Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ruconest

Document Subject

Generated Narrative: MedicinalProductDefinition mp57a928d33300a0b3188f379ca97280de

identifier: http://ema.europa.eu/identifier/EU/1/10/641/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ruconest 2100 Units powder for solution for injection.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-57a928d33300a0b3188f379ca97280de

identifier: http://ema.europa.eu/identifier/EU/1/10/641/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ruconest

Attesters

What is in this leaflet

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

Ruconest contains conestat alfa as the active substance. Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1-INH).

Ruconest is to be used by adults, adolescents, and children (aged 2 years and above) with a rare inherited blood disorder, called Hereditary Angioedema (HAE). These patients have a shortage of the C1 inhibitor protein in their blood. This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms.

The administration of Ruconest is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE.

Do not use Ruconest

• If you are or think you are allergic to rabbits.
• If you are allergic to conestat alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Ruconest. If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently.

Before you start treatment with Ruconest, it is important that you tell your doctor if you have, or have had, problems with your blood clotting (thrombotic events). You will be carefully monitored if this is the case. Hypersensitivity reactions cannot be excluded and may have symptoms similar to angioedema attacks.

Children and adolescents Do not give this medicine to children under 2 years old. Ruconest has not been studied in children younger than 5 years of age. Your doctor will determine whether treatment of your child with Ruconest is appropriate. Additional monitoring of your child for symptoms of allergic reactions during and after administration is needed.

Other medicines and Ruconest Tell your doctor if you are taking, have recently taken or might take any other medicines. If you are receiving tissue type plasminogen activator as acute treatment for blood clots, you should not be treated with Ruconest at the same time.

Pregnancy and breast-feeding It is not recommended to use Ruconest during pregnancy or breast-feeding.
If you plan becoming pregnant, discuss with your doctor before starting to use Ruconest.

Driving and using machines Do not drive or use machinery if you feel dizzy or suffer from headache after using Ruconest.

Ruconest contains sodium (19.5 mg per vial) This should be taken into consideration by patients on a controlled sodium diet.

Ruconest will be initiated by a doctor who is specialised in the diagnosis and treatment of hereditary angioedema.

Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse. Your dose, up to 2 vials, will be worked out based on your weight.

Most of the time a single dose is sufficient. Your doctor may decide that an additional dose should be administered if your symptoms do not improve after 120 minutes (for adults and adolescents) or 60 minutes (for children). No more than 2 doses should be given within 24 hours.

The instructions for use are clearly described in the doctor s information leaflet and are attached.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your symptoms get worse and/or you develop a rash, tingling, difficulty breathing or your face or tongue swells up, get medical attention immediately. This may indicate that you have developed an allergy to Ruconest.

Some side effects may occur during treatment with Ruconest:
Common: may affect up to 1 in 10 people

• Nausea

Uncommon: may affect up to 1 in 100 people

• Abdominal pain, diarrhoea
• Sensation of tingling, prickling or numbness in the mouth
• Headache, dizziness
• Reduced sense of touch or sensation in skin or limbs
• Throat irritation
• Hives
• Swelling of the ears or the area around the ears
• Allergic shock

Not known: the frequency is not known

• Hypersensitivity reactions

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in the 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 carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.

Do not store above 25 C. Store in the original package in order to protect from light.

Before Ruconest can be administered, it needs to be dissolved in water for injections, by a healthcare professional. Once reconstituted, the product should be used immediately.
Do not use this medicine if you notice particles in the solution or if the solution is discoloured.

What Ruconest contains
The active substance is conestat alfa. Each vial contains 2100 units of conestat alfa, corresponding to 2units per 14 ml after reconstitution, or a concentration of 150 units/ml.

The other ingredients are sucrose, sodium citrate (E331) and citric acid.

What Ruconest looks like and contents of the pack Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection. After dissolving the powder in water for injections, the solution is clear and colourless. Ruconest is supplied in a carton box containing one vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Pharming Group N.V. Darwinweg 2333 CR Leiden The Netherlands

Manufacturer: Pharming Technologies B.V. Darwinweg 2333 CR Leiden The Netherlands

This leaflet was last revised in

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