ADTRALZA Solution for injection (2021)

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Περιεχόμενα

1. Name of the medicinal product

Adtralza 150 mg solution for injection in pre-filled syringe.

2. Qualitative and quantitative composition

Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution (150 mg/mL). Tralokinumab is produced in mouse myeloma cells by recombinant DNA technology. For the full list of excipients, see ...

3. Pharmaceutical form

Solution for injection (injection). Clear to opalescent, colourless to pale yellow solution, pH 5.5 and osmolarity approximately 280 mOsm/L.

4.1. Therapeutic indications

Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

4.2. Posology and method of administration

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Posology The recommended dose of tralokinumab for adult patients is an initial ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity If a systemic ...

4.5. Interaction with other medicinal products and other forms of interaction

The safety and efficacy of concurrent use of tralokinumab with live and live attenuated vaccines has not been studied. Immune responses to non-live vaccines were assessed in a study in which adult patients ...

4.6. Fertility, pregnancy and lactation

Pregnancy There is limited amount of data from the use of tralokinumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...

4.7. Effects on ability to drive and use machines

Tralokinumab has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions are upper respiratory tract infections (23.4%; mainly reported as common cold), injection site reactions (7.2%), conjunctivitis (5.4%) and ...

4.9. Overdose

There is no specific treatment for tralokinumab overdose. In clinical studies with tralokinumab, single intravenous doses of up to 30 mg/kg and multiple subcutaneous doses of 600 mg every 2 weeks for 12 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Agents for dermatitis, excluding corticosteroids ATC code: D11AH07 Mechanism of action Tralokinumab is a fully human IgG4 monoclonal antibody that specifically ...

5.2. Pharmacokinetic properties

Absorption After subcutaneous (SC) dose of tralokinumab median time to maximum concentration in serum (tmax) were 5-8 days. The absolute bioavailability of tralokinumab following SC dosing was ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints) and toxicity to reproduction and development. The ...

6.1. List of excipients

Sodium acetate trihydrate (E262) Acetic acid (E260) Sodium chloride Polysorbate 80 (E433) Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

3 years. If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days, within its shelf-life, without being refrigerated again during this period. Do not store ...

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.

6.5. Nature and contents of container

1 mL (150 mg) solution in a siliconised type-1 clear glass pre-filled syringe with 27 gauge ½ inch thin wall stainless steel staked needle, elastomer plunger stopper extended finger flange and needle guard. ...

6.6. Special precautions for disposal and other handling

The solution should be clear to opalescent, colourless to pale yellow. If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used. Do not use if the ...

7. Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

8. Marketing authorization number(s)

EU/1/21/1554/001 EU/1/21/1554/002 EU/1/21/1554/003

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