Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Iodine; Potassium iodide
Thornton & Ross Ltd
D08AG03
Iodine; Potassium iodide
50mg/1ml ; 100mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200; GTIN: 5011309243215
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 Прочитать полный документ
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 Прочитать полный документ