Calcium Resonium 99.934 % Powder for oral or rectal suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Calcium polystyrene sulphonate
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
V03AE; V03AE01
INN (International Name):
Calcium polystyrene sulphonate
Dosage:
99.934 percent weight/weight
Pharmaceutical form:
Powder for oral suspension
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Drugs for treatment of hyperkalemia and hyperphosphatemia; polystyrene sulfonate
Authorization status:
Marketed
Authorization number:
PA0540/141/001
Authorization date:
1983-04-01

For Sanofi-Aventis use only

Technical Data

Modifications

ID number:

727068

Version and Date:

V5- 16/01/2019

Previous ID number:

481237

Product type:

LABEL (7 pages)

Product name:

ETL CALCIUM RES 300G IE-H

Country:

Artwork by:

Vincent Pétin

Plant:

AMILLY PHARMA

Format: 300 x 90 (7 pages)

Number of colors: 2 + Braille

n PMS 1785 C

n PMS Process Black C

n Cutter

MAIN PAGE:

Minimum point size of text: 9 pt

LEAFLET:

Minimum point size of text: 9 pt

Space between lines: 9 pt

Narrowed: 100 %

Fonts: Ocean Sans Pro SAN - C39P24N

Native file: In Design CC

Layout of cutting: AY_ETL_300 x 90_7P_A_1

PACKAGING TEAM

V1 - 03/08/2018 : New regulatory text.

V2 - 31/10/2018 : Add missing text + update revision date.

V3 - 20/11/2018 : Add «reporting side effecs» section.

V4 - 14/01/2019 : Update revision date.

V5 - 16/01/2019 : Delete text.

ATELIER Kayexalate

Base material

Laminate

Ink jet printing area

Page 7 = back

Page 1 = Front

Pre-cut

):AKMIDQ=ZUU\W]:

):AKMIDQ=ZUU\W]:

Calcium Resonium®

99.934%w/w Powder for Oral or Rectal Suspension

calcium polystyrene sulphonate

Powder for oral or rectal administration after reconstitution.

Calcium Cycle ion Exchange Resin.

The product also contains saccharin and vanillin.

Flavoured powder form of calcium polystyrene sulphonate for removing excess

potassium from the body.

KEEP THE CONTAINER TIGHTLY CLOSED IN ORDER TO PROTECT FROM MOISTURE.

300g powder

One measuring spoon contains 15g of Calcium Resonium.

Once diluted the product should be used immediately.

Discard any unused portion.

Please refer to leaflet attached before use and for details

of dosage regimen.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

PA540/141/1

sanofi-aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24.

Calcium Resonium®

99.934%w/w Powder for Oral or Rectal Suspension

calcium polystyrene sulphonate

Powder for oral or rectal administration after reconstitution.

Calcium Cycle ion Exchange Resin.

The product also contains saccharin and vanillin.

Flavoured powder form of calcium polystyrene sulphonate for removing excess

potassium from the body.

KEEP THE CONTAINER TIGHTLY CLOSED IN ORDER TO PROTECT FROM MOISTURE.

300g powder

One measuring spoon contains 15g of Calcium Resonium.

Once diluted the product should be used immediately.

Discard any unused portion.

Please refer to leaflet attached before use and for details

of dosage regimen.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

PA540/141/1

sanofi-aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24.

CALCIUM resonium

*727068*

727068

727068

Page 2

Page 3

Take special care and check with your doctor, nurse or pharmacist

before using Calcium Resonium if:

p It is for your baby, and they were premature, had a low birth-weight

or have reduced gut movement

If you are not sure if any of the above apply to you, talk to your doctor, nurse

or pharmacist before using Calcium Resonium.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently

taken any other medicines. This includes medicines you can buy without

prescription, including herbal medicines. This is because Calcium Resonium

can affect the way other medicines work. Also some medicines can affect the

way Calcium Resonium works.

Calcium Resonium has the potential to bind to other orally administered

medications, which could affect how the medicine works. Dosing seperation

Calcium

Resonium

from

other

orally

administered

medications

recommended. See section 3. How Calcium Resonium is given.

