ACCUSOL 35 POTASSIUM 2MMOL/L 2 mMol. Solution for Haemofiltration

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYDROUS
Available from:
Baxter Healthcare Limited
INN (International Name):
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYD
Dosage:
2 mMol.
Pharmaceutical form:
Solution for Haemofiltration
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization number:
PA0167/123/001
Authorization date:
0000-00-00

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Package leaflet: Information for the user

ACCUSOL 35 Potassium 2 mmol/l,Solution for haemofiltration,

haemodialysis and haemodiafiltration

Read all of this leaflet carefully before you are given this medicine because it

contains important information for you:

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any side effects talk to your doctor. This includes any

possible side effects not listed in this leaflet.

What is in this leaflet

1. What ACCUSOL 35 Potassium 2 mmol/l is and what it is

used for

2. What you need to know before you are given

ACCUSOL 35 Potassium 2 mmol/l

3. How you will be given ACCUSOL 35 Potassium 2 mmol/l

4. Possible side effects

5 How to store ACCUSOL 35 Potassium 2 mmol/l

6. Contents of the pack and other information

1.What ACCUSOL 35 Potassium 2 mmol/l is and what it is

used for

ACCUSOL 35 Potassium 2 mmol/l is a solution for haemofiltration, haemodialysis

and haemodiafiltration.

ACCUSOL 35 Potassium 2 mmol/l is prescribed to you if you have temporary or

permanent kidney failure.

It purifies your blood of waste products; it corrects the acidity or alkalinity and

the level of salts in your blood. As a replacement fluid in haemodiafiltration and

haemofiltration, it can also be used as a source of salts and water for hydration.

ACCUSOL 35 solutions are supplied in a non-PVC bag with two chambers. The

two chambers are separated by a long-seal (interchamber seal). Prior to use,

the two chambers of ACCUSOL 35 solutions must first be mixed by activating the

long-seal (interchamber seal), followed by the activation of the short SafetyMoon

seal near the access port.

ACCUSOL 35 solutions must only be used by or under the direction of a doctor.

2.What you need to know before you are given

ACCUSOL35 Potassium 2 mmol/l

Before starting the therapy, your doctor will ensure that you have a good access

to your vein and artery. He will also ensure that you do not present a high risk

of bleeding.

ACCUSOL 35 solutions are available in different potassium and glucose

concentrations. Your blood levels of potassium and glucose will be monitored

very closely to ensure that the most appropriate ACCUSOL 35 formulation is

used.

YourdoctorwillnotgiveyouACCUSOL35Potassium2mmol/l:

if you do not have good access to the veins and/or arteries.

if you have an excessive risk of bleeding.

if you have a high level of bicarbonate in your blood.

if you have a potassium blood level too low, unless you are

simultaneously receiving potassium supplementation.

if you have a clinical condition whereby the current acidity or alkalinity

of your blood may worsen.

if you have kidney failure where waste products cannot be removed

Warnings and precautions

ACCUSOL 35 Potassium 2 mmol/l can only be used by or

under the direction of a doctor who has experience with

haemofiltration,haemodialysis or haemodiafiltration techniques.

Your doctor will

check the tubing containing ACCUSOL 35 regularly. The bag and tubing

will be immediately replaced if your doctor observes particles floating

in the fluid.

measure the acidity, different salts and waste product levels in your

blood.

ensure that their levels are correct and closely monitored during your

treatment.

ensure that the fluid balance of your body is well maintained.

check your blood glucose very carefully especially if you are diabetic.

measure the potassium level in your blood regularly.

ensure, just before use, the contents of the two chambers are mixed

by activating the long-seal (interchamber seal), followed by the

short SafetyMoon seal near the access port. If your doctor infuses

unmixed solution, your blood bicarbonate level may increase. This may

cause side effects such as nausea, drowsiness, headache, abnormal

heartbeat and difficulty of breathing.

Other medicines and ACCUSOL 35 Potassium 2 mmol/l

Tell your doctor if you are taking, have recently taken or might take any other

medicines.

Taking ACCUSOL 35 Potassium 2 mmol/l may affect and interact with other

medicines.

If you are diabetic your glucose level will be carefully measured.

Your insulin dose will be adjusted as needed as this solution contains

glucose.

If you take Vitamin D or medicines containing calcium, your blood

calcium level may be modified.

If you take additional sodium bicarbonate, there is an increased risk of

abnormal salt and alkali levels (alkalosis) in your blood.

If you use medicines for the heart known as cardiac glycosides you

may need potassium supplements. Your doctor will monitor you closely

during treatment.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding. He will determine the

benefits versus the risks of using ACCUSOL 35 Potassium 2 mmol/l.

3.How you will be given ACCUSOL 35 Potassium 2mmol/l

Depending on your therapy,your doctor will administer ACCUSOL 35

Potassium 2 mmol/l by way of the tubing from the dialysis machine.

The treatment by haemofiltration, haemodialysis or haemodiafiltration that

you receive will depend upon your clinical diagnosis, physical examination,

laboratory results and response to treatment.

Your doctor will determine the right formulation and amount of ACCUSOL 35

solutions for your clinical condition.

How much and how often?

Your doctor will decide and adjust the flow rate and volume of the solution to be

administered.

The amount of fluid required depends upon how ACCUSOL 35 Potassium

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If you are adult or elderly and

treated for chronic renal failure with ACCUSOL 35 Potassium 2 mmol/l

as substitution solution, you should receive 7 to 35 ml/kg/hr or more.

treated for temporary kidney failure with ACCUSOL 35 Potassium

2 mmol/l as substitution solution, you should receive 20 to 35 ml/kg/hr

or more.

treated for chronic or temporary kidney failure with ACCUSOL 35

Potassium 2 mmol/l as dialysis solution, the amount of solution will be

determined by frequency and duration of treatment.

4.Possible side effects

Like all medicines this medicine can cause side effects, but not everyone gets

them.

Possible rare side-effects (occurring in less than 1 in 1000 patients) of

ACCUSOL 35 Potassium 2 mmol/l may include

Low blood glucose (hypoglycaemia).

You may experience other possible side effects. They may not all be due to the

solutions or treatment. The potential undesirable effects that may occur are:

Reduction (hypovolaemia) or increase (hypervolaemia) in body fluid

volume

Reduction (hypotension) or increase (hypertension) in blood pressure

Very low blood phosphate (hypophosphataemia)

Disturbance in the alkali level in your blood (alkalosis)

Feeling sick

Vomiting

Muscle cramps

Bleeding disorder

Infection

Shortness of breath, irregular breathing (caused by air bubbles getting

into the blood stream)

Disturbance in different salt levels in your blood (e.g. disturbance in

sodium, potassium, calcium in your blood)

Increase blood clotting.

If you get any side effects, talk to your doctor. This includes any side effects not

listed in the leaflet.

5.How to store ACCUSOL 35 Potassium 2 mmol/l

Keep this medicine out of the sight and reach of children.

Store between 4°C and 25°C. Do not use this medicine after the expiry date

which is stated on the label and carton after ‘Exp.’ ‘The expiry date refers to the

last day of that month.

Your doctor will not use ACCUSOL 35 if the solution is not clear or if the

container is damaged.

6.Contents of the pack and other information

Name of the Medicinal Product

ACCUSOL 35 Potassium 2 mmol/l, Solutions for haemofiltration, haemodialysis

and haemodiafiltration.

The composition of the solution ACCUSOL 35 Potassium

2mmol/l is:

Ingredients Per 1000 ml ACCUSOL 35

Potassium 2 mmol/l

Largechamber ‘A’

Calcium chloride dihydrate 0.343 g

Magnesium chloride hexahydrate 0.136 g

Sodium chloride 7.52 g

Potassium chloride 0.199 g

Glucose monohydrate 1.47 g

Smallchamber ‘B’

The 5000 ml of final solution results from the mixing of 3750 ml of solution ‘A’

with 1250 ml of solution ‘B’.

