Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - naveruclif

Document Subject

Generated Narrative: MedicinalProductDefinition mp15a641fc1891be6ddabc72928a523139

identifier: http://ema.europa.eu/identifier/EU/1/23/1778/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Naveruclif 5 mg/ml powder for dispersion for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-15a641fc1891be6ddabc72928a523139

identifier: http://ema.europa.eu/identifier/EU/1/23/1778/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - naveruclif

Attesters

What is in this leaflet

1. What Naveruclif is and what it is used for
2. What you need to know before you are given Naveruclif
3. How to use Naveruclif
4. Possible side effects
5. How to store Naveruclif
6. Contents of the pack and other information

Naveruclif contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles. Paclitaxel belongs to a group of medicines called taxanes used in cancer.

Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing this means that they die.

Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and get across the walls of the blood vessels into the tumour. This means that other chemicals that can cause side effects that can be life threatening are not needed. Such side effects occur far less with Naveruclif.

What Naveruclif is used for Naveruclif is used to treat the following types of cancer:

Breast Cancer

Breast cancer which has spread to other parts of the body (this is called metastatic breast cancer).

Naveruclif is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called anthracyclines .

People with metastatic breast cancer who received Naveruclif where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.

Pancreatic Cancer

Naveruclif is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas. People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received Naveruclif with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.

Lung Cancer

Naveruclif is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called non-small cell lung cancer .

Naveruclif is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.

Do not use Naveruclif

if you are allergic to Paclitaxel or any of the other ingredients of this medicine (listed in section 6).

if you are breast-feeding

if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3 - your doctor will advise you on this).

Warnings and precautions
Talk to your doctor or nurse before using Naveruclif

if you have poor kidney function;

if you have severe liver problems;

if you have heart problems.

Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Naveruclif, your doctor may wish to stop treatment or reduce the dose:

if you experience any abnormal bruising, bleeding, or signs of infections such as a sore throat or a fever;

if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness;

if you experience breathing problems, like shortness of breath or dry cough.

Children and adolescents Naveruclif is only for adults and should not be taken by children and adolescents aged below 18 years.

Other medicines and Naveruclif Tell your doctor if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Naveruclif can affect the way some other medicines work. Also, some other medicines can affect the way Naveruclif works.

Take care and speak to your doctor when taking Naveruclif at the same time as any of the following:

medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic), and including medicines for treating fungal infections (e.g. ketoconazole)

medicines used to help you stabilize your mood also sometimes referred to as anti-depressants (e.g. fluoxetine)

medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)

medicines used to help you lower blood lipid levels (e.g. gemfibrozil)

medicine used for heartburn or stomach ulcers (e.g. cimetidine)

medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)

a medicine called clopidogrel used to prevent blood clots.

Pregnancy, breast-feeding and fertility Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant. Your doctor will arrange a pregnancy test before starting treatment with Naveruclif.

Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Naveruclif.

Do not breast feed when taking Naveruclif as it is not known if the active ingredient paclitaxel passes into the mother s milk.

Male patients are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Naveruclif.

Ask your doctor for advice before taking this medicine.

Driving and using machines Some people may feel tired or dizzy after being given Naveruclif. If this happens to you, do not drive or use any tools or machines.

If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.

Naveruclif contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 mg, that is to say essentially sodium free .

Naveruclif will be given to you by a doctor or nurse into a vein from an intravenous drip. The dose you receive is based on your body surface area and blood test results. The usual dose is for breast cancer is 260 mg/m2 of body surface area given over a 30 minute period. The usual dose for advanced pancreatic cancer is 125 mg/m2 of body surface area given over a 30 minute period. The usual dose for non-small cell lung cancer is 100 mg/m2 of body surface area given over a 30 minute period.

How often will you receive Naveruclif? For treatment of metastatic breast cancer, Naveruclif is usually given once every three weeks (on day 1 of a 21-day cycle).

For treatment of advanced pancreatic cancer, Naveruclif is given on days 1, 8 and 15 of each 28-day treatment cycle with gemcitabine being given immediately after the Naveruclif.

For treatment of non-small cell lung cancer Naveruclif is given once every week (i.e. on days 1, 8 and 15 of a 21-day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Naveruclif dose has been given.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

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

The very common side effects may affect more than 1 in 10 people:

Loss of hair (the majority of cases of hair loss happened less than one month after starting Naveruclif. When it happens, hair loss is pronounced (over 50%) in the majority of patients)

Rash

Abnormal decrease in the number of types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood

Deficiency of red blood cells

Reduction in the number of platelets in the blood

Effect on peripheral nerves (pain, numbness, tingling or loss of feeling)

Pain in a joint or joints

Pain in the muscles

Nausea, diarrhoea, constipation, sore mouth, loss of appetite

Vomiting

Weakness and tiredness, fever

Dehydration, taste disturbance, weight loss

Low levels of potassium in the blood

Depression, sleep problems

Headache

Chills

Difficulty in breathing

Dizziness

Swelling of mucosal and soft tissues

Increased liver function tests

Pain in extremities

Cough

Abdominal pain

Nose bleeds

The common side effects may affect up to 1 in 10 people:

Itching, dry skin, nail disorder

Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood, flushing, thrush, severe infection in your blood which may be caused by reduced white blood cells

Reduction in all blood cell counts

Chest or throat pain

Indigestion, abdominal discomfort

Stuffy nose

Pain in back, bone pain

Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes

Changes in heart rate or rhythm, heart failure

Decreased or increased blood pressure

Redness or swelling at the site where the needle entered the body

Anxiety

Infection in the lungs

Infection in the urinary tract

Obstruction in the gut, inflammation of the large bowel, inflammation of the bile duct

Acute kidney failure

Increased bilirubin in the blood

Coughing up blood

Dry mouth, difficulty in swallowing

Muscle weakness

Blurred vision

The uncommon side effects may affect up to 1 in 100 people:

Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased phosphorus in the blood

Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis

Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)

Ear pain, ringing in your ears

Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat

Gas, stomach cramps, painful or sore gums, rectal bleeding

Painful urination, frequent urination, blood in the urine, inability to hold your urine

Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight, skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face

Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst, decreased calcium in the blood, decreased sugar in the blood, decreased sodium in the blood

Pain and swelling in the nose, skin infections, infection due to catheter line

Bruising

Pain at site of tumour, death of the tumour

Decreased blood pressure when standing up, coldness in your hands and feet

Difficulty walking, swelling

Allergic reaction

Decreased liver function, increased size of liver

Pain in the breast

Restlessness

Small bleedings in your skin due to blood clots

A condition involving destruction of red blood cells and acute kidney failure

The rare side effects may affect up to 1 in 1,000 people:

Skin reaction to another agent or lung inflammation following radiation

Blood clot

Very slow pulse, heart attack

Leaking of drug outside the vein

A disorder of the electrical conduction system of the heart (atrioventricular block)

The very rare side effects may affect up to 1 in 10,000 people:

Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known side effects (frequency cannot be estimated from the available data):

Hardening/thickening of the skin (scleroderma)

Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 vial after EXP. The expiry date refers to the last day of that month.

Unopened vials: Keep the vial in the outer carton in order to protect from light.

After first reconstitution the dispersion should be used immediately. If not used immediately, the dispersion may be stored in a refrigerator (2 C-8 C) for up to 24 hours in the vial when kept in the outer carton in order to protect it from light.

The reconstituted dispersion in the intravenous drip may be stored in a refrigerator (2 C-8 C) for up to 24 hours protected from light.

Chemical and physical in-use stability has been demonstrated for 24 hours at 2 C-8 C when protected from light followed by 4 hours at 25 C when not protected from light.

Your doctor or pharmacist is responsible for disposing of any unused Naveruclif correctly.

What Naveruclif contains

The active substance(s) is paclitaxel. Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

The other ingredient is albumin (human) (containing sodium caprylate and N-acetyl-L- tryptophan), see section 2 Naveruclif contains sodium .

What Naveruclif looks like and contents of the pack

Naveruclif is a white to yellow powder or lyophilized cake for dispersion for infusion. Naveruclif is available in glass vials containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.

Each pack contains 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder Accord Healthcare S.L.U. World Trade Center, Moll De Barcelona s/n,
Edifici Est, 6a Planta,
Barcelona, 08039,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o. ul. Lutomierska 50, 95-200 Pabianice, Poland

Or Laboratori Fundaci Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT / NL / NO / PL / PT / RO / SE / SI / SK / UK (NI)

Accord Healthcare S.L.U.
Tel: +34 93 301 00 EL
Win Medica . . : +30 210 74 88 This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: