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ZOLEDRONIC ACID GENFARMA 4 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledronic Acid Genfarma 4 mg/100 ml solution for infusion
Zoledronic acid
Read all of 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 further questions, ask your doctor, nurse or pharmacist.
 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 Genfarma is and what it is used for
2. What you need to know before you use Zoledronic Acid Genfarma
3. How to use Zoledronic Acid Genfarma
4. Possible side effects
5. How to store Zoledronic Acid Genfarma
6. Contents of the pack and other information

1. What Zoledronic Acid Genfarma is and what it is used for
The active substance in Zoledronic Acid Genfarma 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 tumourinduced hypercalcaemia (TIH).

2. What you need to know before you use Zoledronic Acid Genfarma
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with zoledronic acid and will
check your response to treatment at regular intervals.
You should not be given Zoledronic Acid Genfarma:
 if you are breast-feeding.
 if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the
group of substances to which Zoledronic acid belongs), or any of the other ingredients
of Zoledronic acid .
Before you are given Zoledronic Acid Genfarma, 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. Your doctor may recommend a dental examination
before you start treatment with Zoledronic Acid Genfarma.

if you are having dental treatment or are due to undergo dental surgery, tell your dentist that
you are being treated with Zoledronic Acid Genfarmaand inform your doctor about your dental
treatment. While being treated with Zoledronic Acid Genfarma you should maintain good oral
hygiene (including regular teeth brushing) and receive routine dental check-ups.
Contact your doctor and dentist immediately if you experience any problems with your mouth
or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could
be signs of a condition called osteonecrosis of the jaw. Patients who are undergoing
chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery,
who do not receive routine dental care, who have gum disease, who are smokers, or who were
previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a
higher risk of developing osteonecrosis of the jaw.
Other medicines and Zoledronic Acid Genfarma
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.
 Other medicines that also contain zoledronic acid, or any other bisphosphonate, since
the combined effects of these medicines taken together with Zoledronic Acid Genfarma
are unknown.
 Anti-angiogenic medicines (used to treat cancer), since the combination of these with
Zoledronic Acid Genfarma has been associated with reports of osteonecrosis of the jaw
(ONJ).
Patients aged 65 years and over
Zoledronic acid 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 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 Genfarma if you are pregnant. Tell your doctor if you
are or think that you may be pregnant.
You must not be given Zoledronic Acid Genfarma 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
Genfarma You should therefore be careful when driving, using machinery or performing other
tasks that need full attention.
Zoledronic Acid Genfarma contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
“sodiumfree”.

3. How to use Zoledronic Acid Genfarma




Zoledronic Acid Genfarma 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 Genfarma 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.
How often Zoledronic Acid Genfarma 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 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.
How Zoledronic Acid Genfarma is given
 Zoledronic acid 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 Genfarma 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, 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.
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 while being treated with Zoledronic Acid Genfarma or after
stopping treatment.
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 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: 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 1,000 people
 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.
 Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
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 side effects, talk to your doctor, nurse or pharmacist. This includes any possible
side effects not listed in this leaflet.
Reporting of side effects
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 via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Zoledronic Acid Genfarma
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Genfarma properly (see
section 6).
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the bag. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.

6. Contents of the pack and other information
What Zoledronic Acid Genfarma contains
 The active substance of Zoledronic Acid Genfarma is zoledronic acid. One bag contains
4 mg zoledronic acid, corresponding to 4.265 mg zoledronic acid monohydrate.
 The other ingredients are: mannitol (E421), sodium citrate (E331), water for injections,
hydrochloric acid and/or sodium hydroxide (for pH adjustment)
What Zoledronic Acid Genfarma looks like and contents of the pack
Zoledronic acid is supplied as a solution in a clear, colourless bag. One bag contains 100 ml
solution.
Zoledronic acid is supplied as a unit pack containing one bag or as multipacks comprising 4 or 5
bags. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
G.E.S. GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
C/Cólquide 6 Portal 2 1ª Planta – Oficina F
28230 Las Rozas (Madrid)

Manufacturer
BIOMENDI, S.A.U.
Polígono Industrial de Bernedo, s/n
01118 Bernedo (Álava)
This leaflet was last revised in 12/2015

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer Zoledronic Acid Genfarma


Zoledronic Acid Genfarma contains 4 mg zoledronic acid in 100 ml of infusion solution
for immediate use in patients with normal renal function.



For single use only. Any unused solution should be discarded. Only clear solution free
from particles and discoloration should be used. Aseptic techniques must be followed
during the preparation of the infusion.



From a microbiological point of view, the solution for infusion should be used
immediately, after first opening. 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, unless dilution has taken place in controlled and
validated aseptic conditions. The refrigerated solution should then be equilibrated to
room temperature prior to administration.



The solution containing zoledronic acid must not be further diluted or mixed with other
infusion solutions. It 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 Genfarma to assure that they are adequately
hydrated.



Zoledronic Acid Genfarma can be used immediately without further preparation for
patients with normal renal function. In patients with mild to moderate renal impairment,
reduced doses should be prepared as instructed below.

To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Remove the volume of zoledronic acid solution indicated from the bag and replace with an
equal volume of sterile sodium chloride 9 mg/ml (0,9%) solution for injection, or 5% glucose
solution for injection.
Table 1: Preparation of reduced doses of Zoledronic Acid Genfarma
Baseline
creatinine
clearance
(ml/min)

Remove the following
amount of zoledronic
acid solution for
infusion (ml)

Replace with the following
volume of sterile sodium
chloride 9 mg/ml (0,9%) or
5% glucose solution for
injection (ml)

Adjusted dose
(mg zoledronic
acid in 100 ml)

50-60
40-49
30-39

12.0
18.0
25.0

12.0
18.0
25.0

3.5
3.3
3.0

*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75
ml/min). The reduced doses for patients with renal impairment are expected to achieve
the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
 Studies with several types of infusion lines made from polyvinylchloride,
polyethylene and polypropylene showed no incompatibility with Zoledronic Acid
Genfarma

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





Keep Zoledronic Acid Genfarma out of the reach and sight of children.
Do not use Zoledronic Acid Genfarma after the expiry date stated on the pack.
This medicinal product does not require any special storage conditions.
After opening the bag, the product 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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