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 1)

An instructional diagram showing the components of an intraventricular infusion system used for Brineura (cerliponase alfa) administration. It includes a syringe pump connected to an extension line and an infusion set with a 0.2 micron in-line filter. The infusion line leads to an intraventricular access device implanted in the head, consisting of a port needle, reservoir, catheter, and lateral ventricle within the brain.*

FDA Label Image

Intraventricular Electrolytes Injection Vial (Brineura 10)

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

Admin Kit (Brineura 11)

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.*

FDA Label Image

Figure 2 (Brineura 2)

An instructional illustration showing a syringe labeled Brineura, with volume markings up to 20 ml. The image highlights the 10 ml mark with a close-up circle and indicates a connection to an adjacent component via arrows. This diagram likely demonstrates proper syringe filling or connection for the Brineura kit by BioMarin Pharmaceutical Inc.*

FDA Label Image

Figure 3 (Brineura 3)

An illustration of a human brain in sagittal section showing a catheter inserted into the brain's ventricles, depicting the delivery method for Brineura (cerliponase alfa) treatment. The catheter extends from outside the head to the ventricular system, highlighting the intracerebroventricular administration route.*

FDA Label Image

Figure 4 (Brineura 4)

An instructional diagram showing the intracerebroventricular administration route where a syringe is connected to a catheter inserted into the brain's ventricular system of a child's head, depicting the process used with Brineura (cerliponase alfa) kits for delivering medication directly into the brain ventricles.*

FDA Label Image

Figure 5 (Brineura 5)

An instructional illustration showing a 20 ml syringe labeled 'BRINEURA' with volume markings from 0 to 20 ml. The image includes an arrow indicating attachment or detachment of the syringe tip to a connector piece on the left side.*

FDA Label Image

Figure 6 (Brineura 6)

An instructional diagram showing an intraventricular electrolyte syringe with a volume scale up to 20 ml. The image includes a close-up inset highlighting the 2 ml mark on the syringe scale, indicated by an arrow, likely emphasizing a specific measurement or step in usage.*

FDA Label Image

Figure 7 (Brineura 7)

A Kaplan-Meier survival curve comparing probability of no decline over time (Analysis Day) between Brineura-treated patients and a natural history cohort. The chart shows the probability on the y-axis from 0.0 to 1.0 and days on the x-axis up to about 900 days. Brineura-treated patients (solid line) maintain a higher probability of no decline compared to the natural history cohort (dashed line). Number at risk is indicated below the x-axis for both groups at various time points. Shaded regions correspond to confidence intervals at 48, 72, and 96 weeks.*

FDA Label Image

Carton (Brineura 8)

Brineura (cerliponase alfa) Injection 150 mg/5 mL (30 mg/mL) kit carton printed for intraventricular infusion only. The label indicates each carton contains two vials of Brineura injection, each vial containing 150 mg cerliponase alfa in 5 mL solution, plus one vial of intraventricular electrolytes injection 5 mL. The labeler is BioMarin Pharmaceutical Inc. Storage instructions specify freezing at -20°C to -5°C and use immediately after thawing. The carton highlights the need to administer Brineura with the provided administration kit.*

FDA Label Image

Brineura Vial (Brineura 9)

Label for Brineura (cerliponase alfa) injection, 150 mg/5 mL (30 mg/mL), a human prescription drug kit by BioMarin Pharmaceutical Inc. The label includes dosage and administration instructions, NDC 68135-500-00, storage instructions, and warnings for intraventricular infusion use only. The label also designates space for lot and expiry information.*

* 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.