TRUVELOG insulin aspart 100 units/mL solution for injection vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

Insulin aspart, Quantity: 3.5 mg/mL

から入手可能:

Sanofi-Aventis Australia Pty Ltd

医薬品形態:

Injection, solution

構図:

Excipient Ingredients: metacresol; phenol; polysorbate 20; sodium hydroxide; hydrochloric acid; water for injections; zinc chloride; sodium chloride

投与経路:

Subcutaneous, Intravenous

パッケージ内のユニット:

1, 5

処方タイプ:

(S4) Prescription Only Medicine

適応症:

For the treatment of diabetes mellitus

製品概要:

Visual Identification: A clear, colourless aqueous solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

認証ステータス:

Registered

承認日:

2021-08-26

情報リーフレット

Truvelog 10mL vial
1
TRUVELOG 10ML VIAL
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor, diabetes
education nurse or pharmacist.
1.
WHY AM I USING TRUVELOG?
Truvelog contains the active ingredient insulin aspart. Insulin aspart
is a rapid-acting insulin used to treat diabetes mellitus in
adults and children.
For more information, see Section 1. Why am I using Truvelog 10mL
vial?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TRUVELOG?
Do not use if you have ever had an allergic reaction to insulin aspart
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS (ESPECIALLY KIDNEY, LIVER OR GLAND PROBLEMS), TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Truvelog
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Truvelog and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE TRUVELOG?
•
Use immediately (up to 10 minutes) before your meal or carbohydrate
snack. Inject into the abdomen, thighs, buttocks or
upper arms.
•
Change your injection site regularly. Carefully follow the advice on
how to inject under the skin.
More instructions can be found in Section 4. How do I use Truvelog
and in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TRUVELOG?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or diabetes education nurse you
visit that you have diabetes
and are using insulin.
•
Measure your blood sugar levels regularly.
•
Tell your doctor if you often have hypos (low blood sugar levels).
•
Always carry some sugary food or fruit juice with you.
THINGS YOU
SHOULD NOT DO
•
Do not stop using your medicine unless your doctor tells you to.
•
Do not use the medicine if you thi

製品の特徴

Property of the Sanofi group - strictly confidential
Truvelog-ccdsv4-piv3-26aug21
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION – TRUVELOG AND
TRUVELOG SOLOSTAR (INSULIN ASPART (RBE) SOLUTION FOR
INJECTION)
1
NAME OF THE MEDICINE
Insulin aspart (rbe)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Truvelog (insulin aspart) 100 units/mL solution for injection in
cartridge
Truvelog (insulin aspart) 100 units/mL solution for injection in a
pre-filled pen (SoloStar)
Truvelog (insulin aspart) 100 units/mL solution for injection in a
vial
One mL of the solution contains 100 units (equivalent to 3.5 mg)
insulin aspart.
Truvelog is a biosimilar medicine to NovoRapid
®
Penfill
®
and NovoRapid
®
FlexPen
®
. The
comparability of Truvelog with NovoRapid
®
products has been demonstrated with regards to
physicochemical characteristics and pharmacology, efficacy and safety
outcomes.
Insulin aspart is a rapid-acting analogue of human insulin that
rapidly lowers blood glucose.
Insulin aspart is homologous with human insulin with the exception of
a substitution of the
amino acid proline by aspartic acid at position 28 on the B-chain. The
unique structure of
insulin aspart increases the rate of absorption from a subcutaneous
injection site, giving a
faster onset of action, an earlier peak effect and a shorter duration
of action than soluble
human insulin. Insulin aspart is produced by recombinant DNA
technology using
_Escherichia coli_
.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Truvelog is a clear, colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Truvelog has a faster onset and a shorter duration of action than
soluble human insulin. Due
to the
faster onset of action, Truvelog should generally be given immediately
before a
meal
or when necessary, soon after the start of a meal.
Property of the Sanofi group - strictly confidential
Truvelog-ccdsv4-piv3-26