2.5 g powder for infusion solution 
hydroxocobalamin

1. What Cyanokit is and what it is used for

Cyanokit contains the active substance hydroxocobalamin.

Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning in all age groups.

Cyanokit should be used in conjunction with appropriate decontamination and support measures.

Cyanide is a very toxic chemical substance. Cyanide poisoning can be caused by exposure to smoke from residential and industrial fires, inhalation or ingestion of cyanide, or skin contact with cyanide.

2. What you need to know before using Cyanokit

Warnings and cautions

Tell a doctor or other healthcare professional

  • if you are allergic to hydroxocobalamin or vitamin B12. They must take this into account before you are treated with Cyanokit.
  • that you have been treated with Cyanokit if you need to do the following:
    • some blood or urine tests. Cyanokit may affect the results of these tests.
    • assessment of burns. Cyanokite can affect the assessment because it stains the skin red.
    • hemodialysis. Cyanokit may cause the hemodialysis machine to stop working until it has been eliminated from the bloodstream (at least 5.5 to 6.5 days).
    • monitoring of renal function. Cyanokite can cause kidney failure and crystals in the urine.

Other medicines and Cyanokit

Tell your doctor or another healthcare professional if you are taking, have recently taken, or might take any other medicines.

Detailed information for physicians or other healthcare professionals regarding concomitant administration of Cyanokit and other medicinal products can be found at the end of this leaflet (see “Handling instructions”).

Pregnancy and breastfeeding

This medicine is for emergency treatment. It can be given during pregnancy and lactation.

Tell your doctor as soon as possible if you were pregnant or think you may have been pregnant during treatment with Cyanokit.

Your doctor will recommend that you stop breastfeeding after treatment with Cyanokit.

How to use Cyanokit

Your doctor or healthcare professional will give you Cyanokit by infusion(administration) into a vein. You may need one or two infusions.

You will receive the first infusion of Cyanokit in 15 minutes. For adults, the initial dose is 5 g. For children, it is 7mg/kg body weight up to a maximum of 5 g. If you need a second infusion, you will receive it for 15 minutes to 2 hours. It depends on the severity of the poisoning.

The highest recommended total dose is 10 g for adults and 14mg/kg body weight for children up to a maximum of 10 g.

Detailed instructions for physicians or other healthcare professionals on how to prepare an infusion of Cyanokit and how to determine a dose can be found at the end of this leaflet (see “Handling instructions”).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can be expected (frequency can not be calculated from the available data):

Allergy (hypersensitivity)

Tell your doctor immediately if you get the following symptoms during or after this treatment:

  • swelling around the eyes, lips, tongue, throat, at or hands
  • difficulty breathing, hoarseness, ss or speech difficulties
  • redness, hives ( urticaria, ) or itching.

Such side effects can be serious and require immediate care.

Heart and blood pressure problems

  • symptoms such as headache or dizziness, as they may be due to high blood pressure. This high blood pressure occurs especially at the end of treatment and usually drops again within a few hours.
  • irregular heartbeats
  • flushing (hot flashes).

Lowered blood pressure and faster heart rate have also been observed in patients with cyanide poisoning.

Breathing and chest problems

  • fluid in the chest (pleural effusion)
  • breathing difficulties
  • a feeling of tightness in the throat
  • throat dryness
  • pressure over the chest.

Kidney and urine problems

  • kidney damage such as acute renal impairment and crystals in the urine
  • red urine

All patients will show fairly clear dark red urine during the first three days following treatment. Urine staining may persist for up to 35 days after treatment with Cyanokit. This red coloring has no other effect on your body.

Gastrointestinal problems

  • discomfort in the stomach
  • indigestion
  • diarrhea
  • nausea
  • vomiting
  • difficulty swallowing.

Eye problems

  • swelling, irritation, redness.

Skin reactions

  • Most patients will experience a transient redness of the skin and mucous membranes that may persist for up to 15 days after treatment with Cyanokit.
  • blister-like changes in the skin (blisters). These can persist for several weeks and mainly affect the face and neck.
  • inflammation in the part of the body where the drug was administered.

Other side effects ar

  • restlessness
  • memory problem
  • dizziness
  • headache
  • swollen ankles
  • altered results on blood samples of certain white blood cells ( lymphocytes )
  • colored place, which may cause an unnatural increase or decrease in the levels of certain laboratory parameters.

5. How to store Cyanokit

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial, cart, on, and carton after EXP.

Do not store above 25 ° C.

During outpatient use, Cyanokit may be exposed for a short period of time to temperature variations that occur at

  • normal transport (15 days at temperatures varying between 5 ° C and 40 ° C)
  • desert transport (4 days at temperatures varying between 5 ° C and 60 ° C) and
  • freezing or thawing cycles (15 days at temperatures varying between -20 ° C and 40 ° C).

For storage instructions for the reconstituted product, see “Handling instructions” at the end of this leaflet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is hydroxocobalamin. Each vial contains 2.5 g of hydroxocobalamin. After reconstitution with 100 ml of dilute each ml of reconstituted solution contains 25 mg of hydroxocobalamin.
  • The other ingredient is hydrochloric acid (for pH adjustment).

What the medicine looks like and the d contents of the pack

Cyanokit powder for solution for infusion is a dark red, crystalline powder that is supplied in a glass vial with a bromobutyl rubber stopper and an aluminum cap with a plastic closure.

Each pack contains two vials (each vial is packaged in a carton), two sterile transfer needles, a sterile infusion set for intravenous use, and a short sterile catheter for administration to children.

Marketing Authorisation Holder

SERB SA

Avenue Louise 480

1050 Brussels

Belgium

Manufacturer

Merck Santé sas / SEMOY

2, rue du Pressoir Vert

45400 Semoy

France

Or

SERB SA

Avenue Louise 480

1050 Brussels

Belgium

Or

SERBIAN

40 Avenue George V

75008 Paris

France

Muhammad Nadeem

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