BASAGLAR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN GLARGINE

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

A10AE04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN GLARGINE 100 U/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

LILLY FRANCE

Therapeutic area:

INSULIN GLARGINE

Therapeutic indications:

Treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adults patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.

Authorization date:

2020-11-30

Patient Information leaflet

I BASAKPN F 09
Page 1 of 9
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ACTIVE INGREDIENT AND ITS QUANTITY:
Each pre-filled pen contains a 3 mL cartridge.
Each 1 mL contains: 100 units (3.64 mg) of insulin glargine.
INACTIVE INGREDIENTS AND ALLERGENS: see “Important information about
some of the ingredients of this
medicine” in section 2 and section 6 “Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet. You may need to
read it again. This leaflet contains concise information about the
medicine. If you have any further
questions, contact your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
FOR ADULTS:
Note that the Ministry of Health has approved a one-time switch
between an original medicine and a
biosimilar medicine and vice versa. Your doctor will give you an
explanation about the medicine and the
meaning of this switch. Every switch of a biological medicine must be
performed by the attending doctor.
The brand name of the medicine that appears on the prescription must
be identical to the brand name
that appears on the package of the medicine dispensed to you by the
pharmacy. In any case of doubt,
refer to the pharmacist or attending doctor.
FOR CHILDREN:
Note that each time you receive the medicine at the pharmacy, it is
important that you make sure that
you receive the same medicine that was prescribed for you by your
attending specialist. If the medicine
you received looks different from that which you usually receive, or
if the instructions for use have
changed, please refer to the pharmacist immediately to make sure that
you have received the correct
medicine. Any switch or change in dosage of a medicine containing
insulin glargine must be made by the
attending specialist only. Please check that the brand name o

Summary of Product characteristics

X BASAKPN F 09
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
BASAGLAR
100 units/mL KwikPen solution for injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 100 units of insulin glargine* (equivalent to 3.64
mg).
Each pen contains 3 mL of solution for injection, equivalent to 300
units.
* Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear colorless solution.
Basaglar is a biosimilar medicinal product that has been demonstrated
to be similar in quality,
safety and efficacy to the reference medicinal product Lantus. Please
be aware of any differences
in the indications between the biosimilar medicinal product and the
reference medicinal product.
Information regarding interchangeability can be found on the website
of the Ministry of Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult and pediatric patients, 6 years and over, with type
1 diabetes mellitus or adult
patients with type 2 diabetes mellitus who require basal (long acting)
insulin for the control of
hyperglycemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Basaglar contains insulin glargine, an insulin analogue, and has a
prolonged duration of action.
Basaglar should be administered once daily at any time but at the same
time each day.
The dose regimen (dose and timing) should be individually adjusted. In
patients with type 2
diabetes mellitus, Basaglar can also be given together with orally
active antidiabetic medicinal
products.
The potency of this medicinal product is stated in units. These units
are exclusive to Basaglar and
are not the same as IU or the units used to express the potency of
other insulin analogues (see
section 5.1).
X BASAKPN F 09
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_Special population_
_Elderly population (≥65 years old) _
In the elderly, progressive deterioration of r