40 mg / mL concentrate for infusion solution
gemcitabine

1. What Gitrabin is and what it is used for

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

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

Gitrabin is used to treat the following types of cancer:

  • a type of lung cancer (non- small cell lung cancer ), as a single drug or in combination with cisplatin
  • pancreatic cancer
  • breast cancer, along with paclitaxel
  • ovarian cancer, along with carboplatin
  • bladder cancer, together with cisplatin.

Gemcitabine contained in Gitrabin may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Gitrabin

Do not use Gitrabin

  • 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

Talk to your doctor or pharmacist before using Gitrabin.

Before the first infusion, a blood sample will be taken to determine if your kidney and liver function is adequate. Before each infusion, blood samples will be taken to check that you have enough blood cells to receive Gitrabin. Your doctor may decide to change your 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 your kidney and liver function.

Talk to your doctor before using Gitrabin if:

  • you have or have previously had any liver disease, heart disease, vascular disease or problems with your kidneys
  • you have previously received radiation treatment or if such treatment is planned
  • you have recently been vaccinated
  • you have difficulty breathing or feel very weak and are very pale (may be a sign of kidney failure or lung problems).
  • If you experience symptoms such as headache with confusion, seizures or changes in vision during treatment with this medicine, you should contact your doctor immediately. This can be a very rare side effect in the nervous system called posterior reversible encephalopathy syndrome.
  • If you have swelling in your body, shortness of breath or gain weight, you should consult your doctor, as this may be a sign that fluid is leaking from small blood vessels into the tissue .

Children and young people

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

Other drugs and Gitrabin

Tell your doctor or pharmacist if you are taking or have recently taken or might be taking any other medicines, including vaccines and over-the-counter medicines, or if you have recently been or will be having radiation therapy before using this medicine.

Pregnancy, breastfeeding and fertility

Pregnancy

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. Treatment with Gitrabin should be avoided during pregnancy. Your doctor can inform you about the possible risk of Gitrabin when it is given during pregnancy.

Breast-feeding

Tell your doctor if you are breastfeeding.

You should stop breastfeeding during treatment with Gitrabin.

Fertility

Men are advised not to have children during treatment and up to 6 months after treatment with Gitrabin. If you wish to have children during treatment or during the 6 months following treatment, you should seek advice from your doctor or healthcare professional regarding freezing semen before treatment.

Driving and using machines

Gitrabin can make you sleepy.

Do not drive or use machines until you are sure that Gitrabin treatment does not affect your attention.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 Gitrabin

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose of Gitrabin is 1000-1250 mg per square meter of body surface area. Your height and weight are used to calculate your body surface area. Your doctor will use the measurement of your body surface area to calculate the correct dose for you. The dose may need to be changed or the treatment may need to be postponed depending on your blood levels and your general condition.

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

Pharmacy or healthcare professionals will dilute the Gitrabin concentrate before giving it to you.

Gitrabin is always given as an infusion into a vein. Infusion one lasts for about 30 minutes.

This medicine is not recommended for children under 18 years of age.

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

  • Fever or infection (common (may affect up to 1 in 10 people)): if you have a temperature of 38ºC or more, sweat or have other signs of infection (because you may have fewer white blood cells , which is very common).
  • Irregular heartbeat (less common (may affect up to 1 in 100 people)).
  • Pain, redness , swelling or soreness in the mouth (common (may affect up to 1 in 10 people)).
  • Allergic reaction: if you get a rash (very common (may affect more than 1 in 10 people)) / itching (common (may affect up to 1 in 10 users)) or fever (very common (may affect more than 1 in 10 users) )).
  • Anaphylactic reaction (severe hypersensitivity / allergic reaction) with severe rash including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat ( tachycardia ) and possibly a feeling that you will faint ( anaphylactic reaction ) (very rare (may affect up to 1 in 10,000 users))
  • Myocardial infarction (rare (may affect up to 1 in 1,000 people))
  • Fatigue, feeling weak, easy to breathe or if you look pale (because you have less hemoglobin than normal, which is very common (may affect more than 1 in 10 users)).
  • Bleeding in the gums, nose or mouth as well as non-stop bleeding, reddish or pinkish urine, unexpected bruising (because you may have smaller platelets than normal, which is very common (may affect more than 1 in 10 users)).
  • Difficulty breathing (shortly after Gitrabin infusion , it is very common to have mild breathing difficulties, which pass quickly, but in less common or rare cases, more serious lung problems may occur).
  • Headache with vision changes, confusion, seizures or seizures ( Reversible Posterior Leukoencephalopathy Syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) (very rare (may affect up to 1 in 10,000 users))
  • General swelling, shortness of breath or weight gain, as you may have fluid leakage from small blood vessels to the tissues (capillary leakage syndrome ) (very rare (may affect up to 1 in 10,000 users))
  • Severe rash with itching , blistering or scaly skin ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) (very rare (may affect up to 1 in 10,000 users).
  • 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 with Gitrabin may include:

