Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. The antigens are purified in successive chromatographic and precipitation steps. Diphtheria and tetanus toxoids and pertussis antigens (PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. If either of these conditions exists, the vaccine should not be administered. Levels of diphtheria antitoxin ≥0.01 IU/mL were achieved in 100% of the sera tested. A VERO cell toxin-neutralizing test confirmed the ability of infant sera (N = 45), obtained one month after a 3-dose primary series, to neutralize diphtheria toxin. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend the body against the infections. Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib. Infanrix hexa is given by deep injection into a muscle. In a U.S. study, Infanrix was given concomitantly, at separate sites, with ENGERIX-B, IPV (Sanofi Pasteur SA), pneumococcal 7-valent conjugate (PCV7), and Hib conjugate vaccines (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age. When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign’ and makes antibodies against them. The potency of the acellular pertussis components (PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. During this period, the efficacy of Infanrix against WHO-defined pertussis was 78% (95% CI: 62, 87). Because the pertussis antigen components of Infanrix and PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] are the same, Infanrix may be used to complete a DTaP vaccination series initiated with PEDIARIX. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. Available for Android and iOS devices. The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. Subjects also received ENGERIX-B and oral poliovirus vaccine (OPV). When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign’ and makes antibodies against them. In the fifth-dose study, a large swelling reaction was defined as swelling that involved >50% of the injected upper arm length and that was associated with a >30 mm increase in mid-upper arm circumference within 4 days following vaccination. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. Infanrix should not be mixed with any other vaccine in the same syringe or vial. Among subjects, 69% were white, 16% were Hispanic, 8% were black, 4% were Asian, and 2% were of other racial/ethnic groups. Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b. Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances. Manufacturer: GlaxoSmithKline Biologicals. Levels of tetanus antitoxin ≥0.01 IU/mL were achieved in 100% of the sera tested. An additional five studies looked at the effects of a booster vaccination with Infanrix hexa. Infanrix hexa is a vaccine that protects against a range of infections. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination. DTaP vs Tdap Vaccines - What's the difference between them? Immune responses were measured in sera obtained approximately 1 month after the third dose of vaccines. PT is detoxified using glutaraldehyde and formaldehyde. Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile vaccine for intramuscular administration. Generic Name: diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa have been included in the summary of product characteristics and the package leaflet. Less Common and Serious General Adverse Reactions. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. In clinical trials, Infanrix was given concomitantly with Hib conjugate vaccine, pneumococcal 7-valent conjugate vaccine, hepatitis B vaccine, IPV, and the second dose of MMR vaccine [see Adverse Reactions (6.1), Clinical Studies (14.3)]. When a decision is made to withhold tetanus toxoid, other available vaccines should be given, as indicated. The .gov means it’s official.Federal government websites often end in .gov or .mil. Infanrix hexa must not be used in infants who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) and formaldehyde. In addition to reports in clinical trials for Infanrix, the following adverse reactions have been identified during postapproval use of Infanrix. Infanrix is not approved for use in these age groups. Before sharing sensitive information, make sure you're on a federal government site. FHA and pertactin are treated with formaldehyde. Data on solicited adverse reactions were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days) (Table 3). If any of the following reactions occur in temporal relation to receipt of a pertussis-containing vaccine, the decision to give any pertussis-containing vaccine, including Infanrix, should be based on careful consideration of the potential benefits and possible risks: For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a pertussis-containing vaccine, including Infanrix, and for the ensuing 24 hours to reduce the possibility of post-vaccination fever. Infanrix hexa contains the following active substances: Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection. Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin. Infanrix, ENGERIX-B, IPV, Hib Vaccine, & PCV7. The European Medicines Agency therefore decided that Infanrix hexa’s benefits are greater than its risks and recommended that it be given marketing authorisation. This helps to protect against the diseases that these bacteria and viruses cause. Diphtheria Do not use if resuspension does not occur with vigorous shaking. Total Vaccinated Cohort = All subjects who received a dose of study vaccine. Selected adverse reactions reported from a double-blind, randomized Italian clinical efficacy trial involving 4,696 children administered Infanrix or 4,678 children administered whole-cell DTP vaccine (DTwP) (manufactured by Connaught Laboratories, Inc.) as a 3-dose primary series are shown in Table 4. Among 153 subjects, 100% had anti-poliovirus 1, 2, and 3, ≥1:8 following the third dose of IPV. Infanrix is formulated without preservatives. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Sufficient data are not available on the safety and effectiveness of interchanging Infanrix and Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccines from different manufacturers for successive doses of the DTaP vaccination series. The first dose may be given as early as 6 weeks of age. During the third follow-up period, which was conducted in an unblinded manner among children aged 3 to 6 years, the efficacy of Infanrix against WHO-defined pertussis was 86% (95% CI: 79, 91). One month after the third dose of Infanrix, the response rates to each pertussis antigen were similar in all 3 studies. Infanrix is a suspension for injection available in 0.5-mL single-dose vials and 0.5-mL single-dose, prefilled TIP‑LOK syringes. Bronchitis, cellulitis, respiratory tract infection. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin. a with Separate Concomitant Administration of Infanrix, ENGERIX-B, IPV, Haemophilus b (Hib) Conjugate Vaccine, and Pneumococcal Conjugate Vaccine (PCV7) (Modified Intent-to-Treat Cohort), a with Infanrix Administered as the Fourth Dose following 3 Previous Doses of Infanrix or PEDIARIX (Total Vaccinated Cohort), a with a Fifth Consecutive Dose of Infanrix when Coadministered with IPV and MMR Vaccine (Total Vaccinated Cohort), Corynebacterium diphtheriae (C. diphtheriae), diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed suspension, We comply with the HONcode standard for trustworthy health information -, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. All vaccines were administered at 2, 4, and 6 months of age. These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination. Households with at least one other member (i.e., besides index case) aged 6 through 47 months were enrolled. Cards from the whole cohort were returned at subsequent visits and were supplemented by spontaneous reporting by parents and a medical history after the first and second doses of vaccine. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including Infanrix. The corresponding efficacy of Infanrix against ≥14 days of any cough or paroxysmal cough were 73% (95% CI: 59, 82) and 84% (95% CI: 71, 91), respectively. It promotes the immune system to act against microorganisms to prevent such infections. STN: BL 103647. For the prefilled syringes, attach a sterile needle and administer intramuscularly. Active Substance: diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis B surface antigen / poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)) / Haemophilus influenzae type-b polysaccharide The population used in the primary analysis of the efficacy of Infanrix included 4,481 infants vaccinated with Infanrix and 1,470 DT vaccinees. Among subjects, 85% were white, 6% were Hispanic, 6% were black, 1% were Asian, and 2% were of other racial/ethnic groups. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of Infanrix is a contraindication [see Description (11)]. Syncope (fainting) can occur in association with administration of injectable vaccines, including Infanrix. Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C. diphtheriae. In the subset of 2,457, adverse events following the third dose of vaccine were reported via standardized diaries and spontaneous reporting at a follow-up visit. Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. In a U.S. study, Infanrix was given concomitantly, at separate sites, with Hib conjugate vaccine (Sanofi Pasteur SA) at 2, 4, and 6 months of age. The vaccine is ‘adsorbed’. Indications: Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.625 mg aluminum by assay) and 4.5 mg of sodium chloride. Tradename: INFANRIX. Prior to administration, the healthcare provider should review the patient’s immunization history for possible vaccine hypersensitivity. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. Status: AuthorisedAuthorisation Date: 2000-10-23Therapeutic Area: Meningitis, Haemophilus Following the third dose of PCV7 vaccine, 91.8% to 99.4% of subjects (n = 146-156) had anti-pneumococcal polysaccharide ≥0.3 mcg/mL for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 73.0% had a level ≥0.3 mcg/mL for serotype 6B. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein). Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile vaccine for intramuscular administration. It must not be used in infants who have had an allergic reaction to a vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib. Use a separate sterile needle and syringe for each individual. Infanrix is available in vials and prefilled syringes. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). General Disorders and Administration Site Conditions. The incidence of rectal temperature ≥104°F, hypotonic-hyporesponsive episodes, and persistent crying ≥3 hours following administration of Infanrix was significantly less than that following administration of whole-cell DTP vaccine. Apnea following intramuscular vaccination has been observed in some infants born prematurely. An in vivo mouse neutralization assay confirmed the ability of infant sera (N = 45), obtained1 month after a 3-dose primary series, to neutralize tetanus toxin. Calculation of vaccine efficacy was based on attack rates of pertussis in household contacts classified by vaccination status. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Whooping Cough Hepatitis B A double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy assessed the absolute protective efficacy of Infanrix when administered at 2, 4, and 6 months of age. We comply with the HONcode standard for trustworthy health information -. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. When the definition of pertussis was expanded to include clinically milder disease, with infection confirmed by culture and/or serologic testing, the efficacy of Infanrix against ≥7 days of any cough was 67% (95% CI: 52, 78) and against ≥7 days of paroxysmal cough was 81% (95% CI: 68, 89). Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. Infants who did not participate in the safety and immunogenicity study could have received a DTwP vaccine or DT vaccine. Infanrix is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday). IPV manufactured by Sanofi Pasteur SA. Do not administer this product intravenously, intradermally, or subcutaneously. Encephalopathy, headache, hypotonia, syncope. After 3 doses, the absolute protective efficacy of Infanrix against WHO-defined typical pertussis (21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing) was 84% (95% CI: 76, 89). Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Infanrix. Safety and effectiveness of Infanrix in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions. For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed. The average age of infants vaccinated with Infanrix at the end of follow-up in this trial was 13 months (range: 6 to 25 months). A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection; a level of 0.1 IU/mL is regarded as protective.1, Tetanus is an acute toxin-mediated infectious disease caused by a potent exotoxin released by C. tetani. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered. Decisions about when to administer an intramuscular vaccine, including Infanrix, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. The preferred administration site is the anterolateral aspect of the thigh for most infants aged younger than 12 months and the deltoid muscle of the upper arm for most children aged 12 months through 6 years. Subsequent injections should be given in different areas. Last updated on Nov 1, 2019. The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses. INFANRIX. One month after the third dose of Hib conjugate vaccine, 90% of 72 infants had anti-PRP (polyribosyl-ribitol-phosphate) ≥1.0 mcg/mL. This means that the active substances are fixed onto aluminium compounds, to stimulate a better response. In these studies, 29,243 infants have received Infanrix in primary series studies: 6,081 children have received a fourth consecutive dose of Infanrix, 1,764 children have received a fifth consecutive dose of Infanrix, and 559 children have received a dose of Infanrix following 3 doses of PEDIARIX. Infanrix has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility. For active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday). The incidence of large swelling reactions following the fifth consecutive dose of Infanrix was 1.0%. Infanrix Hexa Vaccine 's first dose is given at birth. When the definition of pertussis was expanded to include clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing, the efficacy of Infanrix was calculated to be 71% (95% CI: 60, 78) against >7 days of any cough and 73% (95% CI: 63, 80) against ≥14 days of any cough. In a U.S. study, 335 infants received Infanrix, ENGERIX-B [Hepatitis B Vaccine (Recombinant)], inactivated poliovirus vaccine (IPV, Sanofi Pasteur SA), Haemophilus b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.), and pneumococcal 7-valent conjugate (PCV7) vaccine (Wyeth Pharmaceuticals Inc.) concomitantly at separate sites. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex. INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile vaccine for intramuscular administration. Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course. Efficacy of tetanus toxoid used in Infanrix was determined on the basis of immunogenicity studies. A 0.5-mL dose of Infanrix is approved for intramuscular administration in infants and children aged 6 weeks through 6 years (prior to the 7th birthday) as a 5-dose series. The main measure of effectiveness was the production of protective antibodies. There is no well-established serological correlate of protection for pertussis. Common Name: diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed) In the fourth-dose study, a large swelling reaction was defined as injection site swelling with a diameter of >50 mm, a >50 mm increase in the mid-thigh circumference compared with the pre-vaccination measurement, and/or any diffuse swelling that interfered with or prevented daily activities. For the full list of side effects reported with Infanrix hexa, see the package leaflet. Infanrix is available in 0.5-mL single-dose vials and 0.5-mL single-dose, disposable, prefilled TIP‑LOK syringes (packaged without needles): NDC 58160-810-01 Vial in Package of 10: NDC 58160-810-11, NDC 58160-810-43 Syringe in Package of 10: NDC 58160-810-52. Vaccine efficacy after 3 doses and with no booster dose in the second year of life was assessed in 2 subsequent follow-up periods. In a subset of subjects (n = 2,457), these cards were standardized diaries which solicited specific adverse reactions that occurred within 8 days of each vaccination in addition to unsolicited adverse events which occurred from enrollment until approximately 30 days following the third vaccination. Store refrigerated between 2° and 8°C (36° and 46°F). Respiratory, Thoracic, and Mediastinal Disorders. Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including Infanrix. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The mean length of follow-up was 17 months, beginning 30 days after the third dose of vaccine. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. Although serological correlates for protection have not been established for the pneumococcal serotypes, a threshold level of ≥0.3 mcg/mL was evaluated. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Do not freeze. Data on solicited local reactions and general adverse reactions were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days) (Table 1). The vaccine can only be obtained with a prescription. A prospective efficacy trial was also conducted in Germany employing a household contact study design. Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine. Infanrix Hexa Vaccine is a combination of multiple vaccines. For more information, see the package leaflet. Provide the following information to the parent or guardian: ENGERIX-B, Infanrix, PEDIARIX, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies. Infanrix hexa should be postponed in infants with a severe sudden fever. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years. Of the 173 household contacts who had not received a pertussis vaccine, 96 developed WHO-defined pertussis, as compared with 7 of 112 contacts vaccinated with Infanrix. Angioedema, erythema, pruritus, rash, urticaria. Manufactured by GlaxoSmithKline Biologicals. Efficacy of a 3-dose primary series of Infanrix has been assessed in 2 clinical studies. Pertussis Immune Response to Infanrix Administered as a 3-Dose Primary Series. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level.2,3 A level of 0.1 IU/mL is considered protective.4. Fatigue, injection site induration, injection site reaction, Sudden Infant Death Syndrome. It is used to prevent diphtheria, tetanus, polio, haemophilus influenzae type B disease, and hepatitis B infection in infants and toddlers. Among subjects, 43% were white, 18% Hispanic, 15% Asian, 7% black, and 17% were of other racial/ethnic groups. The immune responses to each of the 3 pertussis antigens contained in Infanrix were evaluated in sera obtained 1 month after the third dose of vaccine in each of 3 studies (schedule of administration: 2, 4, and 6 months of age in the Italian efficacy study and one U.S. study; 3, 4, and 5 months of age in the German efficacy study). Efficacy of diphtheria toxoid used in Infanrix was determined on the basis of immunogenicity studies. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Over 3,000 of the children received a course of vaccination with Infanrix hexa. ATC Code: J07CA09Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.Active Substance: diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin) / hepatitis B surface antigen / poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)) / Haemophilus influenzae type-b polysaccharide

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