CIFOBAN Solution for infusion Ref.[50948] Active ingredients: Sodium citrate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Product name and form

Cifoban 136 mmol/l solution for infusion.

Pharmaceutical Form

Solution for infusion.

Extracorporeal use. To be infused into the extracorporeal blood circuit only.

The solution is clear and colourless and practically free from particles.

Theoretical osmolarity: 544 mOsm/l
pH: 7.1–7.5

Qualitative and quantitative composition

Cifoban is provided in a bag with 1500 ml ready-to-use solution.

1000 ml solution contains:

Sodium citrate 40.0 g
Na+ 408 mmol
Citrate3- 136 mmol

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sodium citrate

Sodium citrate has no relevant pharmacodynamic activity other than that caused by its alkalinity (e.g. its gastric acid neutralising capacity). Sodium citrate is a non-particulate antacid for use by mouth to prior to general anaesthesia for caesarean section.

List of Excipients

Water for injections
Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

The medicinal product is provided pairwise as two identical solution bags which can be separated by a tear seam in the protective bag.

The solution bag is made of polypropylene-elastomer-blends. Each bag is equipped with a connective tubing made of polypropylene-elastomer-blends, a connector made of polycarbonate and is covered by a polyolefine-based protective multilayer bag.

Pack sizes:

SecuNect connector system: 8 bags of 1500 ml.

SafeLock connector system: 8 bags of 1500 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Marketing authorization dates and numbers

PA1350/008/001

Date of first authorisation: 28th January 2022

Drugs

Drug Countries
CIFOBAN Ireland, Romania

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