10 mg / ml concentrate for solution for infusion
vinorelbine
Navirel is a concentrated solution for infusion. The active substance vinorelbine belongs to a group of medicines used to treat cancer. These drugs are called cytostatics, or cell inhibitors because they delay or prevent the growth of cancer cells. Navirel is used to treat certain types of lung cancer (so-called non-small cell lung cancer ) and breast cancer.
Vinorelbine contained in Navirel 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.
- is allergic to vinorelbine, any other similar medicine used to treat cancer called vinca alkaloids or any of the other ingredients of this medicine (listed in section 6).
- have a low number of certain white blood cells or are currently or have recently had a serious infection (within the last 2 weeks).
- has a low platelet count .
- have a serious liver disease that has nothing to do with the cancer treated with vinorelbine.
- get or have recently been vaccinated against yellow fever.
- is pregnant.
- ammar.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Navirel
- you have received radiation therapy where the treatment field includes the liver.
- you have impaired liver function.
- you are receiving or have recently received certain forms of vaccine with live virus particles (so-called live, attenuated vaccines).
- you are also given an antiepileptic medicine called phenytoin or an antifungal medicine called itraconazole.
- you have had a heart attack or severe chest pain.
- you show signs or symptoms of infection (fever, chills, etc.). Inform your doctor immediately, so that he / she can take any necessary samples.
- you belong to the Japanese population, because there is an increased risk of developing diseases of the lung connective tissue.
Carefully avoid all contact with the eyes. There is a risk of severe irritation and even sores on the eye (corneal ulcers). In case of contact with eyes, rinse immediately with sodium chloride solution.
In case of a burning sensation in the infusion area during or after infusion one, inform a doctor immediately. This may be a sign of an injection error. Infusion must be stopped immediately.
Children and young people
This medicine is not recommended for use in children as there are insufficient data on the safety and efficacy in children.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Your doctor should pay special attention if you are taking the following medicines:
- medicines used to thin the blood ( anticoagulants )
- antiepileptic drugs , such as phenytoin , phenobarbital and carbamazepine
- drugs against bacteria, such as rifampicin, clarithromycin, erythromycin
- antiviral drugs , such as ritonavir
- antifungal drugs, such as itraconazole and ketaconazole
- a cancer drug called mitomycin C
- drugs that weaken the immune system, such as ciclosporin and tacrolimus
- drugs for the treatment of heart disease, such as verapamil and quinidine
- a herbal remedy called St. John’s wort ( Hypericum perforatum) .
Live attenuated vaccines (vaccines that contain live virus particles, such as measles vaccine, mumps vaccine, rubella vaccine) are not recommended with Navirel, as they may increase the risk of life-threatening vaccination disease. Because the yellow fever vaccine also contains live virus particles, you must not be given yellow fever vaccines in combination with Navirel.
Pregnancy, breastfeeding and fertility
You should not be treated with Navirel if you are pregnant unless it has been explicitly prescribed by your doctor.
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.
You should not be treated with Navirel if you are breastfeeding. If treatment is necessary, you must stop breastfeeding.
Women should take measures to avoid pregnancy during treatment and for at least three months after stopping treatment by using an effective contraceptive.
Men receiving treatment must ensure that their partner does not become pregnant during treatment and up to six months after treatment by using an effective contraceptive.
Advice on sperm preservation should be sought before treatment due to the risk of irreversible sterility caused by treatment with vinorelbine.
Driving and using machines
Side effects that may impair your ability to drive and/or use machines may occur after treatment with vinorelbine. If you feel unwell, do not perform tasks that require mental concentration, such as driving or using machines.
You are responsible for assessing whether you are fit to drive a 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.
The preparation and administration of Navirel should only be performed by trained healthcare professionals who specialize in cancer treatment. Navirel is for single use only.
Before each treatment, a blood sample will be taken to analyze its constituents to check that you have a sufficient number of blood cells to be treated with Navirel. If the results of this analysis are not satisfactory, your treatment may be postponed and further samples were taken until these values return to normal.
Navirel is usually given once a week. The usual dose for adults is 25-30 mg / m². Always follow your doctor’s instructions.
Dose adjustment
- In case of significant hepatic impairment, the dose may be changed by your doctor. Follow your doctor’s instructions.
- In case of impaired renal function, it is not necessary to adjust dose one. Follow your doctor’s instructions.
Navirel should always be injected into a vein.
It can be given as an injection for 6 to 10 minutes or as a rapid infusion (drip) for 20 to 30 minutes.
After administration, sodium chloride solution will be given as a drip into the same vein so that the drug is distributed.
Your doctor will check that you are getting the right dose for your illness. However, if you are concerned or have symptoms of a possible overdose, such as fever, signs of infection, or constipation, you should contact a doctor, emergency doctor, or pharmacist.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following symptoms, as they may be signs of serious side effects:
Uncommon (may affect up to 1 in 100 people)
- Cough, fever and chills, which can be signs of a severe infection that can lead to organ failure and blood poisoning.
- Difficulty breathing ( dyspnoea ), difficulty breathing caused by contractions of the airways ( bronchospasm ).
Rare ( may affect up to 1 in 1,000 people)
- Severe chest pain can spread to the neck and arms. Such pain can occur due to insufficient blood supply to the heart (angina or heart attack).
- Signs of very low blood pressure , e.g. severe dizziness or dizziness, when getting up.
- Severe constipation with abdominal pain when you have not had a bowel movement for several days (paralytic ileus ).
Has been reported (occurs in an unknown number of users)
- Signs of severe allergic reaction which may include wheezing, swelling of the lips, tongue and throat or body, difficulty swallowing, rash, dizziness and fainting ( anaphylactic reaction or shock , anaphylactoid reaction).
The following is a list of other side effects that may occur:
Very common (may affect more than 1 user in 10)
- Inhibition of bone marrow function with reduced number of red blood cells , which can make the skin pale and cause weakness or shortness of breath, and certain types of white blood cells ( neutrophils ), which are transient within 5 to 7 days.
- Constipation, vomiting, inflammation of the oral mucosa, inflammation of the esophagus.
- Loss of certain reflex reactions (deep tendon reflexes); weakness in the legs has been reported after long-term chemotherapy.
- Transient elevations of blood tests that show changes in liver function without symptoms.
- Hair loss, usually mild.
- Injection site reactions such as reddening of the skin, burning pain, changes in the color of the vein and local inflammation of the vein ( phlebitis ).
- Feeling weak, tired, fever, pain in various places including chest pain and pain at the tumor site.
Common (may affect up to 1 in 10 people)
- Decreased platelet count (particles in the blood, which help to stop bleeding), in rare cases severe.
- Bacterial, viral or fungal infections in various parts of the body, such as the respiratory tract, urinary tract or gastrointestinal tract, are mild to moderate and usually transient with appropriate treatment.
- Difficulty breathing or skin reactions as a result of a hypersensitivity reaction to vinorelbine.
- Diarrhea, usually mild to moderate.
- Muscle pain, joint pain, jaw pain.
- Increased creatinine in the blood, a substance that reflects kidney function.
Uncommon (may affect up to 1 in 100 people)
- Nerve problems such as tingling or tingling and increased or decreased muscle tension ( paresthesia ).
- Low blood pressure .
- High blood pressure .
- Sudden feeling of heat and reddening of the face and neck (hot flashes).
- Feeling of cold in hands and feet.
Rare (may affect up to 1 in 1,000 people)
- Severe low levels of sodium in the blood, which can cause fatigue and confusion, muscle twitching, cramps or coma .
- Inflammation of the pancreas (an organ that regulates blood sugar) which causes severe pain in the stomach and back ( pancreatitis ).
- Transient changes in a curve showing the electrical activity of the heart, including heartbeat (transient ECG changes).
- Respiratory problems caused by diseases of the lung connective tissue (interstitial lung disease).
- Fainting (collapse).
- General skin reactions.
- Severe skin conditions at the injection site, such as tissue death ( injection necrosis ).
Very rare (may affect up to 1 in 10,000 people)
- Blood poisoning with complications and blood poisoning leading to death.
- Heart diseases such as rapid heart rate ( tachycardia ), palpitations (palpitations) and irregular heartbeats (arrhythmias).
- Impaired lung function ( respiratory failure ).
- Guillain-Barré syndrome (symptoms of which may include weakness or paralysis of the arms and legs, difficulty breathing and blood pressure ).
Has been reported (occurs in an unknown number of users)
- Low levels of certain white blood cells accompanied by fever (febrile neutropenia ).
- Severe reduction of all blood cells , which can lead to weakness, bruising or greater risk of infection .
- Systemic infection with fever and an unusually low number of certain white blood cells that can be potentially life-threatening ( neutropenic sepsis ).
- SIADH syndrome (symptoms of this include eg weight gain, nausea, muscle cramps).
- Loss of appetite / decreased appetite.
- Palmoplants erythrodysesthesia (symptoms of this include, for example, numbness, tingling, burning or itching , redness [similar to sunburn], swelling, discomfort, tenderness, rash).
Burning pain and redness in the infusion area may occur during or after infusion one. As this may be a sign of an injection error, you should inform your doctor or nurse, and the infusion must be stopped immediately.
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. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store in the original package. Sensitive to light.
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.
Contents of the pack and other information
Content declaration
The active substance is vinorelbine (as tartrate), 10 mg/ml.
One 1 ml vial contains a total of 10 mg of vinorelbine (as tartrate).
One 5 ml vial contains a total of 50 mg of vinorelbine (as tartrate).
The other ingredient is water for injections.
What the medicine looks like and contents of the pack
Navirel is a clear, colorless to pale yellow concentrate for solution for infusion (sterile concentrate) supplied in glass vials.
Pack sizes: 1 ml or 5 ml concentrate in packs of 1 or 10 vials. Also available as multi-pack with 10 packs, each containing 1 vial.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
medac
Society for clinical
Special preparations mbH
Theater. 6
22880 Wedel
Germany
| This medicinal product is authorized under the European Economic Area under the names: | |
|---|---|
| Denmark | Navirel 10 mg / ml concentrate for solution for infusion |
| Finland | Navirel 10 mg / ml infusioconcentraatti, liuosta varten |
| Netherlands | Navirel 10 mg / ml concentrate for solution for infusion |
| Norway | Navirel 10 mg / ml concentrate for solution for infusion |
| Poland | Navirel |
| Portugal | Vinorelbina Navirel 10 mg / ml concentrated for perfusion solution |
| Slovakia | Navirel 10 mg / ml infusion concentrate |
| Sweden | Navirel 10 mg / ml concentrate for solution for infusion |
| Czech Republic | Navirel 10 mg / ml concentrate for solution for infusion |
| Germany | Navirel 10 mg/ml concentrate for the preparation of an infusion solution |