Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - replagal

Document Subject

Generated Narrative: MedicinalProductDefinition mp82ed3b7e13571c65c8c961f4a21dd3e2

identifier: http://ema.europa.eu/identifier/EU/1/01/189/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Replagal 1 mg/ml concentrate 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

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-82ed3b7e13571c65c8c961f4a21dd3e2

identifier: http://ema.europa.eu/identifier/EU/1/01/189/001-003

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - replagal

Attesters

What is in this leaflet

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

The active substance in Replagal is agalsidase alfa (1 mg/ml). Agalsidase alfa is a form of the human enzyme -galactosidase. It is produced by switching on the gene for -galactosidase A in cells. The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion. Replagal is used to treat adult patients, as well as adolescents and children from the age of 7, with confirmed diagnosis of Fabry Disease. It is used as long-term enzyme replacement therapy when the level of enzyme in the body is absent or lower than normal as in Fabry Disease. After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients. Replagal reduced left ventricle mass in treated patients compared to placebo treated patients. These results suggest the symptoms of the disease are improving or the disease is becoming stable.

You must not be given Replagal

if you are allergic to agalsidase alfa or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before Replagal is used. If you notice any of these effects during or after an infusion you should tell your doctor immediately:

high fever, chills, sweating, fast heart rate.

vomiting.

light-headedness.

hives.

swelling in your hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing. Your doctor may stop the infusion temporarily (5 10 min) until the symptoms go away and then begin the infusion again. Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time you can still be given Replagal even if these symptoms occur. If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor. If treatment with Replagal makes your body produce antibodies this will not stop Replagal from working and the antibodies may disappear with time. If you have advanced renal disease, you may find that your Replagal treatment has a limited effect on your kidneys. Talk to your doctor or pharmacist before using Replagal. Children The experience in children 0-6 years old is limited and therefore no dose can be recommended for this age group. Other medicines and Replagal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin. There is a theoretical risk of decreased agalsidase alfa activity. Pregnancy and breast feeding Very limited clinical data on pregnancies exposed to Replagal have shown no adverse effects on the mother and newborn child. 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. Driving and using machines You may drive and use machines whilst on Replagal. Replagal contains sodium This medicine contains 14.2 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult. Keeping a record In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded by your healthcare professional. Speak with your healthcare professional if you are not sure.

This medicine should be applied and supervised by appropriately trained personnel, who will also calculate the dose that you will be given. While remaining under the physician s supervision, Replagal can be self-administered (by you or your caregiver) after appropriate training by the treating physician and/or nurse. Self-administration should occur in the presence of a responsible adult. The recommended dose is an infusion of 0.2 mg for every kg you weigh. This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual. Use in children and adolescents For children and adolescents 7-18 years old a dose of 0.2 mg/kg every other week may be used. Children and adolescents may be more likely than adults to experience an infusion related reaction. Tell your doctor if you experience any side effects whilst having the infusion. Method of administration Replagal has to be diluted in 9 mg/ml (0.9%) sodium chloride solution before use. After dilution Replagal is given in a vein. This will usually be in your arm. The infusion will be given every two weeks. Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein. Your treatment will be supervised by a doctor who specialises in the treatment of Fabry Disease. For self-administration, the dose and rate of infusion given should not be changed without the agreement of the treating physician. If you use more Replagal than you should If you believe you have used more Replagal than you should, please contact your doctor. If you use less Replagal than you should If you believe you have used less Replagal than you should, please contact your doctor. If you forget to use Replagal If you have missed an infusion of Replagal, please contact your doctor. If you stop using Replagal Do not stop using Replagal without contacting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor. Most side effects are mild to moderate. More than 1 in 10 people (frequency very common ) may have a reaction during or following an infusion of Replagal (infusion related reaction). These effects include chills, headache, nausea, fever, tiredness, unsteadiness, difficulty breathing, shaking, cough and vomiting. However, some effects may be serious and may need treatment. Infusion related reactions involving the heart including heart muscle ischemia and heart failure, may occur in patients with Fabry disease involving the heart structures (frequency not known (cannot be estimated from the available data)). Your doctor may stop the infusion temporarily (5 - 10 min) until the symptoms go away and then begin the infusion again. Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time you can still be given Replagal even if these symptoms occur. List of other side effects: Very common: may affect more than 1 in 10 people

swelling in the tissue (e.g., legs, arm)

tingling or numbness or pain in fingers or toes

ear ringing

palpitations

Sore throat

abdominal pain, diarrhoea

rash

back or limb pain, muscle pain, joint pain

chest pain, cold symptoms, fever, feeling sick Common: may affect up to 1 in 10 people:

change in the taste of food, prolonged sleep

eyes tearing

increased ear ringing

increased heart rate, heart rhythm problems

increased blood pressure, low blood pressure, facial flushing (redness)

hoarseness, or tight throat, runny nose

abdominal discomfort

acne, red or itchy or mottled skin, excessive sweating

muscle and bone discomfort, swelling of the extremities or joints

hypersensitivity

chest tightness, increased feeling lack of energy, feeling cold or hot, flu-like symptoms, discomfort Uncommon: may affect up to 1 in 100 people:

severe allergic (anaphylactic-type) reaction

blink reflex abnormal

increased heart rate

low level of oxygen in your blood and sticky throat secretions

sense of smell is different)

collection of fluid under the skin may lead to swelling of body parts, lace-like discoloration of the skin e.g., in the leg

sensation of heaviness

injection site rash Children and adolescents Side effects reported in children were, in general, similar to those reported in adults. However, infusion related reactions (fever, difficulty breathing, chest pain) and pain aggravated occurred more frequently. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Do not use Replagal if you notice that there is discolouration or other foreign particles present. 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 to protect the environment.

What Replagal contains

The active substance is agalsidase alfa. Each ml of Replagal contains 1 mg of agalsidase alfa.

The other ingredients are: Sodium phosphate monobasic, monohydrate Polysorbate Sodium chloride Sodium hydroxide Water for injections Replagal contains sodium. See section 2. What Replagal looks like and contents of the pack Replagal is a concentrate for solution for infusion. Your medicine is available in vials containing 3.5 mg/ 3.5 ml of agalsidase alfa. Pack sizes of 1, 4 or 10 vials are available. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 D02 HWIreland Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 58 Baggot Street Lower Dublin D02 HWIreland Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV Tel/T l: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com Luxembourg/Luxemburg Takeda Belgium NV Tel/T l: +32 2 464 06 medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta akeda HELLAS S.A. Tel: +30 210 6387medinfoEMEA@takeda.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Takeda Farmac utica Espa a S.A Tel: +34 917 90 42 medinfoEMEA@takeda.com Polska Takeda Pharma Sp. z o.o. Tel: +48223062medinfoEMEA@takeda.com France Takeda France SAS T l. + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

akeda . . : +30 210 6387medinfoEMEA@takeda.com Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com This leaflet was last revised in . Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: