Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cyanokit

Document Subject

Generated Narrative: MedicinalProductDefinition mp58c65c2882289cd285f1ea0608d4e9f7

identifier: http://ema.europa.eu/identifier/EU/1/07/420/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cyanokit 2.5 g powder for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-58c65c2882289cd285f1ea0608d4e9f7

identifier: http://ema.europa.eu/identifier/EU/1/07/420/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cyanokit

Attesters

What is in this leaflet:

1. What Cyanokit is and what it is used for
2. What you need to know before Cyanokit is used
3. How Cyanokit is used
4. Possible side effects
5. How Cyanokit is stored
6. Contents of the pack and other information

Cyanokit contains the active substance hydroxocobalamin. Cyanokit is an antidote for the treatment of known or suspected cyanide poisoning in all age ranges.
Cyanokit is to be administered together with appropriate decontamination and supportive measures.

Cyanide is a highly poisonous chemical. Cyanide poisoning may be caused by exposure to smoke from household and industrial fires, breathing or swallowing cyanide, or contact with cyanide on skin.

Warnings and precautions

Tell your doctor or other health care professional

if you are allergic to hydroxocobalamin or vitamin B12. They will have to take it into account before treating you with Cyanokit.

that you have been treated with Cyanokit if you need to have the following:

• any blood or urine tests. Cyanokit may modify the results of these tests.
• burn assessement. Cyanokit may interfere with the assessment as it causes red coloration of the skin.
• haemodialysis. Cyanokit may lead to shut down of haemodialysis machines until it is eliminated from the blood (at least 5.5 to 6.5 days). monitoring of renal function: Cyanokit may lead to kidney failure and urine crystals.

Other medicines and Cyanokit

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

Detailed information for your doctor or other health care professional regarding simultaneous administration of Cyanokit with other medicines can be found at the end of this package leaflet (see 'Handling instructions').

Pregnancy and breast-feeding

This medicine is an emergency treatment. It can be administered during pregnancy and breast-feeding. 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 you to stop breast-feeding after treatment with Cyanokit.

Your doctor or health care professional will give you Cyanokit by infusion into a vein. You may need one or two infusions.

You will have the first infusion of Cyanokit over 15 minutes. For adults, the initial dose is 5 g. For children, it is 70 mg/kg body weight, up to a maximum dose of 5 g. If you need a second infusion, you will have it over 15 minutes to 2 hours. It depends on how serious the poisoning is. The maximum total recommended dose is 10 g for adults, and 140 mg/kg in children up to a maximum of 10 g.

Detailed instructions for your doctor or other health care professional on how to prepare the Cyanokit infusion and how to determine the dose can be found at the end of this package leaflet (see 'Handling instructions').

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

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

Allergy (hypersensitivity)

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

swelling around the eyes, lips, tongue, throat or hands

breathing difficulties, hoarseness, difficulty in speaking

skin redness, nettle rash (urticaria) or itching. Such side effects may be serious and need immediate attention.

Heart and blood pressure problems

symptoms such as headache or dizziness, as they may be due to a rise in blood pressure. This rise in blood pressure especially occurs at the end of having this treatment and usually settles down within several hours

irregular heart beat

redness of the face (flush). A decrease in blood pressure and a faster heart beat have also been observed in patients who have cyanide poisoning.

Breathing and chest problems

fluid in the chest (pleural effusion)

breathing difficulties

a feeling of tightness in the throat

dry throat

chest pressure.

Renal and urinary problems

kidney injuries such as acute kidney impairment and urine crystals.

red colouration of the urine. All patients will show a dark red colouration of the urine quite marked during the first three days
following administration. Urine colouration may last up to 35 days after administration of Cyanokit. This red colouration has no other consequences on your body.

Gastrointestinal (digestive) problems

discomfort in your stomach

indigestion

diarrhoea

feeling sick (nausea)

being sick (vomiting)

difficulty in swallowing.

Eye problems

swelling, irritation, redness.

Skin reactions

most patients will experience a reversible red colouration of the skin and membranes lining body cavities (mucous membranes) that may last up to 15 days after administration of Cyanokit.

blister-like lesions on the skin (pustular rashes). These may last for several weeks, and affect mainly the face and the neck.

inflammation in the part of the body where the medicine was infused.

Other side effects

restlessness

problems with memory

dizziness

headache

swelling of ankles

changes in the results of blood tests for certain white blood cells (lymphocytes)

coloured plasma, which may cause artificial elevation or reduction in the levels of certain laboratory parameters.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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, the cardboard box and the carton after EXP.

Do not store above 25 C.

For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of

usual transport (15 days submitted to temperatures ranging from 5 to 40 C)

transport in the desert (4 days submitted to temperatures ranging from 5 to 60 C) and

freezing/defrosting cycles (15 days submitted to temperatures ranging from -20 to 40 C).

For storage conditions of the reconstituted medicine, see 'Handling instructions' at the end of this package leaflet.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

What Cyanokit contains

The active substance is hydroxocobalamin. Each vial contains 2.5 g of hydroxocobalamin. After reconstitution with 100 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.

The other ingredient is hydrochloric acid (for pH adjustment).

What Cyanokit looks like and contents of the pack

Cyanokit powder for solution for infusion is a dark red crystalline powder supplied in a glass vial closed with bromobutyl rubber stopper and an aluminium cap with a plastic lid.

Each pack contains two vials (each vial packed in one cardboard box), two sterile transfer devices, one sterile intravenous infusion set and one sterile short catheter for administration to children.

Marketing Authorisation Holder

SERB S.A. Avenue Louise 1050 Brussels Belgium

Manufacturer

Merck Sant s.a.s. / SEMOY 2, rue du Pressoir Vert 45400 Semoy France

Or

SERB S.A. Avenue Louise 1050 Brussels Belgium

Or

SERB 40 avenue George V 75008 Paris France

This leaflet was last revised in MM/YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: