Iodine aqueous oral solution

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Iodine; Potassium iodide

Tilgængelig fra:

Thornton & Ross Ltd

ATC-kode:

D08AG03

INN (International Name):

Iodine; Potassium iodide

Dosering:

50mg/1ml ; 100mg/1ml

Lægemiddelform:

Oral solution

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 06020200; GTIN: 5011309243215

Indlægsseddel

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
elkie.bramall
546132
11577
Addition of reporting of side
effects statement.
MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
500ml
22647308
210 x 148mm (70 x 148mm folded)
3
28.11.2014
Process Black
Keyline (Does not print)
Aqueous Iodine Oral Solution
Helvetica
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
elkie.bramall
546132
11577
Addition of reporting of side
effects statement.
MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
500ml
22647308
210 x 148mm (70 x 148mm folded)
3
28.11.2014
Process Black
Keyline (Does not print)
Aqueous Iodine Oral Solution
Helvetica
FRONT FACE TOP
REVERSE FACE TOP
_Data Matrix: _22647308 VERIFIED
AQUEOUS IODINE ORAL
SOLUTION
(iodine, potassium iodide)
IMPORTANT INFORMATION ABOUT AQUEOUS IODINE
ORAL SOLUTION
• This medicine is taken before an operation to
correct an overactive thyroid gland. The
doctor will decide how much you should take
and how often.
DO NOT TAKE….
• For longer than 6 days before the operation
unless the doctor tells you to do so. See
section 3.
• If you are pregnant or breastfeeding.
• This medicine is not to be used as a long-term
treatment.
• The normal dose is a very small amount.
Measure out the correct amount carefully
using a 1ml syringe supplied by the
pharmacist. See section 3.
• Take extra care when giving this medicine to
children.
• Seek immediate medical help if you
accidentally take too much.
NOW READ THE REST OF THE LEAFLET BEFORE YOU
USE THIS MEDICINE. IT INCLUDES OTHER
INFORMATION WHICH MIGHT BE ESPECIALLY
IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If

Produktets egenskaber

OBJECT 1
AQUEOUS IODINE ORAL SOLUTION BP
Summary of Product Characteristics Updated 02-Dec-2014 | Thornton &
Ross Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6. Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Aqueous Iodine Oral Solution BP
2. Qualitative and quantitative composition
Iodine 5.0% w/v
Potassium Iodide 10.0% w/v
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
4. Clinical particulars
4.1 Therapeutic indications
For use in the pre-operative management of hyperthyroidism.
4.2 Posology and method of administration
Oral.
Dose: adults, children and the elderly: 0.1 – 0.3ml well diluted in
milk or water.
Dosage schedule: to be taken three times a day for six days.
4.3 Contraindications
Contraindicated for patients hypersensitive to iodine or iodides, and
use in pregnancy and lactation.
4.4 Special warnings and precautions for use
Should not be used for long term treatment.
Dispensing pack-not for retail sale.
Keep all medicines away from children.
Use with caution i