38 mg / ml powder for infusion solution
Gemcitabine

1. What Gemcitabine Fresenius Kabi is and what it is used for

Gemcitabine Fresenius Kabi belongs to a group of medicines called “cytotoxic drugs”. These drugs kill dividing cells, including cancer cells.

Gemcitabine Fresenius Kabi can be given alone or in combination with other anticancer medicines, depending on the type of cancer.

Gemcitabine Fresenius Kabi 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, along with paclitaxel.
  • ovarian cancer, along with carboplatin.
  • bladder cancer, along with cisplatin.

Gemcitabine contained in Gemcitabine Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Gemcitabin Fresenius Kabi

Do not use Gemcitabine Fresenius Kabi

  • if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of this medicine (listed in section 6).
  • if you are breast-feeding.

Warnings and cautions

Before the first infusion, you will be given blood samples that are used to assess whether your kidneys and liver are working well enough for you to receive this medicine. Before each infusion, you will be given blood samples which are used to check if you have enough blood cells to get Gemcitabine Fresenius Kabi. Your doctor may change the dose or postpone treatment depending on your general condition or if you have too few blood cells.

You will be regularly given blood samples that are used to find out how well your kidneys and your liver are working.

Talk to your doctor, nurse, or pharmacist before using Gemcitabin Fresenius Kabi.

If you have or have ever had liver disease, heart disease, vascular disease, or kidney problems, talk to your doctor or pharmacist as you may not be able to get Gemcitabine Fresenius Kabi.

If you have recently received radiation therapy or if such treatment is planned, tell your doctor as there may be an immediate or delayed radiation reaction with Gemcitabine Fresenius Kabi.

If you have recently been vaccinated, tell your doctor as this may cause side effects with Gemcitabine Fresenius Kabi.

If you get symptoms such as headache with confusion, seizures, or changes in vision during treatment with this medicine, contact your doctor immediately. This can be a very rare side effect in the nervous system called “posterior reversible encephalopathy syndrome”

If you have difficulty breathing or feel very weak and very pale, tell your doctor as this may be a sign of kidney failure or lung problems.

If you have swelling in your body, shortness of breath, or gain weight, tell your doctor as this may be a sign that fluid is leaking from the small blood vessels to the surrounding tissue.

Children and young people

This medicine is not recommended for children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Gemcitabine Fresenius Kabi

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and vaccines.

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant or planning to become pregnant, tell your doctor. The use of Gemcitabine Fresenius Kabi should be avoided during pregnancy. Your doctor may tell you about the risks of treatment with Gemcitabine Fresenius Kabi during pregnancy.

Breast-feeding

If you are breastfeeding, tell your doctor.

You must stop breastfeeding during treatment with Gemcitabine Fresenius Kabi.

Fertility

Men are advised not to have children during treatment and up to 6 months after treatment with Gemcitabin Fresenius Kabi. If you wish to have children during treatment or during the 6 months following treatment, you should consult a doctor before prescribing sperm preservation.

Driving and using machines

Gemcitabine Fresenius Kabi can make you drowsy, especially if you have been drinking alcohol. Do not drive or use machines until you are sure that treatment with Gemcitabin Fresenius Kabi does not make you drowsy.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Gemcitabine Fresenius Kabi contains sodium

Gemcitabine Fresenius Kabi contains 3.5 mg (<1 mmol) sodium per 200 mg vial , 17.5 mg (<1 mmol) sodium per 1,000 mg vial and 35 mg (1.5 mmol) sodium per 2,000 mg mg vial . This should be considered by patients on a low-sodium diet.

3. How to use Gemcitabine Fresenius Kabi

The usual dose of Gemcitabine Fresenius Kabi is 1,000-1,250 mg per square meter of body surface area. You will be measured and weighed and the values ​​obtained will be used to calculate your body surface area. Your doctor will use your body surface area to calculate the right dose for you. Depending on your general condition and your blood counts, your doctor may change this dose or postpone treatment.

How often you get an infusion of one with Gemcitabine Fresenius Kabi depends on the type of cancer you are being treated for.

Pharmacy or healthcare professionals will make a solution of Gemcitabin Fresenius Kabi powder, before giving it to you.

You will always receive Gemcitabine Fresenius Kabi by infusion into a blood vessel (a vein). Infusion one lasts for about 30 minutes.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should contact your doctor immediately if you notice any of the following:

  • Bleeding in the gums, nose or mouth or any non-stop bleeding, reddish or pinkish urine, unexpected bruising (because you may have smaller platelets than normal, which is very common).
  • Fatigue, feeling weak, short of breath or if you look pale (because you have less hemoglobin than normal, which is very common).
  • If you get mild to moderate rash (very common) / itching (common), or fever (very common) (allergic reactions).
  • If you have a temperature of 38 ° C or more, sweat or have other signs of infection (because you may have smaller white blood cells than normal, along with fever, is called febrile neutropenia ) (common).
  • Pain, redness , swelling or sores in the mouth ( stomatitis ) (common).
  • Irregular heart rhythm ( arrhythmia ) (less common).
  • Extreme fatigue and weakness, bruising or slight bleeding in the skin, acute renal failure (low or no urinary excretion) and signs of infection ( haemolytic uremic syndrome ). It can be fatal (less common).
  • Difficulty breathing (it is very common to have mild breathing difficulties shortly after infusion one with gemcitabine which passes quickly, but in less common or rare cases more serious lung problems may occur).
  • Severe chest pain (heart attack) (rare)
  • Severe hypersensitivity / allergic reaction with severe rash with red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may make it difficult to swallow or breathe), wheezing, rapid heartbeat and fainting ( anaphylactic reaction ) (very rare)
  • General swelling of the body, shortness of breath or weight gain, which may indicate fluid leakage from small blood vessels to surrounding tissue (capillary leakage syndrome ) (very rare)
  • Headache with vision changes, confusion or seizures (posterior reversible encephalopathy syndrome) (very rare)
  • Severe skin rash with itching , blistering or flaking of skin ( Stevens-Johnson syndrome , toxic epidermal necrolysis ) (very rare)

