| Composition : | 3500 IU/0.3ml | | Storage : | Store at room temperature between 36 and 86 degrees F (2 to 30 degrees C) away from light and moisture. | | Contraindications : | Hypersensitivity to tinzaparin sodium, heparin, or any component of the formulation; active major bleeding; heparin-induced thrombocytopenia. | | Adverse Reactions : | As with all anticoagulants, bleeding is the major adverse effect of tinzaparin. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables.
>10%:
Hepatic: Increased ALT (13%)
Local: Injection site hematoma (16%)
1% to 10%:
Cardiovascular: Angina pectoris, chest pain (2%), hyper-/hypotension, tachycardia
Central nervous system: Confusion, dizziness, fever (2%), headache (2%), insomnia, pain (2%)
Dermatologic: Bullous eruption, pruritus, rash (1%), skin disorder
Gastrointestinal: Constipation (1%), dyspepsia, flatulence, nausea (2%), nonspecified gastrointestinal disorder, vomiting (1%)
Genitourinary: Dysuria, urinary retention, urinary tract infection (4%)
Hematologic: Anemia, hematoma, hemorrhage (2%), thrombocytopenia (1%)
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| Adverse Reactions : | Hepatic: Increased AST (9%)
Local: Thrombophlebitis (deep)
Neuromuscular & skeletal: Back pain (2%)
Renal: Hematuria (1%)
Respiratory: Dyspnea (1%), epistaxis (2%), pneumonia, pulmonary embolism (2%), respiratory disorder
Miscellaneous: Impaired healing, infection, unclassified reactions
<1%: Abdominal pain, diarrhea, major bleeding
Additional serious adverse reactions reported in clinical trials and postmarketing experience: Abscess, acute febrile reaction, agranulocytosis, allergic purpura, allergic reaction, angioedema, anorectal bleeding, cardiac arrhythmia, cellulitis, cerebral hemorrhage, cholestatic hepatitis, coronary thrombosis, dependent edema, epidermal necrolysis, erythematous gastrointestinal hemorrhage, granulocytopenia, hemarthrosis, hematemesis, hemoptysis, injection site bleeding, intracranial hemorrhage, ischemic necrosis, melena, MI, necrosis, neoplasm, ocular hemorrhage, pancytopenia, peripheral ischemia, priapism, purpura, rash, retroperitoneal/intra-abdominal bleeding, severe thrombocytopenia, skin necrosis, spinal epidural hematoma, Stevens-Johnson syndrome, thromboembolism, urticaria, vaginal hemorrhage, wound hematoma | | Purity : | Not less than 99%. |
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