ACTRON aspirin paracetamol caffeine 20/30CP

Bayer Santé Familiale Bayer Santé Familiale

ACTRON aspirin paracetamol caffeine 20/30CP

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Used for : influenza States, achiness, headache, toothache

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For the warnings, the precautions and cons-indications, see the manual of ACTRON aspirin paracetamol caffeine 20/30CP.

Description ACTRON aspirin paracetamol caffeine 20/30CP

 

Indication ACTRON aspirin paracetamol caffeine 20/30CP

 

Directions for use and dosage of aspirin paracetamol caffeine ACTRON 20/30CP

 

Introducing ACTRON aspirin paracetamol caffeine 20/30CP

 

Warnings on drugs

Attention drug ACTRON aspirin paracetamol caffeine 20/30CP is not a product like any other. Read the package leaflet before ordering. Do not let the drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please tell your online pharmacist ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual for this product on the website of the National Agency for Drug Safety and health products.

Pharmacovigilance : Reporting an or effect (s) junk (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

ACTRON

Analgesic and antipyretic

aspirin, paracetamol, caffeine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ACTRON: effervescent tablet (white); box of 20.
-

ACTRON: effervescent tablet (white); box of 30.
-

Laboratory

COMPOSITION (summary)
p cp
Acetylsalicylic acid (aspirin) 267 mg
Paracetamol 133 mg
Caffeine 40 mg
Sodium 472 mg

INDICATIONS (summary)
This medicine, analgesic and antipyretic , contains aspirin, paracetamol and caffeine .
It is used to lower fever and in the treatment of painful conditions.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
Aspirin is not an innocuous drug. Overdosage or prolonged intake may cause serious complications.
Many drugs contain aspirin or paracetamol; be sure not to combine several medicines containing these substances simultaneously, as a joint dose may increase the risk of adverse effects.
The use of aspirin requires prior medical advice if there is a history of stomach ulcer or duodenal ulcer , even if it is old, renal insufficiency , G6PD deficiency , asthma , gout, and in women have an intrauterine device (IUD).
Avoid taking this medication during the week prior to dental extraction, operation, or during abundant periods: increased risk of bleeding .
These effervescent tablets contain salt (sodium) in significant quantities.
This medicinal product contains caffeine which is no longer considered to be a prohibited substance in anti-doping tests. Nevertheless, it is part of the surveillance program of the World Anti-Doping Agency. It can be found in athletes' urine to detect any misuse.
DRUG INTERACTIONS (summary)
The interactions are of varying intensity depending on the doses of aspirin used. If you are being treated with any of the medicines listed below, do not take aspirin without the advice of your doctor or pharmacist.
Aspirin used at high doses (over 3 g / day) should not be combined with methotrexate (used at doses greater than 15 mg / week): increased risk of methotrexate toxicity.
Aspirin may interact with: Also tell your doctor or pharmacist if you are taking an antidiabetic , an antihypertensive medication from the family of ACE inhibitors or angiotensin II inhibitors , an antidepressant in the IRS family, a diuretic or a corticosteroid .
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Adverse effects on the mother and the unborn child have been demonstrated when aspirin, like other NSAIDs , is used in the last 4 months of pregnancy; the risk exists even with a single intake and even if the pregnancy is over term.
Consequently, aside from certain very specific medical situations, aspirin can only be used on an ad hoc basis during the first 5 months, and its use is contraindicated from the 6th month.

Breastfeeding:
Aspirin passes into breast milk: it is not recommended for use in breastfeeding women.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication can be taken indifferently during or between meals, respecting an interval of 4 hours between 2 catches. In case of renal insufficiency , the interval between 2 takes must be at least 8 hours.
The tablets should be dissolved in a glass of water, milk or fruit juice.

Usual dosage:

  • Adult: 1 or 2 tablets per dose, to be renewed if necessary, without exceeding 7 tablets per day.
    In the elderly, it is advisable not to exceed 5 tablets per day.
TIPS (summary)
This medicine contains caffeine . A cup of coffee is considered to contain 60 to 100 mg of this substance. In order to limit the undesirable effects of caffeine (excitation, tremors, insomnia, palpitations ), it is preferable to limit the consumption of drinks containing caffeine (coffee, tea ...). It is also recommended to take this medication before 5 pm.
POSSIBLE ADVERSE EFFECTS (summary)
Related to aspirin:
  • gastritis , abdominal pain, nose or gum bleeding;
  • rare and sometimes severe: haemorrhage of the digestive tract (bloody vomiting, black stool or, more often, imperceptible blood loss, responsible for the progressive appearance of anemia ); allergic conditions ( urticaria , edema , asthma );
  • signs suggesting an overdose : ringing in the ears, sensation of hearing loss, headache.
Related to paracetamol: allergic reaction (exceptional).
Related to caffeine : insomnia, excitement, palpitations .


GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


anemia
Reduction in the level of hemoglobin in the blood, which usually results in a decrease in the number of red blood cells. Iron is essential for the synthesis of hemoglobin. Iron deficiency during pregnancy, a vegetarian diet, abundant or repeated haemorrhage (menstruation) is a common cause of anemia. Other causes, more rare, are related to vitamin deficiencies of group B.


analgesic
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Synonym: analgesic.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


antiplatelet agents
Medication that prevents the platelets from clumping and therefore the clots from forming. The oldest platelet antiaggregant is aspirin taken in small doses.
Anti-aggregants should not be confused with anticoagulants with a different mechanism of action.


anti coagulants
Medication that prevents blood from coagulating and therefore prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also prevent the formation of clots in the heart during rhythm disorders such as atrial fibrillation or in the case of an artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: INR (formerly TP);
  • injectable anticoagulants derived from heparin, the efficacy of which can be controlled by the blood assay of anti-Xa activity, Howell's Time (TH) or Cephalin Kaolin Time (TCK) depending on the products used. A regular dosage of blood platelets is necessary throughout the life of a heparin derivative.


antidepressant
Medication that works against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, certain rebellious pain, enuresis, etc.
Depending on their mode of action and adverse effects, antidepressants are divided into different families: imipraminic antidepressants, serotonin reuptake inhibitors, selective or non-selective MAOIs. Finally, other antidepressants do not belong to any of these families, because they possess original properties.
The mode of action of antidepressants has two main aspects: the relief of moral suffering and the fight against inhibition which removes all will to action from the depressed. There may be a time lag between these two effects: moral suffering may persist, while the capacity for action reappears. During this short period, the risk of suicide in some depressed people can be increased. The physician takes it into account in its prescription (possible association with a tranquillizer) and it must imperatively be respected.


antidiabetic
Medicine intended to combat diabetes. There are two categories: oral antidiabetic agents (sulphonylurea, hypoglycaemic and biguanides, mainly) and insulin, which is used only as an injection.


antihypertensive
Medication that fights against excess blood pressure. The main ones are beta-blockers, diuretics, calcium channel blockers, ACE inhibitors, angiotensin II inhibitors and vasodilators.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


antipyretic
Medication used to lower the body temperature during bouts of fever.


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


caffeine
Stimulating substance present in certain beverages and certain medicines.
One cup of coffee contains about 100 mg; one cup of tea, about 50 mg; a cola beverage, 20 to 30 mg. The duration of action of caffeine varies from person to person; it is shorter in smokers and longer in women taking the pill or in pregnant women.


corticoid
Substance close to cortisone. The natural corticoids, necessary for the functioning of the organism, are made by the adrenal glands. Synthetic corticosteroids, chemical derivatives of cortisone, are used as powerful anti-inflammatory drugs.


diuretic
Medication allowing increased kidney water removal. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other rarer ailments.
These drugs cause loss of sodium and potassium (except for some of them called "potassium-sparing"). Their prolonged administration therefore requires regular blood potassium control, to avoid heart problems that may result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible but less frequent consequence of the prolonged use of diuretics; it is also detected by a blood test.


duodenum
A part of the intestine into which food from the stomach penetrates.


G6PD
glucose-6-phosphate dehydrogenase deficiency, an enzyme normally present in the red blood cell. His congenital absence (deficiency) is responsible for a disease called favism; it prohibits the use of certain drugs.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatory drugs.


drop
Disease manifested by redness and sharp pain affecting a joint (that of the big toe most often), due to an accumulation of crystals of uric acid.


hemorrhage
Loss of blood from an artery or vein. Hemorrhage can be external, but also internal and go unnoticed.


angiotensin II inhibitors
These drugs are sometimes called sartans, for the names of the molecules belonging to this family end with sartan (losartan, candesartan, etc.).
This family of drugs blocks the action of angiotensin II, a substance that increases blood pressure and tires the heart.
Angiotensin II inhibitors are used to treat high blood pressure.


ACE inhibitors
This family of drugs blocks the action of an enzyme, which converts angiotensin I (naturally inactive substance) to angiotensin II. This last substance increases blood pressure and fatigue the heart.
ACE inhibitors are used to treat high blood pressure, heart failure or myocardial infarction.


