WEGOVY 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SEMAGLUTIDE

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

A10BJ06

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SEMAGLUTIDE 1.34 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic area:

SEMAGLUTIDE

Therapeutic indications:

Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of • ≥30 kg/m2 (obesity), or • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Authorization date:

2023-04-23

Patient Information leaflet

1
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) -
1986
This medicine is dispensed with a doctor’s prescription only
Wegovy
®
0.25 mg
Wegovy
®
0.5 mg
Wegovy
®
1 mg
Wegovy
®
1.7 mg
Wegovy
®
2.4 mg
Solution for injection in pre-filled pen
Active ingredient
Wegovy 0.25 mg
semaglutide 0.68 mg/ml
Wegovy 0.5 mg
semaglutide 1.34 mg/ml
Wegovy 1 mg
semaglutide 1.34 mg/ml
Wegovy 1.7 mg
semaglutide 2.27 mg/ml
Wegovy 2.4 mg
semaglutide 3.2 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 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?
Wegovy is indicated as an adjunct to a reduced-calorie diet and
increased physical
activity for weight management, including weight loss and weight
maintenance, in
adults with an initial Body Mass Index (BMI) of
•
≥ 30 kg/m
2
(obesity), or
•
BMI ≥ 27 kg/m
2
to < 30 kg/m
2
(overweight) in the presence of at least one weight-
related comorbidity, e.g. impaired blood sugar control (dysglycaemia;
prediabetes
or type 2 diabetes), hypertension, dyslipidaemia (impaired blood lipid
control),
obstructive sleep apnoea or cardiovascular disease (disease of the
heart and
blood vessels)
BMI (Body Mass Index) is a measure of weight in relation to height.
2
Therapeutic group: Medicines for treatment of diabetes, glucagon-like
peptide-1
(GLP-1) analogues.
The active substance semaglutide is similar to a natural hormone
called glucagon-
like peptide-1 (GLP-1) that is released from the intestine after a
meal. It works by
acting on target proteins (receptors) in the brain that control

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Wegovy
®
0.25 mg
Wegovy
®
0.5 mg
Wegovy
®
1 mg
Wegovy
®
1.7 mg
Wegovy
®
2.4 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Wegovy 0.25 mg FlexTouch solution for injection _
Each pre-filled pen contains 1 mg semaglutide* in 1.5 mL solution. One
mL of solution contains
0.68 mg semaglutide*. One pre-filled pen contains 4 doses of 0.25 mg.
_Wegovy 0.5 mg FlexTouch solution for injection _
Each pre-filled pen contains 2 mg semaglutide* in 1.5 mL solution. One
mL of solution contains
1.34 mg semaglutide*. One pre-filled pen contains 4 doses of 0.5 mg.
_Wegovy 1 mg FlexTouch solution for injection _
Each pre-filled pen contains 4 mg semaglutide* in 3 mL solution. One
mL of solution contains
1.34 mg semaglutide*. One pre-filled pen contains 4 doses of 1 mg.
_Wegovy 1.7 mg FlexTouch solution for injection _
Each pre-filled pen contains 6.8 mg semaglutide* in 3 mL solution. One
mL of solution contains
2.27 mg semaglutide*. One pre-filled pen contains 4 doses of 1.7 mg.
_Wegovy 2.4 mg FlexTouch solution for injection _
Each pre-filled pen contains 9.6 mg semaglutide* in 3 mL solution. One
mL of solution contains
3.2 mg semaglutide*. One pre-filled pen contains 4 doses of 2.4 mg.
*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 isotonic solution; pH=7.4.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Wegovy is indicated as an adjunct to a reduced-calorie diet and
increased physical activity for weight
management, including weight loss and weight maintenance, in adults
with an initial Body Mass Index
(BMI) of
•
≥30 kg/m
2
(obesity), or
•
≥27 kg/m
2
to <30 kg/m
2
(overweight) in the presence of at least one weight-related
comorbidity
e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus),
hypertension, dyslipidaemia,
obstructive sleep apnoea or cardiovascular disease