CALCICHEW 500 Milligram Tablets Chewable

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CALCIUM CARBONATE
Available from:
Takeda UK Limited
ATC code:
A12AA04
INN (International Name):
CALCIUM CARBONATE
Dosage:
500 Milligram
Pharmaceutical form:
Tablets Chewable
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Calcium
Authorization status:
Transfer Pending
Authorization number:
PA1547/007/001
Authorization date:
2014-01-06

PATIENT INFORMATION LEAFLET

Calcichew*

500 mg Chewable Tablets

calcium carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist

have told you.

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

Ask your pharmacist if you need more information or advice.

You must talk to a you do not feel better or if you feel worse after two weeks.

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

effects not listed in this leaflet. See section 4.

In this leaflet:

What Calcichew 500 mg is and what it is used for

What you need to know before you take Calcichew 500 mg

How to take Calcichew 500 mg

Possible side-effects

How to store Calcichew 500 mg

Contents of the pack and other information

1.

What Calcichew

500 mg is and what it is used for

Calcichew

500 mg Chewable Tablets are orange flavoured chewable tablets containing the active

ingredient calcium. Calcium is found in the diet and is an important substance in bone formation.

Calcichew

500 mg is used to treat and prevent calcium deficiency which may occur if your diet or

lifestyle does not provide enough, or when body requirements are increased. This medicine may also

be prescribed or recommended for certain bone conditions, for example osteoporosis, or during

pregnancy. It may also be given to patients receiving kidney dialysis to remove the phosphate from

the blood that cannot be removed by dialysis.

2.

What you need to know before you take Calcichew 500 mg

Do not take Calcichew

500 mg Chewable Tablets if you:

are allergic (hypersensitive) to calcium or any of the other ingredients of this medicine (listed

in section 6)

have a condition that causes excessive amounts of calcium in your blood or urine

(hypercalcaemia or hypercalciuria)

have kidney stones.

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcichew

500 mg:

if you have osteoporosis (brittle bones) and are also unable to move around

if you are on long term treatment, especially if you are taking medicines for a heart disorder

(cardiac glycosides), or diuretics (used in the treatment of high blood pressure or oedema)

if you have signs of impaired kidney function or a high tendency to kidney stone (calculus)

formation

if you have cancer or any other conditions that may have affected your bones.

Your serum calcium or phosphate levels, or urinary calcium excretion must be monitored if you

have any of the following conditions.

kidney problems

you are on long-term treatment with Calcichew

you are already taking additional doses of calcium

If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of

Calcichew 500 mg should be reduced or the treatment discontinued.

Other medicines and Calcichew 500 mg

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

medicines.

In particular, the following medicines may interact with Calcichew 500 mg tablets:

thiazide diuretics (water tablets); your serum calcium levels should be monitored regularly.

cardiac glycosides (heart medicines); you should be monitored by electrocardiogram (ECG)

and your serum calcium levels measured.

tetracycline antibiotics; these should be taken at least two hours before, or four to six hours

afterwards. Calcium carbonate may interfere with the absorption of tetracycline preparations

if taken at the same time.

levothyroxine (hormone used to treat thyroid deficiency); these should be taken at least four

hours before, or after taking Calcichew 500 mg.

Quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin); the effect

of these medicines may be reduced if taken at the same time as calcium. Take quinolone

antibiotics two hours before or six hours after taking Calcichew 500 mg.

Bisphosphonates should be taken at least one hour before Calcichew 500 mg.

Calcium

salts

decrease

absorption

iron,

zinc

and

strontium

ranelate.

Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours

before or after Calcichew 500 mg.

taking

above-mentioned

medicines,

your

doctor

will

give

further

instructions.

Taking Calcichew

500 mg with food and drink

For treatment of calcium difficiency or use as an additional osteoporosis therapy, Calcichew

500 mg

can be taken with or without food and drink.

For use as a phosphate binder,

Calcichew

500 mg

should be taken just before, during or just

after each meal.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking Calcichew

500 mg.

During pregnancy the daily intake should not exceed 2500 mg calcium (including food and

supplementation). If you are pregnant, you may use Calcichew 500 mg in case of a calcium

deficiency.

Calcichew 500 mg can be used during breastfeeding. Calcium passes into breast milk.

Driving and using machines

Calcichew

500 mg has no known influence on the ability to drive or use machines.

Calcichew 500 mg contains isomalt

Calcichew 500 mg contains isomalt (E953): if you have been told by your doctor that you have an

intolerance to some sugars, talk to your doctor before taking this medicine. May be harmful to teeth.

3.

How to take Calcichew

500 mg

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

Dosage:

The recommended dose is:

For use as an additional osteoporosis therapy: One tablet 2 or 3 times a day.

For calcium deficiency: One tablet 2 or 3 times a day.

As a phosphate binder (for kidney failure patients on dialysis): Your doctor will decide how

many Calcichew 500 mg Chewable Tablets you need. The label the pharmacist puts on your medicine

will tell you exactly how many tablets to take.

Use in children

The recommended dose for children is one tablet 2 or 3 times a day.

The tablets can be chewed or sucked.

If you take more than you should

If you have taken more Calcichew 500 mg than you should, talk to your doctor or pharmacist

immediately.

If you accidentally take more Calcichew

500 mg than you should, you may have an increase in your

blood calcium levels. Symptoms of this are: excessive thirst, nausea, vomiting, constipation,

abdominal pain, muscle weakness, tiredness, mental disturbances, lack of appetite, bone pain, having

to pass more water than usual, kidney problems and, in severe cases, irregular heartbeat.

Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches

and tingling sensation.

If you forget to take Calcichew

500 mg Chewable Tablets

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking your medicine and see a doctor immediately if you experience any of the following

side effects. These side effects may be a sign of milk-alkali syndrome (also called Burnett’s

Syndrome) that is reported to occur very rarely (affects less than 1 in 10,000 people):

Frequent urge to urinate

Headache

Loss of appetite, nausea or vomiting

Unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney

impairment.

Side effects may include:

Uncommon side effects (may affect up to 1 in 100 people):

excessive amounts of calcium in your blood (hypercalcaemia) or in your urine

(hypercalcuria) may occur with large doses

Rare side effects (may affect up to 1 in 1,000 people):

nausea

stomach ache

constipation

diarrhoea

wind (flatulence)

heartburn (dyspepsia)

Very rare side effects (may affect less than 1 in 10,000 people):

rash

hives

itching

If you are taking Calcichew 500 mg Chewable Tablets because you are having kidney dialysis, tell

your doctor if you notice any white deposits on your skin.

Reporting of side effects

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

this leaflet. You can also report side effects directly to 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.

5.

How to store Calcichew

500mg

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

Store in the original package to protect from moisture. Do not store above 30

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry

date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Calcichew

500 mg Chewable Tablets contain

The active ingredient in each tablet is1250 mg calcium carbonate (equivalent to 500 mg calcium).

The other ingredients are: xylitol (E967), povidone, isomalt (E953), fatty acid mono- and di-

glycerides, magnesium stearate, orange flavour, and sucralose (E955) (see also end of Section 2

“Calcichew 500 mg contains isomalt”).

What Calcichew

500 mg look like and contents of the pack

The tablets are round, white, uncoated convex and orange flavoured; they may have small specks.

The tablets are packed in white, plastic bottles of 100 tablets.

Marketing Authorisation Holder

Takeda UK Ltd., Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS, HP10 0DF,

United Kingdom

Manufacturer

Takeda AS, Drammensveien 852, N-1385 Asker, Norway.

This leaflet was last revised in June 2017.

Additional Information

Calcichew 500 mg contains calcium designed to keep bones healthy. Calcium is an essential

component of bones.

Requirements for calcium increase with age and, although many people obtain enough calcium from

their diet, some people may require a supplement in order that their body has all the calcium it needs

to maintain healthy bones.

People with diets and lifestyles that mean they will obtain less than the recommended intake of

calcium are at risk of weakened bones. Prolonged lack of adequate calcium intake can lead to the

development of osteoporosis, a condition where bones become weak to a level that minimal trauma

(for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.

Calcichew 500 mg have been designed to give people, whose intake of calcium is low, a boost to the

recommended amounts.

Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people.

There are many ways that people can help themselves: regular exercise, a balanced diet with an

adequate intake of calcium and, for some people, advice on how to prevent falls which may lead to

fracture.

The Irish Osteoporosis Society (IOS) is a national charity dedicated to reducing the incidence of

Osteoporosis and promoting bone health. The IOS offers information and support to people with

osteoporosis, their families and everyone at risk from the disease.

If you are concerned about osteoporosis, please contact the Irish Osteoporosis Society, 114 Pembroke

Road, Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751, Fax: +353 (0)1 668 0098, email:

info@irishosteoporosis.ie.

*Registered Trademark

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calcichew 500mg Chewable Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains calcium carbonate 1250 mg equivalent to 500mg of elemental calcium.

Excipients with known effect:

Isomalt (E953) – 62 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable Tablet.

Round, white, uncoated and convex tablet. May have small specks.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

To correct calcium deficiency states and maintain appropriate balance in such disorders as osteoporosis, osteomalacia,

rickets, tetany, malabsorption states and in pregnancy and lactation.

As a phosphate binding agent in the management of renal failure in patients on renal dialysis.

4.2 Posology and method of administration

Posology

Adults:

Adjunctive therapy in osteoporosis:

2 to 3 tablets daily.

Prevention and treatment of calcium

deficiency:

2 to 3 tablets daily.

Phosphate binder:

Dose as required by the individual patient depending on serum phosphate

level.

Special patient populations

Elderly patients:

Dosage as for adults.

Paediatric patients:

Prevention and treatment of calcium

deficiency:

2 to 3 tablets daily.

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Phosphate Binder:

Dose as required by the individual patient depending on serum phosphate

level.

Impaired renal function:

In patients with severe renal failure having a creatinine clearance of less than 30 ml/minute, dosage adjustments may be

necessary dependent on serum calcium levels. See section 4.4.

Impaired hepatic function:

No dose adjustment is required.

Method of administration

Oral.

The tablets should be chewed or sucked.

For phosphate binding, the tablets should be taken just before, during or just after each meal in order to bind phosphate

in the food.

4.3 Contraindications

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

Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria.

Renal calculi (nephrolithiasis)

4.4 Special warnings and precautions for use

In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution

should be exercised in patients with a history of renal calculi.

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through

measurements of serum creatinine. Monitoring is especially important in patients on concomitant treatment with

cardiac glycosides or diuretics (see 4.5), in patients with a high tendency to calculus formation, in cases of

hypercalcaemia, or signs of impaired renal function.

Calcium carbonate should be used with caution in patients with hypercalcaemia or signs of impaired renal function

and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be

taken into account.

During high dose therapy and especially during concomitant treatment with vitamin D and/or medications or nutrients

(such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome (hypercalcaemia,

alkalosis and renal impairment) with subsequent kidney function impairment. In these patients, serum calcium levels

should be followed and renal function should be monitored.

Calcichew 500 mg Chewable Tablets contain isomalt (E953). Patients with rare hereditary problems of fructose

intolerance should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium

should be regularly monitored during concomitant use of thiazide diuretics.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations.

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For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after,

oral intake of calcium.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium. Patients should be

monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If a bisphosphonate is used concomitantly, this preparation should be administered at least three hours before the intake

of Calcichew 500mg Chewable Tablets since gastrointestinal absorption may be reduced.

The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine

absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone

antibiotics should be taken two hours before or after intake of calcium.

Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium

ranelate preparations should be taken two hours before or after calcium carbonate.

4.6 Fertility, pregnancy and lactation

Pregnancy

Calcichew 500mg Chewable Tablets can be used during pregnancy. Daily intake should not exceed 2500 mg of

calcium as permanent hypercalcaemia has been related to adverse effects on the developing foetus.

Breastfeeding

Calcium carbonate can be used during breast-feeding. Calcium passes into breast milk but at therapeutic doses no

effects on the breastfed new-born are anticipated.

4.7 Effects on ability to drive and use machines

Calcium carbonate has no known influence on ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon

(>1/1,000,

1/100), rare (>1/10,000,

1/1,000), or very rare (

1/10,000).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or

vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). Seen usually only in

overdose (see 4.9).

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous tissue disorders

Very rare: Pruritus, rash and urticaria.

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

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

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4.9 Overdose

Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting,

constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain,

nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma

and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Milk-alkali syndrome (may occur in patients who ingest large amounts of calcium and absorbable alkali.

Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics,

lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Treatment: rehydration, and, according

to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and

corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe

cases, ECG and CVP should be followed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Calcium

ATC code: A12A A04

An adequate intake of calcium is of importance during growth, pregnancy and breastfeeding.

5.2 Pharmacokinetic properties

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed

dose.

Distribution and biotransformation: 99% of the calcium in the body is concentrated in the hard structure of bones and

teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content

is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other

anions, the remaining 40% being bound to proteins, principally albumin.

Excretion and elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on

glomerular filtration and calcium tubular reabsorption.

5.3 Preclinical safety data

There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Xylitol (E967)

Povidone

Magnesium stearate

Sucralose (E955)

Isomalt (E953)

Flavouring (orange)

Mono, di-fatty acid glycerides

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6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30°C.

Keep the container tightly closed to protect from moisture.

6.5 Nature and contents of container

HDPE container with screw cap containing 100 tablets.

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

Takeda UK Ltd.

Building 3

Glory Park

Glory Park Avenue

Woodburn Green

BUCKS

HP10 0DF

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA1547/007/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20

December 1993

Date of last renewal: 20

December 2008

10 DATE OF REVISION OF THE TEXT

May 2017

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