Gemaccord Powder for infusion

Gemaccord Powder for infusion is a brand of medicine containing the active ingredient gemcitabine.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

GEMACCORD
(gemcitabine) for Injection 200 mg/vial and 1 g/vial

Gemcitabine Hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor.

All medicines have risks and benefits.

Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgment to meet your individual needs.

If you have any concerns about being given this medicine, talk to your doctor or health care professional.

Keep this leaflet with this medicine. You may need to read it again.

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What GEMCITABINE FOR INJECTION is used for

GEMCITABINE FOR INJECTION is used to treat patients with:

  • Lung cancer
  • Cancer of the pancreas
  • Bladder cancer
  • Breast cancer
  • Ovarian cancer.

GEMCITABINE FOR INJECTION works by killing cancer cells and preventing cancer cells from growing and multiplying.

GEMCITABINE FOR INJECTION belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.

Your doctor may have prescribed GEMCITABINE FOR INJECTION for another reason.

Ask your doctor or health care professional if you have any questions about why GEMCITABINE FOR INJECTION has been prescribed for you.

GEMCITABINE FOR INJECTION may be used in combination with other cytotoxic medicines to treat cancer.

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Before you are given GEMCITABINE FOR INJECTION

Tell your doctor or health professional if you have any of the following conditions or if you have ever experienced any of these conditions.

When you must not be given GEMCITABINE FOR INJECTION

You must not be given GEMCITABINE FOR INJECTION if you have had an allergic reaction to GEMCITABINE FOR INJECTION or to any of the ingredients listed at the end of this leaflet (see ‘Product Description’). You must not be given GEMCITABINE FOR INJECTION if the packaging is torn or shows signs of tampering.

You must not be given GEMCITABINE FOR INJECTION after the expiry date printed on the pack.

Before you are given GEMCITABINE FOR INJECTION, tell your doctor if you have allergies to:

  • Any other medicines
  • Any other substances such as foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • Liver problems
  • Kidney problems.

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines used to treat cancer, GEMCITABINE FOR INJECTION, is not recommended to be given during pregnancy. If there is a need to consider GEMCITABINE FOR INJECTION, during your pregnancy, your doctor will discuss with you the benefits and risks involved.

Tell your doctor if you are breastfeeding or plan to breast-feed. It is recommended that you do not breastfeed while you are receiving GEMCITABINE FOR INJECTION, as it is not known whether GEMCITABINE FOR INJECTION, passes into breast milk.

Tell your doctor or health care professional about these things, before you are given GEMCITABINE FOR INJECTION.

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 FOR INJECTION, or may affect how it works. Your doctor and health care professional may have more information on medicines to be careful with or avoid while being given GEMCITABINE FOR INJECTION.

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How GEMCITABINE FOR INJECTION is given

GEMCITABINE FOR INJECTION is given as an infusion (drip) into your veins over a 30-minute period.

Your doctor or nurse will inject GEMCITABINE FOR INJECTION for you.

Never inject GEMCITABINE FOR INJECTION yourself. Always let your doctor or nurse do this.

How much GEMCITABINE FOR INJECTION will be given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

How often will GEMCITABINE FOR INJECTION be given

For Lung Cancer
GEMCITABINE FOR INJECTION can be given once a week for three consecutive weeks, followed by one week without treatment or once a week for two consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

For Pancreatic Cancer
Initially, GEMCITABINE FOR INJECTION is given once a week for up to seven weeks followed by a week without treatment. Subsequent cycles of GEMCITABINE FOR INJECTION are given once a week for three consecutive weeks followed by a week without treatment. Your doctor will decide how many of these cycles you will need.

For Bladder Cancer
GEMCITABINE FOR INJECTION is given once a week for three consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

For Breast Cancer
GEMCITABINE FOR INJECTION is given once a week for two consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

For Ovarian Cancer
GEMCITABINE FOR INJECTION can be given once a week for two consecutive weeks, followed by one week without treatment. Your doctor will decide how many of these cycles you will need.

Overdose

As GEMCITABINE FOR INJECTION is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects after being given GEMCITABINE FOR INJECTION, tell your doctor immediately.

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While you are being given GEMCITABINE FOR INJECTION

Things you must do

Be sure to keep all 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 FOR INJECTION.

If you are about to be started on any new medicine, tell your doctor or health care professional that you are being given GEMCITABINE FOR INJECTION.

Tell your doctor if you become pregnant while you are being given GEMCITABINE FOR INJECTION.

Things to be careful of

Do not drive or operate machinery after receiving GEMCITABINE FOR INJECTION until you know how GEMCITABINE FOR INJECTION affects you.

GEMCITABINE FOR INJECTION may cause sleepiness in some people.

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Side effects

Tell your doctor or health care professional as soon as possible if you do not feel well while you are being given GEMCITABINE FOR INJECTION. Like other medicines that treat cancer, GEMCITABINE FOR INJECTION may have unwanted side effects, some of which may be serious. You may need medical treatment if you experience some of the 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 as:

  • 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
  • Generally feeling unwell
  • Inability to sleep
  • Runny or blocked nose, sneezing.

Tell your doctor as soon as possible if you notice any of the following side effects:

  • Frequent infections such as fever, severe chills, sore throat or ulcers
  • Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips or tongue or other parts of the body, shortness of 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 of breath; slightly bluish, greyish or dark purple discolouration of the skin; cold extremities
  • Quick shallow breathing followed by shortness of breath and difficulty in breathing
  • Tiredness, headaches and bruising or bleeding more easily than normal; yellowing of the skin and/or eyes; passing less urine than is normal
  • Chest pain, changes in the rhythm or rate of the heart beat
  • Discolouration or loss of sensation in the extremities.

These are very serious side effects. You may 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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

The benefits and side effects of GEMCITABINE FOR INJECTION may take some time to occur. Therefore, even after you have finished your GEMCITABINE FOR INJECTION treatment, you should tell your doctor or health care professional immediately if you notice any of the side effects listed in this section.

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Storage

Do not store above 25°C.

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Product description

What it looks like

GEMCITABINE FOR INJECTION is white to off-white lyophilized powder in clear glass vial.

Ingredients

GEMACCORD (gemctabine) FOR INJECTION is available in two strengths.

  • GEMACCORD (gemctabine) FOR INJECTION 200 mg contains the active ingredient Gemcitabine Hydrochloride, equivalent to 200 mg of gemcitabine.
  • GEMACCORD (gemctabine) FOR INJECTION 1 g contains the active ingredient Gemcitabine Hydrochloride, equivalent to 1 g of Gemcitabine.

Both strengths of GEMACCORD (gemctabine) FOR INJECTION contain the inactive ingredients

  • mannitol,
  • sodium acetate trihydrate,
  • sodium hydroxide,
  • hydrochloric acid and
  • water for injection.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

200 mg/vial - Aust R 159102
1 g/vial - Aust R 159103

Sponsor:

Accord Healthcare Pty Ltd
Unit 702/23,
Queens Road,
Melbourne, Victoria, 3004
Australia

DATE OF TGA APPROVAL
25th March 2011

Date of most recent amendment
18th July 2011

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CMI provided by MIMS Australia, August 2014  

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