GEMCIT. 1000 mg. 50 ml.
Gemcitabine belongs to a group of medicines called "cytotoxic". These drugs kill dividing cells, including cancer.
Gemcitabine can be administered alone or in combination with other anticancer drugs, depending on the type of tumor. not
available data on safety and efficacy of the use of gemcitabine in children.
GEMCIT. 1000 mg. 50 ml.
Gemcitabine WHAT IS AND WHAT IT IS USED
Gemcitabine belongs to a group of medicines called " cytotoxic " . These drugs kill dividing cells , including cancer .
Gemcitabine can be administered alone or in combination with other anticancer drugs , depending on the type of tumor . not
available data on safety and efficacy of the use of gemcitabine in children.
Gemcitabine is used in the treatment of the following cancers:
non-small cell lung cancer (NSCLC ) , alone or in combination with cisplatin ;
pancreatic cancer ;
breast cancer in combination with paclitaxel;
ovarian cancer , in combination with carboplatin ;
carcinoma of the bladder, in combination with cisplatin.
2 . BEFORE YOU TAKE gemcitabine
Do not take gemcitabine :
if you are allergic (hypersensitive) to gemcitabine or any other ingredients of gemcitabine ;
if you are breastfeeding .
Take special care with gemcitabine :
Before the first infusion ( infusion) will take blood for laboratory tests to assess whether you have sufficient function
kidneys and liver. Before each infusion will take blood tests to assess whether you have sufficient number of cells to receive gemcitabine . Your doctor may decide to change the dose or delay your treatment based on your condition and if the number of your blood is too low. Periodically you will have blood tests to evaluate your kidney function and liver.
Please tell your doctor if:
have or have had liver disease , heart or blood vessels ;
have recently had or will undergo radiotherapy ;
appeared difficulty breathing or feel very weak and are very pale (may be a sign of worsening renal function).
Men are advised not to father a child during and up to 6 months after treatment with gemcitabine . If you want to father a child during treatment or during the 6 months after treatment , seek advice from your doctor or pharmacist. You may need to seek advice on conservation of sperm prior to treatment.
Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccines and medicines obtained without a prescription .
Pregnancy and lactation
Tell your doctor if you are pregnant or intend to become pregnant. The use of gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking gemcitabine during pregnancy .
If you are breastfeeding , tell your doctor.
You should stop breast-feeding during treatment with gemcitabine .
Driving and using machines
Gemcitabine can cause drowsiness , especially if you have consumed alcohol. Do not drive or operate machinery until you are sure that treatment with gemcitabine does not make you drowsy.
Important information about some of the ingredients of gemcitabine
Gemcitabine containing 3.5 mg (< 1 mmol) sodium per vial of 200 mg, 17,5 mg (< 1 mmol) sodium per vial 1000 mg, 26,3 mg (<1,1 mmol) sodium per vial 1500 mg and 35 mg (1,5 mmol) of sodium per vial than 2000 mg.
Be considered in patients who are on a controlled sodium diet on sodium.
3 . HOW TO TAKE gemcitabine
The usual dose of gemcitabine is 1000 - 1250 mg per square meter of your body's surface. Will measure your height and weight to calculate your body surface. Your doctor will use this body surface area to calculate the correct dose for you. This dose may be adjusted or treatment may be delayed depending on the number of your blood cells and your general condition .
How often receive gemcitabine infusion depends on the type of cancer that treated .
Hospital pharmacist or doctor will dissolve the powder gemcitabine before you implement it.
You'll get gemcitabine always 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 .
The frequency of reported adverse reactions are defined as:
very common: affects more than 1 in 10;
common: affects 1 to 10 users in 100 ;
uncommon: affects 1 to 10 patients in 1000 ;
rare: affects 1 to 10 patients in 10,000 ;
very rare: affects less than 1 user in 10 000 ;
not known from the available data can not be estimated .
You should contact your doctor immediately if you notice any of the following symptoms:
Fever or infection (common ) : if you have a temperature of 38 ° C or more , sweating or other signs of infection ( as you may have fewer white blood cells than normal , and it happens very often ) ;
Irregular heart rhythm ( arrhythmia) ( not known ) ;
Pain, redness , swelling or sores ( ulcers ) in the mouth ( common) ;
Allergic reactions: if you develop a skin rash ( very common) / itching ( often ), or fever (very common) ;
Fatigue , fainting, shortness of breath easily or pallor ( as you may have less hemoglobin than normal , it happens very often ) ;
Bleeding from the gums , nose or mouth or any bleeding that would not stop, reddish or pinkish urine , unexpected bruising ( as you may have less platelets than normal , it happens very often ) ;
Difficulty breathing ( very common to have mild difficulty breathing shortly after infusion of gemcitabine , which soon passes , however uncommonly or rarely have more severe lung problems).
Side effects of gemcitabine may include:
Very common side effects:
Low level of hemoglobin ( anemia ) ;
Low white blood cells;
Low platelet count ;
Difficulty breathing ;
Skin rash - allergic skin rash, often itchy ;
hair loss ;
Liver problems : found through abnormal results from blood tests ;
Blood in urine ;
Abnormal urine : protein in the urine;
Flu-like symptoms , including fever ;
Edema (swelling of the ankles , fingers , feet, face) .
Common side effects:
Temperature accompanied by low Bray of white blood cells ( neutropenia ) ;
Anorexia (lack of appetite) ;
Pain, redness , swelling or sores in the mouth;
Muscle pain ;
Uncommon side effects
Interstitial pneumonitis ( Replacement of the air sacs of the lungs with a connective tissue ) ;
Airways ( wheezing) ;
Abnormal X ray / scan of the chest ( scarring of the lungs ) .
Rare side effects:
Heart attack ( myocardial infarction) ;
Low blood pressure;
Flaking , formation of wounds or blisters ;
Reactions at the injection site .
Very rare side effects:
Increased platelet count ;
Anaphylactic reaction (severe hypersensitivity / allergic reaction) ;
Peeling of large areas of skin and the formation of large blisters on the skin.
Side effects with unknown frequency:
Irregular heart rhythm ( arrhythmia) ;
Respiratory distress syndrome ( a severe inflammation of the lungs causing respiratory failure) ;
Rash after exposure ( skin rash similar to sunburn ), which can occur on skin that previously exposed to radiotherapy ;
Fluid in the lungs ;
Radiation toxicity - Replacement of the air sacs of the lungs with the connective tissue associated with radiation therapy ;
Ischaemic colitis ( inflammation of the lining of the colon caused by reduced blood supply ) ;
Heart failure ;
Renal failure ;
Gangrene of the fingers or toes ;
Serious liver damage , including liver failure ;
You can have any of these symptoms and / or conditions. You should inform your doctor as soon as possible when you receive any of these side effects .
If any side effects worry you , talk to your doctor.
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor.
5 . HOW TO STORE GEMCIT
Keep out of reach of children.
Do not use after the expiry date ( EXP :) is stated on the carton.
This medicinal product does not require any special storage conditions .
The product should be used immediately. When reconstituted as directed, the chemical and physical stability over a period of use of the prepared solution of gemcitabine from 35 days at 25 ° C. Further dilution can be done by a medical professional . Reconstituted solutions of gemcitabine does not need to be kept refrigerated , as crystallisation can occur .
This medicine is for single use only , any unused solution should be discarded in accordance with local legal requirements.
6 . ADDITIONAL INFORMATION
Contents of gemcitabine
The active substance is gemcitabine. Each vial contains 200 mg, 1000 mg, 1500 mg or 2000 mg gemcitabine ( gemcitabine hydrochloride).
The other ingredients are mannitol ( E421 ), sodium acetate trihydrate , hydrochloric acid and sodium hydroxide.
Gemcitabine looks like and contents of pack
Gemcitabine is a white to off- white powder for infusion in a vial. Each vial contains 200 mg, 1000 mg, 1500 mg or 2000 mg gemcitabine.
Each pack contains 1 vial of gemcitabine .
Marketing Authorisation Holder:
Fresenius Kabi Bulgaria EOOD, Bulgaria .
Medac, Germany ;
Fresenius Kabi Oncology Plc., UK.
Date last approved package : December 2010 .
The following information is intended for medical professionals :
Special precautions for the disposal (and use ):
For single use only .
This product is shown to be compatible only with sodium chloride 9 mg / ml (0.9%) solution for injection . Accordingly , only this diluent should be used for reconstitution . Compatibility with other substances not studied. Therefore not recommended mixing this product with other active substances , when reconstituted .
Reconstitution at concentrations higher than 38 mg / ml may result in incomplete dissolution , and should be avoided .
To reconstitute , slowly add the appropriate volume of sodium chloride 9 mg / ml (0.9%) for injection (as shown in
the table below ) . Shake to dissolve.
Packing Volume sodium chloride 9 mg / ml (0.9%) solution for injection , which must be added to the volume of solution Final concentration
200 mg of 5 ml 5.26 ml 38 mg / ml
1000 mg 25 ml 26.3 ml 38 mg / ml
1500 mg 37.5 ml 39.5 ml 38 mg / ml
2000 mg, 50 ml 52.6 ml 38 mg / ml
The appropriate amount of the medicinal product can be further diluted with sodium chloride 9 mg / ml (0.9%) solution for injection .
Medicinal products for parenteral administration should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any unused portion of the solution must be discarded as described below .
Information for safe handling of cytotoxic drugs:
National guidelines for safe handling and preparation of cytotoxic drugs should be observed. Pregnant staff should work with cytotoxics . Preparation of injectable solutions of cytotoxic agents must be carried out only by trained personnel with knowledge of the medicines used . This should be done in a designated area .
The work surface should be covered with a removable unilateral impregnated absorbent paper.
Must provide adequate eye protection , disposable gloves , face mask and disposable apron .
You need to take precautions to avoid accidental contact of the drug with the eye. If this occurs , the eye should be washed immediately with plenty of water .
Syringes and infusion sets should be assembled carefully to avoid leakage (recommended to use Luer-lock devices) . Recommended needles with a vent to minimize pressure and the possible formation of aerosols. The latter may also be reduced with the use of a valve needle .
Spillage or leakage, the solution should be wiped up by personnel wearing protective gloves. Excreta and vomit must be cleaned carefully.