Pabrinex Intravenous High Potency, Concentrate for Solution for Infusion

Change in Market Authorisation holder from Kyowa Kirin Ltd,, UK, to: Kyowa Kirin Hoildings B.V., Netherlands.

Chyange in MArket Authorisation Number from PA 1049/013/001, to: PA2288/001/001

Date of Revision of the Text chagned from June 2018 to November 2018

 

Changes to sections 1 and 3 relate to change in nomenclature of pharmaceutical form

From:

Pabrinex Intravenous High Potency Solution for Injection

To:

Pabrinex Intravenous High Potency, Concentrate for Solution for Infusion.

In addition

Section 2:

Sodium content updated to reflect current sodium expression: i.e. sodium content in mg, and equivalent percentage of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Section 6.5

To include the addition of the six pair pack

Section 10

Changed from:

December 2017

To:

June 2018

1.             Marketing Authorisation Holder

changed from: archimedes pharma uk limited, to: kyowa kirin LIMITED.  

 

2.             Marketing Authorisation Number

 

Changed from: PA 0757/007/001, to: PA 1049/013/001

4.             Date of Revision of the Text

 

Changed From: February 2017, To: December 2017

2. Qualitative and quantitative composition

Change from: Anhydrous glucose

To: Glucose (as monohydrate)

Primarily:

Removal of the bolus dose from the SmPC, and clarification of the indication: for use in adults for the rapid depletion of thiamine, particularly in alcoholism where a severe depletion of thiamine can lead to Wernicke’s encephalopathy; and other minor changes

 

Comprehensive view of changes per section as outlined below:

 

Section 1. NAME OF THE MEDICINAL PRODUCT

Changed from:

Pabrinex Intravenous High Potency Solution for Injection or Infusion

To:

Pabrinex Intravenous High Potency Solution for Infusion

 

Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Changed from:

Each No. 1 5ml ampoule contains:

 

Thiamine Hydrochloride                                  250mg

Riboflavin (as Phosphate Sodium)                 4mg

Pyridoxine Hydrochloride                                50mg

 

Each No. 2 5ml ampoule contains:

 

Ascorbic Acid                                                       500mg

Nicotinamide                                                      160mg

Anhydrous Glucose                                            1g

 

For a full list of excipients, see section 6.1.

 

To:

                Each presentation (carton) contains 5 ml ampoules.  Each pair of ampoules to be used in

                treatment is labelled Pabrinex No 1 and Pabrinex No 2.

 

                Each No. 1 5ml ampoule (5 ml) contains:

                Thiamine Hydrochloride                                                                       250 mg

                Riboflavin (as Phosphate Sodium)                                                      4 mg

                Pyridoxine Hydrochloride                                                                    50 mg

 

                Each No. 2 5ml ampoule (5 ml) contains:

                Ascorbic Acid                                                                                        500 mg

                Nicotinamide                                                                                        160 mg

                Anhydrous Glucose                                                                             1000 mg

 

Excipients with known effect:

This medicinal product contains approximately 3.4 mmol (or 79 mg) sodium per dose (1 pair of 5 ml ampoules).  To be taken into consideration by patients on a controlled sodium diet.

 

For a the full list of excipients, see section 6.1.

 

Section 3. PHARMACEUTICAL FORM

 

Changed from:

Solution for injection or infusion…

 

To:

Solution for infusion…

 

Section 4.1 Therapeutic Indications

 

Changed From:

In the management of alcoholism for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C where a severe depletion of thiamine can lead to Wernicke's encephalopathy. Wernicke's encephalopathy may also occur as a consequence of other medical conditions.

 

To:

Pabrinex is indicated in adults for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C:

•             particularly in alcoholism where a severe depletion of thiamine can lead to Wernicke’s encephalopathy.

 

Wernicke’s encephalopathy may also occur as a consequence of other medical conditions.

 

Section 4.2 Posology and Method of Administration

 

Changed From:

Facilities for resuscitation and for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered.

 

The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion.

 

The contents of each pair of ampoules should be diluted with 50 to 100ml physiological saline or 5% glucose and infused over 30 minutes (see “Special Precautions and Storage” section).

 

Alternatively the contents of each pair of ampoules (total 10ml) are drawn up into a syringe to mix them just before use, then injected slowly, over a period of not less than 30 minutes, into a vein.

 

Adults:

 

[Dosing Table]

 

Wernicke's encephalopathy may occur as a consequence of other medical conditions. In these situations the requirements of thiamine may be different to those for patients who suffer with alcoholism.

 

Elderly: As for adults.

 

To:

Adults and elderly: 

[Dosing table: Removal of ‘* or equivalent volume of 5ml’]

Wernicke’s encephalopathy may occur as a consequence of other medical conditions.  In these situations the requirements of thiamine may be different to those for patients who suffer with alcoholism.

