REGIOCIT (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Representative Container Label
(click image for full-size original)

Carton Label

DIN 02496755

Product Code: 955791

REGIOCIT

Sodium chloride and sodium citrate solution
5.03 g / L, 5.29 g / L
Solution de chlorure de sodium et de citrate de sodium
5,03 g / L, 5,29 g / L

Sterile / Stérile
Nonpyrogenic / Apyrogène
For hemofiltration and regional citrate anticoagulation during
Continuous Renal Replacement Therapy (CRRT) /
Pour hémofiltration et anticoagulation régionale au citrate pendant la thérapie deremplacement rénal continue (TRRC).

Representative Container Label Table 1
(click image for full-size original)

Hydrochloric acid (pH adjuster) / Acide chlorhydrique (ajusteur de pH)
Water for Injection / Eau pour injection
Solution for Extracorporeal use only. Not for direct intravenous infusion. To be used in
pre-dilution only during CRRT.

For single use only. Discard any unused portion. Product Monograph available upon
request. See patient medication information. This product is not made with natural rubber
latex.

Solution pour administration extracorporelle seulement. Ne pas administrer par
perfusion intraveineuse directe. Ne doit être utilisé en mode pré-dilution que pour la
thérapie de remplacement rénal continu (TRRC).

Pour usage unique seulement. Jeter toute portion non utilisée. Monographie disponible sur
demande. Voir les renseignements pour le patient sur le médicament. Ce produit n’est pas
fabriqué avec du latex de caoutchouc naturel.

18 Citrate
mmol / L mmol / L

140 Na+ mmol / L

5 000 mL

Representative Container Label Table 2
(click image for full-size original)

Store at 4°C to 30 °C. Do not freeze or
expose to excessive heat.

Conserver à une température comprise
entre 4 °C et 30 °C. Ne pas congeler ni
exposer à une chaleur excessive.

Questions and Concerns /
Des questions ou problèmes
Baxter Corporation
Mississauga, ON L5N 0C2
Customer Service /
Service à la clientèle1-888-719-9955

2 x 5 000 mL

07-05-00-0207

Baxter logo

Representative bag label
(click image for full-size original)

Container Label

18 Citrate mmol / L

140 Na+
mmol / L

DIN 02496755

Product code: 955791

REGIOCIT
Sodium chloride and sodium citrate solution
5.03 g / L, 5.29 g / L
Solution de chlorure de sodium et de citrate de sodium
5,03 g / L, 5,29 g / L

Sterile / Stérile

Nonpyrogenic / Apyrogène

For hemofiltration and regional citrate anticoagulation during Continuous Renal Replacement Therapy (CRRT) /Pour hémofiltration et anticoagulation régionale au citrate pendant la thérapie de remplacement rénal continue (TRRC).

Representative Carton Label Table 1
(click image for full-size original)

244 mOsm/L

5000 mL

Approx pH 7.4

Solution for Extracorporeal use only. Not for direct intravenous infusion. To be used in pre-dilution only during Continuous
Renal Replacement Therapy (CRRT).
Use only if overwrap and solution bag are not damaged and there is no leakage.
The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit. Mix the solution thoroughly when additives have been introduced. Use only if solution is clear and free from visible particles.

Single use only. Discard unused portion. Product Monograph available upon request.
Dose: Read the package insert before use. This product is not made with natural rubber latex.
Store: 4°C to 30°C. Do not freeze or expose to excessive heat.

Solution pour administration extracorporelle seulement. Ne pas administrer par perfusion intraveineuse directe. Ne doit être utilisé en mode pré-dilution que pour la thérapie de remplacement rénal continu (TRRC). N’utiliser que si le suremballage et le sac de solution sont intacts et ne présentent aucune fuite. Il faut toujours injecter et mélanger les additifs avant de connecter le sac de solution au circuit extracorporel.
Bien mélanger la solution après l’injection des additifs. La solution ne doit être utilisée que si elle est limpide et ne contient aucune particule visible.

Usage unique seulement. Jeter la portion non utilisée. Monographie disponible sur demande.
Posologie : Lire la notice d’emballage avant l’utilisation. Ce produit n’est pas fabriqué avec du latex de caoutchouc naturel.
Conservation : entre 4 °C et 30 °C. Ne pas congeler ni exposer à une chaleur excessive.

Questions and Concerns / Des questions ou problèmes

Baxter Corporation
Mississauga, ON L5N 0C2
Customer Service / Service à la clientèle
1-888-719-9955

2D barcode

Baxter Logo

Barcode00000955791

07-25-00-1832

REGIOCIT sodium chloride, sodium citrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24571-123
Route of Administration EXTRACORPOREAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 5.03 g in 1000 mL
SODIUM CITRATE, UNSPECIFIED FORM (ANHYDROUS CITRIC ACID and SODIUM CATION) SODIUM CITRATE, UNSPECIFIED FORM 5.29 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24571-123-02 2 BAG in 1 CARTON contains a BAG
1 5000 mL in 1 BAG This package is contained within the CARTON (24571-123-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/18/2020
Labeler — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Bieffe Medital S.p.A. 437668413 ANALYSIS (24571-123), LABEL (24571-123), MANUFACTURE (24571-123), PACK (24571-123), STERILIZE (24571-123)

Revised: 08/2020 Baxter Healthcare Corporation

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