40 mg / mL concentrate for infusion solution
gemcitabine

1. What Gemcitabin Sandoz is and what it is used for

Gemcitabine Sandoz belongs to a group of medicines called cytostatics. This type of drug kills cells that divide, including cancer cells.

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

Gemcitabine Sandoz is used to treating the following cancers:

  • non- small cell lung cancer (NSCLC), as a single drug or in combination with cisplatin.
  • pancreatic cancer (cancer of the pancreas).
  • breast cancer, in combination with paclitaxel.
  • ovarian cancer (cancer of the ovaries), in combination with carboplatin.
  • bladder cancer, in combination with cisplatin.

Gemcitabine contained in Gemcitabine Sandoz 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 using Gemcitabin Sandoz

Do not use Gemcitabine Sandoz

  • 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 cautions

Before the first infusion, a blood sample will be taken to check that your liver and kidneys are working well enough for you to receive this medicine. Before each infusion, blood samples will be taken to check that the amount of blood cells is sufficient to obtain Gemcitabine Sandoz. Your doctor may decide to change the dose or postpone treatment depending on your general condition or if your blood levels are too low. Blood tests will be taken regularly to check how well your kidneys and liver are working.

Talk to your doctor or hospital pharmacist before using Gemcitabin Sandoz if:

  • you have or have had liver disease, heart disease or vascular disease or problems with your lungs or kidneys, as you may not be able to get Gemcitabine Sandoz.
  • you have recently received radiation therapy or if such treatment is planned, as an early or delayed radiation reaction may occur with Gemcitabin Sandoz
  • you have recently been vaccinated (especially against yellow fever), as this may have a detrimental effect with Gemcitabine Sandoz
  • you have difficulty breathing or feel very weak and very pale (as this may be a sign of kidney failure or lung problems)
  • you swell in the body, become short of breath or gain weight (because this can be a sign that fluid is leaking from small blood vessels to tissue one).

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

Children and young people

This medicine is not recommended for children under 18 years of age as there are insufficient data on safety and efficacy.

Other medicines and Gemcitabine Sandoz

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant or planning to become pregnant, tell your doctor. Treatment with Gemcitabine Sandoz should be avoided during pregnancy. Your doctor may inform you about the possible risk of Gemcitabine Sandoz when given during pregnancy.

Breast-feeding

Tell your doctor if you are breastfeeding.

Breast-feeding should be discontinued during treatment with Gemcitabine Sandoz.

Fertility

Men are advised against having children during treatment and up to 6 months after treatment with Gemcitabine Sandoz. If you wish to have children during treatment or during the 6 months following treatment, you should seek the advice of your doctor or pharmacist regarding the preservation of semen before treatment.

Driving and using machines

Treatment with Gemcitabine Sandoz may make you feel sleepy, especially if you have been drinking alcohol. Do not drive or use machines until you are sure that treatment with Gemcitabin Sandoz does not make you sleepy.

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.

3. How to use Gemcitabine Sandoz

The usual dose of Gemcitabine Sandoz is 1000-1250 mg per square meter of body surface area. Your height and weight are used to calculate body surface area. Your doctor will use the measurement of your body surface area to calculate the correct dose for you. This dose can be adjusted or the treatment can be postponed depending on your blood levels and your general condition.

How often you receive an infusion of Gemcitabine Sandoz depends on the type of cancer you are being treated for.

Gemcitabine Sandoz is always given as an infusion (after dilution) into 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, fainting, shortness of breath or paleness (because your hemoglobin value may be lower than normal, which is very common)
  • Mild to moderate rash (very common) / itching (common) or fever (very common) (allergic reactions)
  • Body temperature of 38 ° C or higher, sweating or other signs of infection (because you may have fewer white blood cells than normal along with fever, which is called febrile neutropenia ) (common)
  • Pain, redness , swelling or sores in the mouth (inflammation of the mouth) (common)
  • Arrhythmia in the heart (less common)
  • Extreme fatigue and weakness, slight bleeding in the skin (bruising), acute renal failure (low or no urine output) and signs of infection ( hemolytic uremic syndrome ); the condition can be fatal (less common)
  • Difficulty breathing (it is very common to have mild breathing difficulties shortly after Gemcitabin Sandoz infusion, 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 (including red, itchy skin), swelling of hands, feet, ankles, face, lips, mouth or throat (may cause difficulty swallowing or breathing), wheezing, palpitations and fainting. ( anaphylactic reaction ) (very rare)
  • General swelling, shortness of breath or weight gain, as fluid may leak from small blood vessels to tissues (capillary leakage syndrome) (very rare)
  • Headache with vision changes, confusion, seizures (posterior reversible encephalopathy syndrome) (very rare)
  • Severe rash with itching , blistering or scaly skin (Stevens-Johnson syndrome, toxic epidermal necrolysis ) (very rare)
  • Extreme fatigue and weakness, purple or small areas with bleeding in the skin (bruising), acute renal failure (low urine output or no urine output) and signs of infection . These can be signs of thrombotic microangiopathy (blood clots that form in small blood vessels) and hemolytic uremic syndrome , which can be fatal.

Other side effects are of Gemcitabine Sandoz may include:

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

  • Low white blood cell count
  • 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
  • Headache
  • Sleeping problems
  • Somnolence
  • Cough
  • Snuva
  • Constipation
  • Diarrhea
  • Itching
  • Sweating
  • Muscle pain
  • Back pain
  • Fever
  • Impotence
  • Overindulge
  • Elevated liver values ​​( bilirubin )
  • Infection is.

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

  • Scarring of the lung air sacs (interstitial pneumonitis )
  • Wheezing (respiratory cramps)
  • Scarring of the lungs (abnormal X-ray of the chest)
  • Stroke
  • Heart failure
  • Kidney failure
  • Serious liver damage, including liver failure that can lead to death.

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

  • Low blood pressure
  • Skin peeling, skin sores or blistering
  • Flaky skin and severe blisters on the skin
  • Injection site reactions
  • Severe pneumonia causing respiratory failure ( acute respiratory failure syndrome)
  • Skin rash that is similar to severe sun damage, which can occur on skin that has previously been subjected to radiation treatment (so-called radiation recall)
  • Fluid in the lungs
  • Scarring in the air bubbles of the lung in connection with radiation therapy (radiation toxicity)
  • Gangrene (cold sores) in fingers or toes
  • Inflammation of blood vessels
  • Elevated liver values ​​(gamma-glutamyltransferase, GGT).

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 )
  • Thrombotic microangiopathy: blood clots that form in small blood vessels.

Has been reported (occurs in an unknown number of users):

  • Sepsis: when bacteria and its toxins er (toxins) circulate in the blood and begin to damage organs
  • Pseudocellulite: Reddening of the skin with swelling.

Low hemoglobin ( anemia ), low white blood cell count, and altered platelet count, as seen in blood samples.

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 Sandoz

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 label after EXP. or EXP. The expiration date is the last day of the specified month.

The hospital pharmacy must store the Gemcitabine Sandoz bottles at 2 ° C – 8 ° C. Do not freeze.

If the solution is stored at temperatures below 2 ° C, the precipitate may form.

If the solution looks discolored or contains visible particles, discard it.

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 (as hydrochloride).

1 ml concentrate for solution for infusion contains 40 mg gemcitabine (as hydrochloride).

One 5 ml bottle contains 200 mg gemcitabine (as hydrochloride).

One 25 ml bottle contains 1000 mg of gemcitabine (as hydrochloride).

One 50 ml bottle contains 2000 mg gemcitabine (as hydrochloride).

The other ingredients are water for injections and dilute hydrochloric acid (for pH adjustment).

What the medicine looks like and contents of the pack

The drug is a concentrated solution for infusion.

The concentrate for solution for infusion is a clear, colorless to light yellow solution in a colorless glass bottle (type I glass) closed with a gray rubber stopper ( Ph. EUR, type I) with or without plastic protection (Onco ‑ Safe or protective foil). “Onco ‑ Safe” and protective foil are not in contact with the medicine and provide increased safety during transport, which increases the safety of pharmacy and medical staff during transport.

Pack sizes:

200 mg / 5 ml: 1 vial , 5 vials, 10 vials.

1,000 mg / 25 ml: 1 vial .

2,000 mg / 50 ml: 1 vial .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

EBEWE Pharma Ges.mbH Nfg. KG, 4866 Unterach, Austria

Muhammad Nadeem

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