HUMULIN

Main information

  • Trade name:
  • HUMULIN R biosynthetic human neutral insulin 100IU/mL injection multidose cartridge
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HUMULIN R biosynthetic human neutral insulin 100IU/mL injection multidose cartridge
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 39666
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

39666

HUMULIN R biosynthetic human neutral insulin 100IU/mL injection multidose cartridge

ARTG entry for

Medicine Registered

Sponsor

Eli Lilly Australia Pty Ltd

Postal Address

112 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

11/05/1992

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. HUMULIN R biosynthetic human neutral insulin 100IU/mL injection multidose cartridge

Product Type

Single Medicine Product

Effective date

20/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

OTHER CONDITIONS: Refrigerate - do not freeze. INDICATIONS: For the treatment of insulin dependent diabetic patients.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Cartridge

Not recorded

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Protect from direct

sunlight

Pack Size/Poison information

Pack Size

Poison Schedule

5x3mL

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear, sterile, colourless solution.

Active Ingredients

insulin

100 IU/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 06:50:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

HUMULIN

®

CARTRIDGES

Biosynthetic Human Insulin (rbe)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about HUMULIN.

It does not contain all the available

information. It does not take the

place of talking with your doctor or

pharmacist.

The information in this leaflet was

last updated on the date shown on the

final page. More recent information

on this medicine may be available.

Make sure you speak to your

pharmacist, nurse or doctor to obtain

the most up to date information on

this medicine. You can also

download the most up to date leaflet

from www.lilly.com.au. The updated

leaflet may contain important

information about HUMULIN and its

use that you should be aware of.

All medicines have risks and

benefits.

Your doctor has weighed the risks

of you taking HUMULIN against

the benefits they expect it will have

for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with this

medicine.

You may need to read it again.

What HUMULIN is

used for

HUMULIN is used to reduce high

blood sugar (glucose) levels in

patients with diabetes mellitus.

Diabetes is a condition in which your

pancreas does not produce enough

insulin to control your blood sugar

level. Extra insulin is therefore

needed.

There are two types of diabetes

mellitus:

Type 1 diabetes - also called juvenile

onset diabetes.

Type 2 diabetes - also called maturity

onset diabetes.

Patients with type 1 diabetes always

require insulin to control their blood

sugar levels.

Some patients with type 2 diabetes

may also require insulin after initial

treatment with diet, exercise and

tablets.

HUMULIN is identical to the insulin

produced by the pancreas.

There are 3 different types of

HUMULIN cartridges:

HUMULIN R

HUMULIN NPH

HUMULIN 30/70.

Your doctor will tell you the type of

HUMULIN that is best suited to you.

The duration of action of the insulin

you inject will vary according to the

type being used, the dose, injection

site, blood flow, temperature and

level of physical activity.

Your doctor may tell you to use a

short acting human insulin such as

HUMULIN R in combination with a

longer acting human insulin such as

HUMULIN NPH.

The abbreviation "rbe" indicates the

method of genetic engineering used

to manufacture the insulin.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Before you use

HUMULIN

When you must not use it

Do not use HUMULIN if:

1.

you have an allergy to:

any medicine containing insulin

any of the ingredients listed at the

end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

redness, swelling, rash and

itching at the injection site

rash, itching or hives on the skin

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body.

The only time you would take this

medicine if you have an allergy to it,

is if your doctor has you on a

desensitisation program to minimise

allergic reactions.

2.

you are experiencing low blood

sugar levels (a "hypo").

If you have a lot of hypos discuss

appropriate treatment with your

doctor.

Do not use this medicine after the

expiry date on the pack or if the

HUMULIN

CARTRIDGES

packaging is torn or shows signs of

tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start using this medicine,

talk to your doctor.

Before you start to use it

Tell your doctor if you have any

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

liver problems

overactive thyroid glands

(hyperthyroidism)

overactive adrenal glands

(Cushing's Syndrome)

enlargement of the face, hands

and feet (acromegaly)

a tumour of the adrenal gland

(phaeochromocytoma)

fluid retention especially in the

hands, ankles or feet

heart disease.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Pregnancy may make managing your

diabetes more difficult. Insulin needs

usually decrease during the first three

months of pregnancy and increase

during the last six months. Your

doctor can discuss with you the risks

and benefits involved.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

Your doctor/pharmacist can discuss

with you the risks and benefits

involved.

If you have not told your doctor

about any of the above, tell them

before you start using HUMULIN.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines may affect the way

HUMULIN works.

These include:

oral hypoglycaemic medicines

that are used to treat type 2

diabetes

medicines that affect your

metabolism (corticosteroids such

as prednisone, cortisone)

medicines used for oral

contraception

medicines used in thyroid

replacement therapy

certain medicines used to treat

tuberculosis, such as isoniazid

medicines such as aspirin or other

salicylates

certain medicines used to treat

depression

certain medicines used to treat

asthma, such as salbutamol or

terbutaline

some antibiotics

certain medicines used to treat

high blood pressure or other heart

conditions

certain medicines used to treat

people with growth disorders and

tumours, such as octreotide

alcohol

thiazolidinediones (TZDs), also

used to treat type 2 diabetes;

when used with insulin there may

be an increased risk of fluid

retention and heart disease.

Tell your doctor about any other

medicines that you are taking.

This is very important. Your doctor

will advise you if it is all right to

keep taking them or if you should

stop taking them.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while using this

medicine.

How to use HUMULIN

Your doctor, diabetes education

nurse or pharmacist will have

shown you how to use HUMULIN.

Carefully follow all the directions.

They may differ from the

information contained in this leaflet.

Do not inject HUMULIN into a

vein or muscle.

Any change in dose or type of

insulin should be made cautiously

and only under medical

supervision.

If you change the type of insulin that

you use, you may have to use more

or less than before. This may happen

with the first dose or over a period of

time.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

How much to use

Your doctor will tell you how much

HUMULIN you need to use each

day.

It is very important that you manage

your diabetes carefully. Too much or

too little insulin can cause serious

effects.

When to use it

Your doctor will tell you when to use

HUMULIN.

How to use it

Checking your HUMULIN

cartridge

Check the HUMULIN cartridge

before each preparation and

injection. Make sure you are using

the correct cartridge.

HUMULIN 3.0 mL cartridges are

only for use with the HumaPen.

The manufacturer's instructions

for the HumaPen injection delivery

systems should be followed for

loading the cartridge, attaching the

needle and administering the

insulin injection.

HUMULIN

CARTRIDGES

Do not use HUMULIN NPH or

HUMULIN 30/70 suspension if it is

no longer a cloudy white

suspension after shaking or has

solid pieces in it.

Do not use HUMULIN if the

cartridge appears frosted. This can

occur when solid white particles

stick to the bottom and walls, after

mixing. If this occurs, please

return to the place of purchase for

exchange.

Do not use HUMULIN R if it is

thickened, coloured or has solid

pieces in it.

Always check your insulin

injection device for insulin flow

(priming) before use.

The priming procedure may highlight

a malfunction with your insulin

injection device. Priming also

removes any air bubbles and helps

indicate whether or not a needle is

broken.

Preparing a dose

Wash your hands.

If your cartridge is already inside

your pen, check the amount of

insulin remaining. Stop using the

cartridge if the leading edge of

the plunger has gone to, or

beyond, the left side of the gauge

on the side of the cartridge. You

can see how much HUMULIN is

left by looking at the gauge on the

side of the cartridge. The distance

between each mark on the gauge

is about 20 units. If there is not

enough for your dose, change the

cartridge.

If you are using a cloudy insulin,

just before use, roll the cartridge/

pen between the palms 10 times

and invert 10 times until the

suspension appears uniformly

cloudy or milky. Do not shake.

Inspect the cartridge for uniform

mixing and repeat the above steps

if necessary.

Put the cartridge into the pen.

Attach a needle.

Checking for insulin flow

(Priming)

Remove the needle cap.

Set the dose to 1 or 2 units.

Hold the pen with the needle

pointing up and tap the side of the

pen so that any bubbles float to

the top.

With the pen still pointing up,

press the injection button. Do this

until a drop or stream of

HUMULIN comes out of the

needle. This is very important to

help make sure you inject the

correct dose.

Repeat steps 2-4 until you see a

drop of insulin at the needle tip. If

a drop of insulin still does not

appear hold the pen with the

needle facing upwards and away

from your face. Attach a new

needle. Repeat steps 2-4 again. If

you are still unable to get insulin

flowing out of the needle, do not

use the pen. Return the pen to

your doctor, diabetes education

nurse or pharmacist to obtain a

replacement pen.

Only dial up your required dose

after you see a drop of insulin at

the needle tip. There may still be

some small air bubbles left in the

cartridge. These are harmless.

If the air bubble is too big, you

should prime the cartridge again.

If you need to put the pen down,

make sure the needle does not

touch anything.

Injecting a dose

Choose a site for injection.

Inject HUMULIN in the upper arms,

thighs, buttocks or abdomen.

Change the injection site so that

the same position is not used more

often than once a month.

This will reduce the chance of local

skin reactions developing.

Pinch the skin between two fingers,

push the needle into the raised skin

and inject the full dose of insulin

under the skin.

Slowly count to 5 or 6 before

pulling the needle out.

Apply gentle pressure over the

injection site for several seconds.

Do not rub the area.

After injecting

Using the outer needle cap,

unscrew the needle and dispose of

it safely into a yellow plastic sharps

container.

Do not share needles, cartridges or

pens.

Leave the cartridge in the pen until

it needs to be replaced.

How long to use it

Do not stop using your insulin

unless your doctor tells you to.

If you take too much

(overdose) - Hypoglycaemia

Your blood sugar level may become

too low (you may experience

hypoglycaemia or a "hypo") if you:

accidentally use too much

HUMULIN

have too much or unexpected

exercise

delay eating meals or snacks

eat too little food

are ill.

The first symptoms of mild to

moderate hypos can come on

suddenly. They may include:

cold sweat, cool pale skin

fatigue, drowsiness, unusual

tiredness and weakness

nervousness, anxious feeling,

tremor, rapid heart beat

confusion, difficulty

concentrating

excessive hunger

vision changes

headache, nausea.

Always carry some sugary food or

fruit juice with you.

If you experience any of these

symptoms of a hypo, immediately

eat some sugary food or have a

drink, e.g. lollies, biscuits or fruit

juice.

HUMULIN

CARTRIDGES

Tell your relatives, friends, close

workmates or carers that you have

diabetes. It is important that they

recognise the signs and symptoms

of a hypo.

Make sure they know to give you

some sugary food or fruit juice for

mild to moderate symptoms of a

hypo.

If you lose consciousness, make

sure they know:

to turn you on your side and get

medical help immediately

not to give you anything to eat

or drink.

This is because you could choke.

An injection of the hormone

glucagon may speed up recovery

from unconsciousness. This can be

given by a relative, friend, workmate

or carer who knows how to give it.

If glucagon is used, eat some

sugary food or have a drink as

soon as you are conscious again.

If you do not feel better after this,

contact your doctor, diabetes

education nurse, or go Accident

and Emergency at the nearest

hospital.

If you do not respond to glucagon

treatment, you will have to be treated

in a hospital.

See your doctor if you keep having

hypo reactions, or if you have ever

become unconscious after using

insulin.

Your insulin dose may need to be

changed.

If a severe hypo is not treated, it can

cause brain damage and death.

If you miss a dose -

Hyperglycaemia

If you forget your insulin dose, test

your blood sugar level as soon as

possible.

If you are not sure what to do, talk

to your doctor, diabetes education

nurse or pharmacist.