Ionic Composition of Final Solution:

Per 1000 ml ACCUSOL 35

Calcium (Ca++) 1.75 mmol

Magnesium (Mg++) 0.5 mmol

Sodium (Na+) 140 mmol

Potassium (K+) 2 mmol

Chloride (Cl-) 111.3 mmol

Glucose Anhydrous 5.55 mmol

Bicarbonate (HCO3-) 35 mmol

Theoretical Osmolarity: 296 mOsm/l

The other ingredients are: Water for Injections, Hydrochloric acid, Sodium

hydroxide and Disodium phosphate dihydrate.

What ACCUSOL 35 Potassium 2 mmol/l looks like and

contents of the pack

ACCUSOL 35 Potassium 2 mmol/l is supplied in a carton box containing two

units of 5 litre two-chamber non-PVC bags.

Each bag is over-wrapped in its overpouch.

The solution in the bag is clear and colourless.

Marketing Authorisation Holder:

Baxter Healthcare Ltd.,

Caxton Way,

Thetford, Norfolk,

IP24 3SE, United Kingdom

Phone: + 44 (0) 1635 206345

Manufacturers:

Baxter Healthcare S.A. Bieffe Medital S.p.A.

Moneen Road Via Nuova Provinciale

Castlebar 23034 Grosotto

County Mayo – Ireland Italy

This leaflet was last approved in 12/2013

Baxter, Accusol and Clear-Flex are trademarks of Baxter International Inc.

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The following information is intended for medical or Healthcare professionals only

INFORMATION FOR THE HEALTH PROFESSIONAL

ACCUSOL 35 Potassium 2 mmol/l,Solution for haemofiltration,haemodialysis

and haemodiafiltration

1.NAME OF THE MEDICINAL PRODUCT

ACCUSOL 35 Potassium 2 mmol/l

Solution for haemofiltration, haemodialysis and haemodiafiltration

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition Per 1000 ml ACCUSOL 35

Largechamber ‘A’

Calcium chloride dihydrate 0.343 g

Magnesium chloride hexahydrate 0.136 g

Sodium chloride 7.52 g

Potassium chloride 0.199 g

Glucose monohydrate 1.47 g

Smallchamber ‘B’

Sodium bicarbonate 13.4 g

Final solution after mixing Per 1000 ml ACCUSOL 35

Calcium chloride dihydrate 0.257 g

Magnesium chloride hexahydrate 0.102 g

Sodium chloride 6.12 g

Potassium chloride 0.149 g

Glucose anhydrous 1.0 g

Sodium bicarbonate 2.94 g

Equivalent to the following ionic composition:

Ionic Composition of Final Solution Per 1000 ml ACCUSOL 35

Calcium (Ca++) 1.75 mmol

Magnesium (Mg++) 0.5 mmol

Sodium (Na+) 140 mmol

Potassium (K+) 2 mmol

Chloride (Cl-) 111.3 mmol

Glucose Anhydrous 5.55 mmol

Bicarbonate (HCO3-) 35 mmol

Theoretical Osmolarity: 296 mOsm/l

The 5000 ml of final solution results from mixing 3750 ml of solution ‘A’ with

1250 ml of solution ‘B’.

The pH of the final solution is between 7.0 – 7.5

The number “35” in the name specifies the buffer concentration of the solution

(bicarbonate = 35 mmol/l).

3.PHARMACEUTICAL FORM

Solution for haemofiltration, haemodialysis and haemodiafiltration.

ACCUSOL 35 is a sterile, non pyrogenic, clear and colourless solution.

4.CLINICAL PARTICULARS

4.1Therapeutic indications

ACCUSOL 35 is indicated for the treatment of acute and chronic renal failure, as

substitution solution in haemofiltration and haemodiafiltration, and as dialysis

solution in haemodialysis and haemodiafiltration.

4.2Posology and method of administration

For haemofiltration, haemodialysis and haemodiafiltration.

ACCUSOL 35 as substitution solution

The amount of substitution solution to be administered in adults is determined

by the ultrafiltration rate and is set for each individual case to ensure an

adequate electrolyte fluid balance.

