HEMLIBRA Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Hemlibra 30 mg/mL solution for injection. Hemlibra 150 mg/mL solution for injection.
Qualitative and quantitative composition
Hemlibra 30 mg/mL solution for injection: Each mL of solution contains 30 mg of emicizumab*. Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL. Hemlibra 150 mg/mL solution for ...
Pharmaceutical form
Solution for injection. Colourless to slightly yellow solution.
Therapeutic indications
Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with: haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors severe haemophilia A (congenital factor ...
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. Posology Treatment (including routine prophylaxis) with bypassing ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Thrombotic microangiopathy associated ...
Interaction with other medicinal products and other forms of interaction
No adequate or well-controlled drug-drug interaction studies have been conducted with emicizumab. Clinical experience indicates a drug interaction exists with emicizumab and aPCC (see sections 4.4 and ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception Women of childbearing potential receiving Hemlibra should use effective contraception during, and for at least 6 months after cessation of Hemlibra treatment ...
Effects on ability to drive and use machines
Hemlibra has no influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most serious adverse drug reactions (ADRs) reported from the clinical trials with Hemlibra were thrombotic microangiopathy (TMA) and thrombotic events, including cavernous ...
Overdose
There is limited experience with overdose of Hemlibra. Symptoms Accidental overdose may result in hypercoagulability. Management Patients who receive an accidental overdose should immediately contact their ...
Pharmacodynamic properties
Pharmacotherapeutic group: antihemorrhagics, other systemic hemostatics ATC code: B02BX06 Mechanism of action Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific ...
Pharmacokinetic properties
The pharmacokinetics of emicizumab was determined via non-compartmental analysis in healthy subjects and using a population pharmacokinetic analysis on a database composed of 389 patients with haemophilia ...
Preclinical safety data
Preclinical data reveal no special hazards for humans based on studies of acute and repeated dose toxicity, including safety pharmacology endpoints and endpoints for reproductive toxicity. Fertility Emicizumab ...
List of excipients
L-Arginine L-Histidine L-Aspartic acid Poloxamer 188 Water for injections
Incompatibilities
No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes , polycarbonate vial adapters and stainless steel needles have been observed. In the absence of compatibility studies, ...
Shelf life
Shelf life Unopened vial Hemlibra 30 mg/mL solution for injection: 30 months. Hemlibra 150 mg/mL solution for injection: 3 years. Once removed from the refrigerator, unopened vials can be kept at room ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3. ...
Nature and contents of container
Hemlibra 30 mg/mL solution for injection: 3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk. ...
Special precautions for disposal and other handling
Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted. Hemlibra should be inspected visually to ensure there is no particulate ...
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/18/1271/001 (30 mg/1 ml) EU/1/18/1271/002 (60 mg/0.4 ml) EU/1/18/1271/003 (105 mg/0.7 ml) EU/1/18/1271/004 (150 mg/1 ml)
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 February 2018
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