Active ingredients: Iron
FERLIXIT 62.5 mg / 5 ml solution for oral and intravenous use
Why is Ferlixit used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Anti-anemic drug, preparation based on trivalent iron.
THERAPEUTIC INDICATIONS
Iron-free anemia: parenteral use of the product is limited to patients in whom oral treatment is not effective.
Contraindications When Ferlixit should not be used
Ferlixit should not be administered in case of
- hypersensitivity to the active substance or to one of the excipients.
- excessive accumulation of iron (hemochromatosis, chronic haemolysis) or disorders of iron metabolism (sideroacrestic anemia, sideroblastic anemia, saturnine anemia, thalassemia),
- severe inflammatory diseases of the liver or kidneys,
- infants and children under 3 years of age.
Due to the presence of benzyl alcohol, the product should not be administered to infants and children under three years of age.
Precautions for use What you need to know before taking Ferlixit
Pediatric population
The use of Ferlixit is not recommended in children between three and six years of age due to insufficient safety data available.
Keep this medicine out of the reach and sight of children to avoid accidental iron poisoning.
Parenterally administered iron preparations can cause anaphylactic reactions and / or anaphylactoid reactions, which can be potentially fatal.
Intravenous use:
the preparation must be injected very slowly and cannot be mixed with other preparations. If necessary, dilution is only possible with physiological sodium chloride solution. Do not mix with other medicines. Do not mix with nutritional parenteral solutions.
Hypotensive episodes may occur if the injection is given too quickly. Allergic reactions, sometimes with arthralgia, have been observed more commonly when the recommended dose has been exceeded.
Interactions Which drugs or foods can modify the effect of Ferlixit
Tell your doctor if you have recently taken any other medicines, even those without a prescription
If taken by mouth the absorption of tetracyclines can be inhibited.
Iron can reduce the gastrointestinal absorption of penicillamines. If both therapies are to be taken, penicillamines should be administered at least 2 hours before or 2 hours after taking the iron preparation.
Chloramphenicol can delay the response of iron therapy.
Concomitant administration of antacids and oral iron preparations may reduce iron absorption.
Concomitant administration of iron preparations may interfere with the absorption of some oral quinolones such as ciprofloxacin, norfloxacin and ofloxacin as results from the decreased concentration of quinolones in serum and urine.
In addition, the absorption of methyldopa and, in subjects with primary hypothyroidism, that of thyroxine may decrease.
The incidence and severity of possible anaphylactic / anaphylactoid reactions during Ferlixit therapy may increase if Ferlixit is used in patients receiving ACE inhibitors.
The benzidine test for the diagnosis of gastric diseases may be falsely positive.
Warnings It is important to know that:
Considering the high incidence of side effects resulting from the parenteral administration of iron-based preparations, the use of the specialty in this way must be limited to strictly necessary cases.
Ferlixit should be administered with special caution in case of:
- patients with known allergic diathesis eg. in asthmatics, or in patients with eczema or other atopic allergies,
- chronic inflammatory diseases (Crohn's disease, progressive rheumatoid arthritis)
To avoid hemosiderosis, it is essential to calculate the amount of iron required before intravenous administration of iron.
Accidental paravenous or intramuscular injection is painful due to the benzyl alcohol content and should therefore be avoided. In addition, accidental paravenous administration may cause reddish-brown discoloration of the skin.
Pregnancy and breastfeeding
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Intravenous use: the use of the product during pregnancy is not recommended
There are no adequate data on the use of sodium ferric gluconate - sucrose complex during pregnancy. Studies in guinea pigs have shown reproductive toxicity. The potential risk for the woman is unknown. Administration during pregnancy should only be considered if oral iron administration is ineffective or cannot be tolerated and if the anticipated benefits to the mother outweigh all possible risks to the fetus.
Because of the rare circulatory reactions that an "iron injection can cause (see" Undesirable effects "), there is a potential risk for pregnant women of developing fetal nutrition disorders due to insufficient blood supply to the placenta.Therefore, particular attention should be paid to correct use (see "Dose, method and time of administration").
Pregnancy
It is not known whether iron excretion in breast milk is increased after parenteral iron administration. Ferlixit should therefore only be administered during lactation after careful consideration of the benefits and risks.
Effects on ability to drive and use machines
No studies on the ability to drive or use machines have been performed.
Important information about some of the ingredients
This medicine contains benzyl alcohol. This medicine should not be given to premature babies or newborns. It can cause toxic and allergic reactions in children up to 3 years of age.
This medicinal product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dosage and method of use How to use Ferlixit: Dosage
Oral use:
Adults: 2 ampoules per day - Children: 1 ampoule per day.
In the opinion of the doctor the dose can be increased.
It is advisable to take Ferlixit during meals, pure or diluted in a little plain or sugared water or in any drink or liquid food. Pour the contents, shaking the vial and tapping lightly on the bottom.
Intravenous use: 1-2 ampoules of 5 ml (62.5 mg of Fe +++) per day in the opinion of the doctor.
It is recommended, based on the data of the hemoglobin analysis, to adopt the following formula to calculate the iron deficit to be supplemented:
(Hb norm.g 16 - g ... Hb paz) x 225
-------------------------------------------------- ------- = n. vials
mg Fe per vial
The intravenous injection should always be given very slowly with the patient supine.
The vial, without the use of the file, breaks at the point of pre-breaking and does not give rise to splinters.
Overdose What to do if you have taken too much Ferlixit
In case of accidental ingestion / intake of an excessive dose of Ferlixit, notify your doctor immediately or go to the nearest hospital.
Signs of a Ferlixit overdose may include circulatory collapse, shock, paleness, dyspnoea, restlessness and even confusion and coma. Fever and seizures have also been reported.
Treatment must be as prompt as possible in addition to suitable supportive therapy.
Should overdose syndromes occur, proceed in analogy to all preparations containing iron (gastric lavage, restoration of volume, administration of deferoxamine).
If you have any questions about the use of Ferlixit, ask your doctor or pharmacist
Side Effects What are the side effects of Ferlixit
Like all medicines, Ferlixit can cause side effects, although not everybody gets them.
The assessment of undesirable effects is based on the frequencies listed below
Very common (≥ 10%)
Common (≥ 1% - <10%)
Uncommon (≥ 0.1% - <1%)
Rare (≥ 0.01% - <0.1%)
Very rare (<0.01%)
Not known: (frequency cannot be estimated from the available data)
Disorders of the blood and lymphatic system
Very rare: haemolysis, haemoglobinuria (overload of the transferrin system)
Vascular pathologies
Rare: hypotensive events also with evolution in circulatory collapse
Respiratory, thoracic and mediastinal disorders
Rare: pulmonary edema, bronchial mucosal edema with dyspnoea
Skin and subcutaneous tissue disorders
Rare: Exanthematous changes of the skin
General disorders and administration site conditions
Rare: anaphylactic reactions with edema in various parts of the body, including face, mouth and pharynx (e.g. edema of the glottis), malaise, warmth
Disorders of the immune system
Rare: anaphylactic reactions, anaphylactoid reactions
The frequency of the underlying undesirable effects cannot be estimated from the available data.
Cardiac pathologies
Palpitations, tachycardia
Metabolism and nutrition disorders
Hyperkalaemia, hypokalaemia
Nervous system disorders
Paresthesia, dizziness, taste disturbances, headache
Gastrointestinal disorders
Diarrhea, heartburn, nausea, vomiting, abdominal pain. Constipation (prolonged administration). Dark discolouration of the stool (meaningless). Musculoskeletal and connective tissue disorders Chest and back pain, muscle and joint pain, especially in patients with rheumatic disorders
Skin and subcutaneous tissue disorders
Skin rash
Vascular pathologies
Hypertension, facial erythema
Use in children
The following events were observed in a clinical study in children on dialysis
Cardiac pathologies
Very common: palpitations Infections and infestations
Common: infections, pharyngitis, sinusitis
Vascular pathologies
Very common: hypertension, hypotension
Common: thrombosis
Gastrointestinal disorders
Very common: nausea, vomiting, abdominal pain
Musculoskeletal and connective tissue disorders
Common: muscle and joint pain, chest and back pain
General disorders and administration site conditions
Very common: headache
Common: fever, face edema
Rarely, benzyl alcohol can cause hypersensitivity reactions.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Store at a temperature not exceeding 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION
1 vial of 5 ml contains:
Active principles:
sodium ferric gluconate complex 177.5 mg
equal to trivalent iron 62.5 mg
Excipients:
sucrose
benzyl alcohol 9 mg / ml
water for injections.
PHARMACEUTICAL FORM AND CONTENT
Solution for oral use and intravenous use
Packaging:
Box containing 5 ampoules of 5 ml (62.5 mg Fe +++)
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FERLIXIT 62.5 MG / 5 ML
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of 5 ml contains:
Active principle:
sodium ferric gluconate complex 177.5 mg.
equal to trivalent iron 62.5 mg.
Excipients:
benzyl alcohol: 9 mg / ml.
sucrose: 975 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Solution for oral use and intravenous use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Iron-free anemia: parenteral use of the product is limited to patients in whom oral treatment is not effective.
04.2 Posology and method of administration
Oral use:
- adults: 2 ampoules per day
- children: 1 ampoule per day
In the opinion of the doctor the dose can be increased.
It is advisable to take Ferlixit during meals, pure or diluted in a little plain or sugared water or in any drink or liquid food. Pour the contents, shaking the vial and tapping lightly on the bottom.
Intravenous use:
1-2 ampoules of 5 ml (62.5 mg of Fe +++) per day in the opinion of the doctor. It is recommended, based on the data of the hemoglobin analysis, to adopt the following formula to calculate the iron deficit to be supplemented:
The intravenous injection should always be given very slowly with the patient supine.
04.3 Contraindications
Ferlixit should not be administered in case of
- hypersensitivity to the active substance or to one of the excipients.
- excessive accumulation of iron (hemochromatosis, chronic haemolysis) or disorders of iron metabolism (sideroacrestic anemia, sideroblastic anemia, saturnine anemia, thalassemia),
- severe inflammatory diseases of the liver or kidneys,
- infants and children under 3 years of age.
Due to the presence of benzyl alcohol, the product should not be administered to infants and children under three years of age.
04.4 Special warnings and appropriate precautions for use
Pediatric population
The use of Ferlixit is not recommended in children between three and six years of age due to insufficient safety data available.
Keep this medicine out of the reach and sight of children to avoid accidental iron poisoning.
Parenterally administered iron preparations can cause anaphylactic reactions and / or anaphylactoid reactions, which can be potentially fatal.
Intravenous use: the preparation must be injected very slowly with the patient supine and cannot be mixed with other preparations. A dilution is possibly only possible with physiological solution. Do not mix with other medicines. Do not mix with nutritional parenteral solutions.
Hypotensive episodes may occur if the injection is given too quickly. Allergic reactions, sometimes with arthralgia, have been observed more commonly when the recommended dose has been exceeded.
Considering the high incidence of side effects (see section 4.8) following the parenteral administration of iron-based preparations, the use of the product by this route should be limited to strictly necessary cases.
Ferlixit should be administered with special caution in case of:
• patients with known allergic diathesis eg. in asthmatics, or in patients with eczema or other atopic allergies,
• chronic inflammatory diseases (Crohn's disease, progressive rheumatoid arthritis)
To avoid hemosiderosis, it is essential to calculate the amount of iron required before intravenous administration of iron.
Accidental paravenous or intramuscular injection is painful due to the benzyl alcohol content and should therefore be avoided. In addition, accidental paravenous administration may cause reddish-brown discoloration of the skin.
Important information about some of the ingredients
This medicine contains benzyl alcohol. Benzyl alcohol can cause toxic and anaphylactic reactions in infants and children up to 3 years of age.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
If taken by mouth the absorption of tetracyclines can be inhibited.
Iron can reduce the gastrointestinal absorption of penicillamines. If both therapies are to be taken, penicillamines should be administered at least 2 hours before or 2 hours after taking the iron preparation.
Chloramphenicol can delay the response of iron therapy.
Concomitant administration of antacids and oral iron preparations may reduce iron absorption.
Concomitant administration of iron preparations may interfere with the absorption of some oral quinolones such as ciprofloxacin, norfloxacin and ofloxacin as results from the decreased concentration of quinolones in serum and urine.
In addition, the absorption of methyldopa and, in subjects with primary hypothyroidism, that of thyroxine may decrease.
The incidence and severity of possible anaphylactic / anaphylactoid reactions during Ferlixit therapy may increase if Ferlixit is used in patients receiving ACE inhibitors.
The benzidine test for the diagnosis of gastric diseases may be falsely positive.
04.6 Pregnancy and lactation
Pregnancy
Intravenous use : the use of the product during pregnancy is not recommended
There are no adequate data on the use of sodium ferric gluconate-sucrose complex during pregnancy. Studies in guinea pigs have shown reproductive toxicity (see section 5.3). The potential risk for the woman is unknown. Administration in pregnancy should be only considered if oral iron administration is ineffective or cannot be tolerated and if the anticipated benefits to the mother outweigh all possible risks to the fetus (see section 5.3).
Because of the rare circulatory reactions that an injection of iron can cause (see section 4.8), there is a potential risk for pregnant women of developing fetal nutrition disorders due to an insufficient blood supply to the placenta. particular attention to correct use (see section 4.2).
Feeding time
It is not known whether iron excretion in breast milk is increased after parenteral iron administration. Ferlixit should therefore only be administered during lactation after careful consideration of the benefits and risks.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive or use machines have been performed.
04.8 Undesirable effects
The assessment of undesirable effects is based on the following frequencies:
Disorders of the blood and lymphatic system
Very rare: haemolysis, haemoglobinuria (overload of the transferrin system)
Vascular pathologies
Rare: hypotensive events also with evolution in circulatory collapse
Respiratory, thoracic and mediastinal disorders
Rare: pulmonary edema, bronchial mucosal edema with dyspnoea
Skin and subcutaneous tissue disorders
Rare: Exanthematous changes of the skin
General disorders and administration site conditions
Rare: anaphylactic reactions with edema in various parts of the body, including face, mouth and pharynx (e.g. edema of the glottis), malaise, warmth
Disorders of the immune system
Rare: anaphylactic reactions, anaphylactoid reactions
The frequency of the underlying undesirable effects cannot be estimated from the available data.
Cardiac pathologies
Palpitations, tachycardia
Metabolism and nutrition disorders
Hyperkalaemia, hypokalaemia
Nervous system disorders
Paresthesia, dizziness, taste disturbances, headache
Gastrointestinal disorders
Diarrhea, heartburn, nausea, vomiting, abdominal pain.
Constipation (prolonged administration).
Dark discolouration of the stool (meaningless).
Musculoskeletal and connective tissue disorders
Chest and back pain, muscle and joint pain, especially in patients with rheumatic disorders
Skin and subcutaneous tissue disorders
Skin rash
Vascular pathologies
Hypertension, facial erythema
Use in children
The following events were observed in a clinical study in children on dialysis
Cardiac pathologies
Very common: palpitations
Infections and infestations
Common: infections, pharyngitis, sinusitis
Vascular pathologies
Very common: hypertension, hypotension
Common: thrombosis
Gastrointestinal disorders
Very common: nausea, vomiting, abdominal pain
Musculoskeletal and connective tissue disorders
Common: muscle and joint pain, chest and back pain
General disorders and administration site conditions
Very common: headache
Common: fever, face edema
Rarely, benzyl alcohol can cause hypersensitivity reactions.
04.9 Overdose
Signs of a Ferlixit overdose may include circulatory collapse, shock, paleness, dyspnoea, restlessness and even confusion and coma. Fever and seizures have also been reported.
Treatment must be as prompt as possible in addition to suitable supportive therapy.
Should overdose syndromes occur, proceed in analogy to all preparations containing iron (gastric lavage, restoration of volume, administration of deferoxamine).
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: trivalent iron, parenteral preparations.
ATC code B03AC07.
Ferlixit allows to carry out a targeted martial therapy, exactly dosed, with normalization of erythrocyte and hemoglobin values.
In fact, a sufficient quantity of iron is supplied to the organs of erythropoiesis for the formation of hemoglobin, also allowing the reconstitution of the biological reserves of iron.
The efficacy of iron restoration is reflected in an increase in the number of reticulocytes, in the levels of hemoglobin, in the concentration of hemoglobin in the single erythrocyte and in the number of erythrocytes.
05.2 Pharmacokinetic properties
The iron of the ferrigluconate complex, inserted in the anionic sugar group (macromolecule), administered orally, is gradually released in the gastrointestinal tract; administered i.v., it progressively transfers to transferrin (the protein that transports iron in the blood) and from this to the organs of erythropiesis and to the iron deposits.
This mechanism explains the good local (gastrointestinal) and general tolerability.
If there is no pathological loss of iron through bleeding, the body's iron reserves remain virtually intact, apart from a minimal physiological elimination of iron.
05.3 Preclinical safety data
The toxicological data collected in various animal species (LD50 rat, i.v .: 21.9 ml / kg) agree with the clinical finding of good tolerability.
Preclinical data on safety, pharmacology and toxicity for single or repeated administration did not provide additional information beyond what is already reported in other parts of the Summary of Product Characteristics.
There is no evidence of potential iron mutagenicity in mammalian cells in vivo. There are no long-term studies on carcinogenic potential.
Studies in rats and mice showed no evidence of teratogenic effects, but embryonic and fetal toxicity occurred at doses much higher than the therapeutic dose in humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sucrose, benzyl alcohol, water for injections.
06.2 Incompatibility
In case of oral intake, the benzidine test for the diagnosis of gastric affections can be falsely positive.
06.3 Period of validity
In intact packaging: 5 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Box containing 5 vials of 5 ml.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n °. 021455023
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
26.08.1969/01.06.2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of March 2012
11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY
12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL
25 October 2013
Stricter recommendations on the risk of severe hypersensitivity reactions with intravenous iron-containing medicinal products
Dear Doctor, Dear Doctor,
Important information on intravenous (IV) iron-containing medicines has emerged following a European-wide reassessment of their benefit / risk ratio, following concerns about the risk of severe hypersensitivity reactions.
Summary
All IV iron-containing medicines can cause serious, potentially fatal hypersensitivity reactions. Such reactions can also occur when a previous administration has been tolerated (including a negative test dose, see below). Based on currently available data, the benefits of all IV iron-containing medicinal products continue to outweigh the risks, provided the following recommendations are followed.
• IV iron-containing medicines should not be used in patients with hypersensitivity to the active substance, to the medicine itself or to any of its excipients, and in patients with severe hypersensitivity to other parenteral iron-containing medicines.
• The risk of hypersensitivity is higher in patients with known allergies (including drug allergies) and in patients with inflammatory or immune system disorders (e.g. systemic lupus erythematosus, rheumatoid arthritis), as well as in patients with a history of severe asthma, eczema or other atopic allergy. In these patients, IV iron-containing medicinal products should only be used if the benefit clearly outweighs the possible risk.
• To minimize the risks, IV iron-containing medicinal products should be administered according to the posology and method of administration described in the product information of each individual medicinal product.
• IV iron-containing medicinal products should only be administered when qualified personnel capable of evaluating and managing anaphylactic / anaphylactoid reactions and resuscitation equipment are immediately available.
• All physicians prescribing these medicines should inform patients of the risk of hypersensitivity before each administration. Patients should be informed of related symptoms and asked to contact their physician urgently in case of a reaction.
• Patients should be closely monitored for signs of hypersensitivity during and for at least 30 minutes after each administration of an IV iron-containing medicine.
• IV iron medicines should not be used during pregnancy unless absolutely necessary. Treatment should be limited to the 2nd or 3rd trimester if the benefits are considered to clearly outweigh the possible risks to both the mother and the fetus. Risks to the fetus can be serious and include anoxia and fetal distress.
This Important Information Note is sent in agreement with the European Medicines Agency and the Italian Medicines Agency.
Further information
IV iron-containing medicinal products are indicated in iron deficiency situations, when oral administration is insufficient or poorly tolerated. Diagnosis must be based on accurate laboratory tests.
Security Issues
A European-wide re-evaluation has been initiated due to safety concerns in relation to the risk of severe hypersensitivity reactions, including during use during pregnancy. All IV iron-containing medicinal products can cause severe hypersensitivity reactions, such reactions may also occur after previous administration has been tolerated (including a negative test dose). fatal.
The product information has been carefully revised and edited regarding the risk of severe hypersensitivity reactions and is now consistent for all IV iron-containing medicinal products. In the "Annex to this letter, changes to the Summary of Product Characteristics (SmPC) specific to hypersensitivity reactions are highlighted. These measures are intended to raise awareness of the risk of serious hypersensitivity reactions with medicinal products containing iron by route. IV, minimize risk where possible and ensure that patients are adequately informed.
Note that prescribing and safety information differ between IV iron-containing medicinal products and, as appropriate, the specific Summary of Product Characteristics (SmPC) should be consulted before and during use.
Precautions for use in pregnancy
There are no adequate and well-controlled studies in pregnant women. Animal studies have shown reproductive toxicity.
Iron deficiency anemia, which occurs during the first trimester of pregnancy, can usually be treated with oral iron (you should not use intravenous iron). The benefits of using iron-containing medicines for via IV must be carefully weighed with respect to subsequent risks in pregnancy. Anaphylactic / anaphylactoid reactions that occur with IV iron medicines can have consequences for both mother and fetus (eg, anoxia, fetal distress and death).
Test dose
A test dose was previously recommended for some IV iron medicines. However, no accurate data is available to support its protective effect with certainty. The test dose can provide false reassurance, as allergic reactions can also occur in patients who have had a negative test dose. As a result, test doses are no longer recommended and are replaced by the above risk minimization recommendations. Caution should be exercised with any dose of IV iron-containing medicinal product, even if previous administrations have been well tolerated. IV iron-containing medicinal products should be administered according to the posology and method of administration described in the product information of each individual medicinal product. In the event of a hypersensitivity reaction, healthcare professionals are advised to discontinue treatment immediately and consider appropriate therapy.
For more details, refer to the sections of the CPR in the annex.
Call to report
Physicians and other healthcare professionals are required to report any suspected adverse reactions associated with intravenous iron-containing medicines.
Doctors and other health professionals must, by law, send reports of suspected adverse reactions, using the special paper form (available on the website http://www.agenziafarmaco.gov.it/sites/default/files/tipo_fil ecb84.pdf) or by filling out the electronic form online (http://www.agenziafarmaco.gov.it/sites/default/files/scheda_ aifa_oper_sanitario16.07. 2012.doc) promptly, to the Pharmacovigilance Manager of the healthcare facility to which they belong or, if operating in private healthcare facilities, through the Health Department, to the Pharmacovigilance Manager of the ASL competent for the area.
Reports of Suspected Adverse Reaction from Drugs must be sent to the Head of Pharmacovigilance of the Structure to which the Operator belongs.
This Information Note is also published on the AIFA website (www.agenziafarmaco.it) whose regular consultation is recommended for the best professional and service information to the citizen.
