Active ingredients: Palivizumab
Synagis 50 mg powder and solvent for solution for injection.
Indications Why is Synagis used? What is it for?
Synagis contains an active substance called palivizumab, an antibody that acts specifically against a virus called respiratory syncytial virus, RSV.
The child is at high risk of getting the disease caused by a virus called respiratory syncytial virus (RSV).
Babies who are most likely to have severe RSV disease (high-risk babies) are babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.
Synagis is a medicine that helps protect your child from having severe RSV disease.
Contraindications When Synagis should not be used
Do not use Synagis in the child
If you are allergic to palivizumab or any of the other ingredients of this medicine listed in section 6.
Signs and symptoms of a severe allergic reaction can include:
- severe rash, hives, itchy skin
- swelling of the lips, tongue, or face
- throat obstruction, difficulty swallowing
- difficult, rapid or irregular breathing
- bluish color of the skin, lips, or under the nails
- muscle weakness or flaccidity
- a drop in blood pressure
- lack of responsiveness
Precautions for use What you need to know before taking Synagis
Take special care with Synagis
- if the baby feels unwell. Please tell your doctor if your child feels unwell, as the administration of Synagis may need to be delayed.
- if the child has bleeding manifestations as Synagis is usually injected into the thigh.
Interactions Which drugs or foods may change the effect of Synagis
There are no known interactions of Synagis with other medicines. However, before starting Synagis therapy you should tell your doctor about all the medicines your child is currently taking.
Dosage and method of use How to use Synagis: Dosage
How often should Synagis be given to the child?
Synagis should be given to the child at a dose of 15 mg / kg body weight once a month as long as the risk of RSV infection remains. For better protection of the baby, you should follow your doctor's instructions on when to return for further doses of Synagis.
If the child has had a heart operation (cardiac bypass surgery), he may need an additional dose of Synagis after the surgery. Afterwards, the child can resume the original injection schedule.
How does the child receive Synagis?
Synagis will be given to your child by injection into a muscle, usually in the outer thigh.
What happens when the child misses an injection of Synagis?
If your baby misses an injection, you should contact your doctor as soon as possible. Each injection of Synagis protects your baby for about a month before another injection is needed.
Always use this medicine exactly as your doctor or pharmacist has told you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Synagis
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Synagis can cause serious side effects including:
- severe allergic reactions, these reactions can be life-threatening or fatal (see "Do not use Synagis in your child" for a list of signs and symptoms).
- unusual bruising or clusters of small red spots on the skin.
Tell your doctor or get medical help right away if your child experiences any of the serious side effects listed above after receiving a dose of Synagis.
Other side effects
Very common (affects at least 1 in 10 people):
- rash
- fever
Common (affects 1 to 10 users in 100):
- pain, redness or swelling at the injection site
- a pause in breathing or other breathing difficulties
Uncommon (affects less than 1 in 100 people):
- convulsions
- urticaria
Reporting of side effects
If your child gets any side effects, please contact your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label.
Store in a refrigerator (2 ° C - 8 ° C).
Use within 3 hours of reconstitution.
Do not freeze.
Keep the vial in the outer carton in order to protect it from light.
Other information
What Synagis contains
- The active ingredient is palivizumab. 50 mg per vial, which delivers 100 mg / ml of palivizumab when reconstituted according to directions.
- The other ingredients are:
- for the powder: histidine, glycine and mannitol.
- for the solvent: water for injections.
What Synagis looks like and contents of the pack
Synagis comes in the form of powder and solvent for solution for injection (50 mg of powder in vial) + 1 ml of solvent in ampoule - Pack of 1.
Synagis is a white to off-white lyophilisate.
Instructions for the doctor
The 50 mg vial of powder contains an extra amount that allows withdrawal of 50 mg when reconstituted if you follow the instructions below.
For reconstitution, remove the aluminum flap from the vial cap and clean the stopper with 70% ethanol or equivalent.
Slowly add 0.6 ml of water for injections along the inner wall of the vial to avoid foaming. After adding the water, tilt the vial gently and swirl it gently for 30 seconds.
Do not shake the vial.
The palivizumab solution should rest at room temperature for a minimum of 20 minutes until it becomes clear. Palivizumab solution does not contain preservatives and should be administered within 3 hours of preparation. Single use vial. Discard any unused medicine.
Once reconstituted according to the instructions, the final concentration is 100 mg / ml.
Palivizumab must not be mixed with other medicinal products or diluents other than water for injections.
Palivizumab is administered once a month for intramuscular use, preferably in the anterolateral aspect of the thigh. The gluteus muscle should not be used routinely as an injection site as it can damage the sciatic nerve. Injection should be performed using standard aseptic technique. Medicinal quantities greater than 1 ml should be administered in divided doses.
When using palivizumab 100 mg / mL, the volume (in mL) of palivizumab to be administered at one-month intervals = [patient weight in kg] multiplied by 0.15
For example, for a child with a body weight of 3 kg, the calculation becomes:
(3 x 0.15) mL = 0.45 mL palivizumab per month.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SYNAGIS 50 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of palivizumab *, providing 100 mg / ml of palivizumab when reconstituted as recommended.
* Palivizumab is a recombinant humanized monoclonal antibody produced by DNA technology in mouse myeloma host cells.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is a white to off-white lyophilisate.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Synagis is indicated in the prevention of severe lower respiratory tract diseases requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease:
• Babies born with gestational age of 35 weeks or less and less than 6 months of age at the time of the onset of the seasonal RSV outbreak.
• Children less than 2 years of age who have been treated for bronchopulmonary dysplasia in the past 6 months.
• Children less than 2 years of age with haemodynamically significant congenital heart disease.
04.2 Posology and method of administration
Dosage
The recommended dose of Palivizumab is 15 mg per pound of body, given once monthly during periods when RSV risk is anticipated in the community.
Volume (in mL) of palivizumab to be administered at one-month intervals = [patient weight in kg] multiplied by 0.15.
Whenever possible, the first dose should be given before the onset of the critical season. Subsequent doses should be given once a month during the risk period. The efficacy of palivizumab at doses other than 15 mg per kg has not been established. or at different dosages from once a month during the RSV season.
Most experiences, including major phase III clinical trials, with palivizumab have been gained with 5 injections during one season (see section 5.1). Data, although limited, are available on more than 5 doses (see sections 4.8 and 5.1), therefore the protection benefit above 5 doses has not been established.
To reduce the risk of repeated hospital admissions, in children taking palivizumab who have been hospitalized for RSV, it is recommended that monthly palivizumab doses be continued for the duration of the virus season.
For children undergoing cardiac bypass, it is recommended that a 15 mg / kg body weight injection of palivizumab be administered as soon as it has stabilized after surgery to ensure adequate palivizumab serum levels. Subsequent doses should resume monthly during treatment. remaining RSV season for children who continue to be at high risk of RSV infection (see section 5.2).
Method of administration
Palivizumab is administered intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteus muscle should not be used often as an injection site as it can damage the sciatic nerve. The "injection" must be done using standard aseptic technique.
Quantities greater than 1 ml should be administered in divided doses.
To ensure that the correct volume of Synagis is reconstituted, see section 6.6.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.
04.4 Special warnings and appropriate precautions for use
Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following administration of palivizumab. In some cases, deaths have been reported (see section 4.8).
Medicines for the treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, should be available for use immediately following palivizumab administration.
The use of palivizumab may be postponed in the presence of severe or moderate infections or in the presence of febrile illness, unless the physician judges delayed administration of palivizumab as an additional risk factor. A moderate febrile syndrome, such as for example mild upper respiratory tract infection, usually does not lead to postponement of palivizumab administration.
Palivizumab should be administered with caution in patients with thrombocytopenia or other clotting problems.
The efficacy of palivizumab when administered to patients as a second course of prophylaxis during a new RSV epidemic season has not been formally evaluated in a study with this objective. The possible risk of RSV infection occurring in the second epidemic season in which patients have been treated with palivizumab has not been definitively excluded with studies to evaluate this particular aspect.
04.5 Interactions with other medicinal products and other forms of interaction
No specific interaction studies with other medicinal products have been conducted. In phase III clinical trials of the incidence of RSV in the pediatric population born prematurely and with bronchopulmonary dysplasia, patients receiving placebo and patients receiving palivizumab who were also given routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids exhibited a similar distribution and no increases in adverse reactions were observed.
Since the monoclonal antibody is specific for respiratory syncytial virus, palivizumab is not expected to interfere with the immune response to vaccines.
Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen-based tests. Additionally, palivizumab inhibits virus replication in cell culture and therefore may also interfere with viral culture tests. Palivizumab does not interfere with reverse transcriptase polymerase chain reaction tests. Interference with tests could lead to false-negative RSV diagnostic test results. Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical results to guide medical decisions.
04.6 Pregnancy and breastfeeding
Not relevant. Synagis is not indicated for use in adults. There are no data on fertility, use in pregnancy and lactation.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
Summary of the safety profile
The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. The most common adverse reactions occurring with palivizumab are fever, rash and injection site reaction.
Table of adverse reactions
Both clinical and laboratory adverse reactions, which occurred in studies in premature and pediatric patients with bronchopulmonary dysplasia and in patients with congenital pediatric heart disease, are listed by system organ class and frequency (very common ≥ 1/10; common ≥1 / 100 in
Adverse reactions identified through post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship with palivizumab exposure. The frequency of these adverse reactions (ARs), as reported in the table below, was estimated using safety data from the two clinical studies The incidence of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related.
* For full study description, see Section 5.1 Clinical Studies
# RAs identified by post-marketing surveillance
Description of selected adverse reactions
Post-marketing experience
Serious post-marketing spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV epidemic seasons were evaluated. A total of 1291 serious reports were received in which palivizumab was administered as indicated and the duration of therapy was over one season. Adverse reactions occurred after the sixth dose or above, in only 22 of these. reports (15 after the sixth dose, 6 after the seventh and 1 after the eighth dose). These adverse reactions have similar characteristics to those after the initial 5 doses.
The palivizumab treatment schedule and adverse reactions were monitored in a group of approximately 20,000 children followed through a patient adherence program between 1998 and 2000. Of this group, 1250 enrolled children had 6 injections. 183 had 7 and 27 had 8 or 9. Adverse reactions observed in patients after the sixth dose or above had similar characteristics and frequency to those after the initial 5 doses.
In a database-based observational post-marketing study, a small increase in the frequency of asthma was observed among preterm patients treated with palivizumab; however, the causal relationship is uncertain.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency. website: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
In clinical trials, three children were given doses above 15 mg / kg. These doses were 20.25 mg / kg, 21.1 mg / kg and 22.27 mg / kg. There were no clinical consequences in these subjects.
From post-marketing experience, overdoses with doses up to 85 mg / kg have been reported and in some cases, the reported adverse reactions were not different from those observed with the 15 mg / kg dose (see section 4.8). of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: serum immune immunoglobulins, specific immunoglobulins.
ATC code J06BB16.
Palivizumab is a humanized IgG1K monoclonal antibody directed against an epitope at the antigenic site A of respiratory syncytial virus (RSV) fusion protein. This humanized monoclonal antibody has a human (95%) and murine (5%) antibody sequence. It has a potent neutralizing and inhibitory activity of fusion mechanisms against VRS in both subtype A and subtype B strains.
In cotton rats, serum palivizumab concentrations of approximately 30 mcg / mL have been shown to produce a 99% reduction in RSV replication in the lungs.
Education in vitro of antiviral activity
The antiviral activity of palivizumab was evaluated in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to the addition of human HEp-2 epithelial cells. After an incubation period of 4-5 days, the VRS antigen was measured in an enzyme immunoassay (ELISA). The neutralization titer (50% effective concentration [EC50]) is expressed as the antibody concentration capable of reducing the detection of VRS antigen by 50% compared to untreated virus-infected cells. Palivizumab shows mean EC50 values of 0.65 mcg / mL (mean [standard deviation] = 0.75 [0.53] mcg / mL, n = 69, range 0.07-2.89 mcg / mL) and of 0.28 mcg / mL (mean [standard deviation] = 0.35 [0.23] mcg / mL, n = 35, range 0.03-0.88 mcg / mL), in RSV A and RSV B, respectively clinical isolates. Most of the RSV clinical isolates tested (n = 96) were collected from subjects in the United States.
Resistence
Palivizumab binds to a highly conserved region in the extracellular domain of the mature RSV protein F, referred to as antigenic site II or antigenic site A, which includes amino acids 262-275. A genotypic analysis conducted on 126 clinical isolates from 123 children who failed immunoprophylaxis, all RSV mutants showing resistance to palivizumab (n = 8) showed amino acid changes in this region of protein F. No changes were shown. in the polymorphic or non-polymorphic sequence outside the antigenic site A of the VRS protein F that renders RSV resistant to neutralization by palivizumab. At least one palivizumab resistance associated with amino acid substitutions N262D, K272E / Q, or S275F / L was identified in these 8 RSV clinical isolates resulting in a 6.3% mutation-associated resistance frequency. Analysis of clinical data revealed no "association between changes in antigenic site A sequence and RSV disease severity in children receiving palivizumab immunoprophylaxis and developing lower respiratory tract RSV disease." 254 RSV clinical isolates collected from immunoprophylaxis naïve subjects found resistance to palivizumab associated with 2 substitutions (1 with N262D and 1 with S275F), resulting in a 0.79% mutation-associated resistance rate.
Immunogenicity
Anti-palivizumab antibodies were found in approximately 1% of patients in the Impact-RSV study during the first phase of therapy. It was a transient phenomenon of low titre, resolved despite continued use (first and second seasons), and not. was shown on 55 of 56 infants during the second season (including 2 with titration during the first season).
Immunogenicity was not investigated in the congenital heart disease study.
Antibodies to palivizumab were evaluated in four additional studies in 4,337 patients (infants born at 35 weeks of gestation or less and 6 months of age or less, or 24 months of age or less with bronchopulmonary dysplasia, or with significant hemodynamically congenital heart disease. significant when included in these studies) and were observed in 0% - 1.5% of patients at different study intervals. No association was observed between the presence of antibodies and adverse events.
Therefore, the immune responses to the anti-drug antibody (anti-drug antibody, ADA) appear to be non-clinically relevant.
Clinical studies with lyophilized palivizumab
In a placebo-controlled clinical study in RSV prophylaxis (Impact-RSV study) performed on 1502 high-risk children (1002 Synagis; 500 placebo), 5 monthly doses of 15 mg / kg reduced the incidence of hospitalization related to VRS of 55% (p =
The rate of hospitalization due to respiratory syncytial virus in the placebo group was 10.6%. On this basis, the absolute risk reduction is 5.8% which means that the number of patients to be treated needed to prevent hospitalization is 17. The severity of RSV infection in hospitalized children, despite palivizumab prophylaxis, does not it reduced in percentage terms neither the days of hospitalization in intensive care nor the days of assisted mechanical respiration.
A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when administered for the second RSV season. One hundred and three children received palivizumab injections monthly for the first time, and 119 children received palivizumab for two consecutive seasons. There was no difference between groups in immunogenicity in either study. However, as the efficacy of palivizumab when given to patients as a second treatment course during the onset of RSV season was not formally investigated in either study. study conducted with this objective, the relevance of these data in terms of efficacy is unknown.
