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Galsulfase Injection 1 mg/mL

Uses

For metabolism disorder.

Instructions

This is an IV medicine. It is given through a sterile tube directly into the vein by a healthcare provider.

This medicine is given gradually through the IV line.

Carefully follow the instructions for preparing this medicine before injection.

Read and make sure you understand the instructions for measuring your dose and using the syringe before using this medicine.

The medicine needs to be mixed before being injected.

Dilute with 0.9% sodium chloride, as directed.

If using the vial, do not remove the medicine from the vial until ready to use.

Always inspect the medicine before using.

The liquid should be clear or light yellow.

Do not use the medicine if it contains any particles or if it has changed color.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

Do not shake the medicine before using.

Store new medicine in the refrigerator until you are ready to use it. Do not allow them to freeze.

Keep the medicine in its original container.

If the medicine becomes frozen, you will need to throw it away.

Protect medicine from light.

Take the medicine out of the refrigerator about 30 to 60 minutes before use to warm to room temperature.

Speak with your nurse or pharmacist about how long the medicine can be stored safely at room temperature or in the refrigerator before it needs to be discarded.

Never use any medicine that has expired.

Discard any remaining medicine after your dose is given.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

This medicine should only be used by a person who has been trained to recognize when and how it should be used.

This medicine should be given by a trained health care provider.

Wash your hands before and after handling this medicine.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

If your symptoms do not improve or they worsen while on this medicine, contact your doctor.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Pain or fever reducers may relieve some side effects. Please speak with your healthcare provider or pharmacist.

It is very important that you keep all appointments for medical exams and tests while on this medicine.

Do not use more than 1 dose each week.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine. Symptoms of an allergic reaction can include trouble breathing, skin rash, itching, swelling, or severe dizziness.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Ask your pharmacist if this medicine can interact with any of your other medicines. Be sure to tell them about all the medicines you take.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Please tell all your doctors and dentists that you are on this medicine before they provide care.

Do not start or stop any other medicines without first speaking to your doctor or pharmacist.

Used needles and syringes should be thrown away properly in a medical waste container. Ask your doctor or pharmacist if you need help.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • coughing
  • dizziness
  • feeling of heat or flushing
  • fever or chills
  • pain in the joints
  • nausea
  • vaginal itching or yeast infection
  • vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • severe abdominal or pelvic pain
  • back pain
  • chest pain
  • ear problems (ringing in the ears, hearing loss)
  • hearing loss
  • signs of kidney damage (such as bloody or bubbly urine, or changes in urine color or amount)
  • new or worsening movement problems
  • eye pain or swelling
  • redness of eyes
  • shortness of breath
  • unusual or unexplained tiredness or weakness
  • inability to control urine or stool
  • blurring or changes of vision
  • severe or persistent vomiting

A few people may have an allergic reactions to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Extra

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it.Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions.Always follow their advice. There is a more complete description of this medicine available in English.Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist.

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