oral solution118 mL Multiple-Dose Bottle
Read this Instructions for Use before you start taking or giving SUCRAID to a child, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.
Important information you need to know before taking or giving SUCRAID:
- Your healthcare provider will decide the right dose of SUCRAID for you or your child. Do not change the dose of SUCRAID without talking to your healthcare provider.
- The dose of SUCRAID depends on body weight. Your healthcare provider will tell you how much SUCRAID you should take or give your child.
- The dose for a child 33 pounds (15 kg) or less is 1 mL or 28 drops of SUCRAID in 2 ounces of water, milk, or infant formula.
- The dose for a child or adult more than 33 pounds (15 kg) is 2 mL or 56 drops of SUCRAID in 4 ounces of water, milk, or infant formula.
- SUCRAID can only be dissolved with cold or room temperature water, milk, or infant formula. Do not put SUCRAID in warm or hot liquids. Do not dissolve SUCRAID with fruit juice. Do not take or give SUCRAID with fruit juice.
- Do not warm or heat the mixed solution before taking or giving SUCRAID.
- Measure your dose or your child’s dose of SUCRAID using the measuring scoop that comes with the SUCRAID bottle. Do not use a kitchen teaspoon or other measuring device.
- SUCRAID should be taken or given with each meal or snack. Half of the SUCRAID dose should be taken or given at the beginning of each meal or snack. Take or give the remaining SUCRAID dose during the meal or snack.
- Do not use the SUCRAID multiple-dose bottle if the seal has been damaged. Contact your pharmacist or healthcare provider if you cannot use the SUCRAID multiple-dose bottle.
Supplies needed to take or give SUCRAID:
- SUCRAID 118 mL multiple-dose bottle
- 1 measuring scoop (included in SUCRAID carton)
- 2 to 4 ounces of cold or room temperature water, milk, or infant formula (not included)
- Meal or snack (not included)
How to take or give SUCRAID:
Step 1: Check the expiration date on the SUCRAID bottle. Do not use SUCRAID after the expiration date on the bottle
Step 2: Write down the date the bottle is first opened in the space provided on the bottle label.
Step 3: Each bottle of SUCRAID has a plastic screw cap that covers a dropper dispensing tip. Remove the plastic screw cap by twisting it to the left.
Step 4: Use the measuring scoop that comes in your SUCRAID carton to measure your or your child’s prescribed dose. See Figure 1. Reseal the bottle after each use by replacing and twisting the plastic screw cap to the right until tight.
Step 5: Mix your or your child’s prescribed dose in 2 ounces or 4 ounces of cold or room temperature water, milk, or infant formula as instructed by your healthcare provider. See Figure 2.
Step 6: Take or give half of the mixed solution at the beginning of each meal or snack. Take or give the remaining mixed solution during the meal or snack.
Step 7: Rinse the measuring scoop with water after each use.
Throwing away (disposal of) SUCRAID:
- Throw away (discard) the SUCRAID multiple-dose bottle and any remaining medicine in your household trash 4 weeks after first opening.
How should I store SUCRAID?
- Store the SUCRAID multiple-dose bottle in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Protect SUCRAID from heat and light.
Keep SUCRAID and all medicines out of the reach of children.
Manufactured by:QOL Medical, LLC Vero Beach, FL 32963
U.S. License No. 2195
For more information, go to www.sucraid.com or call 1-866-469-3773.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: May 2022
|Patient Information SUCRAID® (Su-kreid)sacrosidaseoral solution|
|What is SUCRAID? SUCRAID is an oral replacement therapy for people who were born with a sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). People with this condition cannot digest certain sugars.It is not known if SUCRAID is safe and effective in children under 5 months of age.|
| Do not take or give your child SUCRAID if you or your child: |
|Before you take or give your child SUCRAID, tell your healthcare provider about all of your medical conditions, including if you or your child: |
| How should I take or give SUCRAID? |
What are the possible side effects of SUCRAID?
SUCRAID may cause serious side effects, including:
Your healthcare provider may need to monitor you or your child carefully when first starting treatment with SUCRAID. Get medical help right away and tell your healthcare provider as soon as possible if you or your child have any of the symptoms listed above.
Other side effects of SUCRAID may include:
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
| How should I store SUCRAID? |
|General information about the safe and effective use of SUCRAID. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SUCRAID for a condition for which it was not prescribed. Do not give SUCRAID to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SUCRAID that is written for health professionals.|
What are the ingredients in SUCRAID?
Active ingredient: sacrosidase.Inactive ingredients: Citric acid, glycerol, sodium hydroxide, and water.
Manufactured by:QOL Medical, LLC Vero Beach, FL 32963U.S. License No. 2195For more information, go to www.sucraid.com or call 1-866-469-3773.
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: May 2022
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.