Brineura Kit
Product Images NDC 68135-811

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Brineura (NDC 68135-811). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biomarin Pharmaceutical Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Brineura 01)

Illustration of the Brineura intravenous infusion system showing components including a syringe pump, syringe, extension line, infusion set with 0.2 micron in-line filter, and an intraventricular access device system comprised of port needle, reservoir, catheter, and lateral ventricle within a human head. It highlights the infusion setup for intraventricular drug administration.*

FDA Label Image

Figure 2 (Brineura 02)

An instructional illustration showing a syringe labeled with 'BRINEURA' attached to a needle. The syringe is marked with volume increments from 5 to 20 milliliters, with an arrow indicating the direction for connecting the needle to the syringe.*

FDA Label Image

Figure 3 (Brineura 03)

An instructional diagram showing a side view of a human head with a catheter inserted into the brain's ventricle. The illustration depicts the setup for intracerebral administration, with an arrow indicating the catheter connection point at the scalp. The image relates to the delivery method used with Brineura (cerliponase alfa) kit.*

FDA Label Image

Figure 4 (Brineura 04)

An anatomical line drawing illustrating the administration of Brineura (cerliponase alfa) into the brain. A syringe connected by tubing to a catheter inserted into a cerebral ventricle is shown, indicating the method of intracerebroventricular infusion.*

FDA Label Image

Figure 5 (Brineura 05)

An illustration showing a syringe labeled 'BRINEURA' with milliliter graduations from 5 to 20 ml. The syringe is depicted with a separate small component on the left, with arrows indicating connection or assembly direction.*

FDA Label Image

Figure 6 (Brineura 06)

An instructional diagram showing a syringe labeled for intraventricular electrolytes with volume markings from 0 to 20 ml. A magnified circular inset highlights the 2 ml measurement mark on the syringe, emphasizing precise volume measurement.*

FDA Label Image

Figure 7 (Brineura 07)

A Kaplan-Meier survival curve showing the probability of no decline over analysis days up to 900. The graph compares Brineura-treated patients and a natural history cohort, with distinct lines for Brineura treatment durations of 48 and 96 weeks and natural history cohort at 72 weeks. Patient numbers at risk are indicated below the x-axis over time.*

FDA Label Image

Principal Display Panel (Kit Carton)

Label for Brineura (cerliponase alfa) Injection 150 mg/5 mL (30 mg/mL) by BioMarin Pharmaceutical Inc. This label specifies it is for intraventricular infusion only and contains warnings about administration with an administration kit supplied separately. The carton includes two vials of Brineura and one vial of Intraventricular Electrolytes Injection.*

FDA Label Image

Principal Display Panel (150 mg/5 mL Vial Label)

Label for Brineura (cerliponase alfa) Injection, 150 mg/5 mL (30 mg/mL) single-dose vial. The label includes dosage instructions to thaw at room temperature and use immediately, with a warning to discard unused portion. It is produced by BioMarin Pharmaceutical Inc., Novato, CA. The label specifies use for intraventricular infusion and includes regulatory and lot/expiration information.*

FDA Label Image

Principal Display Panel (5 mL Vial Label)

Label for Brineura (cerliponase alfa) injection, 5 mL vial. The label includes instructions for intraventricular infusion, notes to thaw at room temperature and use immediately, and states single-dose only with discard of unused portion. It is labeled by BioMarin Pharmaceutical Inc. Additional area is reserved for lot and expiry information.*

FDA Label Image

Principal Display Panel (Kit Carton)

Flat layout of the Brineura administration kit packaging by BioMarin Pharmaceutical Inc. The label includes instructions indicating the kit is for intraventricular infusion only, with contents listed such as syringes, needles, and infusion sets. It notes that it is an administration kit for use with Brineura (cerliponase alfa) and includes cautions and storage instructions. Various seals and placement markings are visible on the label.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.