Carbaglu

Main information

  • Trade name:
  • Carbaglu carglumic acid 200 mg dispersible tablets tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Carbaglu carglumic acid 200 mg dispersible tablets tube
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215632
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215632

Carbaglu carglumic acid 200 mg dispersible tablets tube

ARTG entry for

Medicine Registered

Sponsor

Emerge Health Pty Ltd

Postal Address

Suite 3 Level 1 / 2 Theatre Place,CANTERBURY, VIC, 3126

Australia

ARTG Start Date

12/02/2015

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. Carbaglu carglumic acid 200 mg dispersible tablets tube

Product Type

Single Medicine Product

Effective date

12/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Carbaglu is indicated in treatment of: Hyperammonaemia due to N-acetylglutamate synthase primary deficiency; - Hyperammonaemia due to Organic

Acidaemias such as: Hyperammonaemia due to isovaleric acidaemia, Hyperammonaemia due to methymalonic acidaemia, Hyperammonaemia due to

propionic acidaemia

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

30 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Protect from Light

Protect from Moisture

Replace the cover

firmly after use

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

5 Tablets

(S4) Prescription Only Medicine

60 Tablets

(S4) Prescription Only Medicine

Components

1. Carbaglu carglumic acid 200 mg dispersible tablets tube

Dosage Form

Tablet, dispersible

Route of Administration

Oral

Visual Identification

A bar-shaped tablet, with 4 punches on one side ('c c c c'), size 18.0 x 6.0

mm, with 3 break-marks both sides

Active Ingredients

carglumic acid

200 mg

© 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 26.11.2017 at 08:26:56 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

Carbaglu AU CMI 1.0

CARBAGLU

®

Carglumic acid, 200 mg Dispersible Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

more common questions about

Carbaglu.

It does not contain all of the

available information. It does

not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you taking

Carbaglu against the benefits

he/she expects it will have for

you.

If you have any concerns

about taking this medicine,

ask your doctor or

pharmacist.

Keep this leaflet with your

medicine.

You may need to read this again.

What CARBAGLU

is used for

Carbaglu is used to eliminate

excessive levels of ammonia,

referred to as

hyperammonaemia. The high

levels of ammonia in the blood

may be caused by the lack of a

specific liver enzyme called N-

acetyl glutamate synthase

(NAGS) or due to isovaleric

acidaemia, methylmalonic

acidaemia or propionic

acidaemia.

High levels of ammonia in the

blood are toxic for the brain and

leads in severe cases, to reduced

levels of consciousness and

coma.

Some people are born with

inherited diseases that cause

some of the body’s enzymes to

be missing or defective. The

deficiency of NAGS is a rare

disorder and results in patients

not being able to eliminate

nitrogen waste from the body

which builds up after eating

protein. This disorder persists

for life and therefore the need

for this treatment is lifelong.

Isovaleric acidaemia,

methylmalonic acidaemia and

propionic acidaemias are rare

disorders that can inhibit NAGS

and cause episodes of

hyperammonaemia. The

treatment of elevated ammonia

in these disorders is required

during these episodes.

Carbaglu helps the body’s

natural process to eliminate

ammonia by triggering the

enzymes required to convert this

to urea. This is eliminated from

the body in urine.

Ask your doctor if you have

any questions about why

Carbaglu has been prescribed

for you.

This medicine is available only

with a doctor’s prescription.

Before your doctor

gives you

CARBAGLU

Tell your doctor if you:

Have allergies to any

medicines

Are taking or using any

other medicines. These

include medicines

bought from

pharmacies,

supermarkets and health

food stores

Have any other medical

conditions

Are pregnant or breast

feeding.

If you want further information,

consult your doctor.

How to take

CARBAGLU

Follow all directions given to

you by your doctor and

pharmacist carefully.

These directions may differ from

the information contained in this

leaflet.

Your doctor may discuss with

you the need to be on a

restricted diet while you take

Carbaglu.

If you do not understand the

instructions, ask your doctor

or pharmacist for help.

Carbaglu AU CMI 1.0

Your doctor will evaluate your

individual responsiveness to

Carbaglu before initiating any

long term treatment.

The dose will be individually

adjusted in order to maintain

normal ammonia plasma levels.

Once the bottle containing the

Carbaglu tablets has been

opened, the tablets can be used

for 1 month. Write the date

when the bottle was first opened

in the space provided on the

bottle label.

How much to take

Each tablet contains 200mg.

The normal initial dose of

Carbaglu is 100mg per kilogram

of body weight per day. This

dose maybe increased to 250 mg

per kilogram of body weight per

day.

For patients suffering from

NAGS deficiency, in the long

term, the daily dose usually

ranges from 10 mg to 100 mg

per kilogram of body weight.

The total daily dose should be

divided into 2 to 4 doses and

round to the nearest 100 mg

(half a Carbaglu tablet).

Your doctor may also

recommend other therapies to

help lower your ammonia levels.

Always consult your doctor

with questions about your

prescribed dose.

How to take it

Carbaglu tablets should not be

swallowed whole or crushed.

Adults

Each 200 mg tablet should be

dispersed in 5 to 10 ml of water

and taken immediately.

Carbaglu tablets do not dissolve

completely in water and

undissolved particles of the

tablet may remain in the mixing

container. To ensure complete

delivery of the dose, rinse the

mixing container with additional

volumes of water and swallow

the contents immediately.

The suspension may taste

slightly acidic.

Children

Each 200 mg tablet should be

dispersed in a minimum of 2.5

ml of water. For swallowing

using a syringe, draw up the

volume of the liquid using an

oral syringe and administer

immediately. The syringe may

be refilled with a small amount

of water (1 – 2 mL) and

administered.

For use with a nasogastric tube,

the dose is given in the same

way as above, with the tube

flushed with water after

administration.

When to take it

Carbaglu treatment should be

initiated under the supervision

of a doctor and given before

meals or feeding.

How long to take it

Take Carbaglu for as long as

your doctor tells you.

Carbaglu helps to lower your

levels of ammonia in the blood,

but it does not cure your

condition.

If you forget to take it

Do not take a double dose to

make up for the dose that you

missed.

This may increase the chance of

you getting an unwanted side

effect.

If you are not sure what to do,

talk to your doctor or

pharmacist.

If you take too much of it

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone Australia 13

11 26 or New Zealand 0800

764 766) for advice, or go to

Accident and Emergency at

the nearest hospital, if you

think that you or anyone else

may have taken too much

Carbaglu. Do this even if there

are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are taking

CARBAGLU

Things you must do

Your doctor may ask you to

have your liver, kidney, heart

functions and blood tested from

time to time to make sure the

medicine is working to prevent

unwanted side effects.

Your blood ammonia levels also

need to be checked regularly

while you are taking this

medicine.

If you become pregnant while

you are taking Carbaglu,

contact your doctor

immediately.

If you are about to be started

on any new medication,

remind your doctor and

Carbaglu AU CMI 1.0

pharmacist that you are

taking Carbaglu.

Tell any other doctors, dentists

and pharmacists who treat

you that you are taking this

medicine.

Things you must not do

Do not give Carbaglu to

anyone else even if they have

the same condition as you.

Do not take Carbaglu to treat

any other complaints unless

your doctor tell you.

Side Effects

All medicines can have side

effects. Sometimes they are

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

Do not be alarmed by the list

of possible side effects.

You may not experience any of

them.

Ask your doctor or

pharmacist to answer any

questions you may have.

Tell your doctor if

Tell your doctor or

pharmacist if you notice any of

the following and they worry

you:

Increased sweating

Slow heart beat

Diarrhoea

Abdominal Pain

Fever or high

temperature

Vomiting.

After taking

CARBAGLU

Storage

Keep your tablets in the

container until it is time to

take them.

If you take the tablets out of the

bottle they may not keep well

Store the unopened bottle in a

refrigerator. Do not freeze the

tablets.

Once the tablet container has

been opened, the opened bottle

can be stored in a cool dry place

out of direct sunlight.

The container must be used

within 1 month of the container

being opened.

Keep your tablets where

children cannot reach them.

Disposal

If your doctor tells you to stop

taking Carbaglu, or it has

passed its expiry date, ask

your pharmacist what to do

with any tablets that are left

over.

Product Description

What it looks like

Carbaglu dispersible tablets are

a bar-shaped tablet, with 4

punches on one side and with 3

break-mark on both sides.

Carbaglu is supplied in two

container sizes, one containing 5

tablets and the other containing

60 tablets. The tablets are stored

in a re-sealable container.

Ingredients

The active ingredient of

Carbaglu is carglumic acid.

The other ingredients are:

microcrystalline

cellulose

sodium lauryl sulphate

hypromellose

croscarmellose sodium

silica colloidal

anhydrous

sodium stearyl fumarate.

This medicine does not contain

lactose or gluten.

Supplier

Carbaglu is supplied in Australia

Emerge Health Pty Ltd

Suite 3, Level 1, 2 Theatre Place

Canterbury VIC 3126

Ph: +61 3 9077 4486

www.emergehealth.com.au

Under license from:

Orphan Europe SARL

70 avenue du Général de Gaulle,

92800 Puteaux, France

Date of preparation

This leaflet was prepared in

January 2015.

AUST R 215632

® Carbaglu is a registered

trademark of Recordati Orphan

Drugs.

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Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety