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

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledronic Acid MCM PHARMA 4mg/5ml 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.
2.
3.
4.
5.
6.

What Zoledronic acid MCM PHARMA is and what it is used for
What you need to know before you are given Zoledronic acid MCM PHARMA
How to Zoledronic acid MCM PHARMA is used
Possible side effects
How to store Zoledronic acid MCM PHARMA
Contents of the pack and other information

1. WHAT ZOLEDRONIC ACID MCM PHARMA 4 MG/5 ML IS AND WHAT IT
IS USED FOR
The active substance in Zoledronic Acid MCM PHARMA 4 mg/5 ml 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 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC
ACID MCM PHARMA 4 MG/5 ML
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid MCM
PHARMA 4 mg/5 ml and will check your response to treatment at regular intervals.
You should not be given Zoledronic Acid MCM PHARMA 4 mg/5 ml:
− if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of
substances to which zoledronic acid MCM PHARMA belongs), or any of the other ingredients
of this medicine (listed in section 6 .
− if you are breast-feeding.
Warnings and precautions:
− 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 MCM PHARMA 4 mg/5 ml.
Patients aged 65 years and over
Zoledronic Acid MCM PHARMA 4 mg/5 ml can be given to people aged 65 years and over.
There is no evidence to suggest that any extra precautions are needed.
Children and adolescents
Zoledronic Acid MCM PHARMA 4 mg/5 ml is not recommended for use in adolescents and
children below the age of 18 years.
Other medicines and Zoledronic Acid MCM PHARMA 4 mg/5ml
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.
− Zoledronic Acid MCM PHARMA contains the same active substance as found in
medicinal products indicated for treatment of osteoporosis and Paget’s disease of the
bone. Patients being treated with Zoledronic Acid MCM PHARMA should not be
treated with such products concomitantly since the combined effects of these agents
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 (ONJ).
Pregnancy and breast-feeding
You should not be given Zoledronic Acid MCM PHARMA 4 mg/5 ml if you are pregnant.
Tell your doctor if you are or think that you may be pregnant.
You must not be given Zoledronic Acid MCM PHARMA 4 mg/5 ml if you are breast-feeding.
Ask your doctor for advice before taking any medicine while you are pregnant or breastfeeding.
Driving and using machines
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid
MCM PHARMA 4 mg/5 ml. You should therefore be careful when driving, using machinery
or performing other tasks that need full attention.

Zoledronic acid MCM PHARMA 4mg/5ml contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial., i. e.
essentially ‘sodium-free’.
3. HOW ZOLEDRONIC ACID MCM PHARMA 4 MG/5 ML IS USED
− Zoledronic Acid MCM PHARMA 4 mg/5 ml 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 MCM PHARMA 4 mg/5 ml 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 an the
severity of your kidney problem.
How often Zoledronic Acid MCM PHARMA 4 mg/5 ml 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 MCM PHARMA 4 mg/5 ml 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 MCM PHARMA 4 mg/5 ml.
How Zoledronic Acid MCM PHARMA 4 mg/5 ml is given
− Zoledronic Acid MCM PHARMA 4 mg/5 ml is given as a drip (infusion) into a vein which
should take of 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 MCM PHARMA 4 mg/5 ml than you should be
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, Zoledronic Acid MCM PHARMA 4 mg/5 ml can cause side effects,
although not everybody gets them. The most common ones are usually mild and will
probably disappear after a short time.


.

Tell your doctor about any of the following serious side effects straight away:

Common (may affect up to 1 in 10 people)



Severe kidney impairment (will normally be determined by your doctor with certain
specific blood tests).
Low level of calcium in the blood.

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

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 (may affect more than 1 in 10 people):

Low level of phosphate in the blood.
Common (may affect up to 1 in 10 people):

Headache and a flu-like syndrome
drowsiness, chills and bone, joint and/or

consisting of fever, pain, weakness,
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 (may affect up to 1 in 100 people):

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 (may affect up to 1 in 1000 people):

Slow heart beat.

Confusion.


Unusual fracture of the thigh bone particularly in patients an 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 (may affect up to 1 in 10,000 people):

Fainting due to low blood pressure.

Severe bone, joint and/or muscle pain, occasionally incapacitating.

Painful redness and/or swelling of the eye.
If you get any o side effects, talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet,.
5.

HOW TO STORE ZOLEDRONIC ACID MCM PHARMA 4 MG/5 ML

Keep Zoledronic Acid MCM PHARMA 4 mg/5 ml out of the sight and reach of children
Do not use Zoledronic Acid MCM PHARMA 4 mg/5 ml after the expiry date which is stated
on the pack. The expiry date refers to the last day of that month.
The unopened vial does not require any specific storage conditions.
The readily prepared Zoledronic Acid MCM PHARMA4 mg/5 ml infusion solution should
preferably be used immediately in order to avoid microbial contamination. If the solution is
not used immediately, storage prior to use is the responsibility of the user and should be in a
refrigerator at 2°C – 8°C.
The total time between dilution, storage in the refrigerator and end of administration must not
exceed 24 hours.
Chemical and physical in-use stability has been

demonstrated for 24

hours at 2°C- 8°C when diluted with 100ml of physiological saline or 5%w/v glucose.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Zoledronic Acid MCM PHARMA 4 mg/5 ml contains

Each vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate,
corresponding to 4.264 mg zoledronic acid monohydrate).
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
The other ingredients are: mannitol (E421), sodium citrate (E331), water for injections.
What Zoledronic Acid MCM PHARMA 4 mg/5 ml looks like and contents of the pack
Zoledronic Acid MCM PHARMA 4 mg/5 ml is supplied as a clear and colourless liquid
concentrate for solution for infusion in a vial.
Each pack contains the vial with concentrate. Zoledronic Acid MCM PHARMA 4 mg/5 ml is
supplied as packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
The Marketing Authorisation Holder is:
MCM Pharma GmbH
Kleine Johannisstrasse 10
20457 Hamburg
Germany
The Manufacturers are:
PharmIdea SIA
4 Rupnicu Str., Olaine
LV-2114
Latvia
This leaflet was last revised in 12/2012
PL 35498/0003

This medicinal product is authorised in the Member States of the EEA under the
following names:
Germany

Zoledronsäure MCM PHARMA 4mg/5ml, Konzentrat zur Herstellung
einer Infusionslösung

Czech Republic

Zoledronic acid Pharmacenter 4 mg/5 ml koncentrát pro přípravu
infuzního roztoku

France

Zoledronic acid MCM PHARMA 4 mg/5 ml, solution à diluer pour
perfusion

Greek

Zolmestat, 4 mg/5 ml, concentrate for solution for infusion

Hungary

Zoledronsav Pharmacenter 4 mg/5 ml koncentrátum oldatos infúzióhoz

Ireland

Zoledronic acid MCM PHARMA 4 mg/5 ml concentrate for solution for
infusion

Slovakia

Zoledronic acid Pharmacenter 4 mg/5 ml infúzny koncentrát

Spain

Ácido Zoledrónico MCM PHARMA 4mg/5ml, concentrado para
solución para perfusion

United Kingdom

Zoledronic acid MCM PHARMA 4 mg/5 ml concentrate for solution for
infusion

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer Zoledronic Acid MCM PHARMA 4
mg/5 ml
- To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic
Acid MCM PHARMA 4 mg/5 ml concentrate (5.0 ml) with 100 ml of calcium-free or other
divalent cation-free infusion solution. If a lower dose of Zoledronic Acid MCM PHARMA 4 mg/5
ml 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 MCM PHARMA 4 mg/5 ml concentrate with calciumcontaining or other divalent cationcontaining solutions such as lactated Ringer's
solution.
Instructions for preparing reduced doses of Zoledronic Acid MCM PHARMA 4 mg/5 ml:
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

− For single use only. Any unused solution should be discarded. Only clear solution free
from particles and discolouration should be used. Aseptic techniques must be followed during
the preparation of the infusion.
− From a microbiological point of view, the diluted solution for infusion should be used
immediately. If not used immediately,in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2°C — 8°C. The
refrigerated solution should then be equilibrated to room temperature prior to administration.
− The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a
separate infusion line. The hydration status of patients must be assessed prior to and following
administration of Zoledronic Acid MCM PHARMA 4 mg/5 ml to ensure that they are adequately
hydrated.
− Studies several types of infusion lines made from polyvinylchloride, polyethylene and
polypropylene showed no incompatibility with Zoledronic Acid MCM PHARMA 4 mg/5 ml.
− Since no data are available on the compatibility of Zoledronic Acid MCM PHARMA 4 mg/5
ml with other intravenously administered substances, Zoledronic Acid MCM PHARMA 4 mg/5
ml must not be mixed with other medications/substances and should always be given through a
separate infusion line.
How to store Zoledronic Acid MCM 4 mg/5 ml
− Keep Zoledronic Acid MCM PHARMA4 mg/5 ml out of the reach and sight of children.
− Do not use Zoledronic Acid MCM PHARMA4 mg/5 ml after the expiry date stated on the
pack.
− The unopened vial does not require any specific storage conditions.
− The diluted Zoledronic Acid MCM PHARMA 4 mg/5 ml infusion solution should be used
immediately in
order to avoid microbial contamination.

+ Expand Transcript

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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