PANPOTIN® contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen). Epoetin alfa is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way. PANPOTIN® is a biosimilar to EPREX® (Epoetin-alfa).

● PANPOTIN® is used to treat symptomatic anemia caused by kidney disease
- in children on hemodialysis
- in adults on hemodialysis or peritoneal dialysis
- in adults with severe anemia and they are not on dialysis yet
If you have kidney disease, your red blood cells may be low if your kidney does not produce enough erythropoietin which is necessary for red blood cells production. PANPOTIN® is prescribed to stimulate your bone marrow to produce more red blood cells
● PANPOTIN® is used to elevate or maintain red blood cell level and to decrease the need for transfusions.
● PANPOTIN® is used in moderately anemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation. Because PANPOTIN® stimulates the production of red blood cells, doctors can take more blood from these people

Do not use PANPOTIN®:
● if you are allergic to epoetin alfa or any of the other ingredients of this medicine (listed in section 6).
● if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including PANPOTIN®). See section 4 “Possible Side Effects”.
● if you have high blood pressure not properly controlled with medicines.
● if you have anemia other than neoplastic anemia (aplastic anemia, pancytopenia, aluminum accumulation, etc.).

● to stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
● if you are due to have major elective orthopedic surgery (such as hip or knee surgery), and you:
- have severe heart disease
- have severe disorders of the veins and arteries
- have recently had a heart attack or stroke
- can’t take medicines to thin the blood
PANPOTIN® may not be suitable for you. Please discuss with your doctor. While on PANPOTIN®, some people need medicines to reduce the risk of blood clots. If you can’t take medicines that prevent blood clotting, you must not have PANPOTIN.
Warnings and precautions:
Take special care with PANPOTIN®.

− PANPOTIN® and other products that stimulate red cell production may increase the risk of developing blood clots in all patients. This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness). Please tell your doctor about any of these things. Your doctor will help you to decide if PANPOTIN® is suitable for you.
− It is important to tell your doctor if any of the following apply to you. You may still be able to use PANPOTIN® but discuss it with your doctor first.
If you know you suffer, or have suffered, from:
● High blood pressure;
● epileptic seizures or fits

● liver disease;
● anaemia from other causes;
● porphyria (a rare blood disorder).
− If you are a patient with chronic renal failure, and particularly if you do not respond properly to PANPOTIN®, your doctor will check your dose of PANPOTIN® because repeatedly increasing your dose of PANPOTIN® if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
− If you are a cancer patient be aware that products that stimulate red blood cell production (like PANPOTIN®) may act as a growth factor and therefore in theory may affect the progression of your cancer. Depending on your individual situation a blood transfusion may be preferable. Please discuss this with your doctor.
− If you are a cancer patient, be aware that use of PANPOTIN® may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
− If you are a patient with hepatitis C and you receive interferon and ribavirin, you should discuss this with your doctor because a combination of epoetin alfa with interferon and ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases. PANPOTIN® is not approved in the management of anaemia associated with hepatitis C.
− Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications.
If you develop a serious rash or another of these skin symptoms, stop taking PANPOTIN® and contact your doctor or seek medical attention immediately.
Take special care with other products that stimulate red blood cell production:
PANPOTIN® is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your healthcare professional will always record the exact product you are using.
If you are given a product in this group other than PANPOTIN® during your treatment, speak to your doctor or pharmacist before using it.
Other medicines and PANPOTIN®
Tell your doctor if you are taking, have recently taken or might take any other medicines.

● If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), since cyclosporine is bound by red blood cells there is potential for a drug interaction. Your doctor may order blood tests to check the level of cyclosporin while you are taking PANPOTIN®.
● Iron supplements and other blood stimulants may increase the effectiveness of PANPOTIN®. Your doctor will decide if it is right for you to take them.
If you visit a hospital, clinic or family doctor, tell them you are having PANPOTIN® treatment. It may affect other treatments or test results.
Pregnancy and breast-feeding

It is important to tell your doctor if any of the following apply to you. You may still be able to use PANPOTIN® but discuss it with your doctor first.
● If you are pregnant, or think you may be pregnant.
● If you are breast feeding.
PANPOTIN® contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your doctor has carried out blood tests and decided you need PANPOTIN®.
PANPOTIN® is given by injection into a vein or a tube that goes into a vein (intravenously) only. It is not given by subcutaneous injection. Therefore, PANPOTIN® should be given to you by a doctor, nurse or other health care professional.
PANPOTIN® should not be administered in conjunction with other drug solutions.
PANPOTIN® should not be used:

● after the expiry date on the label and outer carton
● if you know, of think that it may have been accidentally frozen, or
● if there has been a refrigerator failure
● If the liquid is not clear or colored and when particle is present

The dose of PANPOTIN® you receive is based on your body weight in kilograms. The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Your doctor will monitor your blood pressure regularly while you are using PANPOTIN®.
● Patients with kidney disease on dialysis
- Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death. In children the haemoglobin level should be maintained between 9.5 and 11 g/dL.
- The usual starting dose for adults and children is 50 International Units (IU) per kilogram (/kg) of bodyweight given three times a week by injection into a vein or a tube that goes into a vein (intravenously). The dose increase is dependent upon the initial response. The dose can be increased, if necessary, by 25 IU/kg three times per week at intervals of at least 4 weeks until the target haemoglobin concentration 10-12 g/dL in adults and 9.5-11 g/dL in children is achieved. The recommended total weekly dose is between 75 and 300 IU/kg.
- For patients on peritoneal dialysis PANPOTIN® may be given twice a week.
- Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks. A rise in haemoglobin of greater than 2 g/dL over a four week period should be avoided.
- Once your anaemia has been corrected, your doctor will continue to check your blood regularly. Your PANPOTIN® dose and frequency of administration may be further adjusted to maintain your response to treatment. Your doctor will use the lowest effective dose to control the symptoms of your anemia.
- If you do not respond adequately to PANPOTIN®, your doctor will check your dose and will inform you if you need to change doses of PANPOTIN®.
- If you are on a more extended dosing interval (greater than once weekly) of PANPOTIN®, you may not maintain adequate haemoglobin levels and you may require an increase in PANPOTIN® dose or frequency of administration.
- Your doctor will check your iron stores before starting PANPOTIN®. You may be given iron supplements before and during PANPOTIN® treatment to make it more effective.
- If you are having dialysis treatment when you begin treatment with PANPOTIN®, your dialysis regime may need to be adjusted. Your doctor will decide this.
- If you are in aluminum intoxication or if you are infected, delayed or diminished responses may occur.
● Adult Patients with kidney disease not on dialysis
- The maintenance dose will be individualized according to the severity of your anemia or age, however, the dose of 75 – 150 IU/kg/week given by injection into a vein have been shown to maintain haemoglobin concentration between 10-12 g/dL in adults for >6 months.
● Adult patients donating their own blood
- The usual dose is 600 IU per kilogram body weight twice a week.
- PANPOTIN® is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
- You may be given iron supplements before and during PANPOTIN® treatment to make it more effective.
● If you receive more PANPOTIN® than you should
Tell your doctor or nurse immediately if you think too much PANPOTIN® has been injected. Side effects from an overdose of PANPOTIN® are unlikely.
If you miss a PANPOTIN® dose Call your doctor for instructions if you miss a dose of epoetin alfa.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you notice any of these effects:
Very common side effects (These may affect more than 1 in 10 people)
● Diarrhoea
● Feeling sick in your stomach
● Vomiting
● Fever
● Respiratory tract congestion, such as stuffy nose and sore throat, has been reported in patients with kidney disease not yet on dialysis.
Common side effects (These may affect up to 1 in 10 people)
● Increased blood pressure. Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure. This requires urgent treatment. Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure)
● Blood clots (including deep vein thrombosis and embolism) that may require urgent treatment. You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
● Cough
● Skin rashes, which may result from an allergic reaction
● Joints or muscle pain
● Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills, tiredness and dizziness. These may be more common at the start of treatment. If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
● Swelling of the ankles, feet or fingers

● Arm or leg pain
● Redness, burning and pain at site of injection)
Uncommon side effects (These may affect up to 1 in 100 people)
● High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).Heart attack (myocardial infarction)

● Elevation of Liver enzymes and total bilirubin may occur occasionally

● Increased blood urea nitrogen (BUN), creatinine and uric acid have been reported
● Seizure
● Nose or airway congestion
● Allergic reaction
● Hives
Rare side effects (These may affect up to 1 in 1,000 people)
● Symptoms of pure red cell aplasia (PRCA)
PRCA means the bone marrow does not make enough red blood cells. PRCA causes sudden and severe anaemia. The symptoms are:
− unusual tiredness,
− feeling dizzy,
− breathlessness
PRCA has been very rarely reported mostly in patients with kidney disease after months to years of treatment with epoetin alfa and other products that stimulate red blood cell production.
● An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment, also increased number of white blood cells (Leukocytosis), increased number of eosinophils (eosinophilia) has been reported. Your doctor will check on this.

● Granulocytopenia may occur in premature infants.
● Severe allergic reaction that may include:
− a swollen face, lips, mouth, tongue or throat,
− difficulty swallowing or breathing,
− itchy rash (hives).
● Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
● Shock has been reported, full observation should be taken. If the symptoms appear, the administration should be discontinued, and an appropriate treatment should be taken
If you are receiving haemodialysis:
● Blood clots (thrombosis) may form in your dialysis shunt. This is more likely if you have low blood pressure or if your fistula has complications.
● Blood clots may also form in your haemodialysis system. Your doctor may decide to increase your heparin dose during dialysis.
An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving epoetin alfa. These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis and myocardial infarction. Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Others: edema, dizziness, fever, fatigue, arthralgia, myalgia, bitter taste in the mouth, tremor and edema of eyelid may occasionally be associated with PANPOTIN® therapy.

Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with PANPOTIN®.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 of SFDA. 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.
● Store and transport medicine refrigerated (2°C-8°C), in a sealed container
● Do not freeze or shake vigorously.
● Store in the original package in order to protect from light.
● When the product is about to be used, it may be removed from the refrigerator and stored at room temperature (below 25°C) for a maximum single period of seven days.
● Do not use this medicine if you notice that it may have been accidentally frozen, or if there has been a refrigerator failure, the liquid is coloured or you can see particles floating in it, the seal is broken.
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.