Humulin R solution for injection

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

insulin human regular (recombinant DNA)

Saatavilla:

Lilly France S.A.S.

ATC-koodi:

A10AB01

INN (Kansainvälinen yleisnimi):

insulin human regular (recombinant DNA)

Annos:

100IU/ml

Lääkemuoto:

solution for injection

Kpl paketissa:

(5) cartridges 3ml

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2021-08-24

Pakkausseloste

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

Valmisteyhteenveto

HUMULIN
R CARTRIDGE
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
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).
One cartridge contains 3 ml equivalent to 300 IU of soluble insulin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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
Humulin R in cartridges is only suitable for subcutaneous injections
from a reusable pen. If
administration by syringe or intravenous injection is necessary, a
vial should be used.
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.
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 WARNIN