ZEMPLAR 1 MICROGRAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PARICALCITOL

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

H05BX02

Pharmaceutical form:

CAPSULES SOFT

Composition:

PARICALCITOL 1 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ABBVIE LTD., UK

Therapeutic area:

PARICALCITOL

Therapeutic indications:

Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis.

Authorization date:

2020-03-25

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
ZEMPLAR
® 1 MICROGRAM
Soft capsules
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each capsule of Zemplar 1 microgram )mcg( contains:
paricalcitol 1 microgram )mcg(
For the list of inactive and allergenic ingredients in the
preparation, see section 2 “Important information about
some of the ingredients of the medicine” and 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 the treatment of
your ailment/for you. Do not pass it on to others. It may harm
them, even if it seems to you that their ailment/medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is indicated for the prevention and treatment
of secondary hyperparathyroidism in patients who suffer
from chronic renal insufficiency )chronic kidney disease
at stage 3 or 4( or in patients suffering from renal failure
)chronic kidney disease stage 5( and undergoing
hemodialysis or peritoneal dialysis.
THERAPEUTIC GROUP: An anti-parathyroid agent.
This medicine is a synthetic form of active vitamin D.
Active vitamin D is required for the normal function of
many tissues in the body, including the parathyroid gland
and bones. In people who have normal kidney function,
this form of active vitamin D is produced naturally by the
kidneys, but in people with kidney failure, the production
of active vitamin D is markedly reduced.
Zemplar therefore provides a source of active vitamin D
when the body cannot produce enough active vitamin D,
and helps to prevent the consequences of low levels
of active vitamin D, namely, high levels of parathyroid
hormone, which may cause bone problems. Zemplar is
used in adult patients with chronic kidney disease stages
3, 4 and 5.
2. BEFORE

Summary of Product characteristics

ZEM API JAN 23 CL
1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Zemplar® 1 microgram
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule of Zemplar 1 microgram contains 1 microgram of
paricalcitol.
Excipient with known effect:
Each capsule of Zemplar 1 microgram contains 0.71 mg of ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft
1 microgram capsule: oval, grey soft capsule imprinted with ZA
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zemplar is indicated for the prevention and treatment of secondary
hyperparathyroidism
associated with chronic renal insufficiency (chronic kidney disease
Stages 3 and 4) patients and
chronic renal failure (chronic kidney disease Stage 5) patients on
haemodialysis or peritoneal
dialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Chronic Kidney Disease (CKD) Stages 3 and 4
Zemplar should be administered once a day, either daily or three times
a week taken every other
day.
_Initial dose _
The initial dose is based on baseline intact parathyroid hormone
(iPTH) levels.
TABLE 1. INITIAL DOSE
ZEM API JAN 23 CL
2
BASELINE IPTH LEVEL
DAILY DOSE
THREE TIMES A WEEK DOSE
*
≤ 500 pg/ml (56 pmol/l)
1 microgram
2 micrograms
> 500 pg/ml (56 pmol/l)
2 micrograms
4 micrograms
*
To be administered no more frequently than every other day
_Dose titration _
Dosing must be individualised based on serum or plasma iPTH levels,
with monitoring of serum
calcium and serum phosphorus. Table 2 presents a suggested approach
for dose titration.
TABLE 2. DOSE TITRATION
IPTH LEVEL RELATIVE TO BASELINE
DOSE ADJUSTMENT AT 2 TO 4 WEEK INTERVALS
DAILY DOSE
THREE TIMES A WEEK DOSE
1
The same or increased
Increase
1 microgram
Increase
2 micrograms
Decreased by < 30%
Decreased by ≥30%, ≤60%
Maintain
Maintain
Decreased > 60%
Decrease
2
1 microgram
Decrease
2
2 micrograms
iPTH < 60 pg/ml (7 pmol/l)
1
To be administered no more frequently than every other day.
2
If a patient is taking the lowest dose on the daily or three times a
week re