10 mg/ml concentrate for infusion liquid , solution
vinorelbine
What Vinorelbine Accord is and what it is used for
Vinorelbine Accord is a concentrate for infusion solution. The active substance vinorelbine belongs to the group cytostatics (cell-inhibiting agents). These agents interfere with the growth of malignant (malignant) cells.
Vinorelbine Accord is intended for adults for the treatment of cancer, specifically nonnon-smallll lung cancer and breast cancer.
Vinorelbine contained in Vinorelbine Accord may also be approved to treat 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.
What you need to know before you use Vinorelbine Accord
Do not use Vinorelbine Accord
- if you are allergic to vinorelbine or to any medicine in the group called vinca alkaloids
- if you are allergic to any other ingredient in Vinorelbine Accord (see section 6)
- if you are pregnant or think you may be pregnant
- if you are breastfeeding
- if you have a low number of white blood cells ( neutrophils ) or have had (within the last 2 weeks) a serious infection
- if you have a low platelet count
- if you plan to be vaccinated (or have recently been vaccinated) against yellow fever
- this medicine is for intravenous use only and should not be injected into the spine.
Warnings and precautions
Talk to your doctor or pharmacist before using Vinorelbine Accord
- if you have previously had heart attacks or severe chest pain
- if you have received radiation therapy and the treatment area included the liver
- if you have symptoms of infection (such as fever, chills, cough)
- if you plan to get vaccinated
- if your liver is not working normally
- Vinorelbine Accord must not come into contact with the eyes as there is a risk of severe irritation and even corneal ulceration. If this occurs, immediately flush the eyes with physiological saline and consult an ophthalmologist.
- Men and women treated with Vinorelbine Accord must use an effective method of contraception during treatment and after treatment. See the section on pregnancy and brebreastfeedingOTH men and women should read the pregnancy and breastfeeding information below.
Before each administration of the Vinorelbine Accord, a blood sample is taken for analysis of the constituents of the blood. If the results of this analysis are not satisfactory, your treatment may be delayed and additional samples were taken until these values return to normal.
Other medicines and Vinorelbine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The doctor must be especially careful if you are taking any of the following medicines:
- medicines used to thin the blood ( anticoagulants )
- a medicine for epilepsy called phenytoin
- an antifungal medicine called itraconazole
- a cancer medicine called mitomycin C
- medicines that affect the immune system, such as ciclosporin and tacrolimus
- simultaneous use with lapatinib (cancer medicine)
- St. John’s wort ( Hypericum perforatum )
- antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
- antiviral drugs for AIDS ( HIV ) such as ritonavir ( HIV protease inhibitor )
- verapamil, quinidine (used for heart problems)
Vaccines (eg chickenpox, mumps, measles) and yellow fever vaccines are not recommended during treatment with Vinorelbine Accord as they may increase the risk of fatal systemic disease.
Concomitant use of Vinorelbine Accord and other drugs are known to be toxic to the bone marrow (affects white and red blood cells and platelets ) may worsen some of the side effects.
Vinorelbine Accord with food and drink
There are no special restrictions on food and drink during treatment with Vinorelbine Accord.
Children and young people
Safety and efficacy for children and adolescents have not been established.
Pregnancy, breastfeeding, and fertility
Pregnancy
- Do not take Vinorelbine Accord if you are pregnant or think you may be pregnant.
- If you have to start treatment with Vinorelbine Accord and are pregnant or if you become pregnant during treatment with Vinorelbine Accord, you must immediately contact your doctor for advice.
Breast-feeding
- Do not take Vinorelbine Accord if you are brebreastfeedingreast-feeding must be discontinued if treatment with Vinorelbine Accord is necessary.
Fertility
Men treated with Vinorelbine Accord should be advised not to impregnate their partner during and up to 6 months after the end of treatment and to seek advice on sperm storage before treatment. Vinorelbine Accord may alter male fertility.
Women of childbearing potential must be advised to use an effective method of contraception during treatment and 3 months after the end of treatment and must inform the doctor if they become pregnant.
Driving ability and use of machinery
No studies have been performed on the effect of Vinorelbine Accord on the ability to drive or use machines. Do not drive if your doctor has advised you not to or if you feel unwell.
You yourself 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 . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Vinorelbine Accord
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage
Vinorelbine Accord can only be prepared and administered by trained healthcare professionals specialized in oncology . Before each administration , a blood sample will be taken to analyze the components of the blood to confirm that you have enough blood cells to receive Vinorelbine Accord. If the results of this analysis are not satisfactory, your treatment may be delayed and additional samples taken until these values return to normal. The usual dose for adults is 25 to 30 mg/m².
Treatment frequency
Treatment with Vinorelbine Accord is scheduled for once a week. How often you should receive treatment is determined by the doctor.
Always follow your doctor’s instructions.
Dose adjustment:
- In case of severely impaired liver function, the doctor must adjust the dose . You must follow the doctor’s instructions.
- In case of impaired renal function, dose adjustment is not necessary. You must follow the doctor’s instructions.
Method and method of administration
Vinorelbine Accord must be diluted before it is given.
Vinorelbine Accord may only be given as an infusion into a vein.
It takes between 6 and 10 minutes.
After administration , the vein will be thoroughly flushed with a sterile solution.
If you have taken too much Vinorelbine Accord
The doctor must always ensure that you receive the dose that is appropriate for your situation. However, if you suspect or have symptoms of a possible overdose, such as fever, signs of infection or constipation, contact a doctor, emergency department or pharmacist. If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have further questions, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Serious side effects – if any of the following side effects occur, contact a doctor immediately:
Uncommon (may affect up to 1 in 100 users)
Serious infection with failure of various organs or blood poisoning. Shortness of breath and narrow airways ( bronchospasm ).
Rare (may affect up to 1 in 1,000 users)
Chest pain, which may spread to the back of the neck and arm, due to lack of blood supply to the heart ( angina pectoris ). Heart attack (myocardial infection).
Has been reported (may occur in an unknown number of users)
Extensive and very severe allergic reactions. Symptoms may include sudden wheezing, swelling of the lips, tongue and throat or body, difficulty swallowing, rash, feeling unsteady, fainting (anaphylaxis/anaphylactic shock/anaphylactoid reaction).
These side effects are very serious. You may need immediate medical attention.
Other side effects – if any of the following side effects occur, contact a doctor as soon as possible:
Very common (may affect more than 1 in 10 users)
Low number of white blood cells , which can increase the risk of infection . Low red blood cell count ( anemia ), which can make you feel tired. Loss of deep tendon reflexes. Weakness in legs (lower extremity ). Inflammation in the mouth or esophagus. Nausea and vomiting. Constipation. Abnormal liver function tests. Hair loss. Redness ( erythema ), burning pain, vein discoloration and/or inflammation of the veins (local phlebitis ) at the injection site.
Common (may affect up to 1 in 10 users)
Infections ( bacterial , viral or fungal infections) in the body (respiratory, urinary, gastrointestinal system and possibly others) with symptoms such as fever, pain and chills. Low platelet count (risk of bleeding). Diarrhea. Pain in muscles and joints, including jaw pain. Altered kidney function (increased creatinine values). Weakness, fatigue, fever, pain in various places.
Uncommon (may affect up to 1 in 100 users )
Severe numbness ( paresthesia ). Low blood pressure , high blood pressure , redness and cold hands and feet.
Rare (may affect up to 1 in 1,000 users)
Low levels of sodium in the blood (which can cause symptoms of tiredness, confusion, muscle twitching and coma ). Changes in the activity of the heart ( ECG changes). Severely low blood pressure or collapse. Lung disease (interstitial pneumopathy). Inflammation of the pancreas. Intestinal ulceration ( ileus ). Skin reactions such as rash, itching and hives . Necrosis at the injection site.
Very rare (may affect up to 1 in 10,000 users)
Blood poisoning which can be life-threatening. Strong heartbeats, fast heartbeats, heart rhythm disturbances.
Has been reported (occurring in an unknown number of users)
A general infection combined with a reduced number of white blood cells ( neutropenic sepsis ). Decreased number of white blood cells with fever (febrile neutropenia ). Reduced number of white and red blood cells and platelets . Low sodium levels due to overproduction of a hormone that leads to fluid retention and weakness, tiredness or confusion (SIADH syndrome). Decreased appetite ( anorexia ). Redness ( erythema ) on the hands and feet.
Like other vinca alkaloids, vinorelbine may lead to moderate blistering.
As changes in the blood may occur, the doctor may order blood tests to check this (low white blood cell count , anemia and/or low platelet count , effects on liver or kidney function and the body’s electrolyte balance).
How to store Vinorelbine Accord
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the vial and outer carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C to 8 °C). Do not freeze.
Store in the original packaging. Light sensitive.
Shelf life after dilution
Chemical and physical stability of the ready-to-use solution has been demonstrated for 24 hours at 25 °C. From a microbiological point of view, unless the method of opening/dilution excludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is vinorelbine (in the form of tartrate). 1 ml of solution contains 10 mg of vinorelbine (as vinorelbine tartrate).
Other ingredients are water for injections.
Each 1 ml vial contains a total of 10 mg of vinorelbine (as tartrate).
Each 5 ml vial contains a total of 50 mg of vinorelbine (as tartrate).
Appearance and package sizes of the medicine
Clear, colorless to pale yellow solution. Vinorelbine Accord is packaged in clear type 1 glass vials with bromobutyl rubber stoppers and a blue aluminum flip-top seal.
Vinorelbine Accord is available in:
Vial of 1 ml
Vial of 5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Holland
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands