Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
INSULIN LISPRO
ELI LILLY ISRAEL LTD, ISRAEL
A10AB04
SOLUTION FOR INJECTION
INSULIN LISPRO 100 U/ML
S.C
Required
ELI LILLY & COMPANY LTD., USA
INSULIN LISPRO
Humalog KwikPen is indicated for the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabalization of diabetes mellitus.
2015-04-30
M HUMAKP 100 S 05 Page 1 of 8 USER MANUAL HUMALOG KWIKPEN 100 UNITS/ML HUMALOG MIX 25 ® KWIKPEN HUMALOG MIX 50 ® KWIKPEN Solution for injection in a pre-filled pen Suspension for Injection in a pre-filled pen Suspension for Injection in a pre-filled pen 100 UNITS/ML, KWIKPEN 3 ML _ _ PLEASE READ THIS USER MANUAL BEFORE USE Read the User Manual before you start taking your insulin and each time you get another KwikPen. There may be new information. This information does not take the place of talking to your healthcare professional about your medical condition or your treatment. KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin. You can give yourself multiple doses using one Pen. The Pen dials 1 unit at a time. You can give from 1 to 60 units in a single injection. IF YOUR DOSE IS MORE THAN 60 UNITS, YOU WILL NEED TO GIVE YOURSELF MORE THAN ONE INJECTION. The plunger only moves a little with each injection, and you may not notice that it moves. The plunger will only reach the end of the cartridge when you have used all 300 units in the Pen. DO NOT SHARE YOUR PEN WITH OTHER PEOPLE, EVEN IF THE NEEDLE HAS BEEN CHANGED. DO NOT REUSE OR SHARE NEEDLES WITH OTHER PEOPLE. YOU MAY GIVE AN INFECTION TO THEM OR GET AN INFECTION FROM THEM. This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen. KWIKPEN PARTS Cap Clip Cartridge Holder Label Dose Indicator Dose Knob Pen Cap Rubber Seal Plunger Pen Body Dose Window M HUMAKP 100 S 05 Page 2 of 8 PEN NEEDLE PARTS (Needles Not Included) Paper Tab Outer Needle Shield Inner Needle Shield Needle HOW TO RECOGNIZE YOUR KWIKPEN: HUMALOG KWIKPEN 100 UNITS/ML HUMALOG MIX 25 KWIKPEN HUMALOG MIX 50 KWIKPEN Solution Suspension (cloudy insulin) Suspension (cloudy insulin) Pen color: Blue Blue Blue Dose Knob: Burgundy Yellow Red Labels: White with Burgundy Color Bar White with Yellow Color Bar White with Red Color Bar SUPPLIES NEEDED TO GIVE YOUR INJECTION: • KwikPen conta Pročitajte cijeli dokument
X HUMAKPN 100 FS 10 Page 1 of 11 HUMALOG KWIKPEN 100 UNITS/ML 1. NAME OF THE MEDICINAL PRODUCT HUMALOG KWIKPEN 100 UNITS/ML , solution for injection in a pre-filled pen HUMALOG KWIKPEN 100 UNITS/ML , solution for injection in a junior pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg). Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. Each KwikPen delivers 1-60 units in steps of 1 unit. Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units. *produced in _E.coli_ by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog KwikPen is also indicated for the initial stabilisation of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be determined by the physician, according to the requirement of the patient. _Junior KwikPen _ _ _ Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments. Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals. X HUMAKPN 100 FS 10 Page 2 of 11 Humalog KwikPen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a Humalog injection (or, in the case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. The faster onset of action compared to soluble human insulin is maintained regardless of injection site. As with all insulin preparations, the duration of acti Pročitajte cijeli dokument