sanofi-aventis

Section 1 – Added ‘99.934% w/w Powder for Oral/Rectal Suspension’ to name of product

Sections 2, 4.5, 4.8, 4.9, 5.3, 6.1, 6.2, 6.3, 6.5, 6.6 – Minor update to wording and/or formatting

Sections 3 and 5.1 – Updated to include further detail

Section 4.3 – Added ‘Hypersensitivity to the active substance or to any of the excipients.’

Section 4.6 – Added ‘fertility’ to title

Sections 9 and 10 – Updated dates

Section 7: Marketing Authorisation Holder

                Sanofi-Synthelabo Limited (trading as Sanofi Winthrop or Sanofi-aventis)

                One Onslow Street

                Guildford

                Surrey

                GU1 4YS

                UKAventis Pharma Limited

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

United Kingdom

            or trading as:

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom           Sanofi-Synthelabo

            PO Box 597

            Guildford

            Surrey

Section 8: Marketing Authorisation Number(s)

PL 11723/001004425/0620

The text in bold has been added to section 4.2:

Calcium Resonium is for oral or rectal administration only.

The dosage recommendations detailed below are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte determinations.

Adults, including the elderly:

Oral

The usual dose is 15g three or four times a day. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices which contain potassium) in the ratio of 3 to 4ml per gram of resin.

Rectal

 This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus or it may be used simultaneously with the oral route for more rapid initial results. The resin may be given rectally as a suspension of 30g resin in 150ml of water or 10% dextrose  as a daily retention enema.  In the initial stages administration by this route as well as orally may help to achieve a rapid lowering of the serum potassium level.

The enema should if possible be retained for a least nine hours, then the colon should be irrigated to remove the resin.  If both routes are used initially it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.

Children:

Oral

In smaller children and infants correspondingly smaller doses should be employed by using as a guide a rate of 1mEq of potassium per gram of resin as the basis for calculation. An appropriate initial dose is 1g/kg body weight daily in divided doses, in acute hyperkalaemia.  Dosage may be reduced to 0.5g/kg body weight daily in divided doses for maintenance therapy.

Section 4.4 – Added the following:

Sorbitol: concomitant use of Sorbitol with calcium polystyrene sulphonate is not recommended since cases of intestinal necrosis, which may be fatal, have been reported (see Section 4.5 Interactions and Section 4.8 Undesirable effects)

 
Section 4.5 - Added the text in bold
Sorbitol (oral or rectal): Concomitant use of Sorbitol with calcium polystyrene sulphonate is not recommended due to cases of intestinal necrosis, which may be fatal (see Section 4.4 Special warnings and Section 4.8 Undesirable effects). 

Section 4.8 – Added the text in bold:

Metabolism and nutrition disorders
In accordance with its pharmacological actions, the resin may give rise to hypokalaemia and hypercalcaemia, and their related clinical manifestations (see Section 4.4 Special warnings and Section 4.9 Overdose).
Cases of hypomagnesaemia have been reported.
Hypercalcaemia has been reported in well dialysed patients receiving calcium resin, and occasionally in patients with chronic renal failure.  Many patients in chronic renal failure have low serum calcium and high serum phosphate, but some, who cannot be screened out beforehand, show a sudden rise in serum calcium to high levels after therapy.  The risk emphasises the need for adequate biochemical control.
• Gastrointestinal disorders
Gastric irritation, anorexia, nausea, vomiting, constipation and occasionally diarrhoea may occur.  Faecal impaction following rectal administration particularly in children and gastrointestinal concretions (bezoars) following oral administration have been reported.  Intestinal obstruction has also been reported, although this has been extremely rare and, possibly, a reflection of co-existing pathology or inadequate dilution of resin.

Ischemic colitis, gastro-intestinal tract ulceration or necrosis which could lead to intestinal perforation have been reported.

Intestinal necrosis has been reported with concomitant use of Sorbitol (see Section 4.4 Special warnings and Section 4.5 Interactions).

• Respiratory, thoracic and mediastinal disorders
Some cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulphonate have been described. 

Section 10 - Changed date of revision