Gemcitabine 200 Mg Powder For Solution For Infusion
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GEMCITABINE 200 mg & 1000 mg 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 or pharmacist.
In this leaflet:
1. What Gemcitabine is and what it is used for
2. Before you are given Gemcitabine
3. How Gemcitabine will be given to you
4. Possible side effects
5. How to store Gemcitabine
6. Further information
1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR
The name of your medicine is Gemcitabine 200 mg or 1000 mg Powder for solution for infusion. In the rest of this leaflet your medicine is called Gemcitabine.
Gemcitabine is one of a group of medicines called cytotoxics. These medicines kill dividing cells, including cancer cells.
Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine 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.
2. BEFORE YOU ARE GIVEN GEMCITABINE
Do not use Gemcitabine
- if you are allergic (hypersensitive) to gemcitabine hydrochloride or any other ingredient of gemcitabine.
- if you are breast-feeding.
Take special care with Gemcitabine
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. 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.
- if you have recently had, or are going to have radiotherapy,
- if you have been vaccinated recently
- if 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. 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 pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription. Pa e 1
Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine during pregnancy.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Gemcitabine 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 treatment has not made you feel sleepy.
Important Information about some of the ingredients of Gemcitabine
Gemcitabine contains 5 mg (< 1 mmol) of sodium in each 200 mg vial and 22.966 mg (< 1 mmol) sodium in each 1000 mg vial. To be taken into consideration by patients on a controlled sodium diet.
3. HOW GEMCITABINE WILL BE GIVEN TO YOU
Gemcitabine will always be given to you by a healthcare professional, who will have dissolved the Gemcitabine powder beforehand.
The usual dose of Gemcitabine is 1000-1250 mg 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.
You will always receive Gemcitabine by infusion into one of your veins. The infusion will last approximately 30 minutes.
If you are given too much Gemcitabine
Your doctor will ensure that the correct dose for your condition is given. In cases of suspected overdose, your blood count should be monitored. Appropriate treatment should be started if required.
If you have any further questions on the use of this product, ask your doctor or healthcare staff.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gemcitabine 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 38°C 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 you 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 haemoglo bin 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).
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THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Below is a summary of information to assist in the administration of GEMCITABINE. You should be experienced in the handling and use of cytotoxic agents and be familiar with the SPC for GEMCITABINE.
Instructions for use, handling and disposal
1. Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.
2. Calculate the dose and the number of vials needed.
3. Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively. This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder. Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative may be done. The resulting solution is clear and ranges in colour from colourless to light straw-coloured.
4. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
5. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
6. Gemcitabine solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Preparation and administration precautions
The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses.
If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.
Disposal
All items used for preparation, administration or otherwise coming into contact with gemcitabine should undergo disposal according to local guidelines for the handling of cytotoxic compounds.
Side effects with gemcitabine 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
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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
• ischaemic 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.
5. HOW TO STORE GEMCITABINE
Keep out of the reach and sight of children.
Do not use Gemcitabine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Unopened vial: Store in the original package.
Reconstituted solution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution (and further dilution, if applicable) has taken place in controlled and validated aseptic conditions.
The reconstituted solution should not be refrigerated, as crystallisation may occur.
Do not use Gemcitabine if you notice a cloudy solution or an insoluble precipitate.
This medicine is for single use only; any unused solution should be discarded under the local requirements.
6. FURTHER INFORMATION What Gemcitabine contains
The active substance is gemcitabine hydrochloride. Each vial contains 200 mg or 1000 mg of the active ingredient gemcitabine hydrochloride.
The other ingredients are mannitol, sodium acetate trihydrate, sodium hydroxide and hydrochloric acid.
What Gemcitabine looks like and contents of the pack
Gemcitabine powder is a white to off white freeze dried cake presented in Type I flint moulded glass vial.
The 200 mg and 1000 mg vials are available separately in single packs.
Marketing Authorisation Holder
Cipla (EU) Ltd,Hillbrow House,Hillbrow Road, Esher,Surrey, KT10 9NW.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited, 9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Limited, 9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
This leaflet was last revised in July 2010.
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