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


IRS
Abbreviation for inhibitor of serotonin reuptake. See this term.


edema
Accumulation of water or lymph causing localized swelling.


palpitations
Abnormal perception of irregular heartbeat.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


salicylates
A family of drugs, the best known of which is acetylsalicylic acid (aspirin).


salt
Chemical substance of which the best known is sodium chloride, or table salt. The diet salt does not contain sodium; this is generally replaced by potassium.


overdose
Taking an excessive amount of a drug exposes you to an increase in the intensity of adverse effects, or even to the appearance of particular adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


urticaria
Eruption of pimples on the skin, whose origin is mostly allergic. The buds look like nettles and their color varies from pale pink to red.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Updated on: 24/02/2016

Name of the medicinal product

ACTRON, effervescent tablet

Acetylsalicylic acid / Paracetamol / Caffeine

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult your doctor.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

1. WHAT IS ACTRON, effervescent tablet AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE ACTRON, effervescent tablet?

3. HOW TO TAKE ACTRON, effervescent tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE ACTRON, effervescent tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS ACTRON, effervescent tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

ANTALGIC and ANTIPYRETIC

(N: central nervous system)

Therapeutic indications

This medication contains two analgesics: aspirin and paracetamol and caffeine.

It is indicated in diseases with pain and fever such as headaches, flu-like conditions, dental pain and aches in adults.

2. BEFORE YOU TAKE ACTRON, effervescent tablet?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never take ACTRON, an effervescent tablet in the following cases:

· child under 15 years due to the presence of caffeine.

· from the 6th month of pregnancy,

· allergy to aspirin, paracetamol or a related drug (including non-steroidal anti-inflammatory drugs),

· severe liver disease,

· ulcer of the stomach or duodenum in evolution,

· hemorrhagic disease or hemorrhagic risk,

· in case of treatment by:

o methotrexate (doses above 15 mg per week),

o oral anticoagulants when aspirin is prescribed at high doses (greater than or equal to 3 g per day).

This medication MUST NOT BE GENERALLY USED, unless directed to do so by your doctor,

· in case of breastfeeding,

· in case of treatment by:

o oral anticoagulants (for doses of aspirin less than 3 g per day),

o other non-steroidal anti-inflammatory drugs (for high doses of aspirin 3 g or more per day),

o injectable heparins,

o uricosuric drugs (gout medication),

o ticlopidine,

o enoxacine.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Precautions for use; special warnings

Take special care with ACTRON, effervescent tablet:

Special warnings

If the pain persists more than 5 days, fever more than 3 days or if they worsen, do not continue treatment without the advice of your doctor or pharmacist.

In case of overdosage or mistakenly taking too high a dose, immediately notify a doctor.

Reye syndromes (a rare but very severe disease mainly associated with neurological disorders and liver damage) have been observed in children with viral diseases and receiving aspirin.

Consequently :

· in the event of a viral illness such as chickenpox or an episode of flu-like illness: do not administer aspirin to a child without the advice of a doctor,

· in the event of a conscious or behavioral disorder and vomiting in a child taking aspirin, tell a doctor immediately.

Precautions for use

Before taking aspirin, it is necessary to CONSULT YOUR DOCTOR in case:

· of gout.

· of digestive antecedents: hemorrhage, old ulcer of the stomach or duodenum,

· kidney disease or liver disease,

· of Asthma: The occurrence of asthma attacks in some individuals may be related to aspirin or NSAID allergy; in this case this drug is contraindicated.

· important rules or IUD contraception.

Aspirin increases the risk of haemorrhage at very low doses even when the dose is several days old. PREVENT YOUR DOCTOR, THE SURGER, THE ANESTHESIST OR YOUR DENTIST, in case a surgical gesture, even a minor one, is envisaged.

This medicine contains sodium. This medicine contains 472 mg sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.

This drug may cause insomnia, it should not be taken at the end of the day.

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.

Interaction with other medicines

Taking or using other medicines

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, particularly with other non-steroidal anti-inflammatory drugs, certain anticoagulants, uricosuric drugs (gout), enoxacin, IT SHOULD SYSTEMATICALLY REPORTED ANY OTHER PROCESSING IN PROGRESS AT YOUR DOCTOR OR TO YOUR PHARMACIST.

This medication contains two analgesics: aspirin and paracetamol, and caffeine. Other medicines contain it. Do not combine them so as not to exceed the maximum recommended doses. ( see "Posology" ).

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Pregnancy

1) - During the 5 FIRST MONTHS of your pregnancy, your doctor may be required to prescribe this medication on an ad hoc basis.

2) - FROM THE 6TH MONTH OF PREGNANCY, IN NO EVENT SHOULD YOU TAKE YOURSELF THIS MEDICINE, as its effects on your child can have serious consequences, especially on a vascular and renal plan, even with a single intake and even when the child is full term.

feeding

This drug passes into breast milk. It is therefore not advisable during breast-feeding regardless of the dose of aspirin to be taken.

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

Sport

Sport

The attention of athletes is drawn to the fact that this medicinal product contains an active ingredient which can induce a positive reaction of the tests carried out during doping controls.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

List of excipients with a known effect: sodium.

3. HOW TO TAKE ACTRON, effervescent tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

RESERVED FOR ADULTS

· The catch must be spaced at least 4 hours apart.

o Adults :
As an indication: 1 tablet to be renewed if necessary after 4 hours. In case of more intense pain, 2 tablets per dose.
Do not exceed 7 tablets per day.
The maximum daily dose of aspirin and paracetamol is 3 g.

o Elderly :
As an indication: 1 tablet to be renewed if necessary after 4 hours. In case of more intense pain, 2 tablets per dose.
Do not exceed 5 tablets per day.
The maximum daily dose of aspirin and paracetamol is 2 g.

Administration mode

ORAL TRACK

Drink immediately after dissolving the effervescent tablet completely in a glass of sweetened or unsweetened water, milk or fruit juice.

Frequency of Administration

The catches spread throughout the day help to avoid the peaks of fever or pain. They must be spaced at least 4 hours apart.

In case of severe kidney disease (severe kidney failure), catches will be spaced at least 8 hours apart.

Due to the presence of caffeine, avoid taking this medication at the end of the day.

Duration of the treatment

Do not exceed 3 days of treatment in case of fever or 5 days of treatment in case of pain without the advice of your doctor.

DO NOT USE EXTENDEDLY WITHOUT MEDICAL ADVICE.

Symptoms and Instructions for Overdose

If you take more ACTRON, effervescent tablet than you should:

During the course of the treatment, it is possible that there may be ringing in the ears, a feeling of hearing loss, headache, dizziness, usually as an overdose of aspirin. THEREFORE YOU MUST INTERRUPT YOUR TREATMENT AND PREVENT A DOCTOR.

In case of accidental poisoning, CONSULT A DOCTOR IMMEDIATELY.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

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

IMMEDIATELY STOP YOUR TREATMENT and tell your doctor if:

· allergic reactions such as rash, asthma attack, angioedema (facial urticaria with respiratory discomfort);

· haemorrhage (discharge of blood through the mouth or in the stools, coloring of the stools in black). This is all the more frequent as the dosage used is high;

· ringing in the ears, sensation of hearing loss, headache: they usually translate an overdose of aspirin.

Tell your doctor if you have abdominal pain, nose bleeds, gums.

Possibility of excitement, insomnia and palpitations due to the presence of caffeine.

Cases of stomach ulcers have been reported.

Exceptionally, an abnormally low level of certain blood components (platelets) appears, which can be manifested by nosebleeds or gums. This requires a check of the blood balance.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

Declaration of side effects :

If you experience any side effects, talk to your doctor or pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national drug and health products (ANSM) and network of Regional Centers of Pharmacovigilance - website: www.ansm.sante.fr .

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE ACTRON, effervescent tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use ACTRON, effervescent tablet after the expiry date stated on the carton.

Storage conditions

Store at a temperature not exceeding 25 ° C.

If necessary, warnings against visible signs of deterioration

Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What ACTRON contains, effervescent tablet

· The active substances are:

Acetylsalicylic acid ................................................ .................................................. ............. 0.267 g

Paracetamol ................................................. .................................................. .......................... 0.133 g

Caffeine anhydrous ................................................ .................................................. ...................... 0.040 g

For an effervescent tablet.

· The other components are:

Anhydrous citric acid, sodium bicarbonate.

Pharmaceutical form and content

Aspect of ACTRON, effervescent tablet and contents of the pack

This medication is in the form of an effervescent tablet.

Box of 10, 20, 30 or 40.

Not all pack sizes may be marketed.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

BAYER HEALTHCARE SAS

220 AVENUE OF RESEARCH

59120 LOOS

exploiting

BAYER HEALTHCARE SAS

33 STREET OF INDUSTRY

74240 GAILLARD

Maker

BAYER BITTERFELD GmbH

Salegaster Chaussee 1

06803 GREPPIN

GERMANY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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