Country: Израел
Језик: Енглески
Извор: Ministry of Health
INSULIN LISPRO; INSULIN LISPRO AS PROTAMINE
ELI LILLY ISRAEL LTD
A10AB04
SUSPENSION FOR INJECTION
INSULIN LISPRO 25 %; INSULIN LISPRO AS PROTAMINE 75 %
S.C
Required
ELI LILLY & COMPANY LTD., USA
INSULIN LISPRO
INSULIN LISPRO
Humalog Mix 25 KwikPen is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
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 Прочитајте комплетан документ
X HUMIKPN FS 07 Page 1 of 12 HUMALOG MIX 25 KWIKPEN & HUMALOG MIX 50 KWIKPEN 1. NAME OF THE MEDICINAL PRODUCT HUMALOG MIX 25 KWIKPEN suspension for injection in a pre-filled pen. HUMALOG MIX 50 KWIKPEN suspension for injection in a pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units of insulin lispro* (equivalent to 3.5 mg). Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension. Humalog Mix 50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension. Each pre-filled pen contains 300 units of insulin lispro in 3 ml suspension. Each KwikPen delivers 1-60 units in steps of 1 unit. *produced in _E.coli_ by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Humalog Mix 25 and Humalog Mix 50 are indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be determined by the physician, according to the requirement of the patient. Humalog Mix 25 or Humalog Mix 50 may be given shortly before meals. When necessary, Humalog Mix 25 or Humalog Mix 50 can be given soon after meals. Humalog Mix 25 or Humalog Mix 50 should only be given by subcutaneous injection. Under no circumstances should Humalog Mix 25 or Humalog Mix 50 be given intravenously. X HUMIKPN FS 07 Page 2 of 12 The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix 25 or Humalog Mix 50. This allows Humalog Mix 25 or Humalog Mix 50 to be given very close to mealtime. The duration of action of the insulin lispro protamine suspension component of Humalog Mix 25 or Humalog Mix 50 is similar to that of a basal insulin (NPH). The time course of action of any insulin may vary considerably in different individu Прочитајте комплетан документ