Truvelog SoloStar

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Insulin aspart 100 U/mL (3.5 mg/mL)

可用日期:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

剂量:

100 U/mL

药物剂型:

Solution for injection

组成:

Active: Insulin aspart 100 U/mL (3.5 mg/mL) Excipient: Hydrochloric acid Metacresol Phenol Polysorbate 20 Sodium chloride Sodium hydroxide Water for injection Zinc chloride

处方类型:

Prescription

疗效迹象:

Treatment of diabetes mellitus

產品總結:

Package - Contents - Shelf Life: Cartridge, fitted into pen device - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration, do not freeze - Cartridge, fitted into pen device - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration, do not freeze - Cartridge, fitted into pen device - 10 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration, do not freeze

授权日期:

2020-11-20

资料单张

Truvelog SoloStar®
1
TRUVELOG SOLOSTAR®
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 or pharmacist.
1.
WHY AM I USING TRUVELOG SOLOSTAR®
Truvelog SoloStar®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
SoloStar®? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TRUVELOG SOLOSTAR®
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 while using
Truvelog? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Truvelog SoloStar®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 SOLOSTAR®?
•
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
SoloStar® and in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TRUVELOG SOLOSTAR®?
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 te

产品特点

Property of the Sanofi group - strictly confidential
truvelog-ccdsv4-dsv1-15dec22
Page 1 of 21
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Truvelog (insulin aspart) 100 units/mL solution for injection in a 3
mL cartridge
Truvelog SoloStar® (insulin aspart) 100 units/ mL solution for
injection in a 3 mL pre-filled
pen.
Truvelog (insulin aspart) 100 units/mL solution for injection in a 10
mL vial
Truvelog is a biosimilar medicine to NovoRapid®, NovoRapid® Penfill
®
and NovoRapid
®
FlexPen
®
. The comparability of Truvelog with NovoRapid
®
has been demonstrated with regard
to physicochemical characteristics and pharmacology, efficacy and
safety outcomes.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of the solution contains 100 units (equivalent to 3.5 mg)
insulin aspart.
Truvelog (insulin aspart) 100 units/mL solution for injection in a 3
mL cartridge – equivalent
to 300 units.
Truvelog SoloStar® (insulin aspart) 100 units/ mL solution for
injection in a 3 mL pre-filled
pen – equivalent to 300 units.
Truvelog (insulin aspart) 100 units/mL solution for injection in a 10
mL vial – equivalent to
1000 units.
For further information regarding the biosimilarity of Truvelog to
Novorapid, see Section 5.1.
The prescribing physician should be involved in any decision regarding
interchangeability. For
further information see:
www.medsafe.govt.nz/profs/RIss/Biosimilars.asp
_ _
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Truvelog is a clear, colourless aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
Property of the Sanofi group - strictly confidential
truvelog-ccdsv4-dsv1-15dec22
Page 2 of 21
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.
The dosage of insulin aspart is determined by