Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Är Cyramza® (ramucirumab) infusionslösning kompatibel med de vanliga infusionsseten, slangar och filter?

Inga kända inkompatibiliteter förekommer med materialen i de vanliga infusionsseten på marknaden. Det finns heller ingen begränsning i produktresumén vad gäller typ av intravenösa påsar och infusionsset som kan användas.

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Compatibilities with materials of common containers, tubings and filters

At Eli Lilly and Company (Lilly), we have not performed specific compatibility studies to directly support all types of intravenous bags and infusion sets on the market. However, we have evaluated the materials used to construct the commonly available infusion sets.

We found the materials shown in Acceptable Materials for Ramucirumab Administration to be compatible.1

Acceptable Materials for Ramucirumab Administration1

Container, Tubing, or Filter Material

Description of Material

EVA

Ethylene vinyl acetate

Polyolefin

Polyolefin

PVC

Poly vinyl chloride

Evacuated IV bottle (USP type II)

USP type II glass (dealkalized soda-lime glass)

AVIVA bag (0.9% sodium chloride injection, USP)

Non-PVC, nonlatex, and non-DEHP container composed of polyolefin, polypropylene, and polyethylene.

0.22-µm paclitaxel set

Non-DEHP PVC tubing with polyethylene lining with protein-sparing polyethersulfone filter. The surface area of the filter is 10 cm2. The pump segment tubing is plasticized with TOTM. The material in the injection site is dry natural-rubber latex.

Infusion set with 0.2-µm filter

Non-DEHP, nonlatex, polyethylene-lined PVC tubing with protein-sparing polyethersulfone filter. The surface area of the filter is 10 cm2. The infusion set is DEHP and latex free.

SmartSite extension set with 0.2-μm filter

PVC tubing with protein-sparing 0.2-micron filter made of polyethersulfone. Surface area of the in-filter is 10 cm2. Needle-free valve port, latex free, and DEHP free.

Nitroglycerin primary IV pump set

Nonlatex, polyethylene-lined PVC tubing.

0.2-µm filter with 4.2 cm2 surface area

0.2-micron filter made of polyethersulfone. The surface area of the filter is 4.2 cm2. It is sterile and free of all natural rubber.

PVC tubing

Continu-Flo solution set with Duo-Vent Spike. This is PVC tubing with DEHP.

Intrapur® inline, infusion set

Intrapur inline, infusion set. Intrafix®. Air G Neutrapur with 0.2-µm filter made of polyethersulfone (Supor® membrane), surface area of 10 cm2. The infusion set is PVC free, made of polyurethane.

Polybutadiene tubing

Polybutadiene tubing with 0.2-micron filter made of polysulfone of 9 cm2 surface area.

Infusomat solution set

PVC tubing with DEHT as plasticizer.

Mirafilter

PVC-free EVA set with 0.22-µm polyethersulfone filter.

Safti ultraguard

Infusion set with 0.2-µm filter.

Normal saline

0.9% sodium chloride injection USP, packaged in VIAFLEX plastic solution container. The material in VIAFLEX container is PVC with the addition of the plasticizer, DEHP. The material in medication port is synthetic polyisoprene.

Abbreviations: DEHP = di-2-ethylhexyl phthalate; DEHT = di-2-ethylhexyl terephthalate; EVA = ethylene vinyl acetate; IV = intravenous; PVC = poly vinyl chloride; TOTM = trioctyl trimellitate; USP = United States Pharmacopeia.

Is ramucirumab compatible with closed-system vial-transfer devices (CSTD’s)? 

Lilly has not performed compatibility studies with ramucirumab and closed-system vial-transfer devices (CSTD’s), such as the “PhaSeal” System.1

During clinical trials, only syringes were used for the transfer of ramucirumab.1

Before using a CSTD consider the following:

  • The dose of ramucirumab must be calculated and only the required volume should be removed from the vial to prepare the infusion solution.
  • The ramucirumab vials contain an excess of solution.  This excess will vary from one vial to the next. The excess solution accommodates for vial retention and allows for the removal of at least the volume claimed on the label.1 

Product Description

Ramucirumab is a sterile, preservative-free solution for infusion of ramucirumab formulated in an aqueous solution at a concentration of 10 mg/mL (500 mg/50-mL vial). The buffer contains 10 mM histidine, 75 mM sodium chloride, 133 mM glycine, and 0.01% polysorbate 80.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Datum fӧr senaste ӧversyn August 06, 2019


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