VERACER 5000 U.I./1 ML Injectable solution

Зміст інструкції

1. VERACER 5000 U.I./1 ml injectable solution, 25000 U.I./5 ml injectable solution
   1. What is VERACER and what is it 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

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

Sodium heparin

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is VERACER and what is it used for

VERACER contains sodium heparin (derived from porcine intestinal mucosa), an anticoagulant
(blood thinner), belonging to the group of antithrombotics, 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 hemodialysis or procedures involving
extracorporeal circulation.

2. What you need to know before using VERACER

Do not use VERACER

• If you are allergic to sodium heparin or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe thrombocytopenia (low platelet count);
• if you suffer from disorders accompanied by a predisposition to bleeding (haemorrhagic diathesis), for example diseases characterized by an alteration of blood coagulation (coagulopathies);
• if you suffer from severe liver, kidney or pancreas diseases;
• if appropriate coagulation tests such as blood coagulation time cannot be carried out at appropriate intervals when Veracer is administered at therapeutic doses;
• if you have an uncontrolled bleeding condition;
• if you have disseminated intravascular coagulation (DIC) attributable to heparin-induced thrombocytopenia;
• in case of locoregional anesthesia for elective surgical procedures, as it is contraindicated in patients receiving heparin at anticoagulant doses;

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• if you have haemorrhagic cerebrovascular accidents or stroke;
• if you have organ lesions at high risk of bleeding, such as ulcers in the stomach and/or intestines, cerebral haemorrhage, a dilation of a cerebral artery (aneurysm) or brain tumor (cerebral neoplasm);
• if you have trauma or have undergone surgery to the central nervous system (brain and spinal cord), eyes or ears;
• if you have a retinal disease (retinopathy) or vitreous haemorrhage (a part of the eye);
• if you suffer from an inflammation of the inner lining of the heart caused by germs (infective endocarditis);
• due to the content of benzyl alcohol, the 5000 U.I./1 ml dosage should not be administered to children under 3 years of age and to pregnant and breastfeeding women (see sections “Warnings and precautions” and “Pregnancy, breastfeeding and fertility”);

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

• suspect a tumor associated with a predisposition to bleeding,
• have problems with alcohol dependence,
• are an elderly person, as the risk of bleeding is greater, especially in women;
• have previously had an allergic reaction to low molecular weight heparin,
• suffer from diabetes mellitus, kidney problems, metabolic acidosis, high levels of potassium in the blood or are taking medications that increase potassium levels in the blood or heparin for a long time, as sodium heparin may elevate the level of potassium in the blood;
• are at risk of bleeding, due to conditions such as:

Cardiovascular:

• inflammation of the heart of infectious subacute origin (subacute bacterial endocarditis),
• high blood pressure not controlled by therapy (hypertension not controlled by anti-hypertensive therapy).

Hematological:

• congenital or acquired diseases characterized by reduced blood coagulation (haemophilic syndromes or coagulation factor deficiency),
• reduction in the number of platelets (thrombocytopenia),
• alteration of platelet function (thrombocytopathies),
• some haemorrhagic vascular purpura (like Rendu-Osler disease).

Gastrointestinal:

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

Surgical:
during and immediately after:

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

Hepatic:
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• liver diseases with alterations in coagulation parameters and/or esophageal varices or portal hypertension gastropathy with high bleeding risk.

Other:

• threat of abortion,
• during the menstrual cycle,
• postpartum period,
• concomitant treatment with fibrinolytics or oral anticoagulants, with antiplatelet agents (e.g. acetylsalicylic acid, ticlopidine, clopidogrel), with non-steroidal anti-inflammatory drugs and/or glycoprotein IIb/IIIa receptor antagonists. In all cases of bleeding, even minor, stop treatment with VERACER and contact your doctor. Take particular care to avoid the risk of injury during treatment with VERACER.

If you suffer from or have ever suffered from hyperpotassaemia, a condition characterized by increased
potassium in the blood, your doctor will perform tests to measure potassium in
blood before starting therapy and at regular intervals during treatment, especially in case
of treatment longer than 7 days.
If you suffer from or have ever suffered from heparin-induced thrombocytopenia (low platelet count), the
doctor will carefully monitor your platelet count throughout the course of
treatment with sodium heparin.
If you experience fever, thrombosis, thrombophlebitis, infections with a tendency to thrombosis, states
inflammatory, sometimes during myocardial infarction, cancer, congenital or developed deficiency of antitrombin III
following surgery, you may have a decreased sensitivity
to heparin; your doctor will evaluate these conditions.
Heparin should not be administered intramuscularly due to the risk of hematomas.
During treatment with VERACER avoid intramuscular administration of other drugs, due to
the risk of hematomas.
If you are taking heparin, if you should experience any of the undesirable effects listed in
“Possible side effects”).
In patients undergoing spinal or epidural anesthesia, epidural analgesia or lumbar puncture,
prophylaxis with low doses of unfractionated heparin (i.e. that administered for
by intravenous route) can be rarely associated with spinal or epidural hematomas that can lead to
prolonged or permanent paralysis of the lower limbs. The risk is increased by:

• the use of “permanent” epidural catheters for continuous infusion;
• the concomitant use of drugs that affect haemostasis (stopping of a haemorrhage) such as non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents or anticoagulants;
• trauma or repeated spinal punctures;
• the presence of an underlying haemostasis disorder;
• advanced age. The presence of one or more of these risk factors must be carefully evaluated before proceeding with this type of anesthesia/analgesia, during prophylaxis with unfractionated heparins.

You should therefore be monitored frequently to identify signs and symptoms of neurological alterations, such as back pain, sensory and motor deficits (numbness and weakness
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in the lower limbs), bowel and/or bladder dysfunction. Immediately inform a doctor or healthcare professional if any of the above symptoms occur.
It is not strictly necessary, as with dicoumarol therapy, to monitor heparin therapy
with laboratory tests; however, for control, it is sufficient to determine the coagulation time in tube (Lee White) and there is no need for prothrombin determination.
The use of heparin may alter your thyroid function tests (e.g. falsely elevated levels of T3 and
T4).
Given the animal origin of heparin, if you have had previous allergic reactions, your doctor
may subject you to a reduced administration of heparin to test for any reactions.
Bleeding may occur, which may occur in any district of the body in
patients receiving sodium heparin. An unexplained decrease in hematocrit, a drop
in blood pressure, or any other sign or symptom not attributable to other causes must make
suspect a bleeding event.
In any case of bleeding, the doctor will interrupt the treatment with heparin.

Children
Due to the presence of benzyl alcohol, VERACER 5000 U.I./1 ml injectable solution is
contraindicated in newborns and children up to three years of age, unless otherwise indicated by
the doctor.

Other medicines and VERACER
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular:

• Oral anticoagulants: sodium heparin at anticoagulant dosage may slightly prolong prothrombin time (PT) (increase of approximately 0.5 of the INR, international normalized ratio). This aspect must be considered in the evaluation of this parameter, especially when combining heparin therapy with oral anticoagulant therapy. Great clinical-laboratory attention (frequent evaluation of PT and APTT) is recommended in case of combined use of unfractionated heparin at anticoagulant doses with these drugs.
• Antiplatelet agents, fibrinolytics and other medicines associated with a risk of bleeding: such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (such as phenylbutazone, ibuprofen, indomethacin, ketorolac and diclofenac), drugs with antiplatelet effect (e.g. ticlopidine, clopidogrel, sulfinpyrazone), some antibiotics of the cephalosporin class (e.g. cefaclor, cefixime, ceftriaxone, cefamandole, cefoperazone), dextran, dipyridamole, hydroxychloroquine, fibrinolytics (e.g. streptokinase, urokinase, alteplase), coumarin derivatives (, glycoprotein IIb/IIIa receptor antagonists (e.g. epifibatide, abciximab), epoprostenol
• Intravenous nitroglycerin, as it can cause a significant attenuation of the effect of heparin.
• Drugs that increase potassium levels in the blood, such as ACE inhibitors, sartans, potassium-sparing diuretics, potassium salts, beta-blockers (drugs used in the treatment of cardiovascular diseases):
• Other drugs that may reduce the anticoagulant effect of heparin, such as digitalis (used to increase the force of heart contraction), 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 be altered. (false increase in thyroid hormones T3 and T4).

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Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist before using this medicine.
Pregnancy
The safety of use in pregnancy has not been fully established. In the absence of safe data
the decision to use heparin in pregnancy must be made after a careful evaluation
of the risk-benefit ratio in individual circumstances.
VERACER 5000 U.I./1 ml injectable solution contains benzyl alcohol. Benzyl alcohol can
cross the placenta, therefore you should use a formulation that does not contain alcohol
benzyl (see section Warnings and Precautions).
Breastfeeding
Heparin is not excreted in breast milk.
Fertility
No specific information is available on fertility with the use of heparin.

Driving and operating machinery
VERACER does not impair the ability to drive vehicles and operate machinery.

Veracer 5000 U.I./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 can cause allergic reactions. Benzyl alcohol has been associated with the risk of
serious side effects, including respiratory problems (respiratory distress syndrome) in
small children. Do not administer to newborns up to 4 weeks of age unless otherwise recommended by
the doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by your doctor or pharmacist.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).

Veracer 5000 U.I./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 medicine, in order to improve the traceability of
heparins, the healthcare professional will record on your medical record the trade name and
batch number of the product that has been administered to you.

3. How to use VERACER

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose is that prescribed by your doctor. If this medicine is administered to you
at anticoagulant doses, the dose to be taken must be determined based on frequent coagulation tests.
VERACER 5000 U.I./1 ml injectable solution is for subcutaneous use.
VERACER 25000 U.I./5 ml injectable solution is for intravenous use.
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If you use more VERACER than you should
If you use more VERACER than you should, or in case of accidental ingestion, call a doctor or go to
the nearest hospital bringing the packaging of the medicine with you. This way, the doctor
will immediately know what you have taken.
Heparin is a compound used to keep blood fluid and if taken in excessive doses it can
cause bleeding (abundant blood loss) particularly from the skin or mucous membranes, from
wounds, from the gastrointestinal or genitourinary tract (bleeding from the nose, blood in the urine,
in the stool), to the formation of hematomas and petechiae, to hemorrhages. Symptoms of bleeding
may be a drop in blood pressure or a reduction in hematocrit, detectable with
the blood count.
If you notice the appearance of any of these symptoms, stop treatment with VERACER and contact
your doctor immediately or go to the nearest hospital.
If necessary, you will be given a substance called protamine which serves to neutralize
the anticoagulant effect of heparin.

If you forget to use VERACER
Never use a double dose to make up for a missed 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 the use of this medicine, ask 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 gets serious, or if you notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.
If you experience any of the following severe reactions, stop taking VERACER and contact
your doctor immediately or go to the nearest emergency room:

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

Other side effects that may occur with unknown frequency (frequency cannot be estimated
based on available data) are:

• 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 kidney damage and diabetes mellitus)
• Hyperlipidaemia (increased lipids in the blood) rebound, upon discontinuation of therapy
• Bronchospasm (difficulty breathing)
• Increased transaminases (enzymes produced by the liver)
• Increased levels of FT3 and FT4 (thyroid hormones)
• Priapism (persistent and painful erection, not associated with sexual stimulation)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through
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 which is reported on the label after Scad. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VERACER 5000 U.I./1 ml contains

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

What VERACER 25000 U.I./5 ml contains

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

Description of the appearance of VERACER and contents of the pack
Solution for injection of 5000 U.I. for subcutaneous/intramuscular use in packs of 10 vials of
1 ml.
Solution for injection of 25000 U.I. for intravenous use in packs 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 U.I./1 ml:
SAVIO INDUSTRIAL S.R.L.- Via E. Bazzano 14 - Ronco Scrivia (GE) – Italy

Manufacturers VERACER 25000 U.I./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 for healthcare professionals only:

Dosage and administration
Prophylaxis of arterial and venous thromboembolism
Perioperative prophylaxis
The initial dose is 5,000 IU subcutaneously 2 hours before surgery followed by 5,000
IU every 8-12 hours for at least 7 days or until you resume walking.
Prophylaxis in non-surgical patients
The same dose is used for prophylaxis in high-risk non-surgical patients.
The choice of administration every 8 or 12 hours should take into account the risk
of thromboembolism and the risk of bleeding in the individual patient.
Extracorporeal circulation (cardiopulmonary bypass)
The dose is 300 IU/kg intravenously, which will be adjusted to maintain
the Activated Clotting Time (ACT) in the range of 400-500 seconds.
Hemodialysis
The initial dose is 1,000-5,000 IU intravenously, followed by 1,000-2,000 IU/h, to
be adjusted as needed.
Monitoring:
Routine monitoring is not required.

Treatment of arterial and venous thromboembolism
The initial dose is 80 U/kg i.v. bolus or 5,000 IU as an intravenous bolus injection
(10,000 IU in case of severe pulmonary embolism)
The maintenance dose is 18 U/kg/h by continuous intravenous infusion (range between 1000 IU
and 2000 U/h), to be adjusted based on response or 1,000IU/h continuous infusion
Alternative treatment regimens
Intermittent intravenous injection: 10,000 IU i.v. bolus followed by 5000-10,000 IU i.v.
every 4-6
hours.
Intermittent subcutaneous injection: initial dose of 333 IU/kg followed by 250 IU/kg every 12
h (range 10,000 IU-20,000 IU) or 8000-10000 IU every 8 h.
Monitoring:
When sodium heparin is administered at an anticoagulant dose, the dosage must be determined
based on coagulation tests. The most commonly used test is the activated partial thromboplastin time (aPTT). The aPTT of patients undergoing treatment should be maintained at a value
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1.5-2.5 times the normal values. Regular monitoring of aPTT values is recommended, possibly on a daily basis.
If coagulation tests are above the therapeutic range or if bleeding occurs, the dose should be reduced or, if necessary, heparin should be discontinued.

Special populations
Paediatric population
Prophylaxis of arterial and venous thromboembolism
No recommendations are available regarding the dosage.

Treatment of arterial and venous thromboembolism
The initial dose: is 50 U/kg as an intravenous bolus injection
The maintenance dose is 15-25 IU/kg/hour by continuous intravenous infusion, or 100
IU/kg i.v. every 4 hours as an intermittent injection; or 250 IU/kg every 12 hours subcutaneously.
Monitoring:
When sodium heparin is administered at an anticoagulant dose, the dosage must be adjusted
based on aPTT values.
Smaller children may require higher doses and infusion rates to achieve
levels of anticoagulation and aPTT prolongation similar to those of older children.

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

Route of administration
Intravenously by continuous infusion or intermittent injection, or by subcutaneous injection.
Since the effects of sodium heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferred over intermittent intravenous injection.

Overdose
Symptoms of overdose
Bleeding, mainly from the skin and mucous membranes, wounds, the gastrointestinal or
genitourinary tract (epistaxis, hematuria, melena, hematomas, petechiae). A drop in blood
pressure or a decrease in hematocrit may be signs of occult bleeding.

Overdose therapy
Minor bleeding
Discontinuation of heparin therapy.

Severe bleeding
Protamine is used for the rapid neutralization of heparin activity in case of
significant bleeding. The amount required depends on the heparin blood level
administered and the time elapsed since the injection. 1 mg i.v. neutralizes 100 IU of heparin
present in the patient. The dose of protamine to be administered to neutralize a heparin bolus decreases in proportion to the time elapsed since the administration of the bolus (immediately after
the bolus 100% of the dose, after 30 minutes 50%). The dose of protamine to be administered in case
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of continuous heparin infusion is that useful to neutralize the IU of heparin infused in the last
4 hours.
The administration of protamine must be carried out by slow intravenous infusion; the dose of 50 mg in 10 minutes should not be exceeded.
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