Penmix 30 Penfill

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Isophane insulin, human, pyr 70 IU/mL;  ; Neutral insulin, human, pyr 30 IU/mL;  

から入手可能:

Novo Nordisk Pharmaceuticals Ltd

INN（国際名）:

Isophane insulin, human, pyr 70 IU/mL

医薬品形態:

Suspension for injection

構図:

Active: Isophane insulin, human, pyr 70 IU/mL   Neutral insulin, human, pyr 30 IU/mL   Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Protamine sulfate Sodium hydroxide Water for injection Zinc as chloride, approx

パッケージ内のユニット:

Cartridge, 3.0mL, 5 dose units

クラス:

Prescription

処方タイプ:

Prescription

製:

Novo Nordisk A/S

適応症:

Treatment of diabetes mellitus.

製品概要:

Package - Contents - Shelf Life: Cartridge, 3.0mL - 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

承認日:

1988-08-05

情報リーフレット

Ins Susp Penf PIL 6.docx
1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
PENMIX
® 30 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE
PENMIX
® 40 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE
PENMIX
® 50 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE
PROTAPHANE
® PENFILL
® 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE
Insulin human (rDNA)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING YOUR INSULIN
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, nurse or your
pharmacist.
–
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms
are the same as yours.
–
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor, nurse or your pharmacist.
1. WHAT PENMIX
® AND PROTAPHANE
® ARE AND WHAT THEY ARE USED FOR
PENMIX
® AND PROTAPHANE
® ARE HUMAN INSULINS USED TO TREAT DIABETES.
Diabetes mellitus is a disease where your
body does not produce enough insulin to control the level of your
blood sugar. PenMix
®
is a mixture of fast-acting
insulin and long-acting insulin. This means that it will start to
lower your blood sugar about ½ hour after you take it,
and the effect will last for approximately 24 hours. Protaphane
®
is a long-acting insulin. This means that it will start to
lower your blood sugar about 1½ hours after you take it, and the
effect will last for approximately 24 hours.
Protaphane
®
is often given in combination with fast-acting insulin products.
2. BEFORE YOU USE PENMIX
® OR PROTAPHANE
®
DO NOT USE PENMIX
® OR PROTAPHANE
®
:
►
IN INSULIN INFUSION PUMPS.
►
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to human insulin or any of the other ingredients in PenMix
®
or Protaphane
®
(see 7. FURTHER INFORMATION)
►
IF YOU SUSPECT HYPOGLYCAMIA
(low blood sugar) is starting (see 4. WHAT TO DO IN AN EMERGENCY).
►
IF THE CARTRIDGE OR THE DEVICE CONTAINING THE CARTRIDGE IS DROPPED,
DAMAGED OR CRUSHED
.
�

製品の特徴

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.