NAGLAZYME 1 mg /Ml Инфузионный Раствор
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Инструкция по применению NALATSYME
Содержание инструкции
Naglazyme 1 mg/ml concentrate for solution for infusion
Galsulfase
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor.
Contents of this leaflet:
- 1. What this medicine is and what it is used for
- 2. What you need to know before you are given this medicine
- 3. How to administer this medicine
- 4. Possible side effects
- 5. How to store this medicine
- 6. Contents of the pack and other information
1. What this medicine is and what it is used for
Naglazyme is used to treat patients with MPS VI (Mucopolysaccharidosis VI).
People affected by MPS VI have a deficiency, or absence, of an enzyme called
N-acetylgalactosamine 4-sulfatase, which allows the degradation of specific substances
(glycosaminoglycans) present in the body. Consequently, these substances are not
degraded by the body as they should, but accumulate in many tissues causing the symptoms of
MPS VI.
How this medicine works
This medicine contains a recombinant enzyme called galsulfase, capable of replacing
the natural enzyme that is missing in patients affected by MPS VI. Treatment with this medicine has
demonstrated to improve the ability to walk and climb stairs and to reduce the levels of
glycosaminoglycans present in the body. This medicine may improve the symptoms of
MPS VI.
2. What you need to know before you are given this medicine
Do not receive this medicine if:
- You have experienced severe or potentially life-threatening allergic (hypersensitivity) reactions to galsulfase or any of the excipients of Naglazyme and the re-administration of the medicine has not had the desired effect.
Warnings and precautions
- If you are treated with Naglazyme, you may develop infusion-related reactions. An infusion-related reaction is an undesirable effect that occurs during the infusion or at the end of the infusion day (see section 4 “Possible side effects”). If such a reaction should occur, contact your doctor immediately.
- If you develop an allergic reaction, your doctor may slow down or stop the infusion. The doctor may also give you appropriate medical therapy to manage allergic reactions.
- If you have a fever or have difficulty breathing, consult your doctor about the possibility of delaying the infusion with Naglazyme before you are given this medicine.
- If you have pre-existing heart disease, inform your doctor at any time during treatment with Naglazyme. The doctor may modify the infusion based on this information.
- This medicine has not been tested in patients with liver or kidney problems. Contact your doctor if you have renal or hepatic insufficiency.
- Inform your doctor if you experience muscle pain, numbness in the arms or legs, or problems with the bowel or bladder, as these may be caused by pressure on the spinal cord.
Other medicines and Naglazyme
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Pregnancy and breastfeeding
Naglazyme should not be given during pregnancy unless absolutely necessary.
Ask your doctor or pharmacist for advice before taking any medicine. It is not known whether
galsulfase is excreted in breast milk, so breastfeeding must be discontinued during treatment with
Naglazyme. Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
No studies have been conducted on the effects of the medicine on the ability to drive and
operate machines.
This medicine contains sodium
Each vial of 5 ml contains 0.8 mmol (18.4 mg) of sodium and is administered in a sodium chloride 9 mg/ml injectable solution. To be taken into consideration in patients on a controlled sodium diet.
3. How to administer this medicine
The doctor or nurse will administer Naglazyme to you.
The dose you receive will depend on your body weight. The recommended dose is 1 mg/kg of weight
to be administered once a week drop by drop into a vein (in the form of an intravenous
infusion). Each infusion will last approximately 4 hours. For the first hour, the infusion rate will be slow
(approximately 2.5% of the total solution), while the remainder (approximately 97.5%) will be
administered over the next 3 hours.
If you are given too much Naglazyme
Naglazyme is administered under the supervision of a nurse or doctor who will monitor
that you receive the correct dose and will act accordingly, if necessary.
If you forget to take this medicine
If you miss an infusion of Naglazyme, contact your doctor. If you have any doubts about the use of this
medicine, contact your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects have been observed mainly during the administration of the medicine,
or shortly after (“infusion-related reactions”). The most serious side effects have been swelling of the
face, fever (very common), longer intervals between breaths than normal, difficulty breathing,
asthma and hives (common); swelling of the tongue and throat and severe allergic reaction to this
medicine (frequency not known).
If you experience any of these reactions, tell your doctor immediately. You may
need to be given further medicines to prevent an allergic reaction (e.g. antihistamines and/or
corticosteroids) or to lower your fever (antipyretics).
The most common symptoms of the infusion reaction include fever, chills, skin rash, hives and
shortness of breath.
Very common side effects (may affect more than 1 in 10 people):
- Sore throat
- Gastroenteritis
- Slowed reflexes
- Headache
- Eye inflammation
- Blurred vision
- Hearing impairment
- High blood pressure
- Nasal congestion
- Umbilical protrusion
- Vomiting
- Nausea
- Itching
- Pain (including ear pain, abdominal pain, joint and chest pain)
- Feeling unwell
Common side effects (may affect up to 1 in 10 people):
- Tremor
- Low blood pressure
- Cough
- Shortness of breath
- Skin redness
Other side effects with frequency not known:
- Bluish skin
- Pale skin
- Low blood oxygen
- Rapid breathing
If any side effect occurs, including those not listed in this leaflet, tell your doctor
immediately. You can also report side effects directly through the national reporting system
described in Annex V. By reporting side effects you can help to provide more information on the
safety of this medicine.
5. How to store this medicine
Keep Naglazyme out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial after the wording
"EXP.". The expiry date refers to the last day of the month.
Intact vials:
Store in a refrigerator (2 C - 8 C).
Do not freeze.
Diluted solutions: chemical and physical stability during use has been demonstrated for a period of up to 4
days at room temperature (23 C - 27 C).
From a microbiological point of view, Naglazyme must be used immediately.
If not, the storage times and conditions of the solution during administration
- Shock
- Tingling
- Decrease in heart rate
- Increase in heart rate
are the responsibility of the user and must not normally exceed 24 hours at a
temperature of 2 C - 8 C and subsequently up to 24 hours at room temperature (23 C - 27 C).
Do not use Naglazyme if you notice the presence of suspended particles.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Naglazyme contains
- The active substance is galsulfase. Each ml of Naglazyme contains 1 mg of galsulfase. Each 5 ml vial contains 5 mg of galsulfase. Galsulfase is a recombinant form of human N-acetylgalactosamine-6-sulfate sulfatase and is produced using recombinant DNA technology through Chinese hamster ovary (CHO) cell lines.
- The excipients are: sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.
Description of the appearance of Naglazyme and contents of the pack
Naglazyme is presented as a concentrate for solution for infusion. The concentrate must
have an appearance from clear to slightly opalescent and a colour from transparent to light yellow and must
be free from visible suspended particles. The solution must be further diluted before
infusion.
Pack sizes:1 and 6 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
BioMarin International Limited
Shanbally, Ringaskiddy
County Cork, P43 R298
Ireland
Manufacturer
BioMarin International Limited
Shanbally, Ringaskiddy
County Cork, P43 R298
Ireland
More detailed information on this medicine is available on the European Medicines
Agency website: http://www.ema.europa.eu/. Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.
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The following information is intended exclusively for physicians or healthcare professionals:
Naglazyme must not be mixed with other medicines in the same infusion, except for
those listed below.
Each vial of Naglazyme is for single use only. The concentrate for solution for infusion must be
diluted in a 9 mg/ml (0.9%) sodium chloride solution for infusion using aseptic technique. It is
recommended to administer the diluted Naglazyme solution through an infusion device
equipped with a 0.2 µm inline filter.
Any unused product residue must be disposed of in accordance with current local regulations.
Preparation of the Naglazyme infusion (use aseptic technique)
The vials to be diluted, the number of which is determined based on the individual patient's weight, must be
removed from the refrigerator approximately 20 minutes before preparation, to bring them to room temperature.
Before dilution, each vial must be visually inspected to exclude the
presence of suspended material and colour change. The solution should have an appearance from clear to
slightly opalescent and a colour from transparent to light yellow and must be free of visible
suspended particles.
From a 250 ml infusion bag, aspirate and discard a volume of 9 mg/ml (0.9%) sodium chloride infusion solution
equal to the total volume of Naglazyme to be added. For
patients susceptible to fluid accumulation and weighing less than 20 kg, 100 ml infusion bags should be considered; in this case the infusion rate (ml/min) must be reduced so that
the total infusion duration remains at least 4 hours. When using 100 ml bags,
the volume of Naglazyme can be added directly to the infusion bag.
The volume of Naglazyme must be added slowly to the 9 mg/ml (0.9%) sodium chloride infusion solution.
Before infusion, the solution must be gently mixed.
Before use, the solution must be visually inspected to exclude the presence of suspended particles.
Only clear and colourless solutions free from visible suspended particles must be used.
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- Страна регистрации
- Форма выпускаInfusion solution, 1 MG/ML
- Код АТХA16AB08
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги NALATSYMEФорма выпуска: Concentrate for infusion solution, 500 UДействующее вещество: ЛаронидазаПроизводитель: SANOFI B.V.Отпускается по рецептуФорма выпуска: Infusion solution, 150 MGДействующее вещество: Серлипоназа альфаПроизводитель: BIOMARIN INTERNATIONAL LIMITEDОтпускается без рецептаФорма выпуска: Powder for concentrate for infusion solution, 200 UДействующее вещество: ИмиглюцеразаПроизводитель: SANOFI B.V.Отпускается по рецепту
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NALATSYME производится компанией BIOMARIN INTERNATIONAL LIMITED. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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