Mixtard 30

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Novo Nordisk Pharmaceuticals Ltd

INN (আন্তর্জাতিক নাম):

Isophane insulin, human, pyr 70 IU/mL

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection

রচনা:

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

প্যাকেজ ইউনিট:

Vial, 10 mL

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Novo Nordisk A/S

থেরাপিউটিক ইঙ্গিত:

Treatment of diabetes mellitus.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Vial, - 10 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

অনুমোদন তারিখ:

1993-06-09

তথ্য লিফলেট

Ins Susp vial PIL 6.doc
Page 1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MIXTARD
® 30 100 IU/ML SUSPENSION FOR INJECTION IN VIAL
PROTAPHANE
® 100 IU/ML SUSPENSION FOR INJECTION IN VIAL
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 MIXTARD
® 30 AND PROTAPHANE
® ARE AND WHAT THEY ARE USED
FOR
MIXTARD
® 30 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. Mixtard
®
30 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 hour 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 MIXTARD
® 30 OR PROTAPHANE
®
DO NOT USE MIXTARD
®
30 OR PROTAPHANE
®
:
►
IN INSULIN INFUSION PUMPS.
►
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to human insulin or any of the other ingredients in Mixtard
®
30 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 PROTECTIVE CAP IS LOOSE OR MISSING.
Each vial has a protective, tamper-proof plastic cap. If it is not in
perfect condition when you get the vial, return the vial to your
supplier.
►
IF IT HAS NO

পণ্য বৈশিষ্ট্য

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.