Archimedes Pharma UK Ltd

Various changes to multiple sections.
Words in bold have been added to the previous version of the document.

Section 1
Solution for injection

Section 2
Each presentation (carton) contains either 5ml or 10ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2

The information following this added statement has been rearranged into a loose table format.

Section 3
Information has been removed and replaced with: Solution for injection

Section 4.1
...particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy; after acute infections...

Section 4.2
In section 1, removed "15 to" in the sentence: ...and infused over 15 to 30 minutes...
so that it reads: ...and infused over 30 minutes...

Under the subheading "Adults":
"Coma or delirium from alcohol, narcotics or barbiturates; collapse following continuous narcosis" has been replaced with: Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularyl in alcoholism, where a sever depletion of thiamine can lead to Wernicke's encephalopathy.

The information at the bottom of the table describing the administration and composition of pabrinex has been removed and changed to: 2 to 3 pairs of 5ml ampoules* (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.
* or equivalent volume of 5ml and/or 10ml ampoules

Section 4.3
Known hypersensitivity to any of the active constituents or to the excipients.

Section 4.4
"Special warnings and precautions for use": all information has been removed and replaced with:
Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after. parenteral administration of Pabrinex, such rare occurence of serious allergic reactions should not preclude the use of Pabrinex in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential. Initial warning signs of a reaction to Pabrinex are sneezing or mild asthma and those treating patients need to note that the administration of futhur injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered.  To minimise the risk of such events with Pabrinex Intravenous High Potency, the preferred mode of administration is by infusion over a period of 30 minutes.
This medicine is for injection into a vein only and should not be given by any other route
Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.

Section 4.6
Addition of: However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women.

Section 4.7
Change all text to: No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.

Section 6.6
Change all text to: In common with parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

Section 10
Change to date of revision of text. Addition of: Change all text to: Change all text to: Change to date of revision of text.