Zometa 4mg100ml infusion bottles

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Zoledronic acid monohydrate

Доступно од:

Novartis Pharmaceuticals UK Ltd

АТЦ код:

M05BA08

INN (Међународно име):

Zoledronic acid monohydrate

Дозирање:

40microgram/1ml

Фармацеутски облик:

Infusion

Пут администрације:

Intravenous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: ; GTIN: 5010678926064

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMETA
® 4 MG/100 ML 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. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zometa is and what it is used for
2.
What you need to know before you are given Zometa
3.
How Zometa is used
4.
Possible side effects
5.
How to store Zometa
6.
Contents of the pack and other information
1.
WHAT ZOMETA IS AND WHAT IT IS USED FOR
The active substance in Zometa 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 ZOMETA
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zometa and will check your
response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOMETA:_ _
−
if you are breast-feeding.
−
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Zometa 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 ZOMETA:
−
if you ha

Карактеристике производа

OBJECT 1
ZOMETA 4MG/100ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 17-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Zometa
®
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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
Clear and colourless solution
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
Zometa must only be prescribed and administered to patients by
healthcare professionals experienced in
the administration of intravenous bisphosphonates. Patients treated
with Zometa 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
mmol/l) is a single dose of 4 mg zoledronic acid.
_Renal impairment_
_TIH:_
Zometa treatment in TIH patients who also have severe renal impairment
should be considered only after
evaluating the risks and benefits of treatment. In the clinical