Hepathrombin gel 1000ij/g 40g

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

1. NAME OF THE MEDICINE
Hepathrombin®
, 1000 ij/g, gel
INN: heparin-sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 1000 IU of sodium heparin.
Auxiliary substances with confirmed effect:
One gram of gel contains 1.173 mg of methylparahydroxybenzoate (E218).
One gram of gel contains 0.280 mg of propylparahydroxybenzoate (E216).
For a list of all excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gel.
Colorless to slightly yellowish gel, slightly opalescent, characteristic smell of lavender, lemon and ethanol.
4. CLINICAL DATA
4.1. Therapeutic indications
The drug Hepathrombin, gel is used in the symptomatic therapy of diseases of superficial veins such as: superficial
thrombophlebitis, superficial periphlebitis, chronic venous insufficiency, postoperative varicophlebitis and sequelae
saphenectomy.
Also, the drug Hepathrombin, gel is used for therapy and relief of problems with: hematoma, swelling and pain after
sports injuries or other injuries such as contusions, dislocations, distortions and post-puncture hematomas
vein.
4.2. Dosage and method of administration
The drug is intended for dermal application.
Apply the gel once to three times a day in a length of 3 to 10 cm, in a thin layer with gentle rubbing
affected area.
In case of localized trauma and injuries (hematomas, infiltrates, swelling), the drug Hepathrombin, gel can be applied
until symptoms subside.
At the initial symptoms of venous insufficiency (heaviness and pain in the legs, swelling of the veins), the drug Hepathrombin,
the gel can be applied for 1-3 weeks depending on the intensity of the symptoms.
In case of chronic venous insufficiency (varicose dilatation, superficial periphlebitis, superficial thrombophlebitis),
drug Hepathrombin, gel can be applied for 2-4 weeks depending on the intensity of the symptoms.
In case of postoperative varicophlebitis and sequelae of saphenectomy, the drug Hepathrombin, gel can be applied
for 3-6 weeks depending on the intensity of the symptoms.
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The doctor should assess the need for continuation of therapy.
Due to limited experience and based on available data, the gel should not be used in children.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the auxiliary substances listed in section 6.1.
4.4. Special warnings and precautions when using the drug
Hepathrombin, gel should not be applied in the area of the eyes, nose and mouth.
Hepathrombin, gel should not be applied in case of bleeding, open wounds, on the mucous membranes or on the site
infections in the case of purulent processes.
During local application of heparin, resorption of heparin through undamaged (healthy) skin has been described, therefore, in
in case of suspicion of thromboembolic complications, during the differential diagnosis, it must be considered
existence of heparin-induced thrombocytopenia type II and therefore control the platelet count.
Hepathrombin, gel contains auxiliary substances methylparahydroxybenzoate and propylparahydroxybenzoate, which
can cause allergic reactions, even delayed ones.
4.5. Interactions with other drugs and other types of interactions
There are no known clinically significant interactions with other drugs when applied topically, but they cannot be excluded.
especially with prolonged use, because resorption of heparin has also been described through intact skin.
Interactions with the following drugs have been described during parenteral administration of heparin:
- inhibitors of platelet aggregation (acetylsalicylic acid, ticlopidine, clopidogrel, dipyridamole in large
doses)
- fibrinolytics, other anticoagulants (coumarin derivatives)
- non-steroidal anti-inflammatory drugs (phenylbutazone, indomethacin, sulfinpyrazone)
– glycoprotein IIb / IIIa receptor antagonists
- Penicillin in high doses and
– dextran.
An increased risk of bleeding cannot be excluded. Hematomas may accumulate or become more frequent.
Pediatric population
Interaction studies were conducted in adults only.
4.6. Fertility, pregnancy and breastfeeding
Fertility
No data are available on the effect of heparin on fertility when applied topically.
Pregnancy
When heparin was applied locally in pregnant rats or rabbits during the period of organogenesis, it was shown that it was not
any influence on fetal development and the development of fetal malformations.
Heparin does not cross the placenta. However, no specific data on the use of the drug during human pregnancy are available.
Therefore, during pregnancy, the drug Hepathrombin gel can be used after a careful assessment of the benefit/risk ratio.
Breastfeeding
There are no specific data on the use of the drug in women who are breastfeeding. Therefore, during the period of breastfeeding, the drug
Hepathrombin gel can be used after a careful benefit/risk assessment.
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4.7. The influence of the drug on the ability to drive vehicles and operate machines
The drug Hepathrombin, gel has no effect or has a negligible effect on the ability to drive a vehicle and
handling machines.
4.8. Adverse effects
Adverse effects are listed according to the following frequency categories:
Very common: ≥1/10
Common: ≥1/100 to <1/10
Uncommon: ≥1/1000 to <1/100
Rare: ≥1/10000 to <1/1000
Very rare: <1/10000
Unknown: cannot be estimated from the available data.
General disorders and administration site conditions
Very rare: Allergic reactions to heparin.
Disorders of the skin and subcutaneous tissue
Not known: skin redness, pruritus (especially with long-term local application), usually disappear quickly after
discontinuation of the drug.
Reporting adverse reactions
Reporting of suspected adverse reactions after obtaining a drug license is important. This makes it possible
continuous monitoring of the benefit-risk ratio of the drug. Healthcare workers should report any suspicion of
adverse reactions to this medicine to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
fax: +381 (0)11 39 51 131
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
4.9. Overdose
There have been no reported cases of overdose with local application of preparations with heparin. System availability
of heparin after topical application is negligible with no demonstrated effects on standard coagulation tests.
Given that there are no reports of accidental ingestion of the drug, there are no specific recommendations either.
General precautions may apply.
5. PHARMACOLOGICAL DATA
5.1. Pharmacodynamic data
Pharmacotherapeutic group: Antivaricose therapy; Heparin or heparinoids for local use
ATC code: C05BA03
Experimental pharmacological data show that heparin-sodium applied to the skin shows significant
anti-edematous, anti-granulomatous, anti-exudative, anti-inflammatory and anticoagulant activity.
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5.2. Pharmacokinetic data
Pharmacokinetic tests performed in rats showed that heparin plasma concentrations were measurable
up to 24 hours after application, with maximum values after eight hours. Excretion is primarily renal.
Dermal application of sodium heparin in gel form did not cause any coagulation changes
parameters in humans.
5.3. Preclinical data on the safety of the drug
Acute toxicity tests performed on mice and rats have shown that heparin sodium has a very
low sc and ip toxicity (LD50 2000 mg/kg). Also, during subchronic and chronic application on the skin
demonstrated good local and systemic tolerability of the drug.
6. PHARMACEUTICAL INFORMATION
6.1. List of excipients
Lemon essential oil;
Lavender essential oil;
Carbomer;
Methyl parahydroxybenzoate E218;
Propylparahydroxybenzoate E216;
Trolamine;
Ethanol, concentrated;
Water, purified.
6.2. Incompatibility
She is not known.
6.3. Expiration date
2 years.
After the first opening, the gel in the original packaging can be used for 6 months if it is stored at
temperature up to 25°C.
6.4. Special precautions for storage
This medicine does not require special temperature storage conditions. Store in the original packaging in order to protect against
light.
For storage conditions after first opening, see section 6.3.
6.5. Nature and contents of packaging
The inner packaging is an aluminum tube coated on the outside and on the inside with varnish. The inner protective layer makes
epoxy-phenol-amino varnish, while the outer layer of the tube is polyurethane varnish. The aluminum tube is closed
with an aluminum membrane and a white polypropylene screw cap with a mandrel for opening and contains
40 g of gel.
The outer packaging is a collapsible cardboard box containing one tube (total of 40 g of gel) and an instruction manual.
6.6. Special precautions for the disposal of materials that should be discarded after the application of the drug (and others
drug handling instructions)
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Any unused amount of the drug or waste material after its use should be disposed of, in accordance with
valid regulations.
7. PERMIT HOLDER
HEMOFARM AD VRŠAC
Beogradski put bb
Vrsac
8. NUMBER OF PERMIT FOR PLACING THE MEDICINE ON THE MARKET
515-01-00761-20-001
9. DATE OF FIRST LICENSE AND DATE OF RENEWAL OF LICENSE FOR PLACING THE MEDICINE IN
TRAFFIC
04.08.2021.
10. TEXT REVISION DATE
August, 2021.