In an open-label prospective clinical study designed to evaluate pharmacokinetics, safety and immunogenicity following administration of 7 doses of palivizumab over a single RSV season, pharmacokinetic data indicated that adequate mean palivizumab levels had been reached in all 18 children recruited. Low and transient antibody levels of anti-palivizumab antibodies were observed in a child after the second dose of palivizumab and these antibodies decreased to an unmeasurable level at the fifth and seventh dose.
In a placebo-controlled study of 1287 patients ≤ 24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo) 5 monthly doses of 15 mg / kg of Synagis reduced the incidence of RSV hospitalization by 45% ( p = 0.003) (congenital heart disease study) The groups were equally balanced between cyanotic and non-cyanotic patients.The RSV hospitalization rate was 9.7% in the placebo group and 5.3% in the Synagis group. The second objective of the efficacy study on 100 children showed significant reductions in the Synagis group compared to the placebo group in the total days of hospitalization for RSV (reduction of 56%, p = 0.003) and on the total number of RSV days with l " addition of an oxygen supplement (reduction of 73%, p = 0.014).
A retrospective observational study was conducted in children with hemodynamically significant congenital heart disease (HSCHD) to compare the occurrence of serious primary adverse events (infection, arrhythmia and death) among those who received Synagis prophylaxis and those who did not receive it combined for age, type of heart injury and previous corrective surgery. The incidence of arrhythmia and death was similar in both children who received prophylaxis and children who did not. "incidence of infection was lower in children who received prophylaxis than in those who did not." Study results indicate that the risk of severe infection, severe arrhythmia or death in children with haemodynamically significant congenital heart disease associated with Synagis prophylaxis did not increase compared with children who did not receive the profile axes.
Studies using liquid palivizumab
Two clinical studies were conducted to directly compare the liquid and lyophilized formulations of palivizumab. In the first study, all 153 premature infants received both formulations in different sequences. In the second study, 211 and 202 premature infants or children with chronic lung disease received liquid and lyophilized palivizumab, respectively. In two additional studies, liquid palivizumab was used as an active control (3918 pediatric subjects) to evaluate an investigational monoclonal antibody for severe RSV disease prophylaxis in premature infants or children with chronic lung disease or heart disease. hemodynamically significant (see below for further details on these two studies). The overall rate and pattern of adverse events, the analysis of treatment discontinuation due to adverse events, and the number of deaths reported in these clinical trials were consistent with those observed during clinical development programs for the lyophilized formulation. No deaths were considered related to palivizumab and no new adverse events were identified in these studies.
Preterm infants and children with chronic pulmonary disease of prematurity (BPD): This study, conducted in 347 centers in North America, the European Union and 10 other countries, studied patients aged 24 months or younger with BPD and patients with premature birth (less than or equal to 35 weeks of gestation), who were 6 months or younger at study initiation. Patients with haemodynamically significant congenital heart disease were excluded from this study and were investigated in a separate study In this study, patients were randomized to receive 5 monthly injections of 15mg / kg of liquid palivizumab (N = 3306), used as an active control for an investigational monoclonal antibody (N = 3329). Safety and efficacy were monitored in these subjects for 150 days. Ninety-eight percent of all patients who received palivizumab completed the study, and 97% received all five injections. The primary endpoint was the incidence of RSV hospitalization. RSV hospitalizations occurred among 62 of 3306 (1.9%) patients in the palivizumab group. The observed RSV hospitalization rate in patients enrolled with a diagnosis of BPD was 28 of 723 (3.9%) and in patients enrolled with a diagnosis of prematurity without BPD it was 34 of 2583 (1.3%).