In particular, check with your doctor if you are taking the following medicines:

Medicines that contain salts such as magnesium, potassium or calcium. Ask

your doctor if you are not sure

Some medicines for constipation (laxatives) that contain magnesium

Some medicines for indigestion (antacids) that contain magnesium or

aluminium

Digoxin or similar medicines from digitalis - for heart problems

Levothyroxine or thyroxine - for an under-active thyroid

Lithium - for mental illness

If you are not sure if any of the above applies to you, talk to your doctor, nurse

or pharmacist before using Calcium Resonium.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if:

You are pregnant, might become pregnant, or think you may be pregnant

You are breast-feeding or planning to breast-feed

Ask your doctor or pharmacist for advice before taking any medicine.

3. How Calcium Resonium is given

Your doctor or nurse will normally give you this medicine. If you are not sure

why you are being given Calcium Resonium or have any questions about how

much Calcium Resonium is being given to you, speak to your doctor, nurse or

pharmacist.

The dose will depend on the results of blood tests

For children the dose is also worked out according to how much the child

weighs

Having the medicine

Calcium Resonium can be given by mouth or put into the back passage

(rectum)

If given by mouth the powder can be swallowed with a little water or be

made into a paste with something sweet, such as jam or honey

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Calcium Resonium 99.934%w/w Powder for Oral or Rectal

Suspension

calcium polystyrene sulphonate

Is this leaflet hard to see or read?

Phone 01 403 5600 for help

Read all of this leaflet carefully 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, nurse or pharmacist.

This medicine is only for you. Do not pass it on to others. It may harm them,

even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed

in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1. What Calcium Resonium is and what it is used for

2. Before you are given Calcium Resonium

3. How Calcium Resonium is given

4. Possible side effects

5. How to store Calcium Resonium

6. Further information

1. What Calcium Resonium is and what it is used for

Calcium Resonium contains a medicine called calcium polystyrene sulphonate.

This belongs to a group of medicines called ‘ion exchange resins’.

Calcium Resonium is used to treat something called ‘hyperkalaemia’. This is

when there is too much potassium in your blood. It works by removing this extra

potassium to bring your levels back to normal. It is often given to people who

have kidney problems and people on dialysis.

2. Before you are given Calcium Resonium

Do not use this medicine and tell your doctor or nurse if:

Ð You are allergic (hypersensitive) to calcium polystyrene sulphonate or any of

the other ingredients in this medicine (listed in section 6 Further Information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems,

swelling of your lips, face, throat or tongue

Ð You have been told that you have a low level of potassium in your blood

Ð You have been told you have problems that result in high levels of calcium in

your body such as thyroid problems or some types of cancer

Ð Your gut is partially or completely blocked (obstructive bowel disease)

Ð You are taking a sweetener called sorbitol (used to sweeten food). This is

because taking sorbitol and Calcium Resonium at the same time can damage

your gastrointestinal tract which may be fatal

Do not use this medicine if any of the above applies to you. If you are not sure,

talk to your doctor, nurse or pharmacist before using Calcium Resonium.

Page 4

Page 5

It should not be mixed with fruit juice, this will stop the medicine working

properly

If given by mouth, it is important to sit up while taking the medicine so that

you do not breathe in any powder into your lungs

If given by mouth Calcium Resonium should be given at least 3 hours before

or after other oral medications. For patients with a disease of the muscles

of the stomach (Gastroparesis) a 6 hour separation should be considered.

If given by the back passage you should try to keep the medicine in your

back passage for at least 9 hours. Then it needs to be thoroughly washed

How much is normally given:

Adults (including the elderly)

By mouth

The usual dose is 15g (one spoonful) three or four times a day

Into the back passage

The usual dose is 30g (two spoonfuls) once a day

In some cases, the medicine may be given both by mouth and into the

back passage. This is where your potassium levels need to be lowered more

quickly.

Children

If your child cannot take the medicine by mouth, it may be given into the

back passage.

The daily dose is 1g for each kilogram of bodyweight

Once the medicine has started working the dose may be lowered to 0.5g

daily for each kilogram of bodyweight

New-born babies

Calcium Resonium is only given into the back passage

The daily dose is between 0.5g and 1g for each kilogram of bodyweight

It is important to give the right dose for children and babies. If too much is

given, children and babies could get serious constipation.

If you have more Calcium Resonium than you should

It is unlikely that your doctor or nurse will give you too much medicine. Your

doctor and nurse will be checking your progress, and checking the medicine

that you are given. Ask them if you are not sure why you are getting a dose

of medicine.

If you are given too much Calcium Resonium the following effects may

happen:

Feeling irritable or confused

Being unable to concentrate

Muscle weakness and poor reflexes leading to paralysis

Breathing problems

Faster or pounding heartbeat

Muscle cramps

If you miss a dose of Calcium Resonium

Your doctor or nurse will give instructions about when to have your medicine.

It is unlikely that a dose will be missed. If you think that you may have missed

a dose, talk to your doctor or nurse.

If you stop being given Calcium Resonium

Keep having Calcium Resonium until your doctor tells you to stop. If you stop

having Calcium Resonium, your illness may come back.

Blood Tests

Your doctor may do regular blood tests while you are taking this medicine. This

is to check the levels of salts (potassium, sodium, calcium and magnesium)

in your blood.

If you have any further questions on the use of this product, ask your

doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, Calcium Resonium can cause side effects, although not

everybody gets them.

Tell a doctor or nurse straight away if you notice any of the following

serious side effects:

You have an allergic reaction. The signs may include: a rash, swallowing or

breathing problems, swelling of your lips, face, throat or tongue

Blood in your sick (vomit) or black tarry stools

Talk to your doctor or nurse if you get any of the following side effects:

Feeling tired, confused, having muscle weakness, cramps or a change in

heart rate. These may be due to having low levels of potassium T in your

body (hypercalcemia/hypomagnesemia)

Feeling jittery, having fits or muscle cramps. This may be due to low levels

of calcium in your body

Increased thirst or needing to go to the toilet more often

High blood pressure, kidney problems, heart problems or swelling in your

limbs. This may be due to high levels of sodium in your body

Stomach upset, pain in your gut or blockage of the gut

Loss of appetite

Feeling sick, being sick, constipation or diarrhoea

Intestinal Necrosis

Feeling short of breath or coughing. This could be the first sign of a

serious chest infection. This can be caused by accidentally breathing in this

medicine

Talk to your doctor, nurse or pharmacist if any of the side effects gets serious

or lasts longer than a few days, or if you notice any side effects not listed in

this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This

includes any possible side effects not listed in this leaflet. You can also report

side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL -

Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;

e-mail: medsafety@hpra.ie . By reporting side effects you can help provide

more information on the safety of this medicine.

Page 6

5. How to store Calcium Resonium

This medicine will be kept by your doctor or pharmacist in a safe place where

children cannot see or reach it. Keep the container tightly closed in order to

protect from moisture.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not use Calcium Resonium after the expiry date which is stated on the

label after EXP. The expiry date refers to the last date of that month.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These

measures will help to protect the environment.

6. Further Information

What Calcium Resonium contains

99.934% w/w of the active substance, calcium polystyrene sulphonate

The other ingredients are saccharin and vanillin

What Calcium Resonium looks like and contents of the pack

Calcium Resonium is a buff coloured powder. It is supplied in containers of

300g with a 15g scoop.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

sanofi-aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24, Ireland.

Tel: 00 353 1 403 5600

Fax: 00 353 1 403 5687

email: IEmedinfo@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie, 196 avenue du Maréchal Juin, 45200 Amilly, France

This leaflet does not contain all the information about your medicine. If you

have any questions or are not sure about anything, ask your doctor, nurse or

pharmacist.

This leaflet was last revised in January 2019.

© Sanofi-aventis, 2012

727068

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 1 of 7

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calcium Resonium 99.934 % Powder for oral or rectal suspension.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Calcium polystyrene sulphonate 99.934 % w/w

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Powder for oral or rectal suspension.

A buff-coloured, fine powder for oral or rectal suspension.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Calcium Resonium is an ion-exchange resin that is recommended for the treatment

of hyperkalaemia associated with anuria or severe oliguria. It is also used to treat

hyperkalaemia in patients requiring acute dialysis and in patients on regular

haemodialysis or on prolonged peritoneal dialysis.

4.2 Posology and method of administration

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, 3 to 4 times a day. The resin is given by mouth in a little water,

or it may be made into a paste with some sweetened vehicle.

Administer Calcium Resonium at least 3 hours before or 3 hours after other oral

medications. For patients with gastroparesis, a 6-hour separation should be

considered

(see Section 4.4 and Section 4.5).

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 2 of 7

Rectal

In cases where vomiting may make oral administration difficult, the resin may be

given rectally as a suspension of 30g resin in 100ml 2% methylcellulose 450 BP

(medium viscosity) and 100ml of water, as a daily retention enema. In the initial

stages administration by this route as well as orally may help to achieve a more rapid

lowering of the serum potassium level.

The enema should, if possible, be retained for at 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 reached the rectum.

Children:

Oral

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.

The resin is given orally, preferably with a drink (not a fruit squash because of the

high potassium content) or a little jam or honey.

Rectal

When refused by mouth it should be given rectally using a dose at least as great as

that which would have been given orally, diluted in the same ratio as described for

adults. Following retention of the enema, the colon should be irrigated to ensure

adequate removal of the resin.

Neonates:

Calcium Resonium should not be given by the oral route. With rectal

administration, the minimum effective dosage within the range 0.5g/kg to 1g/kg

should be employed, diluted as for adults and with adequate irrigation to ensure

recovery of the resin.

4.3 Contraindications

In patients with plasma potassium levels below 5mmol/litre.

Conditions associated with hypercalcaemia (e.g. hyperparathyroidism,

multiple myeloma, sarcoidosis or metastatic carcinoma).

History of hypersensitivity to polystyrene sulphonate resins.

Obstructive bowel disease.

Calcium Resonium should not be administered orally to neonates and is

contraindicated in neonates with reduced gut motility (post-operatively or

drug-induced).

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 3 of 7

4.4 Special warnings and precautions for use

Binding to other orally administered medications: Calcium Resonium may bind to

orally administered medications, which could decrease their gastrointestinal

absorption and efficacy. Avoid co-administration of Calcium Resonium with other

orally administered medications. Administer Calcium Resonium at least 3 hours

before or 3 hours after other oral medications. For patients with gastroparesis, a

6-hour separation should be considered (see Section 4.2 and Section 4.5).

Sorbitol: Gastrointestinal stenosis, intestinal ischemia and its complications

(necrosis and perforation)may occur in patients treated with polystyrene

sulfonate, especially in patients using sorbitol.

Risk factors for gastrointestinal adverse events were present in many of the

cases including gut reduced motility( post-surgery or drug induced) prematurity,

history of intestinal disease or surgery, and renal insufficiency and failure.

Concomitant use of sorbitol with calcium polystyrene sulfonate is not

recommended (see sections 4.5 and 4.8)

Hypokalaemia: The possibility of severe potassium depletion should be considered

and adequate clinical and biochemical control is essential during treatment,

especially in patients on digitalis. Therapy should be discontinued as soon as serum

potassium falls below 5 mEq/l. (see 4.5 Interactions).

Other electrolyte disturbances: Like all cation-exchange resins, calcium polystyrene

sulphonate is not totally selective for potassium. Hypomagnesaemia and/or

hypercalcaemia may occur. Accordingly, patients should be monitored for all

applicable electrolyte disturbances. Serum calcium levels should be estimated at

weekly intervals to detect the early development of hypercalcaemia, and the dose of

resin adjusted to levels at which hypercalcaemia and hypokalaemia are prevented.

In acute hyperkalaemia not due to the administration of excess potassium the

intravenous infusion of glucose together with the administration of soluble insulin is

recommended in addition to commencement of therapy with this product.

Other risks: In the event of clinically significant constipation, treatment should be

discontinued until normal bowel movement has resumed. Magnesium-containing

laxatives should not be used (see section 4.5 Interactions).

The patient should be positioned carefully when ingesting the resin, to avoid

aspiration, which may lead to bronchopulmonary complications.

This product is unsuitable for use where a rapid lowering of serum potassium is

required.

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 4 of 7

Children and neonates: In neonates, calcium polystyrene sulphonate should not be

given by the oral route. In children and neonates, particular care is needed with rectal

administration as excessive dosage or inadequate dilution could result in impaction

of the resin.

Due to the risk of digestive haemorrhage or colonic necrosis, particular care should

be observed in premature infants or low birth weight infants.

