Gemcitabine 200mg Powder For Solution For Infusion
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 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 misplacement 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 room temperature. 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.
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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 bleedtng 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
• 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 the 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 or toes
Very rare side effects
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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://yellowcard.mhra.gov.uk/. 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 carton and the vial.
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 room temperature. 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
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 looks like and contents of the pack
Gemcitabine is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200 or 1000 mg of gemcitabine. Each pack of Gemcitabine contains 1 vial.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom.
This leaflet was last revised in 07/2014
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