NAVELBINE 10 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. NAVELBINE 20 mg soft capsules
   1. What is NAVELBINE soft capsules and what is it used for
   2. What you need to know before you take NAVELBINE soft capsules
   3. How to take NAVELBINE soft capsules
   4. Possible side effects
   5. How to store NAVELBINE soft capsules
   6. Package Contents and Other Information
   7. What you need to know before using NAVELBINE 10 mg/ml concentrate for solution for
   8. How to use Navelbine 10 mg/ml concentrate for solution for infusion
   9. Possible side effects
   10. How to store NAVELBINE 10 mg/ml concentrate for infusion solution
   11. Package contents and other information

NAVELBINE 20 mg soft capsules

NAVELBINE 30 mg soft capsules
Vinorelbine (as tartrate)
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What NAVELBINE soft capsules is and what it is used for
• 2. What you need to know before you take NAVELBINE soft capsules
• 3. How to take NAVELBINE soft capsules
• 4. Possible side effects
• 5. How to store NAVELBINE soft capsules
• 6. Contents of the pack and other information

1. What is NAVELBINE soft capsules and what is it used for

NAVELBINE soft capsules contain the active ingredient Vinorelbine (as tartrate) and belong to a
family of medicines used to treat tumors, called vinca alkaloids.
NAVELBINE soft capsules is used to treat some types of lung cancer and some types of breast
cancer in patients over 18 years of age.

2. What you need to know before you take NAVELBINE soft capsules

Do not take NAVELBINE soft capsules:

• if you are allergic to vinorelbine (active ingredient), to any of the drugs belonging to the family of antitumor agents called vinca alkaloids, or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding;
• if you have undergone surgery on the stomach or small intestine, or if you suffer from intestinal disorders;
• if you have a low neutrophil count (less than 1,500/mm³) and/or platelets (less than
• 100,000/mm³), or if you are currently or have recently (within the last 2 weeks) suffered from a serious infection;
• if you are planning to get a yellow fever vaccination or have just had one;
• if you need long-term oxygen therapy;
• if you suffer from conditions that significantly affect absorption.

Warnings and precautions
Talk to your doctor or pharmacist before taking NAVELBINE soft capsules:

• if you have a history of heart attack or severe chest pain;
• if your ability to perform daily activities is severely reduced;
• if you have received radiotherapy in which the treatment area included the liver;
• if you have signs or symptoms of infection (such as fever, chills, cough);
• if you need to get a vaccination. Live attenuated vaccines (e.g. measles vaccine, mumps vaccine, rubella vaccine, etc.) are not recommended with NAVELBINE as they may increase the risk of life-threatening vaccine-related diseases; the use of NAVELBINE soft capsules is specifically contraindicated in conjunction with the yellow fever vaccine;
• if you have a serious liver condition not related to cancer;
• if you are pregnant. Before and during treatment with NAVELBINE soft capsules, your blood cell count will be checked to verify that you can receive the treatment. If the results of these tests are not satisfactory, treatment may be delayed and further checks may be performed until these values return to normal.

Children and adolescents
Use is not recommended in children under 18 years of age.

Other medicines and NAVELBINE soft capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The doctor must pay special attention if you are taking the following medicines:

• medicines used to thin the blood (anticoagulants);
• antiepileptic drugs (e.g. phenytoin);
• antifungal drugs (e.g. itraconazole, ketoconazole);
• anticancer drugs such as mitomycin C, cisplatin, lapatinib;
• drugs that suppress the immune system, such as cyclosporine and tacrolimus;
• drugs that modulate glycoprotein-P activity;
• bactericidal antibiotics and inducers of the CYP3A4 isoenzyme (e.g. rifampicin). The combination of NAVELBINE soft capsules with other drugs with known bone marrow toxicity (which alter white blood cells, red blood cells and platelets) may also worsen some undesirable effects.

NAVELBINE soft capsules with food and drink
NAVELBINE soft capsules must be swallowed whole with water, without chewing or
sucking on the capsule. It is preferable to take NAVELBINE soft capsules with a light meal.
NAVELBINE soft capsules should not be taken with a hot drink as it may dissolve
the capsule too quickly.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor
for advice before using this medicine because there are potential risks to the baby. Do not breastfeed
while using NAVELBINE soft capsules.
Women of childbearing potential must use an effective method of contraception (birth control) during treatment and for at least three months after treatment.
Men treated with NAVELBINE soft capsules are advised not to father a child during and
for at least 3 months after taking the last capsule and to seek advice on sperm preservation before starting treatment, as NAVELBINE soft capsules may alter
male fertility irreversibly.

