Gemcitabine Stada 38mg/Ml Concentrate For Solution For Infusion
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Gemcitabine STADA 38 mg/ml Concentrate 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 any further questions, ask your doctor, pharmacist or nurse.
- 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 STADA is and what it is used for
2. What you need to know before you are given Gemcitabine STADA
3. How Gemcitabine STADA is given
4. Possible side effects
5. How to store Gemcitabine STADA
6. Contents of the pack and other information
1. What Gemcitabine STADA is and what it is used for
Gemcitabine STADA belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells.
Gemcitabine STADA may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer.
Gemcitabine STADA 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 STADA You should not be given Gemcitabine STADA
• 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 STADA. 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, pharmacist or nurse before you are given Gemcitabine STADA
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 STADA.
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 STADA.
If you have been vaccinated recently, please tell your doctor as this can possibly cause bad effects with Gemcitabine STADA.
If during treatment with this medicine, you get symptoms such as 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 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.
If you are suffering from alcoholism, as this medicinal product contains ethanol (alcohol)
If you are suffering from epilepsy, as this medicinal product contains ethanol (alcohol)
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 STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The amount of alcohol in this medicinal product may alter the effects of other medicines.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. The use of Gemcitabine STADA should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine STADA during pregnancy.
Breast-feeding
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine STADA treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine STADA. 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 STADA 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 treatment with Gemcitabine STADA has not made you feel sleepy.
The amount of alcohol in this medicine may impair your ability to drive or use machines. Gemcitabine STADA contains alcohol
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 21 g per 2 g dose, equivalent to 525 ml beer or 220 ml wine per dose
• Harmful for those suffering from alcoholism.
• To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
• The amount of alcohol in this medicinal product may alter the effects of other medicines.
• The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Gemcitabine STADA contains sodium
This medicinal product contains 7.6 mmol (175 mg) sodium per 2 g dose. To be taken into consideration by patients on a controlled sodium diet.
3. How Gemcitabine STADA is given
The usual dose of Gemcitabine STADA is 1,000-1,250 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 STADA infusion depends on the type of cancer that you are being treated for.
A hospital pharmacist or doctor will have diluted the Gemcitabine STADA concentrate before it is given to you.
You will always receive Gemcitabine STADA 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, pharmacist or nurse.
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:
• 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).
• Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
• Mild to moderate skin rash (very common) / itching (common), or fever (very common); (allergic reactions).
• 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).
• Pain, redness, swelling or sores in your mouth (stomatitis) (common).
• Irregular heart rate (arrhythmia) (uncommon).
• 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 uraemic syndrome). It may be fatal (uncommon).
• Difficulty breathing (it is common to have mild breathing difficulty soon after the Gemcitabine STADA 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).
Other side effects with Gemcitabine STADA may include:
Very common side effects (may affect more than 1 in 10 people)
• Low white blood cells
• Difficulty 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 ankles, fingers, feet, 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
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.
5. How to store Gemcitabine STADA
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 after “EXP”.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Solution for infusion:
Chemical and physical in-use stability after dilution in 0.9 % sodium chloride solution has been demonstrated for 3 days at 2 °C to 8 °C or at 30 °C.
From a microbiological point of view, the solution for infusion 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 2 °C to 8 °C unless dilution has taken place in controlled and validated aseptic conditions.
This medicine will be prepared and administered to you by healthcare staff. Any unused medicine must be disposed of by the healthcare staff.
6. Contents of the pack and other information
What Gemcitabine STADA contains
• The active substance is gemcitabine.
Each ml of the concentrate for solution for infusion contains 38 mg gemcitabine (as gemcitabine hydrochloride).
Each vial contains either 200 mg, 1,000 mg, 1,500 mg or 2,000 mg gemcitabine (as gemcitabine hydrochloride).
• The other ingredients are ethanol 96 %, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
What Gemcitabine STADA looks like and contents of the pack
This medicine is a concentrate for solution for infusion.
The concentrate is a clear, colourless to slightly yellow solution. It is filled in clear glass vials sealed with rubber stoppers and aluminium flip-off caps.
Each vial of 5.26 ml contains 200 mg gemcitabine.
Each vial of 26.3 ml contains 1,000 mg gemcitabine.
Each vial of 39.5 ml contains 1,500 mg gemcitabine.
Each vial of 52.6 ml contains 2,000 mg gemcitabine.
Each pack contains 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
Manufacturer
cell pharm GmbH Feodor-Lynen-Str. 35
30625 Hannover Germany
This leaflet was last approved in 02/2015
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Belgium
Czech Republik
Denmark
Estonia
France
Germany
Hungary
Lithuania
Luxembourg
Netherlands
Portugal
Romania
Sweden United Kingdom
Gemcitabin STADA 38 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Gemcitabine EG 38 mg/ml concentraat voor oplossing voor infusie GEMSTAD38 mg/ml koncentrat pro pnpravu infuzmho roztoku Gemstada
GEMCITABINE STADA
GEMCITABINE EG 38 mg/ml, solution a diluer pour perfusion GEMCI-cell 38 mg/ml Konzentrat zur Herstellung einer Infusionslosung GEMSTAD38 mg/ml koncentratum oldatos infuziohoz Gemcitabine STADA 38 mg/ml koncentratas infuziniam tirpalui Gemcitabine EG 38 mg/ml solution a diluer pour perfusion Gemcitabine CF 38 mg/ml, concentraat voor oplossing voor infusie Gemcitabina Stada 38 mg/ml Concentrado para solugao para perfusao Gemcitabin Stada 38 mg/ml concentrat pentru solute perfuzabilaSlovak Republic GEMSTAD
Gemcitabin STADA koncentrat till infusionsvatska, losning Gemcitabine STADA 38 mg/ml Concentrate 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 preparation of gemcitabine for intravenous infusion administration.
2. Calculate the dose and the number of Gemcitabine STADA vials needed.
3. Gemcitabine STADA concentrate for solution for infusion is a clear, colourless to slightly yellow solution with a concentration of 38 mg/ml gemcitabine. The concentrate should be diluted with sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative.
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. Chemical and physical in-use stability of the solution for infusion has been demonstrated for 3 days at 2°C to 8°C or at 30 °C. From a microbiological point of view, the solution for infusion 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 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
6. Gemcitabine infusion 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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