Gemcitabine 38mg/Ml Powder For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 38 mg/ml,
powder for solution for infusion
Gemcitabine
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 any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any 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 is and what it is used for
2. What you need to know before you use Gemcitabine
3. How to use Gemcitabine
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other information
1. What GEMCITABINE 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 Do not use Gemcitabine:
- 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
Talk to your doctor, pharmacist or nurse before using 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.
If you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys talk to your doctor or hospital pharmacist as you may not be able to receive Gemcitabine.
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.
If you have been vaccinated recently please tell your doctor as this can possibly cause bad effects with Gemcitabine.
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 problem 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.
Other medicines and GEMCITABINE
Tell your doctor or hospital pharmacist if you are taking, have recently taken or might take any other medicines.
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. 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 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 (200 mg and 1000 mg vials) contains less than 1 mmol sodium per vial, i.e. essentially 'sodium-free'.
Gemcitabine (2000 mg vial) contains 1.5 mmol sodium per vial. To be taken into consideration by patients on a controlled sodium diet.
3. How to use GEMCITABINE
The usual dose of Gemcitabine is 1 000-1250 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 any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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).
- I rregular 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).
.--A.............................../-A................................
The following information is intended for healthcare professionals only:
Handling of this cytotoxic agent by health professional requires a set of precautions to protect the handler and his/her environment.
The preparation of cytotoxic solutions for injection must be carried out by trained specialist personnel who know about the drugs involved, under conditions that ensure protection of the environment and above all protection of the staff handling the solutions. It must be done in a designated area. Smoking, eating and drinking are prohibited in this area.
The personnel preparing the solutions must be provided with all the equipment required for this task, notably long-sleeved laboratory coats, protective masks, head-covering, safety goggles, sterile single-use gloves, protective covering for the work surface, containers and sacks for waste.
Any excreta or vomit must be handled with adequate precautions.
Pregnant women should be informed and avoid handling cytotoxics.
Any broken container must be dealt with using the same precautions and considered to be contaminated waste.
The disposal of contaminated waste is carried out by incineration in labelled rigid containers provided for the purpose. See section "Disposal of waste" hereafter.
If gemcitabine comes in contact with the skin, it must be rinsed immediately with large amounts of water. Precautions must be taken to avoid any accidental spraying of the medicinal product into the eyes. If it is sprayed accidentally into the eyes, rinse the eyes immediately with large amounts of water.
Reconstitution
This medicinal product has only been shown to be compatible with an injectable solution of 9 mg/mL (0.9%) sodium chloride. Accordingly, only this diluent should be used to reconstitute the solution. Compatibility with other drugs has not been studied, and therefore, it is not advisable to mix gemcitabine with other drugs during reconstitution.
- 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 may include:
Very common: may affect more than 1 in 10 people 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: may affect up to 1 in 10 people
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: may affect up to 1 in 100 people Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheeze)
Abnormal chest X ray/scan (scarring of the lungs)
Stroke
Irregular heart beat (arrhythmia)
Heart failure
Serious liver damage, including liver failure Kidney failure
Rare: may affect up to 1 in 1,000 people Heart attack (myocardial infarction)
Low blood pressure
Skin scaling, ulceration or blister formation Injection site reactions Gangrene of fingers or toes Fluid in the lungs
Adult respiratory distress syndrome (severe lung inflammation causing respiratory failure)
Severe skin reactions, including desquamation and bullous skin eruptions
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy
Very rare: may affect up to 1 in 10,000 people Increased platelet count
Anaphylactic reaction (severe hypersensitivity/ allergic reaction)
Sloughing of skin and severe 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet 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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and box. The expiry date refers to the last day of that month.
Before reconstitution: this medicinal product does not require any special storage conditions.
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 25°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.
6. Contents of the pack and other information
What Gemcitabine contains
The active substance is gemcitabine. Each vial contains 200 or 1 000 mg or 2000 mg of gemcitabine (as gemcitabine hydrochloride).
1 mL of solution for infusion contains 38 mg of gemcitabine.
The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
What Gemcitabine looks like and contents of the pack
This medicine is a powder for solution for infusion.
Vial of 200 mg of powder. Box of 1,5, 10 or 20 vials.
Vial of 1 000 mg of powder. Box of 1,5, 10 or 20 vials.
Vial of 2000 mg of powder. Box of 1,5, 10 or 20 vials.
Not all of the presentations may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.
Manufacturer:
MYLAN S.A.S, 1 17 allee des Parcs, 69800 Saint Priest Cedex, France Or
CEMELOG BRS Kft, 2040 Budaors, Vasut u.13., Hungary.
This leaflet was last revised in September 201 3.
10004060
|
Presentation |
Volume of 9 mg/mL (0.9%) sodium chloride solution to add |
Displacement volume |
Final concentration |
|
200 mg |
5 mL |
0.26 mL |
38 mg/mL |
|
1 g |
25 mL |
1.3 mL |
38 mg/mL |
|
2000 mg |
50 ml |
2.6 mL |
38 mg/mL |
Reconstitution at concentrations greater than 38 mg/mL may result in incomplete dissolution, and should be avoided.
For the reconstitution, slower add the appropriate volume of 9 mg/mL (0.9%) Sodium Chloride Solution for Injection (as shown in the table below) and shake till completely dissolved.
The appropriate amount of the medicinal product can again be diluted in a 9 mg/mL (0.9%) sodium chloride solution.
Medicinal products administered by the parenteral route should be inspected visually for particulate matter and discolouration, prior to administration, whenever the solution and container permit.