4.5 Interaction with other medicinal products and other forms of interactions

Concomitant use not recommended

Orally administered medications: Calcium Resonium has the potential to bind to

other orally administered medications. Binding of Calcium Resonium to other oral

medications could cause decrease in their gastrointestinal absorption and efficacy.

Dosing separation of Calcium Resonium from other orally administered medications

is recommended (see Section 4.2 and Section 4.4).

Sorbitol (oral or rectal): Concomitant use of sorbitol with calcium polystyrene

sulphonate is not recommended due to cases of intestinal necrosis and other serious

gastrointestinal adverse reactions, which may be fatal. (see sections 4.4 Special

warnings and special precautions for use and 4.8 Undesirable effects)

To be used with caution

Cation-donating agents: may reduce the potassium binding effectiveness

of Calcium Resonium.

Non-absorbable cation-donating antacids and laxatives: There have been

reports of systemic alkalosis following concurrent administration of

cation-exchange resins and non-absorbable cation-donating antacids and

laxatives such as magnesium hydroxide and aluminium carbonate.

Aluminium hydroxide: Intestinal obstruction due to concretions of

aluminium hydroxide has been reported when aluminium hydroxide has

been combined with the resin (sodium form).

Digitalic drugs: The toxic effects of digitalis on the heart, especially various

ventricular arrhythmias and A-V nodal dissociation, are likely to be

exaggerated if hypokalaemia and/or hypercalcaemia are allowed to

develop. (see 4.4 Special warnings and special precautions for use).

Lithium: Possible decrease of lithium absorption.

Thyroxine: Possible decrease of thyroxine absorption.

Fat-soluble vitamins: Adsorption of these vitamins may be inhibited.

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 5 of 7

4.6 Fertility, pregnancy and lactation

No data are available regarding the use of polystyrene sulphonate resins in

pregnancy and lactation. The administration of Calcium Resonium in pregnancy and

during breast-feeding is therefore not advised unless, in the opinion of the physician,

the potential benefits outweigh any potential risks.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

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

Warnings and Precautions and Overdosage). Cases of hypomagnesemia, 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. Gastrointestinal stenosis and intestinal obstruction have also been reported,

possibly due to co-existing pathology, or inadequate dilution of the resin.

Gastrointestinal ischemia, ischemic colitis, gastro-intestinal tract ulceration or

necrosis which could lead to intestinal perforation have been reported which is

sometime fatal.

The majority of cases has been reported with concomitant use of sorbitol (see

sections 4.4 Special warnings and special precautions for use and 4.5 Interactions)

Respiratory, thoracic and medicinal disorders

Some cases of acute bronchitis and/or bronchopneumonia associated with inhalation

of particles of calcium polystyrene sulphonate, have been described.

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 6 of 7

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

6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

4.9 Overdose

Biochemical disturbances from overdosage may give rise to clinical signs of

symptoms of hypokalaemia, including irritability, confusion, delayed thought

processes, muscle weakness, hyporeflexia and eventual paralysis. Apnoea may be a

serious consequence of this progression. Electrocardiographic changes may be

consistent with hypokalaemia or hypercalcaemia; cardiac arrhythmia may occur.

Appropriate measures should be taken to correct serum electrolytes and the resin

should be removed from the alimentary tract by appropriate use of laxatives or

enemas.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Ion-exchange resin.

5.2 Pharmacokinetic properties

Not applicable as this product is not absorbed.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to

that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Saccharin (E954)

Vanillin

6.2 Incompatibilities

This product must not be mixed with other medicinal products except those listed in

section 4.2

Health Products Regulatory Authority

04 January 2019

CRN008K0V

Page 7 of 7

6.3 Shelf life

Unopened: 4 Years.

Once diluted: Use immediately, any unused portion should be discarded.

6.4 Special precautions for storage

Keep the tub tightly closed, in order to protect from moisture.

6.5 Nature and contents of container

Highly density polyethylene (HDPE) container of 300 g with a low density

polyethylene (LDPE) closure. A 15 g plastic spoon accompanies the product.

6.6 Special precautions for disposal of a used medicinal product or waste

materials derived from such medicinal product and other handling of the

product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Sanofi-Aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0540/141/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

April 1983

Date of last renewal: 1

April 2008

10 DATE OF REVISION OF THE TEXT

January 2019

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