Gemcitabine 200mg Powder For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Gemcitabine 200 mg Powder for Solution for Infusion Gemcitabine 1000 mg Powder for Solution for Infusion
Gemcitabine
Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor, nurse or pharmacist.
If you get any side effects, talk to your doctor, nurse or pharmacist. 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 are given Gemcitabine Powder for Solution for Infusion
3. How Gemcitabine Powder for Solution for Infusion is given
4. Possible side effects
5. How to store Gemcitabine Powder for Solution for Infusion
6. Contents of the pack and other information
1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
3. HOW GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS GIVEN
4. POSSIBLE SIDE EFFECTS
Your medicine is known as “GEMCITABINE POWDER FOR SOLUTION FOR INFUSION” and is referred to as “Gemcitabine Infusion” throughout this leaflet.
Gemcitabine infusion belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.
Gemcitabine infusion may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine infusion 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 ARE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
You should not be given Gemcitabine infusion:
if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6).
if you are breast-feeding
Warnings and precautions:
Before the first infusion you will have samples of your blood taken to check if your liver and kidneys are working well enough for you to receive this medicine.
Before each infusion you will have samples of your blood taken to check if you have enough blood cells to receive Gemcitabine infusion.
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 check how well your kidneys and liver are working.
Talk to your doctor , hospital pharmacist or nurse before using Gemcitabine Infusion:
if you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys as you may not be able to receive Gemcitabine Infusion. if you have recently had, or are going to have radiotherapy, as there may be an early or late radiation reaction with Gemcitabine Infusion. if you have been vaccinated recently as this can possibly cause bad effects with Gemcitabine Infusion.
if during treatment with this medicine, you get symptoms such as a headache with confusion, seizures (fits) or changes in vision, call your doctor right away. This could be a very rare nervous system side effect named posterior reversible encephalopathy syndrome. if you develop breathing difficulties or feel very weak and 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
This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Gemcitabine infusion Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take 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 infusion should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine infusion during pregnancy.
Breast-feeding
If you are breast-feeding, tell your doctor. You must stop breast-feeding during treatment with Gemcitabine infusion.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine infusion. 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 infusion 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 your treatment has not made you feel sleepy.
Gemcitabine infusion contains sodium
Gemcitabine infusion contains 3.5 mg (<1 mmol) of sodium in each 200 mg vial and 17.5 mg (<1 mmol) sodium in each 1000 mg vial , i.e. essentially sodium free.
Usual dose
The usual dose of Gemcitabine infusion 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 often will you receive this medicine?
How frequently you receive your Gemcitabine infusion depends on the type of cancer that you are being treated for.
How will you be given this medicine?
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 pharmacist.
Like all medicines, Gemcitabine infusion 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
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The following information is intended for medical or healthcare professionals only:
4.
5.
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 powder for solution for infusion 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.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter is observed, do not administer.
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
5. HOW TO STORE GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
6. FURTHER INFORMATION
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
You must contact your doctor immediately if you notice any of the following:
Temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal accompanied by fever also known as febrile neutropenia) (common).
Irregular heart rate (arrhythmia) (uncommon). Pain, redness, swelling or sores in your mouth (stomatitis) (common).
Allergic reactions: if you develop a mild to moderate skin rash (very common) / itching (common), or fever (very common).
Extreme tiredness and weakness, purpura or small areas of bleeding in the skin (bruises), acute renal failure (low urine output/ or no urine output), and signs of infection (haemolytic uraeemic syndrome). It may be fatal (uncommon).
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 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).
Severe chest pain (myocardial infarction) (rare). Severe hypersensitivity/ allergic reaction with severe skin rash including red itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), wheezing, fast beating heart and you may feel you are going to faint (anaphylactic reaction) (very rare). Generalised swelling, shortness of breath or weight gain, as you might have fluid leakage from small blood vessels into the tissues (capillary leak syndrome) (very rare).
Headache with changes in vision, confusion, seizures or fits (posterior reversible encephalopathy syndrome) (very rare).
Severe rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
Side effects with Gemcitabine may include:
Very common side effects (may affect more than 1 in 10 people)
Low white blood cells Difficulties in breathing Vomiting Nausea Hair loss
Liver problems: found through abnormal blood test results Blood in urine
Abnormal urine tests: protein in urine Flu like symptoms including fever Swelling of the ankles, fingers, feet or face (oedema)
Common side effects (may affect up to 1 in 10 people)
Poor appetite (anorexia)
Headache Insomnia Sleepiness Cough Runny nose Constipation Diarrhoea Itching Sweating Muscle pain Back pain Fever Weakness Chills
Uncommon side effects (may affect up to 1 in 100 people)
Scarring of the air sacs of the lung (Interstitial pneumonitis)
Wheeze (spasm of the airways)
Scarring of the lungs (abnormal chest X ray/ scan)
Heart failure Kidney failure
Serious liver damage, including liver failure Stroke
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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
Rare side effects (may affect up to 1 in 1,000 people)
• Low blood pressure
• Skin scaling, ulceration or blister formation
• Sloughing of the skin and severe skin blistering
• Injection site reactions
• Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)
• A skin rash like severe sunburn which can occur on skin that has previously been exposed to radiotherapy (radiation recall)) Fluid in the lungs
• Scarring of the air sacs of the lung associated with radiation therapy (radiation toxicity)
• Gangrene of fingers or toes
• Inflammation of the blood vessels (peripheral vasculitis)
Very rare side effects (may affect up to 1 in 10,000 people)
• Increased platelet count
• Inflammation of the lining of the large bowel, caused by reduced blood supply (ischaemic colitis).
Low haemoglobin level (anaemia), low white blood cells and low platelet count will be detected by a blood test.
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.
Keep this medicine out of the sight and reach of children.
Do not use Gemcitabine powder for solution for infusion after the expiry date, which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Unopened vial: Store below 30°C Reconstituted solution: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 24 hours at 30°C. Further dilution by a healthcare provider may be done. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
This medicine is for single use only; any unused solution should be discarded under the local requirements.
What Gemcitabine powder for solution for infusion contains
The active substance is gemcitabine. Each vial contains 200 or 1000 mg of gemcitabine (as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
What Gemcitabine powder for solution for infusion looks like and contents of the pack
Gemcitabine powder for solution for infusion is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200 mg or 1000 mg of gemcitabine. Each pack of Gemcitabine powder for solution for infusion contains 1 vial.
The vials are sold separately in single packs.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Glenmark Generics (Europe) Limited,
Laxmi House, 2B Draycott Avenue Harrow, Middlesex hA3 0BU, United Kingdom
Manufacturers:
Glenmark Pharmaceuticals s.r.o Fibichova 143,566 17 Vysoke Myto,
Czech Republic
Glenmark Generics (Europe) Limited Croxley Green Business Park Watford, WD18 8YA, United Kingdom The leaflet was last revised in 01/2015.
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