Gemcitabine 200 Mg Powder For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gemcitabine 200mg 1g and 2g Powder for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you .
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse 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 you get any of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Gemcitabine Powder for Solution for Infusion is and what it is used for
2. What you need to know before you use Gemcitabine Teva
3. How to use Gemcitabine Teva
4. Possible side effects
5. How to store Gemcitabine Teva
6. Contents of the pack and other information
1. WHAT GEMCITABINE TEVA IS AND WHAT IT IS USED FOR
Gemcitabine belongs to 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. WHAT YOU NEED TO KNOW BEFORE YOU USE GEMCITABINE TEVA Do not use Gemcitabine Teva:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine.
- if you are breast-feeding.
Warnings and Precautions:
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.
Talk to your doctor, nurse or hospital pharmacist before using Gemcitabine Teva
If you have, or have previously had liver disease, heart disease or vascular diseaseor problems with your kidneys talk to your doctor or hospital pharmacist as you may not be able to receive Gemcitabine Teva.
If you have recently had, or are going to have radiotherapy, please tell your doctor as there may be an early or late radiation reaction with Gemcitabine Teva.
If you have been vaccinated recently, please tell your doctor as this can possibly cause bad effects with Gemcitabine Teva.
If you develop breathing difficulties or feel very weak and are very pale, please tell your doctor as this may be a sign of kidney failure or problems with your lungs.
If you develop generalised swelling, shortness of breath or weight gain, please tell your doctor as this may be a sign of fluid leaking from your small blood vessels into the tissue.
Children and adolescents
There is no relevant use of Gemcitabine Teva in the paediatric population.
Other medicines and Gemcitabine Teva
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, breast-feeding and fertility Pregnancy
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.
Breast-feeding
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine Teva. 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.
Driving and using machines
Gemcitabine Teva 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.
Gemcitabine Teva contains sodium
Gemcitabine Teva contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, 17.5 mg (< 1 mmol) sodium in each 1 g vial and 35 mg (1.5 mmol) sodium in each 2 g vial. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE GEMCITABINE TEVA
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.
A hospital pharmacist or doctor will have dissolved the Gemcitabine powder before it is given to you.
You will always receive Gemcitabine 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 hospital pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gemcitabine Teva 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
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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) (uncommon).
Pain, redness, swelling or sores in your mouth (common).
Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common) Contact your doctor if you get a severe rash or itching or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis.
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). Generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (very rare).
Side effects with Gemcitabine Teva 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 neutropenia)
• 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 air sacs of the lung)
• Spasm of the airways (wheeze)
• Abnormal chest X ray/scan (scarring of the lungs)
• Irregular heart beat (arrhythmia)
• Heart failure
• Kidney failure
• Serious liver damage, including liver failure
• Stroke
Rare side effects:
• Heart attack (myocardial infarction)
• Low blood pressure
• Skin scaling, ulceration or blister formation
• Injection site reactions
• 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 Gangrene of fingers of toes.
Very rare side effects ;
• Increased platelet count
• Anaphylactic reaction (severe hypersensitivity/allergic reaction)
• Sloughing of the skin and sever skin blistering
• Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
• Capillary leak syndrome (fluids from your small blood vessels leak out into the tissue)
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GEMCITABINE TEVA
Keep out of the reach and sight of children.
Do not use after the expiry date (EXP) which is stated on the carton and vial. The expiry date refers to the last day of that month.
Unopened vial: No special storage conditions are required.
Reconstituted solution:
The product should be used immediately. When prepared as directed, chemical and physical in-use stability of gemcitabine has been demonstrated for 24 hours at 25 n C for the reconstituted product with a concentration of 38mg/ml. Further dilution by a healthcare provider may be done. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
From a microbiological point of view, the reconstituted and diluted 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.
For single use only. Discard any unused solution.
Do not use Gemcitabine Teva if you notice any particles or visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Your doctor should dispose of medicines that are no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Gemcitabine Teva contains
The active substance is gemcitabine. Each vial contains 200 mg, 1 g or 2 g of gemcitabine (as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate trihydrate (E262), hydrochloric acid (E507) and sodium hydroxide (E524).
What Gemcitabine Powder For Solution For Infusion looks like and contents of the pack
Each vial of Gemcitabine contains a white to off-white powder supplied in a glass vial closed with a rubber stopper and aluminium cap with a plastic cover.
Gemcitabine Teva 200 mg Powder for solution for infusion are available in packs containing 1, 5 and 10 vials.
Gemcitabine Teva 1g Powder for solution for infusion are available in packs containing 1, 5 and 10 vials. Gemcitabine Teva 2g Powder for solution for infusion are available in packs containing 1, 5 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: and Manufacturer:
Marketing Authorisation Holder is TEVA UK Limited, Eastbourne. BN22 9AG
Manufacturer is: Pharmachemie B.V, 2031 GA Haarlem. The Netherlands
This leaflet was last revised in August 2013
The following information is intended for medical or healthcare professionals only:
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 Gemcitabine Teva 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 1 g vial or 50 ml sterile sodium chloride solution for injection. without preservative to the 2 g vial. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial). 26.3 ml (1 g vial) or 52.6 ml (2 g 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 25 C for the reconstituted product with a concentration of 38mg/ml. Chemical and physical in-use stability has been demonstrated for ambient conditions (15-25°C, ambient light) or in a refrigerator (2-8°C) for at most 72 hours (3 days) for the diluted solution at concentrations between 0.1 mg/mL and 30 mg/mL in 0.9% sodium chloride for injection. From a microbiological point of view. the reconstituted and diluted 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.
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
Any unused product should be disposed of in accordance with local requirements.
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