Driving and operating machinery
No studies have been conducted on the ability to drive and operate machinery. However, as in
all cases, you should not drive if you do not feel well or if your doctor has advised you not to drive.

NAVELBINE soft capsules contains sorbitol, ethanol
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars,
contact him before taking this medicine.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to take NAVELBINE soft capsules

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Before and during treatment with NAVELBINE soft capsules, your doctor will perform blood cell counts. The doctor will tell you how many capsules and the dosage you should take, how often
you should take the capsules and for how long you should be treated, taking into account your body
surface area, blood test results and your general condition.

The total dose should never exceed 160 mg per week.
Never take NAVELBINE soft capsules more than once a week.
Before opening the blister pack containing NAVELBINE soft capsules, make sure there are no
damaged capsules as the liquid contained in them is an irritant and may be harmful if it comes into
contact with skin, eyes or mucous membranes. If this happens, wash the affected area immediately and thoroughly.

Do not swallow damaged capsules, but return them to your doctor or pharmacist.
To open this package:

• 1. Cut the blister along the dotted black line with a pair of scissors.
• 2. Remove the thin plastic sheet.
• 3. Push the capsule through the aluminum foil.

Administration of NAVELBINE soft capsules:

• Take NAVELBINE with some water, preferably with a light meal. It should not be taken with a hot drink as it would dissolve the capsule too quickly.
• Do not chew or suck on the capsules.
• If you accidentally chew or suck on the capsule, rinse your mouth carefully with water and inform your doctor immediately.
• If you vomit within a few hours of taking NAVELBINE soft capsules, contact your doctor immediately. Do not repeat the dose.

If you are taking a medicine against nausea
Vomiting may occur with NAVELBINE soft capsules (see section “4. Possible side effects”). If your doctor has prescribed you a medicine against nausea, take it exactly
as your doctor told you to do.
Take NAVELBINE soft capsules during a light meal; this will help to reduce the feeling of nausea.

If you take more NAVELBINE soft capsules than you should
If you have taken more NAVELBINE soft capsules than the prescribed dose, contact your doctor immediately.
Serious symptoms related to blood components may occur and signs of
an infection (such as fever, chills, cough) may appear. You may also become severely constipated.

If you forget to take NAVELBINE soft capsules
Do not take a double dose to make up for a missed dose. Contact your doctor who will decide
on rescheduling the dose.

If you stop taking NAVELBINE soft capsules
Your doctor will decide when you should stop treatment. However, if you want to stop the
treatment early, you should discuss possible alternatives with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you develop any of the following symptoms while using NAVELBINE soft capsules:

• signs of a serious infection such as cough, fever and chills;
• severe constipation with abdominal pain, when your bowel does not move for several days;
• severe dizziness, feeling lightheaded when standing up, a sign of a serious drop in

blood pressure;

• severe chest pain that is unusual for you, the symptoms may be due to impaired cardiac function resulting from insufficient blood flow, defined as myocardial infarction (sometimes with a fatal outcome);
• difficulty breathing, dizziness, low blood pressure, rash all over the body, or swelling of the eyelids, lips or throat, which may be signs of an allergic reaction;
• signs of allergy such as itching, shortness of breath.

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

• Infections in different locations;
• Stomach disorders; diarrhea; constipation, abdominal pain; nausea, vomiting;
• Inflammation in the mouth;
• A reduction in red blood cells which can make the skin pale and cause weakness or shortness of breath;
• A reduction in platelets which can increase the risk of bleeding or bruising;
• A reduction in white blood cells which makes you more vulnerable to infections;
• Loss of some reflexes, occasionally changes in the perception of touch;
• Hair loss, normally mild;
• Fatigue;
• Fever
• Feeling unwell;
• Weight loss, loss of appetite.

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

• Difficulty coordinating muscle movement;
• Visual disturbances;
• Shortness of breath, cough;
• Difficulty urinating, other genitourinary symptoms;
• Difficulty sleeping;
• Headache; dizziness; changes in taste and flavors;
• Inflammation of the throat, difficulty swallowing food or liquids;
• Skin reactions;
• Chills
• Weight gain;
• Joint pain, jaw pain, muscle pain;
• Pain in different locations of the body and pain at the tumor site;
• High blood pressure;
• Liver disorders (abnormalities in liver function tests).

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

• Heart failure which can cause shortness of breath or swelling of the ankles;
• Irregular heartbeat
• Lack of muscle control which can be associated with abnormal gait, changes in speech and eye movement abnormalities (ataxia);

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Blood infection (sepsis) with symptoms such as high fever and general deterioration of health;
• Heart attack (myocardial infarction);
• Gastrointestinal bleeding;
• Low level of sodium in the blood causing weakness, muscle contractions, fatigue, confusion or loss of consciousness. This decrease may be in some cases attributed to excessive production of a hormone that causes fluid retention (syndrome of inappropriate antidiuretic hormone secretion SIADH);

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system, at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store NAVELBINE soft capsules

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton (Exp.).
The expiry date refers to the last day of that month.
Store in a refrigerator (+2°C - +8 °C). Store in the original package.
Do not dispose of any medicine in waste water or household waste. For safety reasons, unused
capsules must be returned to your doctor or pharmacist for destruction. This will help
to protect the environment.

6. Package Contents and Other Information

What NAVELBINE soft capsules contain

• The active ingredient is: Vinorelbine (as tartrate) 20 or 30 mg.
• Other ingredients are: The solution contains: Anhydrous ethanol, purified water, glycerol, macrogol 400. The capsule shell contains: gelatin; glycerol 85%; sorbitol/sorbitan (anhydrosorb 85/70); medium chain triglycerides and PHOSAL 53 MCT (phosphatidylcholine, glycerides, anhydrous ethanol) and coloring agents (E171 - titanium dioxide and E172 red and/or yellow iron oxide depending on the dosage). The edible ink for printing contains: cochineal extract (E120), hypromellose, propylene glycol.

Description of the appearance of NAVELBINE Soft Capsules and package contents
NAVELBINE 20 mg soft capsules: light brown soft capsules for oral use, marked
N20.
NAVELBINE 30 mg soft capsules: pink soft capsules for oral use, marked N30.
The 20 and 30 mg soft capsules are available in packs containing 1 blister of 1 soft capsule.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pierre Fabre Pharma S.r.l.
Via G.Washington,70
20146 Milan - ITALY

Manufacturer
Pierre Fabre Médicament Production, Avenue du Béarn, Idron, 64320 Bizanos, France

NAVELBINE 10 mg/ml concentrate for solution for infusion
Vinorelbine (as tartrate)
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What NAVELBINE 10 mg/ml concentrate for solution for infusion is and what it is used for
• 2. What you need to know before you use NAVELBINE 10 mg/ml concentrate for solution for infusion
• 3. How to use NAVELBINE 10 mg/ml concentrate for solution for infusion
• 4. Possible side effects
• 5. How to store NAVELBINE 10 mg/ml concentrate for solution for infusion
• 6. Contents of the pack and other information
• 1. What NAVELBINE 10 mg/ml concentrate for solution for infusion is and what it is used forNAVELBINE 10 mg/ml concentrate for solution for infusion contains the active ingredient Vinorelbine (as tartrate) and belongs to a family of medicines used to treat cancer, called the vinca alkaloid family. NAVELBINE 10 mg/ml concentrate for solution for infusion is used to treat some types of lung cancer and some types of breast cancer in patients over the age of 18.

2. What you need to know before using NAVELBINE 10 mg/ml concentrate for solution for

infusion
Do not use NAVELBINE 10 mg/ml concentrate for solution for infusion:

• If you are allergic to vinorelbine (the active substance) or to any of the excipients of this medicine (listed in section 6), or to any of the other components of this medicine.
• If you are breastfeeding.
• If you have a low count of neutrophils (less than 1,500/mm³) and/or platelets (less than
• 100,000/mm³), or if you currently have or have recently had (within 2 weeks) a severe infection.
• If you are planning to get a yellow fever vaccination or have just had one.

Warnings and precautions
Talk to your doctor or pharmacist before using NAVELBINE 10 mg/ml concentrate for solution
for infusion:

• If you have a history of heart attack or severe chest pain.
• If you have received radiotherapy where the treatment area included the liver.
• If you have signs or symptoms of infection (such as fever, chills, cough).
• If you are going to have a vaccination. Live attenuated vaccines (e.g. measles vaccine, mumps vaccine, rubella vaccine, etc.) are not recommended with NAVELBINE 10 mg/ml concentrate for solution for infusion as they may increase the risk of life-threatening vaccine-related diseases. The use of NAVELBINE 10 mg/ml concentrate for solution for infusion is specifically contraindicated in combination with the yellow fever vaccine.
• If your liver function is not normal.
• If you are pregnant.

Before and during the treatment plan with NAVELBINE 10 mg/ml concentrate for solution for
infusion, your blood cell count will be checked to verify that you can receive the
treatment. If the results of these tests are not satisfactory, the treatment may be
delayed and further checks may be performed until these values return to normal.

Children and adolescents
Use is not recommended in children under 18 years of age.

Other medicines and NAVELBINE 10 mg/ml concentrate for solution for infusion:
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor must pay special attention if you are taking the following medicines:

• medicines used to thin the blood (anticoagulants);
• an anti-epileptic drug called phenytoin;
• antifungal drugs (e.g. itraconazole, ketoconazole);
• anticancer drugs such as mitomycin C, cisplatin or lapatinib;
• drugs that act on the immune system, such as cyclosporine and tacrolimus;
• drugs modulating the activity of glycoprotein-P;
• bactericidal antibiotics and inducers of the CYP3A4 isoenzyme (e.g. rifampicin). The combination of NAVELBINE 10 mg/ml concentrate for solution for infusion with other drugs with known bone marrow toxicity (which alter white blood cells, red blood cells and platelets) may also worsen some side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before using this medicine because there are potential risks to the baby. Do
not breastfeed while using NAVELBINE 10 mg/ml concentrate for solution for
infusion.
Women of childbearing potential must use an effective method of contraception (birth control) during treatment and for at least three months after treatment.
Men treated with NAVELBINE 10 mg/ml concentrate for solution for infusion
are recommended not to father a child during and for at least 3 months after treatment and to seek advice on
sperm preservation before starting treatment, as NAVELBINE may alter
male fertility irreversibly.

Driving and using machines
No studies have been performed on the ability to drive and operate machinery. However, as in
all cases, you should not drive if you do not feel well or if your doctor has advised you not to drive.

3. How to use Navelbine 10 mg/ml concentrate for solution for infusion

Use this medicine following the instructions of your doctor or pharmacist at all times. If you have any doubts, consult your
doctor or pharmacist. Before and during treatment with NAVELBINE 10 mg/ml concentrate for
solution for infusion, your doctor will perform a blood cell count.
The dose that will be administered to you depends on the results of the blood cell count, your
body surface area and your general condition. Your doctor will inform you of the dose you will have to
receive, how often and for how long you will have to be treated.

Method and route of administration
NAVELBINE 10 mg/ml concentrate for solution for infusion must be diluted before
administration. NAVELBINE 10 mg/ml concentrate for solution for infusion must be
administered only into a vein. It must be administered by infusion lasting from 6 to 10
minutes. After administration, the vein must be thoroughly flushed with a sterile solution.

If you are given more NAVELBINE 10 mg/ml concentrate for solution for infusion than
you should.
The dose of NAVELBINE 10 mg/ml concentrate for solution for infusion is carefully monitored and
verified by the doctor and pharmacist. Serious symptoms related to the blood components may appear and you may develop signs of an infection (such as fever, chills, cough). You may also
become severely constipated. If this happens, you should contact your doctor immediately.

If you stop treatment with NAVELBINE 10 mg/ml concentrate for solution for infusion
The doctor will decide when you should stop treatment. However, if you want to stop the
treatment earlier, you should discuss other options with your doctor.

4. Possible side effects

Like all medicines, NAVELBINE 10 mg/ml concentrate for solution for infusion can cause
side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following symptoms while using NAVELBINE 10 mg/ml concentrate for
solution for infusion:

• signs of infection such as cough, fever and chills;
• severe constipation with abdominal pain, when your bowel does not move for several days;
• severe dizziness, feeling faint when standing up, these could be signs of a serious drop in blood pressure;
• severe chest pain that is unusual for you; the symptoms may be due toimpaired cardiac function due to insufficient blood flow, definedas ischemic heart disease, such as angina pectoris and myocardial infarction (sometimeswith fatal outcome);
• difficulty breathing, dizziness, low blood pressure, rash all over the body, or swelling of the eyelids, lips or throat, which may be signs of an allergic reaction.

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

• Nausea; vomiting; constipation;
• A reduction in red blood cells which can make the skin pale and cause weakness or shortness of breath;
• A reduction in white blood cells which makes you more vulnerable to infections;
• Weakness of the lower limbs;
• Loss of some reflexes, occasionally changes in the perception of touch;
• Hair loss, normally not severe for prolonged treatments;
• Inflammation or sores in the mouth or throat;
• Reactions at the NAVELBINE administration site such as redness, stinging pain, discoloration of the veins, inflammation of the veins;
• Liver disorders (Abnormalities in liver function tests).

