Invokana

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Canagliflozin hemihydrate 306mg equivalent to canagliflozin 300 mg

থেকে পাওয়া:

Janssen-Cilag (New Zealand) Ltd

INN (আন্তর্জাতিক নাম):

Canagliflozin hemihydrate 306 mg (equivalent to canagliflozin 300 mg)

ডোজ:

300 mg

ফার্মাসিউটিকাল ফর্ম:

Film coated tablet

রচনা:

Active: Canagliflozin hemihydrate 306mg equivalent to canagliflozin 300 mg Excipient: Croscarmellose sodium Hyprolose Lactose Magnesium stearate Microcrystalline cellulose Opadry white 85F18422

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

থেরাপিউটিক ইঙ্গিত:

Invokana is indicated in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise, to improve glycaemic control as: Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. Add-on combination therapy: Combination therapy with other anti-hyperglycaemic agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Blister pack, PVC/Al inside outer cardboard carton - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al inside outer cardboard carton - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al inside outer cardboard carton - 100 tablets - 24 months from date of manufacture stored at or below 25°C

অনুমোদন তারিখ:

2013-02-12

তথ্য লিফলেট

INVOKANA
®
(160916) ACMI NZ
1
INVOKANA
®
_canagliflozin hemihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Invokana.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING INVOKANA, ASK YOUR DOCTOR OR
PHARMACIST.
Your doctor and pharmacist have
more information.
Keep this information handy. You
can refer to it later if you have any
questions.
Please also refer to Consumer
Medicine Information documents of
other medicines your doctor may
have prescribed for use in
combination with Invokana. Ask
your doctor or pharmacist if you have
any questions.
WHAT INVOKANA IS USED
FOR
Invokana belongs to a group of
medicines called “oral
antihyperglycemics.” It may also be
known as a diabetes medicine.
Invokana is used to lower blood
glucose in patients with type 2
diabetes mellitus, (“non-insulin-
dependent diabetes” or “maturity
onset diabetes”) when diet and
exercise are not enough to control
your blood glucose.
Lowering and controlling blood
sugar may help prevent or delay
complications of diabetes, which
include kidney disease, blindness and
amputation.
Invokana has not been tested in
children and use in children is not
recommended.
Your doctor may prescribe Invokana
to be used alone, or in combination
with other medicines for treating
your diabetes. It is important to keep
following your doctor’s advice about
diet and exercise while you are
taking Invokana.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
_HOW IT WORKS _
Invokana contains the active
ingredient canagliflozin, which
works by inhibiting the activity of a
protein in your kidneys that
reabsorbs glucose (sugar) from the
urine. By inhibiting this protein,
Invokana increases glucose excretion
in your urine. In this way it lowers
elevated blood glucose levels to help
control your diabetes.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE IT _
DO

পণ্য বৈশিষ্ট্য

CCDS 160927
Page 1 of 28
INVOKANA (161111) ADS
DATASHEET
NAME OF THE MEDICINE
INVOKANA
®
Canagliflozin
The chemical name is
(1_S_)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-
D-glucitol present in the tablets as the hemihydrate .
Molecular Formula: C
24
H
25
FO
5
S
.½ H
2
O
CAS: 928672-86-0(hemihydrates) and 842133-18-0(anhydrous)
MW: 453.53
DESCRIPTION
Canagliflozin hemihydrate drug substance is a white to off white
powder, soluble in many organic
solvents (ethanol, methanol, tetrahydrofuran, acetone) but insoluble
in aqueous media. The log P
of the drug substance is 3.44 at 20
o
C and pH=7. There is no pKa in the physiological pH range.
INVOKANA is available as film-coated tablets containing 100 and 300 mg
of canagliflozin present
as 102 mg and 306 mg of canagliflozin hemihydrate in each tablet
strength, respectively. Both
strengths
contain
the
inactive
ingredients
microcrystalline
cellulose-,
lactose
anhydrous,
croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate,
polyvinyl alcohol, titanium
dioxide, macrogol 3350 and talc-purified. In addition, the 100 mg
strength contains iron oxide
yellow.
PHARMACOLOGY
MECHANISM OF ACTION
INVOKANA is an inhibitor of sodium-glucose co-transporter 2 (SGLT2) ,
expressed in the proximal
renal tubules, is responsible for the majority of the reabsorption of
filtered glucose from the tubular
lumen. Patients with diabetes have been shown to have elevated renal
glucose reabsorption which
may
contribute
to
persistent
elevated
blood
glucose
concentrations.
Canagliflozin
is
an
orally-active inhibitor of SGLT2. By inhibiting SGLT2, canagliflozin
reduces reabsorption of filtered
glucose and lowers the renal threshold for glucose (RT
G
), and thereby increases urinary glucose
excretion (UGE), lowering elevated plasma glucose concentrations by an
insulin-independent
CCDS 160927
Page 2 of 28
INVOKANA (161111) ADS
mechanism in patients with type 2 diabetes. The increased UGE with
SGLT2 inhibition also
translates to an osmotic diuresis, with the di