<\/a><\/p>\n\n\n\nZOLSKETIL pegylated liposomal contains soybean oil and sodium<\/h2>\n\n\n\n
ZOLSKETIL pegylated liposomal contains soybean oil. If you are allergic to peanuts or soya, you should not use this medicine.<\/p>\n\n\n\n
ZOLSKETIL pegylated liposomal contains less than 1 mmol (23 mg) of\u00a0sodium\u00a0per\u00a0dose, i.e. is almost “sodium-free”.
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How to use ZOLSKETIL pegylated liposomal<\/h2>\n\n\n\n
ZOLSKETIL pegylated liposomal is a unique pharmaceutical form. It must not be exchanged for other preparations of doxorubicin hydrochloride.<\/p>\n\n\n\n
How much ZOLSKETIL pegylated liposomal is given<\/h2>\n\n\n\n
If you are being treated for breast or ovarian cancer, ZOLSKETIL pegylated liposomal will be given at a dose of 50 mg per square meter of your body surface area (based on your height and weight). Infusion one is repeated every 4 weeks as long as the disease does not worsen and you tolerate the treatment.<\/p>\n\n\n\n
If you are being treated for multiple\u00a0myeloma\u00a0and have already received at least one previous treatment regimen, ZOLSKETIL pegylated liposomal will be given at a\u00a0dose\u00a0of 30 mg per square meter of your body surface area (based on your height and weight).\u00a0ZOLSKETIL pegylated liposomal will be given as a one-hour\u00a0intravenous\u00a0infusion\u00a0on Day 4 of the bortezomib 3-week\u00a0regimen, immediately following the bortezomib infusion.\u00a0Dose\u00a0one is repeated as long as you respond satisfactorily and tolerate treatment.<\/p>\n\n\n\n
If you are being treated for\u00a0Kaposi’s sarcoma, ZOLSKETIL pegylated liposomal will be given at a\u00a0dose\u00a0of 20 mg per square meter of your body surface area (based on your height and weight).\u00a0Infusion\u00a0one is repeated every two to three weeks for two to three months, then as often as needed to maintain an improvement in your condition.
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How ZOLSKETIL pegylated liposomal is given<\/h2>\n\n\n\n
ZOLSKETIL pegylated liposomal will be given by your doctor as a drip (\u00a0infusion\u00a0) into a vein.\u00a0Depending on the\u00a0dose\u00a0and what the medicine is used for,\u00a0the infusion\u00a0can take from 30 minutes to more than an hour (ie 90 minutes).
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If you have used too much ZOLSKETIL pegylated liposomal<\/h2>\n\n\n\n
Acute\u00a0overdose worsens\u00a0side effects\u00a0such as ulcers in the mouth or reduced numbers of\u00a0white blood cells\u00a0and\u00a0platelets\u00a0in the blood.\u00a0Treatment will include\u00a0the administration\u00a0of\u00a0antibiotics,\u00a0transfusion\u00a0of\u00a0platelets, use of factors that stimulate the production of\u00a0white blood cells, and\u00a0symptomatic\u00a0treatment of mouth ulcers.<\/p>\n\n\n\n
If you have further questions about this medicine, contact your doctor or pharmacist.<\/strong>
<\/p>\n\n\n\nPossible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
During the infusion of ZOLSKETIL pegylated liposomal, you should immediately contact a doctor if the following reactions occur:<\/p>\n\n\n\n
- the severe\u00a0allergic reaction\u00a0which may include swelling of the face, lips, mouth, tongue, or throat;\u00a0difficulty swallowing or breathing;\u00a0itchy rash (\u00a0hives\u00a0)<\/li>
- inflamed and narrow airways in the lungs causing coughing, wheezing, and shortness of breath (\u00a0asthma\u00a0)<\/li>
- hot flushes, sweating, chills, or fever<\/li>
- chest pain or discomfort<\/li>
- back pain<\/li>
- high or low\u00a0blood pressure<\/li>
- rapid heartbeat<\/li>
- convulsions (seizures)<\/li><\/ul>\n\n\n\n
Leakage of the injection fluid from the veins into\u00a0the tissue\u00a0under the skin may occur.\u00a0If the drop stings or hurts when you receive a\u00a0dose\u00a0of ZOLSKETIL pegylated liposomal, tell your doctor immediately.<\/p>\n\n\n\n
Your doctor should be contacted immediately if any of the following serious side effects are detected<\/p>\n\n\n\n
- you develop a fever, feel tired or see signs of bruising or bleeding (very common) \u00a0\u00a0\u00a0<\/li>
- skin redness, swelling, scaling, or tenderness, mainly on the hands or feet (“hand-foot syndrome”).\u00a0These\u00a0side effects\u00a0have been seen very often and are sometimes serious.\u00a0In severe cases, these\u00a0side effects\u00a0may affect some daily activities and may persist for 4 weeks or longer before complete healing.\u00a0The doctor may want to delay and\/or reduce the\u00a0dose\u00a0for the next treatment (see below, Strategies for preventing and treating hand-foot syndrome)<\/li>
- mouth ulcers, severe diarrhea or vomiting, or nausea (very common)<\/li>
- infection\u00a0(common), including\u00a0pneumonia\u00a0or\u00a0infection\u00a0affecting your vision<\/li>
- shortness of breath (common)<\/li>
- severe abdominal pain (common)<\/li>
- the severe feeling of weakness (common)<\/li>
- the severe\u00a0allergic reaction\u00a0which may include swelling of the face, lips, mouth, tongue, or throat;\u00a0difficulty swallowing or breathing;\u00a0itchy rash (\u00a0hives\u00a0) (uncommon)<\/li>
- cardiac arrest (the heart stops beating);\u00a0heart failure, when the heart does not pump enough blood to the rest of the body, giving you shortness of breath and can leading to swollen legs (uncommon)<\/li>
- a blood clot that travels to the lung, causing chest pain and giving you shortness of breath (uncommon)<\/li>
- swelling, warmth, or tenderness in the soft parts of the legs, sometimes with pain that gets worse when standing or walking (rare)<\/li>
- severe or life-threatening rash with blisters and peeling skin, mainly around the mouth, nose, eyes, and genitals (\u00a0Stevens-Johnson syndrome\u00a0) or over most of the body (\u00a0toxic epidermal necrolysis\u00a0) (rare)<\/li><\/ul>\n\n\n\n
Other\u00a0side effects\u00a0ar<\/strong><\/p>\n\n\n\nBetween\u00a0infusions, the following may occur:<\/p>\n\n\n\n
Very common side effects (<\/strong> may affect more than 1 in 10 users)<\/p>\n\n\n\n- decrease in the number of\u00a0white blood cells, which can increase the risk of\u00a0infection.\u00a0In rare cases, a low\u00a0white blood cell count\u00a0can lead to severe\u00a0infection.\u00a0Anemia\u00a0(a decrease in\u00a0red blood cells\u00a0) can cause fatigue.\u00a0Decreased number of\u00a0platelets\u00a0can increase the risk of bleeding.\u00a0Because the blood can be affected, you must take blood samples regularly.<\/li>
- decreased appetite<\/li>
- constipation;<\/li>
- skin rash, including redness of the skin, allergic skin rash, red or raised rash on the skin<\/li>
- hair loss<\/li>
- pain, including pain in muscles and chest muscles, joints, arms, or legs<\/li>
- great feeling of fatigue<\/li><\/ul>\n\n\n\n
Common side effects (<\/strong> may affect up to 1 in 10 users):<\/p>\n\n\n\n- infection, including serious\u00a0infection\u00a0of the whole body (\u00a0sepsis\u00a0), lung infections, viral infection with\u00a0herpes\u00a0zoster (\u00a0shingles\u00a0), a type of bacterial infection (\u00a0mycobacterium\u00a0avium complex infection), urinary tract infection, fungal infections (including thrush and oral thrush),\u00a0infection\u00a0in hair roots,\u00a0infection\u00a0or irritation of the throat,\u00a0infection\u00a0of the nose, sinuses or throat (cold)<\/li>
- the low number of a type of\u00a0white blood cell\u00a0(\u00a0neutrophils\u00a0) with fever<\/li>
- severe weight loss and muscle wasting, dehydration (\u00a0dehydration\u00a0), low levels of\u00a0potassium,\u00a0sodium,\u00a0or\u00a0calcium\u00a0in the blood<\/li>
- feeling confused, feeling anxious, depressed, difficulty sleeping<\/li>
- nerve damage that may cause tingling, numbness, pain or lack of pain sensation, nerve pain, unusual sensation in the skin (such as tingling or crawling), decreased sensation or sensitivity, especially in the skin<\/li>
- altered sense of taste, headache, feeling very tired and low energy levels, dizziness<\/li>
- inflammation\u00a0of the eyes (\u00a0conjunctivitis\u00a0)<\/li>
- palpitation<\/li>
- high or low\u00a0blood pressure, cramps<\/li>
- shortness of breath that can occur during physical activity, nosebleeds, coughing<\/li>
- inflammation\u00a0of the lining of the stomach or esophagus, mouth ulcers, indigestion, difficulty swallowing, pain in the mouth,\u00a0dry mouth<\/li>
- skin problems, including flaky and dry skin,\u00a0redness\u00a0of the skin, blisters or sores on the skin,\u00a0itching, dark spots on the skin<\/li>
- abnormally heavy sweating<\/li>
- muscle cramps or muscle pain<\/li>
- pain in the muscles, bones, or back<\/li>
- pain when urinating<\/li>
- allergic reaction\u00a0to the drug infusion, flu-like illness, chills, inflamed mucous membranes in body cavities or passages such as the nose, mouth, or windpipe, feeling weak, feeling generally unwell, swelling caused by fluid retention in the body, swollen hands, ankles or feet<\/li>
- weight loss<\/li><\/ul>\n\n\n\n
When ZOLSKETIL pegylated liposomal alone is used, some of these side effects are less likely to occur and some have not occurred at all.<\/p>\n\n\n\n
Uncommon side effects (<\/strong> may affect up to 1 in 100 users):<\/p>\n\n\n\n- viral infection with\u00a0herpes\u00a0simplex (cold sores or genital\u00a0herpes\u00a0), fungal infection<\/li>
- the low number of all types of\u00a0blood cells, increased number of\u00a0platelets\u00a0(cells that help the blood to clot)<\/li>
- allergic reaction<\/li>
- high levels of\u00a0potassium\u00a0in the blood, low levels of\u00a0magnesium\u00a0in the blood<\/li>
- nerve damage that affects more than one area of \u200b\u200bthe body<\/li>
- convulsions, fainting<\/li>
- unpleasant or painful sensation, especially when touched, sleepiness<\/li>
- blurred vision, watery eyes<\/li>
- heartbeats that feel fast or irregular (\u00a0palpitations\u00a0), disease of the heart muscle, damage to the heart<\/li>
- tissue damage (\u00a0necrosis\u00a0) where\u00a0the injection\u00a0is given, inflamed veins causing swelling and pain, dizziness when sitting or standing<\/li>
- chest discomfort<\/li>
- emission of gases, inflamed gums (\u00a0gingivitis\u00a0)<\/li>
- skin problems or rashes, including flaky or scaly skin, allergic skin rash, sores or\u00a0hives\u00a0on the skin, skin discoloration, change in skin color (pigmentation), small red or purple spots caused by bleeding under the skin, nail problems,\u00a0acne<\/li>
- muscle weakness<\/li>
- pain in the chest<\/li>
- irritation or pain at the injection site<\/li>
- swelling of the face, high body temperature<\/li>
- symptoms (such as\u00a0inflammation,\u00a0redness,\u00a0or pain) come back in places that were previously treated with radiation or that were previously damaged by an\u00a0injection\u00a0of\u00a0chemotherapy\u00a0into a vein<\/li><\/ul>\n\n\n\n
Rare side effects (<\/strong> may affect up to 1 in 1,000 users)<\/p>\n\n\n\n- infection\u00a0that occurs in people with weak immune systems<\/li>
- the low number of\u00a0blood cells\u00a0are produced in the\u00a0bone\u00a0marrow<\/li>
- inflammation\u00a0of the retina that can cause vision changes or blindness<\/li>
- abnormal heart rhythm, abnormal\u00a0EKG\u00a0(\u00a0electrocardiogram\u00a0) which can be caused by a slow heart rhythm, problems with the heart that affect the heartbeat and heart rhythm, blue skin and mucous membranes caused by a lack of oxygen in the blood<\/li>
- dilation of blood vessels<\/li>
- tightness in the throat<\/li>
- sore and swollen tongue, sores on the lips (cold sores)<\/li>
- skin rash with fluid-filled blisters<\/li>
- vaginal infection,\u00a0redness\u00a0of the scrotum<\/li>
- problems with the mucous membranes in body cavities or passages, such as the nose, mouth, or trachea<\/li>
- abnormal liver blood test results increased blood levels of ‘creatinine’<\/li><\/ul>\n\n\n\n
Frequency not known<\/strong> (cannot be estimated from available data)<\/p>\n\n\n\n- cancer of the blood that develops rapidly and affects the blood cells ( acute myeloid leukemia ), bone marrow disease that affects the blood cells ( myelodysplastic syndrome ), cancer of the mouth or lips<\/li><\/ul>\n\n\n\n
How to store ZOLSKETIL pegylated liposomal<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Use before the expiry date stated on the vial label and carton.<\/p>\n\n\n\n
Store in a refrigerator (2 \u00b0C\u20118 \u00b0C). Do not freeze.<\/p>\n\n\n\n
After preparation:<\/p>\n\n\n\n
Chemical and physical in-use stability has been demonstrated for 24 hours at 2\u00b0C-8\u00b0C.<\/p>\n\n\n\n
For microbiological reasons, the product must be used immediately.\u00a0If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would not be longer than 24 hours at 2\u00b0C-8\u00b0C.\u00a0Partially used vials must be destroyed.<\/p>\n\n\n\n
Do not use this medicine if you see any signs of precipitation or other particle formation.<\/p>\n\n\n\n
Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n