bhpardo/ema_en · Datasets at Hugging Face

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INFORMATION FOR THE USER
Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Only solutions which are colourless, clear or slightly opalescent, should be injected.
Patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products.
European Medicines Agency
6.1 List of excipients
Benzalkonium chloride, mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, hydrochloric acid/ sodium hydroxide (to adjust pH) purified water.
2 to 1 to 0 to 9 to w.2 w.3 w.4 w.5 w.63 w.7 w.8
6.
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
14.
8.
(0.71– 0.99)
The reconstituted volume is 5.3 ml.
BEFORE YOU USE CELLCEPT
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ ml.
In combination with a sulphonylurea or insulin, the current sulphonylurea or insulin dose can be continued when starting Actos treatment unless the patient has hypoglycaemia (low blood glucose), when the dose of the sulphonylurea or insulin should be decreased.
86 5.
Pack size:
Very common
Never drive or use machinery if you feel a hypo coming on.
Avandamet is not recommended for people aged under 18, as the safety and effectiveness are not known.
4.
117 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.
Read the package leaflet before use.
Medicinal product subject to medical prescription.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.
2 years.
2.
This leaflet was last approved in
The marketing authorisation was renewed on 27 August 2002 and on 27 August 2007.
14 x 1
5.3 Preclinical safety data
The in vivo net effect of tipranavir/ ritonavir on CYP 1A2, CYP 2C9 and CYP 2C19, indicates, through a preliminary study, an inducing potential of APTIVUS/ ritonavir on CYP1A2 and, to a lesser extent, on CYP2C9 and P-gp after several days of treatment.
DATE OF REVISION OF THE TEXT
Uncommon:
The initial weekly or once every other week pediatric dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.
Immunogenicity data for subcutaneous use of Binocrit in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.
Dialysis patients converting from once weekly to once every other week dosing with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
NAME OF THE MARKETING AUTHORISATION HOLDER
Failure to correctly co-administer tipranavir with ritonavir will result in reduced plasma levels of tipranavir that may be insufficient to achieve the desired antiviral effect.
- Direct effects on tumour vasculature
If you take more Cholestagel than you should Please contact your doctor.
The protein fraction of the molecule contributes about 58% and consists of 165 amino acids.
EXP:
5.3 Preclinical safety data
1.
STEP 6 Remove and Dispose of the Needle
do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus
METHOD AND ROUTE(S) OF ADMINISTRATION
1 pre-filled syringe
Dosing should be titrated as necessary to maintain the haemoglobin target.
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Headache Oral/ perioral paraesthesia, tremors, sleep disorders
The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
• Don’ t breast-feed while you are taking Avandia.
Read all of this leaflet carefully before you start receiving this vaccine.
Inspect the cartridge before use.
43 Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
- you are elderly,
Subcutaneous use
The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.
Cetrotide is a powder and solvent to be made up in a solution for injection.
Cancer patients
Therefore, when methadone is co-administered with amprenavir, patients should be monitored for opiate abstinence syndrome, in particular if low-dose ritonavir is also given.
PHARMACEUTICAL FORM
Seizures, Transient amnesia
7.
Do not store them in or too near the freezer section or cooling element.
General
EU/ 1/ 02/ 229/ 037
Renal and urinary disorders
Slovenija Roche farmacevtska družba d.o.o.
This study was conducted in 705 anaemic patients with non-myeloid malignancies receiving multi-cycle chemotherapy.
The following are the most common and important incidences of adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/ m2 Abraxane once every three weeks in the pivotal phase III clinical study.
51 A.
Problems with OptiClik?
Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Nervous system disorders
PHARMACEUTICAL FORM AND CONTENTS
Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.
• an allergy to latex (the needle cover on the pre-filled pen contains a derivative of latex).
10 mg/ 0.8 ml
ABILIFY 5 mg
Generalised hypersensitivity reactions are potentially life- threatening.
In a placebo-controlled study of 16 weeks duration, BYETTA (n=121) or placebo (n=112) was added to existing thiazolidinedione treatment, with or without metformin.
Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.
The pre-filled syringes are ready to use (see section 4.2 – Method of administration).
Magyarország Roche (Magyarország) Kft.
22 AIDS-KS patients The plasma pharmacokinetics of Caelyx were evaluated in 23 patients with KS who received single doses of 20 mg/ m2 administered by a 30-minute infusion.
1.
1.23 (1.00– 1.51)
If unavoidable, upward dose adjustments for either omeprazole or esomeprazole may be considered based on clinical response to therapy.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
• If you are being treated for genital warts follow these additional precautions:

INFORMATION FOR THE USER

Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs.

Only solutions which are colourless, clear or slightly opalescent, should be injected.

Patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.

No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products.

European Medicines Agency

6.1 List of excipients

Benzalkonium chloride, mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, hydrochloric acid/ sodium hydroxide (to adjust pH) purified water.

2 to 1 to 0 to 9 to w.2 w.3 w.4 w.5 w.63 w.7 w.8

6.

When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.

14.

8.

(0.71– 0.99)

The reconstituted volume is 5.3 ml.

BEFORE YOU USE CELLCEPT

1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ ml.

In combination with a sulphonylurea or insulin, the current sulphonylurea or insulin dose can be continued when starting Actos treatment unless the patient has hypoglycaemia (low blood glucose), when the dose of the sulphonylurea or insulin should be decreased.

86 5.

Pack size:

Very common

Never drive or use machinery if you feel a hypo coming on.

Avandamet is not recommended for people aged under 18, as the safety and effectiveness are not known.

4.

117 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Distribution After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine.

Read the package leaflet before use.

Medicinal product subject to medical prescription.

Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.

2 years.

2.

This leaflet was last approved in

The marketing authorisation was renewed on 27 August 2002 and on 27 August 2007.

14 x 1

5.3 Preclinical safety data

The in vivo net effect of tipranavir/ ritonavir on CYP 1A2, CYP 2C9 and CYP 2C19, indicates, through a preliminary study, an inducing potential of APTIVUS/ ritonavir on CYP1A2 and, to a lesser extent, on CYP2C9 and P-gp after several days of treatment.

DATE OF REVISION OF THE TEXT

Uncommon:

The initial weekly or once every other week pediatric dose of Aranesp (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 240.

Immunogenicity data for subcutaneous use of Binocrit in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.

Dialysis patients converting from once weekly to once every other week dosing with Aranesp should initially receive a dose equivalent to twice the previous once weekly dose.

If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.

NAME OF THE MARKETING AUTHORISATION HOLDER

Failure to correctly co-administer tipranavir with ritonavir will result in reduced plasma levels of tipranavir that may be insufficient to achieve the desired antiviral effect.

- Direct effects on tumour vasculature

If you take more Cholestagel than you should Please contact your doctor.

The protein fraction of the molecule contributes about 58% and consists of 165 amino acids.

EXP:

5.3 Preclinical safety data

1.

STEP 6 Remove and Dispose of the Needle

do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus

METHOD AND ROUTE(S) OF ADMINISTRATION

1 pre-filled syringe

Dosing should be titrated as necessary to maintain the haemoglobin target.

In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients HbA1c was stable in both duloxetine-treated and placebo-treated patients.

Headache Oral/ perioral paraesthesia, tremors, sleep disorders

The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).

• Don’ t breast-feed while you are taking Avandia.

Read all of this leaflet carefully before you start receiving this vaccine.

Inspect the cartridge before use.

43 Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.

- you are elderly,

Subcutaneous use

The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics.

Cetrotide is a powder and solvent to be made up in a solution for injection.

Cancer patients

Therefore, when methadone is co-administered with amprenavir, patients should be monitored for opiate abstinence syndrome, in particular if low-dose ritonavir is also given.

PHARMACEUTICAL FORM

Seizures, Transient amnesia

7.

Do not store them in or too near the freezer section or cooling element.

General

EU/ 1/ 02/ 229/ 037

Renal and urinary disorders

Slovenija Roche farmacevtska družba d.o.o.

This study was conducted in 705 anaemic patients with non-myeloid malignancies receiving multi-cycle chemotherapy.

The following are the most common and important incidences of adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/ m2 Abraxane once every three weeks in the pivotal phase III clinical study.

51 A.

Problems with OptiClik?

Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.

Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.

Nervous system disorders

PHARMACEUTICAL FORM AND CONTENTS

Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.

• an allergy to latex (the needle cover on the pre-filled pen contains a derivative of latex).

10 mg/ 0.8 ml

ABILIFY 5 mg

Generalised hypersensitivity reactions are potentially life- threatening.

In a placebo-controlled study of 16 weeks duration, BYETTA (n=121) or placebo (n=112) was added to existing thiazolidinedione treatment, with or without metformin.

Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.

The pre-filled syringes are ready to use (see section 4.2 – Method of administration).

Magyarország Roche (Magyarország) Kft.

22 AIDS-KS patients The plasma pharmacokinetics of Caelyx were evaluated in 23 patients with KS who received single doses of 20 mg/ m2 administered by a 30-minute infusion.

1.

1.23 (1.00– 1.51)

If unavoidable, upward dose adjustments for either omeprazole or esomeprazole may be considered based on clinical response to therapy.

NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

• If you are being treated for genital warts follow these additional precautions: