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:

Lilly France S.A.S.

код АТС:

A10AC01

ИНН (Международная Имя):

insulin human isophane (recombinant DNA)

дозировка:

100IU/ml

Фармацевтическая форма:

suspension for injection

Штук в упаковке:

(5) cartridges 3ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-08-23

тонкая брошюра

NL047FSXE00
EUSPC20JUL2016
HUMULIN
TM N
NPH
HUMAN INSULIN (RDNA ORIGIN) ISOPHANE SUSPENSION
HUMULIN
TM 70/30
70% HUMAN INSULIN ISOPHANE SUSPENSION
AND 30% HUMAN INSULIN INJECTION (RDNA ORIGIN)
HUMULIN
TM R
REGULAR
INSULIN HUMAN INJECTION (RDNA ORIGIN)
1.
NAME OF THE MEDICINAL PRODUCT
Humulin N 100 IU/ml suspension for injection in cartridge
Humulin 70/30 100 IU/ml suspension for injection in cartridge
Humulin R 100 IU/ml solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU insulin human (produced in
_E. coli_
by recombinant DNA technology).
HUMULIN N
One cartridge contains 3 ml equivalent to 300 IU of isophane insulin.
HUMULIN 70/30
One cartridge contains 3 ml equivalent to 300 IU of biphasic isophane
insulin – 30 % soluble insulin /
70 % isophane insulin.
HUMULIN R
One cartridge contains 3 ml equivalent to 300 IU of soluble insulin.
For a full list of excipients, see section 6.1.
Not all formulations may be marketed.
3.
PHARMACEUTICAL FORM
HUMULIN N
A suspension for injection in a cartridge.
Humulin N is a sterile suspension of a white, crystalline precipitate
of isophane human insulin in an
isotonic phosphate buffer.
HUMULIN 70/30
A suspension for injection in a cartridge.
Humulin 70/30 is a sterile suspension of human insulin in the
proportion of 30 % soluble insulin to
70 % isophane insulin.
HUMULIN R
A solution for injection in a cartridge.
Humulin R is a sterile, clear, colourless, aqueous solution of human
insulin.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of patients with diabetes mellitus who require
insulin for the maintenance of glucose
homeostasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be determined by the physician, according to the
requirement of the patient.
_Paediatric population_
No data are available
Method of administration
Subcutaneous administration should be in the upper arms, thighs,
buttocks or abdomen. Use of injection
sites should be rotated so that the same site is not used more

Характеристики продукта

1
HUMULIN
™ N CARTRIDGE
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Humulin
N
100 IU/ml suspension for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU insulin human (produced in
_E. coli_
by recombinant DNA technology).
One cartridge contains 3 ml equivalent to 300 IU of isophane insulin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A suspension for injection in a cartridge.
Humulin
N
is a sterile suspension of a white, crystalline precipitate of
isophane human insulin
in an isotonic phosphate buffer.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of patients with diabetes mellitus who require
insulin for the maintenance of
glucose homeostasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be determined by the physician, according to the
requirement of the
patient.
_Paediatric population _
_ _
No data are available
Method of administration
Humulin
N
should be given by subcutaneous injection but may although not
recommended,
also
be given by intramuscular injection. This formulation should not be
administered
intravenously.
Subcutaneous administration should be in the upper arms, thighs,
buttocks or abdomen. Use
of injection sites should be rotated so that the same site is not used
more than approximately
once a month.
Care should be taken when injecting any Humulin insulin preparations
to ensure that a blood
vessel has not been entered. After any insulin injection, the
injection site should not be
massaged. Patients must be educated to use proper injection
techniques.
3
Each pack contains a patient information leaflet with instructions on
how to inject insulin.
4.3
CONTRAINDICATIONS
Hypoglycaemia.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1, unless
used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than
Humulin R be given
intravenously.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR