10 mg powder for infusion solution
velmanas alpha
What Lamzede is and what it is used for
Lamzede contains the active substance velmanas alfa, which belongs to a group of medicines called enzyme replacement therapies. It is used to treat patients with mild to moderate alpha-mannosidosis. It is given to treat the non-neurological symptoms of the disease.
Alpha-mannosidosis is a rare genetic disease caused by a lack of enzyme et alpha-mannosidase that is needed to break down certain sugars (so-called mannose-rich oligosaccharides ) in the body. When this enzyme is missing or does not work properly, these sugars accumulate and cause the signs and symptoms present in the disease. The typical manifestations of the disease include characteristic facial features, mental retardation, difficulty controlling movements, hearing and speech difficulties, frequent infections, skeletal problems, muscle pain, and muscle weakness.
Velmanas alfa is intended to replace the missing enzyme in patients with alpha-mannosidosis. This can improve the symptoms of the disease.
What you need to know before using Lamzede
Do not use Lamzede
- if you are allergic to velmanas alfa or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Lamzede.
If you are being treated with Lamzede, you may experience a side effect during or immediately after the drip ( infusion one) used to give the medicine (see section 4). This is called an infusion-related reaction and can sometimes be severe.
- Infusion-related reactions include dizziness, headache, nausea, low blood pressure , fatigue and fever. If you get an infusion-related reaction , tell your doctor immediately.
- If you get an infusion-related reaction, you may be given additional medicines to treat or help prevent future reactions. These medicines may include medicines used to treat allergies ( antihistamines ), medicines used to treat fever (antipyretics) and medicines used to reduce inflammation ( corticosteroids ).
- If the infusion-related reaction is severe, your doctor will immediately discontinue the infusion and give you appropriate medical treatment.
- If the infusion-related reactions are severe and / or the effect of this medicine is weakened, your doctor will take a blood test to see if you have any antibodies that may affect the results of your treatment.
- In most cases, you can continue with Lamzede even if you get an infusion-related reaction.
Other medicines and Lamzede
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Lamzede should be used during pregnancy only if needed medically. It is not known if the alpha of velmanas passes into breast milk. Lamzede can be used during breastfeeding.
Driving and using machines
Lamzede has no or negligible effect on the ability to drive and use machines.
Lamzede contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘sodium-free.
How to use Lamzede
This medicine should only be used under the supervision of a doctor who has experience in the treatment of alpha-mannosidosis or other similar diseases and should only be given by healthcare professionals.
Dosage
The recommended dose of Lamzede is 1 mg/kg body weight given once a week.
Use for children and adolescents
Lamzede can be given to children and adolescents with the same dose and frequency as adults.
Administration
Lamzede is supplied in a vial as a powder for solution for infusion mixed with water for injections before administration.
Once reconstituted, the drug is given via an infusion pump (drip) into a vein for at least 50 minutes under the supervision of a physician.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects occur during or shortly after infusion (“infusion-related reaction”, see section 2 Warnings and precautions).
While you are being treated with Lamzede, you may experience some of the following reactions:
Serious side effects are
Common side effects (may affect up to 1 in 10 people)
- unconsciousness (fainting, which may be preceded by a feeling of dizziness, dizziness or confusion)
- acute renal failure (kidney problems recognized by fluid retention, swelling of the legs, ankles or feet, drowsiness, shortness of breath or fatigue)
- hypersensitivity and severe allergic reaction (symptoms include localized or diffuse itching, dizziness, difficulty breathing, chest pain, chills, fever, gastrointestinal symptoms such as nausea, vomiting, diarrhea, or pain in the intestine, swelling of the throat, face, lips or tongue )
If you get any of these side effects, talk to your doctor immediately.
Other side effects are
Very common side effects (may affect more than 1 in 10 people)
- diarrhea
- weight gain
- fever / elevated body temperature
Common side effects (may affect up to 1 in 10 people)
- slow pulse ( bradycardia )
- blue skin and lips (cyanosis)
- psychotic behavior (mental illness with hallucinations, difficulty thinking clearly and understanding reality, anxiety), difficulty falling asleep
- confused state, fainting, tremors, dizziness, headache
- abdominal pain (stomach), stomach irritation caused by stomach acid (gastritis with acid regurgitation), nausea, vomiting
- infusion site pain, chills, feeling hot, feeling sick, tiredness (fatigue)
- skin rash (hives), increased sweating ( hyperhidrosis )
- nosebleeds
- joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet)
- eye irritation, swelling of the eyelids (eyelid edema), redness of the eyes
- increased appetite
How to store Lamzede
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 label and carton after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 ° C-8 ° C).
Store in the original package. Sensitive to light.
After reconstitution, the drug should be used immediately. If not used immediately, the reconstituted solution can be stored in a refrigerator for a maximum of 24 hours from 2 ° C to 8 ° C.
This medicine must not be used if the reconstituted solution contains opaque particles or is discolored.
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.
Contents of the package and other information
Content declaration
- The active substance is the alpha of velmanas.Each vial contains 10 mg of velmanas alfa.After reconstitution , one ml of the solution contains 2 mg of velmanas alfa (10 mg / 5 ml).
- The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and glycine .
What the medicine looks like and contents of the pack
Lamzede is a white to off-white powder for solution for infusion provided in a glass vial.
Each carton contains 1, 5, or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chiesi Farmaceutici SpA
Via Palermo 26 / A
43122 Parma
Italy
Manufacturer
Chiesi Farmaceutici SpA
Via San Leonardo, 96
43122 Parma
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienChiesi sa / nvTel: + 32 (0) 2 788 42 00 | LithuaniaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 |
| BulgariaChiesi Bulgaria EOODTel: + 359 29201205 | Luxembourg / LuxemburgChiesi sa / nvTel: + 32 (0) 2 788 42 00 |
| Czech RepublicChiesi CZ sroTel: + 420 261221745 | HungaryChiesi Hungary Kft.Tel .: + 36-1-429 1060 |
| DenmarkChiesi Pharma ABTel: + 46 8 753 35 20 | MaltaChiesi Farmaceutici SpATel: + 39 0521 2791 |
| GermanyChiesi GmbHTel: + 49 40 89724-0 | The NetherlandsChiesi Pharmaceuticals BVTel: + 31 88 501 64 00 |
| EestiChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 | NorwayChiesi Pharma ABTel: + 46 8 753 35 20 |
| GreeceChiesi Hellas AEBE:Ηλ: + 30 210 6179763 | AustriaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 |
| SpainChiesi España, SAUTel: + 34 93 494 8000 | PolandChiesi Poland Sp. ZooTel .: + 48 22 620 1421 |
| FranceChiesi SASTel: + 33 1 47688899 | PortugalChiesi Farmaceutici SpATel: + 39 0521 2791 |
| CroatiaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 | RomaniaChiesi Romania SRLTel: + 40 212023642 |
| IrelandChiesi Farmaceutici SpATel: + 39 0521 2791 | SloveniaChiesi Slovenija dooTel: + 386-1-43 00 901 |
| IcelandChiesi Pharma ABPhone: +46 8 753 35 20 | Slovak RepublicChiesi Slovakia sroTel: + 421 259300060 |
| ItalyChiesi Italia SpATel: + 39 0521 2791 | Finland / FinlandChiesi Pharma ABPuh / Tel: +46 8 753 35 20 |
| .ΠροςChiesi Farmaceutici SpA:Ηλ: + 39 0521 2791 | SwedenChiesi Pharma ABTel: +46 8 753 35 20 |
| LatviaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 | United Kingdom(Northern Ireland)Chiesi Farmaceutici SpATel: +39 0521 2791 |
This medicine has been authorized according to the rules of “authorization in exceptional cases”. This means that it has not been possible to obtain complete information about this medicine as the disease is rare.
Every year, the European Medicines Agency reviews any new information and updates this leaflet when necessary.