100 mg / ml concentrate for infusion solution
gemcitabine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– 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. See section 4.

In this leaflet:
1. What Gemcitabine Accord is and what it is used for
2. What you need to know before you use Gemcitabine Accord
3. How to use Gemcitabine Accord
4. Possible side effects
5. How to store Gemcitabine Accord 6. Contents of the pack
and other information

1. What Gemcitabine Accord is and what it is used for

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

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

Gemcitabine Accord is used to treat 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, along with paclitaxel
  • ovarian cancer (cancer of the ovaries), together with carboplatin
  • bladder cancer, together with cisplatin

Gemcitabine contained in Gemcitabine Accord 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 Gemcitabine Accord

Do not use Gemcitabine Accord

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Gemcitabine Accord.

Before the first infusion, blood samples will be taken to find out if your kidneys and liver are working well enough. In addition, blood samples will be taken before each infusion to check that you have enough blood cells to get Gemcitabine Accord. 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.

Tell your doctor:

  • if you have or have ever had any liver disease, heart disease, vascular disease or kidney problems.
  • if you have previously received radiation therapy or such treatment is planned because you may have an immediate or delayed radiation reaction with gemcitabine.
  • if you have recently been vaccinated as it may cause side effects along with gemcitabine.
  • If you get symptoms such as headache with confusion, seizures or vision changes 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 if you feel very weak and if you are very pale (may be a sign of lung problems or kidney failure )
  • if you suffer from alcoholism, as this medicine contains ethanol (alcohol)
  • if you suffer from epilepsy , then this medicine contains ethanol (alcohol).
  • if you suffer from capillary leakage syndrome, when fluid from the smaller blood vessels leaks into tissue one. Symptoms may include swelling of the legs, face and arms, weight gain, hypoalbuminemia (too little protein in the blood), severe hypotension (low blood pressure ), acute renal impairment and pulmonary edema (fluid in the lungs)
  • if you suffer from posterior reversible encephalopathy syndrome. Symptoms include loss of consciousness, seizures, vision problems, focal neurological symptoms and acute high blood pressure .

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 medicines and Gemcitabine Accord

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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Treatment with Gemcitabine Accord should be avoided during pregnancy. Your doctor may inform you about the possible risks of Gemcitabine Accord, as it is given during pregnancy.

Tell your doctor if you are breastfeeding.

You should stop breastfeeding during treatment with Gemcitabine Accord.

Fertility

Men treated with Gemcitabine Accord are advised against having children during and up to 6 months after treatment. If you want to have children during and up to 6 months after treatment, you should seek advice from a doctor or pharmacist. You should also seek advice on saving semen before starting treatment.

Driving and using machines

Gemcitabine Accord can make you sleepy, especially if you have been drinking alcohol. The amount of alcohol in this medicine may affect your ability to drive or use machines. Do not drive or use machines until you are sure that treatment with Gemcitabine Accord 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.

Gemcitabine Accord contains 44% (w / v) ethanol (alcohol), ie up to 9.9 g per maximum daily dose (2250 mg), equivalent to 250 ml beer or 100 ml wine per dose.

  • Harmful to those suffering from alcoholism.
  • This should be considered in women who are pregnant or breastfeeding, children and high-risk patients, such as patients with liver disease or epilepsy .
  • The amount of alcohol in this medicine may affect the effect of other medicines.
  • The amount of alcohol in this medicine may affect your ability to drive or use machines.

Gemcitabine Accord contains 206 mg (9.0 mmol) sodium per maximum daily dose (2250 mg)

This should be considered by patients on a low-salt diet.

3. How to use Gemcitabine Accord

The recommended dose of Gemcitabine Accord is 1000-1250 mg for each square meter of body surface area. Your height and weight are measured to calculate the body surface area. Your doctor will then use your body surface area to calculate the right dose for you. Dose one may change or treatment may be delayed depending on your blood levels and your general condition.

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

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

You will always receive gemcitabine by infusion (drip) into a blood vessel (a vein). Infusion one will last 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.

It is unlikely that you will receive too much of the medicine because it is given to you by healthcare professionals, but if you were to receive a larger dose than prescribed by your doctor, you may feel sleepy, dizzy, and feel your heart beating abnormally.

4. Possible side effects

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

You must contact a doctor immediately if you experience 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, easy to breathe or if you look pale (because you may have less hemoglobin than normal which is very common).
  • Mild to moderate rash (very common) / itching (common), or fever (very common); ( allergic reaction )
  • Temperature of 38ºC or more, sweating or having other signs of infection (because you may have fewer white blood cells than normal along with fever, which is also called febrile neutropenia ) (common)
  • Pain, redness , swelling or soreness in the mouth (common)
  • Irregular heart rate (arrhythmia) (uncommon)
  • 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 (less common)
  • Difficulty breathing ( Mild breathing difficulties after infusion of Gemcitabine Accord are very common , but are transient. In less common or rare cases, however, severe lung problems occur)
  • Severe chest pain (heart attack) (rare)
  • Severe hypersensitivity / allergic reaction with severe skin 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 and possibly a feeling of that you will faint ( anaphylactic reaction ) (very rare)
  • 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)
  • Headache with vision changes, confusion, seizures or seizures ( Reversible Posterior Leukoencephalopathy Syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) (very rare)
  • Severe rash with itching , blistering or scaly skin ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) (very rare).

Other side effects of Gemcitabine Accord may include:

Very common (may affect more than 1 in 10 people)

  • Low white blood cell count
  • Low platelet count
  • Breathing difficulties
  • Vomiting
  • Nausea
  • Hair loss
  • Liver problems: Seen through abnormal blood test results
  • Blood in the urine
  • Abnormal urine samples: egg white in the urine
  • Flu-like symptoms including fever
  • Edema (swelling of the ankles, fingers, feet, face)

Common (may affect up to 1 in 10 people)

  • Poor appetite
  • Headache
  • Insomnia
  • Fatigue
  • Cough
  • Runny nose
  • Constipation
  • Diarrhea
  • Itching
  • Sweating
  • Muscle pain
  • Back pain
  • Fever
  • Weakness
  • Overindulge
  • Infection is

Uncommon (may affect up to 1 in 100 people)

  • Interstitial pneumonitis (scarring of the lungs)
  • Respiratory cramps (hissing)
  • Abnormal lung X-ray (scarred lungs)
  • Heart failure
  • Stroke
  • Severe liver damage, including liver failure
  • Kidney failure

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

  • Low blood pressure
  • Skin peeling, ulceration or blistering
  • Injection site reactions
  • Cold sores in fingers and toes
  • Fluid in the lungs
  • Severe pneumonia that causes respiratory failure
  • Skin reaction caused by radiation (such as severe sunburn) on skin previously exposed to radiation
  • Radiation toxicity – scarring of the lung air sacs after radiation therapy
  • Inflammation of the blood vessels ( peripheral vasculitis )
  • Skin flaking and severe blistering on the skin

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

  • Increased platelet count
  • Ischemic colitis ( inflammation of the colon due to decreased blood flow)
  • Thrombotic microangiopathy: blood clots that form in small blood vessels

Has been reported (may occur 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 levels ( anemia ), low white blood cell counts, and platelets can be detected with blood tests.

You may get any of these symptoms and/or conditions. You need to tell your doctor as soon as you notice any of these 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.

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 Accord

Keep out of sight and reach of children.

No special storage instructions.

After first opening (before dilution):

Each vial is for single use only and should be used immediately after opening. If the preparation is not used immediately, the storage conditions are the responsibility of the user.

After dilution:

After dilution in 0.9% sodium chloride solution, the solution is chemically and physically stable for 60 days at 2-8ºC, and at 25ºC.

For microbiological reasons, the infusion solution should be used immediately. If the preparation is not used immediately, the storage conditions before use are the responsibility of the user. The storage time of reconstituted solution should not normally exceed 24 hours at 2-8ºC, unless dilution has taken place under controlled and validated aseptic conditions.

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

The medicine will be prepared and given to you by a healthcare professional.

Any unused product should be discarded by a healthcare professional.

6. Contents of the packaging and other information

Content declaration

– The active substance is gemcitabine. Each ml of concentrate for solution for infusion contains 100 mg of gemcitabine (as gemcitabine hydrochloride). Each vial contains either 200 mg, 1000 mg, 1500 mg or 2000 mg gemcitabine (as gemcitabine hydrochloride).

The other ingredients are macrogol 300, propylene glycol, anhydrous ethanol , sodium hydroxide ( pH adjuster), hydrochloric acid , concentrated ( pH adjuster).

What the medicine looks like and contents of the pack

Gemcitabine Accord concentrate for solution for infusion is a clear, colorless or slightly yellow solution.

Gemcitabine Accord is filled in colorless glass vials which are closed with a rubber stopper and an aluminum closure (flip-off).

Pack sizes

1 x 2 ml vial

1 x 10 ml vial

1 x 15 ml vial

1 x 20 ml vial

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex, HA1 4HF

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Muhammad Nadeem

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