ZEMPLAR 5 MCG/ML Инъекционный раствор

Содержание инструкции

1. Zemplar 2 micrograms/ml injectable solution, 5 micrograms/ml injectable solution
   1. What is Zemplar and what is it used for
   2. What you need to know before you take Zemplar
   3. How to take Zemplar
   4. Possible side effects
   5. How to store Zemplar
   6. Package contents and other information
2. Zemplar 1 microgram soft capsules, 2 microgram soft capsules
   1. What you need to know before you take Zemplar
   2. How to take Zemplar
   3. Possible side effects
   4. How to store Zemplar
   5. Package contents and other information

Zemplar 2 micrograms/ml injectable solution, 5 micrograms/ml injectable solution

paracalcitol
Read this leaflet carefully before you start this medicine
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, 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 Zemplar is and what it is used for
• 2. What you need to know before you take Zemplar
• 3. How to take Zemplar
• 4. Possible side effects
• 5. How to store Zemplar
• 6. Contents of the pack and other information

1. What is Zemplar and what is it used for

Zemplar contains the active ingredient paracalcitol, a synthetic form of active vitamin D.
Active 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 kidney failure. Zemplar 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 vitamin
D active in patients with chronic kidney disease, i.e., with high levels of parathyroid hormone that
can cause bone problems. Zemplar is indicated in adult patients with stage

• 5.

2. What you need to know before you take Zemplar

Do not take Zemplar

• 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 be able to inform you if your case falls within the above-mentioned conditions.

Warnings and precautions
Talk to your doctor or nurse before you are given Zemplar.

• 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, dried fruit and wheat.
• phosphate binders, 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.
• your doctor will prescribe some blood tests to monitor your treatment.

Other medicines and Zemplar
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines may affect the action of this medicine or may increase the probability of
experiencing undesirable effects. It is particularly important to tell your doctor if you are taking any of the
following medicines:

• to treat fungal infections such as candidiasis or thrush (for example ketoconazole)
• to treat heart problems or high blood pressure (for example digoxin, 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 multivitamin products that can be purchased without a prescription
• that contain magnesium or aluminum, for example, some medicines for digestion (antacids) and phosphate binders
• to treat high cholesterol levels (for example cholestyramine)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before taking this medicine.
It is not known whether the use of 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 Zemplar.

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

Zemplar contains ethanol
This medicine contains 20% v/v ethanol (alcohol). Each dose may contain up to 1.3 g of
ethanol which may be harmful for people with alcohol use disorder and must be taken into
account when administering to pregnant or breastfeeding women, children and high-risk groups such
as patients with liver disease or epilepsy.

Precautions for athletes
For those who practice sports, the use of medicines containing ethyl alcohol may result in positive
doping tests in relation to the alcohol concentration limits indicated by some sports federations.

3. How to take Zemplar

The doctor, based on the results of laboratory tests, will decide the appropriate initial dose for
you. Once therapy with Zemplar has started, it is likely that a dose titration will be performed,
based on the results of routine laboratory tests. Based on the results of the tests,
the doctor will help you establish the appropriate dose of Zemplar.
Zemplar will be administered to you by a doctor or nurse during hemodialysis, through the tube
(bloodline) used to connect you to the machine. An injection will not be necessary, as Zemplar
can be inserted directly into the tube used for your treatment. Zemplar will be
administered on alternate days, no more than three times a week.

If you take more Zemplar than you should
A high amount of Zemplar can lead to excessively high levels of calcium in the blood, which
can be harmful.
Symptoms that may appear immediately after taking a high dose of Zemplar may
include feeling weak and/or drowsy, headache, nausea (feeling unwell) or
vomiting (feeling unwell), dry mouth, constipation, muscle and bone pain, and a metallic taste in the mouth.
If you have high levels of calcium in your blood after taking Zemplar, the doctor will ensure that you receive
appropriate treatment to restore normal calcium levels in the blood. When calcium levels
in the blood return to normal, you will probably receive a lower dose of Zemplar.
The doctor will still check your blood levels. If you notice the appearance of any of the symptoms above
mentioned, consult a doctor immediately.
Symptoms that can develop after taking high doses of Zemplar for a long period of time
include loss of appetite, feeling drowsy, weight loss, eye pain, runny nose,
skin itching, feeling hot and feverish, loss of libido, severe abdominal pain (due to
inflamed pancreas) and kidney stones. Blood pressure may change and
irregular heartbeat (palpitations) may occur. The results of blood and urine tests
may show high levels of cholesterol, urea, nitrogen and increased levels of liver enzymes. Zemplar
can rarely cause mental changes including confusion, feeling drowsy,
insomnia and nervousness.
Zemplar contains 30% v/v propylene glycol as an excipient. Isolated cases of
toxic effects associated with the administration of high doses of propylene glycol have been reported. Such cases should not
occur in patients undergoing hemodialysis, as propylene glycol is removed from the blood during the dialysis process.
If you receive a dose of Zemplar that is too high, or if you notice the appearance of any of the symptoms above
mentioned, consult a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Allergic reactions of varying nature have been reported with Zemplar. Important: Inform your doctor or nurse immediately if you notice any of the following side effects:

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

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

Common (may affect more than 1 in 10 people):

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

Uncommon (may affect more than 1 in 100 people):

• blood infections, pneumonia (lung infection), sore throat, vaginal infections, influenza
• breast cancer
• reduction in the number of red blood cells (anemia - fatigue, shortness of breath, paleness); reduction in the number of white blood cells (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, reduced 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
• blistering skin rash, hair loss, excessive hair growth, excessive and unpredictable sweating
• joint pain, joint stiffness, back pain, muscle contractions, muscle pain
• breast pain, difficulty getting an 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 malaise or discomfort, thirst
• increased bleeding time (blood does not clot quickly), increased liver enzyme, changes in laboratory test results, weight loss Frequency 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; skin itching (urticaria), gastrointestinal bleeding.

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 worsen, or if you notice any effect not listed in this leaflet, tell your doctor or pharmacist.

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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zemplar

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Zemplar must be used immediately after opening.
Do not use this medicine after the expiry date stated on the pack after Scad.
Do not use this medicine if you notice the presence of particles or cloudiness.
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. Package contents and other information

What Zemplar contains
Zemplar 2 micrograms/ml injectable solution

• The active ingredient is paracalcitol. Each ml of solution contains 2 micrograms of paracalcitol.

Zemplar 5 micrograms/ml injectable solution

• The active ingredient is paracalcitol. Each ml of solution contains 5 micrograms of paracalcitol.
• The other ingredients are: ethanol (alcohol), propylene glycol and water for injections.

Description of the appearance of Zemplar and contents of the pack
Zemplar injectable solution is a clear, transparent and colourless aqueous solution, free from visible
particles. It is supplied in packs of 5 glass vials of 1 ml or 2 ml or 5 glass ampoules of 1 ml or 2
ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AbbVie S.r.l.,
S.R.148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT), Italy.
Manufacturer of the vials:
AbbVie S.r.l. S.R.148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy
Manufacturer of the ampoules:
AbbVie S.r.l. S.R.148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy
AbbVie Deutschland GmbH &Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria:Zemplar 5 Mikrogramm/ml - Injektionslösung

Cyprus:Zemplar 2 mcg/ml ενέσιμο διάλυμα, Zemplar 5 mcg/ml ενέσιμο διάλυμα

Czech Republic:Zemplar 2 mcg/ml injekční roztok, Zemplar 5 mcg/ml

Finland:Zemplar 5 mikrog/ml injektioneste, liuos

Germany:Zemplar 5 Mikrogramm/ml Injektionslösung

Greece:Zemplar 2 mcg/ml ενέσιμο διάλυμα, Zemplar 5 mcg/ml ενέσιμο διάλυμα

Hungary:Zemplar 5 mikrogramm/ml oldatos injekció

Ireland:Zemplar 5 micrograms/ml solution for injection

Italy:Zemplar 2 microgrammi/ml soluzione iniettabile, Zemplar 5 microgrammi/ml soluzione
iniettabile

Netherlands:Zemplar, oplossing voor injectie 5 microgram/ml

Portugal:Zemplar 2 microgramas/ml solução Injetável, Zemplar 5 microgramas/ml solução Injetável

Slovakia:Zemplar 5 µg/ml

Spain:Zemplar 2 microgramos/ml solución inyectable, Zemplar 5 microgramos/ml solución
inyectable

Sweden:Zemplar 5 mikrogram/ml injektionsvätska, lösning

United Kingdom:Zemplar 5 micrograms/ml solution for injection
large print> or
for the medicinal product.
The following information is intended for healthcare professionals:

Zemplar 2 micrograms/ml injectable solution
Zemplar 5 micrograms/ml injectable solution
Preparation of the injectable solution
Zemplar 2 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
turbidity before administration.

Compatibility
Propylene glycol interacts with heparin and neutralises its effects. Zemplar injectable solution
contains propylene glycol as an excipient and must be administered via a different access route from
that used for the administration of heparin.
This medicinal product must not be mixed with other medicinal products.

Storage and shelf life
Medicines administered parenterally must be visually inspected for the presence of particulate matter and
turbidity before administration. The solution is clear and colourless.
This medicinal product does not require any special storage conditions.
This medicinal product has a shelf life of 3 years (ampoule) or 2 years (vial).

Dosage, method of administration and duration of treatment
Zemplar injectable solution must be administered via a 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, on alternate days, at any time during the
hemodialysis session.
In clinical studies, the maximum safe dose administered was 40
micrograms.

• 2) Dosage 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 titration performed. If
hypercalcemia or a corrected Ca x P product, persistently elevated, greater than 5.2
mmol /l (65 mg /dl ), is noted, the dosage should be reduced or administration interrupted until such
parameters return to normal. Subsequently, paracalcitol should be
readministered at a lower dosage. It may be necessary to decrease the dosage
of paracalcitol as PTH levels decrease in response to therapy.
The following table proposes an example of a recommended approach to dosage titration:

Zemplar 1 microgram soft capsules, 2 microgram soft capsules

paracalcitol

Read this leaflet carefully before you start taking this medicine 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Zemplar is and what it is used for
• 2. What you need to know before you take Zemplar
• 3. How to take Zemplar
• 4. Possible side effects
• 5. How to store Zemplar
• 6. Contents of the pack and other information
• 2. What Zemplar is and what it is used forZemplar contains the active ingredient paracalcitol, a synthetic form of active vitamin D. Active vitamin D ensures the normal functioning of numerous tissues in the body, including the parathyroid glands and bones. In subjects with normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in the case of kidney failure, the production of active vitamin D is considerably reduced. Zemplar therefore provides a source of active vitamin D when the body is unable to produce enough of it and helps to prevent the consequences of low levels of active vitamin D, namely high levels of parathyroid hormone which can cause problems at the bone level. Zemplar is indicated in adult patients with kidney disease in Stages 3, 4 and 5 and in children aged between 10 and 16 years with kidney disease in Stages 3 and 4.

4. What you need to know before you take Zemplar

Do not take Zemplar

• if you are allergic to paracalcitol or any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium or vitamin D in your blood.

The doctor will be able to inform you if your case falls into the two conditions mentioned above.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zemplar.

• before starting treatment, it is important that you limit the amount of phosphorus you consume in your diet.
• phosphorus binders may be necessary to control phosphorus levels. If you are taking calcium-based phosphorus binders, your doctor must adjust the dose.
• the doctor will prescribe some blood tests to monitor the treatment.
• in some patients with chronic kidney disease stage 3 and 4, an increase in blood levels of a substance called creatinine has been observed. However, this increase does not reflect a decrease in kidney function.

Other medicines and Zemplar
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Some medicines can affect the action of this medicine or make side effects more likely to occur. It is particularly important to tell your doctor if you are taking any of the following medicines:

• to treat fungal infections such as candidiasis or thrush (e.g. ketoconazole)
• to treat heart problems or high blood pressure (e.g. digoxin, diuretics or pills to eliminate excess water from our body)
• that have a high phosphate content (e.g. medicines to reduce 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 (e.g. some medicines for digestion (antacids) and phosphorus binders)
• to reduce cholesterol levels (e.g. cholestyramine)

Zemplar with food and drink
Zemplar can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Data relating to the use of paracalcitol in pregnant women do not exist or are limited in number.
Therefore the potential risk is unknown, so paracalcitol should only be used if
strictly necessary.
It is not known whether paracalcitol is excreted in breast milk. If you are taking Zemplar, ask your doctor
for advice before starting breastfeeding.

Driving and using machines
Zemplar does not impair the ability to drive vehicles or operate machinery.

Zemplar contains ethanol (alcohol)
This medicine contains a small amount of ethanol (alcohol), less than 100 mg per capsule,
which may modify or increase the effect of other medicines. This may be harmful to those
suffering from liver disease, alcoholism, epilepsy, who have suffered brain damage or are affected by
diseases, as well as to pregnant or breastfeeding women and children.