Adults:

Chronic renal failure: 7 to 35 ml/kg/hr,

Elderly: as for adults

These fluid volume recommendations may be adjusted by the prescribing

physician according to the patient’s clinical status.

ACCUSOL 35 can be administered into the extracorporeal blood circuit either in

pre- and/or post- dilution mode according to the physician’s prescription.

ACCUSOL 35 as dialysis solution

The prescription and amount of dialysis solution depend upon the mode of

therapy, frequency and duration of treatment and will be selected by the

prescribing physician according to the patient’s clinical status.

Administration:

Haemodialysis: via the dialysis compartment of the dialyser.

Haemofiltration: via the arterial or venous blood line.

After removal of the overpouch, immediately open the long-seal (interchamber

seal) to mix the two solutions and then open the short SafetyMoon seal (seal

near access port) to allow administration of the mixed solution. For instructions

for use and handling, please refer to section 5.5.

4.3Contraindications

Solution dependent contraindications

Hypokalaemia, if no simultaneous adapted potassium

supplementation.

Metabolic alkalosis.

Haemofiltration / haemodialysis / haemodiafiltration dependent contraindication

due to the technical procedure itself:

Renal failure with increased hypercatabolism in cases where uraemic

symptoms can no longer be relieved by haemofiltration.

Inadequate blood flow from vascular access.

If there is a high risk of haemorrhage on account of systemic

anticoagulation

4.4Special warnings and precautions for use

ACCUSOL 35 solution must only be used by or under the direction

of a physician experienced in haemofiltration, haemodialysis or

haemodiafiltration techniques,

White particulate formation of calcium carbonate has been observed

in the pre-dilution and post-dilution CRRT lines in association with

the use of ACCUSOL 35. Therefore every 30 minutes during CRRT with

ACCUSOL 35, pre- and post-dilution lines should be closely inspected

to verify that the solution in the tubing is clear and without particles. In

some cases precipitation may not appear until several hours after the

start of therapy.

If precipitate is observed, the ACCUSOL 35 solution and CRRT

tubing lines must be replaced immediately and the patient carefully

monitored,

Fluid balance must be carefully monitored,

Acid-base balance must be carefully monitored,

Similarly, electrolyte balance (chloraemia, phosphataemia, calcaemia,

magnesaemia and natraemia) should be monitored regularly to detect

any potential imbalance,

Kalaemia must be monitored regularly before and during treatment.

If hypokalaemia is present or starts to develop, supplementation of

potassium may be required. If hyperkalaemia starts to develop, an

increase in the filtration rate and/or changing to a substitution solution

with a lower potassium concentration may be indicated as well as

usual measures of intensive care medicine,

Blood glucose levels must be monitored closely, especially in diabetic

patients,

In case the long-seal (interchamber seal) is not opened (i.e. only

short SafetyMoon seal near access port opens) and the solution of

the small chamber “B” is given, alkalosis may arise. Most common

clinical signs / symptoms of alkalosis are nausea, lethargy, headache,

ENG

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Barcodes,Symbols and Re-

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4.5Interaction with other medicinal products and other forms of interaction

When prescribing ACCUSOL 35 Potassium 2 mmol/l, consideration should be

given to the potential interactions between this treatment and other concomitant

therapies related to other pre-existing conditions.

Blood concentration of other medicinal products may be altered during

haemodialysis, haemofiltration and haemodiafiltration.

Plasma levels of potassium in patients using cardiac glycosides must

be carefully monitored due to an increased risk of hypokalaemia

associated arrhythmias.

Vitamin D and medicinal products containing calcium can increase the

risk of hypercalcaemia (eg calcium carbonate acting as a chelator of

potassium).

The additional substitution of sodium bicarbonate can increase the risk

of metabolic alkalosis.

4.6Fertility,pregnancy and lactation

There are no preclinical or clinical data on the use of ACCUSOL 35 during

pregnancy and lactation. ACCUSOL 35 should only be administered to pregnant

and lactating women if clearly needed.

4.7Effects on ability to drive and use machines

Not relevant.

4.8Undesirable effects

The undesirable effects reported are based on adverse event reports from

clinical trials (see (1) below), which were assessed by the investigator to be

related to ACCUSOL, as well as from a literature review (see (2) below).

The frequency has been evaluated by using the following criteria:

very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000,

< 1/100), rare (> 1/10,000, < 1/1,000) and very rare (< 1/10,000).

1)Clinical Trials

System Organ

Class Adverse Drug

Reaction Frequency Procedure

related Solution

related

Metabolic and

Nutritional Hypoglycaemia

Rare Yes Yes

2)Literature review

The undesirable effects below listed reflect the type of undesirable effects that

may be reported with haemofiltration or haemodialysis solutions.

Potential adverse reactions related to the treatment may include

nausea, vomiting, muscle cramps, hypotension, bleeding, clotting,

infection and air embolism.

Potential adverse reactions related to the product may include

metabolic alkalosis, electrolyte disturbances and/or fluid imbalances:

hypophosphataemia, hypoglycaemia, hypo- and hypervolaemia, hypo-

and hypertension.

4.9Overdose

Overdose should not occur if the fluid and electrolyte balances are monitored

regularly as recommended in section 4.4. Overdose may lead to hypervolaemia

and electrolyte disturbances. These symptoms can be corrected by adjusting the

ultrafiltration rate and the volume of solution administered.

Electrolyte imbalances should be managed according to the specific electrolyte

5.PHARMACEUTICAL PARTICULARS

5.1Incompatibilities

This medicinal product must not be mixed with other medicinal products except

those mentioned in section 5.5

5.2Shelf life

Shelf life

12 months when stored in the overpouch.

Shelf life after mixing

ACCUSOL 35, once removed from the overpouch and mixed should be used

within 24 hours.

5.3Special precautions for storage

Store between 4°C and 25°C.

5.4Nature and contents of container

ACCUSOL 35 is stored in a non-PVC two-chamber bag made of a coextruded

film of Polypropylene, Polyamide and a blend of Polypropylene, SEBS and

Polyethylene (CLEAR-FLEX). A long-seal (interchamber seal) separates the two

chambers.

The large chamber ‘A’ is fitted with a medication port and the small chamber ‘B’

is fitted with an access port for connection to a suitable administration set.

The two-chamber bag is presented in a protective transparent overpouch made

of copolymers.

The volume of the container after mixing is 5000 ml (3750 ml in the large

chamber and 1250 ml in the small chamber).

ACCUSOL 35 is available as 2 x 5000 ml per box.

5.5Special precautions for disposal and other handling

Check the integrity of the product. If one of the seals is opened

prematurely, do not use the bag. In case of damage, discard the

container.

Do not administer unless the solution is clear.

Aseptic technique should be observed throughout the whole procedure.

Concomitant drugs may be added through the medication port in the

larger chamber. Drug compatibility must be checked before admixture.

Add the medication and activate the long-seal (interchamber seal)

immediately. The product must be used immediately after any drug

addition.

After removal of the overpouch, immediately open the long-seal

(interchamber seal) to mix the two solutions. Ensure the long-seal

(interchamber seal) is completely activated and the two solutions are

completely mixed. Then open the short Safety Moon seal (seal near

access port) to allow administration of the mixed solution. Connect to

the patient line and activate the access port. The solution must be used

within 24 hours of mixing.

Discard any unused remaining solution.

For single use only.

Use ACCUSOL 35 only with adequate equipment able to monitor the

therapy.

6.MARKETING AUTHORISATION HOLDER

Baxter Healthcare Ltd.,

Caxton Way,

Thetford, Norfolk,

IP24 3SE, United Kingdom

Phone: + 44 (0) 1635 206345

7.MARKETING AUTHORISATION NUMBER(S)

PL0116/0415

PA 167/123/1

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Accusol35Potassium2mmol/l

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Equivalenttothefollowingioniccomposition:

The5000mloffinalsolutionresultsfrommixing3750mlofsolution‘A’with1250mlofsolution‘B’.

