qanastek/EMEA-V3 huggingface dataset:
After removing Mixtard Flexpen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tneħħi l- Mixtard FlexPen mill- friġġ, hu rakkomandat li tħalli l- FlexPen tilħaq it- temperatura tal- kamra (mhux iżjed minn 25°C) qabel ma 'tagħmel is- suspensjoni ta' l- insulina mill- ġdid, kif hemm fl- istruzzjonijiet għall- ewwel użu.
100 A.
100 ANNESS II
Name and address of the manufacturer of the biological active substance
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Mixtard 30 Penfill and FlexPen:
Mixtard 30 Penfill u FlexPen:
102 A.
102 ANNESS III
103 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
Mixtard 30 40 IU/ ml suspension for injection in a vial Insulin human (rDNA),
Mixtard 30 40 UI/ ml suspensjoni għall- injezzjoni f' kunjett Insulina umana (rDNA),
Mixtard 30 vial 40 IU/ ml
Mixtard 30 kunjett 40 UI/ ml
105 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 30 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 30 40 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 30 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Mixtard 30 100 UI/ ml suspensjoni għall- injezzjoni f' kunjett Insulina umana (rDNA)
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
108 Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- użu: tagħmlux fil- friġġ jew taħżen f’ temperatura ’ l fuq minn 25°C
Mixtard 30 vial 100 IU/ ml
Mixtard 30 kunjett 100 UI/ ml
108 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
109 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 30 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 30 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
110 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 30 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Mixtard 30 40 UI/ ml suspensjoni għall- injezzjoni f' kunjett Insulina umana (rDNA)
110 Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
Aħżen fi friġġ (2°C - 8°C) Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- użu: tagħmlux fil- friġġ jew taħżen f’ temperatura ’ l fuq minn 25°C
111 PARTICULARS TO APPEAR ON THE PACKAGING
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
114 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
115 PARTICULARS TO APPEAR ON THE PACKAGING
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT
117 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
118 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 10 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Mixtard 10 Penfill is for use by one person only
Mixtard 10 Penfill hu għall- użu minn persuna waħda biss
119 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
120 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 10 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
121 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 20 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard 20 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Mixtard 20 Penfill is for use by one person only
Użu għal taħt il- ġilda L- iskrataċ tal- Penfill huma għall- użu ma ’ sistemi ta ’ l- għoti ta ’ l- insulina Novo Nordisk Erġa 'ifforma s- suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta' tagħrif qabel l- użu.
121 9.
122 9.
122 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
123 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 20 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 20 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
123 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
124 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 30 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA),
Mixtard 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA),
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Mixtard 30 Penfill is for use by one person only
Mixtard 30 Penfill hu għall- użu minn persuna waħda biss
124 9.
125 9.
125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
126 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 30 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
127 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 40 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Mixtard 40 Penfill is for use by one person only
Mixtard 40 Penfill hu għall- użu minn persuna waħda biss
127 9.
128 9.
128 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
129 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 40 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
129 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
130 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 50 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard 50 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Mixtard 50 Penfill is for use by one person only
Mixtard 50 Penfill hu għall- użu minn persuna waħda biss
131 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
132 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 50 Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 50 Penfill 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
132 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
133 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 10 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 10 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Mixtard 10 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Mixtard 10 NovoLet is for use by one person only
Erġa 'ifforma s- suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta' tagħrif qabel l- użu.
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
135 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 10 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 10 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
135 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
136 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 20 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 20 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Mixtard 20 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Mixtard 20 NovoLet is for use by one person only
Mixtard 20 NovoLet hu għall- użu minn persuna waħda biss
136 9.
137 9.
137 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
138 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 20 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 20 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
138 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
139 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 30 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 30 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Mixtard 30 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Mixtard 30 NovoLet is for use by one person only
Erġa 'ifforma s- suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta' tagħrif qabel l- użu.
139 9.
140 9.
140 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
141 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 30 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 30 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu taħt il- ġilda
141 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
142 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 40 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 40 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Mixtard 40 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Mixtard 40 NovoLet is for use by one person only
Erġa 'ifforma s- suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta' tagħrif qabel l- użu.
142 9.
143 9.
143 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
144 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 40 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 40 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
144 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
145 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 50 NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 50 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Mixtard 50 NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Mixtard 50 NovoLet is for use by one person only
Erġa 'ifforma s- suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta' tagħrif qabel l- użu.
146 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
147 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 50 NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 50 NovoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
147 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
148 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 30 InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 30 InnoLet 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Mixtard 30 InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Mixtard 30 InnoLet is for use by one person only
Mixtard 30 InnoLet hu għall- użu minn persuna waħda biss
149 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
150 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 30 InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 30 InnoLet 100 UI/ ml suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
150 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
151 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Mixtard 30 FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Mixtard 30 FlexPen 100 UI/ ml suspensjoni għall- injezzjoni f’ pinna mimlija għal- lest Insulina umana (rDNA)
Subcutaneous use Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Resuspend according to instructions Read the package leaflet before use Mixtard 30 FlexPen is for use by one person only
Mixtard 30 FlexPen hi għall- użu minn persuna waħda biss
151 8.
152 8.
152 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
153 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mixtard 30 FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Mixtard 30 FlexPen 100 UI/ m suspensjoni għall- injezzjoni Insulina umana (rDNA) Għall- użu minn taħt il- ġilda
154 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
WHAT MIXTARD IS AND WHAT IT IS USED FOR
X’ INHU MIXTARD U GĦALXIEX JINTUŻA
Mixtard is human insulin to treat diabetes.
Mixtard hu insulina umana għall- kura tad- dijabete.
Mixtard is a mixture of fast-acting insulin and long- acting insulin.
Mixtard hu taħlita ta 'insulina li taħdem malajr u insulina li taħdem fit- tul.
BEFORE YOU USE MIXTARD
QABEL MA TUŻA MIXTARD
Do not use Mixtard
Tużax Mixtard
Take special care with Mixtard
Oqgħod attent ħafna b’ Mixtard
Pregnancy and breast-feeding
156 Tqala u treddigħ
HOW TO USE MIXTARD
KIF GĦANDEK TUŻA MIXTARD
Before using Mixtard
Qabel tuża Mixtard
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
Jekk il- kunjett ma jkunx f’ kundizzjoni perfetta meta tirċivih, erġa ’ agħtih lura lil min tahulek. ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Mixtard) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
Mixtard is for injection under the skin (subcutaneously).
Mixtard hu magħmul biex ikun injettat taħt il- ġilda.
Mixtard vials are for use with insulin syringes with the corresponding unit scale.
Il- kunjetti ta 'Mixtard huma għall- użu ma' siringi ta ’ l- insulina bi iskala korrispondenti ta 'unitajiet.
Causes of hyperglycaemia
158 Il- kawżi ta ’ ipergliċemija
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual
• Tkun insejt tieħu l- insulina tiegħek • Li ripetutament tieħu anqas insulina milli għandek bżonn • Ikollok infezzjoni jew deni • Tiekol aktar mis- soltu • Tagħmel eżerċizzju fiżiku anqas mis- soltu.
Like all medicines, Mixtard can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Mixtard jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Mixtard may cause hypoglycaemia (low blood sugar).
Mixtard jista 'jikkawża l- ipogliċemija (livell baxx ta' zokkor fid- demm).
You may have a very rare serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni allerġika rari ħafna u serja għal Mixtard jew għal xi wieħed mill - ingredjenti tiegħu (imsejħa reazzjoni allerġika sistemika).
See also warning in 2 Before you use Mixtard.
Ara wkoll it- twissija f’ 2 Qabel ma tuża Mixtard.
6.
159 6.
HOW TO STORE MIXTARD
KIF TAĦŻEN MIXTARD
Do not use Mixtard after the expiry date which is stated on the label and the carton.
Tużax Mixtard wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
See 3 How to use Mixtard.
Ara 3 Kif għandek tuża Mixtard.
Mixtard must be protected from excessive heat and sunlight.
Mixtard għandu jkun protett minn sħana eċċessiva u mid- dawl tax- xemx.
Mixtard should not be disposed of via wastewater or household waste.
Mixtard m’ għandux jintrema ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Mixtard 30 contains – The active substance is insulin human made by recombinant biotechnology (30% as soluble insulin and 70% as isophane insulin).
X' fih Mixtard 30 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (30% bħala insulina li tinħall u 70% bħala insulina isophane).
What Mixtard looks like and contents of the pack The suspension for injection comes as a cloudy, white, aqueous suspension.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja, bajda u opaka Issibu f' pakketti ta ’ 1 jew 5 kunjetti ta' 10 ml jew f' pakkett multiplu ta '5 x (1 x 10 ml) kunjetti.
159 PACKAGE LEAFLET:
160 FULJETT TA 'TAGĦRIF:
Pregnancy and breast-feeding
161 Tqala u treddigħ
Causes of hyperglycaemia
163 Il- kawżi ta ’ ipergliċemija
6.
164 6.
It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja, bajda u opaka Issibu f' pakketti ta ’ 1 jew 5 kunjetti ta' 10 ml jew f' pakkett multiplu ta '5 x (1 x 10 ml) kunjetti.
164 PACKAGE LEAFLET:
165 FULJETT TA 'TAGĦRIF:
Mixtard 10 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard 10 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
► In insulin infusion pumps ► If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk Penfill jew it- tagħmir li jkun fih Penfill jitwaqqa ’, jiġrilu l- ħsara jew jitgħaffeġ, hemm ir- riskju ta ’ tnixxija ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Mixtard) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
Do not refill Mixtard 10 Penfill.
Timliex mill- ġdid Mixtard 10 Penfill.
If you are treated with Mixtard 10 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Mixtard 10 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.
166 Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
167 Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tagħmel suspensjoni mill- ġdid b’ mod uniformi.
Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual ► Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered ► After each injection be sure to remove and discard the needle and store Mixtard without the needle attached.
Uża t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l - infermier/ a tad- dijabete tiegħek u li hi deskritta fil- manwal tiegħek tas- sistema tal- forniment. ► Żomm il- labra taħt il- ġilda tiegħek għal mill- anqas 6 sekondi biex tiżgura li d- doża sħiħa tkun ingħatat ► Wara kull injezzjoni aċċerta ruħek li tneħħi u tarmi l- labra u taħżen Mixtard mingħajr ma l - labra tkun imwaħħla.
Diabetic retinopathy (eye background changes).
169 Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
What Mixtard 10 contains – The active substance is insulin human made by recombinant biotechnology (10% as soluble insulin and 90% as isophane insulin).
X' fih Mixtard 10 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (10% bħala insulina li tinħall u 90% bħala insulina isophane).
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
170 Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni opaka, bajda u akweja Issibu f’ pakketti ta ’ 1, 5 jew 10 skrataċ ta ’ 3 ml.
169 PACKAGE LEAFLET:
171 FULJETT TA 'TAGĦRIF:
Pregnancy and breast-feeding
172 Tqala u treddigħ
Do not refill Mixtard 20 Penfill.
Timliex mill- ġdid Mixtard 20 Penfill.
If you are treated with Mixtard 20 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Mixtard 20 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.
171 Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
173 Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tagħmel suspensjoni mill- ġdid b’ mod uniformi.
Diabetic retinopathy (eye background changes).
175 Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
What Mixtard 20 contains – The active substance is insulin human made by recombinant biotechnology (20% as soluble insulin and 80% as isophane insulin).
X' fih Mixtard 20 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (20% bħala insulina li tinħall u 80% bħala insulina isophane).
What Mixtard looks like and contents of the pack The suspension for injection comes as a cloudy, white, aqueous suspension It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
176 Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni opaka, bajda u akweja Issibu f’ pakketti ta ’ 1, 5 jew 10 skrataċ ta ’ 3 ml.