Precautions for those who practice sports
For those who play sports, the use of medicines containing ethyl alcohol may result in positive
doping tests in relation to the concentration limits of alcohol indicated by some sports federations.

5. How to take Zemplar

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your doctor or pharmacist.

Chronic Kidney Disease Stages 3 and 4
In adult patients the usual starting dose is one capsule a day or on alternate days, up to three times a
week. The doctor, based on laboratory test results, will decide the appropriate dose for
you. Once therapy with Zemplar has started, it is likely that the dose will be adjusted, depending on how
you respond to treatment. The doctor will help you establish the appropriate dose of
Zemplar.

Chronic Kidney Disease Stage 5
In adult patients the usual starting dose is one capsule on alternate days, up to three times a week. Your
doctor, based on laboratory test results, will decide the appropriate dose for you. Once therapy with
Zemplar has started, it is likely that the dose will be adjusted, depending on how you respond to
treatment. The doctor will help you determine the appropriate dose of
Zemplar.

Liver Diseases
If you suffer from a mild or moderate hepatic impairment, it will not be necessary to adjust the dose.
However, there are no data available on patients with severe hepatic impairment.

Kidney Transplant
The usual dose is one capsule a day, or on alternate days, up to three times a week. The doctor
based on laboratory test results will decide the appropriate dose for you. Once therapy with Zemplar has
started, it is likely that the dose will be adjusted, depending on how you respond to treatment. The
doctor will help you determine the appropriate dose of Zemplar.

Use in children and adolescents
In children aged between 10 and 16 years with chronic kidney disease (CKD) in Stages
3 and 4, the usual starting dose is one capsule on alternate days, up to three times a week. Your doctor
will decide the appropriate dose for you based on laboratory test results. Once therapy with Zemplar has
started, it is likely that the dose will be adjusted, depending on how you respond to treatment. The
doctor will help you determine the appropriate dose of Zemplar.
The efficacy of Zemplar in children with CKD at Stage 5 has not been established.
There is no information on the use of Zemplar capsules in children under 10 years of age.

Use in the elderly
There is limited experience with the use of Zemplar in patients over 65 years of age. In general, no
differences related to the efficacy and safety of the medicine have been observed between patients aged
65 years or older and younger patients.

If you take more Zemplar than you should
An overdose of Zemplar can cause an abnormal increase in calcium levels in the blood, which
can be harmful. Symptoms that may appear immediately after taking an overdose
of Zemplar include a feeling of weakness and/or numbness, headache, nausea (feeling of
discomfort) or vomiting, dry mouth, constipation, muscle or bone pain, and a metallic taste.
Symptoms that may occur if you take an overdose of Zemplar for a longer period of time include: loss of
appetite, drowsiness, weight loss, eye discomfort, runny nose, itching, feeling of heat and fever, loss of
libido, severe abdominal pain (due to
pancreatitis) and kidney stones. Blood pressure may change and
irregular heartbeat (palpitations) may occur. Blood and urine tests may show increased cholesterol, urea
and nitrogen, and increased levels of liver enzymes. Zemplar can rarely cause mental alterations
including confusion, drowsiness, insomnia or irritability.
If you take an overdose of Zemplar, or notice the appearance of any of the above symptoms, consult
a doctor immediately.

If you forget to take Zemplar
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for
the next dose, do not take the forgotten dose; simply continue to take Zemplar
according to the instructions provided by the doctor in the prescription (dose and time).
Do not take a double dose to make up for a missed dose.

If you stop taking Zemplar
It is important to continue taking Zemplar according to the instructions provided by the doctor, unless
you have been explicitly instructed to stop therapy.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Important: Tell your doctor immediately if you notice any of the following side effects:

• allergic reactions (such as shortness of breath, wheezing, skin rash, itching, swelling of the face and lips)

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

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

• increased levels in the blood of a substance called calcium, as well as a substance called calcium-phosphorus product derived from the amount of calcium for the amount of another substance in the blood called phosphate (in patients with significant chronic kidney disease)
• phosphorus levels may also increase

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

• pneumonia (lung infection)
• decrease in the levels in the blood of the parathyroid hormone
• loss of appetite
• decrease in calcium levels
• dizziness
• abnormal taste in mouth
• headache
• irregular heartbeat
• stomach discomfort or pain
• constipation
• diarrhea
• dry mouth
• heartburn (reflux or indigestion)
• nausea
• vomiting
• acne
• skin itching
• skin rash
• urticaria (hives)
• muscle cramps
• muscle pain
• breast tenderness
• weakness
• fatigue, feeling unwell
• swelling of the legs
• pain
• increased creatinine levels
• abnormal liver function tests

If you should experience an allergic reaction, contact your doctor immediately.

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 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 Zemplar

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package and on the label after
Exp. The expiry date refers to the last day of that month.
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. Package contents and other information

What Zemplar contains
Zemplar 1 microgram capsules

• The active ingredient is paracalcitol. Each soft capsule contains 1 microgram of paracalcitol.
• The other ingredients are: medium-chain triglycerides, ethanol, butylated hydroxytoluene.
• The capsule shell contains: gelatin, glycerol, water, titanium dioxide (E171), black iron oxide (E172).
• The printing ink contains: propylene glycol, black iron oxide (E172), polyvinyl acetate phthalate, Macrogol 400, ammonium hydroxide.

Zemplar 2 micrograms capsules

• The active ingredient is paracalcitol. Each soft capsule contains 2 micrograms of paracalcitol.
• The other ingredients are: medium-chain triglycerides, ethanol, butylated hydroxytoluene.
• The capsule shell contains: gelatin, glycerol, water, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
• The printing ink contains: propylene glycol, black iron oxide (E172), polyvinyl acetate phthalate, Macrogol 400, ammonium hydroxide.

Description of the appearance of Zemplar and contents of the pack
Zemplar 1 microgram capsules
Zemplar 1 microgram capsules, is an oval soft capsule of grey colour marked with the abbreviation
ZA.
Each box contains 1 or 4 blisters. Each blister contains 7 capsules.
Zemplar 2 micrograms capsules
Zemplar 2 micrograms capsules, is an oval soft capsule of orange-brown colour, marked
with the abbreviation ZF.
Each box contains 1 or 4 blisters. Each blister contains 7 capsules.

Marketing authorisation holder and manufacturer
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Manufacturer: Aesica Queenborough Limited, Queenborough, Kent ME11 5EL, United Kingdom
Manufacturer: AbbVie Deutschland GmbH&Co.KG, Knollstrasse, 67061 Ludwigshafen
Germany

This product is authorised in the Member States of the European Economic Area with the
following designations:
Czech Republic:Zemplar

Estonia:Zemplar, 1 mikrogramm pehmekapslid, Zemplar, 2 mikrogrammi pehmekapslid

Germany:Zemplar 1 Mikrogramm Weichkapseln, Zemplar 2 Mikrogramm Weichkapseln

Greece:Zemplar 1 μικρογραμμάριο καψάκια, μαλακά, Zemplar 2 μικρογραμμάρια καψάκια,
μαλακά

Hungary:Zemplar 1 mikrogramm lágy kapszula, Zemplar 2 mikrogramm lágy kapszula

Ireland:Zemplar 1 microgram capsules, soft, Zemplar 2 micrograms capsules, soft

Italy:Zemplar 1 microgrammo capsule molli, Zemplar 2 microgrammi capsule molli

Latvia:Zemplar 1 mikrograma mīkstās kapsulas, Zemplar 2 mikrogramu mīkstās kapsulas

Lithuania:Zemplar 1 mikrogramas minkštosios kapsulės, Zemplar 2 mikrogramai minkštosios
kapsulės

Netherlands:Zemplar 1 microgram capsules, zacht

Portugal:Zemplar 1 micrograma cápsulas moles, Zemplar 2 microgramas cápsulas moles

Romania:Zemplar 1 microgram, capsule moi, Zemplar 2 micrograme, capsule moi

Slovakia:Zemplar 1 mikrogram mäkké kapsuly, Zemplar 2 mikrogramy mäkké kapsuly

Slovenia:Zemplar 1 mikrogram mehke kapsule, Zemplar 2 mikrograma mehke kapsule

Spain:Zemplar 1 microgramo cápsulas blandas, Zemplar 2 microgramos cápsulas blandas

Sweden:Zemplar 1 mikrogram kapsel, mjuk, Zemplar 2 mikrogram kapsel, mjuk

United Kingdom:Zemplar 1 microgram capsules, soft, Zemplar 2 micrograms capsules, soft

Other sources of information
large print or contact the marketing authorisation holder.