GOHIBIC Concentrate for solution for infusion Ref.[114620] Active ingredients: Vilobelimab

Treatment should be initiated and monitored by a physician experienced in the management of patients treated in an intensive care unit (ICU) setting.

Posology

The recommended dose is 800 mg administered by intravenous infusion after dilution, for a maximum of 6 (six) doses over the treatment period as described below.

Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalised, even if discharged from the intensive care unit (ICU).

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Elderly

No dose adjustment is required in elderly patients.

Paediatric population

The safety and efficacy of Gohibic in children under 18 years have not been established. No data are available.

Method of administration

For intravenous use after dilution. Once diluted, the solution must be administered as an infusion over 30 to 60 minutes. Gohibic should not be infused concomitantly in the same intravenous line with other medicinal products. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Gohibic with other medicinal products.

For instructions on dilution of the medicinal product before administration, see section 6.6.

There is no specific antidote for overdose with vilobelimab. If overdose with vilobelimab occurs, the treatment should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

Unopened vial:

12 months.

Diluted solution:

Chemical and physical in-use stability has been demonstrated for 72 hours at 2 to 8°C and for 4 hours at up to 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution (etc.) has taken place in controlled and validated aseptic conditions.

Store in a refrigerator (2°C–8°C). Do not freeze or shake.

Store in the original package in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

20 mL concentrate in a vial (type I clear glass) closed with a stopper (bromobutyl rubber) and sealed with a flip-off cap.

Pack size of 4 vials.

General handling information:

• This medicinal product should be diluted by a healthcare professional using aseptic technique.
• Dilution of Gohibic with sodium chloride 9 mg/mL (0.9%) solution for injection must be performed in a controlled/dedicated area in accordance and compliance with applicable local regulations and requirements for intravenous administration.
• If the diluted solution is stored in a refrigerator (stored at 2°C to 8°C), it must be left to acclimatise to room temperature prior to administration not more than 4 hours.
• Gohibic must not be diluted in, or administered with, products/disposables containing sensitising compounds such as latex (rubber latex) or silicone oil.

Preparation:

• To achieve a dose of 800 mg vilobelimab for the intravenous infusion, 80 mL of Gohibic (4 vials) is diluted in 170 mL sodium chloride 9 mg/mL (0.9%) solution for injection at room temperature.
• Use a 250 mL infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection as follows:
  • Withdraw 80 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the infusion bag and discard it.
  • Withdraw the 80 mL of Gohibic from the 4 vials and add slowly to the 170 mL of sodium chloride 9 mg/mL (0.9%) solution for injection contained in the infusion bag.
  • To mix the solution, gently invert the bag to avoid foaming.
  • Inspect visually for particulate matter and discolouration prior to administration. If particulates or discolouration are noted, the product should not be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.