ake sure that the amount of medicine in the oral dosing syringe lines up with the amount of mixture prescribed by your doctor (see Figure F).
Figure F
Step 8: Place the tip of the oral dosing syringe into your baby’s mouth. Point the tip of the oral dosing syringe toward either cheek (see Figure G). Push on the plunger slowly, a small amount at a time, until all of the mixture in the oral dosing syringe is given.
Figure G
Step 9: Throw away any remaining mixture. Remove the plunger from the barrel of the oral dosing syringe. Wash the oral dosing syringe and medicine cup with warm water and air dry. When the oral dosing syringe is dry, put the plunger back into the barrel. Store the oral dosing syringe and medicine cup for the next use.
How should I store Kuvan?
Store Kuvan at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Kuvan tablets in the original bottle with the cap closed tightly.
Protect from moisture.
Keep Kuvan and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
BioMarin Pharmaceutical Inc.
Novato, CA 94949
Revised: 07/2015
© BioMarin Pharmaceutical Inc. All rights reserved.
Kuvan is a registered trademark of BioMarin Pharmaceutical Inc.
v2/2015
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Carton and Immediate Container Label
NDC 68135-300-02
KUVAN®
(sapropterin dihydrochloride) Tablets
100 mg*
* Equivalent to 76.8 mg of sapropterin
Rx only
120 Tablets
BIOMARIN®
Manufactured for
BioMarin Pharmaceutical Inc.
Novato, CA 94949
by EXCELLA GmbH
Nürnberger Strasse 12,
90537 FEUCHT
Germany
Store at 20°C to 25°C (68°F-77°F); excursions allowed between 15°C to 30°C (59°F-86°F)
[See USP Controlled Room Temperature]
Keep container tightly closed
Protect from moisture
Usual Dosage:
See Physician Package Insert
75497011-2124
Dimensions 59x59x86mm
Lot:
Exp:
RX only
To open
Fold on the dotted line and tear or cut across top of packet
NDC 68135-301-11
KUVAN®
(sapropterin dihydrochloride) Powder for Oral solution
100 mg*
* Equivalent to 76.8 mg of sapropterin
Directions: Dissolve contents of packet as described in the package insert.
Usual Dosage: see package insert
Store at 20°C to 25°C (68°F-77°F); excursions allowed between 15°C to 30°C (59°F-86°F)
See USP Controlled Room Temperature
Protect from moisture
Keep out of reach of children
RX only
Note New Strength!!
To open
Fold on the dotted line and tear or cut across top of packet
NDC 68135-482-10
KUVAN®
(sapropterin dihydrochloride) Powder for Oral solution
500 mg* per single use packet
* Equivalent to 384 mg of sapropterin
Directions: Dissolve contents of packet as described in the Instructions for Use.
Usual Dosage: see package insert
Store at 20°C to 25°C (68°F-77°F)
See USP controlled room temperature.
Protect from moisture
Keep out of reach of children
500 mg packet Front
500 mg packet Back
BIOMARIN®
