Humalog Mix25 KwikPen 100unitsml suspension for injection 3ml pre-filled pen

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Insulin lispro; Insulin lispro protamine

Tersedia dari:

Eli Lilly and Company Ltd

Kode ATC:

A10AD04

INN (Nama Internasional):

Insulin lispro; Insulin lispro protamine

Dosis:

25unit/1ml ; 75unit/1ml

Bentuk farmasi:

Suspension for injection

Rute administrasi :

Subcutaneous

Kelas:

No Controlled Drug Status

Jenis Resep:

VMP not recommended to prescribe - patient training required

Ringkasan produk:

BNF: 06010102; GTIN: 5014602101428

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMALOG
®
MIX25
™
100 UNITS/ML KWIKPEN
™
, SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
INSULIN LISPRO
EACH KWIKPEN DELIVERS 1 – 60 UNITS IN STEPS OF 1 UNIT.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Humalog Mix25 KwikPen is and what it is used for
2.
What you need to know before you use Humalog Mix25 KwikPen
3.
How to use Humalog Mix25 KwikPen
4.
Possible side effects
5.
How to store Humalog Mix25 KwikPen
6.
Contents of the pack and other information
1.
WHAT HUMALOG MIX25 KWIKPEN IS AND WHAT IT IS USED FOR
Humalog Mix25 KwikPen is used to treat diabetes. It is a premixed
suspension. Its active
substance is insulin lispro. 25 % of the insulin lispro in Humalog
Mix25 KwikPen is dissolved in
water and it works more quickly than normal human insulin because the
insulin molecule has
been changed slightly. 75 % of the insulin lispro in Humalog Mix25
KwikPen is available in a
suspension together with protamine sulphate, so that its action is
prolonged.
You get diabetes if your pancreas does not make enough insulin to
control the level of glucose in
your blood. Humalog Mix25 is a substitute for your own insulin and is
used to control glucose in
the long term. Humalog Mix25 works very quickly and longer than
soluble insulin. You should
normally use Humalog Mix25 within 15 minutes of a meal.
Your doctor may tell you to use Humalog Mix25 KwikPen as well as a
longer-acting insulin.
Each kind of insulin comes with another patient information leaflet

Karakteristik produk

OBJECT 1
HUMALOG MIX25 100 UNITS/ML KWIKPEN,
SUSPENSION FOR INJECTION IN A PRE-FILLED PEN
Summary of Product Characteristics Updated 31-Oct-2017 | Eli Lilly and
Company Limited
1. Name of the medicinal product
Humalog Mix25 100 units/ml KwikPen, suspension for injection in a
pre-filled pen.
2. Qualitative and quantitative composition
One ml contains 100 units (equivalent to 3.5 mg) insulin lispro
(recombinant DNA origin produced in
E.coli). Each container includes 3 ml equivalent to 300 units insulin
lispro.
Humalog Mix25 consists of 25 % insulin lispro solution and 75 %
insulin lispro protamine suspension.
Each KwikPen delivers 1-60 units in steps of 1 unit.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection.
White, sterile suspension
4. Clinical particulars
4.1 Therapeutic indications
Humalog Mix25 is 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
The dosage should be determined by the physician, according to the
requirement of the patient.
Humalog Mix25 may be given shortly before meals. When necessary,
Humalog Mix25 can be given soon
after meals. Humalog Mix25 should only be given by subcutaneous
injection. Under no circumstances
should Humalog Mix25 be given intravenously.
Subcutaneous administration should be in the upper arms, thighs,
buttocks, or abdomen. Use of injection
sites should be rotated so that the same site is not used more than
approximately once a month.
When administered subcutaneously care should be taken when injecting
Humalog Mix25 to ensure that a
blood vessel has not been entered. After injection, the site of
injection should not be massaged. Patients
must be educated to use the proper injection techniques.
The rapid onset and early peak of activity of Humalog itself is
observed following the subcutaneous
administration of Humalog Mix25. This allows Humalog Mix25 to be given
very close to mealtime. The
duration of ac