HUMULIN 7030

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN (HUMAN)

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

A10AB01

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

INSULIN (HUMAN) 100 IU/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ELI LILLY & COMPANY LTD., USA

Therapeutic group:

INSULIN (HUMAN)

Therapeutic area:

INSULIN (HUMAN)

Therapeutic indications:

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

Authorization date:

2021-07-31

Patient Information leaflet

I HUMUCTVL AF 09
Page 1 of 8
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is to be supplied by a physician’s prescription only
HUMULIN R -
Regular
HUMULIN N -
NPH
Solution
10 ml vial
ACTIVE INGREDIENT AND ITS
QUANTITY:
Each vial contains:
Human insulin (rDNA origin)
100 units/ml
Suspension
10 ml vial
ACTIVE INGREDIENT AND ITS
QUANTITY:
Each vial contains:
Isophane human insulin (rDNA
origin)
100 units/ml
HUMULIN R -
Regular
HUMULIN N -
NPH
HUMULIN 70/30
Solution
5 X 3 ml cartridge
ACTIVE INGREDIENT AND ITS
QUANTITY:
Each cartridge contains:
Human insulin (rDNA origin)
100 units/ml
Suspension
5 X 3 ml cartridge
ACTIVE INGREDIENT AND ITS
QUANTITY:
Each cartridge contains:
Isophane human insulin (rDNA
origin)
100 units/ml
Suspension
5 X 3 ml cartridge
ACTIVE INGREDIENT AND ITS
QUANTITY:
Each cartridge contains:
70% Isophane human insulin
and 30% human insulin (rDNA
origin)
100 units/ml
INACTIVE INGREDIENTS AND ALLERGENS: see section 2 “important
information about some of the
ingredients of this medicine” and section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY 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?
To treat patients who suffer from diabetes and need insulin in order
to maintain balanced blood
sugar levels.
THERAPEUTIC GROUP: Insulins and analogue for injection.
Humulin preparations contain insulin of human origin, which is used to
treat diabetes. You get
diabetes if your pancreas does not make enough insulin to control the
level of glucose in your
blood.
Contact your doctor so s/he can explain to you the operating mechanism
of the different types
of insulin and their range of action.
Do not change your in

Summary of Product characteristics

X HUMUCTVL AF 09
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1.
NAME OF THE MEDICINAL PRODUCT
Humulin R
(Soluble Insulin Injection)
Solution for Injection
(100 IU/ml, 10 ml vials;
100 IU/ml 3.0 ml cartridges for use in
a reusable pen
Humulin N
(Isophane Insulin Injection)
Suspension for Injection
(100 IU/ml 10 ml vials;
100 IU/ml, 3.0 ml cartridges for use in
a reusable pen).
Humulin 70/30
(Biphasic Isophane Insulin Injection)
(30% soluble insulin/70% isophane
insulin)
Suspension for Injection
(100 IU/ml, 3.0 ml cartridges for use in
a reusable pen)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human Insulin (produced in
_E. coli_
by recombinant DNA technology).
One vial contains 10 ml equivalent to 1000 IU.
or
One cartridge contains 3 ml equivalent to 300 IU.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
HUMULIN R:
A solution for injection in a vial or in a cartridge.
Humulin R (Soluble) is a sterile, clear, colorless, aqueous solution
of human insulin.
HUMULIN N:
A suspension for injection in a vial or in a cartridge.
Humulin N (Isophane) is a sterile suspension of a white, crystalline
precipitate of isophane human
insulin in an isotonic phosphate buffer.
Humulin 70/30:
A suspension for injection in a cartridge.
Humulin 70/30 (Mixture) is a sterile suspension of human insulin in
the proportion of 30%
soluble insulin to 70% isophane insulin.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of patients with diabetes mellitus who require
insulin for the maintenance of
glucose homeostasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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Posology
The dosage should be determined by the physician, according to the
requirement of the patient.
_Pediatric population _
_ _
No data are available
Method of administration
Cartridges:
Humulin Soluble in cartridges is only suitable for subcutaneous
injections from a reusable pen.
If administration by syringe or intravenous injection is necessary, a
vial should be used.
Humulin Isophane in cartridges is only suitable for