qanastek/EMEA-V3 huggingface dataset:
Any air bubbles will collect at the top of the cartridge • Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture B) • Still with the needle upwards, press the push-button fully down (picture C) • A drop of insulin should appear at the needle tip.
Jekk ikun hemm xi bżieżaq ta ’ l- arja dawn ser jinġabru fin- naħa ta ’ fuq ta ’ l- iskartoċċ • Bil- labra dejjem tħares ’ il fuq, dawwar l- iskartoċċ bi klikk waħda fid- direzzjoni tal- vleġġa (stampa B • Bil- labra għadha tipponta ’ l fuq, agħfas il- buttuna ta ’ l- injezzjon ’ l isfel kemm tista ’ (stampa C) • Qatra insulina għandha tidher fil- ponta tal- labra.
If a drop of insulin still does not appear, the device is defective and must not be used.
Jekk xorta ma tidhirx qatra insulina, l- apparat huwa difettuż u m’ għandux jintuża.
• Put the cap back on the pen, with 0 next to the dosage indicator (picture D) • Check that the push-button is fully down.
• Erġa 'poġġi l- għatu fuq il- pinna, biż- 0 biswit l- indikatur tad- doża (stampa D) • Iċċekkja li l- buttuna ta ’ l- injezjoni tkun kollha ’ l ġewwa, Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun kollha ’ l ġewwa
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your NovoRapid NovoLet horizontally.
104 • Żomm n- NovoRapid NovoLet tiegħek b' mod orizzontali.
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture E) to set the right dose.
Issa inti lest/ a biex tissettja d- doża li teħtieġ • Dawwar l- għatu fid- direzzjoni tal- vleġġa (stampa E) biex tissettja d- doża korretta.
You’ ll feel the cap clicking, and the push-button will rise up • Don’ t put your hand over the push-button when you set the dose.
Ser tħoss l - għatu jikklikkja, u l- buttuna ta ’ l- injezzjoni ser titla '’ l fuq. • Tpoġġix idek fuq il- buttuna ta ’ l- injezzjoni meta tissettja d- doża.
To set 8 units:
Eżempji ta ’ dożi Biex tissettja 8 unitajiet:
To select 26 units:
Dawwar l- għatu sakemm l- indikatur tad- doża jiġi fuq 8; erba ’ tfaqqigħat Biex tagħżel 26 unità:
Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again.
Dawwar l- għatu tidwira sħiħa sakemm l- indikatur tad- doża jiġi fuq 0 mill- ġdid.
You’ ve now set 20 units.
Hekk tkun issettjajt 20 unità.
Keep turning the cap until 6 is opposite the dosage indicator.
Ibqa ’ dawwar l- għatu sakemm l- indikatur tad- doża jiġi fuq 6.
On the push-button scale you’ ll see a 20- line.
Fuq l- iskala tal- buttuna ta ’ l - injezzjoni għandek tara linja li timmarka 20.
Add the 6 from the dosage indicator to the 20 on the push-button scale.
Żid is- 6 mill- indikatur tad- doża ma ’ l- 20 fuq l- iskala tal- buttuna ta ’ l- injezzjoni.
There, you’ ve set 26 units (picture F).
Hekk, issettjajt 26 unità (stampa F).
• Note the figure on the cap next to the dosage indicator • Note the highest figure you can see on the push-button scale • Add the two together to show the dose you set • If you have set a wrong dose, simply turn the cap forwards or backwards until you set the right number of units.
Biex tiċċekkja d- doża li tkun issettjajt • Innota n- numru fuq l- għatu biswit l- indikatur tad- doża • Innota l- ogħla numru li tista 'tara fuq l- iskala tal- buttuna ta ’ l- injezzjoni • Għodd iż- żewġ numri biex tara d- doża li tkun issettjajt • Jekk tkun issettjajt doża ħażina, sempliċiment dawwar l- għatu ’ l quddiem jew lura sakemm tissettja n- numru korrett ta' unitajiet.
The maximum dose is 78 units
Inkella, l- insulina ser tnixxi mil- labra u d- doża mhix ser tkun korretta. • Jekk, bi żball, tkun ippruvajt tissettja doża ogħla minn 78 unità, segwi dawn il- passi:
• Don’ t try to set a dose higher than 78 units.
105 • Dawwar l- għatu lura kemm tista '.
Turn it till the push-button is fully down and you can feel resistance. • Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator.
Dawru sakemm il- buttuna ta ’ l- injezzjoni tkun ’ l isfel għal kollox u tkun tista ’ tħoss ir- reżistenza. • Imbagħad neħħi l- għatu u erġa 'poġġih f' postu, u agħmel iż- 0 biswit l- indikatur tad- doża.
Now set the dose again. • Remember that 78 units is the maximum dose. • After the dose is set, remove the cap to inject the insulin.
Issa, issettja d- doża mill- ġdid. • Ftakar li 78 unità hi d- doża massima. • Wara li d- doża tkun issettjata, neħħi l- għatu biex tinjetta l- insulina.
102 Injecting the insulin
Kif tinjetta l- insulina
Use the injection technique advised by your doctor • Deliver the dose by pressing the push-button all the way in.
Uża t- teknika ta ’ l- injezzjoni kif tak parir it- tabib tiegħek. • Agħti d- doża billi tagħfas il- buttuna ta ’ l- injezzjoni ’ l isfel kemm tista ’.
Be careful only to push the push-button when injecting • Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
Oqgħod attent/ a li tagħfas il- buttuna ta ’ l- injezzjoni biss meta tkun qed tinjetta • Wara l- injezzjoni żomm il- buttuna ta ’ l- injezzjon magħfusa kollha ’ l isfel sakemm il- labra tkun inġibdet ’ il barra minn ġol- ġilda.
• Always check that the push-button is completely down.
Injezzjonijiet sussegwenti • Dejjem iċċekkja li l- buttuna ta ’ l- injezzjoni tkun kompletament magħfusa ’ l isfel.
If not, turn the cap until the push- button is fully depressed, then proceed as described in Getting started • You may hear a clicking sound when you press the push-button.
Jekk dan ma jkunx l- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa kollha ’ l isfel, imbagħad kompli kif deskritt fis- sezzjoni Kif tibda • Tista 'tisma' ħoss ta 'klikk meta tagħfas il- buttuna ta ’ l- injezzjoni.
But you can’ t use it to set or select your dose.
Tużahiex biex tissettja jew biex tiċċekkja d- doża tiegħek; din tista 'ma tagħtikx informazzjoni preċiża • Ma tistax tissettja doża akbar min- numru ta ’ unitajiet li jkun fadal fl- iskartoċċ • Tista' tuża l- indikatur tal- livell ta 'l- insulina biex tagħmel stima ta' kemm baqa 'insulina, iżda ma tistax tużah biex tissettja jew tagħżel id- doża.
• Replace the big outer needle cap and unscrew the needle • Dispose of it carefully.
• Erġa 'poġġi f' postu l- għatu l- kbir ta ’ barra tal- labra u ħoll il- labra. • Armiha bl- attenzjoni.
Remove and discard the needle after each injection and store NovoRapid NovoLet without the needle attached.
Neħħi u armi l- labra wara kull injezzjoni u aħzen NovoRapid Novolet mingħajr ma l- labra tkun imwaħħla.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
Inkella l- likwidu jista ’ jċarċar ’ il barra u jista ’ jkun il- kawża ta ’ teħid ta ’ doża żbaljata.
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
Professjonisti tal- kura tas- saħħa, qraba jew min ikun li jieħu ħsiebek għandhom isegwu l- miżuri neċċessarji għat- tneħħija u r- rimi ta ’ labar biex jiġi eliminat kull riskju ta ’ tingiż aċċidentali.
Close your NovoRapid NovoLet fully with 0 next to the dosage indicator.
Erġa ’ poġġi l- għatu fuq in- NovoRapid NovoLet tiegħek bl- indikatur tad- doża fuq iz- 0.
Dispose of your used NovoRapid NovoLet carefully without the needle attached.
Oqgħod attent kif tarmi n- NovoRapid NovoLet użata tiegħek u aċċerta ruħek li tkun neħħejt il- labra.
Your NovoRapid NovoLet is designed to work accurately and safely.
NovoRapid NovoLet hija maħsuba li taħdem bi preċiżjoni u sikurezza.
It must be handled with care.
Għandha tintuża bl- attenzjoni.
You can clean the exterior of your NovoRapid NovoLet by wiping it with a medicinal swab.
Tista ’ tnaddaf il- parti ta ’ barra ta ’ NovoRapid NovoLet billi timsaħa b’ tajjara b’ diżinfettant.
Do not soak it, wash or lubricate it as this may damage the mechanism.
M’ għandekx ixxarrabha, taħsilha jew tillubrikaha. Dan jista ’ jagħmel ħsara lill- mekkaniżmu.
Do not refill NovoRapid NovoLet.
Terġax timla NovoRapid NovoLet mill- ġdid.
103 PACKAGE LEAFLET:
106 FULJETT TA ’ TAGĦRIF:
NovoRapid FlexPen 100 U/ ml solution for injection in a pre-filled pen insulin aspart
NovoRapid FlexPen 100 U/ ml soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest insulin aspart
You may need to read it again – If you have any further questions, ask your doctor, nurse or pharmacist – This medicine has been prescribed for you personally.
Jista ’ jkollok bżonn terġa ’ taqrah – Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib, lill- infermier/ a jew lill- ispiżjar tiegħek. – Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or your pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermier/ a jew lill- ispiżjar tiegħek.
This side of the leaflet:
F’ dan il- fuljett:
Overleaf:
Fuq in- naħa ta ’ wara:
How to use your FlexPen.
Kif tuża l- FlexPen tiegħek
It comes in a 3 ml pre-filled pen, called FlexPen – see overleaf for detailed instructions.
Jiġi f’ pinna mimlija għal- lest ta ’ 3 ml, bl- isem ta ’ FlexPen - ara fuq in- naħa ta ’ wara għal istruzzjonijiet dettalljati.
Your need for insulin may change ► If you have an infection, fever or an operation you may need more insulin than usual ► If you suffer from diarrhoea, vomiting or eat less than usual you may also need less insulin than usual
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel ►
104 ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of the injections.
107 Jekk għandek infezzjoni, deni jew operazzjoni jista ’ jkollok bżonn tieħu aktar insulina mis - ► soltu Jekk tbati minn dijarrea, rimettar jew tiekol inqas mis- soltu, jista ’ wkoll ikollok bżonn ► inqas insulina mis- soltu Jekk se ssiefer: l- ivvjaġġar minn żona ta ’ ħin għall- oħra jista ’ jaffettwalek il- ħtiġijiet għall - ► insulina u l- ħin meta tieħu l- injezzjonijiet.
Talk about your insulin needs with your doctor and nurse.
Kellem lit- tabib jew lill- infermier/ a tiegħek dwar il- ħtiġijiet tiegħek għall- insulina.
Injecting the insulin
L- injezzjoni ta ’ l- insulina
See overleaf for detailed instructions.
Għal istruzzjonijiet dettalljati ara fuq in- naħa ta ’ wara tal- fuljett
Before using NovoRapid
108 Qabel ma tuża NovoRapid
► Check the label to make sure it is the right type of insulin ► Always use a new needle for each injection to prevent contamination.
Iċċekkja t- tikketta biex taċċerta li hija t- tip korrett ta ’ insulina ► ► Għal kull injezzjoni dejjem uża labra ġdida sabiex tevita l- kontaminazzjoni
105 NovoRapid must not be used
NovoRapid m’ għandux jintuża
► If the FlexPen is dropped, damaged or crushed, there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoRapid) ► If the insulin does not appear clear and colourless.
Jekk il- FlexPen titwaqqa ’, tiġrilha l- ħsara jew titgħaffeġ, hemm riskju ta ’ ħruġ ta ’ insulina ► Jekk ma ġiex maħżun tajjeb jew jekk ġie ffriżat (ara 6 Kif taħżen NovoRapid) ► Jekk l- insulina ma tidhirx ċara u bla kulur. ►
To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.
Biex tieħu l- benefiċċji ta ’ l- infużjoni ta ’ l- insulina, u biex tiskopri l- eventwalità ta ’ ħsara fil- pompa ta ’ l- insulina, hu rakkomandat li inti tiċċekkja l- livell taz- zokkor fid- demm regolarment.
Don’ t take any insulin if you feel a hypo coming on.
Tiħux insulina: jekk tħoss li ġejja xi ipo.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and get medical help straight away.
M’ għandhomx jagħtuk ikel jew xorb, għax tista ’ tifga.
106 Using glucagon
Kif tuża glucagon
(Lipodystrophy).
110 Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
107 Seek medical advice immediately: • If signs of allergy spread to other parts of your body, or • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
Fittex parir mediku minnufih: • Jekk is- sinjali ta ’ l- allerġija jinxterdu għal partijiet oħrajn tal- ġisem, jew • Jekk tħossok ma tiflaħx f’ daqqa, u: tibda tegħreq; tibda titqalla ’ (tirrimetti); ikollok diffikultà biex tieħu n- nifs; ikollok taħbit mgħaġġel tal- qalb; tħossok stordut.
NovoRapid FlexPen that is not being used is to be stored at 2°C – 8°C in the refrigerator, away from the freezer compartment.
NovoRapid FlexPen li mhux qeda tintuża għandha tinħażen fi friġġ f’ temperatura ta ’ 2°C - 8°C, ’ il bogħod mill- kompartiment tal- friża.
NovoRapid FlexPen that is being used or about to be used is not to be kept in the refrigerator.
NovoRapid FlexPen li qeda tintuża jew li dalwaqt se tintuża m’ għandiex tinżamm fil- friġġ.
Always keep the pen cap on your FlexPen when you’ re not using it in order to protect it from light.
Dejjem żomm l- iskartoċċ fil- kartuna ta ’ barra meta mhux qed tużah sabiex tilqa ’ mid- dawl.
What NovoRapid looks like and contents of the pack
111 Id- dehra ta 'NovoRapid u l- kontenuti tal- pakkett
The solution for injection comes as a clear, colourless, aqueous solution in packs of 1, 5 or 10 pre- filled pens of 3 ml (not all packs may be marketed).
Is- soluzzjoni għall- injezzjoni tiġi bħala soluzzjoni akweja, ċara u bla kulur, f' pakketti ta’ 1, 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml (mhux il- pakketti kollha jistgħu jkunu fis- suq).
1 pre-filled pen contains 3 ml equivalent to 300 U.
Pinna waħda mimlija għal- lest fiha 3 ml li huma ekwivalenti għal 300 U.
108 Manufacturer The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
Il- manifattur jista ’ jiġi identifikat permezz tan- numru tal- lott ipprintjat fuq il- kartuna u fuq it- tikketta:
Now turn for information on how to use your FlexPen.
Għal informazzjoni dwar kif tuża l- FlexPen tiegħek dawwar il- paġna.
109 Introduction
112 Introduzzjoni
Please read the following instructions carefully before using your NovoRapid FlexPen.
Jekk jogħġbok aqra sew l- istruzzjonijiet li ġejjin qabel ma tuża NovoRapid FlexPen tiegħek.
Your NovoRapid FlexPen Pen cap
NovoRapid® FlexPen® Tiegħek Għatu tal- pinna
needle cap needle cap
ġewwa tal - labra
tab
Manutenzjoni
Preparing your NovoRapid FlexPen
Kif tipprepara NovoRapid FlexPen tiegħek
110 Disinfect the rubber membrane with a medicinal swab.
Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali.
To avoid injection of air and ensure proper dosing:
114 Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett:
111 E Turn the dose selector to select 2 units.
E Dawwar is- selettur tad- doża sabiex tisselezzjona 2 unitajiet.
H Turn the dose selector to select the number of units you need to inject.
115 H Dawwar is- selettur tad- doża sabiex tisselezzjona n- numru ta ’ unitajiet li jkollok bżonn tinjetta
The dose can be corrected either up or down by turning the dose selector in either direction until the
Id- doża tista ’ tkun aġġustata kemm ’ il fuq u kemm ’ l isfel billi ddawwar is- selettur tad- doża f’ direzzjoni jew oħra sakemm l- indikatur ikun fuq id- doża li tkun trid.
113 K Lead the needle into the big outer needle cap without touching the big outer needle cap.
K Qiegħed il- labra fl- għatu l- kbir ta ’ barra tal- labra mingħajr ma tmiss l- għatu l- kbir ta ’ barra tal- labra.
When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Meta l- labra tkun mgħottija, b’ attenzjoni imbotta l- għatu l- kbir ta ’ barra tal- labra biex jngħalaq sew fuq il- pinna u imbagħad ħoll il- labra.
NovoRapid InnoLet 100 U/ ml solution for injection in a pre-filled pen insulin aspart
NovoRapid InnoLet 100 U/ ml soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest insulin aspart
This side of the leaflet:
Fuq din in- naħa tal- fuljett:
What NovoRapid is and what it is used for 2.
X’ inhu NovoRapid u għaliex jintuża 2.
How to use your InnoLet.
Kif tuża l- InnoLet tiegħek
It comes in a 3 ml pre-filled pen, called InnoLet – see overleaf for detailed instructions.
Jiġi f’ pinna mimlija għal- lest ta ’ 3 ml, bl- isem ta ’ InnoLet - ara fuq in- naħa ta ’ wara għal istruzzjonijiet dettalljati.
Your need for insulin may change ► If you have an infection, fever or an operation you may need more insulin than usual ► If you suffer from diarrhoea, vomiting or eat less than usual you may also need less insulin than usual
118 Jekk qed tagħmel eżerċizzju aktar mis- soltu jew jekk tixtieq tibdel id- dieta tas- soltu ► Jekk int marid: kompli ħu l- insulina tiegħek.
115 ► If you are going abroad: travelling over time zones may affect your insulin needs and the timing of the injections.
Il- ħtieġa tiegħek għall- insulina tista ’ tinbidel ► Jekk għandek infezzjoni, deni jew operazzjoni jista ’ jkollok bżonn tieħu aktar insulina mis - ► soltu Jekk tbati minn dijarrea, rimettar jew tiekol inqas mis- soltu, jista ’ wkoll ikollok bżonn ► inqas insulina mis- soltu Jekk se ssiefer: l- ivvjaġġar minn żona ta ’ ħin għall- oħra jista ’ jaffettwalek il- ħtiġijiet għall - ► insulina u l- ħin meta tieħu l- injezzjonijiet.
Your insulin dosage may need to be changed during pregnancy and after delivery.
Jista 'jkollok bżonn tbiddel id- dożaġġ ta' l- insulina tiegħek matul it- tqala u wara l- ħlas.
Never drive or use machinery if you feel a hypo coming on.
Qatt m’ għandek issuq jew tħaddem magni jekk tħoss ipo ġejja.
You should contact your doctor about the advisability of driving if you have frequent episodes of hypos or reduced or absent warning signs of hypos.
Iddiskuti mat- tabib tiegħek jekk għandekx issuq jew tħaddem magni jekk ikollok episodji frekwenti ta ’ ipos jew jekk is - sinjali ta ’ twissija tagħhom huma ridotti jew assenti għal kollox.
Follow their advice carefully.
Segwi sew il- parir tagħhom.
It is recommended that you measure your blood glucose regularly.
Hu rakkomandat li inti tiċċekkja l- livell ta ’ glucose fid- demm tiegħek regolarment.
Injecting the insulin
119 L- injezzjoni ta ’ l- insulina
116 NovoRapid must not be used
NovoRapid m’ għandux jintuża
► If the InnoLet is dropped, damaged or crushed, there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or if it has been frozen (see 6 How to store NovoRapid) ► If the insulin does not appear clear and colourless.
Jekk l- InnoLet titwaqqa ’, tiġrilha l- ħsara jew titgħaffeġ, hemm riskju ta ’ ħruġ ta ’ insulina ► Jekk ma ġiex maħżun tajjeb jew jekk ġie ffriżat (ara 6 Kif taħżen NovoRapid) ► Jekk l- insulina ma tidhirx ċara u bla kulur. ►
You should always have alternative insulin available for injection under the skin in case of pump system failure.
Dejjem għandu jkollok insulina alternattiva li tista ’ tingħata bħala injezzjoni taħt il- ġilda fil- każ li s - sistema tal- pompa jkollha l- ħsara.
Don’ t take any insulin if you feel a hypo coming on.
120 Tiħux insulina: jekk tħoss li ġejja xi ipo.
117 Using glucagon
Kif tuża glucagon
Vision problems.
121 Problemi bil- vista.
118 Seek medical advice immediately: • If signs of allergy spread to other parts of your body, or • If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
Fittex parir mediku minnufih: • Jekk is- sinjali ta ’ l- allerġija jinxterdu għal partijiet oħrajn tal- ġisem, jew • Jekk tħossok ma tiflaħx f’ daqqa, u: tibda tegħreq; tibda titqalla ’ (tirrimetti); ikollok diffikultà biex tieħu n- nifs; ikollok taħbit mgħaġġel tal- qalb; tħossok stordut.
NovoRapid InnoLet that is not being used is to be stored at 2°C – 8°C in the refrigerator, away from the freezer compartment.
NovoRapid InnoLet li mhux qeda tintuża għandha tinħażen fi friġġ f’ temperatura ta ’ 2°C - 8°C, ’ il bogħod mill- kompartiment tal- friża.
NovoRapid InnoLet that is being used or about to be used is not to be kept in the refrigerator.
NovoRapid InnoLet li qeda tintuża jew li dalwaqt se tintuża m’ għandiex tinżamm fil- friġġ.
Always keep the pen cap on your InnoLet when you’ re not using it in order to protect it from light.
Meta ma tkunx qed tuża l- InnoLet tiegħek dejjem żomm l- għatu fuq il- pinna sabiex tilqa ’ mid- dawl.
7.
122 7.
119 What NovoRapid looks like and contents of the pack
Id- dehra ta 'NovoRapid u l- kontenuti tal- pakkett
The marketing authorisation holder and manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- manifattur:
Now turn for information on how to use your InnoLet.
Għal informazzjoni dwar kif tuża l- InnoLet tiegħek dawwar il- paġna.
120 Please read the following instructions carefully before using your NovoRapid InnoLet.
123 Jekk jogħġbok aqra dawn l- istruzzjonijiet sew qabel ma tuża NovoRapid InnoLet.
NovoRapid InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
NovoRapid InnoLet hija pinna mimlija għal- lest sempliċi u kompatta li tista ’ tagħti dożi minn 1 sa 50 unitajiet f’ żidiet ta ’ unità 1.
NovoRapid InnoLet is designed to be used with NovoFine S needles of 8 mm or shorter in length.
NovoRapid InnoLet hija magħmula u ttestjata biex tintuża mal- labar NovoFine S ta ’ tul ta ’ ta ’ mhux iżjed minn 8mm.
Look for an S on the needle box.
Fittex S fuq il- kaxxa tal- labra.
As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
Bħala miżura prekawzjonarja, dejjem ġorr apparat żejjed għall- għoti ta ’ l- insulina fil- każ li l- InnoLet tintilef jew tiġrilha l- ħsara.
needle cap
Kif tibda
Check the label to be sure that your NovoRapid InnoLet contains the correct type of insulin.
Iċċekkja t- tiketta biex taċċerta li n- NovoRapid InnoLet tiegħek fiha t- tip korrett ta ’ insulina.
Take off the pen cap (as shown by the arrow). • Disinfect the rubber membrane with a medicinal swab • Always use a new needle for each injection to prevent contamination • Remove the protective tab from a NovoFine S short cap needle • Screw the needle straight and tightly onto NovoRapid InnoLet (picture 1A) • Pull off the big outer needle cap and the inner needle cap.
Neħħi l - għatu tal- pinna (kif muri mill- vleġġa). • Iddiżinfetta l- membrana tal- gomma b’ tajjara b’ diżinfettant • Għal kull injezzjoni dejjem uża labra ġdida sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine S bl- għatu qasir • Invita l- labra bi dritt u b' mod issikkat fuq l- Insulatard InnoLet (stampa 1A) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
You may want to store the big outer needle cap in the compartment.
Jista 'jkun li tkun trid taħżen l- għatu l- kbir ta ’ barra tal- labra fil- kompartiment
Prior to each injection small amounts of air may collect in the needle and cartridge during normal use.
Qabel kull injezzjoni jistgħu jinġabru ammonti żgħar ta ’ arja fil- labra u fl- iskartoċċ matul l- użu normali.
To avoid injection of air and ensure proper dosing: • Dial 2 units by turning the dose selector clockwise • Hold NovoRapid InnoLet with the needle upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge • Keeping the needle upwards, press the push-button and the dose selector returns to zero • A drop of insulin should appear at the needle tip (picture 1B).
Biex tevita l- injezzjoni ta ’ l- arja u taċċerta li tingħata d- doża korretta: • Isselezzjona 2 unitajiet billi ddawwar is- selettur tad- doża lejn il- lemin • Żomm NovoRapid InnoLet bil- labra tipponta ’ l fuq u b’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi, biex jekk ikun hemm xi bżieżaq ta ’ l- arja dawn jinġabru fin- naħa ta ’ fuq ta ’ l - iskartoċċ • Filwaqt li żżomm il- labra ’ l fuq, agħfas il- buttuna ta ’ l- injezzjoni u s- selettur tad- doża jirritorna fuq iż- żero • Qatra insulina għandha tidher fil- ponta tal- labra (stampa 1B).
If not, change the needle and repeat the procedure no more than 6 times.
Jekk dan ma jseħħx, ibdel il - labra u irrepeti l- proċedura mhux aktar minn 6 darbiet.
If a drop of insulin still does not appear, the device is defective and must not be used.
Jekk il- qatra ta 'l- insulina tibqa ’ ma titfaċċax, l- apparat hu difettuż u m’ għandux jintuża
• Always check that the push-button is fully depressed and the dose selector is set to zero • Dial the number of units required by turning the dose selector clockwise (picture 2).
• Dejjem iċċekkja li l- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox u li s - selettur tad- doża jkun issettjat fuq iż- żero. • Isselezzjona n- numru ta ’ unitajiet li jkollok bżonn billi ddawwar is- selettur tad- doża lejn il - lemin (stampa 2).
Do not use the residual scale to measure your dose of insulin • You will hear a click for every single unit dialled.
Tużax l- iskala ta ’ kemm fadal insulina biex tkejjel id- doża ta ’ l- insulina tiegħek • Għandek tisma ’ klikk għal kull unità li tisselezzjona.
The dose can be corrected by turning the dial either way.
Id- doża tista ’ tkun irregolata billi ddawwar is- selettur tad- doża naħa jew oħra.
You cannot set a dose larger than the number of units remaining in the cartridge.
125 Ma tistax tissettja doża akbar min- numru ta ’ unitajiet li jkun fadal fl- iskartoċċ.
You will hear clicks as the dose selector returns to zero • After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button.
Għandek tisma ’ l- klikks hekk kif is- selettur tad- doża jmur lura fuq iż- żero. • Wara l- injezzjoni, il- labra għandha tinżamm taħt il- ġilda għal mill- anqas 6 sekondi biex tiżgura li d- doża kollha tkun ingħatat. • Kun żgur li ma timblukkax is- selettur tad- doża waqt li tkun qed/ a tinjetta, għax is- selettur tad- doża jrid jitħalla jmur lura fuq iż- żero meta tagħfas il- buttuna ta ’ l- injezzjoni.
• Replace the big outer needle cap and unscrew the needle (picture 4) • Dispose of it carefully.
• Erġa ’ poġġi f’ postu l- għatu l- kbir ta ’ barra tal- labra u ħoll il- labra (stampa 4). • Armiha bl- attenzjoni.
Remove and discard the needle after each injection and store NovoRapid InnoLet without the needle attached.
Neħħi u armi l- labra wara kull injezzjoni u aħzen NovoRapid InnoLet mingħajr ma l- labra tkun imwaħħla.
Dispose of your used NovoRapid InnoLet carefully without the needle attached.
126 Oqgħod attent kif tarmi n- NovoRapid InnoLet użata tiegħek u aċċerta ruħek li tkun neħħejt il- labra.
Your NovoRapid InnoLet is designed to work accurately and safely.
In- NovoRapid InnoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
You can clean your NovoRapid InnoLet with a medicinal swab.
Għandha tkun immaniġġjata bl- attenzjoni.. Tista ’ tnaddaf in- NovoRapid InnoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
Do not soak it, wash or lubricate it as this may damage the mechanism.
M’ għandekx ixxarrabha, taħsilha jew tillubrikaha. Dan jista ’ jagħmel ħsara lill- mekkaniżmu..
Do not refill NovoRapid InnoLet.
Timliex mill- ġdid NovoRapid InnoLet
What is NovoSeven?
X’ inhu NovoSeven?
NovoSeven is a medicine that contains the active substance eptacog alfa (activated human recombinant coagulation factor VII).
NovoSeven huwa mediċina li fiha s- sustanza attiva eptacog alfa (fattur ta ’ koagulazzjoni VII rikombinanti attivat tal- bniedem).
It is available as a powder and solvent that are made up into a solution for injection.
Dan jinsab disponibbli bħala trab u solvent li jitħalltu flimkien sabiex jiffurmaw soluzzjoni għall- injezzjoni.
Two formulations of NovoSeven are available: the original formulation requires refrigeration and the newer formulation can be stored at room temperature.
Hemm żewġ formulazzjonijiet ta ’ NovoSeven li jinsabu disponibbli: il- formulazzjoni oriġinali teħtieġ refriġerazzjoni u l- formulazzjoni l- ġdida tista ’ tiġi maħżuna f’ temperatura ambjentali normali.
What is NovoSeven used for?
Għal xiex jintuża NovoSeven?
NovoSeven is used for the treatment and prevention of bleeding connected with surgery in the following groups of patients: • patients with congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘ inhibitors ’ (antibodies) against factor VIII or IX; • patients with acquired haemophilia (a disease caused by the spontaneous development of inhibitors to factor VIII); • patients with congenital factor VII deficiency; • patients with Glanzmann’ s thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).
NoveSeven jintuża għat- trattament u l- prevenzjoni ta ’ emorraġiji konnessi mal- kirurġija f’ dawn il - gruppi ta ’ pazjenti li jmiss: • pazjenti b’ emofilija konġenita (problema ta ’ emorraġija li tkun teżisti sa mit- twelid) li jkunu żviluppaw jew li jkunu mistennija li jiżviluppaw ‘ inibituri ’ (antibijotiċi) kontra l- fattur VII jew IX; • pazjenti b’ emofilija akkwiżita (marda kkawżata mill- iżvilupp spontanju ta ’ inibituri għall- fattur VIII); • pazjenti b’ defiċjenza konġenita tal- fattur VII; • pazjenti bi trombastenija ta ’ Glanzmann (tip ta ’ disturb rari ta ’ emorraġija) li ma jkunux jistgħu jiġu trattati bi transfużjoni tal- platelets (komponenti li jgħinu fit- tagħqid tad- demm).
How is NovoSeven used?
Kif jintuża NovoSeven?
Treatment with NovoSeven should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders.
It- trattament ta ’ NovoSeven għandu jinbeda taħt is- superviżjoni ta ’ tabib li jkollu esperjenza fit - trattament ta ’ l- emofilija jew ta ’ disturbi ta ’ l- emorraġija.
NovoSeven is given by injection into a vein. • In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every two to three hours until the bleeding is controlled.
NovoSeven jingħata bħala injezzjoni fil- vina. • Fl- emofilija, id- doża hija ta ’ 90 mikrogramma għal kull kilogramma ta ’ piż tal- ġisem, li għandha tiġi ripetuta kull sagħtejn jew tliet sigħat sakemm ma l- emorraġija tkun ġiet ikkontrollata.
A higher dose may be needed in children.
Jista ’ jkun hemm bżonn ta ’ doża ogħla fit- tfal.
A single dose of 270 micrograms/ kg may be used in adults with a mild or moderate bleeding episode. • In factor VII deficiency, the dose is 15 to 30 micrograms/ kg every four to six hours until the bleeding is controlled. • In Glanzmann’ s thrombasthenia, the dose is 90 micrograms/ kg every two hours, for a minimum of three doses.
Tista ’ tintuża doża singola ta ’ 270 mikrogramma/ kilogramma tal- piż tal- ġisem fl- adulti li jkollhom emorraġija ħafifa jew moderata. • Fid- defiċjenza ta ’ fattur VII, id- doża hija ta ’ 15 sa 30 mikrogrammi/ kg piż tal- ġisem kull erbgħa sa sitt sigħat sakemm ma l- emorraġija tkun ġiet ikkontrollata. • Fi trombastenija ta ’ Glanzmann, id- doża hija 90 mikrogrammi/ kg ta ’ piż tal- ġisem kull sagħtejn, għal minimu ta ’ tliet dożi.
NovoSeven can be administered in the home setting.
NovoSeven jista ’ jingħata mid- dar.
See the Package Leaflet for the full dosing details in all uses.
Ara l- Fuljett ta ’ Tagħrif għal dettalji sħaħ dwar id- dożi f’ kull tip ta ’ użu.
How does NovoSeven work?
Kif jaħdem NovoSeven?
The active substance in NovoSeven, eptacog alfa, is a blood coagulation factor protein that is almost identical to a human protein called factor VII.
Is- sustanza attiva f’ NovoSeven, eptacog alfa, hija proteina tal- fattur ta ’ koagulazjzoni tad- demm li huwa kważi identiku għall- proteina umana msejħa fattur VII.
Eptacog alfa is not extracted from human blood but is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce eptacog alfa.
Eptacog alfa m’ huwiex estratt mid - demm uman iżda huwa prodott minn metodu magħruf bħala ‘ teknoloġija rikombitanti tad- DNA ’: huwa magħmul minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi eptacog alfa.
Eptacog alfa works in the same way as factor VII.
Epatcog alfa jaħdem bl- istess mod bħal fattur VII.
In the body, factor VII is involved in blood coagulation (clotting).
Fil- ġisem, il- fattur VII huwa involut fil - koagulazzjoni tad- demm (tagħqid).
It activates another factor called factor X, which starts the coagulation process.
Dan jattiva fattur ieħor imsejjaħ fattur X, li jibda l- proċess ta ’ koagulazzjoni.
By activating factor X, NovoSeven is able to give temporary control of the bleeding disorder.
Billi jattiva l- fattur X, NovoSeven ikun jista ’ jagħti kontroll temporanju għad- disturb ta ’ l- emorraġija.
Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX.
Minħabba li l- fattur VII jaġixxi direttament fuq il- fattur X, b’ mod indipendenti mill- fatturi VIII u IX, NovoSeven jista ’ jintuża f’ pazjenti b‘ emofilija li jkunu żviluppaw inibituri għall- fattur VII jew IX.
NovoSeven can also be used to replace the missing factor VII in patients with factor VII deficiency.
NovoSeven jintuża wkoll biex jissostitwixxi l- fattur VII nieqes f’ pazjenti b’ defiċjenza tal- fattur VII.
How has NovoSeven been studied?
Kif ġie studjat NovoSeven?
NovoSeven has been studied in patients with haemophilia and in patients with factor VII deficiency.
NovoSeven ġie studjat f’ pazjenti b’ emofilja u f’ pazjenti b’ defiċjenza fil- fattur VII.
The main measure of effectiveness was the number of bleeding episodes.
Il- kejl ewlieni ta ’ l - effikaċja kienet in- numru ta ’ każijiet ta ’ emorraġija.
To find out whether the medicine could be used in the home setting, the company carried out studies in 60 patients with mild to moderate bleeding episodes.
Sabiex jinstab jekk il- mediċina setgħetx tintuża mid- dar, il- kumpanija wettqet studji fuq 60 pazjent li kellhom episodji ta ’ emorraġija ħafifa jew moderata.
NovoSeven has also been studied in patients with Glanzmann’ s thrombasthenia who could not receive platelets.
NoveSeven ġie wkoll studjat f’ pazjenti bi trombastenija ta ’ Glanzmann li ma setgħux jirċievu platelets.
Two further studies compared the single 270 microgram/ kg dose of NovoSeven with three 90 microgram/ kg doses in a total of 51 patients with haemophilia.
Żewġ studji oħra kkumparaw id- doża singola ta ’ NovoSeven ta ’ 270 mikrogramma/ kg ta ’ piż tal - ġisem ma ’ tliet dożi ta ’ 90 mikrogramma/ kg ta ’ piż tal- ġisem f’ total ta ’ 51 pazjent b’ emofilija.
These studies assessed the medicine ’ s effectiveness in reducing the symptoms of pain and joint mobility nine hours after treatment.
Dawn l- istudji stmaw l- effikaċja tal- mediċina fit- tnaqqis tas- sintomi ta ’ wġigħ u ta ’ mobilità tal- ġogi disa ’ sigħat wara t- trattament.
The company also carried out a ‘ bioequivalence’ study in 25 healthy volunteers to show that the two formulations of NovoSeven are treated in the same way by the body.
Il- kumpanija wettqet ukoll studju ta ’ ‘ bijoekwivalenza ’ f’ 25 voluntier tas - saħħa sabiex turi li ż- żewġ formulazzjonijiet ta ’ NovoSeven huma trattati bl- istess mod mill- ġisem.
What benefit has NovoSeven shown during the studies?
X’ benefiċċji ta ’ NovoSeven ħarġu minn dawn l- istudji?
In the largest study, which included 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were treated effectively with NovoSeven.
Fl- ikbar studju, li inkluda 61 pazjent b’ emofilija b’ inibituri, 84% tal- 57 emorraġiji serji u 59% tat- 38 ta ’ l- emorraġiji kirurġiċi ġew trattati b’ mod effikaċi b’ NovoSeven.
In the study where NovoSeven was given in the home setting, 90% of the bleeding episodes were stopped.
Fl- istudju fejn NovoSeven ingħata mid- dar, 90% ta ’ l- episodji ta ’ l- emorraġija ġew imwaqqfa.
In Glanzmann’ s thrombasthenia, the study showed that treatment with NovoSeven was effective in 74% of the bleeds (42 out of 57).
Fit- trombastenija ta ’ Glanzmann, l- istudju wera li t- trattament b’ NovoSeven kein effikaċi f’ 74% ta ’ l - emorraġiji (42 minn 57).
The additional studies showed that a single 270 microgram/ kg dose was as effective as three 90 microgram/ kg doses in improving symptoms.
L- istudji addizzjonali wrew li doża singola ta ’ 270 mikrogramma/ kilogramma ta ’ piż tal- ġisem kienet effikaċi daqs tliet dożi ta ’ 90 mikrogramma/ kilogramma ta ’ piż tal- ġisem fit- titjib tas- sintomi.
What is the risk associated with NovoSeven?
X’ inhuma r- riskji marbuta ma ’ NovoSeven?
The side effects of NovoSeven are generally rare: for every 1,000 doses less than one side effect has been reported.
L- effetti sekondarji ta ’ NovoSeven huma ġeneralment rari: għal kull 1, 000 doża, ġew irrappurtati inqas minn effett sekondarju wieħed.
Serious but very rare side effects include blood clots in the veins or arteries.
Effetti sekondarji serji iżda rari ħafna jinkludu trombożi fil- vini u l- arterji.
For the full list of all side effects reported with NovoSeven, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati b’ NovoSeven, ara l- Fuljett ta' Tagħrif.
NovoSeven should not be used in people who may be hypersensitive (allergic) to human recombinant coagulation factor VII, to mouse, hamster or cow proteins, or to any of the other ingredients.
NovoSeven m’ għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal fattur VII tal - koagulazzjoni rikombinanti tal- bniedem, għal proteini tal- ħamsters, ġrieden jew tal- baqar jew għal xi sustanzi oħra tiegħu.
Why has NovoSeven been approved?
Għaliex ġie approvat NovoSeven?
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoSeven’ s benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann’ s thrombasthenia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ NovoSeven huma ikbar mir- riskji tiegħu għat- trattament ta ’ każijiet ta ’ emorraġija u għall- prevenzjoni ta ’ emorraġija f’ dawk li jkunu għaddejjin minn intervent kirurġiku jew proċeduri invażivi f’ pazjenti b’ emofilija konġenita, emofilija akkwiżita, defiċjenża fil- fattur ta ’ koagulazzjoni VII jew trombastenija ta ’ Glanzmann.
The Committee recommended that NovoSeven be given marketing authorisation.
Il- Kumitat irrakkomanda li NovoSeven jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Which measures are being taken to ensure the safe use of NovoSeven?
X’ miżuri qed jittieħdu biex jassiguraw l- użu sigur ta ’ NovoSeven?
Before the new formulation that can be stored at room temperature becomes available on the market, the company that makes NovoSeven will provide doctor and patient information packs.
Qabel ma l- formulazzjoni l- ġdida li tista ’ tiġi maħżuna f’ temperatura ambjentali normali tkun saret dispnibbli fis- suq, il- kumpanija li tagħmel NovoSeven se tipprovdi pakketti ta ’ informazzjoni lit- tobba u l- pazjenti.
The information packs will explain the differences between the two formulations of NovoSeven, to help avoid errors when calculating doses.
Il- pakketti ta ’ informazzjoni se jispjegaw id- differenzi bejn iż- żewġ formulazzjonijiet ta ’ NovoSeven bil- għan li jgħinu sabiex jevitaw żbalji fl- ikkalkular tad- dożi.
2/ 3 Other information about NovoSeven:
2/ 3 Aktar tagħrif dwar NovoSeven:
The European Commission granted a marketing authorisation valid throughout the European Union for NovoSeven to Novo Nordisk A/ S on 23 February 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Novoseven lil Novo Nordisk A/ S fit- 23 ta ’ Frar 1996.
The authorisation was renewed on 23 February 2001 and on 23 February 2006.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 23 ta ’ Frar 2001 u fit- 23 ta ’ Frar 2006.
The full EPAR for NovoSeven is available here.
L- EPAR sħiħ għal NovoSeven jista ’ jiġi ikkonsultat hawn.
NovoSeven
NovoSeven 1. 2 mg
1.2 mg (60 KIU)
(60 KUI)
Powder and solvent for solution for injection
soluzzjoni għall - injezzjoni
powder: vial (glass); solvent: vial (glass)
Solvent: kunjett (ħġieġ)
1.2 mg (60 KIU); 2.2 ml 0.6 mg/ ml (30 KIU/ ml)
0. 6 mg/ ml (30 KUI / ml)
1 vial + 1 vial + 1 vial adapter for reconstitution + 1 syringe + 1 sterile infusion set + 2 alcohol swabs
kunjett 1 + adapter 1 għal kunjett għar - rikostituzzjoni + siringa 1+ sett 1 sterili għall- infużjoni + 2 biċċiet ta ’ tajjar imxarrbin bl- alkoħol
2.4 mg (120 KIU)
2. 4 mg (120 KUI)
powder: vial (glass); solvent: vial (glass)
Trab: kunjett (ħġieġ) Solvent: kunjett (ħġieġ)
2.4 mg (120 KIU); 4.3 ml 0.6 mg/ ml (30 KIU/ ml)
2. 4 mg (120 KUI); 4. 3 ml 0. 6 mg/ ml (30 KUI / ml)
1 vial + 1 vial + 1 vial adapter for reconstitution + 1 syringe + 1 sterile infusion set + 2 alcohol swabs
kunjett 1 + kunjett 1 + Adapter 1 għal kunjett għar - rikostituzzjoni + siringa 1+ sett 1 sterili għall- infużjoni + 2 biċċiet ta ’ tajjar imxarrbin bl- alkoħol
4.8 mg (240 KIU)
4. 8 mg (240 KUI)
4.8 mg (240 KIU); 8.5 ml 0.6 mg/ ml (30 KIU/ ml)
4. 8 mg (240 KUI); 8. 5 ml 0. 6 mg/ ml (30 KUI / ml)
1 vial + 1 vial + 1 vial adapter for reconstitution + 1 syringe + 1 sterile infusion set + 2 alcohol swabs
kunjett 1 + kunjett 1 + adapter 1 għal kunjett għar - rikostituzzjoni + siringa 1+ sett 1 sterili għall- infużjoni + 2 biċċiet ta ’ tajjar imxarrbin bl- alkoħol
1 mg (50 KIU); (50 KIU/ ml) solvent:
trab: 1 mg (50 KUI); (50KUI/ ml) solvent:
1 vial + 1 vial
kunjett 1 +kunjett 1 +
2 mg (100 KIU); (50 KIU/ ml) solvent:
2 mg (100 KUI); (50 KUI / ml) solvent:
2.1 ml
2. 1 ml
5 mg (250 KIU); (50 KIU/ ml) solvent:
5 mg (250 KUI); (50 KUI / ml) solvent:
5.2 ml
5. 2 ml
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI GĦANDHOM JIĠU MWETTQA MILL - ISTATI MEMBRI FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI GĦANDHOM JIĠU MWETTQA MILL- ISTATI MEMBRI FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all physicians who are expected to prescribe/ use NovoSeven are provided with an Educational pack containing the following: • Physician information pack • Patient information pack
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) għandu jassigura li ma ’ l - introduzzjoni tal- prodott fis- suq, it- tobba kollha li huma mistennija li jordnaw/ jużaw NovoSeven għandhom jiġu pprovduti b’ pakkett Edukattiv li jkun fih dan li ġej: • Pakkett ta ’ informazzjoni għat- tabib • Pakkett ta ’ informazzjoni għall- pazjent
Both information packs are to be used as part of an educational plan provided to minimise risk of medication errors that may be associated with the change in concentration of the new Novoseven formulation.
Iż- żewġ pakketti ta ’ informazzjoni għandhom ikunu użati bħala parti minn pjan edukattiv imfassal biex inaqqas kemm jista ’ jkun ir- riskju ta ’ żbalji ta ’ medikazzjoni li jista ’ jkun hemm minħabba t - tibdil fil- konċentrazzjoni fil- formulazzjoni l- ġdida ta ’ NovoSeven.
The physician information should contain the following key elements: • Clear demarcation of the new formulation of NovoSeven from original NovoSeven, with clear descriptions of any differences in the vial sizes, colour codes and dosing and reconstitution instructions • Clear information about their difference in concentration. • Information about the potential safety risks of errors in dosing calculation resulting from the confusion between the two formulations and its possible clinical consequences (e. g. potential for thrombotic risk if overdose). • Encouragement to report medications errors and their causes and consequences.
Il- pakkett ta ’ informazzjoni għat- tabib għandu jkollu dan li ġej: • Fuljett li jiġbor fil- qosor il- karatteristiċi tal- prodott u l- gwida għar- rikostituzzjoni u fost l - oħrajn għandu juri biċ- ċar it- tibdil li kien hemm għall- formulazzjoni l- ġdida ta ’ NovoSeven. • Sett ta ’ slajds edukattivi • Karta ta ’ referenza għad- dożaġġ • Fuljett ta ’ Mistoqsijiet u Tweġibiet • Pakkett ta ’ informazzjoni għall- pazjent • Ittra għall- professjonisti fil- kura tas- saħħa Fl- informazzjoni għat- tabib għandu jkun hemm dawn il- punti importanti li ġejjien: • Diviżjoni ċara bejn il- formulazzjoni ġdida ta ’ Novoseven u dik oriġinali ta ’ NovoSeven, b’ deskrizzjonijiet ċari ta ’ kull differenza fid- daqsijiet tal- kunjetti, kodiċi ta ’ kuluri u dożaġġ u istruzzjonijiet ta ’ rikostituzzjoni. • Informazzjoni ċara dwar id- differenza fil- konċentrazzjoni • Informazzjoni dwar ir- riskji potenzjali għas- sigurtà ġejjien minn żbalji fil- kalkulazzjoni tad - doża minħabba l- konfużjoni bejn iż- żewġ formulazzjonijiet u l- konsegwenzi kliniċi li dawn jistgħu jġibu (e. g. riskju potenzjali ta ’ trombożi f’ każ ta ’ doża eċċessiva) • L- inkoraġġiment biex jiġu rrapportati l- iżbalji fil- medikazzjoni u l- kawżi u l- konsegwenzi tagħhom.
The patient information pack to be used by healthcare professionals in the education of the patients should contain the same above described key elements.
Il- pakkett ta ’ informazzjoni għall- pazjent għall- użu mill- professjonisti fil- kura tas- saħħa għall - edukazzjoni tal- pazjenti għandu jkollu l- istess punti importanti deskritti hawn fuq.
The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jwettaq dan il- pjan edukattiv fuq skala nazzjonali qabel ma l- prodott jitqiegħed fis- suq u kif miftiehem ma ’ l- awtoritajiet kompetenti fl- Istati Membri.
NovoSeven 1.2 mg (60 KIU) - powder and solvent for solution for injection
NovoSeven 1. 2 mg (60 KIU) - trab u solvent għal soluzzjoni għall- injezzjoni
NovoSeven is presented as powder and solvent for solution for injection containing 1.2 mg eptacog alfa (activated) per vial (corresponds to 60 KIU/ vial).
NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni li fih 1. 2 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 60 KUI/ kunjett).
1 KIU equals 1000 IU (International Units).
1 KUI huwa daqs 1000 UI (Unità Internazzjonali).
eptacog alfa (activated) is recombinant coagulation factor VIIa with a molecular mass of approximately 50,000 Dalton produced by genetic engineering from baby hamster kidney cells (BHK Cells).
eptacog alfa (attivat) huwa l- fattur VIIa rikombinanti tal- koagulazzjoni b’ massa molekulari ta ’ madwar 50, 000 Dalton prodott bl- inġinerija ġenetika miċ- ċelluli tal- kliewi tal- frieħ tal- ħamster (Ċelluli BHK).
After reconstitution the product contains 0.6 mg/ ml eptacog alfa (activated) when reconstituted with solvent.
Wara r- rikostituzzjoni l- prodott fih 0. 6 mg/ ml eptacog alfa (attivat) meta jiġi rrikostitwit bis- solvent.