RYBELSUS 3 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SEMAGLUTIDE

متاح من:

NOVO NORDISK LTD., ISRAEL

ATC رمز:

A10BJ06

الشكل الصيدلاني:

TABLETS

تركيب:

SEMAGLUTIDE 3 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVO NORDISK A/S, DENMARK

المجال العلاجي:

SEMAGLUTIDE

الخصائص العلاجية:

Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications• in combination with other medicinal products for the treatment of diabetes.

تاريخ الترخيص:

2021-02-17

نشرة المعلومات

Rybelsus IL PIL NOV23
–
notification
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
RYBELSUS 3 MG
RYBELSUS 7 MG
RYBELSUS 14 MG
TABLETS
ACTIVE INGREDIENT:
RYBELSUS 3 MG: EACH TABLET CONTAINS SEMAGLUTIDE 3 MG
RYBELSUS 7 MG: EACH TABLET CONTAINS SEMAGLUTIDE 7 MG
RYBELSUS 14 MG: EACH TABLET CONTAINS SEMAGLUTIDE 14 MG
Inactive ingredients and allergens: see section 2 sub-section
"Important information about
some of this medicine’s ingredients
", 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, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Rybelsus is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes
mellitus to improve glycaemic control as an adjunct to diet and
exercise:
•
as monotherapy
–
when metformin is considered inappropriate due to intolerance or
contraindications.
•
in combination with other medicinal products for the treatment of
diabetes.
It is important that you continue with your diet and exercise plan as
agreed with your doctor,
pharmacist or nurse.
THERAPEUTIC GROUP: Medicines for diabetes. GLP-1 (Glucagon-like
peptide-1) analog.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a condition in which your body does not make enough
insulin, and the
insulin produced does not lower your blood sugar as required. In some
cases, your body can
produce too much blood sugar. If your blood sugar increases and
remains high over a long
period of time, this may lead to harmful effects such as heart
problems, kidney disease, eye
disorders and poor blood flow to the limbs. That is why it is
important to keep your blood
sugar levels

خصائص المنتج

Rybelsus IL SPC NOV23 - notification
1.
NAME OF THE MEDICINAL PRODUCT
Rybelsus
(R)
3 mg
Rybelsus
(R)
7 mg
Rybelsus
(R)
14 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rybelsus 3 mg
Each tablet contains 3 mg semaglutide*.
Rybelsus 7 mg
Each tablet contains 7 mg semaglutide*.
Rybelsus 14 mg
Each tablet contains 14 mg semaglutide*.
*human glucagon-like peptide-1 (GLP-1) analogue produced in
_Saccharomyces cerevisiae_ cells
by recombinant DNA technology.
Excipient with known effect
Each tablet, regardless of semaglutide strength, contains 23 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Rybelsus 3 mg tablets
White to light yellow, oval shaped tablet (7.5 mm x 13.5
mm) debossed with ‘3’ on one side and
‘novo’ on the other side.
Rybelsus 7 mg tablets
White to light yellow, oval shaped tablet (7.5 mm x 13.5
mm) debossed with ‘7’ on one side and
‘novo’ on the other side.
Rybelsus 14 mg tablets
Rybelsus IL SPC NOV23 - notification
White to light yellow, oval shaped tablet (7.5 mm x 13.5
mm) debossed with ‘14’ on one side and
‘novo’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rybelsus is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes
mellitus to improve glycaemic control as an adjunct to diet and
exercise
•
as monotherapy when metformin is considered inappropriate due to
intolerance or
contraindications
•
in combination with other medicinal products for the treatment of
diabetes.
For study results with respect to combinations, effects on glycaemic
control and cardiovascular
events, and the populations studied, see sections 4.4, 4.5 and 5.1._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The starting dose of semaglutide is 3 mg once daily for one month.
After one month, the dose
should be increased to a maintenance dose of 7 mg once daily. After at
least one month with a
dose of 7 mg once daily, the dose can be increased to a maintenance
dose of 14 mg once daily to
further improv