hemofiltration fluid
citrate, sodium, chloride
What Regiocit is and what it is used for
This drug is a haemofiltration fluid that prevents the blood from clotting during continuous kidney replacement therapy (CRRT), which is a form of dialysis treatment. This medicine is used in seriously ill patients, especially when the medicine heparin, which is usually given to prevent blood clotting, can not be used. The effect on the blood’s ability to coagulate is achieved by citrate binding to calcium in the blood.
The active substances (citrate, sodium, chloride) contained in Regiocit may also be authorized for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Regiocit
Do not use this medicine in case of:
Allergy to the active substances or any of the other ingredients (listed in section 6)
Severe hepatic impairment
Significantly reduced blood flow in the muscles
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using this medicine.
This medicine is not intended for direct intravenous infusion. It should only be used with a machine that can perform continuous kidney replacement therapy (CRRT) which is a type of dialysis used specifically for seriously ill patients with kidney failure. The CRRT machine must be suitable for use with citrates that counteract the clotting ability of the blood.
Regiocite can be heated to 37 ° C to increase patient well-being. Heating the liquid before use may only be done with dry heat. Liquids should not be heated in water or a microwave oven. Regiocite should be inspected visually for particulate matter and discoloration before administration. Do not administer unless the liquid is clear, free of visible particles and the seal is intact.
If the cover or liquid bag is damaged, the liquid may be contaminated and must not be used. The treatment includes other fluids given by infusion in addition to this medicine. The composition or rate of administration of these other liquids may need to be adjusted to fit well with this medicine.
Your doctor will closely monitor the balance between your blood pressure and blood flow ( hemodynamics status), fluid balance, blood sugar level, electrolyte – and acid/base balance before and during treatment. Sodium, magnesium, potassium, phosphate, and calcium will be closely monitored.
The treatment will be adjusted if necessary.
Regiocite does not contain calcium . Use of Regiocite may lead to low levels of calcium in the blood (hypocalcemia).
Regiocite does not contain magnesium. The use of Regiocite may lead to low levels of magnesium in the blood (hypomagnesemia). The level of magnesium in the blood will be closely monitored and infusion of magnesium may be necessary.
Regiocite does not contain glucose. The use of Regiocite may lead to low blood glucose (hypoglycemia). Blood glucose levels should be monitored regularly.
Regiocite does not contain potassium. Serum potassium levels must be monitored before and after treatment.
Your doctor will pay special attention to the infusion rate of citrate. Too much citrate leads to low blood levels of calcium and a high pH in the blood, which can cause neurological complications and heart complications. A high pH in the blood can be corrected by adjusting the dialysis settings and by infusing 0.9% sodium chloride solution after the hemofilter or changing the composition of the CRRT fluid. Low blood levels of calcium can be treated by infusion of calcium.
Your doctor will pay special attention to whether you suffer from liver failure or shock. Because the breakdown of citrate can be significantly reduced, leading to accumulation of citrate and a low pH in the blood. Your doctor will decide if your treatment needs to be adjusted. If the ratio of total / ionized calcium exceeds 2.3, the citrate buffer should be reduced or stopped.
If Regiocit is administered to patients with hepatic impairment, frequent monitoring of pH, electrolytes, and the ratio of total / ionized calcium to systemic ionized calcium is important to avoid electrolyte and/or acid/base imbalance. Do not use it if you have severe hepatic impairment.
In case of the abnormally high volume of fluid in the body ( hypervolemia ), the rate of net ultrafiltration prescribed for the CRRT unit may be increased, and/or the rate of administration of fluids other than replacement fluid and/or dialysate may be reduced.
In case of the abnormally low volume of fluid in the body ( hypovolemia ), the rate of net ultrafiltration prescribed for the CRRT unit may be reduced, and/or the rate of administration of fluids other than replacement fluid and/or dialysate may be increased.
Regiocite is hypoosmolar/hypotonic about common CRRT replacement fluids and should be used with caution in patients with traumatic brain injury, cerebral edema, or elevated intracranial pressure.
The user instructions must be strictly followed. Improper use of outflow ports or other flow restrictions can lead to an improper weight loss in the patient and trigger the dialysis machine alarm. If treatment is continued without addressing the cause of the problem, it could lead to patient injury or death.
Other medicines and Regiocit
Tell your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is important because the concentration of other medicines may decrease during dialysis treatment. Your doctor will decide if the dosage of any of the medicines you are taking needs to be adjusted.
You must tell your doctor if you are taking medicines that contain:
- Vitamin D and other drugs containing calcium and drugs containing calcium chloride or calcium gluconate; as may increase the risk of a high concentration of calcium in the blood (hypercalcemia) and may lead to a reduced anticoagulant effect.
- Sodium bicarbonate, as can increase the level of bicarbonate in your blood.
Pregnancy, breastfeeding, and fertility
Fertility:
No effects on fertility are expected as sodium, chloride, and nitrate are normal components in the body.
Pregnancy and breast-feeding:
There are no data on the use of this medicine during pregnancy or breastfeeding. This medicine should only be given to pregnant or breastfeeding women if there is a clear need.
Driving and using machines
Regiocit has no known effect on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Regiocit
For intravenous use. This medicine should be used in a hospital and should only be given by healthcare professionals. The volume used, and thus the dose of the medicine depends on your condition. The dose-volume will be determined by your doctor.
The recommended rates of administration of this drug in adults and adolescents:
- In continuous venovenous hemofiltration
- 1-2.5 l / h with a blood flow rate between 100 and 200 ml/min.
- In continuous venous-venous hemodiafiltration
- 1-2 l / h with a blood flow rate between 100 and 200 ml/min.
Use in the elderly:
The recommended flow rates are the same as for adults and adolescents.
Use in children:
In neonates and infants (0 to 23 months), a dose of 3 mmol citrates per liter of blood flow Regiocit should be sought, in continuous venous-venous haemofiltration or haemodiafiltration. In children (2 to 11 years), the dosage should be adjusted according to both the patient’s weight and the blood flow rate.
Liver failure or shock:
In these conditions, the initial starting dose of citrate should be reduced.
Instructions for use
Regiocit will be given to you at a hospital. Your doctor will know how to use Regiocit.
The instructions for use can be found at the end of this leaflet.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your blood will be checked regularly by a doctor or nurse to detect any side effects. Use of this liquid may cause:
Common: may affect up to 1 in 10 users
- Acid/base imbalance in the blood
- Disturbed balances of electrolyte levels in the blood (eg decreasing calcium, sodium, magnesium, potassium, and/or phosphate levels in the blood or an elevated level of calcium in the blood)
Has been reported: occurs in an unknown number of users
- Imbalance in the body’s fluid level (dehydration, accumulation of fluid in the body)
- Lowered blood pressure *
- Nausea *, vomiting *
- Cramps *
* Side effects associated with dialysis treatment rather than with this medicine.
How to store Regiocit
Keep this medicine out of the sight and reach of children.
No special storage instructions. Do not freeze.
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiration date is the last day of the specified month.
Do not use this medicine if the product is damaged or if you detect visible particles in the liquid.
The liquid can be flushed out via the drain without damaging the environment.
Contents of the pack and other information
Content declaration
| Composition: | |
|---|---|
| Sodium chloride | 5.03 g / l |
| Sodium citrate | 5.29 g / l |
The active substances are: | |
| Sodium , Na + | 140 mmol / l |
| Chloride, Cl – | 86 mmol / l |
| Citrate, C 6 H 5 O 7 3 – | 18 mmol / l |
Theoretical osmolarity: 244 mOsm / l
pH ≈ 7.4
Other ingredients are:
Dilute hydrochloric acid (for pH adjustment) E 507
Water for injection
What the medicine looks like and the contents of the pack
This drug is a clear and colorless haemofiltration fluid packaged in a single chamber pouch made of a multilayer film containing polyolefins and elastomers. The fluid is sterile and free from bacterial endotoxins. Each bag contains 5,000 ml of liquid and the bag has a cover of transparent film. Each box contains two bags and a package leaflet.
Marketing Authorisation Holder
Baxter Holding BV
Kobaltweg 49
3542CE Utrecht
Netherlands
Manufacturer
Bieffe Medical SpA
Via Stelvio, 94
23035 Sondalo (SO)
Italy
Baxter Healthcare SA
Moneen Road
Castlebar
County Mayo
F23 XR63
Ireland
Local representative
Baxter Medical AB
Box 63
164 94 Kista