Zoledronic acid 4mg100ml solution for infusion vials

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Zoledronic acid monohydrate

Disponibil de la:

Dr Reddy's Laboratories (UK

Codul ATC:

M05BA08

INN (nume internaţional):

Zoledronic acid monohydrate

Dozare:

40microgram/1ml

Forma farmaceutică:

Solution for infusion

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF:

Prospect

SAP CODE
WHAT IS IN THIS LEAFLET
1.
WHAT ZOLEDRONIC ACID IS AND WHAT IT IS USED
FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
ZOLEDRONIC ACID
3.
HOW ZOLEDRONIC ACID IS USED
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZOLEDRONIC ACID
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ZOLEDRONIC ACID IS AND WHAT IT
IS USED FOR
The active substance in Zoledronic acid solution 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
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:
•
if you are breast-feeding
•
if you are allergic to zoledronic acid, another
bisphosphonate (the group of substances to which
Zoledronic acid belongs), or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE YOU ARE GIVEN
ZOLEDRONIC ACID:
•
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 Zolendronic acid.
•
if you are having DENTAL TREATMENT or are due
to undergo dental surgery, tell your dentist that
you are being treated with Zoledronic acid and

Caracteristicilor produsului

OBJECT 1
ZOLEDRONIC ACID 4 MG/100 ML SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 17-Oct-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Zoledronic acid 4 mg/100 ml Solution For Infusion
2. Qualitative and quantitative composition
One bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg
zoledronic acid monohydrate.
Excipient(s) with known effect:
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially 'sodium- free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
Clear and colourless solution; pH 6.0 – 7.0; Osmolality: between 270
and 330 mOsm/kg of water
4. Clinical particulars
4.1 Therapeutic indications
- Prevention of skeletal related events (pathological fractures,
spinal compression, radiation or surgery to
bone, or tumour-induced hypercalcaemia) in adult patients with
advanced malignancies involving bone.
- Treatment of adult patients with tumour-induced hypercalcaemia
(TIH).
4.2 Posology and method of administration
Zoledronic acid must only be prescribed and administered to patients
by healthcare professionals
experienced in the administration of intravenous bisphosphonates.
Patients treated with Zolendronic acid
should be given the package leaflet and the patient reminder card.
Posology
_Prevention of skeletal related events in patients with advanced
malignancies involving bone _
_Adults and older people_
The recommended dose in the prevention of skeletal related events in
patients with advanced
malignancies involving bone is 4 mg zoledronic acid every 3 to 4
weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D daily.
The decision to treat patients with bone metastases for the prevention
of skeletal related events should
consider that the onset of treatment effect is 2-3 months.
_Treatment of TIH _
_Adults and older people_
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium ≥ 12.0 mg/dl or 3.0