Nirahep – Heparin Injection BP 25000 IU/5ml

Description

Nirahep

Composition: Heparin Injection BP 25000 IU/5ml

Dosage Form:  Injection

Packing: 1 Inj

Market Authorization: MBA Pharmaceuticals Pvt Ltd

Country of Origin: India

Similar to Heparin/Beprin

Pharmaceuticals Product

Contraindications

• Absolute contraindications

Heparin allergy or hypersensitivity to other components of the preparation HEPARIN – INJECTION BP 5,000 UNITS/ML Patients with present or previous thrombocytopenia (type II) caused by heparin Diseases accompanied by increased bleeding tendency e.g. hemorrhagic diathesis, clotting factor deficiencies (except disseminated intravascular coagulation during the phase of hyper coagulation) severe hepatic, renal or pancreatic diseases, severe thrombocytopenia Diseases with suspicion of damage to the vascular system, such as gastric ulcers and/or intestinal ulcers, hypertension (above 105 mmHg diastolic), intra-cerebral hemorrhage, injury or surgery of the central nervous system, eye surgeries, retinopathy (severe retina problems), intravitreal hemorrhage, aneurysm of cerebral arteries, sub-acute bacterial endocarditis (inflammation of the endocardium) Risk of miscarriage (Abortus immense) Spinal anesthesia, epidural anesthesia, lumbar puncture.

• Relative contraindications

Suspicion of malignant disease with a tendency to hemorrhage

Renal and urethral calculi

Chronic alcoholism

 

• An especially meticulous medical monitoring is required:

 

During pregnancy, especially in case of long-term use

In elderly patients, especially women

When concomitantly treated with fibrinolytic or oral anticoagulants, with platelet aggregation inhibitors (for example Acetyl Salicylic Acid, Ticlopidine, Clopidogrel) and/or Glycoprotein llb/Illa receptor antagonists.

When concomitanly treated with drugs that increase serum potassium levels. The serum potassium level should be monitored in high-risk patients (patients with increased risk of hyperkalemia such as diabetes mellitus, impaired renal function, or treatment with serum- potassium level raising medication).

• Warnings:

Because of its benzyl alcohol content HEPARIN INJECTION, BP 5,000 UNITS/ML must not be dne used in neonates, especially not in those showing signs of immaturity.

• Use in pregnancy and lactation

Heparin does not cross the placenta and does not appear in breast milk. To date, no incidence of fetal malformations caused by heparin use in pregnancy has been reported. Increased risk of abortions and stillbirth has been reported. Complications in pregnant women caused by treatment or by the disease itself cannot be excluded.

The use of epidural anesthesia during labour, for women being medically treated for anti-coagulation, is absolutely contraindicated.

Side effects

Depending on the dosage of HEPARIN INJECTION BP 5,000 UNITS/ ML, increased hemorrhages especially cutaneous hemorrhages, hemorrhage of the mucous membranes, wounds, in the area of the gastrointestinal tract, the urinary tract and the genitourinary tract should be taken into consideration.

Occasionally at the beginning of the treatment, a slight temporary decrease of the thrombocyte count (Thrombocytopenia Type I) with values between 100,000 and 150,000/μl (caused by a temporary activation of the thrombocytes) can be observed. Complications usually do not occur. The treatment can therefore be continued.

Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%. Platelet counts should be obtained at baseline and periodically during heparin administration. Mild thrombocytopenia (count greater than 100,000/mm³) may remain stable or reverse even if heparin is continued. If the count falls below 100,000/mm³ or if recurrent thrombosis develops (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis), the heparin product should be discontinued and, if necessary, an alternative anticoagulant administered.

The patient must be informed that he must not be treated with drugs containing heparin in the future. Guidelines for use of platelet values: see section 14.

Type II Heparin-induced Thrombocytopenia (HIT) and Type II HIT and Thrombosis can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for Type II HIT and Type II HIT and thrombosis.