testosterone is a male sex hormone, women who are taking Livensa should be monitored to see if they develop any ‘ androgenic’ side effects (development of male characteristics), such as hair growth on the face, deepening of the voice or hair loss.
Billi t- testosteronu huwa ormon sesswali maskili, in- nisa li jkunu qed jieħdu Livensa għandhom jiġu sorveljati biex ikun magħruf jekk jiżviluppawx effetti sekondarji ‘ androġeniċi (l- iżvilupp ta ’ karatteristiċi maskili) bħax- xagħar fil- wiċċ, tħaxxin tal- leħen jew telf ta ’ xagħar.
Livensa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Livensa m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għat- testosteronu jew għal xi sustanza oħra tiegħu.
It should also not be used in women who have, or have had breast cancer or another oestrogen-dependent cancer, or who have other conditions that mean that they cannot take oestrogen-containing medicines.
Lanqas ma għandu jintuża f’ nisa li jkollhom, jew li qabel kellhom kanċer tas - sider jew xi kanċer ieħor dipendenti mill- estroġenu, jew li jkollhom kundizzjonijiet oħra li minħabba fihom ma jkunux jistgħu jieħdu mediċini bl- estroġenu.
Women using Livensa should also use oestrogens, but not of the type known as ‘ conjugated oestrogens ’ as this combination is not as effective.
Nisa li jkunu qegħdin jużaw Livensa għandhom jużaw estroġeni wkoll, iżda mhux tat- tip magħruf bħala ‘ estroġeni konġugati ’ għax din il- kombinazzjoni mhijiex effettiva.
Why has Livensa been approved?
Għaliex ġie approvat Livensa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Livensa’ s benefits are greater than its risks for the treatment of hypoactive sexual desire disorder in bilaterally oophorectomised and hysterectomised women receiving concomitant oestrogen therapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Livensa huma ikbar mir- riskji tiegħu għat- trattament ta ’ disturbi dovuti għal xewqat sesswali baxxi f’ pazjenti li jkunu tneħħewlhom iż- żewġ ovarji u l- utru u li fl- istess ħin ikunu qegħdin jingħataw terapija bl- estroġenu.
The Committee recommended that Livensa be given marketing authorisation.
Il- Kumitat irrakkomanda li Livensa jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Which measures are being taken to ensure the safe use of Livensa?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Livensa?
The company that makes Livensa will monitor some of the side effects of Livensa closely, such as androgenic side effects.
Il- kumpanija li tagħmel Livensa se tissorvelja mill- qrib uħud mill- effetti sekondarji ta ’ Livensa, bħall - effetti sekondarji androġeniċi.
The company will review all ongoing studies with Livensa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Il- kumpanija se tirrevedi l- istudji li għaddejjin bħalissa b’ Livensa, biex tħares lejn ir- riskji potenzjali fit- tul fosthom il- kanċer tas- sider, il- kanċer endometrijali (kanċer fil- kisi ta ’ l- utru) u l- effetti sekondarji li jaffettwaw il- qalb u l- arterji u l- vini.
The company will also provide an education plan for both doctors and patients.
Il- kumpanija se tipprovdi wkoll pjan edukattiv għat- tobba u l- pazjenti.
Other information about Livensa:
Informazzjoni oħra dwar Livensa:
The European Commission granted a marketing authorisation valid throughout the European Union for Livensa to Procter & Gamble Pharmaceuticals - Germany GmbH on 28 July 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Livensa lil Procter & Gamble Pharmaceuticals - Germany GmbH. fit- 28 ta ’ Lulju 2006.
The full EPAR for Livensa can be found here.
L- EPAR sħiħ għal Livensa jista ’ jinstab hawnhekk.
EU/ 1/ 06/ 351/ 001
EMEA/ H/ C/ 000630/ 0000/ 001
Transdermal patch
Gar a li tipprovdi medi ina U u minn fuq il - ilda li tg addi minn ol - ilda
sachet (paper/ PE/ Alu/ ethylene methacrylic acid copolymer)
qartas (karta/ polyethylene/ fojl ta ’ l- aluminju/ ethylene methacrylic acid copolymer)
2 patches
2 gar i
EU/ 1/ 06/ 351/ 002
EMEA/ H/ C/ 000630/ 0000/ 002
8 patches
8 gar i
EU/ 1/ 06/ 351/ 003
EMEA/ H/ C/ 000630/ 0000/ 003
24 patches
24 gar i
Livensa 300 micrograms/ 24 hours transdermal patch
Livensa 300 mikrogramma/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Livensa hu indikat għat- trattament ta ’ mard li fih persuna jkollha nuqqas ta ’ xewqa sesswali (hypoactive sexual desire disorder, HSDD) f’ nisa li kellhom ooforektomija u isterektomija b’ mod bilaterali (menopawsa ikkaġunata b’ mod kirurġiku) li kienu qed jirċievu terapija bl- estroġenu fl- istess ħin.
To prevent interference with the adhesive properties of Livensa, no creams, lotions or powder should be applied to the skin where the patch is to be applied.
Biex tevita l- interferenza mal - proprjetajiet adeżivi ta ’ Livensa, l- ebda kremi, żjut jew terra m’ għandhom jiġu applikati fuq il- ġilda fejn il- garża tkun ser titwaħħal.
Concomitant estrogen treatment The appropriate use and restrictions associated with estrogen therapy should be considered before Livensa therapy is initiated and during routine re-evaluation of treatment.
2 It- trattament bl- estroġenu fl- istess ħin L- użu xieraq u restrizzjonijiet marbuta mat- terapija bl- estroġenu għandhom jiġu kkunsidrati qabel ma tinbeda t- terapija b’ Livensa, u matul l- evalwazzjoni mill- ġdid ta ’ rutina tat- trattament.
Continued use of Livensa is only recommended while concomitant use of estrogen is considered appropriate (i. e. the lowest effective dose for the shortest possible duration).
It- tkomplija ta ’ l- użu b’ Livensa hu rakkomandat biss meta l- użu fl- istess ħin ta ’ l- estroġenu hu kkunsidrat li hu adattat (i. e. l- inqas doża effettiva għall- inqas tul ta ’ żmien possibbli).
2 Patients treated with conjugated equine estrogen (CEE) are not recommended to use Livensa, as efficacy has not been demonstrated (see sections 4.4 and 5.1).
Pazjenti trattati b’ conjugated equine estrogen (CEE) mhumiex rakkomandati li jużaw Livensa, għax l - effikaċja ma ntwerietx (ara sezzjonijiet 4. 4 u 5. 1).