For the use only of Registered Medical Practitioners or a Hospital or a Laboratory HIBERIX

Transcription

1 For the use only of Registered Medical Practitioners or a Hospital or a Laboratory HIBERIX Haemophilus type b conjugated vaccine IP 1. NAME OF THE MEDICINAL PRODUCT Haemophilus type b conjugated vaccine IP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Purified capsular polysaccharide (PRP) of Hib µg covalently bound to Tetanus toxoid (carrier protein)...~25µg Sodium Chloride IP 4.5 mg Sterile Water for Injection IP 0.5 ml HIBERIX is a white powder. The diluent is a transparent, colourless liquid. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder and diluent for solution for injection. 4. Clinical particulars 4.1 Therapeutic indications HIBERIX is indicated for active immunisation of all infants from the age of 2 months against disease caused by Hib. 4.2 Posology and method of administration Posology The primary vaccination schedule consists of three doses administered at intervals of 1 to 2 months in the first 6 months of life and can start from the age of 2 months. To ensure a long term protection, a booster dose is recommended in the second year of life. Infants between the ages of 6 and 12 months previously unvaccinated should receive 2 injections, given with an interval of one month, followed by a booster in the second year of life. Previously unvaccinated children aged 1-5 years should be given one dose of vaccine. 1

2 HIBERIX does not provide protection against illness caused by other types of Haemophilus. influenzae nor against meningitis caused by other organisms. As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations. Method of administration The reconstituted vaccine is for intramuscular injection. However, it is good clinical practice that in patients with thrombocytopenia or bleeding disorders the vaccine should be administered subcutaneously. 4.3 Contraindications HIBERIX is contra-indicated in subjects with known hypersensitivity to one of the vaccine's compounds or in subjects who showed signs of hypersensitivity after an earlier injection of an anti-haemophilus influenzae type B vaccine. As in the case of other vaccines, the administration of HIBERIX is to be postponed in subjects suffering from acute febrile illnesses. The presence of a minor infection is not, however, a contra-indication for immunisation. 4.4 Special warnings and precautions for use In view of the fact that bleedings is likely to occur in subjects suffering from thrombocytopenia or haemorrhaging following intramuscular administration, HIBERIX is to be administered sub-cutaneously. An infection due to the human immunodeficiency virus is not considered as a contraindication for the administration of HIBERIX. Although a limited immune response to the tetanus toxoid may occur, vaccination with HIBERIX alone cannot replace routine anti-tetanus vaccination. Excretion of the capsular polysaccharide antigen in urine has been reported following the administration of anti-haemophilus influenzae vaccines. Thus antigen detection may not have the diagnostic value of a suspected Hib infection 1 to 2 weeks following vaccination. As in the case of all injectable vaccines, appropriate therapeutic treatment must always be available to be in a position to treat the rare occurrence of anaphylactic reaction following administration of the vaccine. This is why the vaccinee must be kept under medical supervision for 30 minutes following vaccination. HIBERIX is never to be administered intravenously. The potential risk of apnea with a need for respiratory monitoring for hours must be carefully taken into account when administering doses of primary vaccination in very premature babies (born after 28 or fewer weeks of pregnancy) and in particular in persons 2

3 with a history of respiratory immaturity. Because vaccination is highly beneficial for infants, the administration should not be suspended or deferred. Syncope (fainting) can occur after, or even before, any vaccination as a psychogenic reaction to injection. It is important that precautions be taken to avoid injury in the event of fainting. 4.5 Interaction with other medicinal products and other forms of interaction HIBERIX may be administered either at the same time as other vaccines or at any other time before or after a different inactivated or live vaccine. Different injectable vaccines must be administered at different injection sites. The HIBERIX vaccine may, however, be combined in the same syringe with the TRITANRIX- HepB vaccine, a combined wholecell diphtheria, tetanus, whole cell pertussis and hepatitis B vaccine, INFANRIX, a combined diphtheria, tetanus and purified antigens from the whooping cough (pertussis) bacillus and INFANRIX-IPV, a combined diphtheria, tetanus with purified antigens from the whooping cough (pertussis) bacillus and the inactivated type 1, 2 and 3 polio virus. These different vaccines thus replace the solvent which is supplied for the reconstitution of HIBERIX. As is the case with other vaccines, it is possible that an adequate response may not be achieved in patients receiving immunosuppressants or suffering from immune deficiency. 4.6 Pregnancy and lactation In the view of the fact that HIBERIX is not designed for use in adults, there is no information on the innocuousness of administering the vaccine during pregnancy or during the period of breast-feeding. 4.7 Effects on ability to drive and use machines It is very unlikely that the vaccine would have any effect on the ability to drive vehicles and use machines. Moreover HIBERIX is not intended to be used in adults. 4.8 Undesirable effects Clinical Trial Data General problems and anomalies at the administration site: Among localised symptoms, the one which was the most frequently reported within the first 48 hours was benign erythema at the injection site, which disappeared spontaneously. The other local symptoms reported consisted of tumefaction and minor pain at the injection site, fever. The general symptoms that have been reported during the first 48 hours have been minor and have disappeared spontaneously. 3

