SULIQUA 10033

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

INSULIN GLARGINE; LIXISENATIDE

Beszerezhető a:

SANOFI ISRAEL LTD

ATC-kód:

A10AE04

Gyógyszerészeti forma:

SOLUTION FOR INJECTION

Összetétel:

LIXISENATIDE 33 MCG / 1 ML; INSULIN GLARGINE 100 UNITS / 1 ML

Az alkalmazás módja:

S.C

Recept típusa:

Required

Gyártó:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Terápiás terület:

INSULIN GLARGINE

Terápiás javallatok:

Suliqua 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 in addition to metformin with or without sodium-glucose co-transporter-2 (SGLT-2) inhibitors

Engedély dátuma:

2022-08-31

Betegtájékoztató

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
SULIQUA 100/33
SOLUTION FOR SUBCUTANEOUS INJECTION
IN AN INJECTION PEN
ACTIVE INGREDIENTS
The active ingredients are:
Insulin glargine and lixisenatide.
For the list of inactive ingredients, see section 6 “Further
information” and section 2 “Important information regarding
some of the ingredients of Suliqua”.
Each pen contains 300 units of insulin glargine and 100
micrograms of lixisenatide in 3 mL of solution.
Each mL contains 100 units of insulin glargine and 33 micrograms
of lixisenatide.
Each ‘dose step’ of Suliqua contains one unit of insulin glargine
and 0.33 micrograms of lixisenatide.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
Keep this leaflet; you may need to read 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 you. Do not pass it on
to others. It may harm them even if it seems to you that their
medical condition is similar.
IN ADDITION TO THE LEAFLET, SULIQUA PREPARATION ALSO HAS
A PATIENT SAFETY INFORMATION CARD. THIS CARD CONTAINS
IMPORTANT SAFETY INFORMATION THAT YOU NEED TO KNOW BEFORE
STARTING TREATMENT AND DURING TREATMENT WITH SULIQUA AND
ACT ACCORDINGLY.
READ THE PATIENT SAFETY INFORMATION CARD AND THE PATIENT
LEAFLET BEFORE STARTING TO USE THE PREPARATION. KEEP THE CARD
FOR LATER READING, IF NECESSARY.
1. WHAT IS THE MEDICINE INTENDED FOR?
Suliqua is intended, in combination with metformin, for treatment
of adults with type 2 diabetes, to improve control of blood sugar
levels when such control is not achieved by treatment with
metformin alone or by treatment with metformin together with
other medicines given orally to treat diabetes, or in combination
with basal insulin.
Suliqua, a medicine for injection to treat diabetes, contains two
active ingredients:
Insulin glargine -

Termékjellemzők

_ _
_ _
_Suliqua SPC version 7.1 dated 11.23 _
1
1.
NAME OF THE MEDICINAL PRODUCT
Suliqua 100/50
solution for injection in a pre-filled pen
Suliqua 100/33
solution for injection in a pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Suliqua 100 units/ml + 50 microgram/ml solution for injection in
pre-filled pen
Each pre-filled pen contains 300 units of insulin glargine* and 150
micrograms lixisenatide in 3 ml
solution.
Each ml contains 100 units of insulin glargine and 50 micrograms of
lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.5 micrograms
of lixisenatide
Suliqua 100units/ml + 33 microgram/ml solution for injection in
pre-filled pen
Each pre-filled pen contains 300 units of insulin glargine and 100
micrograms of lixisenatide in 3 ml
solution.
Each ml contains 100 units of insulin glargine and 33 micrograms of
lixisenatide.
Each dose step contains 1 unit of insulin glargine and 0.33 micrograms
of lixisenatide
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
The dose window on the pen shows the number of dose steps.
Excipient(s) with known effects:
Each ml contains 2.7 milligrams of metacresol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (SoloStar)
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Suliqua 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 in
addition to metformin with or without
sodium-glucose co-transporter-2 (SGLT-2) inhibitors.
(For study results with respect to effect on glycaemic control, and
the populations studied, see section
4.4 and 5.1).
Patient safety information Card
The marketing of SULIQUA is subject to a risk management plan (RMP)
including a 'Patient
information card'.
The 'Patient information card', emphasizes important safety
information that the patient should
be aware of before and during treatment.
Pl