ThepHofthefinalsolutionisbetween7.0-7.5

Forthefulllistofexcipients,seesection6.1.

Thenumber“35”inthenamespecifiesthebufferconcentrationofthesolution(bicarbonate=35mmol/l.)

Composition Per1000ml

Accusol35

Largechamber‘A’

Calciumchloridedihydrate 0.343g

Magnesiumchloridehexahydrate 0.136g

Sodiumchloride 7.52g

Potassiumchloride 0.199g

Glucosemonohydrate 1.47g

Smallchamber‘B’

Sodiumbicarbonate 13.4g

Finalsolutionaftermixing Per1000ml

Accusol35

Calciumchloridedihydrate 0.257g

Magnesiumchloridehexahydrate 0.102g

Sodiumchloride 6.12g

Potassiumchloride 0.149g

Glucoseanhydrous 1.0g

Sodiumbicarbonate 2.94g

IonicCompositionofFinalSolution Per1000ml

Accusol35

Calcium(Ca ++

1.75mmol

Magnesium(Mg ++

0.5mmol

Sodium(Na +

140mmol

Potassium(K +

2mmol

Chloride(Cl -

111.3mmol

GlucoseAnhydrous 5.55mmol

Bicarbonate(HCO

35mmol

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 09/07/2014 CRN 2130021 page number: 1

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration.

Accusol35isasterile,nonpyrogenic,clearandcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Accusol35isindicatedforthetreatmentofacuteandchronicrenalfailure,assubstitutionsolutioninhaemofiltration

andhaemodiafiltration,andasdialysissolutioninhaemodialysisandhaemodiafiltration.

4.2Posologyandmethodofadministration

Forhaemofiltration,haemodialysisandhaemodiafiltration.

Accusol35assubstitutionsolution

Theamountofsubstitutionsolutiontobeadministeredinadultsisdeterminedbytheultrafiltrationrateandissetfor

eachindividualcasetoensureanadequateelectrolytefluidbalance.

Adults:

Chronicrenalfailure:7to35ml/kg/hr,

Acuterenalfailure:20to35ml/kg/hr,

Elderly:asforadults

Thesefluidvolumerecommendationsmaybeadjustedbytheprescribingphysicianaccordingtothepatient’sclinical

status.

Accusol35canbeadministeredintotheextracorporealbloodcircuiteitherinpre-and/orpost-dilutionmodeaccording

tothephysician’sprescription.

Accusol35asdialysissolution

Theprescriptionandamountofdialysissolutiondependuponthemodeoftherapy,frequencyanddurationoftreatment

andwillbeselectedbytheprescribingphysicianaccordingtothepatient’sclinicalstatus.

Administration:

Haemodialysis:viathedialysiscompartmentofthedialyser.

Haemofiltration:viathearterialorvenousbloodline.

Afterremovaloftheoverpouch,immediatelyopenthelong-seal(interchamberseal)tomixthetwosolutionsandthen

opentheshortSafetyMoonseal(sealnearaccessport)toallowadministrationofthemixedsolution.Forinstructions

foruseandhandling,pleaserefertosection6.6.

4.3Contraindications

Solutiondependentcontraindications

-Hypokalaemia,ifnosimultaneousadaptedpotassiumsupplementation

-Metabolicalkalosis

Haemofiltration/haemodialysis/haemodiafiltrationdependentcontraindicationduetothetechnicalprocedureitself:

-Renalfailurewithincreasedhypercatabolismincaseswhereuraemicsymptomscannolongerberelievedby

haemofiltration

-Inadequatebloodflowfromvascularaccess.

-Ifthereisahighriskofhaemorrhageonaccountofsystemicanticoagulation

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 09/07/2014 CRN 2130021 page number: 2

Accusol35solutionmustonlybeusedbyorunderthedirectionofaphysicianexperiencedinhaemofiltration,

haemodialysisorhaemodiafiltrationtechniques,

Whiteparticulateformationofcalciumcarbonatehasbeenobservedinthepre-dilutionandpost-dilutionCRRT

linesinassociationwiththeuseofAccusol35.Thereforeevery30minutesduringCRRTwithAccusol35,pre-

andpost-dilutionlinesshouldbecloselyinspectedtoverifythatthesolutioninthetubingisclearandwithout

particles.Insomecasesprecipitationmaynotappearuntilseveralhoursafterthestartoftherapy.

