HUMALOG U200 KwikPen insulin lispro (rbe) 200 IU/mL solution for injection multidose syringe

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

Insulin lispro, Quantity: 200 IU/mL

Доступна з:

Eli Lilly Australia Pty Ltd

ІПН (Міжнародна Ім'я):

Insulin lispro

Фармацевтична форма:

Injection, solution

Склад:

Excipient Ingredients: glycerol; zinc oxide; trometamol; water for injections; hydrochloric acid; sodium hydroxide; metacresol

Адміністрація маршрут:

Subcutaneous

Одиниць в упаковці:

2 x 3 mL, 5 x 3 mL

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

For the treatment of patients with Type 1 (IDDM) and Type 2 (NIDDM) diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Огляд продуктів:

Visual Identification: Clear colourless solution; Container Type: Syringe; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Licence status A

Дата Авторизація:

2015-11-09

інформаційний буклет

HUMALOG
® U200
_KWIKPEN_
_Insulin Lispro (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It does
not contain all the available
information and does not take the
place of talking with your doctor.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about HUMALOG U200
and its use that you should be aware
of.
All medicines have risks and
benefits. Your doctor has more
information about this medicines
than is contained in this leaflet. Also,
your doctor has had the benefit of
taking a full and detailed history
from you and is in the best position
to make an expert judgement to meet
your individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT HUMALOG U200
IS USED FOR
HUMALOG U200 contains insulin
lispro and is used to reduce high
blood sugar (glucose) levels in
insulin dependent diabetic patients.
Diabetes is a condition in which your
pancreas does not produce enough
insulin to control your blood sugar
level. Extra insulin is therefore
needed.
There are two types of diabetes
mellitus:
Type 1 diabetes - also called Insulin
Dependent Diabetes Mellitus
(IDDM). Patients with type 1
diabetes always need insulin to
control their blood sugar levels.
Type 2 diabetes - also called Non
insulin dependent diabetes mellitus
(NIDDM). Some patients with type 2
diabetes may also need insulin after
initial treatment with diet, exercise
and tablets.
The duration of effect of insulin
lispro varies in each individual and
also depends on dose, site of
injection, blood supply, b

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION
vA3.0_Dec20
SUPERSEDES: vA2.0_Aug19
Page 1 of 12
HUMALOG
® U200 KWIKPEN
® [INSULIN LISPRO (RBE)]
1.
NAME OF THE MEDICINE
Insulin lispro (rbe)
2 AND 3.
QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Insulin lispro solution [recombinant DNA origin] is an aqueous
solution of insulin lispro ([Lys
(B28), Pro (B29)] human insulin analogue, adjusted to pH 7.0 - 7.8. It
also contains
metacresol, glycerol, trometamol, zinc oxide and water for injection.
Hydrochloric acid and
sodium hydroxide may be used to adjust pH.
HUMALOG U200 is available as a clear, colourless solution for
subcutaneous administration
in a concentration of 200 units/mL in a 3 mL prefilled insulin
delivery device (HUMALOG
U200 KwikPen).
HUMALOG U200 is a Lilly human insulin analogue. It has a very quick
onset of action and a
short duration of activity.
HUMALOG U200 should be given immediately (up to 15 minutes) before a
meal. When
necessary, it can be given soon after meals (within 20 minutes of the
start of a meal).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of patients with Type 1 (IDDM) and Type 2 (NIDDM)
diabetes mellitus who
require insulin for the maintenance of normal glucose homeostasis_. _
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
In adults, HUMALOG U200 can be given immediately (up to 15 minutes
before a meal). When
necessary, it can be given soon after meals (within 20 minutes of the
start of the meal). It is
anticipated the same dose of HUMALOG U200 to HUMALOG 100 units/mL will
be required.
In patients with Type 2 diabetes HUMALOG U200 may be administered in
combination
therapy with oral sulfonylurea agents.
CHILDREN
In clinical studies involving children and adolescents (ages 3 –19
years), HUMALOG 100
units/mL has been shown to be safe, effective and well-tolerated.
There have been no studies of HUMALOG U200 in children (see 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
vA3.0_Dec20
SUPERSEDES: vA2.0_Aug19
Page 2 of 12
GENERAL
During changes to a patient’s