Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lamzede

Document Subject

Generated Narrative: MedicinalProductDefinition mpb455bf5933866192c268e98801b21195

identifier: http://ema.europa.eu/identifier/EU/1/17/1258/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lamzede 10 mg 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

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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-b455bf5933866192c268e98801b21195

identifier: http://ema.europa.eu/identifier/EU/1/17/1258/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - lamzede

Attesters

What is in this leaflet

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

Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies. It is used to treat patients with mild to moderate alpha-mannosidosis disease. It is given for the treatment of non-neurological symptoms of the disease.

Alpha-mannosidosis disease is a rare genetic disorder caused by a lack of an enzyme named alpha-mannosidase, which is needed to break down certain sugar compounds (called mannose-rich oligosaccharides ) in the body. When this enzyme is missing or does not work properly, these sugar compounds build up inside cells and cause the signs and symptoms of the disease. The typical manifestations of the disease include distinctive facial features, mental retardation, difficulty in controlling movements, difficulties in hearing and speaking, frequent infections, skeletal problems, muscle pain and weakness.

Velmanase alfa is designed to replace the missing enzyme in patients with alpha-mannosidosis disease.

Do not use Lamzede

• if you are allergic to velmanase alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before Lamzede is used. Hypersensitivity reactions may occur with the administration of Lamzede. These reactions usually appear during or soon after the infusion and may manifest with several symptoms, such as localised or diffuse skin reactions, gastrointestinal symptoms or swelling of the throat, face, lips or tongue (see section 4 Possible side effects ). If the hypersensitivity reaction is severe, immediate discontinuation of Lamzede is recommended and current medical standards for emergency treatment are to be followed. Less severe hypersensitivity reactions may be managed by temporary interruption of the infusion or by slowing down infusion rate; administration of medicines used to treat allergy may be considered by the physician.

If you are treated with Lamzede, you may experience a side effect during or immediately following the drip (infusion) used to give the medicine (see section 4 Possible side effects ). This is known as an infusion-related reaction and can sometimes be severe.

• Your doctor may decide to keep you under observation for one hour or longer after the infusion in relation to the infusion related reactions.
• Infusion-related reactions include dizziness, headache, nausea, low blood pressure, tiredness and fever. If you experience an infusion-related reaction, you must tell your doctor immediately.
• If you have 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 to control inflammation (corticosteroids).
• If the infusion-related reaction is severe, your doctor will stop the infusion immediately and start giving you appropriate medical treatment.
• If the infusion-related reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies that might affect the outcome of your treatment.
• Most of the time you can still be given Lamzede even if you experience an infusion-related reaction.

Antibodies may play a role in hypersensitivity and infusion related reactions observed with the use of Lamzede. Although 24% of patients developed antibodies against Lamzede during its clinical development, no clear correlation was found between antibody titres and reduction in efficacy or occurrence of hypersensitivity reactions.

Other medicines and Lamzede Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding 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 this medicine is used.

You should not take this medicine during pregnancy unless your doctor states it is clearly necessary. Your doctor will discuss that with you.

It is not known whether velmanase alfa passes into breast milk. Lamzede can be used during breast- feeding since the velmanase alfa will not be absorbed by a breastfed child.

Driving and using machines Lamzede has no or negligible influence on the ability to drive and use machines.

Lamzede contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose unit, that is to say essentially sodium-free .

This medicine is only to be used under the supervision of a doctor experienced in the treatment of alpha-mannosidosis or other similar diseases and should only be given by a healthcare professional.

Lamzede is only used under the supervision of a doctor who is knowledgeable in the treatment of Alpha Mannosidosis disease. Your doctor may advice that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home. Dose The recommended dose of Lamzede is 1 mg/kg of body weight given once every week.

Use in children and adolescents Lamzede may be given to children and adolescents at the same dose and frequency as in adults.

Administration Lamzede is supplied in a vial as a powder for infusion which will be made up with water for injections before being given. Once it has been made up, the medicine will be given by infusion pump (drip) into a vein over a period of at least 50 minutes under your doctor s supervision.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects occur during the infusion or shortly after ( infusion-related reaction , see section 2 Warnings and precautions ).

While under treatment with Lamzede, you may experience some of the following reactions:

Serious side effects

Common side effects (may affect up to 1 in 10 people)

• loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused)
• acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue)
• hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, chills, fever, gastrointestinal symptoms such as nausea, vomiting, diarrhoea or intestinal pain, swelling of the throat, face, lips or tongue)

If you experience any side effect like these, please tell your doctor immediately.

Other side effects

Very common side effects (may affect more than 1 in 10 people)

• diarrhoea
• weight increase
• fever/increased body temperature

Common side effects (may affect up to 1 in 10 people)

• low heart beat (bradycardia)
• Blue skin and lips (cyanosis)
• psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), initial difficulty in sleeping
• confused state, fainting, tremor, dizziness, headache
• intestinal (abdominal) pain, irritation of the stomach caused by digestive acids (reflux gastritis), nausea, vomiting
• pain at the site the infusion is given, chills, feeling hot, malaise, tiredness (fatigue)
• skin rashes (urticaria), increased sweating (hyperhidrosis)
• nosebleed
• joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet)
• eye irritation, eyelid swelling (eyelid oedema), eye redness
• increased appetite

Side effects frequency not known (frequency cannot be estimated from the available data)

• infection of the inner wall of the sac around the heart (endocarditis)
• furuncle
• infection caused by a bacteria called Staphylococcus
• decreased appetite
• agitation, stool soiling, nervousness
• inability to coordinate muscle movements
• somnolence
• increased lacrimation
• deafness
• aortic valve incompetence (a condition in which the aortic valve does not close tightly)
• fast and/or rapid heart beat
• low blood pressure
• vascular fragility
• oropharyngeal pain
• wheezing
• painful swallowing
• reddening of the skin
• joint swelling, joint warmth
• weakness

Reporting of side effects If you get any side effects, talk to your doctor. 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 label and the carton after EXP . The expiry date refers to the last day of that month.

Store and transport refrigerated (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light.

After reconstitution, the medicine should be used immediately. If not used immediately, the reconstituted solution may be stored up to 24 hours at 2 C to 8 C.

This medicine must not be used if the reconstituted solution contains opaque particles or is discoloured.

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

What Lamzede contains

• The active substance is velmanase alfa.

One vial contains 10 mg of velmanase alfa.

After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).

• The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate (see section 2 Lamzede contains sodium ), mannitol (E 421) and glycine.

What Lamzede looks like and contents of the pack Lamzede is a white to off-white powder for solution for infusion, supplied in a glass vial.
Each carton contains 1, 5 or 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A. Via Palermo 26/A
43122 Parma
Italy

Manufacturer Chiesi Farmaceutici S.p.A. Via San Leonardo, 43122 Parma
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 Lietuva Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073
Chiesi Bulgaria EOOD
Te .: + 359 29201Luxembourg/Luxemburg Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 esk republika Chiesi CZ s.r.o.
Tel: + 420 261221Magyarorsz g Chiesi Hungary Kft.
Tel.: + 36-1-429 1Danmark Chiesi Pharma AB
Tlf: + 46 8 753 35 Malta Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Deutschland Chiesi GmbH
Tel: + 49 40 89724-0

Nederland Chiesi Pharmaceuticals B.V.
Tel: + 31 88 501 64 Eesti Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073Norge Chiesi Pharma AB
Tlf: + 46 8 753 35
Chiesi Hellas AEBE
: + 30 210 6179 sterreich Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073Espa a Chiesi Espa a, S.A.U.
Tel: + 34 93 494 8Polska Chiesi Poland Sp. z.o.o.
Tel.: + 48 22 620 1France Chiesi S.A.S.
T l: + 33 1 47688Portugal Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Hrvatska Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073Rom nia Chiesi Romania S.R.L.
Tel: + 40 212023Ireland Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Slovenija CHIESI SLOVENIJA, d.o.o.
Tel: + 386-1-43 00 sland Chiesi Pharma AB
S mi: +46 8 753 35 Slovensk republika Chiesi Slovakia s.r.o.
Tel: + 421 259300Italia Chiesi Italia S.p.A.
Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB
Puh/Tel: +46 8 753 35
Chiesi Farmaceutici S.p.A.
: + 39 0521 2Sverige Chiesi Pharma AB
Tel: +46 8 753 35 Latvija Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2This leaflet was last revised in .

This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

Other sources of information

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