Lucrin

Main information

  • Trade name:
  • Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218936
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218936

Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe

ARTG entry for

Medicine Registered

Sponsor

Abbvie Pty Ltd

Postal Address

Locked Bag 5029,BOTANY, NSW, 1455

Australia

ARTG Start Date

13/10/2014

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. Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe

Product Type

Composite Pack

Effective date

20/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lucrin Depot Paediatric 30 mg 3-Month PDS Injection is indicated in the treatment of children with central precocious puberty (CPP).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 prefilled dual chamber syringe

(S4) Prescription Only Medicine

Components

1. Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe: diluent

Dosage Form

Diluent, not applicable

Route of Administration

Intramuscular

Visual Identification

Clear, colourless solution

2. Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe: powder for injection part

Dosage Form

Injection, modified release

Route of Administration

Intramuscular

Visual Identification

White lyophilised powder which, when reconstituted, becomes a milky

suspension

Active Ingredients

leuprorelin acetate

30 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 04:12:58 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

Lucrin

®

Depot

Paediatric

30 mg Injection

Leuprorelin acetate

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Lucrin Depot

Paediatric 30 mg Injection.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your child's doctor has

weighed the risks of your child being

given this medicine against the

benefits he/she expects it will have

for him/her.

If you have any concerns about

your child being given this

medicine, ask your child's doctor

or pharmacist.

Keep this leaflet.

You may need to read it again.

What Lucrin is used

for

Lucrin Depot Paediatric 30 mg is

used to treat central precocious

puberty, or CPP, a condition causing

children to enter puberty too soon.

This results in faster than normal

bone growth and development of

sexual characteristics in girls usually

younger than 8 years of age and in

boys usually younger than 9 years of

age.

It belongs to a group of medicines

called gonadotropin releasing

hormone agonists.

It works by decreasing the amount of

certain hormones in the body.

Ask your child's doctor or

pharmacist if you have any

questions about why it has been

prescribed for your child.

Lucrin is available only with a

doctor's prescription.

Before your child is

given Lucrin

When your child must not be

given it

Your child must not receive Lucrin

if he/she has an allergy to:

any medicine similar to Lucrin

any of the ingredients listed at

the end of this leaflet

Some symptoms of an allergic

reaction include skin rash, itching,

shortness of breath or swelling of the

face, lips or tongue, which may cause

difficulty in swallowing or breathing.

Although it is very unlikely that

your child will be pregnant or

breastfeeding, Lucrin Depot

Paediatric 30 mg should not

be given if they are. If you have

concerns or suspect that your child

might be pregnant before or

during the course of treatment, it is

important to discuss this with your

doctor.

Do not use after the expiry date

printed on the pack or if the

packaging is damaged or shows

signs of tampering.

If it has expired or is damaged return

it to your pharmacist for disposal.

Before your child is given

Lucrin

Tell your child's doctor if your

child has any allergies to any other

medicines, foods, preservatives or

dyes.

Tell your child's doctor if your

child has or has had any of the

following medical conditions:

history of convulsions, fits or

seizures

Young Children

The safety of Lucrin in children

under the age of 2 years has not been

established. Therefore, the use of

Lucrin Depot Paediatric 30 mg

Injection in children under the age of

2 years is not recommended.

If you have not told your child's

doctor about any of the above, tell

him/her before your child is given

Lucrin.

Taking other medicines

Tell your child's doctor if your

child is taking any other medicines,

including any that you buy without

a prescription from your

pharmacy, supermarket or health

food store.

Lucrin would not be expected to

interact with other commonly used

medicines. If you have any questions

LUCRIN DEPOT PAEDIATRIC 30 MG

or concerns, discuss them with your

child's doctor or pharmacist.

How Lucrin is given

How often Lucrin is given

Lucrin Depot Paediatric 30 mg

Injection is given once every three

months as a single injection into the

muscle.

The site of injection should be varied

from time to time.

How to take it

This medicine is given as an injection

into the muscle by a doctor or trained

nurse.

How long to take it

Your child should continue to

receive the medicine for as long as

his/her doctor tells him/her to.

When used in children with CPP,

Lucrin Depot Paediatric 30 mg

injection will likely be stopped by

your child's doctor around 11 years

of age in girls and 12 years of age in

boys.

Continuous therapy is important and

adherence to administration every

three months is essential for

successful treatment. If this dosing

schedule is not followed, pubertal

development may begin again.

If you forget to have your

injection

If your child has missed his/her

injection or you are not sure what to

do, check with your child's doctor or

pharmacist.

Overdose

As Lucrin Depot Paediatric 30 mg is

given to your child under the

supervision of a doctor, it is very

unlikely that he/she will receive too

much. However, if your child

experiences any side effects after

being given this medicine, telephone

your child's doctor, or the National

Poisons Information Centre

(telephone Australia 13 11 26), or go

to Accident and Emergency at your

nearest hospital.

There have not been any unexpected

side effects seen with the high doses

of Lucrin in adults.

While your child is

being given Lucrin

Things you must do

When Lucrin Depot Paediatric 30 mg

is first started, there may be a

temporary increase in some

hormones in the first few weeks after

the injection. Your child's doctor will

monitor your child carefully for any

new or worsening symptoms during

this time.

This increase in symptoms usually

only happen with the first treatment

with this medicine; your child should

not experience them with future

treatments.

If your child is about to be started

on any new medicine, remind your

child's doctor and pharmacist that

he/she is receiving Lucrin Depot

Paediatric 30 mg.

Tell any other doctors, dentists and

pharmacists who treat your child

that he/she is receiving Lucrin

Depot Paediatric 30 mg.

If your child is going to have

surgery, tell the surgeon that he/

she is receiving Lucrin Depot

Paediatric 30 mg.

If your child is about to have any

blood tests, tell your child's doctor

that he/she is receiving Lucrin

Depot Paediatric 30 mg.

Lucrin Depot Paediatric 30 mg may

interfere with the results of some

tests.

Ensure that routine appointments

are made with a paediatric

endocrinologist to manage their

progress, and keep all of your

child's doctor's appointments so

that your child's progress can be

checked and monitored regularly.

Lucrin Depot Paediatric 30 mg

would have been prescribed to your

child after an initial assessment made

by a paediatric endocrinologist. It is

important that your child continues to

have routine visits to this specialist

so that your child's progress can be

regularly monitored.

If your child does not feel well or

his/her condition worsens, tell your

child's doctor immediately.

Things you must not do

Do not give Lucrin Depot

Paediatric 30 mg to treat any other

medical complaints unless your

doctor or pharmacist advises you

to.

Do not give Lucrin Depot

Paediatric 30 mg to anyone else,

even if they have the same

condition as your child.

Do not let your child miss a

scheduled Lucrin Depot Paediatric

30 mg injection unless your child's

doctor or pharmacist advises you

to.

Things to be careful of

If your child feels light-headed,

dizzy or faint when getting out of

bed or standing up, instruct him/

her to get up slowly.

Standing up slowly, especially when

your child gets up from bed or chairs,

will help his/her body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your child's

doctor.

Side effects

Tell your child's doctor or

pharmacist as soon as possible if

your child does not feel well while

he/she is taking Lucrin Depot

Paediatric 30 mg.

In children receiving Lucrin Depot

Paediatric 30 mg for central

LUCRIN DEPOT PAEDIATRIC 30 MG

precocious puberty, new or

worsening symptoms of sexual

development may occur during the

first few weeks of treatment.

In girls receiving Lucrin Depot

Paediatric 30 mg injection for central

precocious puberty, the onset of

menstruation or spotting (light

vaginal bleeding) may occur in the

first few months of treatment. If

bleeding continues, contact your

child's doctor.

All medicines have some unwanted

side effects. Sometimes they are

serious, but most of the time they are

not. Your child may need medical

attention if he/she gets some of the

side-effects.

Do not be alarmed by this list of

possible side effects. Your child

may not experience any of them.

Ask your child's doctor or

pharmacist to answer any

questions you may have relating to

potential side effects.

Tell your child's doctor or

pharmacist if you or your child

notice any of the following and

they worry you:

pain, swelling, redness, or wound

at the injection site

general pain

hot flushes

dizziness or light-headedness

skin problems such as rash,

itching, hives, dry skin or acne

vaginitis, vaginal bleeding or

discharge

sweating

headache

increased weight

altered or unstable mood

tearfulness or crying

The above list includes the more

common side effects of your child's

medicine. They are usually mild and

short-lived.

Tell your child's doctor as soon as

possible if you or your child notice

any of the following:

swelling in limbs

problems with your eye sight

difficulty breathing

numbness or tingling of hands or

feet

blood in the urine

changes in breast size

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

If any of the following happen, tell

your child's doctor immediately or

go to Accident and Emergency at

your nearest hospital:

swelling of the face, lips, mouth,

throat or neck which may cause

difficulty in swallowing or

breathing or sudden collapse

unsteadiness when walking

The above list includes very serious

side effects. Your child may need

urgent medical attention. These side

effects are rare.

Tell your child's doctor or

pharmacist if you or your child

notice anything else that is making

your child feel unwell.

Other side effects not listed above

may occur in some people.

Storage

Lucrin Depot Paediatric 30 mg

Injection should be kept in a cool,

dry place where the temperature

stays below 25°C, and should be

protected from light.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a windowsill. Do not

leave it in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor advises that your

child should stop taking Lucrin

Depot Paediatric 30 mg, or the

medicine has passed its expiry

date, ask your pharmacist what

you should do with any medicine

that is left over.

Product description

What it looks like

PREFILLED DUAL-

CHAMBER SYRINGES

Description:

Lucrin Depot Paediatric 30 mg

Injection is a dual-chamber syringe

containing active ingredient (white

powder) in the front chamber and

diluent (colourless solution) in the

rear chamber.

Ingredients

Lucrin Depot Paediatric 30 mg

Injection contains 30mg leuprorelin

acetate as the active ingredient.

It also contains polylactic acid and

mannitol.

The diluent contains carmellose

sodium, mannitol, polysorbate 80,

water for injections, and glacial

acetic acid.

Supplier

Lucrin is supplied in Australia by:

AbbVie Pty Ltd

241 O'Riordan Street

Mascot NSW 2020

1800 043 460

ABN: 48 156 384 262

This leaflet was prepared in

7 January 2015.

Australian Registration Number(s)

Lucrin Depot Paediatric 30 mg 3-

Month Injection:

LUCRIN DEPOT PAEDIATRIC 30 MG

AUST R 218936

Version 2

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