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ZOLEDRONIC ACID HELM 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

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Package leaflet: Information for the user
Zoledronic acid Helm 4 mg/5 ml concentrate for solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you are given this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

What is in this leaflet
1.
What Zoledronic acid Helm is and what it is used for
2.
Before you are given Zoledronic acid Helm
3.
How to use Zoledronic acid Helm
4.
Possible side effects
5.
How to store Zoledronic acid Helm
6.
Contents of the pack and other information

1.

What Zoledronic acid Helm is and what it is used for

The active substance in Zoledronic acid Helm is zoledronic acid, which belongs to a group of
substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing
down the rate of bone change. It is used:

To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread
of cancer from primary site to the bone)

To reduce the amount of calcium in the blood in adult patients in cases where it is too high
due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that
the release of calcium from bone is increased. This condition is known as tumour-induced
hypercalcaemia (TIH).

2.

Before you are given Zoledronic acid Helm

Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with Zoledronic acid Helm and will
check your response to treatment at regular intervals.
You should not be given Zoledronic acid Helm:
if you are breast-feeding.
if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of
substances to which Zoledronic acid Helm belongs) or any of the other ingredients of
Zoledronic acid Helm.
Before you are given Zoledronic acid Helm, tell your doctor:
if you have or have had a kidney problem.
if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the
jaw or loosening of a tooth.
if you are having dental treatment or are due to undergo dental surgery, tell your dentist that
you are being treated with Zoledronic acid Helm.
Other medicines and Zoledronic acid Helm
1

Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. It is especially important that you tell your doctor if you are
also taking:
Aminoglycosides (medicines used to treat severe infections), since the combination of these
with bisphosphonates may cause the calcium level in the blood to become too low.
Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any
other medicines which may harm your kidneys.
Aclasta (a medicine that also contains zoledronic acid and is used to treat osteoporosis and other
non-cancer diseases of the bone), or any other bisphosphonate, since the combined effects of
these medicines taken together with Zoledronic acid Helm are unknown.
Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic
acid has been associated with reports of osteonecrosis of the jaw.
Patients aged 65 years and over
Zoledronic acid Helm can be given to people aged 65 years and over. There is no evidence to suggest
that any extra precautions are needed.
Use in children and adolescents
Zoledronic acid Helm is not recommended for use in adolescents and children below the age of 18
years.
Pregnancy and breast-feeding
You should not be given Zoledronic acid Helm if you are pregnant. Tell your doctor if you are or think
that you may be pregnant.
You must not be given Zoledronic acid Helm if you are breast-feeding.
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Driving and using machines
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic acid Helm.
You should therefore be careful when driving, using machinery or performing other tasks that need
full attention.
Zoledronic acid Helm contains sodium
This medicinal product contains 45.39 mmol (or 905.6 mg) sodium per usual single infusion, when
diluted with 100 ml 0.9% w/v (9 mg/ml) sodium chloride. To be taken into consideration by patients
on a controlled sodium diet.
If you will receive a lower dose of zoledronic acid, ask your doctor for data on the sodium content.
When diluted in 5% w/v (50 mg/ml) glucose solution, the medicinal product contains less than 1 mmol
sodium (23 mg) per infusion, i.e. essentially ‘sodium- free’.

3.

How Zoledronic acid Helm is used

-

Zoledronic acid Helm must only be given by healthcare professionals trained in administering
bisphosphonates intravenously, i.e. through a vein.
Your doctor will recommend that you drink enough water before each treatment to help prevent
dehydration.
Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.

-

How much Zoledronic acid Helm is given
The usual single dose given is 4 mg.
If you have a kidney problem, your doctor will give you a lower dose depending on the severity
of your kidney problem.
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How often Zoledronic acid Helm is given
If you are being treated for the prevention of bone complications due to bone metastases, you
will be given one infusion of Zoledronic acid Helm every three to four weeks.
If you are being treated to reduce the amount of calcium in your blood, you will normally only
be given one infusion of Zoledronic acid Helm.
How Zoledronic acid Helm is given
Zoledronic acid Helm is given as a drip (infusion) into a vein which should take at least 15
minutes and should be administered as a single intravenous solution in a separate infusion line.
Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D
supplements to be taken each day.
If you are given more Zoledronic acid Helm than you should
If you have received doses higher than those recommended, you must be carefully monitored by your
doctor. This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of
calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney
impairment. If your level of calcium falls too low, you may have to be given supplemental calcium by
infusion.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most
common ones are usually mild and will probably disappear after a short time.
The frequency of possible side effects listed below is defined using the following convention:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
Tell your doctor about any of the following serious side effects straight away:
Common:
Severe kidney impairment (will normally be determined by your doctor with certain specific
blood tests).
Low level of calcium in the blood.
Uncommon:
Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of
heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw
(osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for
postmenopausal osteoporosis. It is currently unclear whether zoledronic acid causes this
irregular heart rhythm but you should report it to your doctor if you experience such symptoms
after you have received zoledronic acid.
Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Tell your doctor about any of the following side effects as soon as possible:
Very common:
Low level of phosphate in the blood.

