Humulin 70/30 suspension for injection

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

insulin human (recombinant DNA)

Commercializzato da:

Lilly France S.A.S.

Codice ATC:

A10AD01

INN (Nome Internazionale):

insulin human (recombinant DNA)

Dosaggio:

100IU/ml

Forma farmaceutica:

suspension for injection

Confezione:

(5) cartridges 3ml

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2021-08-24

Foglio illustrativo

EUSPC20OCT2020
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 than approxi

Scheda tecnica

HUMULIN 70/30 CARTRIDGE
SUMMARY OF PRODUCT CHARACTERISTICS
1 .
NAME OF THE MEDICINAL PRODUCT
Humulin 70/30 100 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 biphasic isophane
insulin – 30 % soluble
insulin / 70 % isophane insulin.
For a full list of excipients, see section 6.1.
3 .
PHARMACEUTICAL FORM
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.
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 70/30 in cartridges is only suitable for subcutaneous
injections from a reusable pen.
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 in order to reduce the risk of lipodystrophy and
cutaneous amyloidosis (see
section 4.4 and 4.8).
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.
Humulin Mixture formulation is a ready-made defined mixture of soluble
and isophane
insulin designed to avoid the need for the patient to mix insulin
preparations. A patient's
treatment regimen should be based on their individual metabolic
requirements.
Each pack contains a patient information leaf