Protos

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Strontium ranelate 2632mg

Fáanlegur frá:

Servier Laboratories NZ Ltd

INN (Alþjóðlegt nafn):

Strontium ranelate 2632 mg

Skammtar:

2 g

Lyfjaform:

Granules for oral suspension

Samsetning:

Active: Strontium ranelate 2632mg Excipient: Aspartame Maltodextrin Mannitol

Einingar í pakka:

Sachet, 2g Sample pack, 7 dose units

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Oril Industrie

Ábendingar:

Treatment of severe (established) osteoporosis in postmenopausal women at high risk of fracture to reduce the risk of fracture.

Vörulýsing:

Package - Contents - Shelf Life: Sachet, 2g Sample pack - 7 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Sachet, 2g - 14 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Sachet, 2g - 28 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Sachet, 2g - 56 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Sachet, 2g - 84 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C - Sachet, 2g - 100 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at or below 30°C

Leyfisdagur:

2004-04-19

Upplýsingar fylgiseðill

PROTOS
®
1
PROTOS
® 2G
_Strontium ranelate (pronounced stron-tee-um ran-ell-ate) _
CONSUMER MEDICINE INFORMATION
WARNING: PROTOS SHOULD ONLY BE USED WHEN OTHER MEDICATIONS FOR THE
TREATMENT FOR OSTEOPOROSIS ARE CONSIDERED
UNSUITABLE. PROTOS MUST NOT BE USED IN PATIENTS WITH ESTABLISHED,
CURRENT OR PAST HISTORY OF: ISCHAEMIC HEART
DISEASE, PERIPHERAL VASCULAR DISEASE, CEREBROVASCULAR DISEASE,
UNCONTROLLED HYPERTENSION, VENOUS THROMBOEMBOLISM,
PULMONARY EMBOLISM. IT SHOULD ALSO NOT BE USED IN PATIENTS WHO ARE
TEMPORARILY OR PERMANENTLY IMMOBILISED.
PROTOS SHOULD BE USED WITH CAUTION IN PATIENTS WITH RISK FACTORS FOR
CARDIOVASCULAR EVENTS OR VENOUS THROMBOSIS:
HYPERTENSION, DIABETES, SMOKING, HYPERLIPIDAEMIA. YOUR DOCTOR WILL
INFORM YOU OF THE RISK OF CARDIOVASCULAR EVENTS
AND VENOUS THROMBOSIS, AND THAT YOU WILL BE REGULARLY MONITORED EVERY
6 MONTHS. PLEASE REFER TO THE SECTION 'BEFORE
YOU TAKE PROTOS' IN THIS DOCUMENT FOR MORE INFORMATION. ASK YOUR
DOCTOR OR PHARMACIST IF YOU HAVE ANY
QUESTIONS.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROTOS. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medications have risks and
benefits. Your doctor has considered
this before prescribing PROTOS for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICATION, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PROTOS IS
The name of your medicine is
PROTOS. The medicine contains the
active ingredient strontium ranelate.
PROTOS does not contain any
hormones.
WHAT PROTOS IS USED
FOR
PROTOS is usually prescribed for
severe (established) osteoporosis.
Osteoporosis is a disease of older
people.
PROTOS should only be used when
other medications for the treatment
for osteoporosis are considered
unsuitable (e.g. because your doctor
has told you that you should not take
other medications prescribed for
osteoporosis, or because you may
have had a side effect with other
medication

Vara einkenni

PROTOS
_®_ 2 G – DATASHEET
1 (13)
PROTOS
®
DATASHEET
PROTOS should only be used when other medications for the treatment
for osteoporosis are
considered unsuitable. PROTOS is contraindicated and must not be used
in patients with
established, current or past history of: ischaemic heart disease,
peripheral vascular disease,
cerebrovascular disease, uncontrolled hypertension, venous
thromboembolism, pulmonary
embolism. It should also not be used in patients who are temporarily
or permanently
immobilised. PROTOS should be used with caution in patients with risk
factors for
cardiovascular events or venous thrombosis: hypertension, diabetes,
smoking,
hyperlipidaemia. All patients prescribed PROTOS should be fully
informed of the risk of
cardiovascular events and venous thrombosis. Patients should be
regularly monitored, every 6
months.
NAME OF THE DRUG
_PROTOS_
_®_
_ _
strontium ranelate 2 g
DESCRIPTION
Description
of
substance
and
solubility:
Strontium
ranelate
is
a
yellowish-white
non-
hygroscopic powder. It crystallises as a nonahydrate form but one
water molecule is
particularly labile and this leads to a compound containing either 8
or 9 water molecules per
strontium ranelate molecule. Strontium ranelate is slightly soluble in
purified water (3.7 mg/mL
at saturation point) and practically insoluble in organic solvents
(e.g. methanol).
_Excipients: _Aspartame (E951, a source of phenylalanine),
maltodextrin, mannitol.
_Chemical name: strontium ranelate _
_ _
_CAS Registry Number: 135459-90-4 _
_Molecular formula:_ C
12
H
6
N
2
O
8
SSr
2
_Chemical structure: _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
PHARMACOLOGY
_ _
_S_trontium ranelate has a dual effect on bone metabolism. _In vitro_
it increases bone formation
by increasing osteoblast precursor replication and collagen synthesis,
and reduces bone
resorption by altering osteoclast ultrastructure and decreasing
resorbing activity in bone cell
culture. The activity of strontium ranelate on both long bones and
vertebral bodies was studied
in various animal models. Str