CIPLA

Main information

  • Trade name:
  • CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220440
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220440

CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

19/03/2015

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. CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial

Product Type

Single Medicine Product

Effective date

3/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: Squamous cell carcinoma of the skin, head and neck, and

oesophagus (primary indication). Squamous cell carcinoma of the larynx, penis and uterine cervix. Squamous cell carcinoma of the bronchus (response

infrequent). Choriocarcinoma and embryonal cell carcinoma of the testis. Advanced Hodgkin's disease and other lymphomas.

Mycosis fungoides

Note. Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used

when other cytotoxic agents are contraindicated.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

10X15000 IU vials

(S4) Prescription Only Medicine

1x15000 IU VIAL

(S4) Prescription Only Medicine

Components

1. CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intraarterial

Intramuscular

Subcutaneous

Intravenous

Visual Identification

A sterile freeze dried powder for reconstitution. White to off white crystalline

powder, very hygroscopic.Clear, colourless solution on reconstitution

Active Ingredients

bleomycin sulfate

15000 IU

© 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 02:24:09 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

CIPLA BLEOMYCIN 15K – Consumer Medicine Information

CIPLA BLEOMYCIN 15K for Injection

CIPLA BLEOMYCIN 15K

Bleomycin Sulfate powder for Injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common questions about

CIPLA BLEOMYCIN 15K for

Injection. It does not contain all

the available information.

It does not take the place of

talking to your doctor and

pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you taking

CIPLA BLEOMYCIN 15K for

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 CIPLA

BLEOMYCIN 15K for

Injection is used for

CIPLA BLEOMYCIN 15K

belongs to a group of

medicines known as

antineoplastic or cytotoxic

agents. You may hear it

referred to as chemotherapy

medicine.

CIPLA BLEOMYCIN 15K is

classified as an antitumour

antibiotic. It interferes with the

growth of cancer cells, which

are eventually destroyed.

Your doctor may have

prescribed CIPLA BLEOMYCIN

15K for another reason.

Ask your doctor if you have

any questions about why

CIPLA BLEOMYCIN 15K has

been prescribed for you.

This medicine is available only

with a doctor’s prescription.

CIPLA BLEOMYCIN 15K is not

recommended for use in

children, as there have not

been enough studies of its

effects in children.

Before you are given

CIPLA BLEOMYCIN

15K

When you must not be given

it

You must not be given CIPLA

BLEOMYCIN 15K for Injection

if you are allergic to any of

the ingredients listed at the

end of this leaflet.

Symptoms of an allergic

reaction to CIPLA

BLEOMYCIN 15K 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

You should not be given

CIPLA BLEOMYCIN 15K if

you have any of the following

conditions:

low white blood cell (WBC)

count

problems with blood clotting

severe lung problems, a

lung infection or reduced

lung function.

Tell your doctor if you have

an infection or high

temperature.

Your doctor may decide to

delay your treatment until the

infection has gone. A mild

illness, such as a cold, is not

usually a reason to delay

treatment.

If you are not sure whether you

should start treatment with

CIPLA BLEOMYCIN 15K, talk

to your doctor.

Before you are given it

Tell your doctor or

pharmacist if you have

allergies to:

any other medicines

any other substances, such

as foods, preservatives or

dyes.

Tell your doctor or

pharmacist if you are

pregnant or intend to become

pregnant.

Your doctor or pharmacist will

discuss the possible risks and

benefits of treatment with

CIPLA BLEOMYCIN 15K

during pregnancy.

CIPLA BLEOMYCIN 15K – Consumer Medicine Information

CIPLA BLEOMYCIN 15K for Injection

CIPLA BLEOMYCIN 15K may

cause birth defects of either the

male or the female is receiving

it at the time of conception or if

it is used during pregnancy.

You should use some form of

birth control while you are

receiving CIPLA BLEOMYCIN

15K and for at least 12 weeks

after stopping. Your doctor will

discuss this with you.

Tell your doctor if you are

breastfeeding or plan to

breast-feed.

Like most antineoplastic

medicines, CIPLA BLEOMYCIN

15K is not recommended while

you are breastfeeding.

Tell your doctor or

pharmacist if you have had

any medical conditions,

especially the following:

kidney disease

liver disease

lung disease.

Tell your doctor if you

smoke. There is a greater

chance of CIPLA

BLEOMYCIN 15K affecting

your lungs if you smoke.

Tell your doctor if you have

had radiation therapy for

cancer. There is a greater

chance of CIPLA BLEOMYCIN

15K affecting your lungs if you

have had radiation therapy,

especially to the chest.

If you have been told by your

doctor or pharmacist about

any of the above, tell them

before you start treatment

with CIPLA BLEOMYCIN 15K.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including medicines that you

buy without a prescription

from your pharmacy,

supermarket or health food

shop.

Some medicines may interfere

with CIPLA BLEOMYCIN 15K.

These include:-

digoxin, a medicine used to

treat heart failure

phenytoin, a medicine used

to treat epilepsy, fits and

seizures

cisplatin, a medicine used

to treat some types of

cancer

oxygen therapy, which may

be given to you during

surgery,

other medicines used to

treat cancer, radiation

therapy or any other

treatment which lowers your

immune system

any medicine which

suppresses your immune

immune system eg

azathioprine

general anaesthetics

granulocyte colony

stimulating factor ( such as

filgrastim and lenograstim).

These medicines may be

affected by CIPLA

BLEOMYCIN 15K, or may

affect how well it works. You

may need to take different

amounts of your medicine, or

you may need to take different

medicines. Some of these

medicines and CIPLA

BLEOMYCIN 15K may interfere

with each other even if they are

not given at the same time.

Your doctor or pharmacist will

advise you.

Do not have any vaccinations

(immunisations) without your

doctor’s approval while you

are being treated with CIPLA

BLEOMYCIN 15K, and for

about one month after you

stop treatment with it.

CIPLA BLEOMYCIN 15K may

lower your body’s resistance

to infection and there is a

chance that you may get the

infection the immunisation is

meant to prevent. In addition,

other people close to you

(such as other persons living

in your household), should

not take oral polio vaccine

(sabin) since there is a

chance they could pass the

polio virus on to you.

Your doctor and pharmacist

may have more information of

medicines to be careful with or

avoid while you are being given

the CIPLA BLEOMYCIN 15K.

How CIPLA

BLEOMYCIN 15K is

given

How much is given

Your doctor will decide what

dose of CIPLA BLEOMYCIN

15K you will receive. This

depends on your condition and

other factors, such as your

weight and height, kidney

function and other

chemotherapy medicines you

are being given.

CIPLA BLEOMYCIN 15K may

be given alone or in

combination with other drugs.

Several courses of CIPLA

BLEOMYCIN 15K therapy may

be needed, depending on your

response to treatment.

Additional treatment may not be

repeated until your blood cell

numbers return to acceptable

levels and any unwanted side

effects have been controlled.

CIPLA BLEOMYCIN 15K – Consumer Medicine Information

CIPLA BLEOMYCIN 15K for Injection

Ask your doctor if you want to

know more about the dose of

CIPLA BLEOMYCIN 15K you

receive.

How it is given

CIPLA BLEOMYCIN 15K

should only be given by a

doctor or nurse.

CIPLA BLEOMYCIN 15K can

be given in a number of

different ways: -

an injection under the skin

an injection into a muscle

an injection into a vain

an injection into an artery

The first time you are given

CIPLA BLEOMYCIN 15K, you

will normally receive a small

test dose to check that you are

not allergic to CIPLA

BLEOMYCIN 15K. If no

reaction occurs, the full dose

will be given.

How long it is given

A course of CIPLA

BLEOMYCIN 15K may consist

of a dose once or twice weekly,

or it may be given as a daily

dose for 7 consecutive days.

This is called one cycle of

chemotherapy. Your doctor will

decide how many of these

cycles you will need.

Overdose

As CIPLA BLEOMYCIN 15K

will be given to you under the

supervision of your doctor, it

is very unlikely that you will

receive too much.

However, if you experience

severe side effects tell your

doctor immediately or go to

the Accident and Emergency

department of your nearest

hospital.

You may need urgent medical

attention.

Symptoms of a CIPLA

BLEOMYCIN 15K overdose

include the side effects listed

below in the ‘ Side Effects’

section, but are usually of a

more sever nature.

While you are using

CIPLA BLEOMYCIN

15K for Injection

Tell your doctor, nurse or

pharmacist if you have any

concerns before, during or after

administration or CIPLA

BLEOMYCIN 15K.

Things you must do

Be sure to keep all your

doctor’s appointments so

your progress can be

checked.

Your doctor may want to do

some blood and other tests

form time to time to check on

your progress and detect any

unwanted side effects.

Keep follow up appointments

with your doctor.

It is important to have your

follow-up doses of CIPLA

BLEOMYCIN 15K at the

appropriate times to get the

best effects from your

treatments.

Tell any other doctors, dentists,

and pharmacists who are

treating you that you are being

given CIPLA BLEOMYCIN 15K.

If you are about to be started

on any new medicine, tell your

doctor, dentist or pharmacist

that you are being given CIPLA

BLEOMYCIN 15K.

If you plan to have surgery that

needs a general anaesthetic,

tell your doctor or dentist that

you are being given CIPLA

BLEOMYCIN 15K.

If you become pregnant while

you are being treated with

CIPLA BLEOMYCIN 15K, tell

your doctor immediately.

CIPLA BLEOMYCIN 15K can

lower the number of white

blood cells and platelets in your

blood. This means that you

have an increased chance of

getting an infection or bleeding.

The following precautions

should be taken to reduce your

risk of infection or bleeding:

Avoid people with

infections. Check with your

doctor immediately if you

think you may be getting an

infection, or if you get a

fever, chills, cough, hoarse

throat, lower back or side

pain, or find it painful or

difficult to urinate;

Be careful when using a

toothbrush, dental floss or

toothpick. Your doctor,

dentist, nurse or pharmacist

may recommend other

ways to clean your teeth

and gums. Check with your

doctor before having any

dental work done;

Be careful not to cut

yourself when you are using

sharp objects such as a

razor or nail cutter.

Avoid contact sports or

other situations where

bruising or injury may occur.

While you are being given

CIPLA BLEOMYCIN 15K

Your doctor should order

regularly tests to check the

number of blood cells in your

blood. The results of these

tests will be used to determine

the amount of CIPLA

BLEOMYCIN 15K you will be

given for your next dose.

While you are being given

CIPLA BLEOMYCIN 15K your

CIPLA BLEOMYCIN 15K – Consumer Medicine Information

CIPLA BLEOMYCIN 15K for Injection

doctor should order regular

tests to check how well your

kidneys are working.

Your doctors should also order

periodic tests to estimate how

well your liver is working during

treatment with CIPLA

BLEOMYCIN 15K.

CIPLA BLEOMYCIN 15K is

known to affect the way the

lungs work in some patients.

This may be serious, therefore

your doctor should arrange

frequent tests to check how

well your lungs are working.

Your doctor may also arrange

weekly chest X-rays while you

are being treated with CIPLA

BLEOMYCIN 15K. These

should continue for up to 4

weeks after completion of

treatment with CIPLA

BLEOMYCIN 15K.

CIPLA BLEOMYCIN 15K and

its breakdown products may be

excreted in body fluids and

waste, including blood, urine,

faeces, vomitus and semen.

In general, precautions to

protect other people should be

taken while you are receiving

chemotherapy and for one

week after the treatment period.

Flush the toilet twice to

dispose of any body fluids

and waste.

Wear gloves to clean any

spill of body fluid or waste.

Use paper towels or old

rags, a strong solution of

non-bleaching detergent

and large amounts of water

to mop up the spills.

Discard the towels or rags

into a separate waste bag

and dispose of fluids in the

toilet.

Wash linen or clothing that

is heavily contaminated

body fluids or waste

separately from other items.

Use a strong solution of

non-bleaching detergent

and large amounts of water.

Place soiled disposable

nappies and other pads in a

plastic bag; seal and

dispose into the garbage.

For sexual intercourse, use

a barrier method such as a

condom.

Things to be careful of

Be careful driving or

operating machinery until

you know how CIPLA

BLEOMYCIN 15K affects you.

As with some other medicines,

CIPLA BLEOMYCIN 15K may

cause dizziness, light-

headedness and tiredness in

some people. Make sure you

know how you react to CIPLA

BLEOMYCIN 15K before you

drive a car, operate machinery,

or do anything else that could

be dangerous if you are dizzy

or light headed. If this occurs

do not drive. If you drink

alcohol, dizziness or light-

headedness may be worse.

Side effects

Tell your doctor, pharmacist

or nurse as soon as possible

if you do not feel well while

you are being give CIPLA

BLEOMYCIN 15K.

Like other medicines that treat

cancer, CIPLA BLEOMYCIN

15K may have unwanted side

effects, some of which may be

serious. You may need medical

treatment if you get some of

these side effects.

If you are over 65 years of age

you may have an increased

chance of getting side effects.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor or nurse if

you notice any of the

following and they worry you:

Nausea, vomiting or loss of

appetite

Tiredness or weakness

Headaches

Pain and inflammation at

the injection site

Rash and other skin

conditions such as

itchiness, tenderness,

altered pain sensation and

altered skin colour

Conjunctivitis

(infection/inflammation of

the eye)

Soreness or ulceration of

the mouth.

These are more common side

effects of CIPLA BLEOMYCIN

15K.

Tell your doctor or nurse

immediately, or go to the

Accident and Emergency

department of your nearest

hospital if you notice any of

the following:

Cough and shortness of

breath

Fever and chills

Signs of allergic reactions

such as those listed at the

start of this leaflet

Disorientation or personality

changes

Severe nausea and

vomiting

Severe abdominal pain

Chest pain

Severe headache

Severe mouth ulceration

and/or anal ulceration

Unusual bleeding or

bruising (including blood in

your stools or urine)

CIPLA BLEOMYCIN 15K – Consumer Medicine Information

CIPLA BLEOMYCIN 15K for Injection

Painful or difficult urination

Blurred vision or eye pain

Yellowing of the skin or

eyes

Fits (seizures)

These are very serious side

effects. You may need urgent

medical attention or

hospitalisation.

Temporary loss of hair,

particularly that o the scalp is a

less common side effect of

CIPLA BLEOMYCIN 15K

occurs in a small number of

patients. The severity of hair

loss will depend on the dose of

CIPLA BLEOMYCIN 15K given.

It is more common when other

anti-cancer medicines are used

together with CIPLA

BLEOMYCIN 15K.

Other side effects not listed

above may occur in some

patients. Tell your doctor or

pharmacist if you feel unwell.

Do not be alarmed by this list of

possible side effects

You may not experience any of

them.

The effects of CIPLA

BLEOMYCIN 15K may take

some time to occur and

therefore the side effects may

be delayed. It is possible that

the unwanted side effects may

not occur until months after

CIPLA BLEOMYCIN 15K is

given.

Therefore, even after you have

finished receiving your

treatment you should tell your

doctor immediately if you notice

any of the side effects listed

above.

_______________________

After you have been

given CIPLA

BLEOMYCIN 15K for

Injection

________________________

Storage

CIPLA BLEOMYCIN 15K for

Injection will be stored in the

pharmacy or on the ward. The

injection is kept in a cool dry

place, protected from light,

where the temperature stays at

between 2 - 8ºC. (Refrigerate.

Do not freeze).

Product description

What it looks like

CIPLA BLEOMYCIN 15K for

Injection is sterile freeze-dried

white to off white powder. It

must be dissolved in Water for

Injections, 0.9% Sodium

Chloride solution or

Bacteriostatic water for

Injection before use.

Ingredients

Active ingredients:

Bleomycin Sulfate 15,000IU

(15 units USP) per vial

There are no other ingredients.

CIPLA BLEOMYCIN 15K glass

vials are available in packs

sizes of 1’s and 10’s.

CIPLA BLEOMYCIN 15K for

Injection does not contain

lactose, sucrose, gluten,

tartrazine or any other azo

dyes.

Sponsor

Cipla Australia Pty Ltd

Level 1, 132 – 136 Albert Rd,

South Melbourne VIC 3205

AUST R 220440

Date of preparation of this

leaflet January 2016

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