Do not use a double dose of your

insulin.

If it is almost time for your next

dose, skip the dose you missed and

use your next dose when you are

meant to.

Otherwise, use it as soon as you

remember, and then go back to using

it as you would normally.

Your blood sugar levels may become

high (hyperglycaemia) if you:

miss doses of insulin or use less

insulin than you need

have uncontrolled diabetes

exercise less than usual

eat more carbohydrates than usual

are ill or stressed.

High blood sugar levels over a long

period of time can lead to too much

acid in the blood (diabetic

ketoacidosis).

Contact your doctor immediately if

your blood sugar level is high or

you recognise any of the following

symptoms.

Symptoms of mild to moderate

hyperglycaemia include:

drowsy feeling

flushed face

thirst, loss of appetite

fruity odour on the breath

blurred vision

passing larger amounts of urine

than usual

getting up at night more often

than usual to pass urine

high levels of glucose and

acetone in the urine.

Symptoms of severe hyperglycaemia

include:

heavy breathing

fast pulse

nausea, vomiting

dehydration

loss of consciousness.

Severe hyperglycaemia can lead to

unconsciousness and in extreme

cases death if untreated.

Discuss any worries you may have

about this with your doctor or

pharmacist.

While you are using

HUMULIN

Things you must do

Measure your blood sugar levels

regularly.

Make sure all friends, relatives,

workmates or carers know that

you have diabetes.

It is important to keep using your

medicine even if you feel well.

This medicine helps to control your

condition, but does not cure it.

Tell your doctor if you often have

hypos (low blood sugar levels).

Your doctor may need to adjust your

insulin dose.

Always carry some sugary food or

fruit juice with you.

If you experience any of the

symptoms of a hypo, immediately eat

some sugary food or have a drink,

e.g. lollies, biscuits or fruit juice.

Tell your doctor if you have

trouble recognising the symptoms

of hypos.

Under certain conditions, the early

warning signs of hypos can be

different or less obvious. Your doctor

may need to adjust your insulin dose.

Make sure that you tell every

doctor, dentist, pharmacist or

other health care professional who

is treating you that you have

diabetes and are using insulin.

Tell your doctor, diabetes

education nurse or pharmacist if

you are travelling.

Ask your doctor for a letter

explaining why you are taking

injecting devices with you. Each

country you visit will need to see this

letter, so you should take several

copies.

You may need to inject your insulin

and eat your meals at different times

because of time differences in and

between countries.

You may not be able to get the same

type of insulin in the country you are

visiting.

HUMULIN

CARTRIDGES

Your doctor, diabetes education

nurse or pharmacist can provide you

with some helpful information.

Tell your doctor if you are having

trouble/difficulty with your

eyesight.

Visual disturbances in uncontrolled

diabetes are reversed during the early

stages of treatment.

Once established on insulin, if your

vision changes, see your doctor as

soon as possible.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are using HUMULIN.

If you become pregnant while

using this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

using this medicine.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Always carry a supply of HUMULIN

cartridges and your pen with you.

Always carry something to show you

have diabetes.

Things you must not do

Do not stop using your medicine

unless your doctor tells you to.

Do not use this medicine if you

think it has been frozen or exposed

to excessive heat.

It will not work as well.

Do not use empty cartridges again.

Do not use HUMULIN to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not adjust the dosage of your

medicine without checking with

your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how the

insulin affects you.

Tell your doctor if you drink

alcohol.

Alcohol may mask the symptoms of

hypos.

Tell your doctor if you are ill.

Illness, especially with nausea and

vomiting, may cause your insulin

needs to change. Even if you are not

eating, you still require insulin. You

and your doctor should design an

insulin plan for those times when you

are sick.

Tell your doctor if you are feeling

particularly excited or upset.

Emotional disturbances may change

your insulin needs.

Tell your doctor if you are

exercising more than usual.

Exercise may lower your need for

HUMULIN. Exercise may also speed

up the effect of a dose of

HUMULIN, especially if the exercise

involves the area of injection site

(e.g. the leg should not be used for

injection prior to jogging or running).

Tell your doctor if your diet

changes.

Changes in diet may cause your

insulin needs to change.

Side effects

Tell your doctor, diabetes

education nurse or pharmacist as

soon as possible if you do not feel

well while you are using

HUMULIN.

This medicine helps most people

with type 1 or type 2 diabetes, but it

may have unwanted side effects in a

few people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor, diabetes nurse

educator or pharmacist to answer

any questions you may have.

The most common side effect when

using insulin is low blood sugar

levels (a hypo).

Tell your doctor or pharmacist if

you notice any of the following:

hypos (mild to moderate)

redness, swelling or itching at the

injection site (local allergy)

Usually these symptoms

disappear within a few weeks

during continued use.

a depression or thickening of the

skin around the injection site

(lipodystrophy)

fluid retention, particularly in the

ankles, feet and hands (oedema).

This list includes the more common

side effects of your medicine.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

More severe symptoms of low blood

sugar levels, including:

disorientation

seizures, fits or convulsions

loss of consciousness.

Tell your relatives, friends, close

workmates or carers that you have

diabetes.

If a severe hypo is not treated, it can

cause brain damage and death.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

skin rashes over a large part of

the body

shortness of breath, wheezing

swelling of the face, lips or

tongue

fast pulse

sweating.

HUMULIN

CARTRIDGES

This list includes very serious side

effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor if you notice

anything that is making you feel

unwell.

Other side effects not listed above

may also occur in some people.

After using HUMULIN

Storage

HUMULIN cartridges should be

kept in the refrigerator between

2°C and 8°C. Do not freeze.

While in the pen or carried as a

spare, cartridges can be kept at

room temperature (below 30°C)

for up to 21 days.

Do not put the cartridge in the

refrigerator while it is inserted in

the pen.

The cartridge-pen combination

should not be refrigerated.

Dispose of unrefrigerated

cartridges after 21 days, even if the

cartridge still contains HUMULIN.

Do not store HUMULIN or any

other medicine in the bathroom or

near a sink. Do not put it near heat

or in the sun.

Keep it where children cannot

reach it.

A locked cupboard or compartment

at least one-and-a-half metres above

the ground is a good place to store

medicines.

Disposal

Dispose of your needles safely into

a yellow plastic sharps container.

If your doctor tells you to stop

using this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product Description

What it looks like

The HUMULIN product range is

differentiated by colour and by

symbols on the carton and cartridge

labels.

HUMULIN R (regular neutral

soluble human insulin (rbe)) is a

clear colourless solution, with a

water-like appearance and

consistency. It is available in 3 mL

cartridges. The carton and label have

a golden yellow band with a white

diamond symbol.

HUMULIN NPH (isophane human

insulin (rbe)) is a milky or cloudy

white suspension. It is available in 3

mL cartridges. The carton and label

have a lime green band with a white

square symbol.

HUMULIN 30/70 (mixture of 30% R

regular neutral soluble human insulin

(rbe) and 70% NPH isophane human

insulin (rbe)) is a milky or cloudy

white suspension. It is available in 3

mL cartridges. The carton and label

have a tan band with a symbol

consisting of a square with triangles

on three sides.

Ingredients

HUMULIN R contains 100 units of

insulin per mL as the active

ingredient.

It also contains:

meta-Cresol

glycerol

water for injections.

HUMULIN NPH and HUMULIN

30/70 contain 100 units of insulin per

mL as the active ingredient.

They also contain:

meta-Cresol

glycerol

zinc oxide

sodium phosphate dibasic

protamine sulfate

phenol

water for injections.