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Common:
Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and
bone, joint and/or muscle ache. In most cases no specific treatment is required and the
symptoms disappear after a short time (couple of hours or days).
Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Conjunctivitis.
Low level of red blood cells (anaemia).
Uncommon:
Hypersensitivity reactions.
Low blood pressure.
Chest pain.
Skin reactions (redness and swelling) at the infusion site, rash, itching.
High blood pressure, shortness of breath, dizziness, sleep disturbances, tingling or numbness of
the hands or feet, diarrhoea.
Low counts of white blood cells and blood platelets.
Low level of magnesium and potassium in the blood. Your doctor will monitor this and take any
necessary measures.
Sleepiness.
Tearing of the eye, eye sensitivity to light.
Sudden coldness with fainting, limpness or collapse.
Difficulty in breathing with wheezing or coughing.
Urticaria.
Rare:
Slow heart beat.
Confusion.
Unusual fracture of the thigh bone particularly in patients on long-term treatment for
osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or
discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of
the thigh bone.
Very rare:
Fainting due to low blood pressure.
Severe bone, joint and/or muscle pain, occasionally incapacitating.
Painful redness and/or swelling of the eye.
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.

5.

How to store Zoledronic acid Helm

Your doctor, nurse or pharmacist knows how to store Zoledronic acid Helm properly (see section 6)

6.

Contents of the pack and other information

What Zoledronic acid Helm contains
The active substance of Zoledronic acid Helm is zoledronic acid.
One vial with 5 ml concentrate of Zoledronic acid Helm contains 4 mg of zoledronic acid and
5.6 mg sodium.
One ml concentrate contains 0.8 mg zoledronic acid and 1.12 mg sodium.
The other ingredients are: mannitol (E421), sodium citrate (E331), water for injections.
What Zoledronic acid Helm looks like and contents of the pack

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Zoledronic acid Helm is supplied as a liquid concentrate in a vial. One vial contains 4 mg of
zoledronic acid.
Each pack contains the vial with concentrate. Zoledronic acid Helm is supplied as packs containing 1
or 4 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Helm AG
Nordkanalstr. 28
20097 Hamburg
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
Greece
Spain
Finland
France
Italy
Norway
Portugal
Sweden
United Kingdom

Zoledronsäure Helm 4mg/5ml - Konzentrat zur Herstellung einer
Infusionslösung
Zoledronic acid Helm 4mg/5ml - πυκνό διάλυμα για παρασκευή διαλύματος
προς έγχυση
Ácido zoledrónico Helm 4mg/5ml - concentrado para solución para perfusión
Tsoledronihappoa Helm 4mg/5ml - infuusiokonsentraatti, liuosta varten
Acide zolédronique Helm 4mg/5ml - solution à diluer pour perfusion
Acido zoledronico Helm 4mg/5ml - concentrato per soluzione per infusione
Zoledronsyre Helm 4mg/5ml - konsentrat til infusjonsvæske, oppløsning
Ácido zoledrónico Helm 4mg/5ml - concentrado para solução para perfusão
Zoledronsyra 4mg/5ml - koncentrat till infusionsvätska, lösning
Zoledronic acid Helm 4mg/5ml - concentrate for solution for infusion

This leaflet was last revised in 09/2012.
The following information is intended for healthcare professionals only:
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer Zoledronic acid Helm
-

To prepare an infusion solution containing 4 mg Zoledronic acid Helm, further dilute the
Zoledronic acid Helm concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cationfree infusion solution. If a lower dose of Zoledronic acid Helm is required, first withdraw the
appropriate volume as indicated below and then dilute it further with 100 ml of infusion
solution. To avoid potential incompatibilities, the infusion solution used for dilution must be
either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Do not mix Zoledronic acid Helm concentrate with calcium-containing or other divalent
cation-containing solutions such as lactated Ringer’s solution.
Instructions for preparing reduced doses of Zoledronic acid Helm:
Withdraw the appropriate volume of the liquid concentrate, as follows:

4.4 ml for 3.5 mg dose

4.1 ml for 3.3 mg dose

3.8 ml for 3.0 mg dose

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-

After preparation, Zoledronic acid Helm infusion solution should preferably be used
immediately. If the solution is not used immediately, storage prior to use is the responsibility of
the care provider and should be in a refrigerator at 2°C – 8°C. Allow the refrigerated solution to
reach room temperature before administration.

-

The total time between dilution, storage in the refrigerator and end of administration must not
exceed 24 hours.

-

The solution containing Zoledronic acid Helm is given as a single 15-minute intravenous
infusion. The hydration status of patients must be assessed prior to and following administration
of Zoledronic acid Helm to ensure that they are adequately hydrated.

-

Studies with glass bottles, several types of infusion bags and infusion lines made from
polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/v sodium chloride
solution or 5% w/v glucose solution) showed no incompatibility with Zoledronic acid Helm.

-

Since no data are available on the compatibility of Zoledronic acid Helm with other
intravenously administered substances, Zoledronic acid Helm must not be mixed with other
medications/substances and should always be given through a separate infusion line.

How to store Zoledronic acid Helm
-

Keep Zoledronic acid Helm out of the reach and sight of children.
Do not use Zoledronic acid Helm after the expiry date stated on the pack.
The unopened vial does not require any specific storage conditions.
The diluted Zoledronic acid Helm infusion solution should be used immediately in order to
avoid microbial contamination.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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