qanastek/EMEA-V3 huggingface dataset:
30 NutropinAq Pen Instructions for use with NutropinAq
31 Pinna NutropinAq Istruzzjonijiet għall- użu ma ’ NutropinAq
DO NOT INJECT THE MEDICINE UNTIL YOUR DOCTOR OR NURSE HAS THOROUGHLY TRAINED YOU IN THE PROPER TECHNIQUES.
TINJETTAX IL- MEDIĊINA QABEL MA TIĠI MĦARREĠ SEW FIL- METODI XIERQA MIT - TABIB JEW NERS TIEGĦEK
Caution:
Attenzjoni:
Before using your NutropinAq Pen, please read the following instructions carefully.
Jekk jogħġbok, qabel ma tuża l- Pinna NutropinAq tiegħek, aqra b’ attenzjoni l- istruzzjonijiet li ġejjin.
We also suggest you consult your doctor or nurse for a demonstration.
Nissuġġerixxu wkoll li tikkonsulta lit- tabib jew ners tiegħek għal demonstrazzjoni.
The NutropinAq Pen is designed for use only with cartridges of NutropinAq (for subcutaneous use only).
Il- Pinna NutropinAq hija maħsuba biss għall- użu ma ’ skrataċ ta ’ NutropinAq (użu għal taħt il- ġilda biss).
As shown by the illustrations below, NutropinAq pen and cartridges are available in two designs (with or without additional yellow colour). The working of the pen and the content of the cartridges are the same for both designs.
Il- mod kif taħdem il- pinna u l- kontenut ta ’ l- iskrataċ huma l- istess għaż- żewġ mudelli.
Either of the NutropinAq cartridge designs can be used with either of the NutropinAq Pen designs.
Kull wieħed miż- żewġ mudelli ta ’ skrataċ jistgħu jintużaw ma ’ kull mudell ta ’ Pinna NutropinAq.
Only use the pen needles recommended by your doctor or nurse.
Uża biss il- labar għall- pinna rakkomandati mit- tabib jew ners tiegħek.
The dosage scale located beside the window of the cartridge holder should not be used as a dose measurement.
L- iskala ta ’ dożaġġ li tidher ħdejn it- tieqa tal- kontenitur ta ’ l- iskartoċċ m’ għandiex tintuża bħala qies għad- doża.
It should only be used to estimate the dosage remaining in the cartridge.
Għandha tintuża biss biex tikkalkula id- dożaġġ li fadal fl- iskartoċċ.
Always refer to the LCD (Liquid Crystal Display), not audible clicks, for setting an injection of NutropinAq.
Dejjem irreferi għall - LCD (Display ta ’ Kristalli Likwidi), u mhux għaċ- ċekċik li jinstema ’, biex tipprepara injezzjoni ta ’ NutropinAq.
The clicks are only audible confirmation that the black dose knob has been moved.
Iċ- ċekċik huwa biss konferma li tinstema ’ li l- buttuna s- sewda tad- doża ġiet imċaqalqa.
Always store the pen and cartridges in a clean, safe place in the refrigerator at a temperature between 2-8°C and out of children’ s reach and sight.
Dejjem aħżen il- pinna u l- iskartoċċ f’ post nadif u sikur fil- friġġ, f’ temperatura ta ’ 2- 8°C u fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Protect from intense light.
Ipproteġġi minn dawl qawwi.
Use a cooler to store your NutropinAq Pen when travelling.
Uża kontenitur għat- tkessiħ biex taħżen il- Pinna NutropinAq tiegħek meta tivvjaġġa.
The NutropinAq is designed to withstand a nominal (one hour maximum) period of time outside of the refrigerator on a daily basis.
NutropinAq huwa iddisinjat biex jiflaħ perjodu ta ’ ħin (siegħa l- aktar) barra mill- friġġ kuljum.
Avoid areas of extreme temperature.
Evita postijiet ta ’ temperatura estrema.
Check the expiry date of the cartridge before use.
Iċċekkja d- data ta ’ skadenza ta ’ l- iskartoċċ qabel l- użu.
To guard against the spread of infection, follow these safety measures:
Biex tipproteġi minn tixrid ta ’ infezzjoni, segwi dawn il- misuri ta ’ sigurtà:
• Wash your hands thoroughly with soap and water before using your pen. • Clean the cartridge rubber seal with an alcohol swab or cotton ball saturated with alcohol. • Avoid touching the cartridge rubber seal at all times. • If you accidentally touch the cartridge rubber seal, clean it with an alcohol swab. • Do not use the same needle for more than one person. • Use needles only once.
• Aħsel idejk tajjeb bl- ilma u s- sapun qabel ma ’ tuża ’ l- pinna tiegħek. • Naddaf is- siġill tal- lasktu tal- iskartoċċ b’ imselħa ta ’ l- alkoħol jew ballun tat- tajjar issaturat bl - alkoħol. • Evita li tmiss is- siġill tal- lasktu ta ’ l- iskartoċċ f’ kull waqt. • Jekk bi żball missejt is- siġill tal- lasktu ta ’ l- iskartoċċ, naddfu b’ imselħa ta ’ l- alkoħol. • Tużax l- istess labra għall- aktar minn persuna waħda. • Uża l- labar darba waħda biss.
NutropinAq Pen Components:
Komponenti tal- Pinna NutropinAq:
31 Shown below are the items necessary for giving an injection.
32 L- oġġetti neċċessarji għall- għotja ta ’ injezzjoni huma murija taħt.
Gather all of these components prior to use.
Iġbor dawn il- partijiet kolla qabel l - użu.
Your NutropinAq cartridge and Pen will be supplied separately.
L- iskartoċċ u l- Pinna NutropinAq tiegħek se jkunu pprovduti separatament.
Part I:
Parti I:
Preparing and Injecting
Preparazzjoni u Injezzjoni
Follow the instructions in this section if you are using the pen for the first time or are replacing an empty cartridge.
Segwi l- istruzzjonijiet f’ din is- sezzjoni jekk qed tuża l- pinna għall- ewwel darba jew qed tbiddel skartoċċ vojt.
Inspect all new cartridges prior to use.
Spezzjona kull skartoċċ ġdid qabel l- użu.
Occasionally, after refrigeration, you may notice that small colourless particles are present in the NutropinAq solution.
Xi drabi, wara li titpoġġa fil- friġġ, tista ’ tinnota li frak żgħar u bla kulur huma preżenti fis- soluzzjoni ta ’ NutropinAq.
This is not unusual for solutions containing proteins like NutropinAq and does not affect the strength of the product.
Din mhux xi ħaġa li m’ hiex komuni f’ soluzzjonijiet li fihom proteini bħal NutropinAq u ma jaffettwawx is- saħħa tal- prodott.
Allow the cartridge to come to room temperature and gently swirl.
Ħalli l - iskartoċċ jilħaq it- temperatura tal- kamra u ħawwad billi ddawwar bil- mod.
If the solution is cloudy or hazy or contains any solid matter, the cartridge should not be used.
Jekk is - soluzzjoni tkun mdardra jew mhux ċara jew fiha xi biċċiet solidi, l- iskartoċċ m’ għandux jintuża.
Return the cartridge to your pharmacist or prescribing doctor.
Irritorna l- iskartoċċ lill- ispiżjar tiegħek jew tabib li ppreskrivielek tiegħek.
Remove the green pen cap and unscrew the cartridge holder from the pen.
Neħħi t- tapp l- aħdar tal- pinna u ħoll il- kontenitur ta ’ l- iskartoċċ minn mal- pinna.
If necessary, remove the empty cartridge and discard it properly.
Jekk hemm bżonn, neħħi l- iskartoċċ vojt u armih kif suppost.
Press the white reset button.
Għafas il- buttuna l- bajda ta ’ risettjar.
Turn the black dose knob counter-clockwise back to its starting position until it no longer turns.
Dawwar il- buttuna s- sewda tad- doża lejn ix- xellug lura fil- pożizzjoni tal- bidu sakemm ma tkunx tista ’ ddur iktar (Ara l- istampa).
(See illustration.) Then turn the dose knob clockwise until the first click position is reached (approximately 1/ 4 turn).
Wara, dawwar il- buttuna tad - doża lejn il- lemin sakemm tintlaħaq il- pożizzjoni ta ’ l- ewwel ċekċika (madwar 1/ 4 ta ’ dawra).
This ensures that the plunger push rod is reset to the starting position.
Dan jiggarantixxi li l- lasta tal- planġer tiġi risettjata lura għall- pożizzjoni tal - bidu.
If this is not done when the dosage knob is first pushed in, NutropinAq will be wasted or the cartridge may crack.
Jekk dan ma jsirx meta l- buttuna ta ’ dożaġġ tkun magħfusa l- ewwel, NutropinAq jinħela jew l- iskartoċċ jista ’ jixxaqqaq.
Insert cartridge into the cartridge holder, then screw the cartridge holder back onto the pen.
Daħħal l- iskartoċċ ġol- kontenitur ta ’ l- iskartoċċ, wara waħħal il- kontenitur ta ’ l - iskartoċċ lura fuq il- pinna.
(Be careful not to touch the rubber seal.)
(Oqgħod attent sabiex ma tmissx is- siġill tal- lasktu.)
Remove the paper seal from a new needle assembly and screw it onto the cartridge holder.
Neħħi is- siġill tal- karta minn fuq il- grupp ta ’ labar ġodda u waħħala fuq il- kontenitur ta ’ l- iskartoċċ.
Carefully remove both protective caps from the needle by pulling gently.
B’ attenzjoni neħħi ż- żewġ għotjien ta ’ protezzjoni minn mal- labra billi tiġbed bil- mod.
Do not throw the larger cap away as it will be used later for proper needle removal and disposal.
Tarmix l - għatu l- kbir minħabba li dan jintuża aktar tard għat- tneħħija u rimi tal- labra kif suppost.
Holding the pen with the needle pointing upward, gently tap the cartridge holder to move any air bubbles to the top.
Żomm il- pinna bil- labra tħares il- fuq, bil- mod taptap il- kontenitur ta ’ l- iskartoċċ biex timbotta xi bżieżaq ta ’ l- arja l- fuq.
While still holding the pen in the upright position, push in the black dose knob until it clicks into position.
Waqt li żżomm il- pinna f’ pożizzjoni wieqfa, imbotta l- buttuna s- sewda tad- doża sakemm tfaqqa fil- pożizzjoni.
You should see a drop of solution appear.
Għandek tara qatra ta ’ soluzzjoni tifforma.
Be patient.
Kun paċenzjuż/ a.
If medicine doesn’ t appear within a few seconds, you may need to push the reset button again.
Jekk il- mediċina ma tidhirx wara ftit sekondi, jista ’ jkollok bżonn terġa tagħfas il- buttuna li tirrisettja.
If no drop of medicine appears, push the white reset button again.
Jekk l- ebda qatra ta ’ mediċina ma tidher, erġa għafas il- buttuna l- bajda li tirrisettja.
Now turn the black dose knob clockwise (See illustration) by one click (0.1mg).
Issa dawwar il- buttuna s- sewda tad- doża lejn il- lemin (Ara l- istampa) b’ ċekċika waħda (0. 1 mg).
If you accidentally turn it too far, go back one click (0.1 mg).
Jekk bi żball iddawwara wisq, mur lura b’ ċekċika waħda (0. 1 mg).
While still holding the pen in the upright position, push in the black dose knob again and watch the needle tip for a drop of medicine to appear.
Waqt li tibqa żżomm il- pinna f’ pożizzjoni wieqfa, erġa mbotta l- buttuna s- sewda tad- doża u osserva l- ponta tal- labra għall- qatra ta ’ mediċina.
Repeat steps 8 and 9 until it appears.
Irrepeti passi 8 u 9 sakemm tidher.
Press the white reset button.
Għafas il- buttuna l- bajda li tirrisettja.
Set the required dose by turning the black dose knob.
Issettja il- doża meħtieġa billi ddawwar il- buttuna s- sewda tad- doża.
If you cannot dial the full dose, either start a new cartridge (as described in Part I), or inject the partial dose.
Jekk ma tkunx tista ’ tissettja d- doża kollha, jew ibda skartoċċ ġdid (kif deskritt f’ Parti I), jew injetta doża parzjali.
Then, start a new cartridge (as described in Part I) to administer the remaining portion of your medication.
Wara, ibda skartoċċ ġdid (kif deskritt f’ Part I) biex tagħti l- bqija tal- mediċina tiegħek.
Your doctor or nurse will advise you on the procedure for administering the last dose in the cartridge.
It- tabib jew in- ners tiegħek jgħarfuk dwar il- proċedura kif tieħu l- aħħar doża fl- iskartoċċ.
Prepare the injection site by wiping with an antiseptic impregnated swab.
Ipprepara il- post ta ’ l- injezzjoni billi timsaħha b’ imselħa mxarrba b’ antisettiku.
Injection sites include the upper arms, abdomen, and upper thighs.
Postijiet ta ’ injezzjoni jinkludu l- parti ta ’ fuq ta ’ l- idejn, żaqq, u l- parti ta ’ fuq tal- koxox.
Change the injection sites to avoid discomfort.
Ibdel il- postijiet ta ’ l- injezzjoni sabiex tevita uġigħ.
Even if you develop a preference for one site, you still should rotate the injection site.
Trid tbiddel il- post ta ’ l- injezzjoni anke jekk għandek preferenza għal- post wieħed.
Upper Arm
L- Parti ta ’ Fuq ta ’ l- Idejn
If you are using the passive shield (or no shield) proceed to step 13.
Jekk qed tuża l- protezzjoni passiva (jew l- ebda protezzjoni) mur
If you are using the active shield, slide the shield onto the pen and push the 2 black lock knobs on the needle shield toward the tip.
Jekk qed tuża il- protezzjoni attiva, żerżaq il- protezzjoni għal fuq il- pinna u mbotta ż - żewġ buttuni suwed li jsakkru fuq il- protezzjoni tal- labra lejn il- ponta.
Set the tip of the pen on the prepared injection site and press the needle into the skin by pushing the pen downward until the shield is totally depressed.
Issettja l- ponta tal- pinna fuq il- post ta ’ l- injezzjoni preparat u għafas il- labra ġol- ġilda billi timbotta l- pinna l- isfel sakemm il- protezzjoni tkun magħfusa għal kollox.
Your doctor or nurse will show
It- tabib jew in- ners tiegħek juruk kif tagħmel dan.
Now you are ready to administer the dose.
Issa inti lest biex tagħti d- doża.
Press down on the black dose knob.
Għafas l- isfel il- buttuna s- sewda tad- doża.
Wait 5 seconds after the button is pushed, then withdraw the pen from the skin.
Stenna 5 sekondi wara li tagħfas il- buttuna, wara iġbed il- pinna minn mal- ġilda.
A drop of blood may appear.
Tista ’ tara qatra demm.
Put a plaster on the injection site if you wish.
Jekk trid, waħħal tejp li teħel fuq il- post ta ’ injezzjoni.
Pull the needle shield off the pen (if you have used one) and place the larger needle cap on a flat surface.
Aqla ’ l- protezzjoni tal- labra minn fuq il- pinna (jekk użajt waħda) u poġġi l- għatu l- kbir tal- labra fuq wiċċ ċatt.
Slide the needle in to pick it up and push the cap completely down over the needle.
Daħħal il- labra fih sabiex tiġbru u imbotta l- għatu kompletament l- isfel fuq il- labra.
Twist off the needle and discard it properly.
Dawwar u aqla ’ l- labra u armijha kif suppost.
Your doctor or nurse will tell you how to dispose of the items you have used for the injection.
It- tabib jew in- ners tiegħek jgħidulek kif għandek tarmi l- oġġetti li wżajt għall- injezzjoni.
Always store your disposal container out of the reach of children.
Dejjen aħżen il- kontenitur tiegħek li fih tarmi l- oġġetti fejn ma jintlaħaqx mit- tfal.
Attach the pen cap and return it to its case with the black dose knob pressed in.
Waħħal l- għatu tal- pinna u rritornha fil- kaxxa tagħha bil- buttuna s- sewda tad- doża magħfusa l - ġewwa.
You should always store the pen in a refrigerator.
Għandek dejjem taħżen il- pinna fil- friġġ.
Do not remove cartridge between injections.
Tneħħix l- iskartoċċ bejn l- injezzjonijiet.
DO NOT FREEZE.
TIFFRIŻAX.
For subsequent injections with the NutropinAq Pen, attach a new needle, push the white reset button and dial your dose.
Għall- injezzjonijiet ta ’ wara bil- Pinna NutropinAq, waħħal labra ġdida, għafas il- buttuna l - bajda li tirresettja u ssettja d- doża tiegħek.
Part II:
Parti II:
Storage and Maintenance
Ħażna u Manutenzjoni
Follow these tips to ensure proper care of your NutropinAq Pen:
Seġwi dawn l- pariri sabiex tiggarantixxi kura xierqa tal- Pinna NutropinAq tiegħek:
• Always keep your NutropinAq Pen and cartridge refrigerated and protected from light when not in use. • You may remove the pen and cartridge from the refrigerator up to 45 minutes prior to use. • Do not let your NutropinAq Pen and/ or cartridge freeze.
• Dejjen żomm il- Pinna NutropinAq tiegħek u l- iskartoċċ fil- friġġ u pproteġijhom mid- dawl meta ma jkunux qed jintużaw. • Tista ’ neħħi l- pinna u l- iskartoċċ mill- friġġ sa 45 minuta qabel l- użu. • Tħallix il- Pinna NutropinAq u/ jew l- iskartoċc tiegħek jiffriżaw.
Contact your doctor or nurse for a replacement if either the pen or cartridge does not work. • Avoid excessive temperatures.
Kellem lit- tabib jew ners tiegħek għal sostituzzjoni jekk il- pinna jew l- iskartoċċ ma jaħdmux. • Evita temperaturi eċċessivi.
The solution in the cartridge is stable for up to 28 days after first use when stored at 2 - 8°C. • If your pen requires cleaning, do not place under water.
Is- soluzzjoni ta ’ l- iskartoċċ hija stabbli sa 28 ġurnata wara l- ewwel użu meta tinħażen f’ temperatura ta ’ 2 - 8°C. • Jekk il- pinna tiegħek tinħtieġ tindif, tpoġġijiex taħt l- ilma.
Use a damp cloth to wipe away dirt.
Uża biċċa mxarrba biex tneħħi l - ħmieġ.
Do not use alcohol. • When priming a new cartridge, you may need to repeat Part I, steps 8 and 9 up to a total of 6 times (0.6 mg) to remove air bubbles.
Tużax alkoħol. • Meta qed tipprepara skartoċċ ġdid, jista ’ jkollok bżonn tirrepeti Part I, passi 8 u 9 sa total ta ’ 6 darbiet (0. 6 mg) biex tneħħi l- bżieżaq ta ’ l- arja.
Small bubbles may remain and will not affect the dose. • The pen should contain the NutropinAq that is being used.
Bżieżaq żgħar jistgħu jibqgħu iżda ma jaffettwawx id- doża. • Il- pinna jrid ikun fiha NutropinAq li qed jintuża.
Do not remove cartridge between injections. • The NutropinAq cartridge may be used for up to 28 days. • Do not store the NutropinAq Pen with needle attached.
Tneħħix l- iskartoċċ bejn l- injezzjonijiet. • L- iskartoċċ ta ’ NutropinAq jista ’ jibqa jintuża sa 28 ġurnata. • Taħżinx il- Pinna NutropinAq bil- labra mwaħħla.
Part III:
Parti III:
Needles for the NutropinAq Pen
Labar għall- Pinna NutropinAq
Your doctor or nurse will recommend a needle that is appropriate for you.
It- tabib jew ners tiegħek jirrakomandawlek labra li hija xierqa għalik.
Always use the needles recommended.
Dejjen uża l- labar rakkomandati.
Needles from other countries may not fit on your NutropinAq Pen.
Labar minn pajjiżi oħra jistgħu ma jaqblux mal- Pinna NutropinAq tiegħek.
If you travel outside the European Union, make sure you take enough needles for the duration of your stay.
Jekk issiefer barra mill - Unjoni Ewropea, kun żgur li għandek biżżejjed labar għat- tul tas- safra.
Part IV:
Parti IV:
Commonly Asked Questions
Mistoqsijiet li Jinstaqsew Komunament
Q:
M:
Do I need to change the needle every time I use my NutropinAq Pen?
Għandi bżonn nibdel il- labra kull darba li nuża il- Pinna NutropinAq tiegħi?
A:
T:
Yes.
Iva.
A new needle should be used for every injection.
Labra ġdida trid tintuża għal kull injezzjoni.
The needle is only sterile on the first use.
Il- labra tkun sterili biss ma ’ l- ewwel użu.
Q:
35 M:
Where should I store my NutropinAq Pen?
Fejn għandi naħżen il- Pinna NutropinAq tiegħi?
Your NutropinAq Pen should be stored in the case, inside a refrigerator when a cartridge is inserted.
Trid taħżen il- Pinna NutropinAq fil- kaxxa, ġol- friġġ meta jiddaħħal skartoċċ.
When travelling, place your pen case in a cooler.
Meta tivvjaġġa, aħżen il- kaxxa tal- pinna f’ kaxxa li tkessaħ.
DO NOT FREEZE.
TIFFRIZAX.
34 Q:
M:
Why do I keep my medication in the refrigerator?
Għalfejn għandi nżomm il- mediċina tiegħi fil- friġġ?
To maintain its strength.
Sabiex iżżomm il- qawwa tagħha.
Can I store my NutropinAq Pen in the freezer?
Nista ’ naħżen il- Pinna NutropinAq tiegħi fil- friża?
No.
Le.
Freezing will damage the pen and medicine.
Jekk tiffriża tagħmel ħsara lill- pinna u lill- mediċina.
How long can I keep my NutropinAq Pen and cartridge outside the refrigerator?
Kemm nista ’ nżomm il- Pinna NutropinAq u l- iskartoċċ tiegħi barra mill- friġġ?
We recommend no longer than one hour.
Nirrakkomandaw mhux aktar minn siegħa.
Your doctor or nurse will advise you regarding pen storage.
It- tabib jew in- ners tiegħek javżawk dwar il- ħażna tal - pinna.
What is the maximum dose the NutropinAq Pen can deliver in one injection?
Liema hija d- doża massima li l- Pinna NutropinAq Pen tista ’ tagħti f’ injezzjoni waħda?
The NutropinAq Pen can give a minimum dose of 0.1 mg up to a maximum dose of 4.0 mg (40 clicks).
Il- Pinna NutropinAq tista ’ tagħti doża minima ta ’ 0. 1 mg sa doża massima ta ’ 4. 0 mg (40 ċekċika).
If you attempt to dose more than 4 mg at a time, the medicine will either be forced out of the needle and wasted or excess pressure will be placed upon the cartridge and it may crack.
Jekk tipprova tieħu doża ta ’ aktar minn 4 mg f’ darba, il- mediċina jew tiġi nbuttata l’ barra mill- labra u tintrema jew pressa żejda titpoġġa fuq l- iskartoċċ u dan jista ’ jixxaqqaq.
Is it possible to turn the black dose knob back if I click too many times?
Huwa possibbli li ndawwar il- buttuna s- sewda tad- doża lura jekk nfaqqaħha wisq drabi?
You can turn the black dose knob backwards until the correct number appears in the LCD.
Tista ’ ddawwar lura l- buttuna s- sewda tad- doża sakemm in- numru korrett jidher fuq l - LCD.
What should I do if there is not enough solution left in the cartridge for my next dose?
X’ għandi nagħmel jekk ma baqax biżżejjed soluzzjoni fl- iskartoċċ għad- doża tiegħi li tmiss?
Your doctor or nurse will advise you what to do for the last dose in the cartridge.
It- tabib jew in- ners tiegħek jgħarfuk dwar x’ tagħmel għal l- aħħar doża fl- iskartoċċ.
Why do I have to rewind the black dose knob on my NutropinAq Pen every time I replace the cartridge?
Għaliex għandi ndawwar lura il- buttuna s- sewda tad- doża fuq il- Pinna NutropinAq tiegħi kull darba li rrid nibdel l- iskartoċċ?
This ensures that the plunger push rod completely resets itself back to the starting position.
Dan jiggarantixxi li l- lasta tal- planġer tirrisettja kompletament lura fil- pożizzjoni tal- bidu.
If this is not done, liquid will come out of the needle when a new cartridge is placed into the pen.
Jekk dan ma jsirx, il- likwidu joħroġ mill- labra meta jitpoġġa skartoċċ ġdid fil- pinna.
Can I use my NutropinAq Pen without the shields?
Nista ’ nuża l- Pinna NutropinAq tiegħi mingħajr il- protezzjonijiet?
Your NutropinAq Pen works without shields.
Il- Pinna NutropinAq tiegħek taħdem mingħajr il- protezzjonijiet.
The shields are optional to help you administer your injection.
Il- protezzjonijiet m’ humiex obbligatorji sabiex jgħinuk tagħti l- injezzjoni tiegħek.
What should I do if I drop my NutropinAq Pen?
X’ nagħmel jekk inwaqqa il- Pinna NutropinAq tiegħi?
If you drop the NutropinAq Pen, check to see if the cartridge is damaged.
Jekk twaqqa l- Pinna NutropinAq Pen, iċċekkja jekk l- iskartoċċ għandux ħsara.
You should also check the pen to see that the black dose knob is moving up and down properly and that the LCD counter is working.
Għandek tiċċekkja wkoll il- pinna sabiex tara jekk il- buttuna s- sewda tad- doża jiċċaqlaqx l- fuq u l- isfel kif suppost u li l - apparat ta ’ l- għadd ta ’ l- LCD qiegħedx jaħdem.
If your cartridge or pen is damaged, ask your doctor or nurse for a replacement.
Jekk l- iskartoċċ jew il- pinna huma bil- ħsara, saqsi lit - tabib jew lin- ners tiegħek għal sostituzzjoni.
How long can I use my NutropinAq Pen?
Kemm nista ’ ndum nuża il- Pinna NutropinAq tiegħi?
The NutropinAq Pen is designed to last 24 months from the time you first use your pen.
Il- Pinna NutropinAq Pen hija maħsuba sabiex iddum 24 xhar minn meta tuża l- pinna l- ewwel darba.
What does a blinking ‘ bt’ mean in the LCD?
Xi tfisser ‘ bt ’ itteptep fl- LCD?
The battery in your NutropinAq Pen is losing its charge.
Il- batterija fil- Pinna NutropinAq tiegħek qed titlef iċ- ċarġ tagħha.
Please contact your doctor or nurse for a replacement pen.
Jekk jogħġbok kellem lit- tabib jew ners tiegħek biex tbiddel il- pinna.
Batteries typically last 24 months and have a 4-week life from the time the ‘ bt’ first starts blinking.
Batteriji ġeneralment iservu 24 xhar u għandhom ħajja ta ’ 4 ġimgħat minn meta ‘ bt ’ tibda tteptep.
How do I replace my NutropinAq Pen?
Kif nibdel il- Pinna NutropinAq tiegħi?
Contact your doctor or nurse if you need a replacement part or if you need to replace your entire pen.
Ikkuntattja it- tabib jew in- ners tiegħek jekk għandek bżonn tibdel xi parti jew jekk għandek bżonn tibdel il- pinna kollha.
For more information, please contact the local representative.
Għal aktar informazzjoni, jekk jogħġbok ikkuntattja ir- rappreżentant lokali.
Your local representative and the manufacturer for the NutropinAq Pen device are the same as for the medicinal product detailed overleaf.
Ir- rappreżentant lokali tiegħek u l- manifattur ta ’ l- apparat Pinna NutropinAq huma l- istess bħal dawk tal- prodott mediċinali deskritt qabel.
Please see section 6 overleaf for contact details.
Jekk jogħġbok ara sezzjoni 6 fil- paġni ta ’ qabel għad- dettalji tal- kuntatt.
CE 0459
36 CE 0459
London, 21 February 2008 Doc.
Londra, 21 ta ’ Frar 2008 Doc.
EMEA/ 166909/ 2008
EMEA/ 166896/ 2008
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NUTROPINAQ
MISTOQSIJA U TWEĠIBA DWAR L- IRTIRAR TA ’ L- APPLIKAZZJONI GĦAL MODIFIKA FL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ għal NUTROPINAQ
International non-proprietary name (INN): somatropin
Denominazzjoni Komuni Internazzjonali (DKI): somatropin
On 24 January 2008, Ipsen Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for NutropinAq, for the long-term treatment of children with severe idiopathic short stature.
Fl- 24 ta ’ Jannar 2008, Ipsen Ltd għarraf uffiċjalment lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) bl- intenzjoni li jirtira l- applikazzjoni tiegħu għal indikazzjoni ġdida għal NutropinAq, għat- trattament ta ’ tfal bi statura żgħira idjopatika gravi.
What is NutropinAq?
X’ inhu NutropinAq?
NutropinAq is a solution for injection in a cartridge, which contains the active substance somatropin.
NutropinAq huwa soluzzjoni għal injezzjoni fi skartoċċ, li fih s- sustanza attiva somatropin.
It is given by injection under the skin, using the injection pen specially designed for the cartridge.
Huwa jingħata b’ injezzjoni taħt il- ġilda, bl- użu ta ’ pinna għall- injezzjoni maħsuba speċifikament għall - iskartoċċ.
NutropinAq is already used to treat children in the following situations: • when they fail to grow because of a lack of growth hormone; • if they are short because of Turner syndrome (a rare genetic disorder affecting girls).
NutropinAq diġà jintuża biex jiġu kkurati tfal fis- sitwazzjonijiet li ġejjin • meta ma jikbrux minħabba nuqqas ta ’ l- ormon tat- tkabbir; • jekk ikunu qosra minħabba s- sindromu ta ’ Turner (disturb ġenetiku rari li jolqot il- bniet).
This must be confirmed by chromosome analysis (DNA testing); • before puberty, when they fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Dan irid jiġi kkonfermat b’ analiżi kromosomika (ittestjar tad- DNA); • qabel il- pubertà, meta ma jikbrux minħabba mard tal- kliewi li jkun ilu preżenti (insuffiċjenza renali kronika).
NutropinAq is used until the child receives a kidney transplant.
NutropinAq jintuża sakemm it- tifel/ tifla jirċievu trapjant tal- kliewi.
NutropinAq is also used to treat adults with growth hormone deficiency, as replacement therapy.
NutropinAq jintuża wkoll għat- trattament ta ’ adulti b’ defiċjenza ta ’ l- ormon tat- tkabbir, bħala terapija sostituttiva.
The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment begins.
Id- defiċjenza tista ’ tkun bdiet fit- tfulija jew f’ età adulta, u trid tiġi kkonfermata b’ testijiet qabel jinbeda t- trattament.
What was NutropinAq expected to be used for?
Għalxiex kien mistenni li jintuża NutropinAq?
In the new indication, NutropinAq was expected to be used to treat children with ‘ severe idiopathic short stature’ (severe growth impairment with no identifiable cause).
