Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zolsketil

Document Subject

Generated Narrative: MedicinalProductDefinition mp55a0c3e4e0760943cb20f19d7e8a0dd1

identifier: http://ema.europa.eu/identifier/EU/1/22/1629/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ZOLSKETIL pegylated liposomal 2 mg/mL concentrate for dispersion for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

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-55a0c3e4e0760943cb20f19d7e8a0dd1

identifier: http://ema.europa.eu/identifier/EU/1/22/1629/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - zolsketil

Attesters

What is in this leaflet

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

ZOLSKETIL pegylated liposomal is an antitumour agent.

ZOLSKETIL pegylated liposomal is used to treat cancer of the breast in patients at risk for heart problems. ZOLSKETIL pegylated liposomal is also used to treat cancer of the ovary. It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.

ZOLSKETIL pegylated liposomal is also used in combination with another medicine, bortezomib, to treat multiple myeloma (a cancer of the blood) in patients who have received at least 1 prior therapy.

ZOLSKETIL pegylated liposomal is also used to produce an improvement in your Kaposi s sarcoma including flattening, lightening and even shrinkage of the cancer. Other symptoms of Kaposi s sarcoma, such as swelling around the tumour, may also improve or disappear.

ZOLSKETIL pegylated liposomal contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells. The doxorubicin hydrochloride in ZOLSKETIL pegylated liposomal is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.

Do not use ZOLSKETIL pegylated liposomal

• if you are allergic to doxorubicin hydrochloride, peanut or soya, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions You should tell your doctor about any of the following:

• if you are receiving any treatment for heart disease or liver disease;
• if you are diabetic, because ZOLSKETIL pegylated liposomal contains sugar which may require an adjustment to the treatment of your diabetes;
• if you have Kaposi s sarcoma and have had your spleen removed;
• if you notice sores, discolouration or any discomfort in your mouth.
• if you have bone marrow bone marrow is not making enough blood cells
• if you have cancer where bone marrow makes abnormal blood cells
• if you have painful, macular reddening skin rash
• if you have leakage of vesicant fluids or medicines from the vein into the surrounding tissue
• if you have hand foot syndrome (redness, swelling and blistering (a pocket of fluid between the upper layers of skin) on the palms of the hands and soles of the feet)

Strategies to prevent and treat hand-foot syndrome include:

soaking hands and/or feet in basins of cold water when possible (e.g., while watching television, reading, or listening to the radio);

keeping hands and feet uncovered (no gloves, socks, etc.);

staying in cool places;

taking cool baths during hot weather;

avoiding vigorous exercise that might cause trauma to the feet (e.g., jogging);

avoiding exposure of skin to very hot water (e.g., jacuzzis, saunas);

avoiding tight fitting footwear or high-heeled shoes.

Pyridoxine (Vitamin B6):

• vitamin B6 is available without prescription;

take 50-150 mg daily beginning at the first signs of redness or tingling.

The cases of Interstitial lung diseases have been observed in patients receiving pegylated liposomal doxorubicin including fatal cases. The symptoms of Interstitial lung disease are cough and shortness of breath sometimes with fever which are not caused by physical activity. Seek immediate medical attention, if you experience symptoms that may be signs of Interstitial lung disease.

Children and adolescents ZOLSKETIL pegylated liposomal should not be used in children and adolescents, because it is not known how the medicine will affect them.

Other medicines and ZOLSKETIL pegylated liposomal Tell your doctor or pharmacist

• if you are taking or have recently taken any other medicines, including medicines obtained without a prescription;
• about any other cancer treatments you are on or have been taking, as particular care needs to be taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells. If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.

Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking this medicine.

Because the active ingredient doxorubicin hydrochloride in ZOLSKETIL pegylated liposomal may cause birth defects, it is important to tell your doctor if you think you are pregnant.
Women must avoid becoming pregnant and use contraception while taking ZOLSKETIL pegylated liposomal and in the eight months following discontinuation of ZOLSKETIL pegylated liposomal treatment. Men must use contraception while taking ZOLSKETIL pegylated liposomal and in the six months following discontinuation of ZOLSKETIL pegylated liposomal, so that their partner does not become pregnant.

Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with ZOLSKETIL pegylated liposomal. Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

Driving and using machines Do not drive or use any tools or machines if you feel tired or sleepy from treatment with ZOLSKETIL pegylated liposomal.

ZOLSKETIL pegylated liposomal contains soya oil and sodium ZOLSKETIL pegylated liposomal contains soya oil. If you are allergic to peanut or soya, do not use this medicine. ZOLSKETIL pegylated liposomal contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

ZOLSKETIL pegylated liposomal is a unique formulation. It must not be used interchangeably with other formulations of doxorubicin hydrochloride.

How much ZOLSKETIL pegylated liposomal is given If you are being treated for breast cancer or ovarian cancer, ZOLSKETIL pegylated liposomal will be administered at a dose of 50 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.

If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, ZOLSKETIL pegylated liposomal will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion. The dose is repeated as long as you respond satisfactorily and tolerate treatment.

If you are being treated for Kaposi sarcoma, ZOLSKETIL pegylated liposomal will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 2 to 3 weeks for 2-3 months, then as often as necessary to maintain an improvement in your condition.

How ZOLSKETIL pegylated liposomal is given ZOLSKETIL pegylated liposomal will be given to you by your doctor in a drip (infusion) into a vein. Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., minutes).

If you use more ZOLSKETIL pegylated liposomal than you should Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood. Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.

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

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

During the infusion of ZOLSKETIL pegylated liposomal, the following reactions may occur:

• severe allergic reaction that may include a swollen face, lips, mouth, tongue or throat; difficulty swallowing or breathing; itchy rash (hives)
• inflamed and narrowed airways in the lungs, causing coughing, wheezing and shortness of breath (asthma)
• flushing, sweating, chills or a fever
• chest pain or discomfort
• back pain
• high or low blood pressure
• fast heart beat
• fits (seizures)

Leaking of the injection fluid from the veins into the tissues under the skin may occur. If the drip stings or hurts while you are receiving a dose of ZOLSKETIL pegylated liposomal, tell your doctor immediately

Your doctor should be contacted immediately if any of the following serious side effects are noticed

• you develop fever, feel tired, or if you have signs of bruising or bleeding (very common)
• redness, swelling, peeling or tenderness, mainly on the hands or feet ( hand-foot syndrome). These effects have been seen very commonly and are sometimes severe. In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely. The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat hand foot syndrome, below)
• sores in mouth, severe diarrhoea or vomiting or nausea (very common)
• infections (common), including lung infections (pneumonia) or infections that may affect your
• vision
• being short of breath (common)
• severe stomach pain (common)
• severe weakness (common)
• severe allergic reaction that may include a swollen face, lips, mouth, tongue or throat; difficulty swallowing or breathing; itchy rash (hives) (uncommon)
• cardiac arrest (heart stops beating); heart failure, in which the heart does not pump enough blood to the rest of the body, which makes you short of breath and may lead to swollen legs (uncommon)
• blood clot that moves to the lungs, causes chest pain and makes you short of breath (uncommon)
• swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk (rare)
• severe or life-threatening rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or over most of the body (toxic epidermal necrolysis) (rare)

Other side effects Between infusions, the following may occur:

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

• decrease in the number of white blood cells, which can increase the chances of infections. In rare cases, having low white blood cells may lead to severe infection. Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding. It is because of the potential changes in your blood cells that you will have regular blood tests.
• decreased appetite;
• constipation;
• skin rashes, including redness of the skin, allergic skin rash, red or raised rash on the skin
• hair loss
• pain including in the muscles and chest muscle, joint, arm, or leg
• feeling very tired

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

• infections, including severe infection throughout the body (sepsis), lung infections, herpes zoster virus infections (shingles), a type of bacterial infection (mycobacterium avium complex infection), urinary tract infection, fungal infections (including thrush and oral thrush in the mouth) infection of the hair roots, infected or irritated throat, infected nose, sinuses or throat (cold)
• low number of a type of white blood cell (neutrophils), with a fever
• severe weight loss and muscle wasting, not enough water in the body (dehydration), low level of potassium, sodium, or calcium in the blood
• feeling confused, feeling anxious, depression, difficulty sleeping
• nerve damage that may cause tingling, numbness, pain or loss of pain sensation, nerve pain, unusual feeling in the skin (such as tingling or a crawling feeling), decreased feeling or sensitivity, especially in the skin
• change in sense of taste, headache, feeling very sleepy with low energy, feeling dizzy;
• inflamed eyes (conjunctivitis)
• fast heart beat
• high or low blood pressure, flushing
• shortness of breath that may be brought on by physical activity, nose bleeds, cough
• inflamed stomach lining or foodpipe, ulcers (sores) in the mouth, indigestion, difficulty swallowing, mouth pain, dry mouth
• skin problems, including flaky or dry skin, redness of the skin, blister or ulcer (sore) on the skin, itching, dark skin patches
• excessive sweating
• muscle spasms or aches
• pain including in the muscles, bone, or back
• pain when passing urine
• allergic reaction to infusion of the medicine, flu-like illness, chills, inflamed lining of the cavities and passages in the body, such as the nose, mouth or windpipe, feeling weak, generally feeling unwell, swelling caused by fluid build up in the body, swollen hands, ankles or feet
• weight loss

When ZOLSKETIL pegylated liposomal is used alone, some of these effects are less likely to occur, and some have not occurred at all.

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

• herpes simplex virus infections (cold sores or genital herpes), fungal infection
• low number of all types of blood cells, increased number of platelets (cells that help blood to clot)
• allergic reaction
• high level of potassium in the blood, low level of magnesium in the blood
• nerve damage affecting more than one area of the body
• fits (seizures), fainting
• unpleasant or painful sensation, especially to touch, feeling sleepy
• blurred vision, watery eyes
• heart beat feels fast or uneven (palpitations), heart muscle disease, heart damage
• tissue damage (necrosis) where the injection is given, inflamed veins that cause swelling and pain, feeling dizzy upon sitting up or standing up
• chest discomfort
• passing wind, inflamed gums (gingivitis)
• skin problems or rashes, including flaky or peeling skin, allergic skin rash, ulcer (sore) or hives on the skin, discoloured skin, change in the natural colour (pigment) of the skin, small red or purple spots caused by bleeding under the skin, nail problems, acne
• muscle weakness
• breast pain
• irritation or pain where the injection is given
• swollen face, high body temperature
• symptoms (such as inflammation, redness or pain) come back at a part of the body that previously received radiation therapy or was previously damaged by a chemotherapy injection into a vein

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

• infection that occurs in people with a weak immune system
• low number of blood cells made in the bone marrow
• inflamed retina, which may cause changes in vision or blindness
• abnormal heart rhythm, abnormal heart tracing on an ECG (electrocardiogram) and may be with a slow heart beat, problem with the heart that affects the heart beat and rhythm, blue colour to the skin and mucosa caused by low oxygen in the blood
• widening of blood vessels
• tight feeling in the throat
• sore and swollen tongue, ulcer (sore) on the lip
• skin rash with fluid-filled blisters
• vaginal infection, redness of the scrotum
• problems with the lining of the cavities and passages in the body, such as the nose, mouth or windpipe
• abnormal liver blood test results, increased level of creatinine in the blood

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

• cancer of the blood that develops quickly and affects the blood cells (acute myeloid leukaemia), bone marrow disease that affects the blood cells (myelodysplastic syndrome), cancer of themouth or lip
• coughing and shortness of breath, possibly accompanied by fever, that is not brought on by physical activity (Interstitial lung disease)

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 vial label and carton.

Store in a refrigerator (2 C 8 C). Do not freeze.

After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 C to 8 C. 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 should not be longer than 24 hours at 2 C to 8 C. Partially used vials must be discarded.

Do not use this medicine if you notice that it shows evidence of precipitation or any other particulate matter.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What ZOLSKETIL pegylated liposomal contains

• The active substance is doxorubicin hydrochloride. One mL of ZOLSKETIL pegylated liposomal contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
• The other ingredient(s) are hydrogenated soy phosphatidylcholine, N- carbonylmethoxypolyethylene glycol-2000)-1,2- distearoyl- sn-glycero-3- phosphoethanolamine, sodium salt (MPEG 2000-DSPE), cholesterol, ammonium sulphate, histidine, sucrose, water for injections, hydrochloric acid, concentrated (for pH-adjustment), sodium hydroxide (for pH-adjustment). See section 2. ZOLSKETIL pegylated liposomal: vials which provide 10 mL (20 mg) or 25 mL (50 mg).

What ZOLSKETIL pegylated liposomal looks like and contents of the pack This medicine is a translucent red coloured dispersion filled in a clear glass vial. ZOLSKETIL pegylated liposomal is available in glass vials as a single pack or packs of ten vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6 planta,
08039,Barcelona,
Spain

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

Accord Healthcare B.V. Winthontlaan 200, Utrecht, 3526KV ,
Netherlands

This leaflet was last revised in {MM/YYYY}.

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