Insulatard InnoLet 100unitsml suspension for injection 3ml pre-filled pen

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Insulin isophane human

Disponible depuis:

Novo Nordisk Ltd

Code ATC:

A10AC01

DCI (Dénomination commune internationale):

Insulin isophane human

Dosage:

100unit/1ml

forme pharmaceutique:

Suspension for injection

Mode d'administration:

Subcutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

VMP not recommended to prescribe - patient training required

Descriptif du produit:

BNF: 06010102; GTIN: 5391501310299

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
INSULATARD®
InnoLet®
100 IU/ML (INTERNATIONAL UNITS/ML) SUSPENSION FOR INJECTION IN
PRE-FILLED PEN
human insulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
_ _
_1. _
_WHAT INSULATARD® IS AND WHAT IT IS USED FOR _
_2. _
_WHAT YOU NEED TO KNOW BEFORE YOU USE INSULATARD® _
_3. _
_HOW TO USE INSULATARD® _
_4. _
_POSSIBLE SIDE EFFECTS _
_5. _
_HOW TO STORE INSULATARD® _
_6. _
_CONTENTS OF THE PACK AND OTHER INFORMATION _
_1. _
_WHAT INSULATARD® IS AND WHAT IT IS USED FOR _
Insulatard® is human insulin with a gradual onset and long duration
of action.
Insulatard® is used to
REDUCE THE HIGH BLOOD SUGAR LEVEL
in patients with diabetes mellitus (diabetes).
Diabetes is a disease where your body does not produce enough insulin
to control the level of your
blood sugar. Treatment with Insulatard® helps to prevent
complications from your diabetes.
Insulatard® will start to lower your blood sugar about 1½ hours
after you inject it, and the effect will
last for approximately 24 hours. Insulatard® is often given in
combination with fast-acting insulin
preparations.
_2. _
_WHAT YOU NEED TO KNOW BEFORE YOU USE INSULATARD® _
DO NOT USE INSULATARD®
►
If you are allergic to human insulin or any of the other ingredients
in this medicine, see section
6.
►
If you suspect hypoglycaemia (low blood sugar) is starting, see
_Summary of serious and very _
_common side effects_
in section 4.
►
In insulin infusion pumps.
►
If InnoLet® is dropped

Résumé des caractéristiques du produit

OBJECT 1
INSULATARD 100 INTERNATIONAL UNITS/ML
Summary of Product Characteristics Updated 11-May-2018 | Novo Nordisk
Limited
1. Name of the medicinal product
Insulatard 100 international units/ml suspension for injection in
vial.
Insulatard Penfill 100 international units/ml suspension for injection
in cartridge.
Insulatard InnoLet 100 international units/ml suspension for injection
in pre-filled pen.
2. Qualitative and quantitative composition
Insulatard vial (100 international units/ml)
1 vial contains 10 ml equivalent to 1,000 international units. 1 ml
suspension contains 100 international
units isophane (NPH) insulin human* (equivalent to 3.5 mg).
Insulatard Penfill
1 cartridge contains 3 ml equivalent to 300 international units. 1 ml
suspension contains 100 international
units isophane (NPH) insulin human* (equivalent to 3.5 mg).
Insulatard InnoLet
1 pre-filled pen contains 3 ml equivalent to 300 international units.
1 ml suspension contains 100
international units isophane (NPH) insulin human* (equivalent to 3.5
mg).
*Human insulin is produced in _Saccharomyces cerevisiae_ by
recombinant DNA technology.
Excipient with known effect:
Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e.
Insulatard is essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection.
The suspension is cloudy, white and aqueous.
4. Clinical particulars
4.1 Therapeutic indications
Insulatard is indicated for treatment of diabetes mellitus.
4.2 Posology and method of administration
POSOLOGY
The potency of human insulin is expressed in international units.
Insulatard dosing is individual and determined in accordance with the
needs of the patient. The physician
determines whether one or several daily injections are necessary.
Insulatard may be used alone or mixed
with fast-acting insulin. In intensive insulin therapy the suspension
may be used as basal insulin (evening
and/or morning injection) with fast-acting insulin given at meals.
Blood glucose monitoring i