ACETYLSALICYLIC ACID 20 SACHETS 500MG ZENTIVA
TECHNICAL SHEET RCP DRUGS FROM DATABASE
[su_spoiler title = "
MEDICINAL NAME"style =" fancy "icon =" chevron-circle "] ACETYLSALICYL ACID ZENTIVA 500 mg powder for oral solution
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[su_spoiler title = "
QUALITATIVE AND QUANTITATIVE COMPOSITION"style =" fancy "icon =" chevron-circle "]
ACETYLSALICYL ACID ZENTIVA 500 mg powder for oral solution
Each sachet contains: 900 mg of lysine acetylsalicylate (equivalent to 500 mg of acetylsalicylic acid).
For the full list of excipients, see section 6.1.
[su_spoiler title = "
PHARMACEUTICAL FORM"style =" fancy "icon =" chevron-circle "] Powder for oral solution. [/ su_spoiler]
[su_spoiler title = "
THERAPEUTIC INDICATIONS"style =" fancy "icon =" chevron-circle "] Algie of different origin.
Rheumatic affections.
Feverish states. [/ Su_spoiler]
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DOSAGE AND METHOD OF ADMINISTRATION"style =" fancy "icon =" chevron-circle "]
Dosage
Adults:
1-2 sachets at a time to be repeated up to three times a day. In the treatment of elderly patients, the dosage must be carefully established by the physician who will have to evaluate a possible reduction of the dosages indicated above.
Method of administration
Pour the powder into a glass - Add water - Shake a few seconds and drink.
The product should be taken on a full stomach, particularly when it is necessary to administer the product at high doses or for prolonged periods of time.
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[su_spoiler title = "
CONTRAINDICATIONS"style =" fancy "icon =" chevron-circle "] Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other non-steroidal anti-inflammatory drugs (NSAIDs) (cross-reactivity)
History of asthma induced by administration of acetylsalicylates or substances with similar activity, especially non-steroidal anti-inflammatory drugs
Third trimester of pregnancy (beyond 24 weeks of pregnancy) (see section 4.6)
Active peptic ulcer
Any constitutional or acquired hemorrhagic disease
Hemorrhagic risk
Severe hepatic insufficiency
Severe renal insufficiency (ClCr
Severe, uncontrolled heart failure
Patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid can induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting)
Co-administration with methotrexate used at doses> 15 mg / week at anti-inflammatory doses of acetylsalicylic acid, or at analgesic or antipyretic doses (see section 4.5)
Co-administration of oral anticoagulants with acetylsalicylic acid used at anti-inflammatory, analgesic or antipyretic doses and in patients with a history of gastro-duodenal ulcers (see section 4.5).
The use of this medicine is contraindicated in children and young people under the age of sixteen.
The drug is also contraindicated during intensive diuretic therapy in subjects with haemorrhagic diathesis, during treatments with anticoagulants as it synergizes their action.
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WARNINGS AND PRECAUTIONS FOR USE"style =" fancy "icon =" chevron-circle "] This product interferes with the synthesis of prostaglandins and their important intermediates, which participate in physiological functions. The drug, therefore, requires particular precautions or requires their exclusion from 'use when the following conditions are present in the patient: states of hypoperfusion of the kidney, kidney disease, heart failure.
Due to the interaction with the metabolism of arachidonic acid, the drug can cause bronchospasm and possibly shock and other allergic phenomena in asthmatics and predisposed subjects.
Pre-operative use can hinder intraoperative haemostasis.
This medicinal product should not be used in children and young people under the age of 16 (contraindications see section 4.3).
People over 70 years of age, especially in the presence of concomitant therapies, should only use this medicine after consulting a doctor.
If prolonged vomiting and profound drowsiness occur during treatment, discontinue administration.
Use with caution in patients with mild or moderate hepatic insufficiency.
In case of co-administration with other medicines, in order to avoid any risk of overdose, make sure that acetylsalicylic acid is absent from the composition of the other medicines.
Reye's syndrome, a very rare and life-threatening disease, has been observed in children and adolescents with signs of viral infection (in particular, chicken pox and flu-like episodes) who were taking acetylsalicylic acid. Consequently, acetylsalicylic acid should be given to children and adolescents with these conditions following medical warnings, when other treatments have failed. In case of persistent vomiting, disturbed consciousness or abnormal behavior, treatment with acetylsalicylic acid should be discontinued.
In children under one month of age, the administration of acetylsalicylic acid is justified only in specific situations and on medical prescription.
In case of long-term administration of analgesics in high doses, the onset of headache should not be treated with higher doses.
Regular use of analgesics, particularly the combination of analgesics, can lead to persistent kidney injury, with the risk of kidney failure.
In patients with G6PD deficiency, acetylsalicylic acid should be administered under medical supervision due to the risk of haemolysis (see section 4.8).
Treatment monitoring should be strengthened in the following cases:
in patients with a history of gastric or duodenal ulcer, or gastrointestinal bleeding, or gastritis
in patients with renal insufficiency
in patients with mild and moderate hepatic insufficiency
in patients with asthma: the occurrence of an asthma attack, in some patients, may be linked to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid, in this case, this medicine is contraindicated (see section 4.3)
In patients with metrorrhagia or menorrhagia (risk of increasing the volume and duration of menstrual periods)
Gastrointestinal bleeding or ulcers / perforations can occur at any time during treatment, without necessarily the presence of recent signs or a history in the patient. The relative risk is increased in elderly subjects, in subjects with a low body weight, and in patients treated with anticoagulants or platelet aggregation inhibitors (see section 4.5). In case of gastrointestinal bleeding, treatment should be stopped immediately.
In view of the inhibitory effect of acetylsalicylic acid on platelet aggregation, which occurs even at very low doses and which persists for several days, the patient should be warned of the risk of bleeding in the event of surgery, even of a minor nature ( e.g. tooth extraction).
At analgesic or antipyretic doses, acetylsalicylic acid inhibits the excretion of uric acid, at the doses used in rheumatology (anti-inflammatory doses), acetylsalicylic acid has a uricosuric effect.
At high doses used in rheumatology (anti-inflammatory doses), patients should be monitored for the possible occurrence of symptoms of overdose. In case of ringing in the ears, hearing difficulties or dizziness, the treatment modalities should be re-evaluated. In children, it is recommended to monitor for salicilism, especially at the beginning of treatment.
The use of this medicinal product is not recommended during breastfeeding (see section 4.6).
Alcohol can increase the risk of gastrointestinal injury and prolong bleeding time when taken together with acetylsalicylic acid. Therefore, alcoholic beverages should be taken with caution by patients during and for 36 hours after taking acetylsalicylic acid (see section 4.5).
In patients receiving concomitant nicorandil and NSAIDs, including acetylsalicylic acid and lysine acetylsalicylate, there is an increased risk of serious complications such as gastrointestinal ulcer, perforation and haemorrhage. Therefore, caution should be exercised in case of concomitant intake of acetylsalicylic acid / lysine acetylsalicylate or NSAIDs and nicorandil (see section 4.5).
Salicylates can inhibit the binding of thyroid hormones to transport proteins and thus lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Therefore, in case of concomitant intake of levothyroxine and salicylates, thyroid hormone levels should be monitored (see section 4.5).
Concomitant treatment with levothyroxine and salicylates should be avoided (see section 4.5).
In patients receiving varicella vaccine, the use of acetylsalicylic acid should be avoided for 6 weeks following vaccination (see section 4.5).
Pediatric population
The 1 g sachets of powder for oral solution are not suitable for use in children weighing less than 50 kg.
There is evidence that the drug, by inhibiting the synthesis of cyclo-oxygenase / prostaglandins, can cause a reduction in female fertility through an effect on ovulation. This effect is reversible upon discontinuation of the drug. [/ Su_spoiler]
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INTERACTIONS"style =" fancy "icon =" chevron-circle "]
Several substances are involved in interactions due to their properties to inhibit platelet aggregation:
Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, ticlopidine and tirofiban.
The use of different platelet aggregation inhibitors increases the risk of bleeding, as does their combination with heparin or related molecules, oral anticoagulants or other thrombolytics, and this possibility must be taken into consideration, maintaining regular clinical monitoring. .
Combinations contraindicated (see section 4.3):
- Methotrexate at doses> 15 mg / week at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, particularly haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid).
- Oral anticoagulants at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid and in patients with a history of gastro-duodenal ulcer: increased risk of haemorrhage.
Combinations not recommended:
- oral anticoagulants at analgesic or antipyretic doses of acetylsalicylic acid and in patients with no history of gastro-duodenal ulcer: increased risk of haemorrhage.
- oral anticoagulants at doses of acetylsalicylic acid used for the inhibition of platelet aggregation and in patients with a history of gastro-duodenal ulcer: increased risk of haemorrhage. Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory doses of acetylsalicylic acid, or at analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.
- Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses in elderly patients (≥ 65 years), regardless of the dose of heparin, and for anti-inflammatory doses or analgesic or antipyretic doses of acetylsalicylic acid: increase the risk of haemorrhage (inhibition of platelet aggregation and lesion of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory medicine or another analgesic or antipyretic should be given.
- Clopidogrel (in addition to the approved indications for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. If co-administration cannot be avoided, clinical monitoring is recommended.
- Uricosurics (benzbromarone, probenecid): reduction of the uricosuric effect due to competition for the elimination of uric acid in the renal tubules.
- Ticlopidine: increased risk of bleeding. If co-administration cannot be avoided, clinical monitoring is recommended.
- Glucocorticoids (except hydrocortisone replacement therapy) for anti-inflammatory doses of acetylsalicylic acid: increased risk of haemorrhage.
- Pemetrexed in patients with mild or moderate renal impairment (creatinine clearance between 45 ml / min and 80 ml / min): Increased risk of pemetrexed toxicity (due to reduced renal clearance of pemetrexed by acetylsalicylic acid) at doses anti-inflammatory drugs of acetylsalicylic acid.
Combinations requiring precautions for use:
- Acetazolamide: Caution is recommended in case of concomitant administration of salicylates and acetazolamide as there is an increased risk of metabolic acidosis.
- Levothyroxine: Salicylates can inhibit the binding of thyroid hormones to transport proteins and thus lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. Therefore thyroid hormone levels should be monitored (see section 4.4).
- Valproic Acid: Concomitant administration of salicylates and valproic acid may cause a reduction in the binding of valproic acid to proteins and inhibition of the metabolism of valproic acid resulting in an increase in serum levels of total and free valproic acid. Valproate levels should be closely monitored during concomitant administration.
- Diuretics, angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists at anti-inflammatory doses of acetylsalicylic acid or analgesic and antipyretic doses of acetylsalicylic acid: acute renal failure may occur in dehydrated patients a due to the reduced glomerular filtration rate secondary to the decreased synthesis of renal prostaglandins. In addition, reduction of the antihypertensive effect may occur. Make sure that the patient is hydrated and that kidney function is checked at the start of treatment.
- Methotrexate at doses ≤ 15 mg / week at anti-inflammatory doses, or at analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid ). Blood cell counts should be checked weekly during the first few weeks of concomitant administration. Careful monitoring is required in patients with (even mild) renal insufficiency, as well as in elderly patients.
- Methotrexate at doses> 15 mg at doses of acetylsalicylic acid used for inhibition of platelet aggregation: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid). Blood cell counts should be checked weekly during the first few weeks of co-administration. Careful monitoring is required in patients with (even mild) renal insufficiency, as well as in elderly patients.
- Metamizole: Metamizole when taken concomitantly with acetylsalicylic acid can reduce its effect on platelet aggregation.
- Clopidogrel (in the approved indications for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. Clinical monitoring is recommended.
- Topical gastrointestinal, antacids and charcoal: increased renal excretion of acetylsalicylic acid due to alkalinization of the urine. It is recommended that gastrointestinal topicals and antacids be administered at least 2 hours away from acetylsalicylic acid.
- Pemetrexed in patients with normal renal function: Increased risk of pemetrexed toxicity (due to decreased renal clearance of pemetrexed by acetylsalicylic acid) at anti-inflammatory doses of acetylsalicylic acid. Renal function should be monitored.
- Low molecular weight heparins (and related molecules) and unfractionated heparins, at preventive doses in patients under 65 years of age: the co-administration of drugs that act at different levels of haemostasis increases the risk of bleeding. Therefore, in patients less than 65 years of age, the co-administration of heparins at preventive doses (or related molecules), and acetylsalicylic acid, regardless of the dose, should be evaluated, maintaining clinical and laboratory monitoring. , when necessary.
- Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses or in elderly patients (≥ 65 years), regardless of the dose of heparin, and for doses of acetylsalicylic acid used for inhibition of platelet aggregation: increase the risk of haemorrhage (inhibition of platelet aggregation and lesion of the gastroduodenal mucosa by acetylsalicylic acid).
- Thrombolytics: increased risk of haemorrhage.
- Oral anticoagulants at doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of haemorrhage.
- Other non-steroidal anti-inflammatory drugs (NSAIDs) with doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of gastrointestinal ulcers and bleeding.
- Potential additive effect on platelet aggregation:
Due to an increased risk of bleeding due to the potential additive effect on platelet aggregation, concomitant administration of drugs associated with bleeding risk should be undertaken with caution.
- Nicorandil: In patients receiving concomitant nicorandil and NSAIDs, including acetylsalicylic acid and lysine acetylsalicylate, there is an increased risk of serious complications such as gastrointestinal ulcer, perforation and haemorrhage (see section 4.4).
- Glucocorticoids (except hydrocortisone for replacement therapy) for analgesic and antipyretic doses of acetylsalicylic acid: increased risk of haemorrhage.
- Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): increased risk of haemorrhage.
- Experimental data indicate that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when administered concurrently (see section 5.1). However, the limitations of such data and the uncertainties regarding extrapolation of the ex vivo data to the clinical situation imply that no firm conclusions can be made for the regular use of ibuprofen, and no clinically relevant effect is considered likely for occasional use. of ibuprofen.
- Chickenpox vaccine: It is recommended that patients who have received chickenpox vaccination should not be given salicylates for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred following the use of salicylates during chickenpox infection.
- Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure particularly in those patients with risk factors for renal dysfunction. Therefore, if tenofovir disoproxil is co-administered with an NSAID, renal function should be adequately monitored.
- Alcohol: when taken together with acetylsalicylic acid, alcohol can increase the risk of gastrointestinal injury and prolong bleeding time. Therefore, alcoholic beverages should be taken with caution by patients during and for 36 hours after taking acetylsalicylic acid (see section 4.4).
There were no interactions between the medicine and laboratory tests or between the medicine and food.
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[su_spoiler title = "FERTILITY, PREGNANCY AND BREASTFEEDING"style =" fancy "icon =" chevron-circle "]
Low doses below 100 mg / day
Clinical studies indicate that acetylsalicylic acid at doses below 100 mg / day appears to be obstetric safe only in extremely limited obstetric cases requiring specialist monitoring. Doses between 100 and 500 mg / day
There are insufficient clinical data regarding the use of acetylsalicylic acid at doses between 100 mg / day and 500 mg / day. Therefore, the recommendations below for doses of 500 mg / day and above also apply to this dose range (see section below). Doses of 500 mg / day and more
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased by less than 1% up to about 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first 24 weeks of pregnancy, acetylsalicylic acid should not be administered except in strictly necessary cases. If acetylsalicylic acid is used by a woman attempting to conceive or during the first 24 weeks of pregnancy, the dose and duration of treatment should be kept as low as possible.
Beyond 24 weeks of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
renal dysfunction, which can progress to renal failure with oligo-hydroamnios.
At the end of pregnancy, the mother and the newborn may present:
prolongation of bleeding time due to inhibition of platelet aggregation, which may occur even after administration of very low doses of acetylsalicylic acid,
inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy (after 24 weeks of gestation) (see section 4.3).
In pregnant or lactating women, the product should be used in case of need and under direct medical supervision.
Feeding time
Acetylsalicylic acid passes into breast milk: acetylsalicylic acid is therefore not recommended during breastfeeding (see section 4.4). [/ Su_spoiler]
[su_spoiler title = "EFFECTS ON THE ABILITY TO DRIVE VEHICLES"style =" fancy "icon =" chevron-circle "] No effects of Acetylsalicylic Acid Zentiva 500 mg on the ability to drive or use machines have been observed. [/ su_spoiler]
[su_spoiler title = "SIDE EFFECTS"style =" fancy "icon =" chevron-circle "] Frequencies cannot be defined based on available data, so frequencies are listed as" not known ".
Disorders of the blood and lymphatic system
Hemorrhagic syndromes (epistaxis, gum bleeding, purpura, etc.) with an increase in bleeding time.
The risk of bleeding may persist for 4-8 days after discontinuation of acetylsalicylic acid. It can cause an increased risk of bleeding in the event of surgery. Intracranial and gastrointestinal bleeding can also occur. Intracranial hemorrhage can be fatal, especially when the drug is given to the elderly.
Thrombocytopenia.
Haemolytic anemia in patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency (see section 4.4).
Pancytopenia, bilinear cytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leukopenia.
Disorders of the immune system
Hypersensitivity reactions, anaphylactic reactions, asthma, angioedema
Nervous system disorders
Headache, dizziness, feeling of hearing loss, tinnitus, which are usually indicative of an overdose.
Intracranial hemorrhage
Cardiac disorders:
Kounis syndrome in the context of a hypersensitivity reaction to acetylsalicylic acid.
Vascular disorders:
Not known: life-threatening haemorrhage, vasculitis including Schönlein-Henoch purpura.
Respiratory, thoracic and mediastinal disorders
Chronic use may result in non-cardiogenic pulmonary edema which may also occur in the context of a hypersensitivity reaction to acetylsalicylic acid.
Gastrointestinal disorders
Upper gastrointestinal disorders:
esophagitis, erosive duodenitis, erosive gastritis, oesophageal ulcer, perforation.
Lower gastrointestinal disorders:
ulcers of the small intestine (jejunum and ileus) and of the large intestine (colon and rectum), colitis and intestinal perforation. These reactions may or may not be associated with haemorrhage and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or with a history of serious gastrointestinal events.
Acute pancreatitis in the context of a hypersensitivity reaction to acetylsalicylic acid.
Abdominal pain
Occult or overt gastrointestinal bleeding (haematemesis, melaena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose-dependent. Gastric ulcers and perforations.
Hepatobiliary disorders
Increased liver enzymes, liver damage, especially hepatocellular, chronic hepatitis.
Skin and subcutaneous tissue disorders
Urticaria, skin reactions, fixed eruptions.
Renal and urinary disorders
Not known: renal failure.
Prolonged high doses can cause acute renal failure and acute interstitial nephritis.
Reproductive system and breast disorders
Not known: haematospermia
General disorders and administration site conditions
Reye's syndrome (see section 4.4).
Edema associated with high doses of acetylsalicylic acid.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Harrap/su_spoiler]
[su_spoiler title = "OVERDOSE"style =" fancy "icon =" chevron-circle "] No cases of overdose have been reported. For acetylsalicylic acid toxic doses are between 200 mg / kg and 300 mg / kg orally. In cases of acute overdose and chronic with acetylsalicylic acid, life-threatening non-cardiogenic pulmonary edema may occur (see section 4.8. The risk of overdose is important in the elderly and particularly young children (therapeutic overdose or, more frequently, accidental intoxication), where it may be Fatal. Overdose with salicylates, particularly in young children, can lead to severe hypoglycemia and potentially fatal intoxication. Symptoms Moderate poisoning: ringing in the ears, feeling of decreased hearing acuity, headache and dizziness are indicative of overdose and can be controlled from a reduction in dosage. Severe poisoning:
fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia. In children, an overdose can be fatal at a dose reduced to 100 mg / kg in a single intake. Emergency management: Immediate transfer to a specialized hospital unit. Gastric lavage and administration of activated charcoal. Control of acid-base balance. Urine alkalinization with urine pH monitoring. Hemodialysis in cases of severe poisoning
Symptomatic treatment [/ su_spoiler]
[su_spoiler title = "
LIST OF EXCIPIENTS"style =" fancy "icon =" chevron-circle "] Glycine, mandarin flavor, glycyrrhized ammonium. [/ su_spoiler]
[su_spoiler title = "
STORAGE"style =" fancy "icon =" chevron-circle "]
Store in the original package at a temperature below 25 ° C. [/ Su_spoiler]
[su_spoiler title = "
MARKETING AUTHORIZATION HOLDER"style =" fancy "icon =" chevron-circle "] Zentiva Italia Srl
Viale L. Bodio, 37 / B
IT-20158 Milan [/ su_spoiler]
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AUTHORIZATION NUMBER - MINSAN"style =" fancy "icon =" chevron-circle "]
Acetylsalicylic acid Zentiva 500 mg powder for oral solution, 20 sachets AIC: 022619086 [/ su_spoiler]