ENDULIN VIAL Injection 100 IU/ml

Negara: Tanzania

Bahasa: Inggris

Sumber: Tanzania Medicinces & Medical Devices Authority

Bahan aktif:

insulin glargine

Tersedia dari:

Mylan Pharmaceutical Private Limited, INDIA

Kode ATC:

Insulins and analogues for injection, long-acting

INN (Nama Internasional):

insulin glargine

Dosis:

100 IU/ml

Bentuk farmasi:

Injection

Diproduksi oleh:

Biocon Limited, INDIA

Ringkasan produk:

Physical description: Clear colourless solution; Local technical representative: Synermed Pharmaceuticals (T) Limited (5197)

Status otorisasi:

Registered/Compliant

Tanggal Otorisasi:

2019-08-02

Karakteristik produk

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR ENDULIN CART
TM ( INSULIN GLARGINE 100
IU/ML) SOLUTION FOR INJECTION
VERSION NUMBER 1
3
RD JANUARY, 2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX
1253, DODOMA – TANZANIA, TELEPHONE: [phone]/+255
(22)
2450512/2450751/2452108, EMAIL: [e-mail], Website:
WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1
1.
INTRODUCTION
Endulin Cart is a generic medicine. Endulin Cart is an antidiabetic
medicine belonging to
A10AE04; Drugs used in diabetes, insulins and analogues for injection,
long-acting.
Endulin Cart exerts is activity by regulation of glucose metabolism.
In addition insulin
has several anabolic and anti-catabolic actions on a variety of
different tissues. Within
muscle
tissue
this
includes
increasing
glycogen,
fatty
acid,
glycerol
and
protein
synthesis and amino acid uptake, while decreasing glycogenolysis,
gluconeogenesis,
ketogenesis, lipolysis, protein catabolism and amino acid output. The
typical activity
profile (glucose utilisation curve) following subcutaneous injection
is illustrated below by
the heavy line. Variations that a patient may experience in timing
and/or intensity of
insulin activity are illustrated by the shaded area. Individual
variability will depend on
factors such as size of dose, site of injection temperature and
physical activity of the
patient. Endulin Cart is approved in Tanzania for use in adults and
elderly.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0261
Brand name
Endulin Cart
Generic
name,
strength
and
form
insulin glargine
100 IU/ml Solution for injection
ATC classification
Drugs used in diabetes, insulins and analogues for
injection, long-acting. ATC Code: A10AE04
Distribution category
POM
Country of origin
India
Associated product
State any other product of formulation, strength or
site that is linked or associated wi