qanastek/EMEA-V3 huggingface dataset:
105 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
107 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog 100 U/ ml solution for injection in vial Insulin lispro Subcutaneous and intravenous use
Liprolog 100 U/ ml soluzzjoni għall- injezzjoni ġo kunjett Insulina lispro Għall- użu taħt il- ġilda u ġol- vina
108 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (5 x 3ml cartridges)
KLIEM FUQ IL- KARTUNA TA ’ BARRA (5 X 3 ml stoċċijiet)
Liprolog 100 U/ ml solution for injection in cartridge Insulin lispro (rDNA origin)
Liprolog 100 U/ ml soluzzjoni għall- injezzjoni fi stoċċ Insulina lispro (oriġini rDNA)
Solution for injection, 5 x 3ml cartridges
Soluzzjoni għall- injezzjonijiet, 5 X3 ml stoċċijiet
These cartridges are for use with a 3 ml pen only.
Dawn l- istoċċijiet għandhom jintużaw biss ma’ pinen ta ’ 3 ml.
If the 40 U/ ml vial is the product normally prescribed, do not take insulin from a 100 U/ ml cartridge using a 40 U/ ml syringe.
Jekk il- kunjett ta ’ 40 U/ ml hu l- prodott normalment li tieħu skond ir- riċetta tat- tabib, tiħux insulina minn stoċċ ta ’ 100 U/ ml billi tuża siringa ta ’ 40 U/ ml.
Once in use cartridges may be used for up to 28 days.
116 La darba jkunu fl- użu, l- istoċċijiet jistgħu jintużaw sa 28 ġurnata.
Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.
Wara li ddaħħal l- istoċċ ġol- pinna, l - istoċċ u l- pinna għandom jinħażnu f’ temperatura taħt 30°C u m’ għandhomx jitpoġġew fil- friġġ.
110 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (2 x 5 x 3ml cartridges)
KLIEM FUQ IL- KARTUNA TA ’ BARRA (2 X 5 X 3 ml stoċċijiet)
Solution for injection Part of a multi-pack of 2 x (5 x 3ml) cartridges.
Soluzzjoni għall- injezzjonijiet, Parti minn pakkett multiplu ta ’ 2 X (5 X3 ml) stoċċijiet.
Once in use cartridges may be used for up to 28 days.
118 La darba jkunu fl- użu, l- istoċċijiet jistgħu jintużaw sa 28 ġurnata.
112 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
119 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog 100 U/ ml solution for injection in cartridge Insulin lispro Subcutaneous and intravenous use
Liprolog 100 U/ ml soluzzjoni għall- injezzjoni fi stoċċ Insulina lispro Għall- użu taħt il- ġilda u ġol- vina
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (5 x 3ml cartridges)
KLIEM FUQ IL- KARTUNA TA ’ BARRA (5 X 3ml stoċċijiet)
Liprolog Mix25 100 U/ ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Liprolog Mix25 100 U/ ml suspensjoni għall- injezzjoni fi stoċċ 25% insulina lispro u 75% insulina lispro protamine suspensjoni (oriġini rDNA)
25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
25% insulina lispro u 75% insulina lispro protamine suspensjoni (oriġini rDNA) 100 U/ ml (3. 5 mg/ ml)
Suspension for injection 5 x 3ml cartridges
Suspensjoi għall- injezzjoni, 5 X 3ml stoċċijiet
These cartridges are for use with a 3 ml pen only.
Dawn l- istoċċijiet huma għall- użu ma ’ pinen ta ’ 3ml biss.
Once in use cartridges may be used for up to 28 days.
121 La darba jkunu fl- użu, l- istoċċijiet jistgħu jintużaw sa 28 ġurnata.
Following insertion in a pen, the cartridge and pen should be stored below 30°C and should not be refrigerated.
Wara li ddaħħal l- istoċċ fil- pinna, l - istoċċ u l- pinna għandom jinħażnu f’ temperatura taħt 30°C u m’ għandhomx ikunu ġol- friġġ.
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
122 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (2 x 5 x 3ml cartridges)
KLIEM FUQ IL- KARTUNA TA ’ BARRA (2 X 5 X 3ml stoċċijiet)
Suspension for injection Part of a multi-pack of 2 x (5 x 3ml) cartridges.
Suspensjoi għall- injezzjoni, Parti minn pakkett multiplu ta ’ 2 X (5 X 3ml) stoċċijiet.
Once in use cartridges may be used for up to 28 days.
123 La darba jkunu fl- użu, l- istoċċijiet jistgħu jintużaw sa 28 ġurnata.
117 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
124 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Mix25 100 U/ ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Liprolog Mix25 100 U/ ml soluzzjoni għall- injezzjoni fi stoċċ 25% insulina lispro u 75% insulina lispro protamine suspensjoni (oriġini rDNA) Għall- użu taħt il- ġilda
118 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
125 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Mix50 100 U/ ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Liprolog Mix50 100 U/ ml suspensjoni għall- injezzjoni fi stoċċ 50% insulina lispro u 50% insulina lispro protamine suspensjoni (oriġini rDNA)
50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
50% insulina lispro u 50% insulina lispro protamine suspensjoni (oriġini rDNA) 100 U/ ml (3. 5 mg/ ml)
Once in use cartridges may be used for up to 28 days.
126 La darba jkunu fl- użu, l- istoċċijiet jistgħu jintużaw sa 28 ġurnata.
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
127 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Once in use cartridges may be used for up to 28 days.
128 La darba jkunu fl- użu, l- istoċċijiet jistgħu jintużaw sa 28 ġurnata.
122 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
129 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Mix50 100 U/ ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Liprolog Mix50 100 U/ ml suspensjoni għall- injezzjoni fi stoċċ 50% insulina lispro u 50% insulina lispro protamine suspensjoni (oriġini rDNA) Għall- użu taħt il- ġilda
123 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
130 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Basal 100 U/ ml suspension for injection in cartridge Insulin lispro protamine suspension (rDNA origin)
Liprolog Basal 100 U/ ml suspensjoni għall- injezzjoni fi skartoċċ Insulina lispro protamine suspensjoni (oriġini rDNA)
125 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
132 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
127 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
134 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Basal 100 U/ ml suspension for injection in cartridge Insulin lispro protamine suspension Subcutaneous use
Liprolog Basal 100 U/ ml suspensjoni għall- injezzjoni fi skartoċċ Suspensjoni ta ’ insulin lispro protamine Għall- użu taħt il- ġilda
128 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
135 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (5 x 3ml Pens)
KLIEM FUQ IL- KARTUNA TA ’ BARRA (5 x 3ml Pinen)
Liprolog Pen 100 U/ ml solution for injection Insulin lispro (rDNA origin)
Pinna Liprolog 100 U/ ml soluzzjoni għall- injezzjoni Insulina lispro (oriġini rDNA)
Solution for injection 5 x 3ml Pens
Soluzzjoni għall- injezzjoni, 5 X 3ml Pinen
Once in use pens may be used for up to 28 days.
La darba jkunu fl- użu, il- pinen jistgħu jintużaw sa 28 ġurnata.
Pens in use should be stored below 30°C and should not be refrigerated.
Pinen li qed jintużaw għandom jinħażnu f’ temperatura taħt 30°C u m’ għandhomx ikunu ġol- friġġ.
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
137 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Solution for injection Part of a multi-pack of 2 x (5 x 3ml) Pens.
Soluzzjoni għall- injezzjoni, Parti minn pakkett multiplu ta ’ 2 X (5 X 3ml) Pinen.
132 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
139 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Pen 100 U/ ml solution for injection Insulin lispro Subcutaneous and intravenous use
Pinna Liprolog 100 U/ ml soluzzjoni għall- injezzjoni Insulina lispro Għall- użu taħt il- ġilda u ġol- vina
133 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
140 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT (5 x 3ml Pens)
KLIEM FUQ IL- KARTUNA TA ’ BARRA (5 X 3ml Pinen)
Liprolog Mix25 100 U/ ml Pen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Pinna Liprolog Mix25 100 U/ ml suspensjoni għall- injezzjoni 25% insulina lispro u 75% insulina lispro protamine suspensjoni (oriġini rDNA)
Suspension for injection 5 x 3ml Pens
Suspensjoni għall- injezzjoni, 5 X 3ml Pinen.
Suspension for injection Part of a multi-pack of 2 x (5 x 3ml) Pens.
Suspensjoni għall- injezzjoni, Parti minn pakkett multiplu ta ’ 2 X (5 X 3ml) Pinen.
137 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
144 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Mix25 100 U/ ml Pen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Pinna Liprolog Mix25 100 U/ ml suspensjoni għall- injezzjoni 25% insulina lispro and 75% insulina lispro protamine suspensjoni Għall- użu taħt il- ġilda
138 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
145 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Mix50 100 U/ ml Pen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Pinna Liprolog Mix50 100 U/ ml suspensjoni għall- injezzjoni 50% insulina lispro u 50% insulina lispro protamine suspensjoni (oriġini rDNA)
Once in use pens may be used for up to 28 days.
148 La darba jkunu fl- użu, il- pinen jistgħu jintużaw sa 28 ġurnata.
142 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
149 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Mix50 100 U/ ml Pen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Pinna Liprolog Mix50 100 U/ ml suspensjoni għall- injezzjoni 50% insulina lispro u 50% insulina lispro protamine suspensjoni Għall- użu taħt il- ġilda
143 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
150 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Basal 100 U/ ml Pen suspension for injection Insulin lispro protamine suspension (rDNA origin)
Pinna Liprolog Basal 100 U/ ml suspensjoni għall- injezzjoni Insulina lispro protamine suspensjoni (oriġini rDNA)
Suspension for injection 5 X 3ml Pens
Suspensjoni għall- injezzjoni, 5 X 3ml Pinen.
145 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
152 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Once in use pens may be used for up to 21 days.
La darba jkunu fl- użu, il- pinen jistgħu jintużaw sa 21 ġurnata.
147 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
154 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Basal 100 U/ ml Pen suspension for injection Insulin lispro protamine suspension Subcutaneous use
Pinna Liprolog Basal 100 U/ ml suspensjoni għall- injezzjoni Insulina lispro protamine suspensjoni Għall- użu taħt il- ġilda
148 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
155 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog KwikPen 100 U/ ml solution for injection Insulin lispro (rDNA origin)
Liprolog 100 U/ ml KwikPen, soluzzjoni għall- injezzjoni Insulina lispro (oriġini rDNA)
150 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
157 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Solution for injection Part of a multi-pack of 2 x (5 x 3ml) pre-filled pens.
Soluzzjoni għall- injezzjoni, Parti minn pakkett multiplu ta ’ 2 x (5 x 3ml) pinen mimlijin għal - lest.
10.
158 10.
152 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
159 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog KwikPen 100 U/ ml solution for injection Insulin lispro Subcutaneous and intravenous use
Liprolog 100 U/ ml KwikPen, soluzzjoni għall- injezzjoni Insulina lispro Għall- użu taħt il- ġilda u ġol- vina
153 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
160 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Mix25 100 U/ ml KwikPen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin)
Liprolog Mix25 100 U/ ml KwikPen, suspensjoni għall- injezzjoni 25% insulina lispro u 75% insulina lispro protamine suspensjoni (oriġini rDNA)
25% insulin lispro and 75% insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
25% insulina lispro u 75% insulina lispro protamine suspension (oriġini rDNA) 100 U/ ml (3. 5 mg/ ml)
Suspension for injection 5 x 3ml pre-filled pens
Suspensjoni għall- injezzjoni, 5 X 3ml pinen mimlijin għal- lest.
155 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
162 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Once in use pens may be used for up to 28 days.
163 La darba jkunu fl- użu, il- pinen jistgħu jintużaw sa 28 ġurnata.
157 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
164 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Mix25 100 U/ ml KwikPen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Liprolog Mix25 100 U/ ml KwikPen, suspensjoni għall- injezzjoni 25% insulina lispro u 75% insulina lispro protamine suspensjoni Għall- użu taħt il- ġilda
158 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
165 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Mix50 100 U/ ml KwikPen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin)
Liprolog Mix50 100 U/ ml KwikPen, suspensjoni għall- injezzjoni 50% insulina lispro u 50% insulina lispro protamine suspensjoni (oriġini rDNA)
50% insulin lispro and 50% insulin lispro protamine suspension (rDNA origin) 100 U/ ml (3.5 mg/ ml)
50% insulina lispro u 50% insulina lispro protamine suspension (oriġini rDNA) 100 U/ ml (3. 5 mg/ ml)
160 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
167 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Once in use pens may be used for up to 28 days.
168 La darba jkunu fl- użu, il- pinen jistgħu jintużaw sa 28 ġurnata.
162 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
169 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Mix50 100 U/ ml KwikPen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Liprolog Mix50 100 U/ ml KwikPen, suspensjoni għall- injezzjoni 50% insulina lispro u 50% insulina lispro protamine suspensjoni Għall- użu taħt il- ġilda
163 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
170 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Liprolog Basal 100 U/ ml KwikPen, suspension for injection Insulin lispro protamine suspension (rDNA origin)
Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni Insulina lispro protamine suspensjoni (oriġini rDNA)
165 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
172 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
10.
173 10.
167 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
174 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Liprolog Basal 100 U/ ml KwikPen, suspension for injection Insulin lispro protamine suspension Subcutaneous use
Liprolog Basal 100 U/ ml KwikPen, suspensjoni għall- injezzjoni Insulina lispro protamine suspensjoni Għall- użu taħt il- ġilda
169 PACKAGE LEAFLET:
176 FULJETT TA ’ TAGĦRIF:
Liprolog 100 U/ ml solution for injection in vial (insulin lispro)
Liprolog 100 U/ ml, soluzzjoni għall- injezzjoni f’ kunjett (insulina lispro)
What Liprolog is and what it is used for 2.
X’ inhu Liprolog u għalxiex jintuża 2.
Before you use Liprolog 3.
Qabel ma tuża Liprolog 3.
How to use Liprolog 4.
Kif għandek tuża Liprolog 4.
How to store Liprolog 6.
Kif taħżen Liprolog 6.
WHAT LIPROLOG IS AND WHAT IT IS USED FOR
X’ INHU LIPROLOG U GĦALXIEX JINTUŻA
Liprolog is used to treat diabetes.
Liprolog huwa użat biex id- dijabete tiġi trattata.
Liprolog works more quickly than normal human insulin because the insulin molecule has been changed slightly.
Taħdem aktar malajr minn insulina umana normali għax il- molekula ta 'l- insulina ġiet mibdula ftit.
Liprolog is a substitute for your own insulin and is used to control glucose in the long term.
Liprolog huwa sostitwent għall- insulina tiegħek u huwa użat biex jikkontrolla l- glukożju fuq medda twila ta ’ żmien.
Your doctor may tell you to use Liprolog as well as a longer-acting insulin.
It- tabib tiegħek jista 'jgħidlek biex tuża Liprolog kif ukoll insulina li ddum taħdem għal ħin itwal.
Liprolog is suitable for use in adults and children.
Liprolog huwa tajjeb għall- użu fl- adulti u fit- tfal.
Liprolog may be used in children, when an advantage is expected compared to soluble insulin, for example, in the timing of the injection in relation to meals.
Liprolog jista 'jintuża fit- tfal, meta vantaġġ huwa mistenni meta mqabbel ma' insulina li tinħall, per eżempju, it- teħid ta 'l- injezzjoni skond il- ħinijiet ta' l- ikliet.
BEFORE YOU USE LIPROLOG
QABEL MA TUŻA LIPROLOG
Do not use Liprolog
Tużax LIPROLOG
- if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of Liprolog.
Oqgħod attent ħafna b’ Liprolog
Take special care with Liprolog • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
177 • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid - demm.
170 • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different.
• Ftit nies li kellhom zokkor baxx fid- demm wara li qalbu minn insulina ta 'l- annimali għal isulina umana rrapportaw li l- ewwel sintomi ta' twissija kienu anqas ovji jew differenti.
If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. • If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse
• Jekk tirrispondi IVA għal xi mistoqsijiet li ġejjin, għid lit- tabib tiegħek, lill- ispiżjar jew lill - infermier tad- dijabete.
Using other medicines Your insulin needs may change if you are taking the contraceptive pill, steroids, thyroid hormone replacement therapy, oral hypoglycaemics, acetyl salicylic acid, sulpha antibiotics, octreotide, “ beta2 stimulants” (for example ritodrine, salbutamol or terbutaline), beta-blockers, or some antidepressants (monoamine oxidase inhibitors), danazol, some angiotensin converting (ACE) inhibitors (for example captopril, enalapril), and angiotensin II receptor blockers.
Meta tuża mediċini oħra Il- bżonnijiet tiegħek ta 'l- insulina jistgħu jinbidlu jekk qed tieħu il- pillola kontraċettiva, sterojdi, terapija biex tpatti għan- nuqqas ta' l- ormoni tat- tirojde, mediċini orali li jbaxxu z- zokkor fid- demm, acetyl salicylic acid, antibijotiċi sulpha, octreotide, "stimulanti tat- tip beta 2" (per eżempju ritodrine, salbutamol jew terbutaline), imblokkaturi tat- tip beta, jew ċerti antidipressanti (impedituri ta ’ monoamine oxidase), danazol, ċerti impedituri t' enżimi li jibdlu l- anġjotensina (per eżempju captopril, enalapril) u sustanzi li jibblokkjaw ir- riċetturi anġjotensin II
Ask your doctor for advice.
Itlob lit- tabib tiegħek għal parir.
3.
• Episodji frekwenti ta 'zokkor baxx fid- demm • Sinjali ta ’ twissija mnaqqsa jew assenti meta jkollok zokkor baxx fid- demm 178 3.
HOW TO USE LIPROLOG
KIF GĦANDEK TUŻA LIPROLOG
Make sure you get the Liprolog that your doctor has told you to use.
Kun żgur li ġġib Liprolog li t- tabib tiegħek qallek biex tuża.
Always use Liprolog exactly as your doctor has told you.
Dejjem għandek tuża Liprolog skond il- parir tat- tabib.
Dosage • You should normally inject Liprolog within 15 minutes of a meal.
• Normalment għandek tinjetta Liprolog fi żmien 15- il minuta qabel ikla.
But your doctor will have told you exactly how much to use, when to use it, and how often.
Imma t- tabib tiegħek ikun qallek eżatt kemm għandek tuża, meta għandek tużaha, u kemm- il darba.
Follow them exactly and visit your diabetes clinic regularly. • If you change the type of insulin you use (for example from a human or animal insulin to a Liprolog product), you may have to take more or less than before.
• Jekk tibdel it- tip ta 'l- insulina li tuża (per eżempju minn insulina umana jew minn ta' l - annimali għall- prodott ta 'Liprolog), jista' jkun ikollok bżonn tieħu aktar jew anqas minn qabel.
This might just be for the first injection or it may be a gradual change over several weeks or months. • Inject Liprolog under the skin.
Dan jista 'jkun biss għal l- ewwel injezzjoni jew tista' tkun bidla gradwali tul ħafna ġimgħat jew xhur.
171 Preparing Liprolog • Liprolog is already dissolved in water, so you do not need to mix it.
• Liprolog huwa diġa maħlul fl- ilma, għalhekk m' għandekx bżonn tħalltu.
Injecting Liprolog • First wash your hands. • Before you make an injection, clean your skin as you have been instructed.
Naddaf it- tapp tal - gomma fuq il- kunjett, imma tneħħix it- tapp.
Clean the rubber stopper on the vial, but do not remove the stopper. • Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of Liprolog you want.
• Uża siringa u labra nadifa u sterili biex ittaqqab it- tapp tal- gomma u iġbed l- ammont ta 'Liprolog li trid.
It doesn’ t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Liprolog injection will still work quicker than soluble human insulin. • Your doctor will tell you if you have to mix Liprolog with one of the human insulins.
Mhux importanti liema sit tuża, jew il- parti ta 'fuq tad- driegħ, il- koxxa, il- warrani jew fiż- żaqq, l- injezzjoni ta' Liprolog xorta taħdem aktar malajr minn insulina umana li tinħall.
For example if you do need to inject a mixture, draw the Liprolog into the syringe before the long acting insulin.
Per eżempju jekk għandek bżonn tinjetta taħlita, iġbed Liprolog f' siringa qabel l- insulina li ddum taħdem għal ħin itwal.
You should not normally mix Liprolog with one of the mixtures of human insulins.
Normalment m' għandekx tħallat Liprolog ma 'waħda mit- taħlitiet ta' l- inulini umani.
You should never mix Liprolog with insulins produced by other manufacturers or animal insulins. • You must not administer Liprolog by the intravenous route.
M' għandek qatt tħallat Liprolog ma 'insulini prodotti minn manifatturi oħra jew ma' insulini minn annimali.
Inject Liprolog as your physician or nurse has taught you.
Injetta Liprolog kif qallek it- tabib jew l- infermier tiegħek.
Only your physician can administer Liprolog by the intravenous route.
It- tabib tiegħek biss jista 'jagħti Liprolog ġol- vina.
Using Liprolog in an infusion pump • Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
• Ċerti Minimed u Disetronic pompi ta 'l- infużjoni ta' l- insulina biss jistgħu jintużaw biex tkun tista 'tieħu l- infużjoni ta' l- insulina lispro.
If repeated or severe low blood glucose levels occur, notify your doctor or clinic and consider the need to reduce or stop your insulin infusion. • A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
Jekk il- livelli tal- glukożju fid- demm jitbaxxew ta 'spiss jew severament, għid lit- tabib tiegħek jew il- klinika u kkunsidra l- bżonn li tnaqqas jew twaqqaf l- infużjoni ta' l- insulina tiegħek.
If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your doctor or clinic. • When used with an insulin infusion pump, Liprolog should not be mixed with any other insulin.
• Meta użat b' pompa ta 'l- infużjoni ta' l- insulina, Liprolog m' għandux jitħallat ma 'xi insulina oħra.
Check your blood sugar.
Jekk tuża Liprolog aktar milli suppost Jekk tuża Liprolog aktar milli suppost, jista ’ jkollok livell baxx ta ’ zokkor fid- demm.
If you forget to use Liprolog If you take less Liprolog than you need, a high blood sugar may occur.
Jekk tinsa tuża Liprolog Jekk tieħu inqas Liprolog milli ghandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
172 If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “ Possible Side Effects”). • Always keep spare syringes and a spare vial of Liprolog. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
If you stop using Liprolog.
Jekk tieqaf tuża Liprolog
If you take less Liprolog than you need, a high blood sugar may occur.
Jekk tieħu inqas Liprolog milli ghandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
180 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Liprolog can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Liprolog jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
rash over the whole body • difficulty in breathing • wheezing •
Tinżillek il- pressjoni tad- demm
blood pressure dropping heart beating fast sweating.
Diffikultà fin- nifs
If you think you are having this sort of insulin allergy with Liprolog, tell your doctor at once.
Jekk taħseb li qed ikollok din it- tip t' allerġija għall- insulina bi Liprolog għid lit- tabib tiegħek minnufih.
This can be caused if: • you take too much Liprolog or other insulin; • you miss or delay meals or change your diet; • you exercise or work too hard just before or after a meal; • you have an infection or illness (especially diarrhoea or vomiting); • there is a change in your need for insulin; or • you have trouble with your kidneys or liver which gets worse.
• Għandek problemi bil- kliewi jew bil- fwied li qed isiru agħar
feeling sick cold sweat.
Uġigħ ta 'ras
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.
181 Meta ma tkunx konfidenti li taf tagħraf is- sintomi ta 'twissija, evita sitwazzjonijiet, eż. li ssuq karozza, li tista' tpoġġi lillek jew lil oħrajn f' riskju minħabba zokkor baxx fid- demm.
Hyperglycaemia and diabetic ketoacidosis
Ipergliċemija u l- ketoaċidożi dijabetika
173 Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.
Ipergliċemija (zokkor għoli fid- demm) ifisser li ġismek m' għandux biżżejjed insulina.
Hyperglycaemia can lead to diabetic ketoacidosis.
Jista ’ jaqbdek zokkor għoli fid- demm minħabba:
The first symptoms come on slowly over many hours or days.
• Li ma tieħux Liprolog tiegħek jew insulina oħra;
HOW TO STORE LIPROLOG
KIF TAĦŻEN LIPROLOG
Before the first use store your Liprolog in a refrigerator (2°C – 8°C).
Qabel ma tuzah l- ewwel darba żomm Liprolog fi friġġ (2°C- 8°C).
Do not put it near heat or in the sun.
Żomm il- kunjett li ħa tuża f' temperatura ambjentali ta 'ġewwa (taħt 30°C) għal użu sa 28 ġurnata. Tħallihx ħdejn is - sħana jew fix- xemx.
Do not use Liprolog after the expiry date which is stated on the label and the carton.
Tużax Liprolog wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna.
Do not use Liprolog, if it is coloured or it has solid pieces in it.
Tużax Liprolog jekk għandu xi kulur jew jidhru xi frak.
What Liprolog 100 U/ml solution for injection in vial contains
182
What Liprolog looks like and contents of the pack Liprolog 100 U/ml, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 U/ml) solution for injection.
Liprolog 100 U/ ml, soluzzjoni għal injezzjoni, hu soluzzjoni akweju, bla kulur, ċar u sterili u fih 100 unità ta ’ insulin lispro f’ kull millilitru (100 U/ ml) soluzzjoni għal injezzjoni.
Liprolog 100 U/ml, solution for injection in vial comes in a pack of 1 vial, 2 vials or a multipack of 5 x 1 vial.
Liprolog 100 U/ ml, soluzzjoni għal injezzjoni ġo kunjett jiġi f’ pakkett ta ’ kunjett 1, 2 kunjetti jew pakkett multiplu ta ’ 5 x 1 kunjett.
Marketing Authorisation Holder and Manufacturer Liprolog 100 U/ml, solution for injection in vial is made by:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
174 • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Lilly Pharma Fertigung und Distribution GmbH & Co.
Liprolog 100 U/ ml, soluzzjoni għal injezzjoni ġo kunjett huwa manifatturat minn: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Lilly Pharma Fertigung und Distribution GmbH & Co.
Ελλάδα ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
183 ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
Polska Eli Lilly Polska Sp. z o.o.
Eli Lilly Polska Sp. z o. o.
176 PACKAGE LEAFLET:
184 FULJETT TA ’ TAGĦRIF:
Liprolog 100 U/ml solution for injection in cartridge (insulin lispro)
Liprolog 100 U/ ml, soluzzjoni għall- injezzjoni ġo stoċċ (insulina lispro)
Liprolog is used to tre at diabetes.
