KALINOR RETARD 600 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Beli Sekarang

Unduh Selebaran informasi (PIL)
15-11-2022
Unduh Karakteristik produk (SPC)
15-11-2022

Bahan aktif:

POTASSIUM CHLORIDE

Tersedia dari:

TRUSTPHARM LTD, ISRAEL

Kode ATC:

A12BA01

Bentuk farmasi:

CAPSULES PROLONGED RELEASE

Komposisi:

POTASSIUM CHLORIDE 600 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

DESMA GMBH , GERMANY

Area terapi:

POTASSIUM CHLORIDE

Indikasi Terapi:

Treatment and prevention of hypokalemia.

Tanggal Otorisasi:

2022-08-28

Selebaran informasi

                                Page 1 of 5
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
KALINOR-RETARD 600 MG
PROLONGED-RELEASE HARD CAPSULES
ACTIVE INGREDIENT
Each capsule contains 600 mg potassium chloride
Potassium content, 315 mg, corresponds to 8 mmol = 8 mval K
+
.
Inactive ingredients and allergens: See section 2 "Important
information about some of this medicine’s
ingredients" and section 6 "Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For prophylaxis and treatment of low blood potassium levels
(hypokalaemia).
THERAPEUTIC GROUP: mineral/potassium for normalisation of potassium
balance.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
−
You are sensitive (allergic) to potassium chloride or to any of the
other ingredients in this
medicine (see section 6).
−
In case of diseases that are commonly linked to an increase in blood
potassium level above
the normal level (hyperkalaemia):
−
restricted excretory kidney function (reduced excretion capability of
the kidneys)
−
dehydration (lack of body water as a result of disruption of the
water-salt balance)
−
Addison’s disease (primary adrenal insufficiency, inadequate
function of the adrenal
gland cortex)
−
Adynamia episodica hereditaria (Gamstorp disease, a rare congenital
disease with
attacks of flaccid paralysis with elevated blood potassium
concentration)
−
sickle cell anaemia (a disorder of haemoglobin formation)
−
metabolic imbalances in the acidic range, e.g. diabetic acidosis
(hyperacidity of the blood
in case of diabetes)
−
In case of an elevated blood potassium level due 
                                
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Karakteristik produk

                                1.
NAME OF THE MEDICINAL PRODUCT
KALINOR-RETARD 600 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Potassium chloride.
1 prolonged-release capsule, hard, contains: 600 mg potassium
chloride, microencapsulated
(potassium content 315 mg corresponds to 8 mmol = 8 mval K
+
).
Excipients with known effect:
Sodium (less than 1 mmol)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prevention of hypokalemia.
4.2
POSOLOGY, METHOD AND DURATION OF ADMINISTRATION
Posology:
Dosage is to be adapted to the individual conditions. The following
guidelines apply: For
prophylaxis of a potassium deficiency in general, 2–3 capsules
Kalinor-retard 600 mg daily
(corresponding to 16–24 mmol K
+
). For treatment of a potassium deficiency, 4-12 capsules Kalinor-
retard 600 mg daily (corresponding to 32-96 mmol K
+
). A daily dose of more than 2 capsules
should be divided into two or three individual doses of 2-4 tablets
(16-32 mmol K
+
).
The dosage should be adapted to serum potassium levels of individual
patient.
If the cause of a potassium deficit cannot be determined, ongoing
replacement is recommended. In
other cases of potassium deficiency, days to weeks often suffice to
balance the potassium deficit.
Paediatric population
There is no indication for use in children and adolescent for
Kalinor-retard 600 mg.
Method of administration:
The capsules should be swallowed whole at mealtimes with plenty of
fluid (at least the equivalent
of a water glass full). The capsules can be opened if there are
swallowing problems. The content
(controlled-release micropellets) is taken in a liquid suspension or
in semi-solid food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
The preparation should not be used in the case of diseases that are
often linked to hyperkalaemia:
-
dehydration
-
restricted excretory kidney function
-
Addison's disease
-
                                
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