Jodbalance

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

potassium iodide

Available from:

Merck KGaA Frankfurter Strasse 250

INN (International Name):

potassium iodide

Dosage:

200mcg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

Translation: July 2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINALPRODUCT
Jodbalance 100 microgram tablets
Jodbalance 200 microgram tablets
2.
QUALITATIVEANDQUANTITATIVECOMPOSITION
Jodbalance 100 microgram:
Each tablet contains 100 microgram iodide as 130.8 microgram potassium
iodide.
Jodbalance 200 microgram:
Each tablet contains 200 microgram iodide as 261.6 microgram potassium
iodide.
Excipients: Contains 84 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICALFORM
Tablet.
Jodbalance 100 microgram tablets
White, circular tablets with dividing score, being embossed: EM 33
The tablet can be divided into equal halves.
Jodbalance 200 microgram tablets
White, circular tablets with dividing score, being embossed: EM 70
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICALPARTICULARS
4.1
THERAPEUTICINDICATIONS

Goitre prevention in the presence of iodide deficiency, particularly
in pregnancy andlactation

Prevention of recurrent goitre growth after completion of thyroid
hormone treatment or after surgery
on goitre due to iodidedeficiency

Goitre due to iodide deficiency in new-born infants, children,
andadolescents
4.2
POSOLOGY AND METHOD OFADMINISTRATION
Consideration must be given to regional and individual variations in
nutritional iodide supply, when
determining the appropriate dose of Jodid for the individual patient.
This is especially important in new-born
infants and children below the age of 4 years. The following
recommendations may be taken as a guidance:
Ingestion: after meals, with a sufficient amount of liquid, i.e. half
a glass of water.
Prophylactic administration of iodide tablets must generally be
carried out over a period of years, in many
cases for life.
For treatment of goitre due to iodide deficiency in new-born infants a
2 - 4 week period of treatment is
usually sufficient. Children and adolescents usually require treatment
for 6 - 12 months and longer.
4.3
CONTRAINDICATION