CHD Study 2: This study, conducted in 162 centers in North America, the European Union and 4 other countries, over two seasons of RSV, studied patients with an age of 24 months or younger with hemodynamically significant CHD. study, patients were randomized to receive 5 monthly injections of 15 mg / kg of liquid palivizumab (N = 612), used as an active control of an investigational monoclonal antibody (N = 624). Subjects were stratified into based on cardiac injury (cyanotic vs other) and safety and efficacy were monitored for 150 days. Ninety-seven percent of all patients who received palivizumab completed the study, and 95 percent received all five injections. The primary endpoint was a summary of adverse events and serious adverse events, and the secondary endpoint was the incidence of RSV hospitalization. The incidence of RSV hospitalization was 16 of 612 (2.6%) in the palivizumab group.
05.2 Pharmacokinetic properties
Lyophilized formulation of palivizumab
In studies in adult volunteers, palivizumab showed a pharmacokinetic profile similar to a human IgG1 antibody with respect to volume of distribution (mean 57 ml / kg) and half-life (mean 18 days).In prophylaxis studies in pediatric populations of preterm infants with bronchopulmonary dysplasia, the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg / kg achieved mean serum concentrations of the active substance at day 30 of approximately 40 μg / ml. after the first injection, about 60 mcg / ml after the second injection, about 70 mcg / ml after the third and fourth injection. In a study of congenital heart disease monthly intramuscular doses of 15 mg / kg reached an average of 30 days the minimum value of serum concentrations of the active ingredient which is approximately 55 mcg / ml after the first injection and approximately 90 mcg / ml after the fourth injection.
In the congenital heart disease study, of approximately 139 children who received palivizumab, in those who had undergone cardiopulmonary bypass and for whom paired serum samples were available, the mean serum concentration of palivizumab was approximately 100 mcg / mL before cardiac bypass and decreased to approximately 40 mcg / mL after bypass.
05.3 Preclinical safety data
In single-dose toxicology studies conducted in monkeys (maximum dose 30 mg / kg), rabbits (maximum dose 50 mg / kg) and rats (maximum dose 840 mg / kg), no significant data were found.
Studies performed on rodents have not shown an increase in the reproduction of RSV, or pathologies induced by RSV or the generation of mutant viruses in the presence of palivizumab under the experimental conditions adopted.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Dust:
Histidine
Glycine
Mannitol (E421)
Solvent:
Water for injections.
06.2 Incompatibility
This medicinal product must not be mixed with other medicinal products or diluents other than water for injections.
06.3 Period of validity
4 years.
After reconstitution, the medicinal product should be used immediately. In any case, stability in use conditions has been demonstrated for 3 hours at 20 - 24 ° C.
06.4 Special precautions for storage
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze.
Keep the vial in the outer carton in order to protect it from light.
06.5 Nature of the immediate packaging and contents of the package
50 mg of powder in a 4 ml vial (type I glass) with a stopper (butyl rubber) and a seal (aluminum).
1 ml of water for injections in a vial (type I glass).
Pack of 1 piece.
06.6 Instructions for use and handling
The 50 mg vial of powder contains an extra amount that allows withdrawal of 50 mg when reconstituted if you follow the instructions below.
For reconstitution, remove the aluminum flap from the vial cap and clean the stopper with 70% ethanol or equivalent.
Slowly add 0.6 ml of water for injections along the inner wall of the vial to avoid foaming. After adding the water, tilt the vial slightly and swirl it gently for 30 seconds. Do not shake the vial. The palivizumab solution should rest at room temperature for a minimum of 20 minutes until it becomes clear. Palivizumab solution does not contain preservatives and should be administered within 3 hours of preparation.
Once reconstituted according to the instructions, the final concentration is 100 mg / ml.
The appearance of the reconstituted solution is clear to slightly opalescent.
Single use vial. Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
AbbVie Ltd
Maidenhead
SL6 4XE
UK
08.0 MARKETING AUTHORIZATION NUMBER
EU / 1/99/117/001
AIC n. 034529014 / E
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 13 August 1999
10.0 DATE OF REVISION OF THE TEXT
04/2015