Ifprecipitateisobserved,theAccusol35solutionandCRRTtubinglinesmustbereplacedimmediatelyandthe

patientcarefullymonitored.

Fluidbalancemustbecarefullymonitored,

Acid-basebalancemustbecarefullymonitored,

Similarly,electrolytebalance(chloraemia,phosphataemia,calcaemia,magnesaemiaandnatraemia)shouldbe

monitoredregularlytodetectanypotentialimbalance,

Kalaemiamustbemonitoredregularlybeforeandduringtreatment.Ifhypokalaemiaispresentorstartsto

develop,supplementationofpotassiumand/orchangingtoasubstitutionsolutionwithhigherpotassium

concentrationmayberequired.Ifhyperkalaemiastartstodevelop,anincreaseinthefiltrationrateand/or

changingtoasubstitutionsolutionwithalowerpotassiumconcentrationmaybeindicatedaswellasusual

measuresofintensivecaremedicine,

Bloodglucoselevelsmustbemonitoredclosely,especiallyindiabeticpatients,

-Incasethelong-seal(interchamberseal)isnotopened(i.e.onlyshortSafetyMoonsealnearaccessportopens)

andthesolutionofthesmallchamber“B”isgiven,alkalosismayarise.Mostcommonclinicalsigns/symptoms

ofalkalosisarenausea,lethargy,headache,arrhythmia,respiratorydepression.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

WhenprescribingAccusol35Potassium2mmol/l,considerationshouldbegiventothepotentialinteractionsbetween

thistreatmentandotherconcomitanttherapiesrelatedtootherpre-existingconditions.

-Bloodconcentrationofothermedicinalproductsmaybealteredduringhaemodialysis,haemofiltrationand

haemodiafiltration.

-Plasmalevelsofpotassiuminpatientsusingcardiacglycosidesmustbecarefullymonitoredduetoanincreasedriskof

hypokalaemiaassociatedarrhythmias.

-VitaminDandmedicinalproductscontainingcalciumcanincreasetheriskofhypercalcaemia(egcalciumcarbonate

actingasachelatorofpotassium).

-Theadditionalsubstitutionofsodiumbicarbonatecanincreasetheriskofmetabolicalkalosis.

4.6Fertility,pregnancyandlactation

TherearenopreclinicalorclinicaldataontheuseofAccusol35duringpregnancyandlactation.Accusol35should

onlybeadministeredtopregnantandlactatingwomenifclearlyneeded.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Theundesirableeffectsreportedarebasedonadverseeventreportsfromclinicaltrials(see(1)below),whichwere

assessedbytheinvestigatortoberelatedtoAccusol,aswellasfromaliteraturereview(see(2)below).

Thefrequencyhasbeenevaluatedbyusingthefollowingcriteria:verycommon(>1/10),common(>1/100,<1/10),

uncommon(>1/1,000,<1/100),rare(>1/10,000,<1/1,000)andveryrare(<1/10,000).

1)ClinicalTrials

SystemOrganClass AdverseDrugReaction Frequency Procedure

related Solution

related

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2)Literaturereview

Theundesirableeffectsbelowlistedreflectthetypeofundesirableeffectsthatmaybereportedwithhaemofiltrationor

haemodialysissolutions.

-Potentialadversereactionsrelatedtothetreatmentmayincludenausea,vomiting,musclecramps,hypotension,

bleeding,clotting,infectionandairembolism.

-Potentialadversereactionsrelatedtotheproductmayincludemetabolicalkalosis,electrolytedisturbancesand/or

fluidimbalances:hypophosphataemia,hypoglycaemia,hypo-andhypervolaemia,hypo-andhypertension.

4.9Overdose

Overdoseshouldnotoccurifthefluidandelectrolytebalancesaremonitoredregularlyasrecommendedinsection4.4.

Overdosemayleadtohypervolaemiaandelectrolytedisturbances.Thesesymptomscanbecorrectedbyadjustingthe

ultrafiltrationrateandthevolumeofsolutionadministered.

Electrolyteimbalancesshouldbemanagedaccordingtothespecificelectrolytedisturbance.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Haemofiltrates,ATCcode:B05ZB

Accusol35ispharmacologicallyinactive.Thesolutionconsistsofionsthatarepresentatconcentrationssimilarto

physiologicallevelinplasma.

Assubstitutionsolution,Accusol35providesacontinuoussourceofelectrolytesandwaterforhydrationandactsasan

alkalinisingagent.

Asdialysissolution,Accusol35removesmetabolicwasteproductsfromthebloodandhelpstomanagetheserum

electrolytesand/orfluidimbalances.

5.2Pharmacokineticproperties

NotrelevantastheactiveingredientsofAccusol35arepharmacologicallyinactiveandneartophysiologicalplasma

concentrations

5.3Preclinicalsafetydata

TherearenopreclinicaldataconsideredrelevanttoclinicalsafetybeyonddataincludedinothersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WaterforInjections,

Hydrochloricacid(pHadjuster),

Sodiumhydroxide(pHadjuster),

Disodiumphosphatedihydrate

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6.

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Shelflife

12monthswhenstoredintheoverpouch.

Shelflifeaftermixing

Accusol35,onceremovedfromtheoverpouchandmixedshouldbeusedwithin24hours.

6.4Specialprecautionsforstorage

Donotstorebelow4°Cand25°C.

6.5Natureandcontentsofcontainer

Accusol35isstoredinanonPVCtwo-chamberbagmadeofacoextrudedfilmofPolypropylene,Polyamideanda

blendofPolypropylene,SEBSandPolyethylene(Clear-Flex).Along-seal(interchamberseal)separatesthetwo

chambers.

Thelargechamber‘A’isfittedwithamedicationportandthesmallchamber‘B’isfittedwithanaccessportfor

connectiontoasuitableadministrationset..AshortSafetyMoonseal(sealnearaccessport)needstobeopenedto

allowadministrationofthemixedsolution.

Thetwo-chamberbagispresentedinaprotectivetransparentoverpouchmadeofcopolymers.

Thevolumeofthecontaineraftermixingis5000ml(3750mlinthelargechamberand1250mlinthesmallchamber).

Accusol35isavailableas2x5000mlperbox.

6.6Specialprecautionsfordisposalandotherhandling

Checktheintegrityoftheproduct.Ifoneofthesealsisopenedprematurely,donotusethebag.Incaseof

damage,discardthecontainer.

Donotadministerunlessthesolutionisclear.

Aseptictechniqueshouldbeobservedthroughoutthewholeprocedure.

Concomitantdrugsmaybeaddedthroughthemedicationportinthelargerchamber.Drugcompatibilitymustbe

checkedbeforeadmixture.Addthemedicationandactivatethelong-seal(interchamberseal)immediately.The

productmustbeusedimmediatelyafteranydrugaddition.

Afterremovaloftheoverpouch,immediatelyopenthelong-seal(interchamberseal)tomixthetwosolutions.

Ensurethelong-seal(interchamberseal)iscompletelyactivatedandthetwosolutionsarecompletelymixed.

ThenopentheshortSafetyMoonseal(sealnearaccrssport)toallowadministrationofthemixedsolution.

Connecttothepatientlineandactivatetheaccessport.Thesolutionmustbeusedwithin24hoursofmixing.

Discardanyunusedremainingsolution.

Forsingleuseonly.

UseAccusol35onlywithadequateequipmentabletomonitorthetherapy.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

CaxtonWay

Thetford

NorfolkIP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/123/1

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Dateoffirstauthorisation:28April2006

Dateoflastrenewal:28April2010

10DATEOFREVISIONOFTHETEXT

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