PARACALCITOLO 2 MICROGRAMMI/ML Roztwór do wstrzykiwań

Treść ulotki

1. Paracalcitolo Sandoz 2 micrograms/ml injectable solution, Sandoz 5 micrograms/ml injectable solution
   1. What is Paracalcitolo Sandoz and what is it used for
   2. What you need to know before you are given Paracalcitolo Sandoz
   3. How Paracalcitolo Sandoz will be administered to you
   4. Possible side effects
   5. How to store Paracalcitolo Sandoz
   6. Content of the pack and other information

Paracalcitolo Sandoz 2 micrograms/ml injectable solution, Sandoz 5 micrograms/ml injectable solution

Equivalent Medicinal Product

Medicinal product because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Paracalcitolo Sandoz is and what it is used for
• 2. What you need to know before Paracalcitolo Sandoz is given to you
• 3. How Paracalcitolo Sandoz will be given to you
• 4. Possible side effects
• 5. How to store Paracalcitolo Sandoz
• 6. Contents of the pack and other information

1. What is Paracalcitolo Sandoz and what is it used for

Paracalcitolo Sandoz is a synthetic analogue of active vitamin D. It is indicated for the prevention and treatment of elevated levels of parathyroid hormone in the blood in patients with renal insufficiency undergoing hemodialysis. Elevated levels of parathyroid hormone may be due to low levels of “active” vitamin D in patients with renal insufficiency.
Vitamin D in its active form ensures the normal function of numerous tissues in our body, including the kidneys and bones.

2. What you need to know before you are given Paracalcitolo Sandoz

You must not be given Paracalcitolo Sandoz

• if you are allergic to paracalcitol or any of the other ingredients of this medicine (listed in section 6).
• if you have very high levels of calcium or vitamin D in your blood. The doctor will monitor your blood levels and will be able to tell you if your case falls within the aforementioned conditions.

Warnings and Precautions
Talk to your doctor, nurse or pharmacist before you are given Paracalcitolo
Sandoz

• Before starting treatment, it is important that you limit the amount of phosphorus you consume in your diet. Examples of foods with a high phosphorus content include tea, soda, beer, cheese, milk

cream, fish, chicken or beef liver, beans, peas, cereals, nuts and wheat.

• Phosphate-binding medicines, which prevent the absorption of phosphate from food, may be needed to control phosphorus levels.
• If you are taking calcium-based phosphate binders, your doctor may need to adjust your dosage.
• The doctor will prescribe some blood tests to monitor your treatment.

Other medicines and Paracalcitolo Sandoz
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Some medicines can affect the action of Paracalcitolo Sandoz or make side effects more likely.
It is particularly important to tell your doctor if you are taking any of the following medicines:

• medicines for the treatment of fungal infections such as candidiasis or thrush (for example, ketoconazole).
• medicines for the heart or for blood pressure (for example, digoxin and diuretics or pills to eliminate excess water from our body).
• medicines containing magnesium (for example, some digestive medicines called antacids, such as magnesium trisilicate).
• medicines containing aluminum (for example, phosphate binders, such as aluminum hydroxide).
• medicines that contain phosphate or vitamin D, which should not be taken at the same time as paracalcitol.
• Medicines that contain high doses of calcium.

Talk to your doctor, nurse or pharmacist before taking any medicine.

Paracalcitolo Sandoz with food and drink
Paracalcitolo Sandoz can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor, nurse or pharmacist for advice before taking this
medicine.
There are no adequate data available on the safe use of this medicine in pregnant women.
Therefore, the use of this medicine during pregnancy is not recommended.
It is not known whether paracalcitol passes into breast milk. Tell your doctor before breastfeeding if you
are taking Paracalcitolo Sandoz.

Driving and using machinesParacalcitolo Sandoz can cause a feeling of
dizziness, which can impair your ability to drive or operate machinery. Do not drive or
operate machinery if you feel dizzy.

Paracalcitolo Sandoz contains ethanol (alcohol)
This medicine contains 20% by volume of ethanol (alcohol), e.g. up to 1.3 g of ethanol per
dose, equivalent to 33 ml of beer, 14 ml of wine per dose. The presence of ethanol in this medicine
is harmful to people suffering from alcoholism and must be taken into consideration when
administering to pregnant or breastfeeding women, children and high-risk groups, such as patients
suffering from liver disease or epilepsy.

3. How Paracalcitolo Sandoz will be administered to you

The doctor, based on the results of laboratory tests, will decide the appropriate initial dose for you.
Once therapy with Paracalcitolo Sandoz has begun, it is likely that the dose will be adjusted,
based on the results of routine laboratory tests. Based on the laboratory test results, the doctor will help
you establish the most appropriate dose of Paracalcitolo Sandoz for you.

Paracalcitolo Sandoz will be administered to you by a doctor or nurse during hemodialysis.It will be
administered through the tubing ( bloodline) used to connect you to the machine. An injection will not
be necessary, as Paracalcitolo Sandoz can be inserted directly into the tubing used for your
treatment. Paracalcitolo Sandoz will be administered on alternate days, no more than
three times a week.

If you are given more Paracalcitolo Sandoz than you should
An overdose of Paracalcitolo Sandoz may cause an abnormal increase in calcium levels in the
blood, which may require treatment. Symptoms that may appear immediately
after taking an overdose of Paracalcitolo Sandoz include:

• feeling of weakness and/or numbness
• headache
• feeling unwell or sick (nausea or vomiting)
• dry mouth, constipation
• muscle or bone pain
• altered taste

Symptoms that may develop over a longer period of time while taking an overdose of Paracalcitolo Sandoz include:

• loss of appetite
• drowsiness
• weight loss
• eye discomfort
• runny nose
• skin itching
• feeling of heat and fever
• loss of libido
• severe abdominal pain
• kidney stones
• Blood pressure may change and irregular heartbeat (palpitations) may occur.

If you have high calcium levels in your blood after taking Paracalcitolo Sandoz, the doctor will ensure
that you receive appropriate treatment to restore normal calcium levels. When your
calcium levels return to normal, you may receive a lower dose of Paracalcitolo
Sandoz.
The doctor will still check your blood levels and if you notice the appearance of any of the
above symptoms, consult a doctor immediately.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions of varying nature have been reported with Paracalcitolo Sandoz.

Important: Tell your doctor or nurse immediately if you experience any of the following side effects:
Not common(may affect up to 1 in 100 people)

• shortness of breath
• difficulty breathing or swallowing
• dyspnea
• skin rash, itchy skin or hives
• swelling of the face, lips, mouth, tongue or throat

Tell your doctor or pharmacist if you notice any of the following side effects:

Common(may affect up to 1 in 10 people):

• headache
• altered taste
• itchy skin
• low levels of parathyroid hormone
• high levels of calcium (feeling unwell or sick, constipation or confusion); phosphorus in the blood (probably without symptoms, but with a greater predisposition to fractures) Not common(may affect up to 1 in 100 people):
• allergic reactions (for example, shortness of breath, dyspnea, skin rash, itching or swelling of the face and lips); itchy blisters
• blood infections; reduced red blood cell count (anemia - fatigue, shortness of breath, paleness); reduced white blood cell count (increased susceptibility to infections); swollen glands in the neck, armpit and/or groin; prolonged bleeding time (blood does not clot as quickly)
• heart attack; stroke; chest pain; irregular/fast heartbeat; low blood pressure;

high blood pressure;

• coma (a deep state of unconsciousness during which the person is unable to respond to the environment)
• unusual fatigue, weakness; dizziness; fainting;
• pain at the injection site
• pneumonia (lung infection); fluid in the lungs; asthma (dyspnea, cough, difficulty breathing);
• sore throat; cold; fever; flu-like symptoms; pink eye (itchy/dry eyelids); increased eye pressure; ear pain; nosebleeds
• nerve twitching; confusion, sometimes severe (delirium); agitation (anxiety); nervousness; personality disorders (not feeling like yourself);
• tingling or numbness; reduced sense of touch; insomnia; night sweats; muscle spasms in arms and legs, even during sleep;
• dry mouth; thirst; nausea; difficulty swallowing; vomiting; loss of appetite; weight loss; heartburn; diarrhea and stomach pain; constipation; anal bleeding;
• erectile dysfunction; breast cancer; vaginal infections
• breast pain; back pain; joint/muscle pain; a feeling of heaviness caused by generalized or localized swelling of ankles, feet and legs (edema); abnormal gait;
• hair loss; excessive hair growth,
• increased liver enzyme; high levels of parathyroid hormone; high levels of potassium in the blood; low levels of calcium in the blood

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

• swelling of the face, lips, mouth, tongue or throat, resulting in possible difficulty swallowing or breathing; itchy skin (urticaria). Gastric bleeding. If you experience these symptoms, see a doctor immediately.

