500 IU powder and solvent for injection , solution
C1 inhibitor ( human )
1. What Cinryze is and what it is used for
Cinryze contains the human protein called “C1 inhibitor” as the active substance.
C1 inhibitor is a naturally occurring protein that is normally found in the blood. If you have a low amount of C1 inhibitors in your blood or if the C1 inhibitor does not work normally, this can lead to swelling attacks (called angioedema ). Symptoms may include abdominal pain and swelling of:
- hands and feet
- face, eyelids, lips, or tongue
- the voice box ( larynx ), which may make it difficult to breathe
- genitals.
In adults and children, Cinryze can increase the amount of C1 inhibitors in the blood and either prevent (before medical or dental procedures) the swelling attacks from occurring or stop the swelling attacks once they have started.
In adults, adolescents and children (6 years of age and older), Cinryze may increase the amount of C1 inhibitors in the blood and regularly prevent the onset of swelling attacks.
2. What you need to know before you use Cinryze
Do not use Cinryze
- If you are allergic to C1 inhibitors or any of the other ingredients of this medicine (listed in section 6). It is important that you tell your doctor if you think you have ever had an allergic reaction to any of the ingredients in Cinryze.
Warnings and cautions
- Before starting treatment with Cinryze, it is important that you tell your doctor if you have, or have had, problems with your blood coagulation ( thrombosis ). In that case, you will be checked carefully.
- If you start to get a rash, tightness in your chest, wheezing or rapid heartbeat after taking Cinryze, you should tell your doctor immediately . See section 4.
- When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. The measures include carefully selecting blood and plasma donors to ensure that donors who can carry the infection are excluded, and that all donations and plasma pools are analyzed for signs of viruses / infections. The manufacturers of these products also take steps in the processing of blood or plasma that can inactivate or remove viruses . Despite these measures, the risk of transmitting an infection can not be completely ruled out when medicinal products made from human blood or plasma administered. This also applies to any unknown or newly developed viruses or other types of infections.
- The measures taken are considered to be effective in the case of enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B and hepatitis C viruses , and non-enveloped hepatitis A virus and parvovirus B19.
- Your doctor may recommend that you get vaccinations against hepatitis A and B if you are regularly or repeatedly receiving C1 inhibitor products made from human plasma .
- To facilitate the traceability of biological drugs, the name and manufacturing batch number of the drug must be documented by the nurse or doctor.
Children
Cinryze should not be used in children under 6 years of age for routine prevention of angioedema attacks.
Other medicines and Cinryze
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. There is only limited information on the safety of Cinryze use during pregnancy and lactation. Your doctor will discuss with you the risks and benefits of taking this medicine.
Driving and using machines
Cinryze has less influence on the ability to drive and use machines.
Cinryze contains sodium
This medicine contains 11.5 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 0.5% of the maximum recommended daily sodium intake for adults.
3. How to use Cinryze
Treatment will be initiated and supervised by a physician experienced in the management of patients with hereditary angioedema (HAE).
A doctor or nurse can prepare and inject Cinryze for you. If your doctor thinks you can inject the medicine yourself, a doctor or nurse will instruct you or a family member on how to prepare and inject Cinryze. The doctor will regularly agree with you or a relative / carer on how preparations and administration are going .
The recommended dose of Cinryze for adults, adolescents, children, the elderly or patients suffering from kidney or liver problems is as follows:
Use in adults and adolescents (12 years and older)
Treatment of swelling attacks
- A dose of 1,000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.
- An additional 1,000 IU injections may be given if symptoms do not subside after 60 minutes.
- If you get a severe attack, particularly if the voice box ( larynx ), swelling, or insertion of the drug is delayed, the second dose one of 1000 IU given earlier than 60 minutes after the first dose one, depending on how you react.
- Cinryze should be injected intravenously (into a vein).
Routine prevention of swelling attacks
- A dose of 1,000 IU (two vials) of Cinryze is injected at 3 or 4 day intervals for routine prevention of swelling attacks.
- The dosing interval can be adjusted by your doctor depending on how you respond to Cinryze.
- Cinryze should be injected intravenously (into a vein).
Prevention of swelling attacks before surgery
- A dose of 1,000 IU (two vials) of Cinryze is injected up to 24 hours before a medical, dental or surgical procedure.
- Cinryze should be injected intravenously (into a vein).
Use for children
| Treatment of angioedema attacks | Prevention of angioedema attacks before surgery | Routine prevention of angioedema attacks |
| 2 to 11 years,> 25 kg:A dose of 1,000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack. Another injection on1,000 IU can be given if your symptoms do not improve after 60 minutes. 2 to 11 years, 10–25 kg:A dose of 500 IU (one vial) of Cinryze should be injected at the first sign of a swelling attack. An additional 500 IU injection may be given if your symptoms have not improved after 60 minutes. | 2 to 11 years,> 25 kg:A dose of 1,000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental or surgical procedure. 2 to 11 years, 10–25 kg: A dose of 500 IU (one vial ) of Cinryze should be injected up to 24 hours before a medical, dental or surgical procedure. | 6 to 11 years:A dose of 500 IU (one vial) of Cinryze should be injected at 3 or 4 day intervals for routine prevention of swelling attacks. Your doctor may need to adjust the dosing interval depending on how you respond to treatment with Cinryze. |
Preparation and method of administration
Cinryze is usually injected into a vein ( intravenously ) by your doctor or nurse. You or your carer can also give Cinryze as an injection , but only after getting enough exercise. If you inject Cinryze yourself, always do as your doctor advised. Consult a doctor if you are unsure. If your doctor thinks you may be suitable for such treatment at home, you will receive detailed instructions from him / her. You must keep a diary to document each treatment you take / receive at home and bring the diary to all your visits to the doctor. Your / your caregiver’s injection technique will be checked regularly to ensure continued appropriate handling.
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.
This may include allergic reactions.
Tell your doctor immediately if you get any of the following symptoms after taking this medicine. Although the symptoms are rare, they can be severe.
Sudden wheezing, difficulty breathing, swelling of eyelids, face or lips, rash or itching(especially if the rash or itching affects the whole body).
Very common side effect are (can occur in more than 1 in 10): headache, nausea.
Common side effects are (may affect up to 1 in 10): hypersensitivity, dizziness, vomiting, rashes, itching or redness , rash or pain at the injection site, fever.
Less common side effects are (may affect up to 1 in 100): high blood sugar, blood clots, pain in the veins, hot flush, cough, abdominal pain, diarrhea, flaky skin, joint swelling and joint pain, muscle pain, and chest discomfort.
Side effects in children and adolescents are expected to be similar to those in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cinryze
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 vials after EXP.
Do not store above 25 ° C. Do not freeze. Store in the original package. Sensitive to light.
When the Cinryze solution is ready, it should be used immediately.
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 a C1 inhibitor made from plasma from human donors. Each vial of powder contains 500 IU C1 inhibitors. After reconstitution , one vial contains 500 IU C1 inhibitor ( human ) per 5 ml, corresponding to a concentration of 100 IU / ml. Two vials of reconstituted Cinryze contain 1,000 IU C1 inhibitor ( human ) per 10 ml, corresponding to a concentration of 100 IU / ml.
The total protein content of the reconstituted solution is 15 ± 5 mg/ml.
An international unit (IU) corresponds to the amount of C1 inhibitors present in 1 ml of normal human plasma .
The other ingredients are sodium chloride, sucrose, sodium citrate, L- valine , L-alanine, L-threonine. (See section 2).
Liquid: water for injection.
What the medicine looks like and contents of the pack
Powder and solvent for solution for injection.
Cinryze is a white powder enclosed in a vial .
When the powder is dissolved in the water for injection , the solution is clear and colorless to bluish.
Each package contains:
2 vials of Cinryze 500 IU powder for injection solution
2 vials of water for injections (5 ml each)
2 transfer units with filters
2 disposable syringes of 10 ml
2 sets for venipuncture
2 protective pads
Use only a silicone-free syringe (included in the package) to administer the product.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Shire Services BVBA
Rue Montoyer 47
1000 Brussels
Belgium
medinfoEMEA@shire.com
Tel: +800 66838470
Manufacturer
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria
Baxter AG
Industriestrasse 67
1221 Vienna
Austria
Shire International Licensing BV
Strawinskylaan 481
1077 XX Amsterdam
Netherlands