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

• A reduction in platelets which can increase the risk of bleeding or bruising;
• Joint pain;
• Jaw pain;
• Muscle pain;
• Fatigue (asthenia, tiredness);
• Fever
• Pain in different locations of the body such as chest pain and at the tumor site;
• Diarrhea;
• Infections in different locations. Uncommon side effects(may affect up to 1 in 100 people):
• Severe difficulty with body movements and sense of touch;
• Dizziness
• Sudden feeling of warmth and redness of the skin on the face and neck
• Coldness in the hands and feet;
• Difficulty breathing or wheezing (dyspnea and bronchospasm);
• Blood infection (sepsis) with symptoms such as high fever and general deterioration of health;
• High blood pressure.

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

• Heart attack (ischemic heart disease, angina pectoris, myocardial infarction, sometimes fatal);
• Lung toxicity (inflammation and fibrosis, sometimes fatal)
• Severe abdominal and back pain (pancreatitis);
• Low levels of sodium in the blood (which can cause symptoms of fatigue, confusion, muscle cramps and loss of consciousness);
• Ulcers at the NAVELBINE administration site (local necrosis);
• Skin rashes on the body such as exanthems and eruptions (generalized skin reactions).

Very rare side effects(may affect up to 1 in 10,000)
Irregular heartbeat (tachycardia), palpitations, heart rhythm disorders, complicated septicemia
(sometimes fatal).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Abdominal pain, gastrointestinal bleeding;
• Heart failure which can cause shortness of breath and swelling of the ankles;
• Redness of hands and feet (erythema);
• Low sodium level due to overproduction of a hormone that causes fluid retention and consequent weakness, fatigue or confusion (syndrome of inappropriate antidiuretic hormone secretion SIADH);
• Lack of muscle control which may be associated with abnormal gait, change in speech and abnormalities in eye movement (ataxia);
• Headache;
• Chills;
• Cough;
• Loss of appetite
• Weight loss,.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system, at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store NAVELBINE 10 mg/ml concentrate for infusion solution

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the vial and the packaging (Exp.).
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original packaging to protect from light.
NAVELBINE will be diluted and stored by hospital staff.

6. Package contents and other information

What NAVELBINE 10 mg/ml concentrate for solution for infusion contains

• The active ingredient is vinorelbine (as tartrate). One ml of solution contains 10 mg of vinorelbine.
• The other component is water for injections.

Description of the appearance of NAVELBINE 10 mg/ml concentrate for solution for infusion and
package contents
NAVELBINE 10 mg/ml concentrate for solution for infusion is a concentrate for solution for
infusion in a transparent glass vial (1ml or 5 ml). The concentrate is a transparent solution from
colorless to pale yellowish.
NAVELBINE 10 mg/ml concentrate for solution for infusion is available in:
Pack of 1 vial of 1 ml,
Pack of 1 vial of 5 ml.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Pierre Fabre Pharma S.r.l.
Via G. Washington, 70
20146 Milan - Italy

Manufacturer:
Pierre Fabre Médicament Production
Avenue du Béarn
64320 Idron
France
<----------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for medical professionals or healthcare operators
The preparation and administration of NAVELBINE 10 mg/ml concentrate for solution for
infusion must be carried out by experienced personnel. Suitable eye protection, disposable gloves, face
mask and disposable apron must be worn. Any spills or leaks must be dried.
Any contact with the eyes must be carefully avoided. If contact occurs, wash
the eyes immediately with a 9 mg/ml (0.9%) sodium chloride injection solution. After
completion, any exposed surface must be thoroughly cleaned and hands and face must be washed.
There are no container/content incompatibilities between NAVELBINE 10 mg/ml concentrate for
solution for infusion and glass containers, PVC bags, vinyl-acetate bags or PVC infusion sets.
It is recommended to administer NAVELBINE 10 mg/ml concentrate for solution for infusion for
infusion for 6-10 minutes after diluting it in 20-50 ml of 9 mg/ml (0.9%) sodium chloride injection
solution or 5% glucose injection solution. After administration, the vein must be
thoroughly flushed with at least 250 ml of isotonic solution.
NAVELBINE 10 mg/ml concentrate for solution for infusion must be administered only by
intravenous route: it is extremely important to ensure that the cannula is correctly inserted into the
vein before starting the infusion of NAVELBINE.
If the drug infiltrates into the surrounding tissue during administration, it may cause severe
local irritation. In this case, immediately stop the administration, perform a thorough flushing
of the vein with normal saline and administer the rest of the dose in another vein.
In case of extravasation, to reduce the risk of phlebitis, glucocorticoids can be administered immediately
intravenously.
NAVELBINE 10 mg/ml concentrate for solution for infusion must be stored in a refrigerator at
2-8°C and protected from light. Do not freeze.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.