FORXIGA 10 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

DAPAGLIFLOZIN PROPANEDIOL

から入手可能:

ASTRAZENECA (ISRAEL) LTD

ATCコード:

A10BX09

医薬品形態:

FILM COATED TABLETS

構図:

DAPAGLIFLOZIN PROPANEDIOL 12.30 MG/DOSE

投与経路:

PER OS

処方タイプ:

Required

製:

ASTRA ZENECA AB., SWEDEN

治療領域:

DAPAGLIFLOZIN

適応症:

Forxiga is indicated:- in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •as monotherapy when metformin is considered inappropriate due to intolerance. •in addition to other medicinal products for the treatment of type 2 diabetes. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction- to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Limitations of Use -FORXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FORXIGA is not expected to be effective in these populations.

承認日:

2019-07-31

情報リーフレット

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
FORXIGA® 5 MG FORXIGA® 10 MG
Film coated tablets Film coated tablets
COMPOSITION:
Each tablet contains: Each tablet contains:
Dapagliflozin 5 mg
Dapagliflozin 10 mg
For inactive ingredients please see section 2: "Important information
regarding some
of the medicine ingredients" and Section 6: ‘Further Information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet, you may need it again.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it
on to others. It may harm them, even if it seems to you that their
ailment is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Forxiga is used to treat type 2 diabetes mellitus in adults (aged 18
years and older),
when the diabetes cannot be controlled with other medicines for
diabetes, diet and
exercise.
Your doctor may ask you to take Forxiga on its own, if you are
intolerant to
metformin, or together with other medicines including insulin.
During treatment with Forxiga, it is important to integrate diet and
exercise according
to the advice of your doctor/medical team.
Forxiga is used to reduce the risk of cardiovascular death and
hospitalization for
heart failure in adults with heart failure (NYHA class II‐IV) with
reduced ejection
fraction.
Forxiga is used to reduce the risk of sustained eGFR decline,
end-stage kidney
disease, cardiovascular death, and hospitalization for heart failure
in adults with
chronic kidney disease at risk of progression.
Limitations of Use
Forxiga is not recommended for the treatment of chronic kidney disease
in patients
with polycystic kidney disease or patients requiring or with a recent
history of
immunosuppressive therapy for kidney disease. Forxiga is not expected
to be
effective in the

製品の特徴

1
1.
NAME OF THE MEDICINAL PRODUCT
Forxiga 5 mg film-coated tablets
Forxiga 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Forxiga 5 mg film-coated tablets :
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 5 mg dapagliflozin.
_Excipient with known effect: _
Each tablet contains 25 mg of lactose anhydrous.
Forxiga 10 mg film-coated tablets:
Each tablet contains dapagliflozin propanediol monohydrate equivalent
to 10 mg dapagliflozin.
_Excipient with known effect: _
Each tablet contains 50 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Forxiga 5 mg film-coated tablets
Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with
“5” engraved on one side and
“1427” engraved on the other side.
Forxiga 10 mg film-coated tablets
Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally
diamond-shaped, film-coated tablets with
“10” engraved on one side and “1428” engraved on the other
side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Forxiga is indicated
in adults aged 18 years and older for the treatment of insufficiently
controlled
type 2 diabetes mellitus as an adjunct to diet and exercise
•
as monotherapy when metformin is considered inappropriate due to
intolerance.
•
in addition to other medicinal products for the treatment of type 2
diabetes.
For study results with respect to combination of therapies, effects on
glycaemic control and
cardiovascular events, and the populations studied, see sections 4.4,
4.5 and 5.1.
to reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart
failure (NYHA class II-IV) with reduced ejection fraction.
to reduce the risk of sustained eGFR decline, end-stage kidney
disease, cardiovascular death, and
hospitalization for heart failure in adults with chronic kidney
disease at risk of progression.
Limitations of Use
•
FORXIGA is not recommended for the treatment of chronic kidney disease
in