Liprolog huwa użat biex id- dijabete tiġi trattata.
Take special care with Liprolog • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
185 • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid - demm.
177 • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different.
• Ftit nies li kellhom zokkor baxx fid- demm wara li qalbu minn insulina ta 'l- annimali għal isulina umana rrapportaw li l- ewwel sintomi ta' twissija kienu anqas ovji jew differenti.
- - -
• Jekk tirrispondi IVA għal xi mistoqsijiet li ġejjin, għid lit- tabib tiegħek, lill- ispiżjar jew lill - infermier tad- dijabete.
Have you recently become ill?
- Kont ma tiflaħx dan l- aħħar?
Do you have trouble with your kidneys or liver?
- Għandek xi problemi bil- kliewi jew bil- fwied?
Are you exercising more than usual?
- Qed tagħmel aktar eżerċizzju mis- soltu?
The 3 ml cartridge is only for use in 3ml pens.
L- istoċċ tat- 3ml għandu jintuza biss mal- pinen tat- 3ml.
Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy.
Dejjem eżamina il- pakkett u t- tabella ta ’ l- istoċċ għall- isem u għat- tip ta 'l- insulina meta ġġibu mill- ispiżerija.
178 • If you change the type of insulin you use (for example from a human or animal insulin to a Liprolog product), you may have to take more or less than before.
• Jekk tibdel it- tip ta 'l- insulina li tuża (per eżempju minn insulina umana jew minn ta' l - annimali għall- prodott ta 'Liprolog), jista' jkun ikollok bżonn tieħu aktar jew anqas minn qabel.
Preparing Liprolog • Liprolog is already dissolved in water, so you do not need to mix it.
• Liprolog huwa diġa maħlul fl- ilma, għalhekk m' għandekx bżonn tħalltu.
Getting the pen ready to use • First wash your hands.
Iddisinfetta r- rita tal- gomma ta ’ l- istoċċ.
Disinfect the rubber membrane of the cartridge. • You must only use Liprolog cartridges in compatible CE marked pens.
• Għandek tuża biss stoċċijiet tal- Liprolog f’ pinen kompattibli mmarkati CE.
Please make sure that Liprolog is mentioned in the leaflet accompanying your pen.
Jekk jogħġbok aċċerta ruħek li jissemmew l- istoċċijiet Liprolog jew Lilly fil- fuljett ta ’ mal - pinna.
The 3 ml cartridge only fits the 3 ml pen. • Follow the instructions that come with the pen.
L- istoċċ ta ’ 3 ml jesa biss il- pinna ta ’ 3 ml.
Do this until a drop of Liprolog comes out of the needle.
Agħmel hekk sakemm qatra Liprolog toħroġ minn ġol- labra.
Injecting Liprolog • Before you make an injection, clean your skin as you have been instructed.
• Qabel ma tagħmel l- injezzjoni, naddaf il- ġilda tiegħek kif ġejt mgħallem.
Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.
187 Kun żgur li tinjetta għal ta 'l- anqas nofs pulzier (1 cm)' l bogħod mill- aħħar injezzjoni u li tbiddel il- postijiet li tinjetta, kif ġejt mgħallem.
It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Liprolog injection will still work quicker than soluble human insulin. • You must not administer Liprolog by the intravenous route.
Mhux importanti liema sit tuża, jew il- parti ta 'fuq tad- driegħ, il- koxxa, il- warrani jew fiż- żaqq, l- injezzjoni ta' Liprolog xorta taħdem aktar malajr minn insulina umana li tinħall.
This will keep the Liprolog sterile and prevent leaking.
Dan iżomm Liprolog sterili u jipprevjeni l- ħruġ.
Further injections • Leave the cartridge in the pen.
• Ħalli l- istoċċ ġol- pinna.
Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Liprolog comes out of the needle.
Qabel kull injezzjoni, ikkalibra 1 jew 2 unitajiet u agħfas il - mekkaniżmu ta 'l- injezzjoni bil- pinna tipponta' l fuq sakemm toħroġ qattra ta 'Liprolog mill - labra.
You can see how much Liprolog is left by looking at the gauge on the side of the cartridge.
Tista 'tara hemm baqa' Liprolog billi tħares lejn il- gejġ fuq il- ġenb ta 'l- istoċċ.
If there is not enough for your dose, change the cartridge.
Jekk m’ hemmx biżżejjed għad- doża tiegħek, biddel l- istoċċ.
Do not mix any other insulin in a Liprolog cartridge.
Tħallatx xi insulina oħra fi stoċċ ta ’ Liprolog.
Once the cartridge is empty, do not use it again.
Ladarba l- istoċċ jiżvojta, terġax tużah.
If you take more Liprolog than you need If you take more Liprolog than you need, a low blood sugar may occur.
Jekk tuża Liprolog aktar milli suppost Jekk tuża Liprolog aktar milli suppost, jista ’ jkollok livell baxx ta ’ zokkor fid- demm.
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest.
Imbagħad kul il- frott, gallettini, jew sandwiċċ, kif qallek it- tabib 188 tiegħek u strieħ ftit.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”). • Always keep spare syringes and a spare vial of Liprolog, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
180 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Hyperglycaemia and diabetic ketoacidosis Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.
Ipergliċemija u l- ketoaċidożi dijabetika
181 Do not use Liprolog, if it is coloured or it has solid pieces in it.
Tużax Liprolog jekk għandu xi kulur jew jidhru xi frak.
What Liprolog 100 U/ml solution for injection in cartridge contains
X’ fih Liprolog 100 u/ ml soluzzjoni għal injezzjoni ġo kunjett:
Each cartridge contains 300 units (3 millilitres).
Kull stoċċ fih 300 unità (3 millilitri).
The cartridges come in packs of 5 cartridges or a multipack of 2 x 5 cartridges.
L- istoċċijiet jiġi f’ pakketti ta ’ 5 stoċċijiet jew pakkett multiplu ta ’ 2 x 5 stoċċijiet.
Marketing Authorisation Holder and Manufacturer Liprolog 100 U/ml, solution for injection in cartridge is made by: • Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, • Eli Lilly Italia S.p.A., Via A.
Liprolog 100 U/ ml, soluzzjoni għal injezzjoni ġo stoċċ huwa manifatturat minn: • Lilly France S. A. S., Rue du Colonel Lilly, 67640 Fegersheim, Franza • Eli Lilly Italia S. p. A., Via A.
България ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
191 България ТП “ Ели Лили Недерланд ” Б. В. - България тел. + 359 2 491 41 40
182 Eesti Österreich Eli Lilly Holdings Limited Eesti filiaal Tel: +3726441100
Eesti Österreich Eli Lilly Holdings Limited Eesti filiaal Tel: +3726441100
This leaflet was last approved in {MM/YYYY}.
192 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
183 PACKAGE LEAFLET:
193 FULJETT TA ’ TAGĦRIF:
Liprolog Mix25 100 U/ml suspension for injection in cartridge (insulin lispro)
Liprolog Mix25 100U/ ml, suspensjoni għall- injezzjoni ġo stoċċ (insulina lispro)
What Liprolog Mix25 is and what it is used for 2.
X’ inhu Liprolog Mix25 u għalxiex jintuża 2.
Before you use Liprolog Mix25 3.
Qabel ma tuża Liprolog Mix25 3.
How to use Liprolog Mix25 4.
Kif għandek tuża Liprolog Mix25 4.
How to store Liprolog Mix 25 6.
Kif taħżen Liprolog Mix25 6.
WHAT LIPROLOG MIX25 IS AND WHAT IT IS USED FOR
X’ INHU LIPROLOG MIX25 U GĦALXIEX JINTUŻA
Liprolog Mix25 is a premixed suspension.
Liprolog Mix25 hija użata biex id- dijabete tiġi trattata Hija suspensjoni mħallta lesta..
25% of the insulin lispro in Liprolog Mix25 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly.
25% ta 'l- insulina lispro fi Liprolog Mix25 hija maħlula fl- ilma u taħdem aktar malajr minn insulina umana normali għax il- molekula ta' l- insulina ġiet mibdula ftit.
75% of the insulin lispro in Liprolog Mix25 is available in a suspension together with protamine sulphate, so that its action is prolonged.
75% ta 'l- insulina lispro fi Liprolog Mix25 hija suspensjoni flimkien ma' protamine sulphate, ħalli l - azzjoni tagħha tkun mtawwla.
Liprolog Mix25 is a substitute for your own insulin and is used to control glucose in the long term.
Liprolog Mix25 huwa sostitwent għall- insulina tiegħek u huwa użat biex jikkontrolla l- glukożju fuq medda twila ta ’ żmien.
Liprolog Mix25 works very quickly and longer than soluble insulin.
Liprolog Mix25 jaħdem malajr ħafna u għal tul ta ’ żmien itwal mill- insulina li tinħall.
You should normally use Liprolog Mix25 within 15 minutes of a meal.
Normalment għandek tuża Liprolog Mix25 15- il minuta qabel ikla.
Your doctor may tell you to use Liprolog Mix25 as well as a longer -acting insulin.
It- tabib tiegħek jista 'jgħidlek biex tuża Liprolog Mix25 kif ukoll insulina li ddum taħdem għal ħin itwal.
BEFORE YOU USE LIPROLOG MIX25
QABEL MA TUŻA LIPROLOG
Do not use Liprolog Mix25
Tużax LIPROLOG Mix25
- if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of Liprolog
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal insulina lispro jew sustanzi oħra ta ’
Mix25.
Liprolog
Take special care with Liprolog Mix25 • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low.
194 • Jekk il- livelli taz- zokkor fid- demm tiegħek huma kkontrollati sew bit- terapija ta 'l- insulina li qed tuża bħalissa, tista' ma tħossx is- sintomi ta 'twissija meta jinżillek wisq iz- zokkor fid - demm.
184 • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different.
• Ftit nies li kellhom zokkor baxx fid- demm wara li qalbu minn insulina ta 'l- annimali għal isulina umana rrapportaw li l- ewwel sintomi ta' twissija kienu anqas ovji jew differenti.
HOW TO USE LIPROLOG MIX25
KIF GĦANDEK TUŻA LIPROLOG MIX25
The 3 ml cartridge is only for use in 3ml pens.
L- istoċċ ta ’ 3ml għandu jiġi uzat biss mal- pinna ta ’ 3ml.
Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy.
Dejjem eżamina il- pakkett u t- tabella tal l- istoċċ għall- isem u għat- tip ta 'l- insulina meta ġġibu mill- ispiżerija.
Make sure you get the Liprolog Mix25 that your doctor has told you to use.
Kun żgur li ġġib Liprolog Mix 25 li t- tabib tiegħek qallek biex tuża.
Always use Liprolog Mix25 exactly as your doctor has told you.
Dejjem għandek tuża Liprolog Mix25 skond il- parir tat- tabib.
Dosage • You should normally inject Liprolog Mix25 within 15 minutes of a meal.
• Normalment għandek tinjetta Liprolog Mix25 fi żmien 15- il minuta qabel ikla.
185 • If you change the type of insulin you use (for example from a human or animal insulin to a Liprolog product), you may have to take more or less than before.
• Jekk tibdel it- tip ta 'l- insulina li tuża (per eżempju minn insulina umana jew minn ta' l - annimali għall- prodott ta 'Liprolog), jista' jkun ikollok bżonn tieħu aktar jew anqas minn qabel.
This might just be for the first injection or it may be a gradual change over several weeks or months. • Inject Liprolog Mix25 under the skin.
Dan jista 'jkun biss għal l- ewwel injezzjoni jew tista' tkun bidla gradwali tul ħafna ġimgħat jew xhur.
You should not administer it using a different administration route.
Taħt l - ebda ċirkostanza Liprolog Mix25 m' għandha tingħata ġol- vina.
Under no circumstances should Liprolog Mix25 be given intravenously.
Preparazzjoni ta 'Liprolog Mix25
Preparing Liprolog Mix25 • Cartridges containing Liprolog Mix25 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky.
• Stoċċijiet li għandhom Liprolog Mix25 għandhom ikunu mdawra fil- pali ta 'l- idejn għaxar darbiet u maqlubin 180o għaxar darbiet eżatt qabel l- użu biex tirrisospendi l- insulina sakemm tidher kollha mċajpra jew qiesa ħalib.
Cartridges contain a small glass bead to assist mixing.
L- istoċċijiet fihom żibġa tal- ħġieġ biex tgħin fit- tħallit.
The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance.
L- istoċċijiet għandhom ikunu eżaminati ta 'spiss u m' għandhomx jintużaw jekk hemm materjal miġbur jew jekk partiċelli iebsa u bojod jeħlu mal- qiegħ jew mal- ġenb ta ’ l- istoċċ, u jidher qiesu ġelu.
Disinfect the rubber membrane of the cartridge. • You must only use Liprolog Mix25 cartridges in compatible CE marked pens.
• Għandek tuża biss stoċċijiet tal- Liprolog Mix25 f’ pinen kompattibli mmarkati CE.
Do this until a drop of Liprolog Mix25 comes out of the needle.
Agħmel hekk sakemm qatra Liprolog Mix25 toħroġ minn ġol - labra.
Injecting Liprolog Mix25 • Before you make an injection, clean your skin as you have been instructed.
196 • Qabel ma tagħmel l- injezzjoni, naddaf il- ġilda tiegħek kif ġejt mgħallem.
This will keep the Liprolog Mix25 sterile and prevent leaking.
Dan iżomm Liprolog Mix25 sterili u jipprevjeni l- ħruġ.
Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Liprolog Mix25 comes out of the needle.
Qabel kull injezzjoni, ikkalibra 1 jew 2 unitajiet u agħfas il - mekkaniżmu ta 'l- injezzjoni bil- pinna tipponta' l fuq sakemm toħroġ qattra ta 'Liprolog Mix25 mill- labra.
You can see how much Liprolog is left by looking at the gauge on the side of the cartridge.
Tista 'tara hemm baqa' Liprolog Mix25 billi tħares lejn il- gejġ fuq il- ġenb ta 'l- istoċċ.
If there is not enough for your dose, change the cartridge.
Jekk m’ hemmx biżżejjed għad - doża tiegħek, biddel l- istoċċ.
Do not mix any other insulin in a Liprolog Mix25 cartridge.
Tħallatx xi insulina oħra fi stoċċ ta ’ Liprolog Mix25.
If you take more Liprolog Mix25 than you need If you take more Liprolog Mix25 than you need, a low blood sugar may occur.
Jekk tuża Liprolog Mix25 aktar milli suppost Jekk tuża Liprolog Mix25 aktar milli suppost, jista ’ jkollok livell baxx ta ’ zokkor fid- demm.
This will often get you over mild 186 hypoglycaemia or a minor insulin overdose.
B' hekk ħafna mid- drabi jirnexxilek tirkupra minn effetti ta ’ ftit zokkor baxx fid- demm jew minn doża eċċessiva ħafifa ta ’ insulina.
If you forget to use Liprolog Mix25 If you take less Liprolog Mix25 than you need, a high blood sugar may occur.
Jekk tinsa tuża Liprolog Mix25 Jekk tieħu inqas Liprolog milli għandek bżonn, jista ’ jkollok livell għoli ta ’ zokkor fid- demm.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”). • Always keep a spare pen and cartridges of Liprolog Mix25, in case you lose your pen or cartridges or they get damaged. • Always carry something to show you are diabetic. • Always carry sugar with you.
Jekk l- ipoglicemija (zokkor baxx fid- demm) jew l- ipergliċemija (zokkor għoli fid- demm) ma jkunux ittrattati tista 'tkun serja ħafna u tikkawża uġigħ ta' ras, dardir, remettar, deidratazzjoni, telf mis- sensi, koma kif ukoll l- mewt (ara A u B fis- sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu).
If you stop using Liprolog Mix25.
Jekk tieqaf tuża Liprolog Mix25