NAME OF THE MEDICINAL PRODUCT
KEDRIALB 20% Solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
| KEDRIALB 20% | |
| Solution containing total plasma proteins to | 20% |
| Of which human albumin at least to | 95% |
| A vial of 50 ml contains human albumin equal to | 10 g |
| The solution is | hyperoncotic |
Excipient with known effect :
This medicinal product contains 123.5 – 136.5 mmoles/liter sodium. To be taken into consideration by patients on a controlled sodium diet.
For the full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Solution for infusion.
A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.
CLINICAL PARTICULARS
- Therapeutic indications
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.
- Posology and method of administration
The concentration of the albumin preparation, dosage and the infusion-rate must be adjusted to the patient’s individual requirements.
Posology
The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels must be used to determine the dose required.
If human albumin is to be administered, haemodynamic performance must be monitored regularly. This may include :
-
- Arterial blood pressure and pulse rate
- Central venous pressure
- Pulmonary artery wedge pressure
- Urine output
- Electrolyte
- Haematocrit/haemoglobin.
Paediatric population
The safety and efficacy of KEDRIALB in children have not been established by controlled clinical trials and its use in paediatric population is based only on estabilished medical practice. For this reason, KEDRIALB must be used in children only if clearly necessary.
KEDRIALB can be administered to premature infants.
Patients with renal impairment
KEDRIALB can be administered to dialysis patients as the aluminium content of the finished product is not more than 200 µg/l.
Method of administration
Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride).
The infusion rate must be adjusted according to the individual circumstances and the indication.
In plasma exchange the infusion-rate must be adjusted to the rate of removal.
- Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Special warnings and precautions for use
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock must be implemented.
Albumin must be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are :
-
- Decompensated cardiac insufficiency
- Hypertension
- Oesophageal varices
- Pulmonary oedema
- Haemorrhagic diathesis
- Severe anemia
- Renal and post-renal anuria
The colloid-osmotic effect of human albumin 200 or 250 g/l is approximately four times that of blood plasma.
Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients must be monitored carefully to guard against circulatory overload and hyperhydration.
200 – 250 g/l human albumin solutions are relatively low in electrolytes compared to the 40 – 50 g/l human albumin solutions. When albumin is given, the electrolyte status of the patient must be monitored (see section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.
If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate subtitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
If the haematocrit drops below 30%, packed red cells must be given in order to maintain the oxygen transport capacity of the blood.
Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patients circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.
Viral safety
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time that KEDRIALB is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Paediatric population
Although no specific data are available for paediatric population, the clinical experience on the use of Human Albumin in children suggests that no differences between adults and children are to be expected, provided that a careful attention to the dosage has been observed in order to avoid circulatory overload.
- Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
- Fertility, pregnancy and lactation
Pregnancy
The safety of KEDRIALB for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
In general, particular attention must be paid when a substitution of volume is effected in a pregnant patient.
Breast-feeding
Since human albumin is a normal constituent of human blood, treatment of the nursing mother with KEDRIALB is not expected to present a risk to the breast-fed newborn/infant.
Fertility
No animal reproduction studies have been conducted with KEDRIALB.
However human albumin is a normal constituent of human blood.
- Effects on ability to drive and use machines
KEDRIALB has not or negligible influence on the ability to drive and use machines.
- Undesirable effects
Summary of safety profile
Severe reactions, such as shock, may occur very rarely with human albumin solution. In these cases, the infusion must be stopped and an apropriate treatment must be initiated.
Mild undesirable effects, which may occur rarely with the use of human albumin solutions, are flush, urticaria, fever and nausea.
These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped.
For safety information with respect to transmissible agents, see section 4.4.
Tabulated list of adverse reactions
The table presented below is according to the MedDRA System Organ Classification (SOC) and Preferred Term Level (PT) and it includes undesirable effects occuring with the use of human albumin solutions.
Frequencies have been evaluated according to the following convention :
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
There are no robust data on the frequency of undesirable effects from clinical trials.
The following data is in line with the safety profile of human albumin solutions, and confirmed by the post marketing experience; as the post marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions :
| MedDRA System Organ Class (SOC) | Adverse reactions (MedDRA Preferred Term) | Frequency |
| Vascular disorders | Flushing | Not known |
| Shock | Not known | |
| Gastrointestinal disorders | Nausea | Not known |
| Skin and subcutaneous tissue disorders | Urticaria | Not known |
| General disorders and administration site conditions | Pyrexia | Not known |
Paediatric population
No specific data are available on paediatric population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report anysuspected adverse reactions via the national reporting system.
- Overdose
Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion must be stopped immediately and the patient’s haemodynamic parameters carefully monitored. Additionally, diuresis or cardiac output must be increased in accordance to the severity of the clinical situation.
STORAGE:
STORE BELOW 25ºC.
KEEP THE VIAL IN THE OUTER CARTON IN ORDER TO PROTECT FROM LIGHT
DO NOT FREEZE
THE STORAGE CONDITIONS MUST BE STRICTLY FOLLOWED
Manufactured by :
Kedrion S.p.A.
Gallicano, Italy.
For :
PT. Bernofarm
Sidoarjo, Indonesia
