5 micrograms/ml solution for injection
paricalcitol
What Paricalcitol Accord is and what it is used for
Paricalcitol Accord contains the active substance paricalcitol which is a synthetic form of active vitamin D.
Active vitamin D is needed for many of the body’s tissues, including the parathyroid gland and skeleton, to function normally. In people who have normal kidney function, this active form of vitamin D is produced naturally in the kidneys, but in kidney failure, the production of active vitamin D is markedly reduced. Paricalcitol Accord therefore actively supplies vitamin D, when the body cannot produce enough. Paricalcitol Accord helps prevent the effects of low vitamin D levels in patients with chronic kidney disease, namely high levels of parathyroid hormone, which can cause skeletal problems. Paricalcitol Accord is used in adult patients with stage 5 kidney disease.
Paricalcitol contained in the Paricalcitol Accord may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Paricalcitol Accord
Do not use Paricalcitol Accord
- if you are allergic to paricalcitol or any of the other ingredients of this medicine (listed in section 6).
- if you have elevated levels of calcium or vitamin D in your blood.
Your doctor can tell you if this applies to you.
Warnings and cautions
Talk to your doctor or nurse before using Paricalcitol Accord
- Before starting treatment, it is important to limit the amount of phosphate in your diet. Examples of foods high in phosphate are tea, soft drinks, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, breakfast cereals, nuts, and cereals.
- Phosphate-binding drugs that prevent phosphate from being absorbed from food may be needed to control phosphate levels.
- If you are taking calcium-based phosphate binders, your doctor may need to adjust the dosage.
- Your doctor will need to take blood samples to check your treatment.
Other medicines and Paricalcitol Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may or may not affect the effect of this medicine or increase the risk of side effects. It is especially important to tell your doctor if you are taking any of the following:
- medicines for fungal infections such as candida or cod (eg ketoconazole )
- medicines for heart problems or high blood pressure (eg digoxin, diuretics, or diuretics )
- medicines containing a phosphate source (eg medicines to lower the level of calcium in the blood)
- medicines containing calcium or vitamin D, including supplements and multivitamins that can be bought without a prescription
- medicines containing magnesium or aluminum (eg certain types of medicines for acid stomachs, so-called antacids) and phosphate binders
Paricalcitol Accord with food and drink
Paricalcitol Accord can be given with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
It is not known if it is safe for pregnant women to use this medicine. Therefore, use during pregnancy or if you are planning to become pregnant is not recommended.
It is not known if paricalcitol passes into breast milk. Talk to your doctor before breastfeeding if you are taking Paricalcitol Accord.
Driving and using machines
Paricalcitol Accord may make you feel dizzy, which may affect your ability to drive or use machines.
Do not drive or use machines if you feel dizzy.
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.
Paricalcitol Accord contains anhydrous ethanol
This medicine contains up to 2.21 g of ethanol (alcohol) per dose equivalent to approximately 32 mg/kg. The amount in each dose of this medicine corresponds to 55 ml of beer or 22 ml of wine.
The amount of alcohol in this medicine is unlikely to have any effects on adults and adolescents and its effect on children is probably not noticeable. It can have some effects on younger children, e.g. fatigue.
The alcohol in this medicine may affect the effectiveness of other medicines. Tell your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are or have been addicted to alcohol, ask your doctor or pharmacist for advice before taking this medicine.
How to use Paricalcitol Accord
Your doctor will use the results of your laboratory tests to determine what is the right starting dose for you.
At the beginning of treatment with Paricalcitol Accord, the dose may need to be adjusted depending on the results of routine laboratory tests. With the help of your results, your doctor will help determine what is the right dose for you.
Paricalcitol Accord will be given by a doctor or nurse while you are being treated with dialysis. The medicine will be given through the tubing used to connect you to the dialysis machine. You will not need to receive an injection as Paricalcitol Accord can be administered directly into the tubing used for your treatment.
You will not receive Paricalcitol Accord more often than every other day and no more than three times a week.
If you use more Paricalcitol Accord than you should
Too much Paricalcitol Accord can lead to abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur shortly after taking too much Paricalcitol Accord may be:
- a feeling of weakness and/or drowsiness
- headache
- nausea or vomiting
- dry mouth, constipation
- muscle or skeletal pain
- metallic taste in the mouth
If you get high levels of calcium in your blood after receiving the Paricalcitol Accord, your doctor will make sure you are given the appropriate treatment to get your calcium levels back to normal. When your calcium levels return to normal, you may receive a lower dose of Paricalcitol Accord.
However, your doctor will check your blood levels. If you experience any of the above symptoms or if you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, you should immediately contact a doctor or hospital for risk assessment and advice.
Symptoms that may occur if you take too much Paricalcitol Accord over a long period may be:
- loss of appetite
- drowsiness
- weight loss
- pain in the eyes
- Runny nose
- skin itching
- feeling of fever
- decreased sex drive
- severe abdominal pain (due to inflamed pancreas )
- kidney stone
- your blood pressure may be affected and irregular heartbeat (palpitations) may occur. Results of blood and urine tests may show high levels of cholesterol, urea, nitrogen, and liver enzymes. Paricalcitol Accord can in rare cases cause mental changes including confusion, drowsiness, insomnia, and nervousness.
Paricalcitol Accord contains 30% (v / v) propylene glycol as ingredient. Isolated cases of poisoning associated with high doses of propylene glycol have been reported but are not expected when given to patients via dialysis apparatus as propylene glycol disappears from the blood during dialysis.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Various allergic reactions may occur with Paricalcitol Accord. Important: Contact your doctor or nurse immediately if you get any of the following side effects:
- shortness of breath
- difficulty breathing or swallowing
- rosslingar
- rash, itchy skin, or hives
- swelling of the face, lips, mouth, tongue, or throat
Tell your doctor or nurse if you get any of the following side effects:
Common (may affect up to 1 in 10 people):
- headache
- unusual taste in the mouth
- skin itching
- low levels of parathyroid hormone
- high levels of calcium (nausea or vomiting, constipation or confusion), phosphate in the blood (probably causes no symptoms but may increase the risk of bone fractures)
Uncommon (may affect up to 1 in 100 people):
- sepsis, pneumonia, sore throat, vaginal infection, flu
- breast cancer
- decreased number of red blood cells ( anemia – weakness, shortness of breath, pallor), decreased number of white blood cells (increased risk of infection ), swollen glands in the neck, armpits, and/or groin
- high levels of parathyroid hormone
- high levels of potassium in the blood, low levels of calcium in the blood, decreased appetite
- confusion (sometimes severe, delirium ), personality change, anxiety (restlessness, anxiety), sleep problems, nervousness
- coma (deep unconsciousness when the person in question does not react to the environment), stroke, fainting, muscle twitching in arms and legs, even during sleep, decreased feeling, tingling or numbness, dizziness
- increased pressure in the eye, red eyes (itchy/irritated eyelids)
- earache
- heart attack, irregular/fast heartbeat
- low blood pressure, high blood pressure
- fluid in the lungs, asthma, wheezing, shortness of breath, nosebleeds, cough
- anal bleeding, inflammation of the colon, diarrhea, abdominal pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth
- skin rash with itchy blisters, hair loss, increased hair growth, excessive and unpredictable sweating
- joint pain, joint stiffness, back pain, muscle twitching, muscle pain
- chest pain, erection difficulties
- abnormal gait, general swelling or local swelling of the ankles, feet, and legs ( edema ), injection site pain, fever, chest pain, unusual tiredness or feeling of weakness, general feeling of discomfort, thirst
- prolonged bleeding time (blood coagulates more slowly), increase in liver enzyme, change in laboratory samples, weight loss
Has been reported (occurs in the unknown number of users):
- swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing, skin itching ( hives ), and stomach bleeding.
Some of these side effects you may not even notice you have unless your doctor tells you to.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse, or pharmacist immediately.
How to store Paricalcitol Accord
Keep this medicine out of the sight and reach of children.
No special temperature instructions. Keep the ampoule or vial in the outer carton. Sensitive to light.
Paricalcitol Accord should be used immediately after opening.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice particles or discoloration.
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 paricalcitol. One ml of solution contains 5 micrograms of paricalcitol.
- The other ingredients are anhydrous ethanol (alcohol), propylene glycol, and water for injections.
What the medicine looks like and the contents of the pack
Paricalcitol Accord solution for injection is a clear and colorless aqueous solution, free from visible particles.
The medicine is supplied in cartons of 1 or 5 1 ml or 2 ml glass vials
or 5 glass ampoules are 1 ml or 2 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
UK
Wessling Hungary Kft
Footnote 56., Budapest, 1047, Hungary
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland