KIRSTY™ SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 UNITSML

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

Insulin aspart (rDNA origin)

Sẵn có từ:

ZUELLIG PHARMA PTE. LTD.

Mã ATC:

A10AB05

Dạng dược phẩm:

INJECTION, SOLUTION

Thành phần:

Insulin aspart (rDNA origin) 100 U/ml

Tuyến hành chính:

SUBCUTANEOUS

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Biocon Sdn. Bhd.

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2023-09-20

Đặc tính sản phẩm

SOLUTION FOR SUBCUTANEOUS INJECTION IN PRE-FILLED PEN
1 pre-filled pen with 3 mL of solution
_For the use only of a Registered _
_Medical Practitioner or a Hospital _
_or a Laboratory_
Insulin Aspart for Injection (r-DNA origin)
100 U/ ML
BM/XXXX/XX
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
Insulin Aspart for Injection (r-DNA origin)
KIRSTY
®
100 U/ ML
SOLUTION FOR SUBCUTANEOUS INJECTION IN
PRE-FILLED PEN
1 PRE-FILLED PEN WITH 3 ML OF SOLUTION
\\Bioblrnas11\marcom\EM\3rd SET\Singapore\Kirsty\290324\V5
7505
BLACK
KEYLINE
PAPER: 60 gsm Maplitho / SMPO Paper
Folding & Pharmacode position to be followed as per
Drawing No. 70M1806504
NOTE: Booklet to be sealed with 2 stickers;
Kirsty® 100 units/mL (U-100), 3mL
SIZE: 750 (W) x 440 (H) mm;
FOLDING SIZE: 43.33mm-9 folds,
30mm-1 fold, 20mm-1
fold (W) x 150 (H) mm with pasting.
PEN PI
BM/XXXX/XX
Helvetica Neue LT Pro
8.4 pt
PRODUCT NAME
COMPONENT
DIMENSIONS
ARTWORK CODE
Singapore
COUNTRY
PHARMACODE
SPECIFICATION:
FONT TYPE
FONT SIZE
COLORS
Note : Booklet to be sealed with
2 numbers of transparent perforated stickers.
SIZE:13x30mm plain perforated tape WITH MATT VARNISH
MATERIAL : UPM 6L/RP37/01 PP CLEAR TC50/RP37/WG65
KIRSTY
®
COMPOSITION
1 ml solution contains 100 units (equivalent to 3.5 mg) insulin
aspart*.
Kirsty
®
100 units/ml solution for injection in pre filled pen
Each pre filled pen contains 3 ml equivalent to 300 units.
*Insulin aspart is produced in Pichia pastoris by recombinant DNA
technology.
For the full list of excipients, see “LIST OF EXCIPIENTS” section.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear, colourless and aqueous.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
PHARMACOTHERAPEUTIC GROUP - Drugs used in diabetes. Insulins and
analogues for injection, fast acting. ATC code: A10AB05.
Kirsty
®
is a biosimilar medicinal product.
MECHANISM OF ACTION AND PHARMACODYNAMIC EFFECTS
The blood glucose lowering effect of insulin aspart is due to the
facilitat-
ed uptake o