Gemcitabine

Main information

  • Trade name:
  • Gemcitabine Kabi gemcitabine (as hydrochloride) 2000 mg/52.6 mL concentrated solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Gemcitabine Kabi gemcitabine (as hydrochloride) 2000 mg/52.6 mL concentrated solution for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220682
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220682

Gemcitabine Kabi gemcitabine (as hydrochloride) 2000 mg/52.6 mL concentrated solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

21/10/2014

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. Gemcitabine Kabi gemcitabine (as hydrochloride) 2000 mg/52.6 mL concentrated solution for injection vial

Product Type

Single Medicine Product

Effective date

6/07/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Gemcitabine Kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. Gemcitabine Kabi is indicated for

treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory

pancreatic cancer. Gemcitabine Kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. Gemcitabine Kabi,

in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have

relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

Gemcitabine Kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed

> 6 months following platinum-based therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

2000 mg/52.6 mL - 1's

(S4) Prescription Only Medicine

Components

1. Gemcitabine Kabi gemcitabine (as hydrochloride) 2000 mg/52.6 mL concentrated solution for injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

A clear, colourless to slightly yellow solution

Active Ingredients

Gemcitabine hydrochloride

2277.2 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 02:15:04 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

CMI for Gemcitabine Kabi

May, 2013

Page 1 of 4

Gemcitabine Kabi

Gemcitabine hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Gemcitabine Kabi

Injection. It does not contain all the

available information. It does not

take the place of talking to your

doctor.

medicines

have

benefits

risks. Your doctor has weighed the

risks

using

Gemcitabine

Kabi

against the benefits it is expected

to have for you.

If you have any concerns about

taking

this

medicine,

ask

your

doctor

or

health

care

professional.

Keep this leaflet. You may need to

read it again.

What Gemcitabine Kabi

is used for

Gemcitabine Kabi is used to treat

patients with:

lung cancer

cancer of the pancreas

bladder cancer

breast cancer

ovarian cancer

Gemcitabine

Kabi

belongs

group of anticancer drugs known

antineoplastic

cytotoxic

medicines.

works

killing

cancer cells and preventing cancer

cells from growing and multiplying,

and is used for different types of

cancer. The active ingredient in

Gemcitabine

Kabi

gemcitabine

hydrochloride.

Your doctor will be able to tell you

about

specific

condition

which

have been

prescribed

Gemcitabine Kabi. Ask your doctor

or health care professional if you

have

questions

been

prescribed

you.

Gemcitabine is only available on a

prescription from your doctor.

Your doctors have decided to treat

you with Gemcitabine because they

believe

that

benefit

Gemcitabine

treatment

will

greater

than

unwanted

side

effects.

Many of the side effects from anti

cancer drugs are predictable and

prevented

lessened.

Your doctor and other staff will take

precautions

needed

reduce

unwanted

effects

treatment.

Before

you

are

given

Gemcitabine Kabi

When you must not receive it

Do not use Gemcitabine Kabi if:

have

allergy

Gemcitabine

ingredients listed at the end of

this leaflet

have

kidney

disease

poor kidney function

you have liver disease or poor

liver function

you are pregnant or planning to

get pregnant

you are breastfeeding

If you are not sure whether any of

these apply to you, check with your

doctor.

Before you are given it

Tell your doctor if:

1. you have any allergies to:

any other medicine

any other substance, such as

foods, preservatives or dyes

2. if you are pregnant or intend

to become pregnant.

Gemcitabine

affect

your

developing baby if you take use it

during pregnancy. If it is necessary

for you to be given it, your doctor or

pharmacist

will

discuss

risks

benefits

taking/using

during pregnancy.

3. you are breastfeeding or plan

to breastfeed

Gemcitabine

passes

into

breast

milk and should not be used when

breastfeeding.

If you have not told your doctor

or pharmacist about any of the

above, tell them before you are

given Gemcitabine Kabi.

Taking other medicines

Tell your doctor or health care

professional

if

you

are

taking

any

other

medicines,

including

any

that

you

buy

without

a

prescription

from

your

pharmacy, supermarket or health

food shop.

Some medicines may be affected

by Gemcitabine Kabi, or may affect

how it works.

Your

doctor

health

care

professional will advise you about

continuing to take other medicines

while

receiving

Gemcitabine.

need

different amounts of your medicine,

or you may need to use different

medicines.

CMI for Gemcitabine Kabi

May, 2013

Page 2 of 4

How Gemcitabine Kabi

is given

Gemcitabine Kabi is given as an

infusion (drip) into your veins over

a 30 minute period. Gemcitabine

must only be given by a doctor or

nurse. Never inject Gemcitabine

Kabi

yourself,

always

your

doctor or nurse do this.

How much Gemcitabine Kabi will

be given

Your doctor will decide what dose

you will receive. This depends on

your

condition

other

factors,

such as your weight.

How often will Gemcitabine Kabi

be given

For Lung Cancer

Gemcitabine

Kabi

given

once a week for three consecutive

weeks,

followed

week

without treatment or once a week

consecutive

weeks,

followed

week

without

treatment. Your doctor will decide

how many of these cycles you will

need.

For Pancreatic Cancer

Initially, Gemcitabine Kabi is given

once a week for up to seven weeks

followed

week

without

treatment.

Subsequent

cycles

Gemcitabine Kabi are given once a

week for three consecutive weeks

followed

week

without

treatment. Your doctor will decide

how many of these cycles you will

need.

For Bladder Cancer

Gemcitabine Kabi is given once a

week for three consecutive weeks,

followed

week

without

treatment. Your doctor will decide

how many of these cycles you will

need.

For Breast Cancer

Gemcitabine Kabi is given once a

week for two consecutive weeks,

followed

week

without

treatment. Your doctor will decide

how many of these cycles you will

need.

For Ovarian Cancer

Gemcitabine

Kabi

given

once a week for two consecutive

weeks,

followed

week

without treatment. Your doctor will

decide how many of these cycles

you will need.

If

you

are

given

too

much

(overdose)

This

rarely

happens

Gemcitabine Kabi is administered

under the care of a highly trained

doctor. However, if you are given

much Gemcitabine,

experience

some

effects

listed under side effects below.

If you experience any side effects

after

being

given

Gemcitabine

Kabi, tell your doctor immediately.

Your doctor has information on how

to recognise and treat an overdose.

Ask your doctor if you have any

concerns.

While

you

are

using

Gemcitabine Kabi

Things you must do

sure

keep

your

appointments with your doctor so

your progress can be checked.

Your doctor may do some blood

tests and other tests from time to

time to check on your progress and

detect any unwanted side effects.

Tell all doctors and health care

professionals

who

are

treating

you

that

you

are

being

given

Gemcitabine Kabi.

If you are about to be started on

any

new

medicine,

tell

your

doctor

or

health

care

professional that you are being

given Gemcitabine Kabi.

Tell your doctor if you become

pregnant

while

you

are

being

given Gemcitabine Kabi.

Things to be careful of

Do

not

drive

or

operate

machinery until you know how

Gemcitabine

affects

you.

Gemcitabine may cause dizziness

or tiredness in some people and

therefore may affect alertness.

Side Effects

Gemcitabine Kabi is being given to

you.

Like

other

medicines

that

treat

cancer,

Gemcitabine

Kabi

have unwanted side effects, some

of which may be serious. You may

need

medical

treatment

experience

some

side

effects.

Ask your doctor or health care

professional

to

answer

any

questions you may have. Tell

your

doctor

or

health

care

professional if you notice any of

the

following

side

effects

and

they worry you:

sleepiness, drowsiness

itchy rash

swelling of the hands, feet or

face

unusual hair loss or thinning

soreness in the mouth

scaling,

ulceration,

sore

formation on the skin

pain at the site of injection

dizziness, light-headedness

itching.

Stomach or bowel problems such

feeling sick

vomiting

diarrhoea

constipation.

Influenza-like symptoms such as:

fever

headache

back-pain

cold shivers

cough

sweating

muscle pain

unusual tiredness or weakness

loss of appetite

CMI for Gemcitabine Kabi

May, 2013

Page 3 of 4

generally feeling unwell

inability to sleep

runny

blocked

nose,

sneezing

Tell

your

doctor

as

soon

as

possible if you notice any of the

following side effects:

frequent

infections

such

fever, severe chills, sore throat

or ulcers

sudden signs of allergy such as

rash,

itching

hives

skin, swelling of the face, lips or

tongue

other

parts

body,

shortness

breath,

wheezing or trouble breathing

difficulty in breathing; wheezing

or coughing

shortness of breath

bruising or bleeding more easily

than normal

tiredness,

headaches,

being

short of breath when exercising,

dizziness and looking pale.

Skin reactions such as:

skin lesions

small, solid, raised areas of skin

raised bumps on the skin that

contain fluid (blisters)

open sores on the skin (ulcers)

peeling of skin.

These may be serious side effects.

You may need medical attention.

Tell your doctor immediately or

go to Accident and Emergency

at your nearest hospital if any of

the following happen:

rapid

laboured

breathing;

extreme

shortness

breath;

slightly bluish, greyish or dark

purple discolouration of the skin;

cold extremities

quick shallow breathing followed

shortness

breath

difficulty in breathing

tiredness,

headaches

bruising or bleeding more easily

than

normal;

yellowing

skin and/or eyes; passing less

urine than is normal

chest

pain,

changes

rhythm or rate of the heart beat

discolouration

loss

sensation in the extremities.

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

Other

side

effects

not

listed

above

may

occur

in

some

patients.

Tell

your

doctor

or

health care professional if you

notice anything that is making

you

feel

unwell.

Other

side

effects

may

be

only

seen

by

blood

tests.

Your

doctor

will

carry out any necessary tests.

Do not be alarmed by this list of

possible side effects.

experience

them.

benefits

side

effects

Gemcitabine Kabi may take some

time to occur. Therefore, even after

have

finished

your

Gemcitabine

Kabi

treatment,

should

tell

your

doctor

health

care

professional

immediately

you notice any of the side effects

listed in this section.

After Gemcitabine Kabi

has been given

Storage

Gemcitabine Kabi will be stored in

the pharmacy or on the ward.

The Powder for Injection is stored

cool

place

where

temperature stays below 25°C.

Concentrated

Injection

stored

refrigeration

where

temperature stays at 2°C to 8°C.

Do not freeze.

It

must

not

be

used

after

the

expiry date (Exp) printed on the

vial.

This is not all the information that is

available

Gemcitabine.

have any more questions or are not

sure about anything speak to your

doctor or health care professional.

Product Description

What it looks like

Gemcitabine

Kabi

Powder

Injection

white

off-white

powder which is supplied in a glass

vial with a rubber stopper.

Gemcitabine

Kabi

Concentrated

Injection is is a clear, colourless to

slightly yellow solution supplied in a

glass vial with a rubber stopper.

Each box contains 1 vial.

Gemcitabine

Kabi

available

the following presentations:

Gemcitabine

Kabi

Powder

Injection :

200 mg

1000 mg

2000 mg

Gemcitabine

Kabi

Concentrated

Injection :

200 mg/5.26 mL

1000 mg/26.3 mL

2000 mg/52.6 mL

Ingredients

Gemcitabine

Kabi

Powder

injection contains either

200 mg,

1000

2000

gemcitabine

hydrochloride

active ingredient. It also contain the

inactive

ingredients

mannitol,

sodium acetate, sodium hydroxide

and hydrochloric acid.

Gemcitabine

Kabi

Concentrated

injection

contains

mg/mL

gemcitabine

hydrochloride

active ingredient. It also contain the

inactive

ingredients

sodium

hydroxide,

hydrochloric

acid

water for injections.

Sponsor

Gemcitabine

Kabi

supplied

Australia by:

Fresenius Kabi Australia Pty

Limited

964 Pacific Highway

Pymble NSW 2073

Telephone: (02) 9391 5555

CMI for Gemcitabine Kabi

May, 2013

Page 4 of 4

Australian Registration Number

Gemcitabine Kabi 200 mg Powder

for Injection AUST R 162336

Gemcitabine Kabi 1 g Powder for

Injection AUST R 162337

Gemcitabine Kabi 2 g Powder for

Injection AUST R 162338

Gemcitabine Kabi 200 mg/5.26 mL

Concentrated

Injection

AUST

214724

Gemcitabine

Kabi

1000

mg/26.3

mL Concentrated Injection AUST R

220681

Gemcitabine

Kabi

2000

mg/52.6

mL Concentrated Injection AUST R

220682

This leaflet was prepared in

May, 2013.

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Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety