Veracer

Package leaflet: Information for the user

VERACER 5000 U.I./1 ml solution for injection, 25000 U.I./5 ml solution for injection

Sodium heparin
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What VERACER is and what it is used for
2. What you need to know before using VERACER
3. How to use VERACER
4. Possible side effects
5. How to store VERACER
6. Contents of the pack and other information

1. What VERACER is and what it is used for

VERACER contains sodium heparin (derived from porcine intestinal mucosa), an anticoagulant
(blood thinner) belonging to the group of antithrombotic agents, capable of preventing or
treating the formation of blood clots.
VERACER is used to prevent and treat venous and arterial thromboembolic disease.
It is also used in patients undergoing haemodialysis or surgical procedures requiring
extracorporeal circulation.

2. What you should know before using VERACER

Do not use VERACER

• If you are allergic to sodium heparin or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe thrombocytopenia (low platelet count);
• if you suffer from disorders associated with a tendency to bleeding (hemorrhagic diathesis), for example, diseases characterized by a blood coagulation disorder (coagulopathies);
• if you have severe liver, kidney, or pancreatic diseases;
• if coagulation tests, such as blood clotting time, cannot be performed at appropriate intervals when Veracer is administered at therapeutic doses;
• if you have uncontrolled bleeding;
• if you have heparin-induced thrombocytopenia-associated disseminated intravascular coagulation (DIC);
• in case of loco-regional anesthesia for elective surgical procedures, as it is contraindicated in patients receiving heparin at anticoagulant doses;

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• if you have hemorrhagic cerebrovascular accidents or stroke;
• if you have organ lesions with a high risk of bleeding, such as stomach and/or intestinal ulcers, cerebral hemorrhage, cerebral artery aneurysm, or brain tumor (cerebral neoplasia);
• if you have trauma or have undergone surgery involving the central nervous system (brain and spinal cord), eyes, or ears;
• if you have retinal disease (retinopathy) or vitreous hemorrhage (a part of the eye);
• if you have inflammation of the inner lining of the heart caused by germs (infective endocarditis);
• due to the presence of benzyl alcohol, the 5000 IU/1 ml dosage must not be administered to children under 3 years of age, or to pregnant or breastfeeding women (see sections “Warnings and precautions” and “Pregnancy, breastfeeding and fertility”);

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using VERACER.
During treatment with heparin, your doctor will closely monitor you if you:

• have suspected cancer associated with a tendency to bleeding;
• have alcohol dependence;
• are elderly, as the risk of bleeding is higher, especially in women;
• have previously had an allergic reaction to low molecular weight heparin;
• have diabetes mellitus, kidney problems, metabolic acidosis, high blood potassium levels, or are taking drugs that increase blood potassium levels, or have been on long-term heparin therapy, since sodium heparin may increase blood potassium levels;
• are at risk of bleeding due to conditions such as:

Cardiovascular:

• subacute infectious inflammation of the heart (subacute bacterial endocarditis);
• uncontrolled high blood pressure (uncontrolled hypertension despite antihypertensive therapy).

Hematological:

• congenital or acquired disorders characterized by reduced blood coagulation (hemophilic syndromes or coagulation factor deficiency);
• reduced platelet count (thrombocytopenia);
• impaired platelet function (thrombopathies);
• certain hemorrhagic vascular purpuras (such as Rendu-Osler disease).

Gastrointestinal:

• peptic ulcer;
• esophagitis or erosive gastritis;
• active phase inflammatory bowel disease;
• continuous drainage of the stomach or small intestine.

Surgical:
during and immediately after:

• lumbar puncture or spinal anesthesia or
• major surgery on the brain, spine, or eye.

Hepatic:
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• liver disease with coagulation abnormalities and/or esophageal varices or portal hypertension-related gastropathy with high risk of hemorrhage.

Other:

• threatened abortion;
• during the menstrual cycle;
• postpartum period;
• concomitant treatment with fibrinolytic agents or oral anticoagulants, platelet aggregation inhibitors (e.g., acetylsalicylic acid, ticlopidine, clopidogrel), non-steroidal anti-inflammatory drugs (NSAIDs), and/or glycoprotein IIb/IIIa receptor antagonists. In all cases of bleeding, even minor, stop treatment with VERACER and contact your doctor. Be especially careful to avoid injury during treatment with VERACER.

If you have or have previously had hyperkalemia, a condition characterized by elevated potassium levels in the blood, your doctor will perform tests to measure blood potassium levels before starting therapy and at regular intervals during treatment, especially if treatment lasts longer than 7 days.
If you have or have previously had heparin-induced thrombocytopenia (low platelet count), your doctor must carefully monitor your platelet count throughout the course of treatment with sodium heparin.
If you develop fever, thrombosis, thrombophlebitis, infections with thrombotic tendency, inflammatory states, sometimes during myocardial infarction, cancer, congenital or post-surgical antithrombin III deficiency, you may have reduced sensitivity to heparin; your doctor will evaluate these conditions.
Heparin must not be administered intramuscularly due to the risk of hematoma formation.
During treatment with VERACER, avoid intramuscular administration of other drugs due to the risk of hematoma.
If you are taking heparin and experience any of the side effects listed in this leaflet, contact your doctor immediately (see also section “Possible side effects”).
In patients undergoing spinal or epidural anesthesia, epidural analgesia, or lumbar puncture, prophylaxis with low-dose unfractionated heparin (i.e., administered intravenously) may rarely be associated with spinal or epidural hematomas, which may lead to prolonged or permanent paralysis of the lower limbs. The risk is increased by:

• use of indwelling epidural catheters for continuous infusion;
• concomitant use of drugs affecting hemostasis (bleeding control), such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or anticoagulants;
• repeated trauma or spinal punctures;
• presence of an underlying hemostatic disorder;
• advanced age. The presence of one or more of these risk factors should be carefully evaluated before proceeding with this type of anesthesia/analgesia during prophylaxis with unfractionated heparins.

You should therefore be monitored frequently for signs and symptoms of neurological abnormalities, such as back pain, sensory and motor deficits (numbness and weakness in the lower limbs), and intestinal and/or bladder dysfunction.
Inform a doctor or healthcare provider immediately if any of these symptoms occur.
Unlike treatment with dicoumarol, routine laboratory monitoring of heparin therapy is not strictly necessary; however, for monitoring purposes, measuring the whole blood clotting time (Lee-White) is sufficient, and determination of prothrombin time is not required.
The use of heparin may alter your thyroid function tests (e.g., falsely elevated T3 and T4 levels).
Due to the animal origin of heparin, if you have had previous allergic reactions, your doctor may administer a reduced dose of heparin to test for possible reactions.
Bleeding may occur in any part of the body in patients receiving sodium heparin. An unexplained drop in hematocrit, a fall in blood pressure, or any other sign or symptom not attributable to other causes should raise suspicion of a hemorrhagic event.
In any case of bleeding, your doctor will discontinue treatment with heparin.
Children
Due to the presence of benzyl alcohol, VERACER 5000 IU/1 ml injection solution is contraindicated in neonates and children up to 3 years of age, unless otherwise directed by a physician.
Other medicines and VERACER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular:

• Oral anticoagulants: anticoagulant-dose sodium heparin may slightly prolong prothrombin time (PT) (increase of approximately 0.5 in INR, International Normalized Ratio). This should be considered when evaluating this parameter, especially when combining heparin therapy with oral anticoagulant therapy. Close clinical and laboratory monitoring (frequent evaluation of PT and APTT) is recommended when unfractionated heparin at anticoagulant doses is used in combination with these drugs.
• Platelet aggregation inhibitors, fibrinolytics, and other medicines associated with bleeding risk: such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (e.g., phenylbutazone, ibuprofen, indomethacin, ketorolac, diclofenac), drugs with antiplatelet effects (e.g., ticlopidine, clopidogrel, sulfinpyrazone), certain cephalosporin antibiotics (e.g., cefaclor, cefixime, ceftriaxone, cefamandole, cefoperazone), dextran, dipyridamole, hydroxychloroquine, fibrinolytic drugs (e.g., streptokinase, urokinase, alteplase), coumarin derivatives, glycoprotein IIb/IIIa receptor antagonists (e.g., eptifibatide, abciximab), epoprostenol.
• Intravenous nitroglycerin, as it may significantly reduce the effect of heparin.
• Drugs that increase blood potassium levels, such as ACE inhibitors, sartans, potassium-sparing diuretics, potassium salts, beta-blockers (drugs used in cardiovascular conditions).
• Other drugs that may reduce the anticoagulant effect of heparin, such as digitalis (used to increase heart contraction force), tetracyclines and penicillins (antibiotics), nicotine, glucocorticoids (corticosteroid drugs), phenothiazines (antipsychotic and antihistamine drugs), antihistamines (drugs used to control allergy symptoms). During heparin therapy, thyroid function tests may yield altered results (false increase in thyroid hormones T3 and T4).

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Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of use during pregnancy has not been fully established. In the absence of reliable data, the decision to use heparin during pregnancy should be made after careful assessment of the benefit-risk ratio in individual cases.
VERACER 5000 IU/1 ml injection solution contains benzyl alcohol. Benzyl alcohol can cross the placenta; therefore, you should use a formulation that does not contain benzyl alcohol (see section “Warnings and precautions”).
Breastfeeding
Heparin is not excreted in breast milk.
Fertility
No specific data on fertility with heparin use are available.
Driving and using machines
VERACER does not affect the ability to drive or operate machinery.
Veracer 5000 IU/1 ml contains benzyl alcohol (0.016 mg/ml)
This medicine contains 0.016 mg of benzyl alcohol per vial, equivalent to 0.016 mg/1 ml.
Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems (gasping syndrome) in young children. Do not administer to neonates up to 4 weeks of age unless otherwise recommended by a doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Veracer 5000 IU/1 ml contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is practically ‘sodium-free’.
Since sodium heparin is a biological medicinal product, in order to improve traceability of heparins, the healthcare provider will record the trade name and batch number of the product administered to you in your medical record.

3. How to use VERACER

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is the one prescribed by your doctor. If you are being administered this medicine
for anticoagulant purposes, the dose to be taken must be determined based on frequent coagulation tests.
VERACER 5000 IU/1 ml solution for injection is for subcutaneous use.
VERACER 25000 IU/5 ml solution for injection is for intravenous use.
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If you use more VERACER than you should
If you use more VERACER than recommended, or in case of accidental ingestion, call a doctor or go
to the nearest hospital, taking the medicine package with you. This way, the doctor
will immediately know what you have taken.
Heparin is a compound used to keep the blood fluid, and if taken in excessive doses it may
cause bleeding (significant blood loss), particularly from the skin or mucous membranes, wounds, the
gastrointestinal or genitourinary tract (nosebleeds, blood in urine,
in stools), as well as formation of hematomas and petechiae, and hemorrhages. Symptoms of bleeding
may include a drop in blood pressure or a reduction in hematocrit, detectable through
a blood count.
If you notice the onset of any of these symptoms, stop treatment with VERACER immediately and contact
your doctor immediately or go to the nearest hospital.
If necessary, a substance called protamine will be administered to neutralize
the anticoagulant effect of heparin.
If you forget to use VERACER
Never use a double dose to make up for a forgotten dose.
Call your doctor or pharmacist immediately and follow their instructions.
If you stop using VERACER
Do not stop treatment without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
If you experience any of the following serious reactions, stop taking VERACER immediately and contact your doctor or go to the nearest Emergency Department:

• Bleeding (haemorrhage) in any part of the body
• Severe allergic reactions (may include chills, high fever, urticaria, asthma, rhinitis, increased lacrimation, nausea and vomiting, itching and burning in the feet, hypotension, vasospasm, anaphylactic shock)
• Severe skin lesions with inflammation (skin necrosis), bruises, more or less extensive purplish or reddish spots (purpura or petechiae)
• Thrombocytopenia (reduction in the number of platelets in the blood)
• Disseminated intravascular coagulation (DIC)
• Bruising or ulcers at the injection site
• Liver damage (hepatotoxicity)
• Breathing difficulties or chest pain (may be symptoms of pulmonary oedema or haemopneumothorax)
• Blood in the stools (melena)

Other side effects that may occur with unknown frequency (frequency cannot be estimated from the available data) include:

• Reactions at the site of administration (local irritation, erythema, mild pain)
• Amnesia 6/9
• Cerebral haemorrhage, extradural intracranial haematoma, non-traumatic spinal subdural haematoma, ventricular haemorrhage
• Osteoporosis
• Alopecia (hair loss)
• Hypoaldosteronism (reduced production of aldosterone)
• Hyperkalaemia (increased potassium levels in the blood)
• Metabolic acidosis (particularly in patients with renal impairment and diabetes mellitus)
• Rebound hyperlipidaemia (increase in blood lipids upon discontinuation of therapy)
• Bronchospasm (difficulty breathing)
• Increased transaminase levels (liver enzymes)
• Increased FT3 and FT4 levels (thyroid hormones)
• Priapism (persistent and painful erection not associated with sexual stimulation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VERACER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VERACER 5000 IU/1 ml contains

• The active substance is sodium heparin;
• The other components are: monobasic sodium phosphate; dibasic sodium phosphate; benzyl alcohol; water for injections.

What VERACER 25000 IU/5 ml contains

• The active substance is sodium heparin;
• The other component is water for injections.

Description of the appearance of VERACER and contents of the pack
Injectable solution 5000 IU for subcutaneous/intramuscular use, pack of 10 vials of 1 ml.
Injectable solution 25000 IU for intravenous use, pack of 10 vials of 5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MEDIC ITALIA S.r.l. - Via Bernardino Telesio, 2 - 20145 Milan (MI) - Italy
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Manufacturer VERACER 5000 IU/1 ml:
SAVIO INDUSTRIAL S.R.L. - Via E. Bazzano 14 - Ronco Scrivia (GE) – Italy
Manufacturers VERACER 25000 IU/5 ml:
ESSETI FARMACEUTICI S.r.l. - Via Campobello 15 – 00071 – Pomezia (RM) – Italy
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A. – Via Morolense 87, Ferentino, 03013, Italy
_________________________________________________________________________

The following information is intended exclusively for healthcare professionals:

Dosage and administration
Prophylaxis of arterial and venous thromboembolism
Perioperative prophylaxis
The initial dose is 5,000 IU administered subcutaneously 2 hours before surgery, followed by 5,000
IU every 8–12 hours for at least 7 days or until the patient resumes ambulation.
Prophylaxis in non-surgical patients
The same dose is used for prophylaxis in non-surgical patients at high risk.
The choice between administration every 8 or 12 hours should take into account the individual
patient’s thromboembolic risk and bleeding risk.
Extracorporeal circulation (cardiopulmonary bypass)
The dose is 300 IU/kg administered intravenously, adjusted to maintain the Activated Clotting
Time (ACT) within the range of 400–500 seconds.
Hemodialysis
The initial dose is 1,000–5,000 IU administered intravenously, followed by 1,000–2,000 IU/hour,
adjusted according to clinical need.
Monitoring:
Routine monitoring is not required.
Treatment of arterial and venous thromboembolism
Initial dose: 80 IU/kg intravenously as a bolus, or 5,000 IU as an intravenous bolus injection
(10,000 IU in case of severe pulmonary embolism).
Maintenance dose: 18 IU/kg/hour as a continuous intravenous infusion (range 1,000–2,000 IU/hour),
adjusted according to response, or 1,000 IU/hour as a continuous infusion.
Alternative treatment regimens:
Intermittent intravenous injection: 10,000 IU IV bolus followed by 5,000–10,000 IU IV every 4–6
hours.
Intermittent subcutaneous injection: initial dose of 333 IU/kg followed by 250 IU/kg every 12
hours (range 10,000–20,000 IU) or 8,000–10,000 IU every 8 hours.
Monitoring:
When sodium heparin is administered at anticoagulant doses, dosage must be determined based
on coagulation tests. The most commonly used test is the activated partial thromboplastin time
(aPTT). The aPTT of treated patients should be maintained at 1.5–2.5 times the normal control
value. Regular monitoring of aPTT values is recommended, preferably on a daily basis.
If coagulation tests exceed the therapeutic range or if bleeding occurs, the dose should be reduced
or, if necessary, heparin therapy should be discontinued.

Special populations
Paediatric population
Prophylaxis of arterial and venous thromboembolism
No dosage recommendations are available.
Treatment of arterial and venous thromboembolism
Initial dose: 50 IU/kg as an intravenous bolus injection.
Maintenance dose: 15–25 IU/kg/hour as a continuous intravenous infusion, or 100 IU/kg IV every
4 hours as intermittent injection, or 250 IU/kg every 12 hours administered subcutaneously.
Monitoring:
When sodium heparin is administered at anticoagulant doses, dosage should be adjusted based on
aPTT values.
Younger children may require higher dosages and infusion rates to achieve anticoagulation levels
and aPTT prolongation comparable to older children.

Elderly
Lower dosages may be required due to an increased risk of bleeding.
Monitoring:
When sodium heparin is administered at anticoagulant doses, dosages should be adjusted according
to aPTT values.

Method of administration
Intravenous administration via continuous infusion or intermittent injection, or subcutaneous
injection.
Because the effects of sodium heparin are short-term, administration via continuous intravenous
infusion or subcutaneous injection is preferred over intermittent intravenous bolus injection.

Overdose
Symptoms of overdose
Bleeding, primarily from the skin and mucous membranes, surgical wounds, gastrointestinal or
genitourinary tract (epistaxis, hematuria, melena, hematomas, petechiae). A drop in blood
pressure or a reduction in hematocrit may indicate occult bleeding.
Treatment of overdose
Minor bleeding
Discontinue heparin therapy.
Severe bleeding
Protamine sulfate is used for the rapid neutralization of heparin activity in cases of significant
bleeding. The amount required depends on the plasma concentration of heparin administered and
the time elapsed since injection. 1 mg of protamine sulfate administered intravenously neutralizes
approximately 100 IU of heparin present in the patient. The dose of protamine required to
neutralize a heparin bolus decreases proportionally with time since bolus administration (100% of
the dose immediately after bolus, 50% after 30 minutes). The dose of protamine to be administered
during continuous heparin infusion should neutralize the units of heparin infused over the past 4
hours.
Protamine administration must be performed via slow intravenous infusion; the rate must not
exceed 50 mg over 10 minutes.
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