You may not be able to tell if you have any of the above side effects unless your doctor informs you about them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracalcitolo Sandoz

Keep this medicine out of the sight and reach of children.
Keep the vials in the outer packaging to protect the medicine from light.
Single use.
Once opened, Paracalcitolo Sandoz must be used immediately.
Do not use this medicine after the expiry date which is stated on the packaging and on the vial after
the wording “Exp.”. The expiry date refers to the last day of that month.
Do not use Paracalcitolo Sandoz if you notice the presence of particles or discoloration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Paracalcitolo Sandoz contains

• The active ingredient is paracalcitol. Each ml of injectable solution contains 2 micrograms of paracalcitol. Each vial of 1 ml contains 2 micrograms of paracalcitol. Each vial of 2 ml contains 4 micrograms of paracalcitol

Each ml of injectable solution contains 5 micrograms of paracalcitol.
Each vial of 1 ml contains 5 micrograms of paracalcitol.
Each vial of 2 ml contains 10 micrograms of paracalcitol

• The other ingredients are: ethanol (alcohol), macrogol 15 hydroxystearate and water for injections.

Description of the appearance of Paracalcitolo Sandoz and contents of the pack
This medicine is presented as an injectable solution. The injectable solution is clear and
colourless, free from particulate matter, contained in a transparent type I glass vial.
Pack sizes:
2 micrograms/ml injectable solution
Pack containing 5 vials of 1 mL of injectable solution (2 micrograms/1 ml)
Pack containing 5 vials of 2 mL of injectable solution (4 micrograms/2 ml)
5 micrograms/ml injectable solution
Pack containing 5 vials of 1 ml of injectable solution (5 micrograms/1 ml)
Pack containing 5 vials of 2 mL of injectable solution (10 micrograms/2 ml)
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sandoz Spa
Largo U. Boccioni, 1

• 21040 – Origgio (VA)

Manufacturer
Pharmathen S.A.
6 Dervenakion Street, 153 51 Pallini Attikis, Athens,
Greece

Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana,
Slovenia

Salutas Pharma GmbH
Otto-von Guericke-Alle 1, 39179 Barleben,
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark Paricalcitol Sandoz
Germany Paricalcitol HEXAL 2 Mikrogramm/ml Injektionslösung
Paricalcitol HEXAL 5 Mikrogramm/ml Injektionslösung
Spain Paricalcitol Sandoz 2 micrograms/ml injectable solution EFG
Paricalcitol Sandoz 5 micrograms/ml injectable solution EFG
Italy Paracalcitolo Sandoz
Greece Paricalcitol/Sandoz
Romania Paricalcitol Sandoz 2 micrograme/ml soluție injectabilă
Paricalcitol Sandoz 5 micrograme/ml soluție injectabilă
Croatia Caltopar

The following information is intended exclusively for physicians or healthcare professionals:
Paracalcitolo Sandoz 2 and 5 micrograms/ml injectable solution
Preparation of the injectable solution
Paracalcitolo Sandoz 2 micrograms/ml and 5 micrograms/ml injectable solution is for single use.
As with all medicines administered by injection, the diluted solution should be examined for the presence of particles or discoloration before administration.

Storage and validity
Medicines administered parenterally must be visually inspected for
the presence of corpuscular substances and any change in colouration, before
their administration. The solution is clear and colourless.
Keep the vials in the outer packaging to protect the medicine from light.
This medicine has a validity of 2 years.
Once opened, Paracalcitolo Sandoz must be used immediately.

Dosage and method of administration
Paracalcitolo Sandoz 2 micrograms/ml and 5 micrograms/ml injectable solution, must be
administered via a hemodialysis access.
Adults

• 1) The initial dose must be calculated based on baseline parathyroid hormone (PTH) levels: The initial dose of paracalcitol must be determined based on the following formula:

Initial dose (in micrograms) = baseline intact PTH level expressed in pmol/l
8
or
= baseline intact PTH level expressed in pg/mL
80
and must be administered intravenously as a bolus dose, on alternate days, at
any time during the hemodialysis session. In clinical studies, the maximum safe dose administered was 40 mcg.

• 2) Dose titration: The currently accepted reference range for PTH levels in dialysed patients with end-stage chronic renal failure should not exceed 1.5-3 times the upper non-uremic limit of the normal value of 15.9-31.8 pmol/l (150-300 pg/ml) for intact PTH. To achieve physiologically adequate results, patients need to be carefully monitored and individual dosage determination is required. If hypercalcemia or a corrected Ca x P product, persistently elevated, greater than 5.2 mmol /l (65 mg /dl ), is observed, the dosage should be reduced or administration interrupted until such parameters return to normal. Subsequently, paracalcitol should be readministered at a lower dose. It may be necessary to decrease the dose of paracalcitol as PTH levels decrease in response to therapy.

The following table proposes an example of a recommended approach to dose determination: