medication_name stringlengths 6 170 | section_title stringclasses 42
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Komboglyze 2.5 mg/1,000 mg film-coated tablets | Name of the medicinal product | Komboglyze 2.5 mg/1,000 mg film-coated tablets
2. |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Qualitative and quantitative composition | Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3. |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical form | Film-coated tablet (tablet).
Pale yellow to light yellow, biconvex, oval shaped, film-coated tablets, with "2.5/1000" printed on one side and "4247" printed on the other side, in blue ink.
4. |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Therapeutic indications | Therapeutic indications
Komboglyze is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
• in patients inadequately controlled on their maximally tolerated dose of metformin alone
• in combination with other medicinal products for the treatment ... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
Adults with normal renal function (GFR ≥ 90 mL/min)
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy
Patients not adequately controlled on metformin alone should receive a dose of this medicinal product equivalent to the total d... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Contraindications | Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase 4 (DPP4) inhibitor (see sections 4.4 and 4.8);
- Any type... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
General
Komboglyze should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Acute pancreatitis
Use of DPP4 inhibitors has been associated with a risk of developing acute pancreatitis. Patients should be informed of the chara... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Co-administration of multiple doses of saxagliptin (2.5 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either saxagliptin or metformin in patients with type 2 diabetes.
There have been no fo... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
The use of Komboglyze or saxagliptin has not been studied in pregnant women. Studies in animals have shown reproductive toxicity at high doses of saxagliptin alone or in combination with metformin (see section 5.3). The potential risk for humans is unknown. A limited amoun... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Saxagliptin or metformin has a negligible influence on the ability to drive and use machines. When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin. In addition, patients should be alerted to the risk of ... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Undesirable effects | Undesirable effects
There have been no therapeutic clinical trials conducted with Komboglyze tablets, however, bioequivalence of Komboglyze with co-administered saxagliptin and metformin has been demonstrated (see section 5.2).
Saxagliptin
Summary of the safety profile
There were 4,148 patients with type 2 diabet... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Clinical particulars - Overdose | Overdose
No data are available with regard to overdose of Komboglyze.
Saxagliptin
Saxagliptin has been shown to be well-tolerated with no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose). In the event of an overdose, appropriate su... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
The results of bioequivalence studies in healthy subjects demonstrated that Komboglyze combination tablets are bioequivalent to co-administration of corresponding doses of saxagliptin and metformin hydrochloride as individual tablets.
The following statements reflect the pharmacokinetic prope... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Co-administration of saxagliptin and metformin
A 3-month dog study and embryo-foetal development studies in rats and rabbits have been conducted with the combination of saxagliptin and metformin.
Co-administration of saxagliptin and metformin, to pregnant rats and rabbits during the period of... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Tablet core
Povidone K30
Magnesium stearate
Film coating
Polyvinyl alcohol
Macrogol 3350
Titanium dioxide (E171)
Talc (E553b)
Iron oxide yellow (E172)
Printing ink
Shellac
Indigo carmine aluminium lake (E132)
6.2 |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Store below 25°C.
6.5 |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Alu/Alu blister.
Pack-sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Multipacks containing 112 (2 packs of 56) and 196 (7 packs of 28) film-coated tablets in non-perforated blisters.
60x1 film-coated tablets in perforated unit dose blisters.
Not all pack siz... |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Marketing authorisation holder | AstraZeneca UK Limited
1 Francis Crick Avenue,
Cambridge,
CB2 0AA,
UK.
8. Marketing authorisation number(s)
PLGB 17901/0329
9. |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | 1st January 2021
10. |
Komboglyze 2.5 mg/1,000 mg film-coated tablets | Date of revision of the text | 02 February 2023 |
Konakion MM 10 mg/ml | Name of the medicinal product | Konakion MM Ampoules 10 mg/ml solution for injection
Phytomenadione 10 mg/1 ml solution for injection
2. |
Konakion MM 10 mg/ml | Qualitative and quantitative composition | Each ampoule contains 10 mg vitamin K1 (phytomenadione) in 1 ml.
3. |
Konakion MM 10 mg/ml | Pharmaceutical form | Solution for injection.
Amber glass ampoules containing 10 mg phytomenadione in 1 ml. The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecithin.
4. |
Konakion MM 10 mg/ml | Clinical particulars - Therapeutic indications | Therapeutic indications
Konakion MM/Phytomenadione 10 mg/1 ml is indicated as an antidote to anticoagulant drugs of the coumarin type in the treatment of haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII.
4.2 |
Konakion MM 10 mg/ml | Clinical particulars - Posology and method of administration | Posology and method of administration
Konakion MM/Phytomenadione 10 mg/1 ml is for intravenous injection.
Adults
Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy:
The coumarin anticoagulant should be withdrawn and an intravenous injection of Konakion MM/Phytomenadione 10 mg/1 ml given ... |
Konakion MM 10 mg/ml | Clinical particulars - Contraindications | Contraindications
Use in patients with a known hypersensitivity to any of the constituents.
This medicine should not be administered intramuscularly because the IM route exhibits depot characteristics and continued release of vitamin K1 would lead to difficulties with the re-institution of anticoagulation therapy. Fu... |
Konakion MM 10 mg/ml | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
When treating patients with severely impaired liver function, it should be borne in mind that one 1 ml ampoule of Konakion MM/Phytomenadione 10 mg/1 ml contains 54.6 mg glycocholic acid and this may have a bilirubin displacing effect. Careful monitoring of the INR is necessary a... |
Konakion MM 10 mg/ml | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
No significant interactions are known other than antagonism of coumarin anticoagulants.
4.6 |
Konakion MM 10 mg/ml | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
There is no specific evidence regarding the safety of Konakion MM/Phytomenadione 10 mg/1 ml in pregnancy but, as with most drugs, the administration during pregnancy should only occur if the benefits outweigh the risks.
This medicine is not recommended for pregnant women as prophylaxi... |
Konakion MM 10 mg/ml | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
None
4.8 |
Konakion MM 10 mg/ml | Clinical particulars - Undesirable effects | Undesirable effects
There have been reports of anaphylactoid reactions after intravenous injections of this medicine. Very rarely, venous irritation or phlebitis has been reported in association with intravenous administration of Konakion MM/Phytomenadione 10 mg/1 ml mixed micelles solution.
Reporting of suspected ad... |
Konakion MM 10 mg/ml | Clinical particulars - Overdose | Overdose
Hypervitaminosis of vitamin K1 is unknown.
Reintroduction of anti-coagulation may be affected.
5. Pharmacological properties
5.1 |
Konakion MM 10 mg/ml | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
In blood plasma, 90% of vitamin K1 is bound to lipoproteins. Following an intramuscular dose of 10 mg vitamin K, plasma concentrations of 10-20 mcg/l are produced (normal range 0.4-1.2 mcg/l). Systemic availability following intramuscular administration is about 50% and elimination half-life... |
Konakion MM 10 mg/ml | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
None applicable.
6. |
Konakion MM 10 mg/ml | Pharmaceutical particulars - List of excipients | List of excipients
Glycocholic acid
Sodium hydroxide
Lecithin (phospholipon 100)
Hydrochloric acid
Water for injection
HSE
Ph. Eur
HSE
Ph. Eur.
Ph. Eur.
6.2 |
Konakion MM 10 mg/ml | Pharmaceutical particulars - Incompatibilities | Incompatibilities
None
6.3 |
Konakion MM 10 mg/ml | Pharmaceutical particulars - Shelf life | Shelf life
The recommended shelf-life of Konakion MM/Phytomenadione 10 mg/1 ml is 36 months.
6.4 |
Konakion MM 10 mg/ml | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
The recommended maximum storage temperature is 25°C. Do not use if the solution is turbid.
6.5 |
Konakion MM 10 mg/ml | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Konakion MM/Phytomenadione 10 mg/1 ml is supplied in amber glass ampoules containing 10 mg phytomenadione in 1 ml. The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecith... |
Konakion MM 10 mg/ml | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
See Section 4.2.
7. |
Konakion MM 10 mg/ml | Marketing authorisation holder | Neon Healthcare Limited
8 The Chase, John Tate Road,
Hertford, SG13 7NN,
United Kingdom
8. Marketing authorisation number(s)
PL 45043/0040
9. |
Konakion MM 10 mg/ml | Date of first authorisation/renewal of the authorisation | 08/04/2008
10. |
Konakion MM 10 mg/ml | Date of revision of the text | 16/11/2021 |
Konakion MM Paediatric 2 mg/0.2 ml | Name of the medicinal product | Konakion MM Paediatric 2 mg/0.2 ml solution for injection
Phytomenadione 2 mg/0.2 ml solution for injection
2. |
Konakion MM Paediatric 2 mg/0.2 ml | Qualitative and quantitative composition | Each ampoule contains 2 mg phytomenadione in 0.2 ml.
For the full list of excipients, see section 6.1.
3. |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical form | Solution for injection.
The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecithin.
4. |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Therapeutic indications | Therapeutic indications
Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml is indicated for the prophylaxis and treatment of vitamin K deficiency bleeding (VKDB) in neonates and infants.
Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml can be used, following specialist advice from a haematologist, as an antidote to ant... |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
Prophylaxis of vitamin K deficiency bleeding (VKDB)
Healthy neonates of 36 weeks gestation and older:
Either:
- 1 mg administered by intramuscular injection at birth or soon after birth
or
- 2 mg orally at birth or soon after birth. The oral dose should be follow... |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become turbid or present a phase-separation. In this case the ampoule must no longer be used.
Parenteral administration to premature babies weighing less than 2.5 kg may incre... |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
No significant interactions are known other than antagonism of coumarin anticoagulants.
4.6 |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Not applicable
4.7 |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Not applicable
4.8 |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Undesirable effects | Undesirable effects
There have been reports of anaphylactoid reactions after intravenous injections of this medicine. Local irritation may occur at the injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and ne... |
Konakion MM Paediatric 2 mg/0.2 ml | Clinical particulars - Overdose | Overdose
There is no known clinical syndrome attributable to hypervitaminosis of vitamin K1.
The following adverse events have been reported concerning overdose with use of Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml in neonates and infants: jaundice, hyperbilirubinaemia, increase GOT and GGT, abdominal pain, con... |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
In the mixed micelle solution, vitamin K1 is solubilised by means of a physiological colloidal system consisting of lecithin and a bile acid.
Following oral administration vitamin K1 is absorbed from the small intestine. The systemic availability following oral dosing is approximately 50%, wi... |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
None applicable
6. |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - List of excipients | List of excipients
Glycocholic acid, lecithin, sodium hydroxide, hydrochloric acid and water for injections.
6.2 |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Incompatibilities | Incompatibilities |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Shelf life | Incompatibilities have been observed with diluted Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml solution and certain siliconised syringes, therefore, Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml must not be diluted before injection.
Do not dilute with sodium chloride containing solutions as precipitation may o... |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Special precautions for storage | Shelf life
3 years
6.4 |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Nature and contents of container | Special precautions for storage
This medicine should be stored below 25 °C and be protected from light. The solution should not be frozen. Do not use if the solution is turbid.
6.5 |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Special precautions for disposal and other handling | Nature and contents of container
Amber glass ampoules containing 2 mg phytomenadione in 0.2 ml. Plastic oral dispensers. Packs of 5.
6.6 |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Subsection 7 | Special precautions for disposal and other handling
See section 4.2 Posology and method of administration, section 4.4 Special warnings and precautions for use and section 6.2 |
Konakion MM Paediatric 2 mg/0.2 ml | Pharmaceutical particulars - Subsection 8 | Incompatibilities for advice regarding the administration of this medicine.
Undiluted Konakion MM Paediatric/Phytomenadione 2 mg/0.2 ml solution for injection is compatible with 0.5 ml Omnican 50 syringes supplied by B.Braun.
7. |
Konakion MM Paediatric 2 mg/0.2 ml | Marketing authorisation holder | Neon Healthcare Limited
8 The Chase, John Tate Road,
Hertford, SG13 7NN,
United Kingdom
8. Marketing authorisation number(s)
PL 45043/0041
9. |
Konakion MM Paediatric 2 mg/0.2 ml | Date of first authorisation/renewal of the authorisation | Date of first authorisation: 20 June 1996
Date of latest renewal: 11 March 2008
10. |
Konakion MM Paediatric 2 mg/0.2 ml | Date of revision of the text | 16/11/2021 |
Koselugo 10 mg hard capsules | Introduction | This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. |
Koselugo 10 mg hard capsules | Name of the medicinal product | Koselugo 10 mg hard capsules
2. |
Koselugo 10 mg hard capsules | Qualitative and quantitative composition | Each hard capsule contains 10 mg of selumetinib (as hydrogen sulfate).
For the full list of excipients, see section 6.1.
3. |
Koselugo 10 mg hard capsules | Pharmaceutical form | Hard capsule.
White to off-white, opaque, size 4 (approximately 14 mm x 5 mm), hard capsule, which has a centre band and is marked with “SEL 10” in black ink.
4. |
Koselugo 10 mg hard capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above.
4.2 |
Koselugo 10 mg hard capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
Treatment with Koselugo should be initiated by a physician experienced in the diagnosis and the treatment of patients with NF1 related tumours.
Posology
The recommended dose of Koselugo is 25 mg/m2 of body surface area (BSA), taken orally twice daily (approximately every 12 hours... |
Koselugo 10 mg hard capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe hepatic impairment (see sections 4.2 and 5.2).
4.4 |
Koselugo 10 mg hard capsules | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Left ventricular ejection fraction (LVEF) reduction
Asymptomatic decreases in ejection fraction have been reported in 22% of paediatric patients in the pivotal clinical trial. Median time to initial onset of these adverse reactions was 226 days. A small number of serious repor... |
Koselugo 10 mg hard capsules | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in healthy adults (aged ≥ 18 years).
Active substances that may increase selumetinib plasma concentrations
Co-administration with a strong CYP3A4 inhibitor (200 mg itraconazole twice daily for 4 day... |
Koselugo 10 mg hard capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
Women of childbearing potential should be advised to avoid becoming pregnant while receiving Koselugo. It is recommended that a pregnancy test should be performed on women of childbearing potential prior to initiatin... |
Koselugo 10 mg hard capsules | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Koselugo may have a minor influence on the ability to drive and use machines. Fatigue, asthenia and visual disturbances have been reported during treatment with selumetinib and patients who experience these symptoms should observe caution when driving or using machines.
4.8 |
Koselugo 10 mg hard capsules | Clinical particulars - Undesirable effects | Undesirable effects
Summary of the safety profile
The safety profile of selumetinib monotherapy in paediatric patients with NF1 who have inoperable PN has been determined following evaluation of a combined safety population of 74 paediatric patients (20-30 mg/m2 twice daily). This paediatric 'pool' of patients compri... |
Koselugo 10 mg hard capsules | Clinical particulars - Overdose | Overdose
There is no specific treatment for overdose. If overdose occurs, patients should be closely monitored for signs and symptoms of adverse reactions and treated supportively with appropriate monitoring as necessary. Dialysis is ineffective in the treatment of overdose.
5. Pharmacological properties
5.1 |
Koselugo 10 mg hard capsules | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
At the recommended dose of 25 mg/m2 twice daily in paediatric patients (3 to ≤ 18 years old), the geometric mean (coefficient of variation [CV%]) maximum plasma concentration (Cmax) was 731 (62%) ng/mL and that of the area under the plasma drug concentration curve (AUC0-12) following the firs... |
Koselugo 10 mg hard capsules | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Genotoxicity
Selumetinib was positive in the mouse micronucleus study via an aneugenic mode of action. The free mean exposure (Cmax) at the no observed effect level (NOEL) was approximately 27-times greater than clinical free exposure at the maximum recommended human dose (MRHD) of 25 mg/m2.
... |
Koselugo 10 mg hard capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule content
Vitamin E polyethylene glycol succinate (D α-tocopheryl polyethylene glycol succinate).
Capsule shell
Hypromellose (E464)
Carrageenan (E407)
Potassium chloride (E508)
Titanium dioxide (E171)
Carnauba wax (E903)
Printing ink
Shellac glaze, standard (E904)
Iron oxide black (E172)... |
Koselugo 10 mg hard capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Koselugo 10 mg hard capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years.
6.4 |
Koselugo 10 mg hard capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30 °C.
Store in the original bottle in order to protect from moisture and light.
Keep the bottle tightly closed.
6.5 |
Koselugo 10 mg hard capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
High-density polyethylene (HDPE) plastic bottle with white child-resistant polypropylene closure.
Each bottle contains 60 hard capsules and a silica gel desiccant. Each carton contains one bottle.
6.6 |
Koselugo 10 mg hard capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Patients should be instructed not to remove the desiccant from the bottle.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Koselugo 10 mg hard capsules | Marketing authorisation holder | AstraZeneca UK Limited,
1 Francis Crick Avenue,
Cambridge,
CB2 0AA,
UK.
8. Marketing authorisation number(s)
PLGB 17901/0356
9. |
Koselugo 10 mg hard capsules | Date of first authorisation/renewal of the authorisation | Date of first authorisation: 9th August 2021
Date of latest renewal: 10th August 2022
10. |
Koselugo 10 mg hard capsules | Date of revision of the text | 7th March 2023 |
Koselugo 25 mg hard capsules | Introduction | This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. |
Koselugo 25 mg hard capsules | Name of the medicinal product | Koselugo 25 mg hard capsules
2. |
Koselugo 25 mg hard capsules | Qualitative and quantitative composition | Each hard capsule contains 25 mg of selumetinib (as hydrogen sulfate).
For the full list of excipients, see section 6.1.
3. |
Koselugo 25 mg hard capsules | Pharmaceutical form | Hard capsule.
Blue, opaque, size 4 (approximately 14 mm x 5 mm), hard capsule, which has a centre band and is marked with “SEL 25” in black ink.
4. |
Koselugo 25 mg hard capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above.
4.2 |
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