DBL Remifentanil powder for injection (remifentanil hydrochloride) 5 mg/vial

Main information

  • Trade name:
  • DBL Remifentanil powder for injection (remifentanil hydrochloride) 5 mg/vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DBL Remifentanil powder for injection (remifentanil hydrochloride) 5 mg/vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195555
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195555

DBL Remifentanil powder for injection (remifentanil hydrochloride) 5 mg/vial

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

Level 17 151 Clarence Street,Sydney, NSW, 2000

Australia

ARTG Start Date

12/02/2013

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. DBL Remifentanil powder for injection (remifentanil hydrochloride) 5 mg/vial

Product Type

Single Medicine Product

Effective date

1/11/2017

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

DBL™ Remifentanil powder for injection is indicated - ,· as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during

surgical procedures including cardiac surgery in adults; ,· as an opioid adjunct for use during induction and/or maintenance of general anaesthesia

during surgical but not cardiac procedures in children aged 1 to 12 years;,· for continuation as an analgesic into the immediate post-operative period

under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following

adult cardiac surgery - ,when endotracheal intubation and controlled ventilation are anticipated. ,· for provision of analgesia and sedation in

mechanically ventilated intensive care patients.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Reconstituted Solution

see label for shelf life

Pack Size/Poison information

Pack Size

Poison Schedule

5 vials per pack

(S8) Controlled Drug

Components

1. DBL Remifentanil powder for injection (remifentanil hydrochloride) 5 mg/vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

White to slightly yellow cake or powdery mass in a clear glass vial with a

bromobutyl rubber closure and aluminium seal with flip top cap.

Active Ingredients

remifentanil hydrochloride

5.5 mg

Public Summary

Page 1 of

Produced at 21.05.2019 at 11:07:33 AEST

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

© 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 2 of

Produced at 21.05.2019 at 11:07:33 AEST

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

DBL™ REMIFENTANIL POWDER FOR INJECTION

DBL™

Remifentanil powder for injection

Remifentanil hydrochloride

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some

common questions about

DBL™ Remifentanil powder for

injection. 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 being

given DBL™ Remifentanil

powder for injection against the

benefits this medicine is

expected to have for you.

If you have any concerns about

being given this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What DBL™

Remifentanil powder

for injection is used for

DBL™ Remifentanil powder for

injection is an anaesthetic used

with other anaesthetic

medicines, to produce and/or

maintain heavy sleep during your

operation. If you are a cardiac

patient, it may also be used to help

relieve any pain immediately

following your operation.

DBL™ Remifentanil powder for

injection may also be used for

patients in the Intensive Care Unit

to maintain sedation and relieve

pain.

DBL™ Remifentanil powder for

injection belongs to a group of

medicines called opioids. It

differs from other medicines in this

group by its very quick onset and

very short duration of action.

Your doctor may have prescribed

DBL™ Remifentanil powder for

injection for another reason.

Ask your doctor if you have any

questions about why DBL™

Remifentanil powder for injection

has been prescribed for you.

As with other opioids, DBL™

Remifentanil powder for injection

can be addictive. This is unlikely

to happen when DBL™

Remifentanil powder for injection

is only used during your

operation.

Before you are given

DBL™ Remifentanil

powder for injection

When you must not receive

DBL™ Remifentanil powder for

injection

You must not receive DBL™

Remifentanil powder for injection

if you have ever had an allergic

reaction to remifentanil

hydrochloride or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may be mild or severe. They

usually include some or all of the

following:

Wheezing, swelling of the

lips/mouth, difficulty in breathing,

hayfever, lumpy rash ("hives") or

fainting.

Before you receive DBL™

Remifentanil powder for injection,

you must tell your doctor if:

You have had any adverse

reactions during an operation.

You have had any type of

allergic reaction to opioid

medicines (e.g., morphine,

fentanyl, pethidine, codeine),

or to any medicines used

during an operation.

You probably have an increased

chance of being allergic to DBL™

Remifentanil powder for injection

if you are allergic to other

opioids.

You are allergic to any other

medicines or any other

substance, such as foods,

dyes or preservatives.

You have or have ever had

any of the following medical

conditions:

- slow heart beat

- low blood pressure

- chest or breathing

problems.

You are pregnant, intend to

become pregnant, are

breast feeding or plan to

breast feed.

Like most medicines, DBL™

Remifentanil powder for injection

is not recommended in

pregnancy and breast-feeding.

However, your doctor will discuss

the possible risks and benefits of

being given DBL™ Remifentanil

powder for injection if you are

pregnant or breast-feeding.

If you have not told your doctor

about any of the above, tell them

before you are given DBL™

Remifentanil powder for

injection.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including medicines you buy

without a prescription from a

pharmacy, supermarket or

health food shop.

Tell your doctor if you have

recently been taking medicines

for blood pressure or heart

problems (known as beta-

blockers or

calcium channel blockers).

Some medicines, such as

benzodiazepines, may interfere

with DBL™ Remifentanil

DBL™ REMIFENTANIL POWDER FOR INJECTION

powder for injection. Your

doctor or pharmacist will be

able to tell you what to do when

being given DBL™ Remifentanil

powder for injection with other

medicines.

How DBL™

Remifentanil powder

for injection is given

DBL™ Remifentanil powder for

injection can be given into a vein in

two ways:

As a slow injection, or

As a slow infusion.

DBL™ Remifentanil powder for

injection will be administered by

an anaesthetist or other highly

trained doctor. You will never be

expected to give yourself this

medication. The dosage will vary

according to many factors such as

your body weight and the type of

operation you have.

While you are using

DBL™ Remifentanil

powder for injection

Things to be careful of

If you are discharged early,

following treatment with DBL™

Remifentanil powder for injection

or any other anaesthetic agents,

do not drive or operate

machinery.

Side-Effects

Check with your doctor as soon

possible

have

problems after receiving DBL™

Remifentanil powder for injection,

even

think

problems are connected with the

medicine or are not listed in this

leaflet.

Like

other

medicines,

DBL™

Remifentanil powder for injection

can cause some side-effects.

most

commonly

reported

side-effects are:

slow breathing

breathlessness

slow heart beat

drop in blood pressure

Increased blood pressure

which may cause a headache

or sensation of

warmth/flushing.

muscle stiffness

shivering

nausea

vomiting

aches

Ask your doctor or pharmacist

to answer any questions you

may have.

This is not a complete list of all

possible side-effects. Others

may occur in some people and

there may be some side-effects

not yet known.

Tell your doctor if you notice

anything else that is making

you feel unwell, even if it is not

on this list.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

Do not be alarmed by this list of

possible

side-effects.

not experience any of them.

Product description

What DBL™ Remifentanil

powder for injection looks

like

DBL™ Remifentanil powder for

injection is supplied as 1mg,

2mg or 5mg of white to off-white

powder in a clear, glass vial.

Ingredients

DBL™ Remifentanil powder for

injection

contains

active

ingredient

remifentanil

hydrochloride) 1mg, 2mg or 5mg

vial.

Other

ingredients

glycine

Hydrochloric

acid

Sodium

Hydroxide.

powder is dissolved in a suitable

sterile liquid before use.

DBL™ Remifentanil powder for

injection does not contain gluten

or lactose.

Storage

Unopened DBL™ Remifentanil

powder for injection vials are

stored below 25°C. The 1mg

presentation is protected from

light.

Manufacturer

Your DBL™ Remifentanil

powder for injection is

supplied by:

Hospira Pty Ltd

ABN 13 107 058 328

Level 3, 500 Collins St

Melbourne Victoria 3000

Further Information

Your doctor or pharmacist is the

best person to give you advice on

the treatment of your condition.

Do not throw this leaflet away.

You may need to read it again.

This leaflet was prepared on

February 2012.

The information provided

applies only to: DBL™

Remifentanil powder for

injection.

DBL™ Remifentanil powder for

injection 1 mg: AUST R 195553

DBL™ Remifentanil powder for

injection 2 mg: AUST R 195554

DBL™ Remifentanil powder for

injection 5 mg: AUST R 195555