Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - armisarte

Document Subject

Generated Narrative: MedicinalProductDefinition mp6c6dd9b522aed0e03ebfe1ea0c0a4560

identifier: http://ema.europa.eu/identifier/EU/1/15/1063/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Armisarte 25 mg/ml concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6c6dd9b522aed0e03ebfe1ea0c0a4560

identifier: http://ema.europa.eu/identifier/EU/1/15/1063/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - armisarte

Attesters

What is in this leaflet

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

Armisarte is a medicine used in the treatment of cancer. It contains the active substance pemetrexed. Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts processes that are essential for cells to divide.

Armisarte is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.

Armisarte is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.

Armisarte can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.

Armisarte is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.

Do not use Armisarte

• if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding; you must discontinue breast-feeding during treatment with Armisarte.
• if you have recently received or are about to receive a vaccine against yellow fever.

Warnings and precautions Talk to your doctor or hospital pharmacist before receiving Armisarte. If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Armisarte. Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Armisarte. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.

If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with Armisarte.

If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Armisarte.

If you have heart disease or a history of heart disease, please tell your doctor.

If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Armisarte.

Children and adolescents This medicine should not be used in children or adolescents, since there is no experience with this medicine in children and adolescents under 18 years of age.

Other medicines and Armisarte Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicine for pain or inflammation (swelling), such as medicines called nonsteroidal anti-inflammatory medicinal products (NSAIDs), including medicines purchased without a doctor s prescription (such as ibuprofen). There are many sorts of NSAIDs with different durations of activity. Based on the planned date of your infusion of Armisarte and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them. If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.

Like other chemotherapy medicines Armisarte is not recommended with live attenuated vaccines. Inactive vaccines should be used where possible.

Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The use of Armisarte should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Armisarte during pregnancy. Women must use effective contraception during treatment with Armisarte and for 6 months after receiving the last dose.

Breast-feeding If you are breast-feeding, tell your doctor. Breast-feeding must be discontinued during treatment with Armisarte.

Fertility Men are advised not to father a child during and up to 3 months following treatment with Armisarte and should therefore use effective contraception during treatment with Armisarte and for up to 3 months afterwards. If you would like to father a child during the treatment or in the 3 months following receipt of treatment, seek advice from your doctor or pharmacist. Armisarte can affect your ability to have children. Talk to your doctor to seek advice about sperm storage before starting your therapy.

Driving and using machines Armisarte may make you feel tired. Be careful when driving a car or using machines.

Armisarte 25 mg/ml concentrate for solution for infusion will always be given to you by a healthcare professional. The dose of Armisarte is 500 milligrams for every square metre of your body s surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. A hospital pharmacist, nurse or doctor will have mixed the Armisarte concentrate with 5% glucose solution for injection or 0.9% sodium chloride solution for injection before it is given to you.

You will always receive Armisarte by infusion into one of your veins. The infusion will last approximately 10 minutes.

When using Armisarte in combination with cisplatin: The doctor or hospital pharmacist will work out the dose you need based on your height and weight. Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Armisarte has finished. The infusion of cisplatin will last approximately 2 hours.

You should usually receive your infusion once every 3 weeks.

Additional medicines:
Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Armisarte treatment. This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.

Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are receiving Armisarte. You must take at least 5 doses during the seven days before the first dose of Armisarte. You must continue taking the folic acid for 21 days after the last dose of Armisarte. You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Armisarte and then approximately every 9 weeks (corresponding to 3 courses of Armisarte treatment). Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.

Your condition will be closely monitored during treatment. This routinely involves blood tests, including checks on your liver and kidney function. Your dose may be changed or treatment delayed depending on results from these tests.

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

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

You must contact your doctor immediately if you notice any of the following:

• Fever or infection (respectively, common or very common): if you have a temperature of 38 C or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death
• If you start feeling chest pain (common) or having a fast heart rate (uncommon)
• If you have pain, redness, swelling or sores in your mouth (very common)
• Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common). Rarely, skin reactions may be severe and could lead to death. Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)
• If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common)
• If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is common)
• If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)

Other side effects with Armisarte may include:

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

Infection

Pharyngitis (a sore throat)

Low number of neutrophil granulocytes (a type of white blood cell)

Low white blood cells

Low haemoglobin level

Pain, redness, swelling or sores in your mouth

Loss of appetite

Vomiting

Diarrhoea

Nausea

Skin rash

Flaking skin

Abnormal blood tests showing reduced functionality of kidneys

Fatigue (tiredness)

Common (may affect up to 1 in 10 people)

Blood infection

Fever with low number of neutrophil granulocytes (a type of white blood cell)

Low platelet count

Allergic reaction

Loss of body fluids

Taste change

Damage to the motor nerves which may cause muscle weakness and atrophy (wasting) primary in the arms and legs)

Damage to the sensory nerves that may cause lost of sensation, burning pain and unsteady gait

Dizziness

Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye

Dry eye

Watery eyes

Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea (the clear layer in front of the iris and pupil.

Swelling of the eyelids

Eye disorder with dryness, tearing, irritation, and/or pain

Cardiac Failure (Condition that affects the pumping power of your heart muscles)

Irregular heart rhythm

Indigestion

Constipation

Abdominal pain

Liver: increases in the chemicals in the blood made by the liver

Increased skin pigmentation

Itchy skin

Rash on the body where each mark resembles a bullseye

Hair loss

Hives

Kidney stop working

Reduced functionality of kidney

Fever

Pain

Excess fluid in body tissue, causing swelling

Chest pain

Inflammation and ulceration of the mucous membranes lining the digestive tract

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of red,white blood cells and platelets

Stroke

Type of stroke when an artery to the brain is blocked

Bleeding inside the skull

Angina (Chest pain caused by reduced blood flow to the heart)

Heart attack

Narrowing or blockage of the coronary arteries

Increased heart rhythm

Deficient blood distribution to the limbs

Blockage in one of the pulmonary arteries in your lungs

Inflammation and scarring of the lining of the lungs with breathing problems

Passage of bright red blood from the anus

Bleeding in the gastrointestinal tract

Ruptured bowel

Inflammation of the lining of the oesophagus

Inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)

Inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy

Inflammation of the lung caused by radiation therapy

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

Destruction of red blood cells

Anaphylactic shock (severe allergic reaction)

Inflammatory condition of the liver

Redness of the skin

Skin rash that develops throughout a previously irradiated area

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

Infections of skin and soft tissues

Stevens-Johnson syndrome (a type of severe skin and mucous membranes reaction that may be life threatening)

Toxic epidermal necrolysis (a type of severe skin reaction that may be life threatening)

Autoimmune disorder that results in skin rashes and blistering on the legs, arms, and abdomen

Inflammation of the skin characterized by the presence of bullae which are filled with fluid

Skin fragility, blisters and erosions and skin scarring

Redness, pain and swelling mainly of the lower limbs

Inflammation of the skin and fat beneath the skin (pseudocellulitis)

Inflammation of the skin (dermatitis)

Skin to become inflamed, itchy, red, cracked, and rough

Intensely itchy spots

Not known: frequency cannot be estimated from the available data

Form of diabetes primarily due to pathology of the kidney

Disorder of the kidneys involving the death of tubular epithelial cells that form the renal tubules

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.

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 label and carton after EXP . The expiry date refers to the last day of that month.

Unopened vial Store and transport refrigerated (2 C-8 C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

After first opening of the vial 4 ml vial (100 mg/4 ml) Chemical and physical in-use stability has been demonstrated for 7 days at 2 C-8 C.

20 ml (500 mg/20 ml), 34 ml (850 mg/34 ml) and 40 ml (1000 mg/40 ml) vials Chemical and physical in-use stability has been demonstrated for 14 days at 2 C-8 C.

Infusion Solution Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 24 hours at room temperature and 7 days at refrigerated temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 C-8 C, unless method of opening/dilution has taken place in controlled and validated aseptic conditions.

Armisarte should not been used if there are any signs of particles.

Any unused concentrate left in the vial, which has exceeded the in-use shelf life, must be disposed of in accordance with local requirements.

What Armisarte contains

The active substance is pemetrexed. Each ml of concentrate contains 25 mg pemetrexed (as pemetrexed diacid).

Each vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid) Each vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid) Each vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid) Each vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid)

The other ingredients are trometamol (for pH adjustment), citric acid, methionine and water for injection.

What Armisarte looks like and contents of the pack

Armisarte concentrate for solution for infusion (sterile concentrate) is a clear, colourless to slightly yellowish or yellow-greenish solution. Armisarte is provided in a colourless glass vial with rubber stopper and an aluminium cap with polypropylene disk. Vials may or may not be sheathed in a protective sleeve.

Each pack of Armisarte contains one vial.

Pack sizes 1 x 4 ml vial (100 mg/4 ml) 1 x 20 ml vial (500 mg/20 ml) 1 x 34 ml vial (850 mg/34 ml) 1 x 40 ml vial (1000 mg/40 ml)

Not all pack sizes may be marketed.

Marketing Authorisation Holder Actavis Group PTC ehf. Dalshraun 1 220 Hafnarfj r ur Iceland

Manufacturer PLIVA CROATIA Ltd. 10000 Zagreb Prilaz baruna Filipovi a Croatia

Actavis Italy S.p.A. Via Pasteur 20014 Nerviano (Milan) Italy

S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd. 011171 Bucharest Romania

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

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland ratiopharm GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
TEVA HELLAS A.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o.
Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
TEVA HELLAS A.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in

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