Method of administration

Pabrinex Intravenous High Potency should be administered by drip infusion.  Equal volumes of the contents of ampoules number 1 and 2 should be added to 50 ml to 100 ml physiological saline or 5% glucose and infused over 30 minutes (see sections 6.3 and 6.6).

 

Section 4.3 Contraindications

 

Changed from:

Known hypersensitivity to any of the active constituents or to the excipients

 

To:

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

 

Section 4.4 Special warnings and precautions for use

 

Changed from:

…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

 

To:

… 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, this medicinal product should only be administered 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 product is administered intravenously as intended – reports of unintentional intramuscular administration have been received; these incidents have not been associated with serious adverse reactions.

 

Section 4.5 Interactions with other medicinal products and other forms of interaction

 

Additional paragraph inserted:

Administration of Pabrinex may induce sneezing or mild asthma in patients receiving repeated injections of Vitamin B1 (thiamine) or, potentially, anaphylaxis if they have become hypersensitive.

 

 

4.6 Fertility, pregnancy and lactation

 

Changed from:

No adverse effects have been noted at recommended doses when used as clinically indicated.

 

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…

 

To:

No adverse effects have been reported at recommended doses when used as clinically indicated.

 

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown…

 

Section 5.1 Pharmacodynamic properties

 

Changed from:

Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide and vitamin C.

 

ATC code: A11EB

 

To:

Pharmacotherapeutic group: Vitamin B-complex with vitamin C, ATC code: A11EB

 

Section 6.2 Incompatibilities

 

Changed from:

None reported.

 

To: 

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

 

Section 6.6 Special precautions for disposal and other handling

 

Changed from:

The two 5ml ampoules (a No. 1 and a No. 2) each containing sterile yellow coloured aqueous solutions are to be mixed prior to administration. If it is necessary to administer Pabrinex Intravenous High Potency in infusion, the mixed solution should be further diluted in physiological saline or 5% glucose.

 

In common with all parenteral products each ampoule should be visually inspected prior to administration.

 

To:

The two 5 ml ampoules (a No. 1 and a No. 2) each containing sterile yellow coloured aqueous solutions are to be mixed prior to administration.  The mixed solution should be further diluted in physiological saline or 5% glucose (refer to section 4.2 for instructions on the administration of this product).

 

In common with all parenteral products each ampoule should be visually inspected prior to administration.

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

Section 10. DATE OF THE REVISION OF THE TEXT

 

Changed from:

May 2015

 

To:

February 2017

 

Summary of Changes as follows;

Section 7 Marketing Authorisation Holder

Change from;

250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, United Kingdom

to;

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

 

Section 10 Date of Revision of the Text

Change from;

October 2014

to;

May 2015

Change of address of which HCPs report Adverse Events from IMB, to HPRA.$0$0$0$0Change of Date of revision of the text to October 2014$0

Change to Section 4.8 to include as the last paragraph;

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.imb.ie ; e-mail: imbpharmacovigilance@imb.ie

Change to Section 10 - Date of the revision of the text to May 2014.

Section 4.1 Therapeutic Indications

Previosuly read:

In the management of alcoholism for rapid therapy of severe depletion or malabsorption of the water soluble vitamins  B and C

Now reads:

In the management of alcoholism for rapid therapy of severe depletion or malabsorption of the water soluble vitamins  B and C where a severe depletion of thiamine can lead to Wernicke’s encephalopathy. Wernicke’s encephalopathy may also occur as a consequence of other medical conditions.

Section 4.2 Posology and Method of Administration

1. Removal of the caveat referring to Pabrinex Intramuscular High potency Injection.
2. Change in duration of administration
3. Addition of Wernicke's Encephalopathy
4. Dosing iindication n current in rapid therapy for the depletion or malabsorption of the water soluble vitamins B & C clarified as 'Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke’s encephalopathy' and dosing tabulated/reworded for clarity
Coma or delirium for alcohol removed

Section 4.3 Contra-indication

Wording changed to include known hypersensitivity to any of the active constituents or to the excipients

Section 4.4. Special warnings and precautions for use

Anaphylaxis wording expanded

Warning to check route of administration

Section 4.6 Fertility, pregnancy and lactation

Addition of the following wording

'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 Effects on ability to drive and use machines

The woding 'None stated' replaced with '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 4.8 Undesirable effects

MedDRA and frequency category definitions added

The undesirable effects listing is now classified via the respective MedDRA System Organ Class and tabulated for clarity

Section 6.6 Special precautions for disposal

Wording removed:

Once diluted in either of these solutions, it should be used immediately

Wording added:

In common with all parenteral products each ampoule should be visually inspoected prior to administration

Section 10 Date of revision of text

Changed from June 2010 to September 2013

None provided