38 mg / mL concentrate for infusion solution
gemcitabine
1. What Gemkabi is and what it is used for
Gemkabi belongs to a group of medicines called cytostatics. This type of drug kills cells that divide, including cancer cells.
This medicine can be given alone or in combination with other anticancer medicines, depending on the type of cancer.
This medicine is used to treat the following types of cancer:
- non- small cell lung cancer (NSCLC), as a single drug or in combination with cisplatin
- cancer of the pancreas (pancreatic cancer)
- breast cancer, along with paclitaxel
- ovarian cancer ( ovarian cancer ), together with carboplatin
- bladder cancer, together with cisplatin
Gemcitabine found in Gemkabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Gemkabi
Do not use Gemkabi
- 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 from you to find out if your kidneys and liver are working well enough for you to receive this medicine. Before each infusion, blood samples will be taken from you to check that the amount of blood cells is sufficient for you to receive gemcitabine. Your doctor may decide to change the dose or postpone treatment depending on your general condition or if the values from the blood tests are too low. Blood tests will be taken regularly to find out how well your kidneys and liver are working.
Talk to your doctor, nurse, or pharmacist before using gemcitabine.
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.
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.
If you have recently been vaccinated, tell your doctor as this may cause side effects along with gemcitabine.
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 Gemkabi
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including vaccines and medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant or planning to have a baby, ask your doctor for advice. Treatment with gemcitabine should be avoided during pregnancy. Your doctor will inform you of any possible risks when gemcitabine is given during pregnancy.
Breast-feeding
Tell your doctor if you are breastfeeding.
Breast-feeding should be discontinued during treatment with gemcitabine.
Fertility
Men are advised not to have children during treatment and up to 6 months after treatment with gemcitabine. 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
Gemkabi can make you feel sleepy, especially if you have drunk alcohol. Do not drive or use any tools or machines until you are sure that gemcitabine treatment will 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.
Gemkabi contains sodium and propylene glycol:
The 200 mg bottle contains less than 1 mmol sodium (23 mg) per bottle, ie essentially ‘sodium-free.
The 1000 mg bottle contains 98.36 mg of sodium (the main ingredient in table salt/table salt) per bottle, corresponding to 4.92% of the maximum recommended daily intake of sodium for adults.
The 2000 mg bottle contains 196.72 mg of sodium (the main ingredient in table salt/table salt) per bottle, corresponding to 9.84% of the maximum recommended daily sodium intake for adults.
This medicine contains propylene glycol, which may cause alcohol-like symptoms.
Only use this medicine if you have been advised to do so by a doctor. Your doctor may perform additional checks while you are taking this medicine.
3. How to use Gemcitabine
The usual dose of gemcitabine 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 depends on the type of cancer you are being treated for.
A hospital pharmacist or doctor will have diluted the gemcitabine concentrate before giving it to you.
This medicine must always be diluted before you receive it as an infusion into a vein. Infusion one will last 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 . It can be due to thrombotic microangiopathy (clots in small blood vessels) or hemolytic uremic syndrome , which can be fatal.
- 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 Gemkabi 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
- Infection is
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
- 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
- Thrombotic microangiopathy: clot formation in small blood vessels
No known frequency: can not be calculated from the available data
- Blood poisoning: when bacteria and their toxins circulate in the blood and begin to damage organs
- Pseudocellulitis: Redness and swelling of the skin.
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 Gemcitabine
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 label and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in a cold place. Do not freeze.
Shelf life after dilution ( solution for infusion ):
Chemical and physical in-use stability after dilution with sodium chloride 9 mg/ml at a concentration of 0.1 mg/ml and 5 mg/ml has been demonstrated for 7 days at 2 ° C – 8 ° C or at 25 ° C.
From a microbiological point of view, the product 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 – 8 ° C unless dilution has taken place under control and validated aseptic conditions.
This medicine is for single use only. Any unused solution should be discarded.
Do not use this medicine if it is discolored or contains visible particles.
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 ml of concentrate for solution for infusion contains gemcitabine hydrochloride equivalent to 38 mg gemcitabine.Each vial contains 200 mg of gemcitabine (as gemcitabine hydrochloride)Each vial contains 1000 mg of gemcitabine (as gemcitabine hydrochloride)Each vial contains 2000 mg gemcitabine (as gemcitabine hydrochloride) - The other ingredients are propylene glycol, macrogol 400, sodium hydroxide (E524) (for pH adjustment), concentrated hydrochloric acid (E507) (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
This medicine is a concentrated solution for infusion.
Gemkabi 38 mg/ml is a concentrate for solution for infusion and a clear, colorless to the slightly yellowish solution, free from visible particles.
Each pack contains 1 vial of 5.26 ml, 26.3 ml, or 52.6 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi AB
751 74 Uppsala
Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Gemcitabine Kabi 38 mg/ml concentrate for the preparation of an infusion solution |
| Belgium | Gemcitabine Fresenius Kabi 38 mg / ml concentrate for solution for infusion (200 mg / 5.26 ml)Gemcitabine Fresenius Kabi 38 mg / ml concentrate for solution for infusion (1000 mg / 26.3 ml)Gemcitabine Fresenius Kabi 38 mg / ml concentrate for solution for infusion (2000 mg / 52.6 ml) |
| Czech Republic | Gemcitabine Kabi 38 mg/ml concentrate for infusion of roztok |
| Germany | Gemcitabine Kabi 38 mg/ml concentrate for the preparation of an infusion solution |
| Denmark | Gemkabi |
| Estonia | Gemcitabine Kabi 38 mg / ml |
| Spain | Gemcitabina FK 200 mg concentrate for perfusion solution,Gemcitabina FK 1000 mg concentrate for solution for perfusion, Gemcitabina FK 2000 mg concentrate for solution for perfusion |
| Finland | Gemkabi |
| France | Gemcitabine Kabi 38 mg / ml solution à diluer pour perfusion |
| Hungary | Gemcitabine Kabi 38 mg / ml concentrated infusion solution |
| Ireland | Gemcitabine 38 mg / ml concentrate for solution for infusion |
| Iceland | Gemkabi |
| Latvia | Gemcitabine Kabi 38 mg / ml concentrated infusion solution |
| Lithuania | Gemcitabine Kabi 38 mg / ml concentrate infuziniam tirpalui |
| Luxembourg | Gemcitabine Kabi 38 mg/ml concentrate for the preparation of an infusion solution |
| Malta | Gemcitabine 38 mg / ml concentrate for solution for infusion |
| Netherlands | Gemcitabine Fresenius Kabi 38 mg/ml concentrate for solution for infusion |
| Norway | Gemkabi |
| Poland | Gemcitabine Kabi |
| Portugal | Gemcitabina Kabi |
| Romania | Gemcitabina Kabi 38 mg / ml concentrate for perfusion solution |
| Sweden | Gemkabi |
| Slovenia | Gemcitabine Kabi 38 mg/ml concentrate for raztopino for infusion |
| Slovakia | Gemcitabine Kabi 38 mg / ml, infused concentrate |
| UK | Gemcitabine 38 mg / ml concentrate for solution for infusion |