HUMALOG MIX 50

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

INSULIN LISPRO; INSULIN LISPRO PROTAMINE

Dostopno od:

ELI LILLY ISRAEL LTD

Koda artikla:

A10AB04

Farmacevtska oblika:

SUSPENSION FOR INJECTION

Sestava:

INSULIN LISPRO 50 %; INSULIN LISPRO PROTAMINE 50 %

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

ELI LILLY & COMPANY LTD., USA

Terapevtska skupina:

INSULIN LISPRO

Terapevtsko območje:

INSULIN LISPRO

Terapevtske indikacije:

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Datum dovoljenje:

2014-07-31

Navodilo za uporabo

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed by a physician’s prescription only
HUMALOG MIX 50
SUSPENSION
ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each cartridge contains:
Insulin Lispro 100 U/ml
50% Insulin Lispro (free fast-acting) and 50% Insulin Lispro Protamine
in suspension (long-
acting)
For the list of inactive ingredients, please see section 6.
READ THIS PATIENT LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START
USING THIS MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further questions,
please contact your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of diabetes in patients who require insulin to
maintain balanced blood sugar
levels.
THERAPEUTIC GROUP:
Insulins and insulin analogs.
Insulin is a hormone secreted by the pancreas, a gland located near
the stomach. This
hormone is essential to the body in utilizing glucose obtained from
the food. Diabetes occurs
when the pancreas does not provide the sufficient amount of insulin to
meet the body’s needs.
To balance the diabetes, the doctor has prescribed insulin injections
for you.
HUMALOG MIX 50 is a faster acting insulin than the regular insulin
mixture, therefore it can be
injected close to mealtime, before or shortly after.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THE PREPARATION IF:

You are sensitive (allergic) to one of the medicine’s ingredients.

Do not use in a state of hypoglycemia (low blood sugar).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
Do not inject HUMALOG MIX 50 directly into the vein!
BEFORE STARTING TREATMENT WITH HUMALOG MIX 50 TELL YOUR DOCTOR IF:
-
You suffer from fever and vomiting or an emotional disturbance.
-
You suffer or have suffered in the past from impaired function of: the
liver, kidney/ur

Lastnosti izdelka

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HUMALOG MIX 50
1.
NAME OF THE MEDICINAL PRODUCT
Humalog Mix50 100 units/ml suspension for injection in
cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).
Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin
lispro protamine
suspension.
Each cartridge contains 300 units of insulin lispro in 3 ml suspension
.
*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 Mix50 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
Posology
The dosage should be determined by the physician, according to the
requirement of the patient.
Humalog Mix50 may be given shortly before meals. When necessary,
Humalog Mix50 can be
given soon after meals. Humalog Mix50 should only be given by
subcutaneous injection. Under no
circumstances should Humalog Mix50 be given intravenously.
The rapid onset and early peak of activity of Humalog itself is
observed following the
subcutaneous administration of Humalog Mix50. This allows Humalog
Mix50 to be given
very close to mealtime.
The duration of action of the insulin lispro protamine suspension
component of Humalog Mix50 is
similar to that of a basal insulin (NPH).
The time course of action of any insulin may vary considerably in
different individuals or at different
times in the same individual. As with all insulin preparations, the
duration of action of Humalog Mix50
is dependent on dose, site of injection, blood supply, temperature,
and physical activity.
_Special populations _
_ _
X HUMICT FS 06
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_Renal impairment _
Insulin requirements may be reduced in the presence of renal
impairment.
_Hepatic impairment _
Insulin requirements may be reduced in patients with hepatic
impairment due