SUN 50 mg powder and solvent for solution for injection/infusion
melphalan

What Melfalan is and what it is used for

Melphalan SUN contains the active substance melphalan. Melfalan belongs to the group of chemotherapy drugs (also known as chemotherapy ). Melfalan SUN is used to treat cancer. It works by inhibiting cell growth and slowing down the continued growth of tumor cells.

Melfalan SUN is used to treat:

  • Multiple myeloma (a type of cancer that develops from cells in the bone marrow called plasma cells. Plasma cells help to produce antibodies that are involved in the body’s immune system)
  • advanced ovarian cancer
  • neuroblastoma in children (nervous system cancer)
  • malignant melanoma (a type of skin cancer)
  • soft tissue sarcoma (cancer of muscles, fat, fibrous tissue , blood vessels, or other supporting tissue in the body).

You need to talk to a doctor if you do not feel better or if you feel worse.

Melfalan contained in Melfalan SUN may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you use Melfalan

You should NOT have Melfalan SUN prescribed to you if any of the following apply to you. Tell your doctor about:

  • you are allergic to melphalan or any of the other ingredients of this medicine (listed in section 6)
  • you breastfeed

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Melfalan SUN if:

– you are receiving or have recently received radiation therapy or chemotherapy

– you have impaired kidney function

– you should be vaccinated or have recently been vaccinated. This is because some so-called live vaccines (such as polio, measles, mumps, and rubella) can give you an infection if you get them while you are being treated with Melfalan SUN.

– you have or have ever had, a blood clot in your leg ( thrombosis ), lung ( pulmonary embolism ), or any other part of your body

– you have a condition that gives you an increased risk of getting a blood clot in your arteries

Men who receive Melfalan SUN should not become a father during treatment and for up to 3 months afterward.

Other medicines and Melfalan

Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor or nurse in particular if you are taking any of the following:

  • other chemotherapy ( chemotherapy )
  • nalidixic acid (an antibiotic used to treat urinary tract infections)
  • ciclosporin (used, for example, to prevent organ rejection after a transplant, to treat skin conditions such as psoriasis and eczema , or to treat rheumatism)
  • live vaccines (see Warnings and Precautions)
  • busulfan given to children (used to treat certain types of cancer).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Melfalan SUN should not be used during pregnancy as it may cause permanent birth defects. If you are already pregnant, you must talk to your doctor before receiving Melfalan SUN. Your doctor will assess the risks and benefits for you and your child if you are being treated with Melfalan SUN.

Reliable contraceptives must be used to avoid pregnancy while you or your partner are receiving this injection/infusion.

Breast-feeding

It is unknown whether Melfalan SUN is excreted in human milk. You should not breastfeed while taking Melfalan SUN.

Fertility

Melfalan Sun can affect the ovaries or sperm, which can lead to infertility (inability to have children). In women, menstruation may stop ( amenorrhea ) and in men, a complete lack of sperm may be observed ( azoospermia ) as a result of treatment with Melfalan SUN. Therefore, men are advised to seek advice on sperm preservation before treatment.

Male and female contraceptives

Men receiving Melfalan SUN should not have children during treatment and for up to 3 months afterward. Talk to your doctor about effective and reliable contraceptives.

Driving and using machines

Effects on the ability to drive and use machines in patients taking this medicine have not been studied. It is not expected that this medicine will affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Melfalan contains excipients

Melfalan  SUN contains sodium

This medicine contains less than 1 mmol (23 mg) per dose, ie it is essentially ‘sodium-free’.

Melfalan  SUN contains ethanol (alcohol)

This medicine contains 5% ethanol (alcohol), equivalent to 10 ml beer or 2.4 ml wine per dose.

Harmful to people suffering from alcoholism.

This should be considered in pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.

Melfalan  SUN contains propylene glycol

May cause symptoms similar to alcohol.

How to use Melfalan SUN

If you have been prescribed Melfalan SUN, it will only be given to you by doctors or nurses with experience in giving chemotherapy.

How Melfalan SUN is given

Melfalan SUN can be said

  • as a drop ( infusion ) in your friend
  • into an artery to a specific part of the body ( perfusion ).

How much Melfalan  SUN is given

Your doctor will decide how much Melfalan SUN to give you. The amount of Melfalan SUN depends on

  • your body weight or body surface area (a specific measurement with regard to your weight and your size)
  • other medicines you are taking
  • your illness

– your age

– if you have kidney problems or not.

When you receive Melfalan SUN, your doctor will take blood samples regularly. This is done to check the number of blood cells in your blood. Sometimes your doctor may change your dose as a result of these test results.

Risk of blood clots ( thromboembolic events )

Your doctor will decide if you should receive preventive treatment for blood clots in your veins. This applies during the first 5 months of treatment, or if you have an increased risk of developing blood clots in the veins.

Use for children and adolescents

Melfalan SUN is rarely used in children. Guidelines for how Melfalan SUN should be dosed to children are not available.

Use in elderly patients

Dose adjustment information for elderly patients is not available.

Use in patients with renal impairment

If you have kidney problems, your doctor will usually give you a lower dose than other adults.

If you take more Melfalan SUN than you should

You will get Melfalan SUN from a doctor, so it is unlikely that you will get too much. Tell your doctor or nurse if you think you have received too much or if you have missed a dose.

If you forget to use Melfalan

Your doctor will give you Melfalan SUN, so it is unlikely that you will miss a dose of this medicine. If you think you have missed a dose, skip that dose and you will receive the next dose at the next prescribed time. Do not use an extra dose or increase the amount of your next dose to make up for a missed dose.

If you stop using Melfalan

If you feel that you should stop taking this medicine, talk to your doctor first.

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

Possible side effects

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

Serious side effects are

If you experience any of the following side effects, contact your doctor or hospital immediately:

  • allergic reaction . The characters may include:- skin rash, lumps on the skin or hives- swelling of the face, eyelids or lips- shortness of breath and feeling of tightness in the chest- collapse (due to cardiac arrest)
  • any signs of fever or infection (sore throat, mouth pain or urinary problems)
  • any unexpected bruising or bleeding or extreme fatigue, dizziness or shortness of breath, as this may mean that too few blood cells of a certain type are produced
  • if you suddenly feel sick (even with normal body temperature)
  • if your muscles ache, feel stiff or weak and your urine is darker than usual, brown or red when you have received Melfalan SUN directly in your arm or leg.

Talk to your doctor immediately if you have symptoms of blood clots in your veins, especially in your legs. Symptoms include swelling, pain, and redness on the leg. Blood clots can move through the blood vessels to the lungs, causing pain across the chest as well as difficulty breathing.

Other side effects include:

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

  • fever
  • reduction in the number of blood cells and platelets
  • nausea, vomiting and diarrhea
  • cold sores (with high doses of Melfalan SUN)
  • hair loss (with high dose of Melfalan SUN)
  • a feeling of warmth and tingling at the site of administration
  • problems with your muscles such as stunted growth and pain when you receive Melfalan SUN directly in your arm or leg.

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

  • hair loss with regular dose of Melfalan SUN
  • high levels of urea in the blood – in people with kidney damage who are being treated for myeloma
  • muscle problems that can cause pain, tightness, tingling, burning sensation or numbness (called compartment syndrome). This can happen when you get Melfalan SUN directly in your arm or leg.

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

  • a disease in which you have a low number of red blood cells because they are destroyed prematurely. This can make you feel very tired, short of breath and dizzy and can give you a headache or make your skin or eyes yellow.
  • lung problems that can make you cough or hiss and make it difficult to breathe
  • liver problems that may show up in your blood tests or cause jaundice (yellowing of the whites of the eyes and skin)
  • cold sores with normal doses are of Melfalan SUN
  • skin rash or itching .

Has been reported (occurs in an unknown number of users)

  • blood cancer ( leukemia )
  • in women: missed periods ( amenorrhea )
  • in men: absence of sperm in the semen ( azoospermia )
  • muscle tissue death (muscle necrosis)
  • degradation of muscle fibers ( rhabdomyolysis )
  • occurrence of a blood clot, thrombosis , in a deep vein, especially in the legs (deep venous thrombosis ) and clogged pulmonary artery ( pulmonary embolism )

How to store Melfalan

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 the carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in a cold place. Keep the vial in the outer carton. Sensitive to light.

Your Melfalan SUN is prepared for use by hospital staff. When finished, it should be used immediately and should not be stored or refrigerated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is melphalan hydrochloride. Each vial contains melphalan hydrochloride equivalent to 50 mg melphalan. The other ingredients are povidone and hydrochloric acid . Melphalan is dissolved in 10 ml of diluent before being injected.
  • The diluent contains water for injections, sodium citrate, propylene glycol and anhydrous ethanol .

What the medicine looks like and contents of the pack

Each pack contains a vial of Melfalan SUN powder and a vial of diluent. The powder vial contains 50 mg of the active substance melphalan in powder form and the vial contains 10 ml of diluent to reconstitute (dissolve) the powder. The powder is a white to off-white lyophilized powder/cake and the diluent is a clear colorless liquid/solution. After reconstitution with 10 ml of diluent, the resulting solution contains 5 mg/ml melphalan.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

SC Terapia SA.

124 Fabricii Street

400632, Cluj-Napoca

Cluj County

Romania

This medicinal product is authorized under the European Economic Area under the names:

Austria: Melphalan SUN

Denmark: Melphalan SUN

Germany: Melphalan SUN

France: Melphalan SUN

Italy: Melfalan SUN

Netherlands: Melfalan hydrochloride SUN

Norway: Melphalan SUN

United Kingdom: Melphalan

Muhammad Nadeem

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