Humulin 70/30 suspension for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

insulin human (recombinant DNA)

Available from:

Eli Lilly and Company

ATC code:

A10AD01

INN (International Name):

insulin human (recombinant DNA)

Dosage:

100IU/ml

Pharmaceutical form:

suspension for injection

Units in package:

(1) glass vial 10ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-08-23

Patient Information leaflet

PA003IPXS00
HUMULIN
®
(HU-MU-LIN) 70/30
USPI14NOV2013
PA003IPXS00
HUMULIN
® (HU-MU-LIN) 70/30
(70% HUMAN INSULIN ISOPHANE SUSPENSION AND
30% HUMAN INSULIN INJECTION [RDNA ORIGIN])
1
INDICATIONS AND USAGE
HUMULIN 70/30 is a fixed ratio premix recombinant human insulin
formulation
indicated to improve glycemic control in adult patients with diabetes
mellitus.
2
DOSAGE AND ADMINISTRATION
2.1
IMPORTANT ADMINISTRATION INSTRUCTIONS
Inspect HUMULIN 70/30 visually before use. It should not contain
particulate matter
and should appear uniformly cloudy after mixing. Do not use HUMULIN
70/30 if particulate
matter is seen. Do not mix HUMULIN 70/30 with any other insulins or
diluents.
2.2
ROUTE OF ADMINISTRATION
HUMULIN 70/30 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 70/30 intravenously or intramuscularly and
do not use
HUMULIN 70/30 in an insulin infusion pump.
2.3
DOSAGE INFORMATION
Individualize and adjust the dosage of HUMULIN 70/30 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)]_.
The proportion of rapid acting and long acting insulin is fixed in a
premixed insulin
such as HUMULIN 70/30. Independent adjustment of the basal or prandial
dose is not
possible when using a premixed insulin.
Physiological factors, disease states and concomitant drugs may impact
the onset
and duration of action of all insulins. HUMULIN 70/30 dose
requirements may change with
changes in level of physical activity, meal patterns (i