Mistral

Italy
Brand name Mistral
Form solution for injection
Active substance / Dosage
DERMATAN SODIUM SULFATE
Prescription type Restricted prescription – hospital or equivalent facility use only
ATC code
B01AX04
Registration number 029006
Manufacturer NEOPHARMED GENTILI S.P.A.

MISTRAL 100 mg/2 ml injectable solution for
intramuscular use
MISTRAL 200 mg/2 ml injectable solution for
intramuscular use
MISTRAL 300 mg/3 ml injectable solution for
intramuscular use
Dermatan

COMPOSITION
Each vial contains:
Active substance:
MISTRAL 100 mg/2 ml: sodium salt of dermatan sulfate 100 mg
MISTRAL 200 mg/2 ml: sodium salt of dermatan sulfate 200 mg
MISTRAL 300 mg/3 ml: sodium salt of dermatan sulfate 300 mg

Excipients: sodium chloride, water for injections.

PHARMACEUTICAL FORM AND CONTENT
Injectable solution for intramuscular use
MISTRAL 100 mg/2 ml: 10 vials of 100 mg/2 ml
MISTRAL 200 mg/2 ml: 6 vials of 200 mg/2 ml
MISTRAL 200 mg/2 ml: 10 vials of 200 mg/2 ml
MISTRAL 300 mg/3 ml: 4 vials of 300 mg/3 ml
MISTRAL 300 mg/3 ml: 10 vials of 300 mg/3 ml

PHARMACO-THERAPEUTIC CATEGORY
Dermatan sulfate is an antithrombotic drug that acts by selectively inhibiting thrombin.

MARKETING AUTHORIZATION HOLDER
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo n.15, Milan.

RESponsible PRODUCER FOR BATCH RELEASE
Biologici Italia Laboratories S.r.l., Via F. Serpero 2, Masate (Milan).
Neopharmed Gentili S.p.A., Via S.G. Cottolengo 15, Milan.

THERAPEUTIC INDICATIONS
Prevention of deep venous thrombosis.

CONTRAINDICATIONS
Congenital or acquired coagulation disorders that predispose to hemorrhagic risk.
Severe active or recent hemorrhages. Uncontrolled arterial hypertension. Generally
contraindicated in renal insufficiency (see Warnings and Precautions for use).
Individual hypersensitivity to dermatan sulfate. Generally contraindicated during
pregnancy and lactation (see Special Warnings) and in pediatric age (see Warnings and
Precautions for use).

PRECAUTIONS FOR USE
Unlike heparin, laboratory monitoring of coagulation function is not required during
treatment with dermatan sulfate. However, especially during prolonged treatment,
periodic monitoring of platelet count is advisable.

There is no clinical experience regarding prevention of Deep Venous Thrombosis in
patients with renal insufficiency (serum creatinine > 2 mg/dl).

There are no data on the use of dermatan sulfate in pediatric age.

Keep this medicine out of the reach of children.

INTERACTIONS
Concomitant administration of drugs that inhibit platelet aggregation (including
acetylsalicylic acid and non-steroidal anti-inflammatory drugs) may increase the risk of
bleeding. The use of such drugs should therefore be limited to cases of genuine
necessity and must be carried out under strict medical supervision.

SPECIAL WARNINGS
Pregnancy and lactation: Dermatan sulfate has no teratogenic or embryotoxic effects in
experimental animals.
However, the use of MISTRAL during pregnancy is not recommended due to the lack of
clinical data. There is no information available on whether dermatan sulfate is excreted in
human milk.

DOSAGE, ADMINISTRATION AND DURATION
Dosage varies according to the degree of thromboembolic risk.

  • In internal medicine (bedridden patients; patients with acute superficial phlebitis or varicophlebitis): 100 or 200 mg/day by intramuscular injection as a single daily dose, until complete mobilization of the patient or resolution of phlebitic symptoms.
  • In abdominal, thoracic, gynecological and urological surgery: depending on individual risk, 100 to 300 mg/day by intramuscular injection as a single daily dose. Treatment should begin two days before surgery and continue until complete mobilization of the patient. In patients undergoing surgery for malignant tumors, treatment should also begin two days before surgery; the intramuscular dose is 600 mg on the first day of treatment (300 mg every 12 hours), followed by 300 mg/day as a single daily injection until complete mobilization. Treatment should cover at least the first postoperative week.
  • In major orthopedic surgery (e.g., hip surgery): depending on individual risk, 300 mg/day as a single daily dose or 600 mg/day (300 mg every 12 hours) by intramuscular injection. In elective surgery, treatment should begin two days before surgery and continue until complete mobilization. In trauma surgery (hip fracture), treatment should begin as soon as possible after diagnosis of the fracture and continue during the waiting period for surgery and afterwards until complete mobilization of the patient. Treatment should cover at least the first postoperative week.

OVERDOSAGE
The limited volume suitable for intramuscular injection makes overdosage with dermatan
sulfate unlikely. If it should occur, treatment should be discontinued.
There is no clinical experience with neutralization of dermatan sulfate by protamine.

UNDESIRABLE EFFECTS
MISTRAL does not cause a statistically significant increase in bleeding risk compared
with untreated patients. This does not exclude the possibility of occasional perioperative
bleeding complications.
Bruising or small hematomas at the intramuscular injection site are extremely rare.
Cutaneous rash, which resolves upon discontinuation of treatment, may rarely occur.
An isolated decrease in platelet count, without thrombotic or hemorrhagic manifestations,
has been exceptionally observed.
Rare cases of increased transaminases have been reported, similar to those reported with
unfractionated heparin or low molecular weight heparin.

Following the instructions provided in the package leaflet reduces the risk of
undesirable effects.
Patients are encouraged to inform their physician or pharmacist of any adverse reaction,
even if not listed above.

EXPIRY DATE AND STORAGE
EXPIRY DATE: see the expiry date stated on the packaging.
The shelf life applies to the product in its original, unopened packaging,
correctly stored.
Warning: do not use the product after the expiry date stated on the packaging.

Revision of the package leaflet by the Ministry of Health: 03/2019
Renewal: July 2009.