Humalog Mix25 100unitsml suspension for injection 3ml cartridges

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Insulin lispro; Insulin lispro protamine

Tilgængelig fra:

Eli Lilly and Company Ltd

ATC-kode:

A10AD04

INN (International Name):

Insulin lispro; Insulin lispro protamine

Dosering:

25unit/1ml ; 75unit/1ml

Lægemiddelform:

Suspension for injection

Indgivelsesvej:

Subcutaneous

Klasse:

No Controlled Drug Status

Recept type:

VMP not recommended to prescribe - patient training required

Produkt oversigt:

BNF: 06010102; GTIN: 5014602101176

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMALOG
® MIX25
™ 100 UNITS/ML SUSPENSION FOR INJECTION IN CARTRIDGE
INSULIN LISPRO
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 is and what it is used for
2.
What you need to know before you use Humalog Mix25
3.
How to use Humalog Mix25
4.
Possible side effects
5.
How to store Humalog Mix25
6.
Contents of the pack and other information
1.
WHAT HUMALOG MIX25 IS AND WHAT IT IS USED FOR
Humalog Mix25 is used to treat diabetes. Humalog Mix25 is a premixed
suspension. Its active
substance is insulin lispro. 25% of the insulin lispro in Humalog
Mix25 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 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 as well as a
longer-acting insulin. Each kind of
insulin comes with another patient information leaflet to tell you
about it. Do not change your
insulin unless your doctor tells you to. Be very careful if you do
change insulin.
2.
WHAT YOU NEED

Produktets egenskaber

OBJECT 1
HUMALOG MIX25 100 UNITS/ML SUSPENSION FOR
INJECTION IN CARTRIDGE
Summary of Product Characteristics Updated 31-Oct-2017 | Eli Lilly and
Company Limited
1. Name of the medicinal product
Humalog Mix25 100 units/ml, suspension for injection in cartridge.
2. Qualitative and quantitative composition
2.1 GENERAL DESCRIPTION
Humalog Mix25 is a white, sterile suspension.
2.2 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.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection.
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