Patient Leaflet Updated 01-Jul-2020 | AbbVie Ltd
Zemplar 5 microgram/ml Solution for Injection
Zemplar 5 micrograms/ml solution for injection
paricalcitol
1. What Zemplar is and what it is used for
2. What you need to know before you are given Zemplar
3. How Zemplar is used
4. Possible side effects
5. How to store Zemplar
6. Contents of the pack and other information
Zemplar contains the active substance paricalcitol, which is a synthetic form of active vitamin D.
Active vitamin D is required for the normal functioning of many tissues in the body, including the parathyroid gland and bones. In people who have normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in kidney failure the production of active vitamin D is markedly reduced. Zemplar therefore provides a source of active vitamin D, when the body cannot produce enough and helps to prevent the consequences of low levels of active vitamin D, in patients with chronic kidney disease namely high levels of parathyroid hormone which can cause bone problems. Zemplar is used in adult patients with kidney disease Stages 5.
Your doctor will be able to tell you if these conditions apply to you.
Talk to your doctor or nurse before being given 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 likelihood of side effects.
It is particularly important to tell your doctor if you are taking any of the following medicines:
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine.
It is not known if it is safe for pregnant women to use this medicine, therefore its use is not recommended during pregnancy or if you may become pregnant.
It is not known if paricalcitol passes into human breast milk. Tell your doctor before breast-feeding while taking Zemplar.
Zemplar may make you feel dizzy, which can affect your ability to drive safely or use heavy machines.
Do not drive or use machines if you feel dizzy.
This medicine contains up to 1.3 g of ethanol (alcohol) in each dose which is equivalent to about 18 mg/kg. The amount in each dose of this medicine is equivalent to about 32 ml beer or 13 ml wine.
The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger 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 breast-feeding, talk to your doctor or pharmacist before you are given this medicine.
If you are addicted to alcohol, talk to your doctor or pharmacist before you are given this medicine.
Your doctor will use the results of your laboratory tests to decide the correct starting dose for you.
Once treatment with Zemplar has started, the dose may be adjusted, based upon the results of routine laboratory tests. Using your lab results, your doctor will help determine the correct dose of Zemplar for you.
Zemplar will be given by a doctor or nurse while you are having your treatment on the kidney machine. It will be given through the tube (bloodline) that is used to connect you to the machine. You will not need to have an injection because Zemplar can be put directly into the tube that is being used for your treatment. You will not be given Zemplar more frequently than every other day and not more than three times a week.
Too much Zemplar can cause abnormally high levels of calcium in the blood, which can be harmful.
Symptoms which can appear soon after taking too much Zemplar may include a feeling of weakness and/or drowsiness, headache, nausea (feeling sick) or vomiting (being sick), a dry mouth, constipation, pains in muscles or bones and a metallic taste in the mouth.
If you experience high level of calcium in your blood after taking Zemplar, your doctor will ensure you receive the appropriate treatment to return your calcium to normal limits. Once your calcium levels return to normal limits, you may be given Zemplar at a lower dose.
Your doctor will be checking your blood levels. If you experience any of the above, seek medical advice immediately.
Symptoms which can develop over a longer period of receiving too much Zemplar include loss of appetite, drowsiness, weight loss, sore eyes, a runny nose, itchy skin, feeling hot and feverish, loss of sex drive and severe abdominal pain (due to an inflamed pancreas) and kidney stones. Your blood pressure may be affected and heart beat irregularities (palpitations) can occur. The results of blood and urine tests may show high cholesterol, urea, nitrogen and raised levels of liver enzymes. Zemplar may rarely cause mental changes including confusion, drowsiness, insomnia or nervousness.
Zemplar contains 30% by volume of Propylene glycol as an ingredient. Cases of poisonous effects related to the high doses of Propylene glycol have only rarely been reported and would not be expected when being given to kidney patients on a kidney machine because Propylene glycol is removed from the blood during dialysis.
If you receive too much Zemplar, or experience any of the above, seek medical advice immediately.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Various allergic reactions have been seen with Zemplar. Important: Tell your doctor or nurse immediately if you notice any of the following side effects:
Tell your doctor or nurse if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
You may not be able to tell if you have some of the side effects listed above unless you are told so by your doctor.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist immediately.
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 (see details below).
Ireland:
United Kingdom:
or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
This medicinal product does not require any special storage conditions.
Zemplar should be used immediately after opening.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last date of that month.
Do not use this medicine if you notice particles or discolouration.
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 to protect the environment.
The other ingredients are: ethanol (alcohol), propylene glycol, and water for injections.
Zemplar solution for injection is a watery, clear and colourless solution, free from visible particles.
It is supplied in containers with 5 glass ampoules of 1 ml or 2 ml or 5 glass vials of 1 ml or 2 ml.
Marketing Authorisation Holder:
In the UK:
Vial Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Zemplar 5 Mikrogramm/ml - Injektionslösung
Czech Republic: Zemplar
Germany: Zemplar 5 Mikrogramm/ml Injektionslösung
Ireland: Zemplar 5 micrograms/ml solution for injection
Italy: Zemplar 5 microgrammi/ml soluzione iniettabile
Netherlands: Zemplar, oplossing voor injectie 5 microgram/ml
Portugal: Zemplar 5 microgramas/ml solução Injetável
Slovakia: Zemplar 5 mikrogramov/ml injekčný roztok
Spain: Zemplar 5 microgramos/ml solución inyectable
Sweden: Zemplar 5 mikrogram/ml injektionsvätska, lösning
United Kingdom: Zemplar 5 micrograms/ml solution for injection
This leaflet was last revised in April 2020.
For information in large print, tape, CD or Braille, phone 01628 561090 (UK) or 01 428 7900 (Ireland).
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
www.abbviemedinfo.com
+44 (0)1628 561 092
+44 (0)1628 561 092
www.abbvie.co.uk