Glaritus 100 IUmL Solution for injection

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

Insulin Glargine__

Disponible des:

SM PHARMACEUTICALS SDN. BHD.

Designació comuna internacional (DCI):

Insulin Glargine__

Unidades en paquete:

1x3ml Pieces; 5x3ml Pieces

Fabricat per:

WOCKHARDT LIMITED (BIOTECH PARK)

Informació per a l'usuari

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GLARITUS 100 IU/ML SOLUTION FOR INJECTION
GLARITUS 100 IU/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Each ml contains Insulin Glargine 100IU
_____________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. WHAT GLARITUS IS USED FOR
2.HOW GLARITUS WORKS
3.BEFORE YOU USE GLARITUS
4.HOW TO USE GLARITUS
5.WHILE YOU ARE USING GLARITUS
6.SIDE EFFECTS
7. STORAGE AND DISPOSAL OF GLARITUS
8.PRODUCT DESCRIPTION
9.MANUFACTURER AND PRODUCT REGISTRATION HOLDER
10.DATE OF REVISION WHAT GLARITUS USED FOR
The treatment of type 1 or type 2 diabetes
mellitus patients who require insulin for the
control of hyperglycaemia
.
HOW GLARITUS WORKS
After injection into the subcutaneous tissue,
te acidic solution is neutralised,leading to
formation of microprecipptates from which
small amounts of insulin glargine are
continuously released, providing a
smooth,peakles,predictable
time/concentration profile and a prolonged
duration of action.
This allows once daily dosing to meet a
patient’s basal insulin needs.
BEFORE YOU USE GLARITUS
_WHEN YOU MUST NOT USE IT _
Inform your doctor if you have any problem
listed below, as the doctor will decide
whether you should be started on Glaritus
•
If you have diabetic ketoacidosis_ _
•
In patients with renal impairment,
insulin requirements may be
diminished_ _
•
In
patients
with
severe
hepatic
impairment,
insulin
requirements
may be diminished due to reduced
capacity
for
gluconeogenesis
and
reduced insulin metabolism.
_ _
_ _
_ _
_ _
_ _
_ _
_BEFORE YOU START TO USE IT _
Insulin glargine must not be used in patients
hypersensitive to insulin glargine or any of
its excipients.
_ TAKING OTHER MEDICINES _
A number of substances affect glucose
metabolism and may require insulin dose
adjustment.
Substances that may enhance the blood
glucose lowering effect

Fitxa tècnica

II/XXXX
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY
INSULIN GLARGINE INJECTION
3 ML CARTRIDGE / 100 IU/ML
SOLUTION FOR INJECTION / SUBCUTANEOUS
Composition
Each mL contains:
Insulin Glargine Ph. Eur. …..100 IU
m-Cresol Ph. Eur.…..0.27% w/v as preservative
Water for injection Ph. Eur. ….q.s.
Excipients: Zinc (as Zinc Chloride) 30 μg, Glycerol (85%) 20 mg,
Hydrochloric Acid q. s. to pH, Sodium Hydroxide q. s. to pH
Pharmacotherapeutic group: Anti-diabetic agent (Long acting human
insulin analogue)
ATC (Anatomical Therapeutic Chemical) Classification Code: A10AE04
Description
®
GLARITUS (insulin glargine injection) is a sterile clear and
colourless solution of insulin glargine for subcutaneous use. Insulin
glargine is a recombinant human insulin
analogue that is a long-acting, parenteral blood-glucose-lowering
agent. Insulin glargine has low aqueous solubility at neutral pH. At
pH 4 insulin glargine is completely
soluble. After injection into the subcutaneous tissue, the acidic
solution is neutralized, leading to formation of microprecipitates
from which small amounts of insulin
glargine are slowly released, resulting in a relatively constant
concentration/time profile over 24 hours with no pronounced peak. This
profile allows once daily dosing as
®
basal insulin. GLARITUS is produced by recombinant DNA technology
utilizing a non-pathogenic laboratory strain of Escherichia coli as
the production organism. Insulin
glargine differs from human insulin in that the amino acid asparagine
at position A21 is replaced by glycine and two arginines are added to
the C-terminus of the B-chain.
Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-3030b-L-Arg-human
insulin and has the empirical formula C267 H404 N72 O78 S6 and a
molecular weight is 6063.
Insulin glargine has the following structural formula:
CLINICAL PHARMACOLOGY
Mechanism of Action
The primary activity of insulin, including insulin glargine, is
regulation of glucose metabolism. Insulin and its analogues lower
blood g