174 PACKAGE LEAFLET:
177 FULJETT TA 'TAGĦRIF:
Mixtard 30 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard 30 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
Pregnancy and breast-feeding
178 Tqala u treddigħ
► In insulin infusion pumps ► If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk Penfill jew it- tagħmir li jkun fih l- Penfill jitwaqqa ’, jiġrilu l- ħsara jew jitgħaffeġ, hemm ir- riskju ta ’ ħruġ ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Mixtard) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
Do not refill Mixtard 30 Penfill.
Timliex mill- ġdid Mixtard 30 Penfill.
If you are treated with Mixtard 30 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Mixtard 30 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.
176 Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
179 Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tifforma s - suspensjoni mill- ġdid b’ mod uniformi.
Diabetic retinopathy (eye background changes).
181 Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
Do not store them in or too near the freezer section or cooling element.
Il- Penfill li ma jkunx qed jintuża għandhu jinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ Tagħmilhomx fil- friża.
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
182 Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni opaka, bajda u akweja Issibu f’ pakketti ta ’ 1, 5 jew 10 skrataċ ta ’ 3 ml.
179 PACKAGE LEAFLET:
183 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER Mixtard 40 Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Mixtard 40 Penfill 100 UI/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina umana (rDNA)
Pregnancy and breast-feeding
184 Tqala u treddigħ
Do not refill Mixtard 40 Penfill.
Timliex mill- ġdid Mixtard 40 Penfill.
If you are treated with Mixtard 40 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Mixtard 40 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.
181 Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
185 Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tifforma suspensjoni mill- ġdid b’ mod uniformi.
Diabetic retinopathy (eye background changes).
187 Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
What Mixtard 40 contains – The active substance is insulin human made by recombinant biotechnology (40% as soluble insulin and 60% as isophane insulin).
X' fih Mixtard 40 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (40% bħala insulina li tinħall u 60% bħala insulina isophane).
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
188 Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni opaka, bajda u akweja Issibu f’ pakketti ta ’ 1, 5 jew 10 skrataċ ta ’ 3 ml.
184 PACKAGE LEAFLET:
189 FULJETT TA 'TAGĦRIF:
Pregnancy and breast-feeding
190 Tqala u treddigħ
Do not refill Mixtard 50 Penfill.
Timliex mill- ġdid Mixtard 50 Penfill.
If you are treated with Mixtard 50 Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Jekk inti qed tkun ikkurat/ a b’ Mixtard 50 Penfill u bi skartoċċ ieħor ta ’ l- insulina tal- Penfill, għandek tuża żewġ sistemi tal- forniment ta ’ l- insulina, waħda għal kull tip ta ’ insulina.
186 Check there are at least 12 units of insulin left in the cartridge to allow even resuspending.
191 Iċċekkja li jkun fadal mill- anqas 12- il unità ta 'insulina fl- iskartoċċ biex tkun tista' tifforma suspensjoni mill- ġdid b’ mod uniformi.
Diabetic retinopathy (eye background changes).
193 Retinopatija dijabetika (tibdil fuq in- naħa ta ’ ġewwa ta ’ l- għajn).
What Mixtard 50 contains – The active substance is insulin human made by recombinant biotechnology (50% as soluble insulin and 50% as isophane insulin).
X' fih Mixtard 50 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (50% bħala insulina li tinħall u 50% bħala insulina isophane).
What Mixtard looks like and contents of the pack The suspension for injection comes as a cloudy, white, aqueous suspension.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett
It is supplied in packs of 1, 5 or 10 cartridges of 3 ml.
194 Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni opaka, bajda u akweja Issibu f’ pakketti ta ’ 1, 5 jew 10 skrataċ ta ’ 3 ml.
189 PACKAGE LEAFLET:
195 FULJETT TA 'TAGĦRIF:
What Mixtard is and what it is used for 2.
X’ inhu Mixtard u għalxiex jintuża 2.
Before you use Mixtard 3.
Qabel ma tuża Mixtard 3.
How to use Mixtard 4.
Kif għandek tuża Mixtard 4.
How to store Mixtard 7.
Kif taħżen Mixtard 7.
Using other medicines
196 Meta tuża mediċini ohra
► In insulin infusion pumps ► If NovoLet is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Mixtard) ► If it’ s not uniformly white and cloudy when it’ s resuspended.
► F’ pompi ta ’ l- infużjoni ta ’ l- insulina ► Jekk NovoLet jitwaqqa ’, tiġrilu l- ħsara jew jitgħaffeġ, hemm ir- riskju ta ’ telf ta ’ likwidu ta ’ l- insulina ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Mixtard) ► Jekk ma jkunx abjad u opak b' mod uniformi meta jerġa 'jiġi ffurmat f' suspensjoni.
4.
197 4.
192 Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
Do not use Mixtard after the expiry date which is stated on the label and the carton.
M’ għandekx tuża Mixtard wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C)
Do not store them in or too near the freezer section or cooling element.
199 Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
It is supplied in packs of 5 or 10 pre-filled pens of 3 ml.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja opaka u bajda Issibu f’ pakketti ta ’ 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml.
194 Information on how to use Mixtard 10 NovoLet
200 Informazzjoni dwar kif tuża Mixtard 10 NovoLet
Please read the following instructions carefully before using your Mixtard 10 NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Mixtard 10 NovoLet.
Mixtard 10 NovoLet is a simple, compact pre-filled pen.
Mixtard 10 NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Mixtard 10 NovoLet hi maħsuba biex tintuża mal- labar NovoFine Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta 'l - insulina f' każ li n- NovoLet tiegħek tintilef jew ikollha l- ħsara.
Check the label to make sure that your Mixtard 10 NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Mixtard 10 NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Mixtard 10 NovoLet ġdida.
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • 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 needle • Screw the needle straight and tightly onto Mixtard 10 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Mixtard 10 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Mixtard 10 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Mixtard 10 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Mixtard 10 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture F) to set the right dose.
202 • Żomm il- Mixtard 10 NovoLet tiegħek b' mod orizzontali.
To check a dose you set • 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 turi d- doża li tkun issettjajt • Jekk tkun issettjajt id- doża ħażin, sempliċiment dawwar l- għatu ’ l quddiem jew lura sakemm tissettja n- numru korrett ta' unitajiet.
Otherwise, insulin will leak out of the needle and the dose will be incorrect • If you have, by mistake, tried to set a dose over 78 units, follow these steps:
203 • Jekk, bi żball, tkun ippruvajt tissettja doża ogħla minn 78 unità, segwi dawn il- passi:
Close your Mixtard 10 NovoLet fully with 0 next to the dosage indicator.
Agħlaq il- Mixtard 10 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Mixtard 10 NovoLet carefully without the needle attached.
Armi l- Mixtard 10 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Mixtard 10 NovoLet is designed to work accurately and safely.
Il- Mixtard 10 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Mixtard 10 NovoLet.
Timliex mill- ġdid Mixtard 10 NovoLet.
You can clean the exterior of your Mixtard 10 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Mixtard 10 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
198 PACKAGE LEAFLET:
204 FULJETT TA 'TAGĦRIF:
Many medicines affect the way glucose works in your body and they may influence your insulin dose.
205 Il- mod kif jaħdem glukosju fil- ġisem tiegħek huwa affetwat minn ħafna mediċini, u dawn jistgħu jinfluwenzaw id- doża tiegħek ta ’ l- insulina.
201 Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
Do not store them in or too near the freezer section or cooling element.
208 Tagħmilhomx fil- friża.
203 Information on how to use Mixtard 20 NovoLet
209 Informazzjoni dwar kif tuża Mixtard 20 NovoLet
Please read the following instructions carefully before using your Mixtard 20 NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Mixtard 20 NovoLet.
Mixtard 20 NovoLet is a simple, compact pre-filled pen.
Mixtard 20 NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Mixtard 20 NovoLet hi maħsuba biex tintuża mal- labar NovoFine Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta 'l - insulina f' każ li l- NovoLet tiegħek tintilef jew ikollha l- ħsara.
Check the label to make sure that your Mixtard 20 NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Mixtard 20 NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Mixtard 20 NovoLet ġdida
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • 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 needle • Screw the needle straight and tightly onto Mixtard 20 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Mixtard 20 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Mixtard 20 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Mixtard 20 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Mixtard 20 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture F) to set the right dose.
211 • Żomm il- Mixtard 20 NovoLet tiegħek b' mod orizzontali.
Otherwise, insulin will leak out of the needle and the dose will be incorrect • If you have, by mistake, tried to set a dose over 78 units, follow these steps:
212 • Jekk, bi żball, tkun ippruvajt tissettja doża ogħla minn 78 unità, segwi dawn il- passi:
Close your Mixtard 20 NovoLet fully with 0 next to the dosage indicator.
Agħlaq il- Mixtard 20 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Mixtard 20 NovoLet carefully without the needle attached.
Armi l- Mixtard 20 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Mixtard 20 NovoLet is designed to work accurately and safely.
Il- Mixtard 20 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Mixtard 20 NovoLet.
Timliex mill- ġdid Mixtard 20 NovoLet.
You can clean the exterior of your Mixtard 20 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Mixtard 20 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
207 PACKAGE LEAFLET:
213 FULJETT TA 'TAGĦRIF:
Using other medicines
214 Meta tuża mediċini ohra
210 Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
217 In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
1 ml contains 100 IU of insulin human.
X' fih Mixtard 30 – Is- sustanza attiva hi insulina umana magħmula minn bijoteknoloġija rikombinanti (30% bħala insulina li tinħall u 70% bħala insulina isophane) Millilitru fih 100 UI ta ’ insulina umana.
Not all packs may be marketed.
Id- dehra ta 'Mixtard u d- daqs tal- pakkett Is- suspensjoni għall- injezzjoni tiġi bħala suspensjoni akweja opaka u bajda Issibu f’ pakketti ta ’ 5 jew 10 pinen mimlijin għal- lest ta ’ 3 ml Mhux il- pakketti kollha jistgħu jkunu għal skop kummerċjali.
212 Information on how to use Mixtard 30 NovoLet
218 Informazzjoni dwar kif tuża Mixtard 30 NovoLet
Please read the following instructions carefully before using your Mixtard 30 NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Mixtard 30 NovoLet.
Mixtard 30 NovoLet is a simple, compact pre-filled pen.
Mixtard 30 NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Mixtard 30 NovoLet hi maħsuba biex tintuża mal- labar NovoFine Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta 'l - insulina f' każ li l- NovoLet tiegħek tintilef jew ikollha l- ħsara.
Check the label to make sure that your Mixtard 30 NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Mixtard 30 NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Mixtard 30 NovoLet ġdida
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • 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 needle • Screw the needle straight and tightly onto Mixtard 30 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Mixtard 30 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Mixtard 30 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Mixtard 30 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Mixtard 30 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture F) to set the right dose.
220 • Żomm il- Mixtard 30 NovoLet tiegħek b' mod orizzontali.
Otherwise, insulin will leak out of the needle and the dose will be incorrect • If you have, by mistake, tried to set a dose over 78 units, follow these steps:
221 • Jekk, bi żball, tkun ippruvajt tissettja doża ogħla minn 78 unità, segwi dawn il- passi:
Close your Mixtard 30 NovoLet fully with 0 next to the dosage indicator.
Agħlaq il- Mixtard 30 NovoLet tiegħek kompletament biż- 0 biswit l- indikatur tad- dożaġġ.
Dispose of your used Mixtard 30 NovoLet carefully without the needle attached.
Armi l- Mixtard 30 NovoLet użata tiegħek bl- attenzjoni mingħajr ma ’ l- labra tkun imwaħħla.
Your Mixtard 30 NovoLet is designed to work accurately and safely.
Il- Mixtard 30 NovoLet tiegħek hi magħmula biex taħdem bi preċiżjoni u bla periklu.
Do not refill Mixtard 30 NovoLet.
Timliex mill- ġdid Mixtard 30 NovoLet.
You can clean the exterior of your Mixtard 30 NovoLet by wiping it with a medicinal swab.
Tista 'tnaddaf in- naħa ta' barra tal- Mixtard 30 NovoLet tiegħek billi timsaħa b’ tajjara b’ diżinfettant.
216 PACKAGE LEAFLET:
222 FULJETT TA 'TAGĦRIF:
Using other medicines
223 Meta tuża mediċini ohra
219 Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
The NovoLet that is not being used is to be stored in a refrigerator (2°C - 8°C).
226 In- NovoLet li ma tkunx qeda tintuża għandha tinħażen fi friġġ (2°C - 8°C) Taħżinhomx fil- friża jew qrib ħafna tal- kompartiment tal- friża jew ta 'l- element li jkessaħ.
221 Information on how to use Mixtard 40 NovoLet
227 Informazzjoni dwar kif tuża Mixtard 40 NovoLet
Please read the following instructions carefully before using your Mixtard 40 NovoLet.
Jekk jogħġbok aqra l- istruzzjonijiet li ġejjin bl- attenzjoni qabel ma tuża Mixtard 40 NovoLet.
Mixtard 40 NovoLet is a simple, compact pre-filled pen.
Mixtard 40 NovoLet hi pinna mimlija għal- lest sempliċi u kumpatta.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.
Mixtard 40 NovoLet hi maħsuba biex tintuża mal- labar NovoFine Bħala miżura ta ’ prekawzjoni, għandek dejjem iżżomm fuqek tagħmir spare tal- forniment ta 'l - insulina f' każ li l- NovoLet tiegħek tintilef jew ikollha l- ħsara.
Check the label to make sure that your Mixtard 40 NovoLet contains the correct type of insulin.
Iċċekkja t- tikketta biex taċċerta li l- Mixtard 40 NovoLet tiegħek ikun fiha t- tip korrett ta ’ insulina.
Repeat this movement at
Jekk ikun baqa ’ anqas minn 12- il unità, uża Mixtard 40 NovoLet ġdida
The movement must always be repeated until the liquid appears uniformly white and cloudy • After resuspending, complete all of the following stages of injection without delay • 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 needle • Screw the needle straight and tightly onto Mixtard 40 NovoLet (picture B) • Pull off the big outer needle cap and the inner needle cap.
Dan il- moviment għandu dejjem ikun ripetut sakemm il- likwidu jidher abjad u opak b' mod uniformi • Wara li tifforma s- suspensjoni mill- ġdid, wettaq l- istadji kollha ta ’ l- injezzjoni li ġejjin bla telf ta ’ żmien • Iddiżinfetta l- membrana tal- gomma b’ tajjara mediċinali • Dejjem uża labra ġdida għal kull injezzjoni sabiex tevita l- kontaminazzjoni • Neħħi s- siġill protettiv minn fuq labra NovoFine • Invita l- labra bi dritt u b' mod issikkat fuq Mixtard 40 NovoLet (stampa B) • Neħħi l- għatu l- kbir ta 'barra tal- labra u l- għatu ta' ġewwa tal- labra.
To avoid injection of air and ensure proper dosing: • Hold Mixtard 40 NovoLet with the needle pointing upwards • Tap the cartridge gently with your finger a few times.
Biex tevita l- injezzjoni ta ’ l- arja u tiżgura dożaġġ korrett: • Żomm Mixtard 40 NovoLet bil- labra tipponta ’ l fuq • B’ sebgħek tektek bil- mod l- iskartoċċ għal xi ftit drabi.
If it isn’ t, turn the cap until the push-button is fully depressed • Hold your Mixtard 40 NovoLet horizontally.
Jekk dan ma jkunx il- każ, dawwar l- għatu sakemm il- buttuna ta ’ l- injezzjoni tkun magħfusa ’ l isfel għal kollox
Now you’ re ready to set the dose you need • Turn the cap in the direction of the arrow (picture F) to set the right dose.
229 • Żomm il- Mixtard 40 NovoLet tiegħek b' mod orizzontali.