Victoza solution for s/c injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

liraglutide

Available from:

Novo Nordisk A/S

ATC code:

A10BJ02

INN (International Name):

liraglutide

Dosage:

6mg/ml

Pharmaceutical form:

solution for s/c injection

Units in package:

(2) pre-filled pen 3ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-09-12

Patient Information leaflet

Victoza
®
_Professional leaflet_Restricted
Monotherapy_STF-Sep-2017_8-9695-00-022-1
1
NAME OF THE MEDICINAL PRODUCT
VICTOZA
®
6 mg/ml
Solution for injection in pre-filled pen
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen
contains 18 mg liraglutide in 3 ml.
* human glucagon-like peptide-1 (GLP-1) analogue produced by
recombinant DNA technology in
_Saccharomyces cerevisiae._
For the full list of excipients, see _Pharmaceutical particulars._
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless or almost colourless, isotonic solution; pH=8.15.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Victoza
®
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 _Special warnings and
precautions for use,_ _Interaction with other _
_medicinal products and other forms of interaction_ and
_Pharmacodynamic properties._
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg
liraglutide daily. After at least one week,
the dose should be increased to 1.2 mg. Some patients are expected to
benefit from an increase in dose from
1.2 mg to 1.8 mg and based on clinical response, after at least one
week, the dose can be increased to 1.8 mg
to further improve glycaemic control. Daily doses higher than 1.8 mg
are not recommended.
Victoza
®
can be added to existing metformin or to a combination of metformin
and thiazolidinedione
therapy. The current dose of metformin and thiazolidinedione can be
continued unchanged.
Victoza
®
can be added to existing sulfonylurea or to a combination of metformin
and sulfonylurea the

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
4
1.
NAME OF THE MEDICINAL PRODUCT
Victoza 6 mg/ml
solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen
contains 18 mg liraglutide in 3 ml.
* human glucagon-like peptide-1 (GLP-1) analogue produced by
recombinant DNA technology in
_Saccharomyces cerevisiae._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless or almost colourless, isotonic solution; pH=8.15.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Victoza 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
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg
liraglutide daily. After at least one
week, the dose should be increased to 1.2 mg. Some patients are
expected to benefit from an increase
in dose from 1.2 mg to 1.8 mg and based on clinical response, after at
least one week, the dose can be
increased to 1.8 mg to further improve glycaemic control. Daily doses
higher than 1.8 mg are not
recommended.
Victoza can be added to existing metformin or to a combination of
metformin and thiazolidinedione
therapy. The current dose of metformin and thiazolidinedione can be
continued unchanged.
Victoza can be added to existing sulfonylurea or to a combination of
metformin and sulfonylurea
therapy or insulin. When Victoza is added to sulfonylurea therapy or
insulin, a reduction in the dose of
sulfonylurea or insulin should be considered to reduce the risk of
hypoglycaemia (see s