Humulin I KwikPen 100units/ml suspension for injection 3ml pre-filled pens

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Insulin isophane human

から入手可能:

Eli Lilly and Company Ltd

ATCコード:

A10AC01

INN（国際名）:

Insulin isophane human

投薬量:

100unit/1ml

医薬品形態:

Suspension for injection

投与経路:

Intramuscular; Subcutaneous

クラス:

No Controlled Drug Status

処方タイプ:

Caution - AMP level prescribing advised

製品概要:

BNF: 06010102; GTIN: 5014602101480

情報リーフレット

USER MANUAL
HUMULIN
® I KWIKPEN™ 100 IU/ML
HUMULIN
® M3 KWIKPEN™ 100 IU/ML
PLEASE READ THIS USER MANUAL BEFORE USE
Read the User Manual before you start taking Humulin and each time you
get another Humulin
KwikPen 100 IU/ml. There may be new information. This information does
not take the place of
talking to your healthcare professional about your medical condition
or your treatment.
Humulin KwikPen 100 IU/ml (“Pen”) is a disposable pre-filled pen
containing 300 units (3 ml) of
insulin.
You can give yourself multiple doses using one Pen. The Pen dials 1
unit at a time. You
can give from 1 to 60 units in a single injection. IF YOUR DOSE IS MORE THAN 60
UNITS, YOU WILL
NEED TO GIVE YOURSELF MORE THAN ONE INJECTION.
The plunger only moves a little with each
injection, and you may not notice that it moves. The plunger will only
reach the end of the
cartridge when you have used all 300 units in the Pen.
DO NOT SHARE YOUR PEN WITH OTHER PEOPLE, EVEN IF THE NEEDLE HAS BEEN
CHANGED. DO NOT REUSE
OR SHARE NEEDLES WITH OTHER PEOPLE. YOU MAY GIVE AN INFECTION TO THEM
OR GET AN INFECTION
FROM THEM.
This Pen is not recommended for use by the blind or visually impaired
without the help of
someone trained to use the Pen.
KWIKPEN PARTS
Cap Clip
Cartridge Holder
Label
Dose Indicator
Pen Cap
Rubber Seal
Plunger
Pen Body
Dose
Window
Dose
Knob
PEN NEEDLE PARTS
(Needles Not Included)
Paper Tab
Outer Needle
Shield
Inner Needle
Shield
Needle
HOW TO RECOGNISE YOUR HUMULIN KWIKPEN 100 IU/ML:
HUMULIN
I
HUMULIN
M3
Pen Body colour:
Beige
Beige
Dose Knob:
Labels:
White with Light
Green Colour Bar
White with Brown
Colour Bar
SUPPLIES NEEDED TO GIVE YOUR INJECTION:
•
Humulin KwikPen 100 IU/ml containing your insulin
•
Humulin KwikPen 100 IU/ml compatible Needle (BD [Becton, Dickinson and
Company]
Pen Needles recommended)
•
Alcohol swab
PREPARING YOUR PEN
•
Follow the instructions for sanitary injection technique recommended
by your healthcare
professional.
•
Check the Pen to make sure you are taking the right type of insuli

製品の特徴

OBJECT 1
HUMULIN I KWIKPEN (ISOPHANE) 100IU/ML
SUSPENSION FOR INJECTION
Summary of Product Characteristics Updated 29-Apr-2018 | Eli Lilly and
Company Limited
1. Name of the medicinal product
Humulin
®
I KwikPen
®
(Isophane) 100 IU/ml suspension for injection
2. Qualitative and quantitative composition
1 ml contains 100 IU insulin human (produced in _E. coli _by
recombinant DNA technology).
One pre-filled pen contains 3 ml equivalent to 300 IU of isophane
insulin.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A suspension for injection in a pre-filled pen.
Humulin I is a sterile suspension of a white, crystalline precipitate
of isophane human insulin in an
isotonic phosphate buffer.
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 I should be given by subcutaneous injection but may although
not recommended, also be given
by intramuscular injection. 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.
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 shou