Humulin N suspension for injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

insulin human isophane (recombinant DNA)

Доступна с:

Eli Lilly and Company

код АТС:

A10AC01

ИНН (Международная Имя):

insulin human isophane (recombinant DNA)

дозировка:

100IU/ml

Фармацевтическая форма:

suspension for injection

Штук в упаковке:

(1) glass vial 10ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-08-23

тонкая брошюра

PA002IPXS00
HUMULIN
® (HU-MU-LIN) N
USPI14NOV2013
PA002IPXS00
HUMULIN
® (HU-MU-LIN) N
(HUMAN INSULIN [RDNA ORIGIN] ISOPHANE SUSPENSION)
1
INDICATIONS AND USAGE
HUMULIN N is an intermediate-acting recombinant human insulin
indicated to improve
glycemic control in adults and pediatric patients with diabetes
mellitus.
2
DOSAGE AND ADMINISTRATION
2.1
IMPORTANT ADMINISTRATION INSTRUCTIONS
Inspect HUMULIN N visually before use. It should not contain
particulate matter and
should appear uniformly cloudy after mixing. Do not use HUMULIN N if
particulate matter is
seen.
2.2
ROUTE OF ADMINISTRATION
HUMULIN N should only be administered subcutaneously.
Administer in the subcutaneous tissue of the abdominal wall, thigh,
upper arm, or
buttocks. To reduce the risk of lipodystrophy, rotate the injection
site within the same region
from one injection to the next _[see Adverse Reactions (6)]_.
Do not administer HUMULIN N intravenously or intramuscularly and do
not use
HUMULIN N in an insulin infusion pump.
2.3
DOSAGE INFORMATION
Individualize and adjust the dosage of HUMULIN N based on the
individual’s metabolic
needs, blood glucose monitoring results and glycemic control goal.
Dosage adjustments may be needed with changes in physical activity,
changes in
meal patterns (i.e., macronutrient content or timing of food intake),
changes in renal or
hepatic function or during acute illness _[see Warnings and
Precautions (5.1, 5.2), and Use in _
_Specific Populations (8.6, 8.7)]_.
2.4
DOSAGE ADJUSTMENT DUE TO DRUG INTERACTIONS
Dosage adjustment may be needed when HUMULIN N is coadministered with
certain
drugs _[see Drug Interactions (7)]._
Dosage
adjustment
may
be
needed
when
switching
from
another
insulin
to
HUMULIN N _[see Warnings and Precautions (5.1)]_.
Instructions for Mixing with Other Insulins
HUMULIN N may be used with a prandial insulin if indicated. HUMULIN N
may be mixed
with HUMULIN R or HUMALOG before injection.
•
If HUMULIN N is mixed with HUMULIN R, HUMULIN R should be drawn into
the
syringe first. Injection should