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

  • low white blood cell count
  • breathing difficulties
  • vomiting
  • nausea
  • hair loss
  • liver problems detected by blood tests
  • blood in the urine
  • abnormal urine values: egg white in the urine
  • flu-like symptoms that include fever
  • edema (swelling of the ankles, fingers, feet, face)

Common side effects (may affect up to 1 in 10 people)

  • anorexia (poor appetite)
  • headache
  • insomnia
  • somnolence
  • cough
  • Runny nose
  • constipation
  • diarrhea
  • itching
  • sweating
  • muscle pain
  • back pain
  • fever
  • impotence
  • overindulge
  • infection is

Uncommon side effects (may affect up to 1 in 100 people)

  • stroke ( stroke )
  • heart failure
  • interstitial pneumonitis (scarring of the lungs)
  • respiratory cramps (wheezing when breathing)
  • abnormal X-ray of the breast (scarring of the lungs)
  • severe liver damage, including liver failure, which can be life-threatening
  • kidney failure

Rare side effects (may affect up to 1 in 1000 people)

  • low blood pressure
  • tissue death in fingers or toes
  • fluid in the lungs
  • severe pneumonia causing respiratory failure (respiratory failure syndrome in adults)
  • peeling, sores on the skin or blistering
  • injection site reactions
  • scarring of the lung air sacs after radiation therapy (radiation damage)
  • skin rash, which is similar to severe sun damage, and which can occur on skin that has previously been exposed to radiation (radiation recall)

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

  • increased platelet count
  • ischemic colitis ( inflammation of the wall of the colon caused by decreased blood supply)
  • 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 (toxins) circulate in the blood and begin to damage organs
  • pseudocellulite: Reddening of the skin with swelling

If you have any of these symptoms and/or conditions, or when you start to experience any of these side effects, you must tell your doctor immediately.

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 Gitrabin

Keep this medicine out of the sight and reach of children.

Unopened vial

Store in a refrigerator (2 ºC – 8 ºC).

After the first opening

Chemical and physical in-use stability has been demonstrated for 28 days at 25 ºC and at 2-8 ºC.

From a microbiological point of view, the product should be used immediately, unless the method of opening excludes the risk of microbiological contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Infusion solution

Chemical and physical in-use stability has been demonstrated for 28 days at 2 till to 8 ºC and at approximately 25 ºC after dilution in 0.9% sodium chloride solution to a final concentration between 2-25 mg / ml (2.0 mg / ml, 12 mg / ml and 25 mg / ml). Diluted solutions are stable when packaged in either PVC or PE infusion bags.

From a microbiological point of view, the infusion solution 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 till to 8 ºC unless diluted under controlled and aseptically validated conditions.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.

Gitrabin should not be used if visible particles are present.

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 gemcitabine hydrochloride). Each ml of concentrate for solution for infusion contains 40 mg gemcitabine (as gemcitabine hydrochloride). Each 5 ml vial contains 200 mg of gemcitabine (as gemcitabine hydrochloride). Each 25 ml vial contains 1 g of gemcitabine (as gemcitabine hydrochloride). Each 50 ml vial contains 2 g of gemcitabine (as gemcitabine hydrochloride).
  • The other ingredients are hydrochloric acid (for pH adjustment), water for injections.

What the medicine looks like and contents of the pack

Gitrabin concentrate for solution for infusion is a clear colorless or slightly yellow solution.

Gitrabin is supplied in stained glass vials with a rubber stopper and is sealed with polypropylene sheet aluminum caps.

Each vial is packaged with or without a protective plastic cover.

Pack sizes

1 x 5 ml vial

1 x 25 ml vial

1 x 50 ml vial

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC EHF.

Reykjarvíkurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Actavis Italy SpA-Nerviano Plant

Viale Pasteur 10

20014 Nerviano (MI)

Italy

Muhammad Nadeem

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