OXYTOCIN

Main information

  • Trade name:
  • OXYTOCIN GH Solution for Injection 10 IU/1 mL ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OXYTOCIN GH Solution for Injection 10 IU/1 mL ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207986
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207986

OXYTOCIN GH Solution for Injection 10 IU/1 mL ampoule

ARTG entry for

Medicine Registered

Sponsor

Horizon Hospital Healthcare Pty Ltd

Postal Address

PO Box 175,CARNEGIE, VIC, 3163

Australia

ARTG Start Date

3/12/2013

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. OXYTOCIN GH Solution for Injection 10 IU/1 mL ampoule

Product Type

Single Medicine Product

Effective date

4/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

3 Years

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Protect from Light

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules

(S4) Prescription Only Medicine

1 ampoule

(S4) Prescription Only Medicine

10 ampoules

(S4) Prescription Only Medicine

Components

1. OXYTOCIN GH Solution for Injection 10 IU/1 mL ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear, colourless solution

Active Ingredients

Oxytocin

10 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 27.11.2017 at 11:41:26 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

CONSUMER MEDICINE INFORMATION

Oxytocin GH Injection

Synthetic oxytocin 5IU/1 mL & 10 IU/1mL

Oxytocin GH Injection CMI v3.0 May 2015

What is in this leaflet

This leaflet answers some

common questions about

Oxytocin GH Injection.

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 listed on

the final page. Some more recent

information on the medicine may

be available.

You should ensure that you

speak to your pharmacist or

doctor to obtain the most up to

date information on the

medicine.

Those updates may contain

important information about the

medicine and its use of which

you should be aware.

All medicines have risks and

benefits. Your doctor has

weighed the risks of your

treatment using Oxytocin GH

Injection against the benefits they

expect it will have for you.

If you have any concerns

about taking this medicine, ask

your doctor or pharmacist.

Keep this leaflet with the

medicine.

You may need to read it again.

What Oxytocin GH Injection is

used for

Oxytocin GH Injection can be

used to bring on (induce) labour.

It can also be used during and

immediately after delivery to help

the birth and to prevent or treat

excessive bleeding.

Oxytocin GH Injection is a man-

made chemical that is identical to

a natural hormone called

oxytocin. It works by stimulating

the muscles of the uterus (womb)

to produce rhythmic contractions.

Oxytocin GH Injection is not

suitable in all situations - for

example, if the baby or placenta

are in the wrong position or if you

have had a previous Caesarian

section or other surgery involving

the uterus. Your doctor can give

you more information on the

suitability of Oxytocin GH

Injection in your particular case.

Ask your doctor if you have

any questions about why

Oxytocin GH Injection has

been prescribed for you.

Your doctor may have prescribed

it for another purpose.

Oxytocin GH Injection is only

available with a doctor's

prescription. It is not addictive.

Before Oxytocin GH Injection

is Given

When Oxytocin GH Injection

should not be used

You must not have Oxytocin

GH Injection if:

your doctor thinks that

inducing or enhancing

contractions for normal

labour and vaginal delivery

would be unsuitable for you

or your baby

there are maternal or foetal

reasons for caesarean

delivery

you have been given

medicines call prostaglandins

within the past 6 hours

You must not have Oxytocin

GH Injection if you are allergic

to:

oxytocin (the active

ingredient)

any of the other ingredients

listed at the end of this

leaflet.

Symptoms of an allergic reaction

may include:

shortness of breath

wheezing or difficulty

breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

Oxytocin GH Injection CMI v3.0 May 2015

Before you are given it

Tell your doctor if you have

high blood pressure or any

heart or kidney problems.

Your doctor may want to take

extra precautions. For example,

the amount of fluid you will be

given may need to be reduced if

you have a problem with your

heart or kidneys.

Tell your doctor if you are

allergic to any other

medicines, foods, dyes or

preservatives.

Your doctor will want to know if

you are prone to allergies.

Tell your doctor if you have, or

have ever had, any of the

following problems:

an abnormal electrical signal

called "prolongation of the

QT interval"

any other conditions that

affect the heart

kidney problems

Tell your doctor if you are

taking any medicines that may

affect your heart, or any other

medicines, including

medicines that you buy

without a prescription from a

pharmacy, supermarket or

health food shop.

Tell your doctor if you have

been given anaesthetics or

medicines called

prostaglandins.

If you have not told your

doctor about any of these

things, tell him/her before you

have Oxytocin GH Injection.

How Oxytocin GH Injection is

given

To bring on (induce) or maintain

labour, Oxytocin GH Injection is

given by intravenous infusion

(drip). The speed of the infusion

is set to maintain a pattern of

contractions similar to normal

labour. During the infusion, both

you and your baby will be closely

monitored to prevent

complications.

If Oxytocin GH Injection is

needed at delivery or to prevent

excessive bleeding, it can also

be given intramuscularly (into a

muscle) or by slow intravenous

injection directly into a vein.

Side effects

Tell your doctor or nurse as

soon as possible if you do not

feel well while you are having

Oxytocin GH Injection.

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.

Tell your doctor or nurse

immediately if you notice any

of the following symptoms:

rash, itching or hives on the

skin;

swelling of the face, lips,

tongue or other parts of the

body;

shortness of breath,

wheezing or troubled

breathing;

headache;

nausea (feeling sick) or

vomiting;

feeling drowsy and lethargic;

pain in the abdomen that is

different from labour pains;

dizziness, light headedness

or faintness;

flushing of the face;

chest pain;

fast, slow or irregular heart

beat;

excessive or continuous

contractions;

abnormal clotting or bleeding

The above symptoms may be

signs of allergy or signs of too

much fluid associated with high

doses or long infusions.

Tell your doctor if you notice

anything else that is making

you feel unwell.

Other side effects not listed

above may happen in some

people.

After using Oxytocin GH

Injection

Storage

Store unopened Oxytocin GH

Injection ampoules in a

refrigerator, where the

temperature stays between 2 -

8°C. Protect from light and do

not freeze.

The unopened product may be

stored for up to one month at or

below 25°C. Once removed from

the refrigerator the product must

be discarded if not used, it must

not be returned to the

refrigerator.

Oxytocin GH Injection will be

kept in a locked cupboard in the

hospital pharmacy or operating

theatre.

Oxytocin GH Injection should not

be used after the date (month

and year) printed after "EXP".

The anaesthetist will inspect

Oxytocin GH Injection before use

to determine that it is still within

its use by date.

Oxytocin GH Injection CMI v3.0 May 2015

Disposal

The hospital staff looking after

you will dispose of any remaining

Oxytocin GH Injection

appropriately.

Product Description

What it looks like

Oxytocin GH Injection is a clear,

colourless solution.

Oxytocin GH Injection is

available 1 mL glass ampoules

containing either 8.3 microgram

(5 IU) or 16.7 mg (10 IU) of

oxytocin.

A carton of Oxytocin GH Injection

contains 1, 5 or 10 ampoules.

Not all pack sizes may be

marketed.

Ingredients

Active ingredient:

oxytocin

Other ingredients:

glacial acetic acid

sodium acetate

sodium chloride

water for injections

Sponsor:

Horizon Hospital Healthcare Pty

PO Box 175

Carnegie, Victoria 3163

AUSTRALIA

Distributor:

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australian Registration Numbers:

5 IU/1 mL AUST R 207985

10 IU/1 mL AUST R 207986