Sterilised Water for Injections PL 08801/0057 UKPAR

UKPAR Sterilised Water for Injections
PL 08801/0057
Sterilised Water for Injections
PL 08801/0057
UKPAR
TABLE OF CONTENTS
Lay Summary
Page 2
Scientific discussion
Page 4
Steps taken for assessment
Page 11
Summary of Product Characteristics
Page 12
Patient Information Leaflet
Page 13
Labelling
Page 14
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UKPAR Sterilised Water for Injections
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LAY SUMMARY
Sterilised Water for Injections
This is a summary of the Public Assessment Report (PAR) for Sterilised Water for Injections
(PL 08801/0057). It explains how Sterilised Water for Injections was assessed and its authorisation
recommended, as well as its conditions of use. It is not intended to provide practical advice on how to
use Water for Injections.
For practical information about using Sterilised Water for Injections, patients should read the package
leaflet or contact their doctor or pharmacist.
What is Sterilised Water for Injections and what is it used for?
Sterilised Water for Injections is a special type of water that has been carefully cleaned and purified so it
does not contain any other ingredients. Sterilised Water for Injections is called a diluent because its main
use is for diluting and preparing medicines before use. Sterilised Water for Injections is used to dissolve
and dilute other drugs that require mixing with water before they can be given as an injection or an
infusion (a drip) into your veins, muscles or other tissues in the body.
How does Sterilised Water for Injections work?
Sterilised Water for Injections dissolves and dilutes other drugs that require mixing before they can be
given as an injection or an infusion (a drip). It contains no active ingredients.
How is Sterilised Water for Injections used?
Sterilised Water for Injections is used to dissolve and dilute other medicines before it given by a health
professional as an injection or infusion (a drip).
In the preparation of the medicine for use, the required volume of Sterilised Water for Injections will
vary, depending on the medicine to which it is added.
The health professional will use the correct amount of Sterilised Water for Injections to dissolve or
dilute the medicine that the patient is to receive as an injection, or as an infusion (a drip) into the veins.
The doctor will decide the dose of the medicine that the patient should receive and for how long the
patient will need to take. The dose will depend on the other medicine which is being dissolved or diluted
with Sterilised Water for Injections.
Sterilised Water for Injections can only be obtained on prescription.
For further information on how Sterilised Water for Injections is used, please read section 3 of the
package leaflet, available on the MHRA website.
What benefits of Sterilised Water for Injections have been shown in studies?
No clinical studies have been conducted as Sterilised Water for Injections contains no active ingredients
and it is a well-known diluent. Its benefits and risks, when used as approved, are taken as being the same
as those of the medicines it is used to dissolve or dilute.
What are the possible side effects of Sterilised Water for Injections?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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UKPAR Sterilised Water for Injections
PL 08801/0057
If given on its own, intravenous injection of Sterilised Water for Injections may cause damage to red
blood cells (haemolysis).
Reporting of side effects
The patient’s doctor should be consulted if the patient gets any side effects. This includes any possible
side effects not listed in this report. Side effects can also be reported directly via
www.mhra.gov.uk/yellowcard. The reporting of side effects can help provide more information on the
safety of medicines.
Why is Sterilised Water for Injections approved?
It was concluded that that the use of Sterilised Water for Injections was effective in the use as a diluent
to dissolve and dilute other drugs that require mixing with water before they can be given as an injection
or an infusion (a drip).
The MHRA decided that, for Sterilised Water for Injections, the benefits are greater than the risks and
the grant of the Marketing Authorisation was recommended.
What measures are being taken to ensure the safe and effective use of Sterilised Water for
Injections?
A Risk Management Plan has been developed to ensure that Sterilised Water for Injections is used as
safely as possible. Based on this plan, safety information has been included in the Summary of Product
Characteristics and the package leaflet for Sterilised Water for Injections, including the appropriate
precautions to be followed by healthcare professionals and patients.
Known side effects are continuously monitored. Furthermore, new safety signals reported by
patients/healthcare professionals will be monitored/reviewed continuously.
Other information about Sterilised Water for Injections.
A Marketing Authorisation was granted in the UK to Bio Products Laboratory Limited on 15 August
2014.
The full PAR for Sterilised Water for Injections follows this summary.
For more information about treatment with Sterilised Water for Injections, read the package leaflet, or
contact your doctor or pharmacist.
This summary was last updated in October 2014.
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Sterilised Water for Injections
PL 08801/0057
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction
Page 5
Pharmaceutical assessment
Page 6
Non-clinical assessment
Page 8
Clinical assessment
Page 9
Overall conclusion and benefit/risk assessment
Page 10
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INTRODUCTION
Based on the review of the data on quality, safety and efficacy, the Medicines and Healthcare products
Regulatory Agency (MHRA) granted Bio Products Laboratory Limited a Marketing Authorisation for
the medicinal product Sterilised Water for Injections (PL 08801/0057) on 15 August 2014. The product
is a prescription-only medicine (POM) indicated for use as a vehicle for dilution and reconstitution of
suitable medicinal products for parenteral administration.
The application was submitted under Article 8.3 of Directive 2001/83/EC, as amended.
Sterilised Water for Injections is a solvent and diluting agent. The product contains no active ingredient.
No non-clinical or clinical data were submitted, which is acceptable given that this application was
based on the product being a medicinal product that (i) contains no active ingredient and (ii) is used as a
solvent and diluting agent.
No new or unexpected safety concerns arose during review of information provided by the Marketing
Authorisation Holder and it was, therefore, judged that the benefits of using Sterilised Water for
Injections outweigh the risks and a Marketing Authorisation was granted.
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PHARMACEUTICAL ASSESSMENT
S. ACTIVE SUBSTANCE
As the only constituent in this product is sterilised water for injections, no active substance data were
submitted or required.
P. DRUG PRODUCT
Other ingredients
The only constituent of this product is water for injections. No materials of human or animal origin are
used in the production of Sterilised Water for Injections. No genetically modified organisms are used in
the production of Sterilised Water for Injections.
Pharmaceutical Development
Sterilised Water for Injections has been developed according to the corresponding European
Pharmacopoeia monograph, as a vehicle for dilution and reconstitution of suitable products for
parenteral administration.
Manufacturing Process
An appropriate account of the manufacturing process has been provided. The manufacturing process has
been validated at and has shown satisfactory results.
Control of Finished Product
The finished product specification is satisfactory and in line with the current European Pharmacopoeia.
Test methods have been described and adequately validated, as appropriate. Batch data have been
provided, which comply with the release specification.
Container Closure System
The product is packaged in Type I clear glass 5 ml vials closed with halobutyl rubber stoppers and
aluminium overseals with polypropylene flip off tamper evident caps.
The vials are packaged with the Patient Information Leaflet in cardboard outer cartons, in pack sizes of
2.5 ml and 5 ml vials. Not all pack sizes may be marketed.
Satisfactory specifications and Certificates of Analysis have been provided for all packaging
components. All primary packaging complies with the current European regulations concerning
materials for parenteral use.
Stability of the product
Finished product stability studies were performed in accordance with current guidelines on batches of
finished product packed in the packaging proposed for marketing. The data from these studies support a
shelf-life of 4 years, with the storage conditions ‘Do not store above 30°C. Do not freeze.’
From a microbiological point of view the product should be used immediately.
Suitable post approval stability commitments have been provided to continue stability studies on batches
of finished product.
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Bioequivalence
No bioequivalence studies have been submitted for this application for a parenteral product and none
were required.
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling
The SmPC, PIL and labelling are satisfactory from a pharmaceutical perspective.
A package leaflet has been submitted to the MHRA along with results of consultations with target
patient groups (‘user testing’), in accordance with Article 59 of Council Directive 2001/83/EC, as
amended. The results indicate that the package leaflet is well-structured and organised, easy to
understand and written in a comprehensive manner. The test shows that the patients/users are able to act
upon the information that the leaflet contains.
MAA (Marketing Authorisation Application) Form
The MAA form is satisfactory from a pharmaceutical perspective.
Expert Report (Quality Overall Summary)
The quality overall summary is written by an appropriately qualified person and is a suitable summary of
the pharmaceutical aspects of the dossier.
Conclusion
The grant of a Marketing Authorisation is recommended.
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NON-CLINICAL ASSESSMENT
No non-clinical data have been submitted and none are required for this type of application. The product
consists entirely of sterilised water. When used as indicated, the product is well established as a
non-toxic liquid and has no pharmacological effect in itself. Non-clinical data is included by association
in the dossier of the product it is intended to reconstitute.
An Environmental Risk Assessment was not required for this application, given that the product contains
water only.
The grant of Marketing Authorisation is recommended.
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CLINICAL ASSESSMENT
CLINICAL PHARMACOLOGY
No clinical pharmacology data have been submitted and none are required for this type of application.
The product consists entirely of sterilised water. When used as indicated, the product is well established
as a non-toxic liquid and has no pharmacological effect in itself. All safety and clinical efficacy data is
included by association in the dossier of the product it is intended to reconstitute.
EFFICACY
No efficacy data have been submitted and none are required for this type of application.
SAFETY
No safety data have been submitted with this application and none are required. No new or unexpected
safety concerns arose from this application.
PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN
The Applicant provided a Pharmacovigilance System Master File Summary (version 1.0, September
2012) stating that they have at their service a Qualified Person for Pharmacovigilance (QPPV)
responsible for Pharmacovigilance who is suitably trained and aware of the responsibilities outlined in
the current applicable European Union (EU) legislation. The QPPV has the necessary means for
collection and notification of any adverse drug reaction occurring either in the Community or in a third
country, and the means to fulfil all other requirements of current European Pharmacovigilance
legislation.
An acceptable Risk Management Plan has been provided. Routine risk minimisation is provided through
the Summary of Product Characteristics and the Patient Information Leaflet and this is sufficient.
SUMMARY OF PRODUCT CHARACTERISTICS (SmPC), PATIENT INFORMATION
LEAFLET (PIL) AND LABELLING
The SmPC, PIL and labelling are acceptable from a clinical perspective. The PIL text is consistent with
the details in the SmPC and in line with current guidance. The labelling is also in line with current
guidance.
CLINICAL EXPERT REPORT (CLINICAL OVERVIEW)
A clinical overview has not been submitted and none is required for this type of application.
CONCLUSION
The grant of a Marketing Authorisation is recommended.
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OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT
QUALITY
The important quality characteristics of Sterilised Water for Injections are well-defined and controlled.
The specifications and batch analytical results indicate consistency from batch to batch. There are no
outstanding quality issues that would have a negative impact on the benefit/risk balance.
NON-CLINICAL
No non-clinical data were submitted and none is required for an application of this type.
EFFICACY
No non-clinical data were submitted and none is required for an application of this type. The product
contains no active ingredient and is intended for the reconstitution of lyophilised medicinal products for
parenteral administration.
SAFETY
No safety data was submitted and none is required for an application of this type. The product contains
no active ingredient and is intended for the reconstitution of lyophilised medicinal products for parenteral
administration. No new or unexpected safety concerns arose from this application.
PRODUCT LITERATURE
The SmPC, PIL and labelling are satisfactory and in line with current guidance.
BENEFIT/RISK ASSESSMENT
The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been
identified. The benefit/risk balance is therefore considered to be positive.
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UKPAR Sterilised Water for Injections
PL 08801/0057
Sterilised Water for Injections
PL 08801/0057
STEPS TAKEN FOR ASSESSMENT
1
The MHRA received the Marketing Authorisation application on 10 January 2014.
2
Following standard checks and communication with the applicant the MHRA considered
the application valid on 06 February 2014.
3
Following assessment of the application, the MHRA requested further information relating
to the dossier on 27 February 2014 and 16 July 2014.
4
The applicant responded to the MHRA’s requests, providing further information on the
dossier on 23 June 2014 and 01 August 2014.
5
The application was granted on 15 August 2014.
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SUMMARY OF PRODUCT CHARACTERISTICS
In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for
products granted Marketing Authorisations at a national level are available on the MHRA website.
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PATIENT INFORMATION LEAFLET
In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted
Marketing Authorisations at a national level are available on the MHRA website.
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LABELLING
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