PARACALCITOLO 2 MICROGRAMMI/ML Injectable solution

Зміст інструкції

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

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

paracalcitol

Equivalent medicinal product

Read this leaflet carefully before you start to receive this medicine as it contains
important information for you.

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

Contents of this leaflet:

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

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

Paracalcitolo Mylan contains the active ingredient paracalcitol, a synthetic form of active vitamin D.
Vitamin D is necessary for the normal function of many tissues in the body, including the
parathyroid glands and bones. In people with normal kidney function, this active form of vitamin D is
naturally produced by the kidneys, but the production of active vitamin D is significantly reduced in case of
renal insufficiency. Paracalcitolo Mylan therefore provides a source of active vitamin D when
the body does not produce enough of it and helps to prevent the consequences of low levels of active vitamin D
in patients with chronic kidney disease, i.e., with high levels of parathyroid hormone that can
cause problems with the bones. Paracalcitolo Mylan is indicated in adult patients with stage

• 5.

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

You must not be given Paracalcitolo Mylan:

• 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. Your doctor will be able to tell you if these conditions apply to you.

Warnings and precautions
Talk to your doctor or nurse before you are given Paracalcitolo Mylan

• 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 are: tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts and wheat.
• Medicines that bind with phosphate (chelators), which prevent the absorption of phosphate from food, may be needed to control phosphorus levels.
• If you are taking calcium-based phosphate chelators, your doctor may need to adjust your dosage.
• Your doctor will prescribe some blood tests to monitor your treatment.

Other medicines and Paracalcitolo Mylan
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Some medicines can affect the action of Paracalcitolo Mylan or increase the likelihood of
side effects. 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 to treat heart problems or high blood pressure (for example, digoxin and diuretics
• that contain a source of phosphate (for example, medicines to lower calcium levels in the blood)
• that contain calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription
• that contain magnesium or aluminum, for example, some medicines for digestion (antacids) and phosphate chelators

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor, nurse or pharmacist for advice before taking this medicine.
It is not known whether this medicine is safe for pregnant women, therefore its use is not
recommended during pregnancy or if pregnancy may occur.
It is not known whether paracalcitol passes into breast milk. Tell your doctor before breastfeeding while
you are taking Paracalcitolo Mylan.

Driving and using machines
Paracalcitolo Mylan can cause a feeling of dizziness which may impair your ability to drive
vehicles safely or use heavy machinery. Do not drive or use machines if you feel dizzy.

Paracalcitolo Mylan contains ethanol (alcohol)
This medicine contains 157.80 mg of alcohol (ethanol) in each ml. The amount in each 1 ml vial of
this medicine is equivalent to less than 4 ml of beer or 1.6 ml of wine and in each 2 ml vial of this
medicine is equivalent to less than 8 ml of beer or 3 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents and its effects
in children are not evident. Some effects may occur in small children, for example
feeling sleepy.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist
if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this
medicine.
If you have an alcohol dependence, talk to your doctor before taking this medicine.

3. How to take Paracalcitolo Mylan

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

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

If you take more Paracalcitolo Mylanthan you should
An overdose of Paracalcitolo Mylan can lead to excessively high levels of calcium in the
blood, which can be harmful. The symptoms that may appear immediately after taking a
dose of Paracalcitolo Mylan include:

• feeling of weakness and/or numbness
• headache
• nausea (feeling unwell) or vomiting (feeling unwell)
• dry mouth, constipation
• muscle and bone pain
• metallic taste in the mouth.

If you have high levels of calcium in your blood after taking Paracalcitolo Mylan, the doctor will ensure
that you receive appropriate treatment to restore normal calcium levels in the blood. When blood
calcium levels return to normal you will probably receive a lower dose of
Paracalcitolo Mylan. The doctor will still check blood levels. If you notice the appearance of any
of the symptoms mentioned above, consult a doctor immediately.
The symptoms that may develop over a longer period of time while taking an
overdose of Paracalcitolo Mylan include:

• loss of appetite
• feeling sleepy
• weight loss
• eye pain
• runny nose
• skin itching
• feeling of heat and fever
• loss of libido
• and severe abdominal pain (due to inflamed pancreas)
• and kidney stones. Blood pressure may change and irregular heartbeat (palpitations) may occur. Blood and urine tests may show high levels of cholesterol, urea, nitrogen and increased liver enzyme levels. Paracalcitolo Mylan can rarely cause mental changes including confusion, drowsiness, insomnia and nervousness. If you receive too high a dose of Paracalcitolo Mylan or if you notice the appearance of any of the symptoms mentioned above, 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 Paracalcitol Mylan.

Important: Tell your doctor or nurse immediately if you notice any of the following side effects:
Uncommon (may affect up to 1 in 100 people):

• shortness of breath
• difficulty breathing or swallowing
• dyspnea
• skin rash, itchy skin including urticaria
• 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):

• low levels of parathyroid hormone
• high levels of calcium (nausea or vomiting, constipation or confusion); phosphorus in the blood (probably without symptoms, but with a greater predisposition to fractures).
• headache
• altered taste
• itchy skin

Uncommon(may affect up to 1 in 100 people):

• blood infections, pneumonia (lung infection), sore throat, vaginal infections, influenza
• breast cancer
• 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;
• high levels of parathyroid hormone
• high levels of potassium in the blood,
• low levels of calcium in the blood, loss of appetite
• confusion, which can sometimes be severe (delirium), personality disorders (not feeling like yourself), agitation (feeling nervous, anxious), sleep disorders, restlessness
• coma (a deep state of unconsciousness during which the person is unable to respond to the environment), heart attack, fainting, muscle spasms in arms and legs, even during sleep, reduced tactile sensations, tingling or numbness, dizziness
• increased eye pressure, pink eye (itchy/dry eyelids)
• ear pain
• heart attack, irregular/fast heartbeat
• low blood pressure (hypotension), high blood pressure (hypertension)
• fluid in the lungs, asthma, shortness of breath, difficulty breathing, nosebleeds, cough,
• bleeding from the rectum, colon inflammation, diarrhea, stomach pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth
• skin rash with itchy blisters, hair loss, excessive hair growth, excessive and unpredictable sweating
• joint pain, joint stiffness, back pain, muscle contractions, muscle pain
• breast pain, difficulty with erection
• abnormal gait, generalized or localized swelling of ankles, feet and legs, pain at the injection site, fever, chest pain, unusual fatigue or weakness, general feeling of discomfort, thirst
• increased bleeding time (blood does not clot quickly), increased liver enzyme, changes in laboratory test results, weight loss

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.
If any of the side effects gets serious, tell your doctor or nurse immediately. If
immediately the doctor, the nurse or the pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell 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 Mylan

Keep this medicine out of sight and reach of children .
Keep the vials in the outer packaging to protect the medicine from light.
For single use only.
Once opened, Paracalcitolo Mylan must be used immediately.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry
date refers to the last day of that month.
Do not use this medicine 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. Contents of the pack and other information

What Paracalcitolo Mylan contains
The active ingredient is paracalcitol. Each millilitre contains 2 micrograms or 5 micrograms of
paracalcitol.
The other ingredients are: ethanol (alcohol), macrogol 15-hydroxystearate and water for injections
.

Description of the appearance of Paracalcitolo Mylanand contents of the pack
Paracalcitolo Mylan injectable solution is a clear and colourless aqueous solution, free from visible
particles.
Paracalcitolo Mylan 2 micrograms/ml injectable solution
It is supplied in packs of 5 glass type I vials of 1 ml (2 micrograms/1 ml).
It is supplied in packs of 5 glass type I vials of 2 ml (4 micrograms/2 ml).
Paracalcitolo Mylan 5 micrograms/ml injectable solution
It is supplied in packs of 5 glass type I vials of 1 ml (5 micrograms/1 ml).
It is supplied in packs of 5 glass type I vials of 2 ml (10 micrograms/2 ml).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer
Pharmathen S.A.
6, Dervenakion str.
15351 Pallini, Attiki
Greece
VIATRIS SANTE
1 Rue de Turin
69007 Lyon
France

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

Compatibility
This medicine must not be mixed with other medicines
Storage and validity
Medicines administered parenterally must be visually inspected to
check for the presence of corpuscular substances and any change in colouration, before
proceeding with their administration. The solution is transparent and colourless.
Keep the vials in the outer packaging to protect the medicine from light.
This medicine is valid for 2 years.
Paracalcitolo Mylan must be used immediately after opening.

Dosage, method and duration of administration
Paracalcitolo Mylan injectable solution must be administered via an
hemodialysis access.
Adults

• 1) The initial dose should be calculated based on baseline parathyroid hormone (PTH) levels: The initial dose of paracalcitol should 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 should be administered intravenously as a bolus dose, every other day, at any
time during the hemodialysis session.
In clinical studies, the maximum safe dose administered was 40
micrograms

• 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
limit of the non-uremic 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 necessary. If hypercalcemia or a corrected Ca x P product, persistently elevated above 5.2
mmol /l (65 mg /dl ), is observed, the dosage should be reduced or administration interrupted until these
parameters return to normal.
Subsequently, paracalcitol should be readministered at a lower dose.
It may be necessary to reduce the dose of paracalcitol as PTH levels
decrease in response to therapy.
The following table proposes an example of a recommended approach to dosage determination:

Recommended Dosage Guidelines
(Dose adjustments at intervals of 2-4 weeks)
Baseline iPTH level
Paracalcitol dose adjustment
Equal to or increased
Increase by 2-4 micrograms
Decreased by < 30%
Decreased by ≥ 30%, ≤60% Unchanged
Decreased by > 60%
iPTH level < 15.9 pmol/l (150 pg/ml)
Decrease by 2-4 micrograms