Other side effects of Gemcitabine Fresenius Kabi may include:

Very common: (may affect more than 1 user in 10)

  • Low white blood cell count
  • Breathing difficulties
  • Vomiting
  • Nausea
  • Hair loss
  • Liver problems detected using blood tests
  • Blood in the urine
  • Abnormal urine values: egg white in the urine
  • Flu-like symptoms that include fever
  • Swelling of the ankles, fingers, feet, face ( edema )

Common: (may affect up to 1 in 10 people)

  • Poor appetite ( anorexia )
  • Headache
  • Insomnia
  • Somnolence
  • Cough
  • Runny nose
  • Constipation
  • Diarrhea
  • Itching
  • Sweating
  • Muscle pain
  • Back pain
  • Fever
  • Impotence
  • Overindulge

Uncommon: (may affect up to 1 in 100 people)

  • Scarring of the lung air sacs (interstitial pneumonitis )
  • Beeping sound when breathing (respiratory cramps)
  • Scarring of the lungs (abnormal X-ray of the chest)
  • Heart failure
  • Kidney failure
  • Severe liver damage, including liver failure
  • Stroke

Rare: (may affect up to 1 in 1,000 people)

  • Low blood pressure
  • Skin peeling, skin sores or blistering
  • Skin flaking and severe blistering on the skin
  • Injection site reactions one
  • Severe pneumonia which can cause breathing difficulties (Adult Respiratory Distress Syndrome)
  • Skin rash that resembles severe sunburn, which can occur on skin that has previously been exposed to radiation treatment (radiation recall)
  • Fluid in the lungs
  • Scarring in the alveoli due to radiation therapy (radiation toxicity)
  • Tissue death (cold burn) in fingers or toes
  • Inflammation of the blood vessels ( peripheral vasculitis )

Very rare: (may affect up to 1 in 10,000 people)

  • Increased platelet count
  • Inflammation of the wall of the colon caused by decreased blood supply (ischemic colitis )
  • Low hemoglobin levels ( anemia ), low levels of white blood cells and platelets , can be detected by a blood test

You may get any of these symptoms/conditions. If you get any of these side effects, tell your doctor as soon as possible.

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 also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gemcitabin Fresenius Kabi

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. dat. or EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Reconstituted solution: The solution should be used immediately. Chemical and physical in-use stability has been demonstrated in reconstituted gemcitabine solutions, prepared as directed, for 24 hours at 25 ° C. Healthcare professionals can further dilute the solution. Reconstituted gemcitabine solutions should not be stored in the refrigerator as precipitation may occur.

Diluted solution: Chemical and physical in-use stability of the diluted solution of gemcitabine has been demonstrated for 30 days at 25 ° C.

Do not use Gemcitabine Fresenius Kabi if the solution contains particles and / or is discolored.

This medicine is for single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is gemcitabine. Each vial contains 200, 1,000 or 2,000 mg of gemcitabine (as gemcitabine hydrochloride).
The other ingredients are mannitol (E421), sodium acetate trihydrate, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

What the medicine looks like and contents of the pack

Gemcitabine Fresenius Kabi is a white to off-white powder for solution for infusion in a vial . Each vial contains 200, 1,000 or 2,000 mg of gemcitabine. Each pack of Gemcitabine Fresenius Kabi contains 1 vial.

Marketing Authorization Holder and Manufacturer

Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF,
United Kingdom

This medicinal product is authorized under the European Economic Area under the names:

Belgium: Gemcitabine Fresenius Kabi 38 mg / ml powder for solution for infusion
Cyprus: Gemcitabine Kabi 38 mg / ml can be used as a medicine
Spain: Gemcitabina Kabi 200 mg powder for EFG perfusion solutionGemcitabina Kabi 1,000 mg powder for EFG perfusion solutionGemcitabina Kabi 2000mg polvo para Solucion para perfusion
France: Gemcitabine Kabi 38 mg / ml powder for perfusion solution
Hungary: Gemcitabine Kabi 38 mg / ml by infusion infusion
Ireland: Gemcitabine 200 mg powder for solution for infusionGemcitabine 1 g powder for solution for infusionGemcitabine 2 g powder for solution for infusion
Italy: Gemcitabina Kabi 38 mg / ml powder per solution for infusion
Sweden: Gemcitabine Kabi 38 mg / ml powder for infusion solution
Slovenia: Gemcitabine Kabi 38 mg / ml prescription for infusion
UK: Gemcitabine 38 mg / ml powder for solution for infusion

Muhammad Nadeem

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