Protaphane Innolet

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Isophane insulin, human, pyr 100 IU/mL;  

Disponível em:

Novo Nordisk Pharmaceuticals Ltd

DCI (Denominação Comum Internacional):

Isophane insulin, human, pyr 100 IU/mL

Dosagem:

100 IU/mL

Forma farmacêutica:

Suspension for injection

Composição:

Active: Isophane insulin, human, pyr 100 IU/mL   Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Protamine sulfate Sodium hydroxide Water for injection Zinc

Unidades em pacote:

Cartridge, glass, 3mL, 5 dose units

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Novo Nordisk A/S

Indicações terapêuticas:

Treatment of diabetes mellitus.

Resumo do produto:

Package - Contents - Shelf Life: Cartridge, glass, 3mL - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 weeks opened stored at or below 25°C

Data de autorização:

2002-02-26

Características técnicas

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
PENMIX
®
30
100 IU/ml
PENMIX
®
40
100 IU/ml
PENMIX
®
50
100 IU/ml
MIXTARD
®
30
100 IU/ml
PROTAPHANE
®
100 IU/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin
human,
rDNA
(produced
by
recombinant
DNA
technology
in
_Saccharomyces _
_cerevisiae_).
The PENMIX and Mixtard products contain Biphasic isophane insulin
injection 100 IU/ml.
The PROTAPHANE products contain Isophane (NPH) insulin suspension
injection 100 IU/ml.
3 PHARMACEUTICAL FORM
PENMIX 30 is a cloudy, white, aqueous suspension containing 30%
dissolved insulin and 70%
isophane human insulin in 3 ml Penfill
®
cartridges made of glass, with a plunger (bromobutyl)
and a stopper (bromobutyl/polyisoprene) in a carton.
PENMIX 40 is a cloudy, white, aqueous suspension containing 40%
dissolved insulin and 60%
isophane human insulin in 3 ml Penfill
®
cartridges made of glass, with a plunger (bromobutyl)
and a stopper (bromobutyl/polyisoprene) in a carton.
PENMIX 50 is a cloudy, white, aqueous suspension containing 50%
dissolved insulin and 50%
isophane human insulin in 3 ml Penfill
®
cartridges made of glass, with a plunger (bromobutyl)
and a stopper (bromobutyl/polyisoprene) in a carton.
MIXTARD 30 is a cloudy, white, aqueous suspension containing 30%
dissolved insulin and
70% isophane human insulin in 10 ml glass vials closed with a disc
(bromobutyl/polyisoprene
rubber) and a protective tamper-proof plastic cap in a carton.
PROTAPHANE is a cloudy, white, aqueous suspension containing isophane
insulin suspension
in 3 ml penfill
®
cartridges made of glass, with
a
plunger (bromobutyl)
and
a stopper
(bromobutyl/polyisoprene)
in
a
carton
or
in
10
ml
glass
vials
closed
with
a
disc
(bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic
cap in a carton.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human
insulin.
The penfill cartridges are designed to be used with Novo Nordisk
insulin delivery systems.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of diabetes mellitus.