Gemcitabine 200mg powder for solution for infusion
Gemcitabine 1g powder for solution for infusion
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Gemcitabine powder is and what it is used for
- 2. Before you use
- 3. How to use
- 4. Possible side effects
- 5. How to store
- 6. Further information
What Gemcitabine Powder Is And What It Is Used For
Gemcitabine powder belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.
Gemcitabine powder may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine powder is used in the treatment of the following types of cancer:
- non-small cell lung cancer (NSCLC), alone or together with cisplatin
- pancreatic cancer.
- breast cancer, together with paclitaxel.
- ovarian cancer, together with carboplatin.
- bladder cancer, together with cisplatin.
Before You Use
You should not be given Gemcitabine powder
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine powder
- if you are breast-feeding
Take special care with Gemcitabine powder
Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemcitabine powder. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function.
Please tell your doctor if:
- you have, or have previously had liver disease, heart disease or vascular disease
- you have recently had, or are going to have radiotherapy
- you have been vaccinated recently
- you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure).
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine powder. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.
Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine powder should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine powder during pregnancy.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine powder treatment.
Driving and using machines
Gemcitabine powder may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemcitabine powder treatment has not made you feel sleepy.
Important information about some of the ingredients of Gemcitabine powder
Gemcitabine contains 3.56mg (< 1 mmol) of sodium in each 200mg vial and 17.81mg (< 1 mmol) sodium in each 1000mg vial. To be taken into consideration by patients on a controlled sodium diet.
How To Use
The usual dose of Gemcitabine powder is 1000-1250mg for every square metre of your body’s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
How frequently you receive your gemcitabine infusion depends on the type of cancer that you are being treated for.
A hospital pharmacist or doctor will have dissolved the Gemcitabine powder before it is given to you.
You will always receive Gemcitabine powder by infusion into one of your veins. The infusion will last approximately 30 minutes.
If you have further questions on the use of this product ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Gemcitabine powder can cause side effects, although not everybody gets them.
Frequencies of the observed side effects are defined as:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency can’t be estimated from the available data
You must contact your doctor immediately if you notice any of the following:
- Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
- Irregular heart rate (arrhythmia) (frequency not known).
- Pain, redness, swelling or sores in your mouth (common).
- Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common).
- Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
- Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
- Difficulty breathing (it is very common to have mild breathing difficulty soon after the gemcitabine infusion which soon passes, however uncommonly or rarely there can be more severe lung problems).
Side effects with Gemcitabine powder may include:
Very common side effects
Low haemoglobin level (anaemia)
Low white blood cells
Low platelet count
Difficulty breathing
Vomiting
Nausea
Skin rash- allergic skin rash, frequently itchy
Hair loss
Liver problems: found through abnormal blood test results
Blood in urine
Abnormal urine tests: protein in urine
Flu like symptoms including fever
Oedema (swelling of ankles, fingers, feet, face)
Common side effects
Fever accompanied by low white blood cell count (febrile neutropaenia)
Anorexia (poor appetite)
Headache
Insomnia
Sleepiness
Cough
Runny nose
Constipation
Diarrhoea
Pain, redness, swelling or sores in the mouth
Itching
Sweating
Muscle pain
Back pain
Fever
Weakness
Chills
Uncommon side effects
Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheeze)
Abnormal chest X ray/scan (scarring of the lungs)
Rare side effects
Heart attack (myocardial infarction)
Low blood pressure
Skin scaling, ulceration or blister formation
Injection site reactions
Very rare side effects
Increased platelet count
Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
Sloughing of skin and severe skin blistering
Side effects with frequency not known
Irregular heart beat (arrhythmia)
Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
Fluid in the lungs
Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy
Ischemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
Heart failure
Kidney failure
Gangrene of fingers or toes
Serious liver damage, including liver failure
Stroke
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you
start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell
your doctor.
How To Store
Keep out of the reach and sight of children.
Unopened container
Do not refrigerate or freeze.
Opened container
After opening, the contents should be reconstituted, and if appropriate further diluted, and used immediately. Reconstituted solutions should not be refrigerated, as crystallisation may occur.
Do not use Gemcitabine powder after the expiry date which is stated on the label and carton. The expiry date refers
to the last day of that month.
Gemcitabine powder should not been used if there are any signs of particles.
Further Information
What Gemcitabine powder contains
- The active substance is gemcitabine (as hydrochloride). One vial Gemcitabine powder contains 200mg or 1g gemcitabine.
After reconstitution one ml of Gemcitabine powder contains 38mg gemcitabine. - The other ingredients are mannitol E421, sodium acetate trihydrate and sodium hydroxide 1 N (for pH adjustment)
What Gemcitabine powder looks like and contents of the pack
Gemcitabine powder is a white to off-white compact aggregate powder. After reconstitution in 0.9% sodium chloride solution, the solution is clear to pale opalescent and colourless to pale yellow.
Gemcitabine powder is in colourless glass vials with bromobutylic rubber stopper. Each vial will be packed with or without a protective plastic overwrap.
Pack sizes
One vial containing 200mg Gemcitabine.
One vial containing 1g Gemcitabine.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in October 2008.
If you would like a leaflet with larger text, please contact 01271 311257.
SINPL021
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