Fl- indikazzjoni l- ġdida, NutropinAq kien mistenni li jintuża biex jiġu kkurati tfal bi ‘ statura żgħira idjopatika gravi ’ (indeboliment gravi tat- tkabbir mingħajr ebda kawża identifikabbli).
It was to be used as long-term treatment in children who were predicted to be short, in comparison with their parents’ height, once they had reached adulthood.
Kien jintuża bħala trattament għal żmien twil fi tfal li kienu previsti li se jibqgħu qosra, meta mqabbla mat- tul tal - ġenituri tagħhom, meta jilħqu l- età adulta.
It was to be used if all possible causes of the child’ s short height had been excluded, such as low growth hormone levels.
Huwa kellu jintuża jekk ikunu ġew esklużi l- kawżi possibbli kollha tal- qosor tat- tifel/ tifla, per eżempju livelli baxxi ta ’ l- ormon tat- tkabbir.
How does NutropinAq work?
Kif huwa mistenni li jaħdem NutropinAq?
Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
L- ormon tat- tkabbir huwa sustanza li toħroġ minn glandola li tinsab fil- bażi tal- moħħ imsejħa l - glandola pitwitarja.
It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Huwa jippromwovi t- tkabbir matul it- tfulija u l- adoloxxenza, u jaġixxi wkoll fuq il- mod kif il- ġisem jimmetabolizza l- proteini, ix- xaħam u l- karboidrati.
The active ingredient in NutropinAq, somatropin, is identical to the human growth hormone.
Is- sustanza attiva f’ NutropinAq, somatropin, hija identika għall- ormon tat- tkabbir uman.
It is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce human growth hormone.
Hija prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: l- ormon isir b’ batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċi l- ormon tat- tkabbir uman.
What documentation did the company present to support its application to the CHMP?
X’ dokumentazzjoni ppreżentat il- kumpanija għas- sostenn ta ’ l- applikazzjoni tagħha lis- CHMP?
For the first year, the study compared the effectiveness of NutropinAq given three times a week with that of no treatment.
Il- kumpanija ppreżentat ir- riżultati ta ’ studju wieħed prinċipali li ħares lejn l- effikaċja ta ’ NutropinAq f’ 118- il tifel u tifla bi statura qasira li ma kellhomx defiċjenza ta ’ l- ormon tat- tkabbir jew xi kundizzjoni oħra identifikabbli li setgħet tikkawża l- indeboliment tagħhom tat- tkabbir.
This was based on the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Għall- ewwel sena, l- istudju qabbel l- effikaċja ta ’ NutropinAq mogħti tliet darbiet fil- ġimgħa ma ’ dik ta ’ l- ebda 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. difference between the height that each child was predicted to reach based on their height and bone maturity before they started to receive NutropinAq, and their actual height when they had reached adulthood.
Wara dan, id- disinn ta ’ l- istudju nbidel sabiex il- pazjenti ngħataw NutropinAq jew tliet darbiet fil- ġimgħa jew darba kuljum.
In total, the children received the medicine for up to ten years.
Il- kejl prinċipali ta ’ l- effikaċja kien iż- żieda fit- tul ta ’ l- adulti.
How far into the evaluation was the application when it was withdrawn?
Sa fejn kienet waslet l- evalwazzjoni ta ’ l- applikazzjoni qabel ma din ġiet irtirata?
The evaluation had finished and the CHMP had given a negative opinion.
L- evalwazzjoni waslet fi tmiemha u s- CHMP kien ħareġ opinjoni negattiva.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Il- kumpanija kienet talbet eżami mill- ġdid ta ’ l- opinjoni negattiva, iżda din kienet għadha ma ntemmitx meta l- kumpanija rtirat.
Based on the review of the data and the company’ s response to the CHMP’ s list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of NutropinAq for the long-term treatment of children with severe idiopathic short stature.
Abbażi ta ’ l- analiżi tad- dejta u t- tweġiba mogħtija mill- kumpanija għal- lista ta ’ mistoqsijiet tas- CHMP fi żmien l- irtirar, is- CHMP kien ta opinjoni negattiva u ma rrakkomandax l- approvazzjoni ta ’ NutropinAq għat- trattament fuq perjodu fit- tul ta ’ tfal bi statura żgħira idjopatika gravi.
What were the major concerns of the CHMP?
X’ kien it- tħassib ewlieni tal- CHMP?
The CHMP was concerned that only a modest benefit of NutropinAq in severe idiopathic short stature had been demonstrated, with an average gain in final adult height of around 6 to 7 cm in the main study.
Is- CHMP kien imħasseb li kien intwera biss benefiċċju modest ta ’ NutropinAq fi statura żgħira idjopatika gravi, b’ żieda medja fit- tul adult finali ta ’ madwar 6 sa 7 ċentimetri fl- istudju prinċipali.
In addition, a benefit of the medicine in improving the child’ s psychological or social wellbeing had not been shown.
Barra minn hekk, ma kienx intwera benefiċċju tal- mediċina fit- titjib tal- benesseri psikoloġiku jew soċjali tat- tifel jew tifla.
The Committee raised a concern that the use of NutropinAq for the long periods necessary to treat severe idiopathic short stature might increase the risk of the development of tumours or diabetes later in life.
Il- Kumitat qajjem tħassib li l- użu ta ’ NutropinAq għall- perjodi twal neċessarji biex tiġi trattata statura żgħira idjopatika gravi jista ’ jżid ir- rikju ta ’ l- iżvilupp ta ’ tumuri jew dijabete aktar ’ il quddiem fil- ħajja.
Therefore, at the time of the withdrawal, the CHMP’ s view was that that the benefits of NutropinAq in the long-term treatment of children with severe idiopathic short stature did not outweigh its possible risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċji ta ’ NutropinAq fit- trattament fuq perjodu fit- tul ta ’ tfal bi statura żgħira idjopatika gravi ma kinux jegħlbu r- riskji possibbli tiegħu.
What were the reasons given by the company for withdrawing the application?
X’ kienu r- raġunijiet mogħtija mill- kumpanija għall- irtirar ta ’ l- applikazzjoni?
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA dwar l- irtirar ta ’ l- applikazzjoni tinsab hawn.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using NutropinAq?
X’ inhuma l- konsegwenzi ta ’ l- irtirar għal dawk il- pazjenti li jkunu involuti fi provi kliniċi jew programmi ta ’ użu b’ kumpassjoni bl- użu ta ’ NutropinAq?
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with NutropinAq in this indication.
Il- kumpanija għarrfet lis- CHMP li ma kienu għaddejjin ebda provi kliniċi jew programmi ta ’ użu b’ kumpassjoni fl- Ewropa b’ NutropinAq f’ din l- indikazzjoni.
What is happening for NutropinAq for treatment of failure to grow due to growth hormone deficiency, Turner syndrome or chronic renal insufficiency?
X’ jiġri b’ NutropinAq għat- trattament tan- nuqqas ta ’ tkabbir minħabba defiċjenza ta ’ l- ormon tat- tkabbir, is- sindromu ta ’ Turner jew insuffiċjenza renali kronika?
There are no consequences on the use of NutropinAq in the authorised indications, for which the balance of benefits and risks remains unchanged.
Ma hemm l- ebda konsegwenza fuq l- użu ta ’ NutropinAq fl- indikazzjonijiet awtorizzati, fejn il- bilanċ bejn il- benefiċċju u r- riskju jibqa ’ kif kien.
What is Olanzapine Mylan?
X’ inhu Olanzapine Mylan?
Olanzapine Mylan is a medicine containing the active substance olanzapine.
Olanzapine Mylan huwa mediċina li fiha s- sustanza attiva olanzapine.
2.5, 5, 7.5 and 10 mg; oval:
2. 5, 5, 7. 5 u 10 mg; ovali:
15 and 20 mg).
15 mg u 20 mg).
Olanzapine Mylan is a ‘ generic medicine’.
Olanzapine Mylan huwa ‘ mediċina ġenerika ’.
This means that Olanzapine Mylan is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Zyprexa.
Dan ifisser li Olanzapine Mylan huwa simili għall - ‘ mediċina ta ’ referenza ’ diġà awtorizzata fl- Unjoni Ewropea (UE) li jisimha Zyprexa.
For more information on generic medicines, see the question-and-answer document here.
Għall- aktar informazzjoni dwar il- mediċini ġeneriċi, ara d- dokument mistoqsija- u- tweġiba hawn.
What is Olanzapine Mylan used for?
Għal xiex jintuża Olanzapine Mylan?
Olanzapine Mylan is used to treat adults with schizophrenia.
Olanzipine Mylan jintuża fit- trattament tal- iskizofrenija.
Olanzapine Mylan is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Din hija marda mentali, li għandha numru ta ’ sintomi, inkluż disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (jiġifieri d- dehra u s- smigħ ta ’ affarijiet li jkunu immaġinarji), suspetti u delirji (thewdin u ħsibijiet żbaljati). Olanzine Mylan huwa effikaċi wkoll biex iżomm it- titjib li jkun sar f’ pazjenti li jkunu rrispondew għal kors inizjali ta ’ trattament.
Olanzapine Mylan is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Olanzine Mylan tintuża wkoll fit- trattament ta ’ episodji moderati jew severi tal- manija (burdata tajba b’ mod estrem) f’ adulti.
It can also be used to prevent the recurrence (when symptoms come back) of these episodes in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Jista ’ jintuża wkoll biex jipprevjeni li sintomi ta ’ dawn l- episodji jerġgħu jitfaċċaw f’ pazjenti b’ disturbi polari (marda mentali b’ perjodi jalternaw bejn burdata tajba ħafna u depressjoni) li jkunu rrispondew għal kors inizjali ta ’ trattament.
How is Olanzapine Mylan used?
Kif tintuża Olanzapine Mylan?
The recommended starting dose of Olanzapine Mylan tablets depends on the disease being treated:
Id- doża inizjali rrakomandata ta ’ Olanzapine Mylan tiddependi mill- marda li tkun qed tiġi ttrattata:
10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Doża ta ’ 10 mg kuljum tintuża għall- iskizofrenija u fil- prevenzjoni ta ’ episodji manijaċi, u 15 mg kuljum fit- trattament ta ’ episodji manijaċi, sakemm ma tintużax ma ’ mediċini oħra, f’ liema każ id - doża tal- bidu tista ’ tkun ta ’ 10 mg kuljum.
The dose is adjusted depending on how well the patient responds to and tolerates the treatment.
Id- doża tiġi adattata skont kemm il- pazjent jirrispondi tajjeb għat- trattament u jittollerah.
The usual dose range is between 5 and 20 mg per day.
Id- doża normali tvarja bejn 5 u 20 mg kuljum.
Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Il- pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil- fwied jew fil- kliewi tagħhom jista ’ jkollhom bżonn ta ’ doża iktar baxxa fil- bidu 5 mg kuljum.
Olanzapine Mylan is not recommended for use in patients below 18 years of age because of a lack on information on safety and effectiveness in this age group.
Olanzapine Mylan mhuwiex rakkomandat sabiex jintuża f’ pazjenti ta ’ inqas minn 18- il sena minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l - effikaċja f’ dan il- grupp.
Reproduction is authorised provided the source is acknowledged. receptors on the surface of nerve cells in the brain.
Kif taħdem Olanzapine Mylan?
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Dan ifixkel is - sinjali trażmessi bejn iċ- ċelloli tal- moħħ permezz ta ’ ‘ newrotrażmettituri ’, sustanzi kimiċi li jħallu liċ - ċelloli tal- moħħ jikkomunikaw ma ’ xulxin.
It is thought that olanzapine’ s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Hu maħsub li l- effett benefiku ta ’ olanzapine huwa dovut għall- imblokkar tar- riċetturi għan- newrotrażmettituri 5- idrossitriptamina (5- hydroxytrypamine, msejħa wkoll serotonina) u dopamina.
Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Billi dawn in- newrotrażmettituri għandhom sehem fl- iskizofrenija u fid- disturbi bipolari, olanzapine jgħin fin- normalizzazzjoni tal- attività tal- moħħ, u b’ hekk inaqqas is - sintomi ta ’ dawn il- mardiet.
How has Olanzapine Mylan been studied?
Kif ġie studjat Olanzapine Mylan?
Because Olanzapine Mylan is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Minħabba li Olanzapine Mylan huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jintwera li hija bijoekwivalenti għall- mediċina ta ’ referenza (huma jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What is the risk associated with Olanzapine Mylan?
X' inhu r- riskju assoċjat ma ’ Olanzapine Mylan?
Because Olanzapine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Minħabba li Olanzapine Mylan huwa mediċina ġenerika u hija bijoekwivalenti għall- mediċina ta ’ referenza, il- benefiċċju u r- riskju tiegħu huma meqjusa li huma l- istess bħal dawk tal- mediċina ta ’ referenza.
Why has Olanzapine Mylan been approved?
Għaliex ġie approvat Olanzapine Mylan?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Mylan has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mar- rekwiżiti tal- UE, intwera li Olanzine Mylan għandu kwalità komparabbli ma ’ Zyprexa u li hija bijoekwivlenti għal din il- mediċina tal- aħħar.
Therefore, the CHMP’ s view was that, as for Zyprexa, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal f’ Zyprexa, il- benefiċċji jegħlbu r- riskji identifikati.
The Committee recommended that Olanzapine Mylan be given marketing authorisation.
Il- Kumitat irrakkomanda li Olanzapine Mylan jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Olanzapine Mylan:
Tagħrif ieħor dwar Olanzapine Mylan:
The European Commission granted a marketing authorisation valid throughout the European Union for Olanzapine Mylan to Generics [UK] Ltd. on 7 October 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Olanzapine Mylan lil Generics [UK] Ltd. fil- 7 ta ’ Ottubru 2008.
The full EPAR for Olanzapine Mylan can be found here.
L- EPAR sħiħ għal Olanzapine Mylan jista ’ jiġi kkonsultat hawn.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
L- EPARs sħaħ għall- mediċina ta ’ referenza huma disponibbli fuq il- websajt tal- EMEA wkoll.
Olanzapine Mylan 2.5 mg film-coated tablets
OLANZAPINE MYLAN 2. 5 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 2.5 mg olanzapine.
Kull pillola miksija b’ rita fiha 2. 5 mg olanzapine.
For the 2.5 mg:
Sustanzi mhux attivi Għal dik ta ’ 2. 5 mg:
Each film-coated tablet contains 76 mg lactose anhydrous.
Kull pillola miksija b’ rita fiha 76 mg anhydrous lactose.
The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin
Sustanzi mhux attivi Ir- rita li tiksi kull pillola ta ’ 2. 5 mg fiha 0. 06 mg leċitin tas- soja.
7.0 mm, round, normal convex, white film-coated tablets debossed “ OZ 2.5 ” on one side and “ G” on the other side.
7. 0 mm, tonda, mżaqqa normali, pilloli bojod miksija b’ rita b ’ “ OZ 2. 5 ” imnaqqax fuq naħa waħda u b ’ “ G ” fuq in- naħa l- oħra.
Adults Olanzapine is indicated for the treatment of schizophrenia.
Adulti Olanzapine hija indikata għat- trattament tal- iskiżofrenja.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine hija effettiva biex iżomm it- titjib kliniku waqt terapija kontinwa f' pazjenti li wrew reazzjoni għat- trattament tal- bidu.
Olanzapine is indicated for the treatment of moderate to severe manic episode.
Olanzapine hija indikata għat- trattament ta 'episodju ta' manija moderat jew serju.
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
F' pazjenti li l- episodju ta 'manija tagħhom irreaġixxa għat- trattament ta ’ olanzapine, olanzapine hija indikata għall- prevenzjoni ta' rikorrenza f' pazjenti b' diżordni bipolari (ara sezzjoni 5. 1).
Adults Schizophrenia:
Adulti Skiżofrenja:
The recommended starting dose for olanzapine is 10 mg/ day.
Id- doża tal- bidu rakkomandata għal olanzapine hija 10 mg/ ġurnata.
Manic episode:
Episodju ta 'manija:
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Id- doża tal- bidu hija ta '15 mg bħala doża waħda kuljum bil- monoterapija jew 10 mg kuljum f' terapija flimkien ma' xi sustanza oħra (ara sezzjoni 5. 1).
Preventing recurrence in bipolar disorder:
Il- prevenzjoni tar- rikorrenza fid- diżordni bipolari:
The recommended starting dose is 10 mg/ day.
Id- doża rakkomandata tal- bidu hija 10 mg/ ġurnata.
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Għall- pazjenti li diġà qegħdin jieħdu olanzapine biex ikun trattat episodju ta 'manija, kompli t- terapija bl- istess doża għall- prevenzjoni tar- rikorrenza.
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Jekk ikun hemm episodju ġdid ta 'manija, imħallat, jew ta' depressjoni, it- trattament b ’ olanzapine għandu jitkompla (bl- aħjar użu tad- doża skond il- bżonn), b' terapija supplimentari biex ikunu trattati s- sintomi tal- burdata, kif indikat klinikament.
2 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Żjieda għal doża akbar mid- dża tal- bidu rakkomandata għandha tingħata biss wara rivalutazzjoni klinika xierqa u ġeneralment għandha ssir f' intervalli ta 'mhux anqas minn 24 siegħa.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine tista 'tingħata fuq l- ikel jew fuq stonku vojt għax l - assorbiment ma jiġix affettwat mill- ikel.
Gradual tapering of the dose should be considered when discontinuing olanzapine.
It- tnaqqis gradwali tad- doża għandu jiġi kkunsidrat meta titwaqqaf olanzapine.
Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Fl- istudji ta ’ terminu qasir, ġie rrapportat ammont akbar ta ’ żieda fil- piż u tibdil fix- xaħmijiet u prolactin f’ pazjenti adolexxenti milli fl- istudji ta ’ pazjenti adulti (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Anzjani Doża anqas tal- bidu (5 mg/ ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara sezzjoni 4. 4).
A lower starting dose (5 mg) should be considered for such patients.
Indeboliment renali u/ jew epatiku Għandu jiġi kkunsidrat tnaqqis fid- doża inizjali (5 mg/ ġurnata) għal dawn il- pazjenti.
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
F' każijiet ta 'insuffiċjenza epatika moderata (ċirrożi, Child- Pugh Klassi A jew B), id- doża inizjali għandha tkun 5 mg u tiżdied biss b' kawtela.
The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Sess Id- doża tal- bidu u l- firxa tad- doża m' għandhomx għalfejn jinbidlu normalment għall- pazjenti nisa f' paragun ma 'pazjenti rġiel.
The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Dawk li jpejpu Id- doża tal- bidu u l- medda tad- dożi m' għandhomx għalfejn jinbidlu normalment għal dawk li ma jpejpux f' paragun ma 'dawk li jpejpu.