CINACALCET TEVA 30 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CINACALCET AS HYDROCHLORIDE

متاح من:

TEVA ISRAEL LTD

ATC رمز:

H05BX01

الشكل الصيدلاني:

TABLETS

تركيب:

CINACALCET AS HYDROCHLORIDE 30 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

المجال العلاجي:

CINACALCET

الخصائص العلاجية:

Treatment of secondary hyperparathyrodism (HPT) in patients with end-dtage renal disease (ESRD) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Reduction of hypercalcaemia in patients with parathyroid carcinoma.Reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

تاريخ الترخيص:

2020-08-31

نشرة المعلومات

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
The medicine is dispensed with
a doctor’s prescription only
CINACALCET TEVA 30 MG
TABLETS
COMPOSITION:
Each tablet contains:
Cinacalcet )as
hydrochloride
( 30 mg
CINACALCET TEVA 60 MG
TABLETS
COMPOSITION:
Each tablet contains:
Cinacalcet )as
hydrochloride
( 60 mg
CINACALCET TEVA 90 MG
TABLETS
COMPOSITION:
Each tablet contains:
Cinacalcet )as
hydrochloride
( 90 mg
For information about inactive ingredients,
please see section 6 - “Further
information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for
your treatment. Do not pass it on to others.
It may harm them even if it seems to you
that their medical condition is similar.
THIS MEDICINE IS NOT INTENDED FOR
CHILDREN UNDER 18 YEARS OF AGE.
1. WHAT IS THE MEDICINE INTENDED
FOR?
• This medicine is intended to treat
secondary hyperparathyroidism in
patients with serious kidney disease
who need dialysis to clear their blood
of waste products.
• To reduce hypercalcemia )high levels
of calcium in the blood( in patients with
parathyroid cancer.
• To reduce high levels of calcium in the
blood )hypercalcemia( in patients with
primary hyperparathyroidism when
removal of the gland is not possible.
THERAPEUTIC GROUP:
The medicine controls the levels of
calcium and has anti-parathyroid activity.
It is used to treat ailments caused by
impaired function of organs called the
parathyroid glands.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
you are sensitive )allergic( to the active
ingredient – cinacalcet or to any of the
additional ingredients contained in the
medicine )listed in section 6(.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE:
Consult your doctor or pharmacist or
nurse before taking Cinacalcet Teva.
BEFORE TREATMENT WITH CINACALCET TEVA,
TELL THE DOCTOR IF:
You hav

خصائص المنتج

Cinacalcet Teva 30/60/90 mg Tab New SPC Notification 08-2020 RC
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Teva 30 mg film-coated tablets
Cinacalcet Teva 60 mg film-coated tablets
Cinacalcet Teva 90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg cinacalcet (as hydrochloride).
Each tablet contains 60 mg cinacalcet (as hydrochloride).
Each tablet contains 90 mg cinacalcet (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
30 mg tablets: Light green to green, oval shaped tablet, debossed with
"C30" on one side of the tablet
and plain on the other side.
60 mg tablets: Light green to green, oval shaped tablet, debossed with
"C60" on one side of the tablet
and plain on the other side.
90 mg tablets: Light green to green,, oval shaped tablet, debossed
with "C90" on one side of the tablet
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of secondary hyperparathyroidism (HPT) in patients with
end-stage renal disease (ESRD)
on maintenance dialysis therapy.
Cinacalcet Teva may be used as part of a therapeutic regimen including
phosphate binders and/or
Vitamin D sterols, as appropriate (see section 5.1).
Reduction of hypercalcaemia in patients with:
•
parathyroid carcinoma.
•
primary HPT for whom parathyroidectomy would be indicated on the basis
of serum calcium
levels (as defined by relevant treatment guidelines), but in whom
parathyroidectomy is not
clinically appropriate or is contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Secondary hyperparathyroidism
_ _
Cinacalcet Teva 30/60/90 mg Tab New SPC Notification 08-2020 RC
2
_Adults and elderly (> 65 years) _
The recommended starting dose for adults is 30 mg once per day.
Cinacalcet Teva should be titrated
every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a
target parathyroid hormone
(PTH) in dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l)
in t