Supplier

HUMULIN is supplied in Australia

Eli Lilly Australia Pty. Limited

112 Wharf Road

WEST RYDE NSW 2114

AUSTRALIA

HUMULIN is supplied in New

Zealand by:

Eli Lilly and Company (NZ) Limited

Level 1, 123 Ormiston Rd

South Botany, Auckland

NEW ZEALAND

Australian Registration

Numbers

HUMULIN R cartridges

AUST R 39666

HUMULIN NPH cartridges

AUST R 39662

HUMULIN 30/70 cartridges

AUST R 39659

Further Information

You can get more information about

diabetes and insulin from:

Diabetes Australia

freecall helpline 1300 136 588

www.diabetesaustralia.com.au

Diabetes New Zealand

tollfree helpline 0800 DIABETES

(0800 342 238)

www.diabetes.org.nz

This leaflet was revised in January

2013.

HUMULIN

CARTRIDGES

= Registered Trademark

HUMULIN

CARTRIDGES

14-2-2019

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

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8-2-2019

FDA Announces Second Approved Insulin for Use in Dogs with Diabetes

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The FDA’s Center for Veterinary Medicine announced today the approval of ProZinc (protamine zinc recombinant human insulin) for managing diabetes mellitus in dogs, the second approved insulin for use in dogs with diabetes.

FDA - U.S. Food and Drug Administration

21-6-2018

FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

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FDA - U.S. Food and Drug Administration

19-2-2019


Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

15-2-2019

#ICYMI: FDA authorizes first interoperable insulin pump intended to  allow patients to customize treatment through their individual diabetes  management devices. Read more here:  https://go.usa.gov/xEUuM   #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

14-2-2019

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Active substance: Recombinant human monoclonal antibody to insulin receptor) - Transfer of orphan designation - Commission Decision (2019)1372 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003601

Europe -DG Health and Food Safety

14-2-2019

Liprolog (Eli Lilly Nederland B.V.)

Liprolog (Eli Lilly Nederland B.V.)

Liprolog (Active substance: Insulin lispro) - Centralised - Yearly update - Commission Decision (2019)1331 of Thu, 14 Feb 2019

Europe -DG Health and Food Safety

1-2-2019


First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

23-1-2019

Humalog (Eli Lilly Nederland B.V.)

Humalog (Eli Lilly Nederland B.V.)

Humalog (Active substance: Insulin lispro) - Centralised - Yearly update - Commission Decision (2019)622 of Wed, 23 Jan 2019

Europe -DG Health and Food Safety

22-1-2019

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (Active substance: Chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2) - Transfer of orphan designation - Commission Decision (2019)575 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003313

Europe -DG Health and Food Safety

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration

24-9-2018

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Active substance: Insulin degludec/insulin aspart) - Centralised - Yearly update - Commission Decision (2018)6242 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Tresiba (Novo Nordisk A/S)

Tresiba (Novo Nordisk A/S)

Tresiba (Active substance: Insulin degludec) - Centralised - Yearly update - Commission Decision (2018)6244 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

6-8-2018

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Active substance: insulin lispro) - Centralised - Yearly update - Commission Decision (2018)5375 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

22-6-2018

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice  http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ  pic.twitter.com/wZdrU6tTzf

FDA - U.S. Food and Drug Administration

19-6-2018

Insuman (Sanofi-Aventis Deutschland GmbH)

Insuman (Sanofi-Aventis Deutschland GmbH)

Insuman (Active substance: human insulin) - Centralised - Yearly update - Commission Decision (2018)3889 of Tue, 19 Jun 2018

Europe -DG Health and Food Safety

19-6-2018

Lusduna (Merck Sharp and Dohme B.V.)

Lusduna (Merck Sharp and Dohme B.V.)

Lusduna (Active substance: insulin glargine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3918 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4101/T/6

Europe -DG Health and Food Safety

11-6-2018

Xultophy (Novo Nordisk A/S)

Xultophy (Novo Nordisk A/S)

Xultophy (Active substance: insulin degludec / liraglutide) - Centralised - 2-Monthly update - Commission Decision (2018)3779 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2647/II/23

Europe -DG Health and Food Safety