Gemcitabine 38 Mg/Ml Powder For Solution For Infusion
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gemcitabine hydrochloride
Read all of this leaflet carefully before you start taking 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. Do not pass it on to others. It may harm them, even if their symptoms 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.
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 take Gemcitabine:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingedients 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:
• 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 problems with your lungs
If you develop generalised swelling, shortness of breath or weight gain, please tell your doctor as this may he a sign of fluid leaking from your small blood vessels into the tissue.
Children and adolescents
There is no relevant use of Gemcitabine in the paediatric population. Other medicines and Gemcitabine
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.
Breastfeeding
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 further 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.
Gemcitabine contains sodium
"Gemcitabine Hetero contains 2.11 mg (< 1 mmol) of sodium per 200 mg vial and 10.56 mg (< 1 mmol) sodium per 1000 mg vial i.e. essentially “sodium-free”.
3. How to use Gemcitabine
The usual dose of Gemcitabine is 1000-1250 mg for every square meter 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 pharmacist.
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
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) (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 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 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
Artwork Size: 220 x 315 mm Colour: Black
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Constipation Pack sizes Diarrhoea One vial containing 200 mg gemcitabine. Pain, redness, swelling or sores in the mouth One vial containing 1000 mg gemcitahine. Itching Sweating Marketing Authorisation Holder and Manufacturer Muscle pain Marketing Authorisation Holder Back pain Hetero Europe S.L. Fever Viladecans Business Park - Edificio Brasil Weakness Catalunya 83-85 Chills 08840 Viladecans Uncommon side effects Spain Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways Iwheezel Manufacturer Abnormal chest X ray/scan (scarring of the lungs) Pharmadox Healthcare Limited Irregular heart heat (arrhythmia) KW20A Kordin Industrial Park, Heart failure Paola PLA 3000 Kidney failure Malta Serious liver damage, including liver failure This medicinal product is authorised in the Member States of the EEA Stroke under the following names: Rare side effects Germany Gemcitabin Hetero 38 mg/ml Pulver zur Herstellung Heart attack (myocardial infarction) einer Infusionslosung Low blood pressure France Gemcitabine Hetero 38 mg/ml, poudre pour solution Skin scaling, ulceration or blister formation pour perfusion Injection site reactions The Netherlands Gemcitabine Hetero 38 mg/ml, poeder voor oplossing Adult Respiratory Distress Syndrome (severe lung inflammation causing voor infusie respiratory failure) Norway Gemcitabin Hetero Radiation recall - (a skin rash like severe sunhum) which can occur on Spain Gemcitabina Hetero 200 mg; 1000 mg polvo para skin that has previously been exposed to radiotherapy solution para perfusion EFG Fluid in the lungs United Kingdom Gemcitahine 38 mg/ml Powder for solution for infusion Radiation toxicity - scarring of the air sacs of the lung associated with This leaflet was last revised in 12/2013. radiation therapy Detailed information on this medicine is available on the web site of Gangrene of fingers or toes Medicines and Healthcare Products Regulatory Agency. Very rare side effects The following information is intended for medical or healthcare Increased platelet count --^——- Anaphylactic reaction (severe hypersensitivity/ allergic reaction) Pro esslona s 0,1 y* Sloughing of skin and severe skin hlistering Instruction for use, handling and disposal Ischaemic colitis (inflammation of the lining of the large bowel, caused 1 - Use aseptic technique during the reconstitution and any further dilution hy reduced hlood supply) of gemcitabine for intravenous infusion administration. Capillary leak syndrome (fluids from your small blood vessels leak out 2. Calculate the dose and the number of Gemcitahine vials needed, into the tissue) 3 Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium You might have any of these symptoms and/or conditions. You must tell chloride solution for injection, without preservative, or 25 ml sterile your doctor as soon as possible when you start experiencing any of these sodium chloride solution for injection, without preservative, to the side effects. 1000 mg vial. Shake to dissolve. The total volume after reconstitution If you are concerned about any side effects, talk to your doctor. is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively. This If you get any side effects, talk to your doctor or pharmacist. This includes dilution 3™“® a f™itabine concentration of 38 mg/ml which includes any possible side effects not listed in this leaflet. accounting for the displacement volume of the lyopMised powder. . Further dilution with sterile sodium chloride 9 mg/ml (0.9 %) solution Reporting of side effects for injection, without preservative may be done. The resulting solution If you get any side effects, talk to your doctor, pharmacist or nurse. This is clear and ranges in colour from colourless to light straw-coloured, includes any possible side effects not listed in this leaflet. You can also 4 Parenteral medicinal products should be inspected visually for particulate report side effects directly via matter and discolouration prior to administration. If particulate matter Yellow Card Scheme is observed, do not administer. Website: www.mhra.gov.uk/yellowcard. 5. Solutions of reconstituted gemcitabine should not be refrigerated, as By reporting side effects you can help provide more information on the crystallisation may occur. Chemical and physical in-use stability has safety of this medicine. been demonstrated for 24 hours at 30°C. 5. How to store Gemcitabine From a microbiological point of view, the product should be used T, , , _ , , immediately. If not used immediately, in-use storage times and conditions Keep this medicine out of the sight and reach of children. prior to use are the responsibility ofthe user and would normally not Do not use this medicine after the expiry date which is stated on the label be longer than 24 hours at room temperature, unless and carton. The expiry date refers to the last day of that month. reconstitution/dilution has taken place in controlled and validated Unopened vial aseptic conditions. This medicinal product does not require any special temperature storage 6. Gemcitahine solutions are for single use only. Any unused product or conditions. waste material should he disposed of in accordance with local Reconstituted solution requirements. The product should be used immediately. When prepared as directed, Preparation and administration precautions chemical and physical in-use stability of reconstituted solutions of ^ normal saf utions for cytostatic agents must be observed when gemcitabme were demonstrated for 24 hours at 30° C. Further dilution by ^ ^ ^ sin ofthe infusion solution. Handling ofthe solution a healthcare provided may be done. Solutions of reconstituted gemcitabme f()r should be done ^ a safety box and protective coats and gloves should not be refrigerated, as crystallisation may occur. should be used If no safety box is ;vailabl(/the equipment should be This medicine is for single use only; any unused solution should be supplemented with a mask and protective glasses, discarded under the local requirements. Ifthe preparation comes into contact with the eyes, this may cause serious 6. Contents of the pack and other information irritation. The eyes should be rinsed immediately and thoroughly with What Gemcitabine contains water. If there is lasting irritation, a doctor should be consulted. If the - The active substance is gemcitahine (as hydrochloride). One vial solution is spilled on the skin, rinse thoroughly with water. Gemcitahine contains 200 mg or 1000 mg gemcitabine. After DisDosal reconstitution one ml of Gemcitabine contains 38 mg gemcitabine. —-- __ ,, a , , Any unused product should be disposed of in accordance with local - The other ingredients are mannitol (E421), sodium acetate trihydrate reoiiirements (E262), sodium hydroxide (E524) (for pH adjustment) and hydrochloric q acid (E507) (for pH adjustment). What Gemcitabine looks like and contents of the pack Gemcitabine powder for solution for infusion is a white to off-white lyophilised powder. After reconstitution in 0.9% sodium chloride solution, the solution is clear to pale opalescent and colourless to pale yellow. Gemcitabine is contained in a flint glass vial with bromobutyl rubber stopper with flip off seal. | ||