OZEMPIC

দেশ: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

SEMAGLUTIDE

থেকে পাওয়া:

NOVO NORDISK LTD., ISRAEL

এটিসি কোড:

A10BJ06

ফার্মাসিউটিকাল ফর্ম:

SOLUTION FOR INJECTION

রচনা:

SEMAGLUTIDE 1.34 MG / 1 ML

প্রশাসন রুট:

S.C

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

থেরাপিউটিক এলাকা:

SEMAGLUTIDE

থেরাপিউটিক ইঙ্গিত:

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

অনুমোদন তারিখ:

2019-04-17

তথ্য লিফলেট

PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
OZEMPIC
® 0.5 MG
SOLUTION FOR INJECTION IN PRE-FILLED PEN
THE ACTIVE INGREDIENT IS SEMAGLUTIDE.
1 ML OF SOLUTION FOR INJECTION CONTAINS 1.34 MG SEMAGLUTIDE.
SEMAGLUTIDE 1.34 MG/ML
Inactive ingredients and allergens in the medicine: see section 2
'Important information about
some of this medicine's ingredients' and section 6 'Additional
information'.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE 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?
Ozempic is intended for treating adults with type 2 diabetes whose
disease in not well-
controlled, in addition to diet and exercise:
•
on its own when treatment with metformin is not suitable due to
intolerance or
contraindication.
•
in addition to other medicines for the treatment of diabetes.
Ozempic is given in addition to other diabetes medicines to control
your blood sugar levels
when the other medicines are not enough on their own. These medicines
include medicines
that are taken by mouth or by injection such as insulin.
THERAPEUTIC GROUP: DIABETES MEDICINES, GLP-1 ANALOGS
Ozempic contains the active substance semaglutide. It_ _helps your
body reduce your blood
sugar level only when blood sugar level is too high, and it can help
prevent heart disease. It
is important that you continue with your diet and exercise plan as
told by your doctor,
pharmacist or nurse.
2.
BEFORE USING THIS MEDICINE
_ _
DO NOT USE OZEMPIC IF:
you are sensitive (allergic) to semaglutide or to any of the other
ingredients of this
medicine (as listed in section 6 ‘Additional information’).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
Talk to y

পণ্য বৈশিষ্ট্য

Ozempic IL SPC FEB
2023
-notification
Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Ozempic®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ozempic 0.25 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg semaglutide*
in 1.5 ml solution. Each dose contains 0.25 mg of semaglutide in 0.19
ml solution.
Ozempic 0.5 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 2 mg semaglutide*
in 1.5 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37
ml solution.
Ozempic 1 mg solution for injection
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled
pen contains 4 mg semaglutide*
in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml
solution.
*Human glucagon-like peptide-1 (GLP-1) analogue produced in
_Saccharomyces cerevisiae _
cells
_ _
by
_ _
recombinant DNA technology
_._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless or almost colourless, isotonic solution; pH=7.4.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ozempic is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus
as an adjunct to diet and exercise
•
as monotherapy when metformin is considered inappropriate due to
intolerance or
contraindications
•
in addition to 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 is 0.25 mg semaglutide once weekly. After 4 weeks
the dose should be increased to
0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once
weekly, the dose can be
increased to 1 mg once weekly to further improve glycaemic control.
Ozempic IL SPC MAY2023
-
notification
Page 2 of 19
Semaglutide 0.25 mg is not a maintenance dose