4 During clinical trials, HIBERIX was administered concomitantly with vaccines containing DTP valences. The following general symptoms cannot be directly attributed to the administration of HIBERIX. Gastro-intestinal disorders: Diarrhoea, vomiting Metabolism and nutrition disorders Loss of appetite Psychiatric disorders: Abnormal crying, agitation Post-marketing monitoring The following undesirable effects have been rarely reported: Immune system disorders Allergic reactions, including anaphylactic and anaphylactoid reactions, angiooedema Nervous system disorders Hypotonic-hyporesponsiveness episodes, convulsions (with or without fever) syncope or vasovagal response to the injection, somnolence Respiratory, thoracic and mediastinal disorders Apnoea (see "4.4 Special warnings and precautions for use" section for apnoea in highly premature infants born at 28 weeks of pregnancy or less) Skin and subcutaneous tissue disorders Urticaria, rash General disorders and administration site conditions Extensive swelling of the injected limb, induration at the injection site 4.9 Overdose Not applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic category: J07A G 01 A titre of 0.15 µg/ml was observed in % of the infants one month after the completion of the primary vaccination programme. A titre of 0.15 µg/ml was observed in 4

5 100% of infants one month after the administration of the booster (94.7% with a titre of 1 µg/ml). 5.2 Pharmacokinetic Properties An evaluation of pharmacokinetic properties is not required for vaccines. 5.3 Pre-clinical safety data None 6. PHARMACEUTICAL PARTICULARS 6.1 List of Excipients Powder: Lactose Solvent: sodium chloride - water for injections 6.2 Incompatibilities HIBERIX must not be mixed with other vaccines in the same syringe, with the exception of TRITANRIX HB and INFANRIX vaccines. 6.3 Shelf Life 36 months The expiry date is indicated on the label and packaging. 6.4 Special precautions for storage Keep in the refrigerator (between +2 and +8 C) and away from direct light. Deep-freezing does not affect the lyophilized vaccine. Do not freeze the diluent. KEEP OUT OF REACH OF CHILDREN. 6.5 Nature and contents of container The lyophilised vaccine is presented as a white powder in a glass vial as monodose or 2-dose. The sterile diluent (saline) is clear and colourless and presented in a glass vial, ampoules or pre-filled syringe. 5

6 The vials, ampoules and syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements. 6.6 Special precautions for disposal and other handling The suspension contained in the syringe and the reconstituted vaccine must be visually examined before administration to verify the absence of foreign particles and/or variation in the appearance of the vaccine. If either of these anomalies is found, discard the liquid or reconstituted vaccine. Instructions for reconstitution of the vaccine with the diluent presented in a vial/ampoules HIBERIX must be reconstituted by adding the entire contents of the vial/ampoule of diluent provided to the vial containing the powder. After adding the diluent to the powder, shake vigorously until the powder is completely dissolved in the diluent. The reconstituted vaccine is a transparent, colorless solution. The vaccine should be injected rapidly after reconstitution. The vaccine should be administered with a new needle. Collect the entire contents of the vial. Instructions for reconstitution of the vaccine wirh the diluent presented in a pre-filled syringe HIBERIX must be reconstituted by adding the entire contents of the pre-filled syringe of diluent to the vial of powder. Refer to the diagram below to attach the needle to the syringe. The syringe provided with HIBERIX may however be slightly different from that described in the drawing. Needle Needle cap Syringe Syringe piston Body of the Syringe Syringe cap 1. While holding the body of the syringe with one hand (do not hold the piston), unscrew the syringe cap by turning it counterclockwise. 6

7 2. To attach the needle to the syringe, insert the needle into the syringe and turn it clockwise until you can tell that it is firmly attached (see the illustration). 3. Remove the needle cap, which can sometimes be slightly stiff. Add the diluent to the powder. After adding the diluent to the powder, shake vigorously until the powder is completely dissolved in the diluent. The reconstituted vaccine is a transparent, colorless solution. The vaccine should be injected rapidly after reconstitution. The vaccine should be administered with a new needle. Collect the entire contents of the vial. As indicated in the "6.2 Incompatibilities" section above, the HIBERIX vaccine can be reconstituted with the INFANRIX vaccine or with the TRITANRIX HB vaccine for simultaneous administration by a single injection. In this case, the diluent provided in the HIBERIX packaging is replaced by the liquid vaccine. Ensure that the container containing the vaccine to be mixed with HIBERIX is a single-dose container. Discard the vial containing the diluent in the HIBERIX packaging. The combined vaccine should be reconstituted by adding the entire contents of a container of the other vaccine to the vial containing the white Hib powder. This extemporaneously prepared combined vaccine should be handled in the same way as the reconstituted single-component HIBERIX vaccine. Any unused product or waste should be disposed of in compliance with the regulations in effect. Not all presentations are available in India. 7. MARKETING AUTHORISATION HOLDER GlaxoSmithKline Asia Private Limited Registered Office: Patiala Road, Nabha (Punjab) MARKETING AUTHORISATION NUMBER(S) Import Permission No.: Not applicable 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization (Form 45): 27 th May,

8 Following sites are involved in manufacturing, import and marketing of Hiberix: Manufactured by: GlaxoSmithKline Biologicals s.a. Rue de l Institut, 89 B-1330 Rixensart, Belgium. Imported, Labelled & Packed by: GlaxoSmithKline Asia Pvt Ltd., A-10/1, MIDC, Ambad, Nashik For further information please contact: GlaxoSmithKline Pharmaceuticals Limited, Registered office: Dr. Annie Besant Road, Worli Mumbai , India HIBERIX, TRITANRIX AND INFANRIX are registered trademarks of GlaxoSmithKline Version: HBX/PI/IN/2016/01 dated 3 rd February 2016 Adapted from Belgian SPC approved on May 2013 [Adapted from GDS 06 / IPI 4 dated 9 th Feb, 2012 and GDS 07/ IPI 5 dated 18 Dec, 2012] 8