Cerezyme 400unit powder for solution for infusion vials

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Imiglucerase

제공처:

Genzyme Therapeutics Ltd

ATC 코드:

A16AB02

INN (국제 이름):

Imiglucerase

복용량:

400unit

약제 형태:

Powder for solution for infusion

관리 경로:

Intravenous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 09080100; GTIN: 5030045000197

환자 정보 전단

Cerezyme should not be given as a mixture with other
medicinal products in the same infusion (drip).
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 or
pharmacist for advice before taking this medicine. Cautious
use of Cerezyme during pregnancy and breastfeeding is
recommended.
CEREZYME CONTAINS SODIUM
This medicine contains sodium and is administered in 0.9%
sodium chloride intravenous solution. To be taken into
consideration by patients on a controlled sodium diet.
3. HOW CEREZYME IS GIVEN
Instructions for proper use
Cerezyme is given through a drip into a vein (by
intravenous infusion).
It is supplied as a powder which will be mixed with sterile
water before it is given.
Cerezyme is only used under the supervision of a doctor
who is knowledgeable in the treatment of Gaucher disease.
Your doctor may advise 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.
Your dose will be specific to you. Your doctor will work out
your dose based on how severe your symptoms are, and
other factors. The recommended dose is 60 units/kg body
weight given once every 2 weeks.
Your doctor will keep a close check on your response to
your treatment, and may change your dose (up or down)
until he/she finds the best dose to control your symptoms.
Once this dose is found your doctor will still keep a check
on your responses to make sure you are using the right
dose. This might be every 6 to 12 months.
There is no information on the effect of Cerezyme on brain-
based symptoms of patients with chronic neuronopathic
Gaucher disease. Therefore no special dosage regimen can
be recommended.
The ICGG Gaucher Registry
You can ask your doctor to register your patient
information into the “ICGG Gaucher Registry”. The aims of
this Registry are to increase the understanding of Gaucher
disease and to check how well enzyme replacement
therapy, like Cerezyme, works. This s

제품 특성 요약

OBJECT 1
CEREZYME 400 U POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 17-Aug-2016 | Genzyme
Therapeutics
1. Name of the medicinal product
Cerezyme 400 U Powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately
1.0 mg) of imiglucerase per ml (400
U/10 ml).
* An enzyme unit (U) is defined as the amount of enzyme that catalyses
the hydrolysis of one micromole
of the synthetic substrate para-nitrophenyl β-D-glucopyranoside
(pNP-Glc) per minute at 37°C.
** Imiglucerase is a modified form of human acid β-glucosidase and is
produced by recombinant DNA
technology using a mammalian Chinese Hamster Ovary (CHO) cell culture,
with mannose modification
for targeting macrophages.
Excipients:
For the full list of excipients, see section 6.1.
This medicinal product contains sodium and is administered in 0.9%
sodium chloride intravenous
solution (see section 6.6). After reconstitution, the solution
contains 1.24 mmol sodium (400 U/10 mL).
To be taken into consideration by patients on a controlled sodium
diet.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
Cerezyme is a white to off-white powder.
4. Clinical particulars
4.1 Therapeutic indications
Cerezyme (imiglucerase) is indicated for use as long-term enzyme
replacement therapy in patients with a
confirmed diagnosis of non-neuronopathic (Type 1) or chronic
neuronopathic (Type 3) Gaucher disease
who exhibit clinically significant non-neurological manifestations of
the disease.
The non-neurological manifestations of Gaucher disease include one or
more of the following conditions:
• anaemia after exclusion of other causes, such as iron deficiency
• thrombocytopenia
• bone disease after exclusion of other causes such as Vitamin D
deficiency
• hepatomegaly or splenomegaly
4.2 Posology and method of administration
Disease management should be directed